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 UNITED
STATES

 SECURITIES
AND EXCHANGE COMMISSION

 WASHINGTON,
D.C. 20549

 FORM

 (Mark
One)

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 For
the Fiscal Year Ended December 31, 2023

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 Commission
File Number 001-36019

 TONIX
PHARMACEUTICALS HOLDING CORP.

 (Exact
name of registrant as specified in its charter)

 Nevada

 26-1434750

 (State
 or other jurisdiction of incorporation or organization)

 (IRS
 Employer Identification No.)

Main Street, Suite 101

 Chatham,
 New Jersey

 07928

 (Address
 of principal executive office)

 (Zip
 Code)

 (862) 799-8599

 (Registrant's
telephone number, including area code)

 Securities
registered pursuant to Section 12(b) of the Act:

 Title
 of each class

 Trading
 Symbol

 Name
 of each exchange on which registered

 Common Stock, $0.001
 par value

 TNXP

 The NASDAQ Stock
 Market LLC

 Securities
registered pursuant to Section 12(g) of the Act: None

by check mark if the registrant is a well-known seasoned issuer, as defined by Rule 405 of the Securities Act. Yes No

by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes No

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days. Yes No

by check mark whether the registrant has submitted electronically, if any, every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months (or for such shorter period
that the registrant was required to submit such files). Yes No

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See definitions of "large accelerated filer," "accelerated filer,"
"smaller reporting company," and an "emerging growth company" in Rule 12b-2 of the Exchange Act

 Large accelerated filer

 Accelerated filer

 Non-accelerated filer

 Smaller reporting company

 Emerging growth company

 If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report.

 If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the
registrant included in the filing reflect the correction of an error to previously issued financial statements.

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b).

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

 The
aggregate market value of the voting common equity held by non-affiliates as of June 30, 2023, based on the closing sales price
of the common stock as quoted on The NASDAQ Global Market was $ 16,996,283. For purposes of this computation, all officers and
directors are deemed to be affiliates. Such determination should not be deemed an admission that such directors, officers, or
5 percent beneficial owners are, in fact, affiliates of the registrant.

 As
of April 1, 2024, there were 84,490,862 shares of registrant's common stock outstanding.

 DOCUMENTS
INCORPORATED BY REFERENCE

 None.

 TABLE
OF CONTENTS

 PAGE

 Item 1.

 Business

 Item 1A.

 Risk Factors

 Item 1B.

 Unresolved Staff Comments

 Item 1C.

 Cybersecurity Disclosures

 Item 2.

 Properties

 Item 3.

 Legal Proceedings

 Item 4.

 Mine Safety Disclosures

 Item 5.

 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

 Item 6.

 Reserved

 Item 7.

 Management's Discussion and Analysis of Financial Condition and Results of Operations

 Item 7A.

 Quantitative and Qualitative Disclosures about Market Risk

 Item 8.

 Financial Statements and Supplementary Data

 – F-30

 Item 9.

 Changes in and Disagreements with Accountants on Accounting and Financial Disclosures

 Item 9A.

 Controls and Procedures

 Item 9B.

 Other Information

 Item 9C.

 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

 Item 10.

 Directors, Executive Officers and Corporate Governance

 Item 11.

 Executive Compensation

 Item 12.

 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 Item 13.

 Certain Relationships and Related Transactions, and Director Independence

 Item 14.

 Principal Accounting Fees and Services

 Item 15.

 Exhibits, Financial Statement Schedules

 Signatures

 PART
I

 ITEM
1 - BUSINESS

 This
Annual Report on Form 10-K (including the section regarding Management's Discussion and Analysis of Financial Condition
and Results of Operations) contains forward-looking statements regarding our business, financial condition, results of operations
and prospects. Words such as "expects," "anticipates," "intends," "plans," "believes,"
"seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking
statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements as denoted in this
Annual Report on Form 10-K. Additionally, statements concerning future matters are forward-looking statements.

 Although
forward-looking statements in this Annual Report on Form 10-K reflect the good faith judgment of our Management, such statements
can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject
to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or
anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes
include, without limitation, those specifically addressed under the heading "Risks Factors" below, as well as those
discussed elsewhere in this Annual Report on Form 10-K. Readers are urged not to place undue reliance on these forward-looking
statements, which speak only as of the date of this Annual Report on Form 10-K. We file reports with the Securities and Exchange
Commission ("SEC"). You can read and copy any materials we file or will file with the SEC, which, among other places,
can be found on the SEC's website at  as well as on our corporate website at www.tonixpharma.com).

 We
undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that
may arise after the date of this Annual Report on Form 10-K. Readers are urged to carefully review and consider the various disclosures
made throughout the entirety of this Annual Report, which attempt to advise interested parties of the risks and factors that may
affect our business, financial condition, results of operations and prospects.

 Forward-looking
statements include, but are not necessarily limited to, those relating to:

 Our prospects are dependent on the success of Tonmya TM
and progressing our pipeline through development stages. To the extent regulatory approval of Tonmya is delayed or not granted or, if
approved, Tonmya is not commercially successful, our business, financial condition and results of operations may be materially adversely
affected and the price of our common stock may decline.

 The
 commercial success and market acceptance of our products, including the coverage of our
 products by payors and pharmacy benefit managers; our ability to successfully develop
 and execute our sales, marketing and non-personal and digital promotion strategies, including
 developing and maintaining relationships with customers, physicians, payors and other
 constituencies, the entry of other products competitive with our commercial products;

 Our
 ability to successfully execute business development, strategic partnerships, and investment
 opportunities to build and grow for the future;

 Our
 ability to achieve the expected financial performance from our marketed products Tosymra
 and Zembrace Symtouch which we recently acquired from Upsher Smith Laboratories,
 as well as delays, challenges and expenses, and unexpected costs associated with integrating
 and operating this new commercial business;

 The
 ability of our third-party manufacturers to manufacture adequate quantities of commercially
 saleable inventory and active pharmaceutical ingredients for each of our products, and
 our ability to maintain our supply chain, which relies on single-source suppliers;

 Our
 ability to raise additional capital or refinance or pay-off our debt, if necessary;

 The
 timing and results of any future research and development efforts including potential
 clinical studies relating to any future product candidates;

 Our
 common stock maintaining compliance with Nasdaq's minimum closing bid requirement
 of at least $1.00 per share.

 Business
Overview

 We are a fully-integrated
biopharmaceutical company focused on developing and commercializing therapeutics to treat and prevent human disease and alleviate suffering.

 Our near-term priority is
to submit a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for Tonmya * (also
known as TNX-102 SL, cyclobenzaprine HCl sublingual tablet) for the management of fibromyalgia ("FM"). FM is a chronic pain
disorder characterized by chronic widespread pain, non-restorative sleep, fatigue and impaired cognition. Tonmya is a non-opioid analgesic
designed for long-term bedtime use and has completed two positive Phase 3 studies. Tonix announced the positive results of the second
Phase 3 study in December of 2023. Tonmya treatment resulted in highly statistically significant improvement in the primary endpoint of
pain reduction (p=0.00005) and statistical significance in all six of the key secondary endpoints. Tonmya was well tolerated. Systemic
adverse events were similar between Tonmya and placebo. No serious adverse events were reported. The FDA conditionally accepted Tonmya
as the trade name for TNX-102 SL for the management of fibromyalgia in January 2024. We have scheduled a type B pre-NDA meeting with the
FDA in the first half of 2024, plan to submit an NDA for the approval of Tonmya in the second half of 2024 and expect an FDA decision
on the NDA in the second half of 2025. We are preparing for a commercial launch of Tonmya conditional on FDA approval.

 Tonmya is a proprietary sublingual
tablet formulation of cyclobenzaprine ("CBP") designed for bedtime administration. In December 2020, we reported positive
results from the Phase 3 RELIEF study of Tonmya 5.6 mg for the management of FM. In July 2021, we had disappointing results from a second
Phase 3 study, RALLY. In December 2023, we reported positive results from the third Phase 3 RESILIENT study, which met its pre-specified
endpoint by significantly reducing daily pain compared to placebo in patients with fibromyalgia.

 In preparation for the launch
of Tonmya, we have built a team of professionals to market and distribute our products. Our commercial portfolio consists of two FDA-approved
prescription products for the treatment of migraine which were acquired from Upsher-Smith Laboratories ("Upsher Smith") in June 2023:
Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are both indicated
for the treatment of acute migraine with or without aura in adults. Zembrace SymTouch is the only branded sumatriptan autoinjector professionally
promoted in the United States and is designed for ease of use and favorable tolerability with a low 3 mg dose. Tosymra is a novel intranasal
sumatriptan product formulated with a permeation enhancer that provides rapid and efficient absorption of sumatriptan. Tosymra was approved
on the basis of bioequivalence to subcutaneous ( s.c.) sumatriptan. Our commercial team is engaged in marketing and distributing
our products, and also engaged in planning the launch of Tonmya.

 In addition to Tonmya and
our marketed products, we have a pipeline of products in development that include therapeutics and vaccines which are based on small molecules
and biologics. Our pipeline has been generated from internal discovery, as well as licenses, acquisitions and collaborations with academic
institutions and non-profit organizations.

 Our portfolio is focused on
central nervous system ("CNS"), disorders, but also consists of rare disease, immunology, and infectious disease product candidates. The
CNS portfolio includes small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Our immunology portfolio
includes TNX-1500*, a biologic to address organ transplant rejection and autoimmune diseases. Finally, our infectious disease portfolio
includes a vaccine in development to prevent smallpox and mpox (formerly known as monkeypox), TNX-801*. TNX-801 also serves as the live
virus vaccine platform or recombinant pox vaccine ("RPV") platform for vaccines to protect against other infectious diseases,
including TNX-1800* and TNX-1850* for COVID-19.

 In addition to fibromyalgia,
TNX-102 SL* is being developed as a potential treatment for a type of Long COVID, the symptoms of which overlap with fibromyalgia, that
we term fibromyalgia-type Long COVID. TNX-102 SL has completed a Phase 2 proof-of-concept study. Long COVID is also known as PASC, ("post-acute
sequelae of SARS-CoV-2 infection") is a chronic post-acute COVID-19 condition. We initiated enrollment in the Phase 2 PREVAIL study, in
August 2022, and topline results were reported in September 2023. The study did not meet the primary endpoint of change in mean pain from
baseline but did show activity in improving fatigue, a hallmark symptom of Long COVID.

 TNX-102 SL also is being
developed also as a treatment for acute stress reaction ("ASR") and to prevent acute stress disorder ("ASD")
and posttraumatic stress disorder ("PTSD") under a physician-initiated Investigational New Drug Application
("IND") in partnership with the University of North Carolina ("UNC") Institute for Trauma Recovery. The
Phase 2 OASIS study at UNC is supported by the U.S. Department of Defense ("DoD"). We expect enrollment in the OASIS
study to begin in the second quarter of 2024. The UNC-led OASIS study will build upon the existing AURORA initiative, a major
national research initiative to improve the understanding, prevention, and recovery of individuals who have experienced a traumatic
event.

 In addition, TNX-102 SL has
active INDs for PTSD, agitation in Alzheimer's disease ("AAD"), and alcohol use disorder ("AUD"). TNX-102
SL for AAD has been granted Fast Track designation by the FDA. We are currently not actively studying TNX-102 SL in PTSD, AAD or AUD.

 Another CNS candidate in
development is TNX-1300* (double-mutant cocaine esterase) which is in Phase 2 for the treatment of cocaine intoxication. TNX-1300
has been granted Breakthrough Therapy designation by the FDA. TNX-1300 was licensed from Columbia University in 2019 after a Phase 2
study showed that it rapidly and efficiently disintegrates cocaine in the blood of volunteers who received intravenous (i.v.)
cocaine. In August of 2022, we received a Federal Grant from the U.S. National Institute on Drug Abuse ("NIDA") a part
of the U.S. National Institutes of Health ("NIH") to advance the development of TNX-1300 as a treatment for cocaine
intoxication. We expect to initiate enrollment in a potentially pivotal Phase 2 study of TNX-1300 in emergency rooms in the second
quarter of 2024.

 Our rare disease
portfolio includes TNX-2900* (intranasal potentiated oxytocin) for Prader-Willi syndrome ("PWS"), a genetic disorder characterized by
complex symptoms. The formulation technology for TNX-2900 was acquired from Trigemina, Inc. and licensed from Stanford University in
2020. The potentiated formulation includes magnesium, which has been shown in animal studies to potentiate binding of oxytocin to
the oxytocin receptor. The therapeutic technology was licensed from Inserm, the French National Institute of Health and Medical
Research. TNX-2900 was granted Orphan-Drug Designation by the FDA in the second half of 2023 and the IND was cleared by the FDA in
the fourth quarter of 2023 and received Rare Pediatric Disease Designation on March 21, 2024. PWS, an orphan condition, is a rare
genetic disorder of failure to thrive in infancy, associated with uncontrolled appetite beginning in childhood with complications of
obesity and diabetes. We have sponsored a research program at Inserm to study oxytocin on suckling behavior in mice that have been
engineered to express one of the PWS genes.

 We are developing a different intranasal
oxytocin product, TNX-1900* (intranasal potentiated oxytocin with magnesium) for several CNS disorders through investigator-initiated
studies. TNX-1900 is in development through investigator-initiated studies for the treatment of binge eating disorder ("BED"),
adolescent obesity, social anxiety disorder ("SAD"), and bone health in pediatric autism. We received IND clearance from the
FDA in the fourth quarter of 2021 to study TNX-1900 in chronic migraine and we initiated the Phase 2 PREVENTION study for the prevention
of migraine headaches in chronic migraineurs in the first quarter of 2023. Topline results from the study, reported in December 2023,
showed that TNX-1900 did not meet the primary endpoint as measured by a reduction from 28-day run-in baseline in the mean number of migraine
headache days during the last 28 days of the treatment phase. PREVENTION was a small proof-of-concept study with 88 patients enrolled
across three arms (TNX-1900 30 IU QD, TNX-1900 30 IU BID, and placebo), and was not powered to result in a statistically significant outcome.
In the trial, TNX-1900 was generally well-tolerated with no treatment-emergent serious or severe adverse events. We have discontinued
development of TNX-1900 in chronic migraine.

 Our lead candidate in the immunology pipeline
is TNX-1500, an Fc-modified humanized mAb, directed against CD40-ligand (CD40L, also known as CD154). TNX-1500 was engineered to modulate
binding to Fc receptors. TNX-1500 is being developed as a prophylaxis against organ transplant rejection as well as to treat autoimmune
conditions. The IND was cleared and a Phase 1 study of TNX-1500 in healthy volunteers was initiated in the second quarter of 2023 and
completed the clinical phase in the first quarter of 2024. TNX-1500 is being studied in combination with other immunosuppressive agents
in allogeneic and xenogeneic organ transplants in non-human primates at Massachusetts General Hospital, a teaching hospital of Harvard
Medical School ("MGH"). In experiments at MGH, TNX-1500 is being studied as monotherapy or in combination with other immunosuppressive
agents in heart and kidney allogeneic organ transplants in non-human primates. Results from experiments in kidney and heart transplants
indicate that TNX-1500 appears to have comparable efficacy to historical experiments using the chimeric mouse/human IgG1 version (5c8H1)
of the anti-CD40L mAb 5c8. Some results from this collaboration were published in the peer-reviewed journal, American Journal of Transplantation
in 2023.

 TNX-1500 also is being studied in combination
with other immunosuppressive agents in xenogeneic organ transplants in non-human primates at MGH. In some of these studies, genetically
engineered ("GE") pigs in baboon transplants were treated with cold perfused ischemia minimization and a novel costimulation-based
immunosuppressive regimen including TNX-1500. The results of these preclinical studies were encouraging and demonstrated the potential
of genetically engineered pig hearts in the context of a clinically applicable regimen. The multi-GE pigs were provided by eGenesis and
Revivicor. Revivicor is a subsidiary of United Therapeutics. Some results from the collaboration with MGH and eGenesis were published
in the peer-reviewed journal, Nature in 2023. In March of 2024, MGH announced the first GE pig kidney transplant into a living
recipient supported in part by the pre-clinical work with TNX-1500. TNX-1500 therapy was not used in the human transplant recipient.

 Our immunology pipeline also includes
TNX-1700*, a recombinant Trefoil Factor Family 2 ("rTFF2") fusion protein that was licensed from Columbia University in 2019.
TNX-1700 consists of TFF2 fused to human serum albumin (HAS) and is a biologic being developed to treat gastric and colorectal cancers
by an immune-oncology mechanism, in combination with PD1 blockers, and is in the preclinical stage of development. We presented data that
show a murine version of TNX-1700 consisting of a fusion protein with murine serum albumin was able to evoke anti-tumor immunity in the
MC38 mouse model of colorectal cancer as monotherapy and that TNX-1700 augmented the efficacy of anti-PD1 therapy in both the MC38 model
and the CT26.wt mouse models of colorectal cancer.

 Our infectious disease
portfolio includes vaccines based on our live virus vaccine or RPV platform. Live virus vaccines are believed to protect against
poor clinical outcomes of infectious diseases by eliciting T cell responses in addition to antibody responses. TNX-801, a live
attenuated vaccine based on synthesized horsepox, is in the pre-IND stage of development to protect against smallpox and mpox. Mpox
has become endemic in the U.S. since it spread in the U.S. and other countries outside of Africa, mostly in populations of men who
have sex with men. Non-human primates vaccinated with TNX-801 were protected from mpox in studies reported in the first quarter of
2020. These data were published in the peer-reviewed journal Vaccines in 2023. In October 2023, at the World Vaccine Congress
- Europe, we reported that the TNX-801 vaccine was shown to be greater than 10 to 1,000-fold more attenuated than older
vaccinia-based smallpox vaccines in both human primary cell lines and immunocompromised mice. That work has been posted on
BioRxiv, which is not peer-reviewed. TNX-801 also serves as the live virus vaccine platform for other infectious diseases for which subsequent products
will be designed by expressing other viral antigens in the horsepox vector.

 TNX-1800 is a live virus
vaccine on the RPV platform that expresses the SARS-CoV-2 spike protein from the ancestral Wuhan strain, which has shown encouraging
results in non-human primates. In the third quarter of 2023, TNX-1800 was selected by the U.S. National Institute of Allergy and
Infectious Diseases ("NIAID"), a part of the NIH, to be included in their Project NextGen initiative,
an initiative to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19. The COVID-19 vaccines approved for
use in the U.S. have provided significant health benefits to the vaccinated population; however, they have shown limitations in the
durability of protection conferred, and in their ability to block forward transmission. Live virus vaccines that protect against
other viral diseases by eliciting T cell responses have shown durability of protection that lasts years to decades, and some live
virus vaccines have significantly inhibited forward transmission. With respect to TNX-1800 vaccination, we reported positive
efficacy data from animal challenge studies using live SARS-CoV-2 in the first quarter of 2021. These data were published in the
peer-reviewed journal Vaccines in 2023. In this study, TNX-1800 vaccinated, SARS-CoV-2 challenged animals had undetectable
SARS-CoV-2 in the upper airways, which we believe relates to potential inhibition of forward transmission of this respiratory
pathogen.

 Tonix has three pre-clinical research
and development programs developing broad spectrum antivirals. The DoD announced in December 2022 a plan to move beyond a 'one bug,
one drug' approach and are seeking broad-spectrum drugs since it may be hard to predict which or how many viruses may be deployed
on the battlefield. TNX-3900* are broad-spectrum small molecule oral antivirals which inhibit essential cathepsins required by viruses
such as coronaviruses and filoviruses to infect cells. TNX-4200* are orally available CD45 antagonists in preclinical development. We
believe that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations and
a lower dose, and therefore will have a higher safety window. Tonix plans to leverage previous research on phosphatase inhibitors, specifically
compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents. TNX-4000* are viral glycan-targeted
engineered biologics. These antivirals are currently in preclinical development.

 Relating to our development programs,
we own and operate the Research and Development Center ("RDC") in Frederick, Maryland consisting of one building totaling
approximately 48,000 square feet. The RDC conducts research on central nervous system, immunology, and infectious disease candidates.
The RDC facility is mostly biosafety level 2 (BSL-2), with some components designated BSL-3. We also own and operate an Advanced Development
Center ("ADC") located in the New Bedford business park in Dartmouth, Massachusetts. This approximately 45,000 square foot
BSL-2 facility is intended to accelerate development and clinical scale manufacturing of live-virus vaccines and biologics to support
clinical trials. We have engaged CBRE, an international real estate brokerage firm, to find a strategic partner for, or buyer of, ADC.

 *Tonix's product development candidates are investigational new drugs or biologics and have not been approved for any indication.

 We
are led by a management team with significant industry experience in drug development. We complement our management team with
a network of scientific, clinical, and regulatory advisors that includes recognized experts in their respective fields.

 Our
Strategy

 Our
strategy is to use our integrated development engine to advance innovative programs across multiple therapeutic areas through
the drug development process, with the ultimate objectives of FDA approval and commercialization. The principal components of
our strategy are to:

 Pursue CNS, rare disease, immunology, and infectious disease indications with high unmet medical need and significant commercial potential. We are pursuing multiple indications that are underserved with limited, effective treatment options. One of our latest stage product candidates is Tonmya for the management of FM, a condition which affects between 6-12 million adults in the U.S. Fewer than half of those treated for FM receive relief from the three FDA-approved drugs.

 We
are also pursuing a treatment using TNX-102 SL for FM-type Long COVID, a condition for which there is no currently approved therapy.
Our broader development strategy is to leverage the patented formulation and proven mechanism of action to explore the clinical potential
of TNX-102 SL in multiple other, psychiatric, and addiction conditions, including ASR, ASD, AAD and AUD, all of which are underserved
by currently approved medications or have no approved treatment. Within CNS, Tonix is also developing TNX-1300 to treat cocaine intoxication
and TNX-1900 to treat binge eating disorder, adolescent obesity, social anxiety disorder and bone loss associated with autism. Cocaine
intoxication is one of the leading causes of overdose deaths and for which there is no currently approved drug. With TNX-1500, we are
pursuing a treatment to prevent organ transplant rejection as well as autoimmune conditions. TNX-1500 is a third generation humanized
mAb targeting CD40L that has the potential to deliver efficacy without compromising safety, based on modulated binding to Fc receptors.
At this time, no mAb against CD40L has been licensed anywhere in the world. Within infectious diseases, we are currently focusing on
the development of TNX-801 to prevent smallpox and mpox, and TNX-1800 to protect against COVID-19. While there are FDA-approved vaccines
to prevent smallpox and mpox, we believe TNX-801 has potential to provide durable protection. While there are FDA-approved COVID-19 vaccines
which use mRNA technology, or other technologies, we believe that there are limitations to these vaccines relating to durability of protection
and their relative inability to block forward transmission.

 Maximize
the commercial potential of our lead product candidates. We plan to commercialize each of our lead product candidates, including
our latest stage candidate, TNX-102 SL, either on our own or through collaboration with partners. We believe the acquisition of our two
FDA-approved, marketed products for the treatment of acute migraine (Zembrace SymTouch and Tosymra) positions Tonix to build out commercial
capability to market the migraine products and to launch Tonmya for fibromyalgia. An alternative strategy would be to enter into partnership
agreements with drug companies that already have significant marketing capabilities in the same, or similar, therapeutic areas. If we
determine that such a strategy would be more favorable than developing our own sales capabilities, we would seek to enter into collaborations
with pharmaceutical or biotechnology companies for commercialization.

 Pursue a broad
 intellectual property strategy to protect our product candidates. We are pursuing a broad patent strategy for our
 product candidates, and we endeavor to generate new patent applications as supported by our innovations and conceptions as
 well as to advance their prosecution. In the case of TNX-102 SL, we own patents and patent applications protecting its composition-of-matter,
 certain methods of its use, its formulation, and its pharmacokinetic properties. In the case of TNX-801 and TNX-1800, we own
 patent applications protecting their composition-of-matter and certain methods of use. We also own patents through in-licensing
 transactions for TNX-1300, TNX-1900, TNX-2900, and TNX-1700. We have filed patent applications for TNX-1500. We plan to opportunistically
 apply for new patents to protect our product candidates.

 Pursue
additional indications and commercial opportunities for our product candidates. We will seek to maximize the value of our other
product candidates by pursuing other indications and commercial opportunities for such candidates. For example, we own rights related
to the development and commercialization of TNX-102 SL for generalized anxiety disorder, depression, and fatigue related to disordered
sleep. For TNX-1900, we own the rights to develop this for craniofacial pain, and insulin resistance. Finally, our live virus platform
using our RPV technology may be developed as vaccines for future pandemics, infectious diseases generally and oncology, in addition to
smallpox and mpox.

 Disease
and Market Overview

 Our
product candidates address disorders that are not well served by currently available therapies or have no approved treatment which
represent large potential commercial market opportunities. Background information on the disorders and related commercial markets
that may be addressed by our product candidates in or nearing the clinical stage of development is set forth below.

 Central
Nervous System

 Fibromyalgia
(FM)

 FM
is a chronic syndrome characterized by widespread pain accompanied by fatigue, non-restorative sleep, cognitive dysfunction or
"brain fog" and mood issues. The peak incidence of FM occurs between 20-50 years of age, and the majority of diagnosed
patients are female. FM may have a substantial negative impact on social and occupational function, including disrupted relationships
with family and friends, social isolation, reduced activities of daily living and leisure activities, avoidance of physical activity,
and loss of career or inability to advance in career or education. According to the American Chronic Pain Association, an estimated
six to twelve million adults in the U.S. have FM.

 According
to a report by Frost and Sullivan that we commissioned, despite the availability of approved medications, the majority of patients
fail therapy due to either insufficient efficacy, poor tolerability, or both. Prescription pain and sleep medications are frequently
prescribed off-label for symptomatic relief, despite the lack of evidence that such medications provide a meaningful or durable
therapeutic benefit, and many of these medications carry significant safety risks and risk of dependence. For example, approximately
30% of patients diagnosed with FM take chronic opioids, despite the lack of evidence for their effectiveness and the risk of addiction
and toxicity, including overdose.

 Fibromyalgia-type
Long COVID

 Long COVID, or PASC, is a
condition that some survivors of COVID-19 infection experience in varying degrees of severity. It is a chronic disabling condition that
is expected to result in a significant global health and economic burden. We are focusing the development of TNX-102 SL specifically on
fibromyalgia-type Long COVID, the symptoms of which include intense fatigue, sleep problems, multi-site pain, and cognitive issues ("brain
fog"). The proposed indication is for the management of multi-site pain associated with PASC.

 Post
infection, many patients experience one or many of the symptoms of Long COVID: some patients have initial symptoms that become prolonged;
others manifest entirely new syndromes that impact more than one system or organ. According to a 2021 publication in the Journal of
American Medical Association, over 1 in 10 healthcare workers who had recovered from COVID-19 were still coping with at least one
moderate to severe symptom eight months later. Research shows that Long COVID occurs in approximately 19% of recovered COVID-19 patients.
There is currently no approved drug for the treatment of Long COVID.

 Migraine
Headaches

 Migraine
is a primary headache disorder characterized by recurrent headaches that are moderate to severe. Typically, episodes affect one
side of the head, are pulsating in nature, and last from a few hours to three days. Associated symptoms may include nausea, vomiting,
and sensitivity to light, sound, or smell. The pain is generally made worse by physical activity, although regular exercise may
have prophylactic effects. Up to one-third of people affected have aura, typically a short period of visual disturbance that signals
that the headache will soon occur. Occasionally, aura can occur with little or no headache following it. Approximately one billion
individuals worldwide suffer from migraine (~14% of the population). Migraine is the second leading cause of years lived with
disability.

 Cocaine
Intoxication

 Cocaine
is an illegal recreational drug taken for its pleasurable effects and associated euphoria. Pharmacologically, cocaine blocks the
reuptake of the neurotransmitter dopamine from central nervous system synapses, resulting in the accumulation of dopamine within
the synapse and an amplification of dopamine signaling that is related to its role in creating positive feeling. With the continued
use of cocaine, however, intense cocaine cravings occur resulting in a high potential for abuse and addiction, or dependence,
as well as the risk of cocaine intoxication. Cocaine intoxication refers to the deleterious effects on other parts of the body,
especially those involving the cardiovascular system. Common symptoms of cocaine intoxication include tachyarrhythmias and elevated
blood pressure, either of which can be life-threatening. As a result, individuals with known or suspected cocaine intoxication
are sent immediately to the emergency department, preferably by ambulance in case cardiac arrest occurs during transit. There
are approximately 505,000 emergency room visits for cocaine abuse each year in the U.S., of which 61,000 require detoxification
services. According to the National Institute on Drug Abuse, cocaine-involved deaths rose nearly 54% from 2019 to 2021, resulting
in over 24,486 deaths total.

 Acute
Stress Disorder (ASD)

 ASD is a
mental health condition that can occur within the first month of experiencing a traumatic event. The symptoms are similar to those of
PTSD and can affect both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and
50% of women experience at least one trauma in their lives. In the U.S. alone, one-third of emergency department visits (40-50 million
patients per year) involve evaluation after trauma exposures, and in a 2014 study involving U.S. veterans, 87% reported exposure to at
least one potentially traumatic event during their service. No medications are currently available at or near the point of care to treat
patients suffering from acute traumatic events and to support long-term health.

 Rare
Disease

 Prader-Willi
Syndrome (PWS)

 PWS is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females
with equal frequency and all races and ethnicities. The hallmarks of PWS are lack of suckling in infants and, in children and
adults, severe hyperphagia, an overriding physiological drive to eat, leading to severe obesity and other complications associated
with significant morbidity and mortality. PWS is an orphan disease that occurs in approximately one in 15,000 births. There is
currently no approved treatment for obesity and hyperphagia in adults and older children associated with PWS.

 Immunology

 Organ
Transplant Rejection

 Organ
transplant rejection occurs when the immune system of the organ recipient attacks the new organ as if it was an infection or tumor.
Often transplantation is the last resort for most end-stage organ failure patients, affecting either kidneys, liver, heart, lungs,
and/or pancreas. Genetic disparity between organ donor and recipient is often at the root of the rejection. Mismatched or not
closely matched organs triggers an immune reaction that leads to rejection. Overcoming this difficulty is paramount to a patient's
survival as organ donations are in limited supply.

 Gastric
and Colorectal cancers

 Gastric
or stomach cancer is a disease in which malignant cancer cells line the inner lumen of the stomach. Development of this form of
cancer is often influenced by age, diet and other stomach diseases. This type of cancer begins to form in the mucosa, the surface
of the lumen that is in direct contact with the contents of the stomach, and spreads through the outer layers of the stomach as
the tumor grows.

 Currently,
per the National Cancer Institute, the 5-year relative survival for stomach cancer is 33.3%. According to 2017-2019 data, approximately
0.8 percent of men and women will be diagnosed with stomach cancer during their lifetime. In 2019, there were an estimated 123,920
people living with stomach cancer in the U.S.

 Colorectal
cancer includes cancers in the colon and the rectum, organs that are crucial to absorption of water by the body and the elimination
of food-waste. Most colorectal cancers start as a growth or polyp on the inner lining of the colon or rectum. Some types of polyps
can change into cancer over time (usually many years), but not all polyps become cancer. Adenomatous polyps are the ones that
turn malignant with time. Similar to gastric cancer, the malignancy begins in the mucosal layer and spreads outwards.

 The
5-year relative survival rate is 65.1%, per the National Cancer Institute. According to 2017-2019 data, approximately 4.1 percent
of men and women will be diagnosed with colorectal cancer during their lifetime. In 2019, there were an estimated 1,369,005 people
living with colorectal cancer in the United States.

 Infectious
Diseases

 Smallpox
and Mpox

 Smallpox is an acute contagious disease
caused by the variola virus, or VARV, which is a member of the orthopoxvirus family. Smallpox was declared eradicated in 1980 following
a global immunization campaign. Smallpox is transmitted from person to person by infective droplets during close contact with infected
symptomatic people. Mpox is an acute contagious disease caused by the monkeypox virus or MPXV, which is also a member of the orthopoxvirus
family. Mpox symptoms are similar to those of smallpox, although less severe. Mpox is emerging as an important zoonotic infection in
humans in Central and West Africa. Until 2022, only a few cases of mpox had been reported outside of Africa in patients who had been
infected while in Africa. Starting in May of 2022, mpox Clade 2 cases spread rapidly in the U.S. and other countries. More than 30,000
cases in the U.S. have been reported according to the U.S. Centers for Disease Control and Prevention. An outbreak of Clade 1 mpox in
the Democratic Republic of the Congo is raising concerns by the U.S. Bipartisan Commission on Biodefense.

 Smallpox was eradicated by a World Health
Organization program that vaccinated individuals with live replicating vaccinia vaccines wherever smallpox appeared. In the 1970s, vaccination
of civilians to protect against smallpox was discontinued in the U.S.; however, smallpox remains a material threat to national security
and a proportion of military personnel, including members of the Global Response Force continue to be vaccinated. Vaccines for smallpox
and mpox are stockpiled by the U.S. government in the strategic national stockpile and for potential widespread immunization in the event
of malicious reintroduction of VARV. The U.S. National Academy of Sciences has recently issued a consensus report raising concerns about
the state of new mpox vaccines in development.

 COVID-19

 SARS-CoV-2
is a contagious virus causing the disease COVID-19 that became a global pandemic in 2019 and has resulted in more than three million
deaths. While the infection and mortality rates have slowed in regions of the world with high vaccination rates, the struggle
with the pathogen is ongoing and evolving since SARS-CoV-2 is mutating into new variants. COVID-19 is characterized by fever,
sore throat, acute shortness of breath, cough, and oxygen desaturation in the blood. At least three major variants have swept
across the world in successive waves and overwhelmed healthcare systems during these waves. With new variants of the virus emerging,
therapeutic research is addressing the challenge of keeping up with this rapidly mutating virus. The early vaccines have been
effective in limiting the severity of disease in vaccinated individuals. Vaccines that elicit strong T cell responses are believed
to have the potential to provide long-term or durable protection.

 Tonix's
Marketed Migraine Products

SymTouch and Tosymra – Acute Migraine in Adults

 In June 2023, we acquired two FDA-approved, marketed products from Upsher-Smith
: Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are both indicated
for the treatment of acute migraine with or without aura in adults. These products collectively generated combined gross retail product
sales of approximately $28.5 million for the twelve months ended December 31, 2023.

 Zembrace SymTouch is the only
actively promoted brand of sumatriptan autoinjector in the United States. It has a unique low dose and has demonstrated onset of migraine
pain relief in as few as 10 minutes (17% of patients vs. 5% for placebo). Zembrace SymTouch also demonstrated migraine pain freedom for
46% of patients (vs 27% for placebo) at 2 hours in a single-attack, double-blind study (N=230). Zembrace SymTouch currently has patent
protection to 2036. Tosymra employs Intravail permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous
sumatriptan. Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo).
Tosymra currently has patent protection to 2031.

 Lead
Product Candidates

 We
believe that our product candidates offer innovative therapeutic approaches and may provide significant advantages relative to
available therapies. We have worldwide commercialization rights to all of our product candidates listed below. The following table
summarizes our later stage product candidates that are in or nearing the clinic:

 Product
 Candidate

 Indication

 Stage
 of Development

 Tonmya
 (TNX-102 SL)

 Fibromyalgia

 Two Positive
 Phase 3 studies completed, preparing NDA submission

 SL

 Fibromyalgia-type
 Long COVID

 Phase
 2 study completed

 SL

 Acute
 Stress Reaction

 Phase
 2 ready* – investigator-initiated IND

 TNX-1300

 Cocaine
 Intoxication

 Mid-Phase
 2, targeted 2Q 2024 start

 TNX-2900

 Prader-Willi
 Syndrome

 Phase
 2 ready, IND cleared

 TNX-1900

 Adolescent
 Obesity, Binge Eating Disorder, Bone Health in Pediatric Autism, Social Anxiety Disorder, *

 Phase
 2 completed for chronic migraine and currently enrolling for other indications*

 TNX-1500

 Kidney
 Transplant Rejection

 Phase
 1 study ongoing

 TNX-801

 Smallpox
 and Mpox vaccine

 Preclinical,
 pre-IND

 TNX-1800

 COVID-19
 vaccine

 Preclinical,
 pre-IND

 *Investigator
Initiated Studies

SL

 Overview

 TNX-102 SL is a proprietary
sublingual tablet formulation of CBP that efficiently delivers CBP across the oral mucosal membrane into
the systemic circulation. We have active IND's for TNX-102 SL as a bedtime treatment for fibromyalgia, PTSD, fibromyalgia-type Long
COVID, AAD and AUD. The University of North Carolina has an investigator-initiated IND for ASD that references our
INDs. We own all rights to TNX-102 SL in all geographies, and we bear no obligations to third parties for any future development or commercialization.
Excipients used in TNX-102 SL are approved for pharmaceutical use. Some of the excipients were specially selected to promote a local oral
environment that facilitates mucosal absorption of CBP.

 The
current TNX-102 SL sublingual tablets each contain 2.8 mg of CBP. TNX-102 SL 5.6 mg (two 2.8 mg tablets) at
bedtime has completed two positive Phase 3 studies for the management of fibromyalgia. We selected this dose with the goal of
providing a balance of efficacy, safety, and tolerability that would be acceptable as a first-line therapy and for long-term use,
and in-patient populations characterized by burdensome symptoms and sensitivity to medications.

 The
active ingredient in TNX-102 SL is CBP, a multi-functional drug that blocks the serotonin-2A, alpha-1 adrenergic, muscarinic M1
and histaminergic H1 receptors.

 CBP
is the active ingredient of two products that are approved in the U.S. for the treatment of muscle spasm: Flexeril (5 mg
and 10 mg oral immediate-release, or IR, tablet) and Amrix (15 mg and 30 mg oral extended-release capsule). The
Flexeril brand of CBP IR tablet has been discontinued since May 2013. There are numerous generic versions of CBP IR tablets on
the market. CBP-containing products are approved for short term use (two to three weeks) only as an adjunct to rest and physical
therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. CBP IR tablets are recommended for
three times per day dosing, which results in relatively stable blood levels of CBP after several days of treatment. Extended-release
CBP capsules taken once a day mimic, and flatten, the pharmacokinetic profile of three times per day CBP IR tablets.

 We
designed TNX-102 SL to be administered once-daily at bedtime and with the intention for long-term use. We believe the selected dose
of TNX-102 SL and its unique pharmacokinetic profile will enable it to achieve a desirable balance of efficacy, safety, and
tolerability. Our Phase 1 pharmacokinetic comparative trials showed that, on a dose-adjusted basis, TNX-102 SL results in faster
systemic absorption and significantly higher plasma levels of CBP in the first hour following sublingual administration relative to
oral IR CBP tablets. It also showed that the sublingual route of administration, which largely bypasses the "first pass"
hepatic metabolism that swallowed medications undergo, results in a higher plasma ratio of CBP to its main active metabolite,
norcyclobenzaprine. In clinical studies, TNX-102 SL 2.8 mg and TNX-102 SL 5.6 mg were generally well-tolerated, with no drug-related
serious and unexpected adverse reactions reported in these studies. Some subjects experienced transient numbness of the tongue after
TNX-102 SL administration.

 We have successfully completed
the pivotal exposure bridging study with TNX-102 SL compared to Amrix. Results from this study support the approval of TNX-102 SL
under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FDCA) with Amrix as the reference listed drug (RLD). In general, the
development timeline for a 505(b)(2) NDA is shorter and less expensive than an NDA developed under Section 505(b)(1), which is for new
chemical entities, or NCEs, that have never been approved in the U.S. We believe that TNX-102 SL has the potential to provide clinical
benefit to fibromyalgia, fibromyalgia-type Long COVID, and PTSD patients and possibly other CNS (central nervous system) indications that
are underserved by currently marketed products or have no approved treatment.

 We have also successfully
completed a bridging pharmacokinetic study in ethnic Japanese and Chinese volunteers that shows similar characteristics to our historical
data in Caucasian volunteers. We believe this will satisfy one of the criteria for approval in Japan and China and will allow us to reference
the U.S. efficacy data to support marketing applications in those countries.

 Tonmya
(TNX-102 SL) – FM program

 We
are developing Tonmya as a bedtime treatment for FM under an active IND application. The potential approval of Tonmya for FM is
expected to be under Section 505(b)(2) of the FDCA.

Development Plan

Positive Phase 3 RESILIENT Study (F307)

 The first patient was enrolled
in the pivotal Phase 3 RESILIENT study in April 2022. The RESILIENT study was a double-blind, randomized, placebo-controlled adaptive
design trial designed to evaluate the efficacy and safety of Tonmya in FM. The two-arm trial enrolled 457 participants in the U.S. The
first two weeks of treatment consist of a run-in period in which participants start on Tonmya 2.8 mg (1 tablet) or placebo. Thereafter,
all participants increase their dose to Tonmya 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The RESILIENT
study achieved statistical significance on the pre-specified primary efficacy endpoint: change from baseline in the weekly average of
daily diary pain severity numerical rating scale (NRS) scores for Tonmya 5.6 mg (LS mean [SE]: -1.8 [0.12] units) versus placebo (-1.2
[0.12] units), analyzed by mixed model repeated measures with multiple imputation (LS mean [SE] difference: -0.7 [0.16] units, p=0.00005).
In addition, all pre-specified sensitivity analyses of the primary endpoint were statistically significant (p 0.001). We observed reduction
in pain across all weeks of the 14-week study, with nominal p<0.01 for every week. The rapid onset of action with separation from placebo
at Week 1 was sustained throughout all weeks of dosing. Tonmya was well tolerated and consistent with prior trials, with no new safety
signals observed. Among participants randomized to the Tonmya and placebo arms, 81.0% and 79.2%, respectively, completed the 14-week dosing
period. As expected based on prior Tonmya studies, administration site reactions were the most commonly reported adverse events and were
higher in the Tonmya treatment group. Hypoaesthesia oral and paraesthesia oral, or tongue and mouth numbness or tingling, product taste
abnormal (typically a bitter aftertaste upon dosing), and tongue discomfort were local effects nearly always temporally related to dose
administration and transiently expressed (<60 minutes) in most occurrences. The only treatment-emergent adverse events that occurred
at a rate of 3.0% or greater in either arm were these four oral adverse events, along with COVID-19, somnolence, and headache. Adverse
events resulted in premature study discontinuation in 6.1% of those who received Tonmya compared with 3.5% of placebo recipients. There
were a total of seven serious adverse events in five patients, five of which were experienced by three patients in the placebo arm, and
two of which were in the Tonmya arm. Of the two in the Tonmya arm, one was renal cancer, deemed unrelated to study drug, and the other
was acute pancreatitis with onset 14 days after dosing was completed, reported as possibly related to study drug, and was resolved before
the final study visit.

Phase 3 RALLY Study (F306)

 The RALLY study was a double-blind,
randomized, placebo-controlled adaptive design trial intended to evaluate the efficacy and safety of Tonmya in FM. The trial was designed
to enroll approximately 670 patients across approximately 40 U.S. sites. For the first two weeks of treatment, there was a run-in period
in which patients started on Tonmya 2.8 mg (1 tablet) or placebo. After the first two weeks, all patients had the dose increased to Tonmya
5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for 12 weeks. The primary endpoint was daily diary pain severity score change from
baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures
with multiple imputation. We reported pre-planned interim analysis results from a Phase 3 study, RALLY (F306), in July 2021. Based on
the recommendation from the independent data monitoring committee that the RALLY trial was unlikely to demonstrate a statistically significant
improvement in the primary endpoint, we stopped enrollment of new participants but allowed those participants who were already enrolled
to complete the study. We reported topline data from the completed study in March of 2022. As expected based on interim analysis results,
Tonmya did not achieve statistical significance over placebo on the primary endpoint of reduction in daily pain, and relative to the previous
positive Phase 3 Study (RELIEF), RALLY had an unexpected increase in study participant adverse event-related discontinuations in both
drug and placebo groups.

Positive Phase 3 RELIEF Study (F304)

 In
the fourth quarter of 2020, we announced the results of a randomized, double-blind, placebo-controlled, 12-week Phase 3 study
of Tonmya in 503 participants with FM, which we refer to as the RELIEF study. The primary objective of this study was to evaluate
the potential clinical benefit of using Tonmya to treat FM at a dose of 5.6 mg, administered sublingually once daily at bedtime
for 12 weeks. The primary endpoint of the RELIEF trial was the daily diary pain severity score change from baseline to Week 14
(using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple
imputation. The RELIEF study achieved statistical significance on the primary efficacy endpoint: change from baseline in the weekly
average of daily diary pain severity numerical rating scale (NRS) scores for Tonmya 5.6 mg (LS mean [SE]: -1.9 [0.12] units) versus
placebo (-1.5 [0.12] units), analyzed by mixed model repeated measures with multiple imputation (LS mean [SE] difference: -0.4
[0.16] units, p=0.010).

 The
statistically significant improvement in pain is further substantiated when diary pain was analyzed by another standard statistical
approach, a 30 percent responder analysis, with 46.8% on active and 34.9% on placebo having a 30 percent or greater reduction
in pain (logistic regression; odds ratio [95% CI]: 1.67 [1.16, 2.40]; p=0.006). Consistent with the proposed mechanism that Tonmya
acts in fibromyalgia through improving sleep quality, Tonmya showed nominal improvement of sleep by several measures. For daily
diary sleep quality ratings, TNX-102 SL (-2.0 [0.12] units) compared to placebo (-1.5 [0.12] units) was nominally significant
(LS mean difference: -0.6 [0.17] units; p<0.001). For the PROMIS Sleep Disturbance instrument, Tonmya was also nominally significant
over placebo on T-scores (LS mean difference: -2.9 [0.82] units; p<0.001). The effect sizes on the diary sleep ratings and
PROMIS Sleep Disturbance instrument were 0.31 and 0.32, respectively.

 In the RELIEF study, Tonmya
was similarly well tolerated as in the Phase 2 BESTFIT and Phase 3 AFFIRM studies, which both studied Tonmya at a lower dose of 2.8 mg
daily. There were no new safety signals observed in the RELIEF study at the 5.6 mg daily dose. Among participants randomized to the Tonmya
and placebo arms, 82.3% and 83.5%, respectively, completed the 14-week dosing period. As expected, based on prior studies, administration
site reactions are the most commonly reported adverse events and were higher in the Tonmya treatment group, including rates of hypoaesthesia
oral (17.3% vs. 0.8%), oral pain/discomfort (11.7% v. 2.0%), product taste abnormal (6.5% vs. 0.4%), and paraesthesia oral (5.6% v. 0.4%).
Hypoaesthesia or paraesthesia oral and product taste abnormal were local administration site effects nearly always temporally related
to dose administration and transiently expressed (<60 minutes) in almost all occurrences. The only systemic treatment-emergent adverse
events that occurred at a rate of 5.0% or greater in either arm was somnolence/sedation at 5.6% in the Tonmya arm vs. 1.2% in placebo,
which was consistent with known side effects of marketed oral cyclobenzaprine. Adverse events resulted in premature study discontinuation
in 8.9% of those who received Tonmya compared with 3.9% of placebo recipients. There was a total of seven serious adverse events reported
during the study, none of which were deemed related to investigational product; five in placebo arm, and two in Tonmya arm. Of the two
in the Tonmya arm, one was a motor vehicle accident with multiple bone fractures, and the other was a case of pneumonia secondary to an
infection.

Phase 3 AFFIRM Study (F301)

 In
the third quarter of 2016, we announced the results of a randomized, double-blind, placebo-controlled, 12-week Phase 3 study of
Tonmya 2.8 mg in 519 participants with FM, which we refer to as the AFFIRM study. The primary objective of this study was to evaluate
the potential clinical benefit of using Tonmya to treat FM at a dose of 2.8 mg, administered sublingually once daily at bedtime
for 12 weeks. The primary endpoint of the AFFIRM trial was the 30% pain responder analysis in which a responder is defined as
a subject for whom pain intensity was reduced by at least 30% at Week 12 as compared to baseline. AFFIRM did not achieve statistical
significance at the primary endpoint (p=0.095). Yet, statistical significance was achieved when pain was analyzed instead as a
continuous variable, either by mixed model for repeated measure ("MMRM"0 (p<0.001) or by MMRM with multiple imputation
for missing data (p=0.005), a generally accepted approach to pain data. Tonmya also showed statistically significant improvements
in the declared secondary analyses of the Patient Global Impression of Change, or PGIC (p=0.038) and the Fibromyalgia Impact Questionnaire-Revised,
or FIQ-R (p<0.001). The study also showed statistically significant improvement with Tonmya on measures of sleep quality, including
the Patient-Reported Outcomes Measurement Information System, or PROMIS, Sleep Disturbance instrument (p<0.001).

 Tonmya
was well tolerated in the AFFIRM trial. Among patients randomized to the active and control arms, 78% and 86%, respectively, completed
the 12-week dosing period. The most common adverse events were local in nature, with transient hypoaesthesia oral occurring
in 40% of participants on Tonmya vs. 1% on placebo. These local adverse events did not appear to affect either rates of retention
of study participants or their compliance with taking Tonmya. Systemic adverse events were similar between Tonmya and placebo.
No serious adverse events were reported.

 Other
NDA Requirements

 An Agreed Initial Pediatric
Study Plan ("Agreed iPSP") is required for the initial NDA submission. The Agreed iPSP was accepted by the FDA in September
2015. We submitted an amended iPSP in the third quarter of 2021 and received comments from the FDA in the fourth quarter of 2021. We
submitted a second amended iPSP in first quarter 2024 and plan to come to an Agreed PSP by the time of NDA submission. An acceptable
Pediatric Study Plan will be determined at the time of the NDA approval.

 Based
on our discussions with the FDA and the FDA official meeting minutes, we will not have to conduct special populations, such as
geriatric and renal/hepatic impaired patients, drug-drug interaction or cardiovascular safety studies to support the Tonmya NDA
filing since the pivotal systemic exposure bridging study using Amrix as the reference listed drug (RLD) has been successfully
completed. Due to the well-established safety profile of CBP at much higher doses than we proposed for FM and the long-term safety
data in PTSD, up to 15 months, on Tonmya 5.6 mg, the FDA has not requested a risk management plan or medication guide for this
product.

 Other
NDA Requirements

 Phase
1 Bioequivalence, Bridging PK, Food-Effect and Dose-Proportionality Studies

 We
have completed the required Phase 1 bioequivalence, multi-dose bridging pharmacokinetic, and food effect and dose-proportionality
studies.

Hydrochloride Nonclinical Development

 In
October 2016, we completed the six-month repeated-dose toxicology study of the active ingredient, CBP, in rats and a nine-month
repeated-dose toxicology study in dogs required for the NDA filing. These chronic toxicity studies were requested by the FDA to
augment the nonclinical information in the AMRIX prescribing information, or labeling, which is necessary to support the TNX-102
SL labeling for long-term use. Due to the lack of evidence of potential abuse in clinical studies of TNX-102 SL, the FDA agreed
that nonclinical study to assess CBP abuse potential is not required to support the TNX-102 SL NDA filing.

 We
are planning to develop TNX-102 SL for the treatment of FM in Japan. Cyclobenzaprine, the active ingredient of TNX-102 SL, has
not been approved in Japan, and is considered a new chemical entity NCE. In February 2022, we held an End of Phase 2 Consultation
with the Pharmaceuticals and Medical Devices Agency, or PMDA, an independent administrative institution responsible for ensuring
the safety, efficacy and quality of pharmaceuticals and medical devices in Japan, to discuss the Japan development plan. Agreement
was reached on the design of a Phase 1 bridging study (TNX-CY-F108/F108) in ethnic Japanese healthy volunteers to enable clinical
studies of TNX-102 SL in Japan. PMDA also provided guidance on the overall nonclinical package to support a Japan NDA filing for
TNX-102 SL for the treatment of FM.

 The
F108 Phase 1 study was initiated in March 2022 and the clinical phase was completed in May 2022. Since the similarity in PK profile
between people of Japanese and Chinese descent was confirmed, the PK data from the two ethnic groups were pooled as for Asian
data (n=20) and compared retrospectively with the Caucasian study data from Study TNX-CY-F110 (n=16). The Asian/Caucasian geometric
mean ratios of cyclobenzaprine Cmax, AUC 0-T and AUC 0- were between 0.9 and 1.11 after both the 5.6
mg dose and the 2.8 mg dose. The 90% CI of Asian/Caucasian geometric mean ratios for Cmax, AUC 0-T and AUC 0-,
were all within the formal narrow equivalence limit of 0.8 to 1.25 after both the 5.6mg dose and 2.8mg dose, respectively. These
results support similarity in cyclobenzaprine PK between Asian (pooled Japanese and Chinese) and Caucasian samples.

 We
have initiated nonclinical safety, pharmacology and embryo-fetal development toxicology studies as part of the agreed IND-enabling
nonclinical data package to support clinical studies of Tonmya in Japan.

 TNX 102 SL – Fibromyalgia-type Long COVID Program

 We are developing TNX-102
SL as a bedtime treatment for fibromyalgia-type Long COVID. The potential approval of TNX-102 SL for Long COVID is expected to be under
Section 505(b)(2) of the FDCA.

Phase 2 PREVAIL Study (TNX-CY-PA201)

 We initiated a Phase 2 study
of TNX-102 SL as a treatment for fibromyalgia-type Long COVID, in August 2022. The study is a randomized, double-blind, placebo-controlled
study designed to evaluate the efficacy and safety of TNX-102 SL for fibromyalgia-type Long COVID. In the study, 63 subjects were enrolled
and randomized 1:1 across approximately 30 U.S. sites to receive either TNX-102 SL or placebo daily at bedtime for 14 weeks. Subjects
started with one TNX-102 SL 2.8 mg tablet or one placebo tablet for the first 2 weeks and then increased to TNX-102 SL 5.6 mg (2 x 2.8
mg tablets) or two placebo tablets for the remaining 12 weeks of the treatment period. Given the lack of Long COVID treatments and the
size of the current proof-of-concept study, an effect size ("ES") 0.2 was the pre-specified threshold for declaring the
primary endpoint positive. The study trended towards a benefit but did not achieve statistical significance on the primary efficacy endpoint
of change from baseline in the diary numerical rating scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity
scores for TNX-102 SL at the Week 14 endpoint versus placebo ES = 0.08)

 The change from baseline to
the Week 14 endpoint for the daily sleep quality diary, PROMIS Sleep Disturbance, PROMIS Fatigue, PROMIS Cognitive function, the Insomnia
Severity Index (ISI) and Sheehan Disability Scale showed numerical improvements in (MMRM, ES 0.2): sleep diary (MMRM, ES =0.23), PROMIS sleep Disturbance (MMRM, ES=0.32), PROMIS fatigue (MMRM, ES=0.50), PROMIS Cognitive Function –
Abilities, (MMRM, ES=0.21), the ISI (ANCOVA, ES=0.24) and the Sheehan Disability Scale (ANCOVA, ES=0.26). Moreover, robust activity was
observed in the PGIC responder (very much improved or much improved) rate for TNX-102 SL compared to placebo: week 6 (31.3%
vs. 9.7%, difference=21.6%), week 10 (28.1% vs. 12.9%, difference=15.2%), week 14 (34.4% vs. 16.1%, difference=18.2%). TNX-102 SL was
generally well tolerated with an adverse event ("AE") profile comparable to prior studies with TNX-102 SL. AE-related discontinuations
were similar in drug and placebo arms. No new safety signals were observed.

 We intend to request an End-of-Phase
2 meeting with the FDA to discuss a potential Phase 3 program based on a proposed primary outcome measure using the PROMIS Fatigue scale.
Fatigue is the symptom of Long COVID that principally overlaps with chronic fatigue syndrome/myalgic encephalomyelitis and fibromyalgia.
In the NIH funded RECOVER study analysis, fatigue was the top featured symptom and is common in each of the four clusters.

SL – Acute Stress Disorder Program

SL is being developed as a bedtime treatment for ASR in collaboration with the University of North Carolina under an investigator-initiated
IND.

 Phase
2 OASIS Study

 This
investigator-initiated study will be conducted by the University of North Carolina Institute for Trauma Recovery. The University of North Carolina has been
awarded a $3 million grant from the DoD to investigate the potential of Tonix's TNX-102 SL to reduce the frequency and severity
of adverse effects of acute trauma. The proposed Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) trial
will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting
to the emergency department after a motor vehicle collision. The trial will enroll approximately 180 individuals who acutely experienced
trauma at study sites across the U.S. and participants will be randomized in the emergency department to receive a two-week course
of either TNX-102 SL or placebo.

 The OASIS trial will build upon a foundation of knowledge and infrastructure developed
through the University of North Carolina-led, $40 million AURORA initiative. The AURORA study is a major national research initiative
to improve the understanding, prevention, and recovery of individuals who have experienced a traumatic event. AURORA is supported by funding
from the NIH, leading brain health nonprofit One Mind, private foundations, and partnerships with leading tech companies such as Mindstrong
Health and Verily Life Sciences, the health care arm of Google's parent company Alphabet.

 Initiation of patient enrollment
in the proposed investigator sponsored OASIS trial is anticipated in the second quarter of 2024. The FDA granted IND clearance in the
first quarter of 2024.

 Long-Term
Safety Exposure Study for TNX-102 SL

 In October 2019, we completed
long-term safety exposure studies in participants with PTSD to evaluate the tolerability of TNX-102 SL 5.6 mg to support an NDA for the
treatment of PTSD. The data provide us with exposure data of daily dosing of TNX-102 SL 5.6 mg for at least 12 months in more than
50 individuals, and daily dosing of TNX-102 SL 5.6 mg for at least 6 months in more than 100 individuals. The data was collected in OLE
studies of the PTSD program. Based on the FDA's guidance, the long-term safety exposure studies in PTSD are also expected
to support an NDA for the management of fibromyalgia.

 Manufacturing

 Tonmya drug product for Phase
3 and the associated registration batches for the NDA were manufactured at commercial cGMP facilities. We currently have 36-month stability
data in the proposed packaging configurations ready for commercialization. The FDA has reviewed the proposed CMC data package to support
TNX-102 SL's NDA approval and commercial manufacturing plans as part of the IND process. Tonix is ready to manufacture TNX-102
SL commercial product for the forecasted fibromyalgia market.

 TNX-1300
– Cocaine Intoxication

 TNX-1300
(T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is being developed for the treatment of cocaine intoxication.
TNX-1300 is a recombinant protein enzyme produced through rDNA technology in a non-disease-producing strain of E. coli bacteria.
Cocaine Esterase (CocE) was identified in bacteria (Rhodococcus) that use cocaine as the sole source of carbon and nitrogen and
that grow in soil surrounding coca plants. The gene encoding CocE was identified and the protein was extensively characterized.
CocE catalyzes the breakdown of cocaine into metabolite ecgonine methyl ester and benzoic acid. Wild-type CocE is unstable at
body temperature, so targeted mutations were introduced in the CocE gene and resulted in the T172R/G173Q double-mutant CocE, which
is active for approximately 6 hours at body temperature.

 Currently
there is no specific pharmacotherapy indicated for cocaine intoxication, a state characterized by acute agitation, hyperthermia,
tachycardia, arrhythmias, and hypertension, with the potential life-threatening sequalae of myocardial infarction, cerebrovascular
accident, rhabdomyolysis, respiratory failure, and seizures. Patients are currently managed only by supportive care for the adverse
effects of cocaine overdose on the cardiovascular and central nervous systems. By targeting the cause of cocaine intoxication,
rather than the symptoms like other medicines in emergency usage, we believe TNX-1300 may offer significant advantages to the
current standard of care for cocaine overdose. TNX-1300 was developed by Columbia University, University of Kentucky and University
of Michigan, and in-licensed by Tonix from Columbia University in 2019.

 In a Phase 2 randomized,
double-blind, placebo-controlled clinical study, TNX-1300 at 100 mg or 200 mg i.v. doses was well tolerated and interrupted cocaine
effects after cocaine 50 mg i.v. challenge.

 In
August 2022, we announced that we received a Cooperative Agreement grant from NIDA, part
of NIH, to support development of TNX-1300. A positive Phase 2a study of volunteer cocaine users in a controlled
laboratory setting has been previously completed. TNX-1300 has been granted Breakthrough Therapy designation by the FDA.

 As
a biologic and new molecular entity, TNX-1300 is eligible for 12 years of U.S. market exclusivity upon approval by the FDA, in
addition to expected patent protection through 2029. Since in-licensing, Tonix has requalified existing inventory, developed a
lyophilized drug product to facilitate enhanced stability and handling conditions applicable for an ER treatment, updated the
process and analytical methods to current standards and is in the process of manufacturing Phase 2/3 drug product clinical supply.

 We
expect to initiate a Phase 2 clinical trial of TNX-1300 in the second quarter of 2024. The Phase 2 trial is a single-blind, open-label, placebo-controlled, randomized study comparing the safety of a single 200 mg dose of TNX-1300 to standard of care alone in approximately 60 emergency department patients presenting with cocaine intoxication.

 TNX-2900
– Prader-Willi Syndrome (PWS)

 TNX-2900 is based on our patented intranasal potentiated oxytocin formulation,
or TNX-1900, but being developed for PWS. Tonix licensed technology using oxytocin-based therapeutics for the treatment of PWS and non-organic failure to thrive disease from the French National Institute of Health and Medical Research (Inserm). The licensing
agreement has been negotiated and signed by Inserm Transfert, the private subsidiary of Inserm, on behalf of Inserm (the French National
Institute of Health and Medical Research), Aix-Marseille Universit and Centre Hospitalier Universitaire of Toulouse. PWS is recognized
as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races
and ethnicities. There is currently no approved treatment for either the suckling deficit in infants or the obesity and hyperphagia in
older children associated with PWS. Since PWS is an orphan disease that occurs in approximately one in 15,000 births, TNX-2900 for PWS
has been granted Orphan Drug Designation and Rare Pediatric Disease Designation by the FDA. Tonix completed a pre-IND meeting with the
FDA in November 2022 to discuss the most efficient and appropriate investigational plan to establish the safety and effectiveness evidence
to support the approval of TNX-2900, and Tonix has received IND clearance.

 In 2022, Tonix entered into
a research collaboration with Inserm involving in vitro and in vivo animal studies designed to validate and characterize
the role of oxytocin in suckling and in the maturation of feeding behavior during infancy in order to support an intranasal therapeutic
approach to restore a normal nutritive suckling. The studies will include mice that have been engineered to precisely recapitulate the
genetic issue underlying PWS in humans.

 The
mechanisms involved in suckling activity required for normal feeding and the role of oxytocin system in this process will be investigated.
The results of this work are expected to be useful in the clinical care of infants requiring support to achieve efficient suckling
behavior. Intranasal oxytocin has previously been shown to improve suckling in newborn animals and suppress feeding behaviors
in adult animal models.

 TNX-1500
– Organ Transplant Rejection/Autoimmune Conditions

 TNX-1500 is a humanized mAb
directed against CD40-ligand, or CD40L (also known as CD154), engineered to modulate binding to Fc receptors, that is being developed
to prevent and treat organ transplant rejection as well as to treat autoimmune conditions. TNX-1500 incorporates the antigen binding
fragment (Fab) region of hu5c8, which has been extensively characterized including at the atomic level in complex with CD40-ligand. A
Phase 1 study of TNX-1500 in healthy volunteers was initiated in the second quarter of 2023 and has completed the clinical phase. Topline
results are expected in the third quarter of 2024.

 In
pre-clinical experiments at MGH, TNX-1500 is being studied as monotherapy or in combination with immunosuppressive drugs in heart
and kidney organ transplants in non-human primates. The data demonstrates that TNX-1500 showed activity in preventing organ rejection
and was well tolerated in non-human primates. Blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic
alloimmunity in non-human primate models of cardiac and kidney allograft model without clinical thrombosis. Furthermore, pre-clinical
research supports TNX-1500's activity in preventing pig xenograft organ rejection.

 CD40-ligand
is a protein expressed on the surface of activated T lymphocytes that mediates T cell helper function. CD40-ligand is also known
as CD154, the T cell-B cell activating molecule (T-BAM), TRAP and gp39. CD154 is a member of the Tumor Necrosis Factor (TNF) Super
Family. No mAb against CD154 has been approved for commercial use anywhere in the world. Other TNF Super Family members have been
successfully targeted by antagonist mAbs. Approved mAbs against TNF include: infliximab (Remicade), adalimumab (Humira),
certolizumab pegol (Cimzia), and golimumab (Simponi) for the treatment of certain autoimmune conditions. Also, etanercept
(Enbrel) is a TNF antagonist receptor fusion protein. An approved mAb against RANKL (CD254) is denosumab (Prolia
or Xgeva) for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.

 In
January 2021, the World Intellectual Property Organization published a patent application filed under the Patent Cooperation Treaty
covering TNX-1500, a humanized mAb directed against CD40-ligand, which is also known as CD154. The patent application is titled
"Anti-CD154 Antibodies and Uses Thereof" and published under International Publication No. WO 2021/001458 A1. The
application entered national phase in December 2021. The patent applications include claims related to proprietary anti-human
CD40-ligand mAbs that were engineered to have modified effector function, including TNX-1500, which have reduced potential for
Fc binding to Fc RII. The patent applications also claim uses of TNX-1500 for preventing and treating conditions, such as
organ transplant rejection and autoimmune disorders. If claims are granted, a patent issuing from a national stage of this application
could potentially provide U.S. patent coverage for the TNX-1500 composition of matter through 2040 excluding possible patent term
extensions or patent term adjustments. We also have filed a PCT patent application, PCT/US2022/011404, in January 2022, entitled
"Methods of Inducing Immune Tolerance with Modified Anti-CD154 Antibodies." It claims methods of inducing immune tolerance
in transplant recipients using anti-CD154 antibodies having modified effector functions. Tonix completed a pre-IND meeting with
the FDA in October 2022 to discuss the most efficient and appropriate investigational plan to establish the safety and effectiveness
evidence to support the licensure of TNX-1500. The IND was cleared and a Phase 1 study of TNX-1500 in healthy volunteers was initiated
in the second quarter of 2023 and completed the clinical phase in the first quarter of 2024.

 Remicade
and Simponi are trademarks of Janssen; Humira is a trademark of AbbVie Inc.; Cimzia is a trademark of UCB S. A.;
Enbrel, Prolia and Xgeva are trademarks of Amgen Inc.

 TNX-801
– Potential Smallpox and Mpox Vaccine

 TNX-801 is a novel potential
smallpox- and mpox-preventing vaccine based on a synthetic version of live horsepox virus, grown in cell culture. Though it shares structural
characteristics with vaccinia-based vaccines, TNX-801 has unique properties that we believe indicate potential safety advantages over
existing live replicating vaccinia virus vaccines, which have been associated with adverse side effects such as myopericarditis in some
individuals. Emergent BioSolutions' ACAM2000 is the only replicating vaccinia virus vaccine currently approved by the
FDA to protect against smallpox. We believe replicating virus vaccines have potential efficacy advantages over non-replicating vaccines,
relating to the stimulation of cell mediated immunity. Bavarian Nordic's Jynneos is the only non-replicating virus vaccine
currently approved by the FDA to protect against smallpox and mpox. Jynneos requires two-doses, with an efficacy of approximately
35% after one dose. During the most recent mpox outbreak in the United States, dropout between doses was 24%. We believe TNX-801 has
the potential to have improved tolerability relative to replicating vaccinia vaccines and the potential to have improved efficacy relative
to non-replicating vaccinia vaccines. We also believe that TNX-801 would require only one dose.

 Smallpox was eradicated by
a World Health Organization program that vaccinated individuals with live replicating vaccinia vaccines wherever smallpox appeared. In
the 1970s, vaccination of civilians to protect against smallpox was discontinued in the U.S.; however, smallpox remains a material threat
to national security and a proportion of military personnel, including members of the Global Response Force, continue to be vaccinated.
The Bipartisan Commission on Biodefense (2024) noted that "Smallpox and other orthopoxviruses pose significant threats to the United
States and the world due to their potential for weaponization, accidental release, and vulnerability of populations who stopped routinely
vaccinating against smallpox in the 1970s" (Bipartisan Commission on Biodefense.

 We
are developing TNX-801 as a potential smallpox- and mpox-preventing vaccine for the U.S. strategic national stockpile and for
potential widespread immunization in the event of malicious reintroduction of variola, the virus that causes smallpox.

 Mpox remains a growing epidemic threat
in certain regions of Africa and beyond. Starting in May of 2022, cases of mpox have been reported outside of Africa in patients who had
not been infected while in Africa. More than 93,000 cases have been reported as of Feb. 2024 with 32,000 reported in the U.S. according
to the U.S. Centers for Disease Control and Prevention.

 In January 2020 at the American Society of Microbiology Biothreats conference,
we reported the results of experiments on TNX-801 that were performed in collaboration with Southern Research, that showed TNX-801 vaccinated
macaques were protected against monkeypox challenge. The TNX-801 vaccinated macaques showed no overt clinical signs after monkeypox challenge.
Furthermore, eight of eight animals vaccinated with two different doses of TNX-801 showed no lesions after monkeypox challenge. These
results were published in the peer-reviewed journal Viruses in 2023. In October 2023, at the World Vaccine Congress - Europe, we
reported that the TNX-801 vaccine was shown to be greater than 10-1,000 fold more attenuated than older vaccinia-based smallpox vaccines
in both human primary cell lines and immunocompromised mice and that work has been posted on BioRxiv, which is not peer-reviewed.

 We
hold a U.S. Patent for TNX-801 smallpox and mpox vaccine and Recombinant Pox Virus (RPV) platform technology. This patent is expected
to provide Tonix with U.S. market exclusivity until 2037, excluding any possible patent term extensions or patent term adjustments.
In addition, we expect that TNX-801 will be eligible for 12 years of non-patent-based exclusivity under the Patient Protection
and Affordable Care Act, or PPACA.

 In
August 2023 we received pre-IND meeting written responses from the FDA. Tonix believes the
FDA feedback provides a path to agreement on the design of a Phase 1/2 study and the overall clinical development plan. The Phase
1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance
of an IND. We are actively working to develop a vaccine that meeting cGMP quality to support a clinical study.

 TNX-1800
– Potential COVID-19 Vaccine

 TNX-1800 is an attenuated, live virus
vaccine based on our RPV platform that expresses the SARS-CoV-2 spike protein from the ancestral Wuhan strain. TNX-1800 is being further
developed to rapidly address new variants as they emerge. The vaccine platform itself can carry a payload of genes. The vaccine protects
against COVID-19 by eliciting a durable T cell, humoral and mucosal immune response. It is delivered in only one dose and is being configured
for simplified delivery by using a microneedle patch to increase accessibility and acceptability. In November 2023, Tonix announced that
the NIAID, a part of the NIH, will conduct a Phase 1 clinical trial with TNX-1800 as part of the Project NextGen Covid-19 Vaccine initiative.
This NIAID/NIH program is funded to take selected NextGen vaccine candidates into Phase 1 and Phase 2 trials.

 The COVID-19 vaccines that are
approved for use in the U.S. have provided significant health benefits to the vaccinated population; however, they have shown
limitations in the durability of protection conferred and in their limited ability to block the spread of infection (forward
transmission). Live virus vaccines that protect against other viral diseases by eliciting T cell responses have shown durability of
protection that lasts years to decades and some live virus vaccines have significantly inhibited forward transmission (e.g.
smallpox). The TNX-1800 vaccine development plan is wholly consistent with priority vaccine attributes advanced by the White House
Office of Science and Technology Policy's Pandemic Preparedness Plan ("AP3") from September 2021, the National
Biodefense Science Board report from August 2023, and the BARDA Strategic Plan 2022-2026. Tonix believes its RPV platform can
address a wide variety of disease targets of public health interest.

 The results of a non-human
primate study data showing the protective effect of TNX-1800 vaccine was published in the peer-reviewed journal Vaccines in 2023
and show that TNX-1800 induces complete protection against SARS-CoV-2 infection as well as evidence that indicates an impact on spread
of infection. These data also confirm that "take" is a biomarker of protection of upper and lower airways from SARS-CoV-2
challenge, and a biomarker of immunological response to TNX-1800's cargo COVID-19 antigen, which is the CoV-2 spike protein. Tonix
has also began undertaking studies to show attenuation of the RPV platform itself, in order to evaluate the potential use of the live
vaccine platform in the immunocompromised host by the use of mouse model system. These data (detailed below) demonstrate that the RPV
vaccine platform that is used for TNX-1800 is >10- to 1,000-fold more attenuated than older VACV-based smallpox vaccines in human
primary cell lines and immunocompromised mice (Trefry, SV et al. Recombinant chimeric Horsepox Virus (TNX-801) is attenuated relative
to Vaccinia Virus Strains in Human Primary Cell Lines and in Immunocompromised Mice.

 We received pre-IND meeting
written responses from the FDA in 2021 regarding our investigational plan to establish the safety and effectiveness evidence in support
of the licensure of TNX-1800. We believe that the FDA feedback provides a clear pathway forward towards utilizing its underlying RPV platform
for a COVID-19 vaccine.

 We
announced the issuance of U.S. Patent for TNX-801 smallpox and mpox vaccine and RPV platform technology.
This patent is expected to provide Tonix with U.S. market exclusivity until 2037, excluding any possible patent term extensions
or patent term adjustments, and also expect 12 years of non-patent-based exclusivity under PPACA.

 Scientific
Results

 At the World Vaccine Congress in October
2023, Tonix presented its positive, published non-human primate data for the TNX-1800 (spike from Wuhan strain) from animal challenge
studies using live SARS-CoV- 2. In this study TNX-1800 vaccinated, SARS-CoV-2 challenged animals had undetectable SARS-CoV-2 in the upper
airways, which we believe relates to potential inhibition of forward transmission of this respiratory pathogen. Further, as an expected
additional outcome, all 16 animals vaccinated with either dose of TNX-1800 or the control TNX-801 manifested a "take", or
cutaneous response, signaling that the horsepox vector elicits a strong T cell immune response. These results support the expectation
that TNX-1800 at the low dose of 1 x 10 6 PFU is an appropriate dose for a one-dose vaccine in humans. These data were
published in the peer-reviewed journal Vaccines in 2023.

 Additional studies have been undertaken to show attenuation of the RPV platform
alone (TNX-801), in order to evaluate the potential use of this live vaccine in the immunocompromised host. These data demonstrate that
the RPV platform used with TNX-1800 is >10- to 1,000-fold more attenuated than older VACV-based smallpox vaccines in human primary
cell lines and immunocompromised mice.

 TNX-1900
–Adolescent Obesity, Binge Eating Disorder and Social Anxiety

 TNX-1900
(intranasal potentiated oxytocin) is a proprietary formulation of oxytocin primarily in development under investigator-initiated
INDs for the treatment of adolescent obesity, binge eating disorder, bone health in pediatric autism, and social anxiety disorder.
In 2020, TNX-1900 was acquired from Trigemina, Inc. and licensed from Stanford University. TNX-1900 is a drug-device combination
product, based on an intranasal actuator device that delivers oxytocin into the nose.

 Oxytocin
is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential.
It has been observed that low oxytocin levels in the body can lead to an increase in migraine headache frequency, and that increased
oxytocin levels can relieve migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin
levels.

 With
TNX-1900, the addition of magnesium to the oxytocin formula enhances oxytocin receptor binding as well as its effects on trigeminal
neurons and craniofacial analgesic effects in animal models. Intranasal oxytocin has been well tolerated in several clinical trials
in both adults and children.

 We
initiated a Phase 2 study of TNX-1900 for the prevention of migraine headaches in chronic migraineurs in the first quarter of
2023. Topline results from the study, reported in December 2023, showed that TNX-1900 did not meet the primary endpoint of reducing
migraine days. We discontinued the program. TNX-1900 was generally well-tolerated with no treatment-emergent serious or severe
adverse events.

 There
are three ongoing Phase 2 investigator-led studies enrolling at MGH: the POWER study for the treatment of adolescent obesity,
the STROBE study for the treatment of BED, and the BOX study for the treatment of bone health in pediatric autism. In addition
to the studies at MGH, Tonix is conducting an investigator-initiated study of TNX-1900 for the treatment of SAD at the University
of Washington.

 Tonix's
Facilities Overview

 Relating
to our COVID-19 and other infectious disease development programs, we seek to be a leader in the movement to re-build domestic
U.S. research, development and manufacturing capabilities. Because this movement follows a protracted period when domestic research,
development and manufacturing were moved out of the U.S., or "off-shore" by other companies to save on labor and other
costs, the movement to reverse that trend has been described as "on-shoring" or "re-domestication". The
COVID-19 pandemic demonstrated that national borders may close during a health emergency. Therefore, domestic capabilities are
essential for the health security of the U.S., which has also been described as pandemic preparedness and biodefense. As articulated
in the American Pandemic Preparedness Plan, or AP3 released by the U.S. Office of Science and Technology Policy, this 100-day
goal for vaccines is a key component of preparedness for future pandemics. Our goal is to establish the infrastructure necessary
to support the pandemic preparedness goals established in the AP3, specifically with respect to our RPV vaccine platform and potentially
to other vaccine and therapeutic platforms.

 The
Research & Development Center (RDC)

 We
own the approximately 48,000 square foot RDC facility in Frederick, Maryland. The RDC facility is operational and focuses on our
development of vaccines and antiviral drugs against COVID-19, its variants, and other infectious diseases. The RDC also conducts
research on CNS and immunology drugs. The RDC facility is biosafety level 2 (BSL-2) with BSL-3 components.

 The
Advanced Development Center (ADC)

 The
ADC located in the New Bedford business park in Dartmouth, Massachusetts is operational and intended to accelerate development
and clinical scale manufacturing of live-virus vaccines and biologics to support Phase 1 and Phase 2 clinical trials. ADC includes
single-use bioreactors and purification suites with equipment for Good Manufacturing Practice (GMP) production of vaccines for
and biologics clinical trials, including the capability of producing sterile vaccines in glass bottles.

 The ADC is an approximately 45,000
square foot BSL-2 facility which can employ up to 70 researchers, scientists, manufacturing, and technical support staff. We have engaged
CBRE, an international real estate brokerage firm, to find a strategic partner for, or buyer of, ADC.

 Marketing,
Sales and Distribution

 Marketing activity for Zembrace
Symtouch and Tosymra in the United States will be conducted by our wholly-owned subsidiary, Tonix Medicines, Inc. We focus our sales and
marketing efforts on physicians in private practice and in public treatment systems. We employ standard pharmaceutical marketing practices
to promote our products, encompassing advertisements, professional symposia, sales initiatives, and educational outreach aimed at physicians,
nurses, social workers, counselors, and other stakeholders involved in treating acute migraine in adults. We have established contracts
with third-party vendors to handle logistics, offer customer services, and manage other related aspects for our products. These services
include managing product-specific websites, conducting insurance research, processing orders, and handling delivery and fulfillment services.
Zembrace Symtouch and Tosymra are primarily sold to pharmaceutical wholesalers, pharmacies, and specialty distributors.

 We
intend to implement patient access programs and expand distribution channels in our marketing efforts for our migraine drugs.

 Competition

 Our
sector faces intense competition and experiences rapid, substantial technological advancements both domestically and internationally.
Our potential competitors encompass major pharmaceutical and biotechnology firms, specialty pharmaceutical and generic drug manufacturers,
academic institutions, government agencies, and research organizations. We consider efficacy, safety, tolerability, reliability,
pricing, and reimbursement levels as crucial competitive factors influencing the development and commercial success of our product
candidates. Numerous potential competitors, including some of the organizations listed below, possess considerably larger financial,
technical, and human resources, as well as extensive experience in discovering and developing product candidates, securing FDA
and other regulatory approvals, and commercializing those products, far surpassing our own capabilities. Hence, our competitors
might achieve greater success in securing FDA approval for drugs and gaining widespread market acceptance compared to us. The
drugs offered by our competitors may prove to be more effective or better marketed and sold than any product we bring to market,
potentially rendering our product candidates obsolete or non-competitive before we can recoup the expenses incurred in their development
and commercialization. We expect to encounter heightened competition as the market sees the introduction of new drugs and the
emergence of advanced technologies. Additionally, the evolution of novel treatment approaches for the conditions we are focusing
on may potentially diminish the competitiveness or relevance of our drugs. Below, we provide an overview of the competitive landscape
for the indications where Tonix has product candidates either in or nearing the clinical stages of development.

 Migraine

Symtouch and Tosymra are indicated for the treatment of acute migraine and compete with generic versions of sumatriptan.
Zembrace is an autoinjector formulation of sumatriptan and competes with generic subcutaneous products. Tosymra is an intranasal
formulation of sumatriptan and competes with generic intranasal products. Zembrace and Tosymra also compete with the new molecular
entities including oral migraine therapies such as Nurtec (Rimegepant) from Pfizer Inc. and Ubrelvy (Ubrogepant) and
QULIPTA (atogepant) from AbbVie Inc. and intranasal migraine therapies such as Zavzpret (vazegepant) by Pfizer, Inc.

 Fibromyalgia

 Tonix is developing TNX-102
SL for the treatment of fibromyalgia. Products approved for the treatment of fibromyalgia include Lyrica (pregabalin), developed
by Pfizer, Inc., Cymbalta (duloxetine), developed by Eli Lilly and Company, and Savella (milnacipran) marketed by AbbVie. Pregabalin
and duloxetine are available as generics, while Savella still enjoys exclusivity. Tonix is aware of several other companies developing
treatments for fibromyalgia. Axsome Therapeutics expects to submit an NDA for AXS-14 (esreboxetine) for the management of fibromyalgia in
the first half of 2024. UCB S.A. is developing Rystiggo (rozanolixizumab), a monoclonal antibody targeting the neonatal Fc receptor
(FcRn) blocker in a Phase 2 trial to treat adults with severe fibromyalgia syndrome. Scilex Pharmaceuticals, Inc. have a Phase 1, open
label, randomized, single-dose, 3-period, 3-treatment crossover study to evaluate the pharmacokinetics of SP-104 under fasting and fed
conditions and to compare to Naltrexone Hydrochloride Tablets USP in healthy adult subjects in New Zealand. Virios Therapeutics, Inc.
is investigating IMC-1 for the treatment of fibromyalgia. In September 2023, Tryp Therapeutics, Inc. initiated a Phase IIa, open-label,
pilot study to assess the safety and efficacy of Psilocybin (TRP-8802) administration in concert with psychotherapy among adult patients
with fibromyalgia. In the first quarter of 2024, Silo Pharma announced preclinical data on SP-26, its novel time-released, dose-controlled
formulation of ketamine initially targeted for fibromyalgia.

 Long
COVID (Post-Acute Sequelae of SARS-CoV-2 Infection or PASC)

 There
currently are no approved products for the treatment of long COVID/PASC. Tonix is aware of several companies developing therapeutics
for long COVID including, but not limited to, Direct Biologics, LLC (DB-001 in Phase III), American CryoStem Corporation, Ampio
Pharmaceuticals, Inc. (AMPE), Pieris Pharmaceuticals, Inc., Resolve Therapeutics, LLC, GeNeuro, Organicell Regenerative Medicine,
Inc., Berlin Cures Holding AG (Phase II currently enrolling in Europe) and Statera BioPharma, Inc.

 PaxMedica, Inc. is developing PAX-101 for the treatment of long COVID-19. Virios Therapeutics, Inc. announced
that it is targeting the initiation of a phase II program for IMC-2 (combination of valacyclovir and celecoxib) as a treatment for the
fatigue, orthostatic intolerance and other symptoms associated with Long COVID in second half of 2024.

 Acute
Stress Reaction/Acute Stress Disorder (ASR/ASD)

 There are no approved drugs
for treating ASR or for the prevention of ASD or PTSD.

 Cocaine
Intoxication

 There are no approved antidotes
for the treatment of cocaine intoxication. Patients generally receive supportive care. We are not aware of any drugs in development for
the treatment of cocaine intoxication. We are aware of companies that are targeting cocaine use disorder and we monitor their progress.

 Anti-CD40-ligand
Monoclonal Antibodies

 We are aware of several companies
developing biologics that target the CD40L molecule and block its interaction with CD40 including Sanofi, UCB, Eledon Pharmaceuticals,
and Amgen (which acquired Horizon Therapeutics plc). In February 2024, Sanofi published their Phase II clinical trial of frexalimab in
people with relapsing multiple sclerosis in The New England Journal of Medicine. The phase II trial involving participants with
multiple sclerosis, inhibition of CD40L with frexalimab had an effect that generally favored a greater reduction in the number of new
gadolinium-enhancing T1-weighted lesions at week 12 as compared with placebo. In August 2023, H.Lundbeck A/S (in partnership with AprilBio)
completed their phase I, 2-part, single ascending dose, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of Lu AG22515 (APB-A1) in healthy adult subjects. There are multiple companies in the process
of developing antagonistic anti-CD40 mAbs, including Novartis, Boehringer Ingelheim GmbH, Kiniska Pharmaceuticals, Boston Immune Therapies,
and NapaJen Pharma Inc.

 Prader-Willi
Syndrome (PWS)

 Somatropin, which targets the Growth Hormone
Receptor is approved in the U.S. and marketed by Pfizer Inc. and Novo Nordisk. Novartis AG markets Omnitrope in Europe. There are
no approved products for the treatment of hyperphagia or over-eating in PWS. Patients generally receive care to best manage individual
symptom presentation. ACADIA Pharmaceuticals Inc. currently have ACP-101 (intranasal carbetocin) (acquired Levo Therapeutics in June 2022)
in a Phase 3, randomized, double-blind, placebo-controlled, 8-week clinical study to assess the efficacy, safety, and tolerability, of
ACP-101 in PWS with long term follow-up. Soleno is developing diazoxide chloride controlled release (DCCR) which had positive results
in a randomized withdrawal study of PWS and based on which Soleno expects to file an NDA. Tonix is aware of several companies that are
focused on developing a therapeutic for the treatment of PWS including, but not limited to, Aadvark Therapeutics, ConSynance Therapeutics,
Lipidio Pharma, Helsinn, Inversago Pharma, Saniona, 9 Meters Biopharma, Neuren Pharmaceuticals, Neuracle Science, Harmony Biosciences
Holding Inc., and Notitia Biotechnologies.

 Carmot
Therapeutics Inc. announced that they plan to release Phase I single ascending dose (SAD)/MAD data for CT-PYY in 2025 for the
treatment of PWS. Harmony Biosciences Holdings, Inc. just received Orphan Drug Designation for their asset Wakix (pitolisant hydrochloride)
for the treatment of PWS. Harmony Biosciences announced initial topline results from its Phase II proof-of-concept study in patients
with PWS, which showed a signal on improvement in the primary outcome related to excessive daytime sleepiness in November 2022.
Neuren Pharmaceuticals Limited initiated their Phase II in August 2023.

 Gastric
and Colorectal Cancer

 The effectiveness of KEYTRUDA
has sparked a surge of activity in the field of oncology and immunotherapy, driving a multitude of research endeavors focused on enhancing
cancer treatment results and prolonging patient survival. GRANITE for colorectal
cancer is in Phase III for Gritstone bio, Inc. Last year, Amgen Inc. announced topline results for the global Phase III CodeBreaK
300 study evaluating LUMAKRAS combined with Vectibix vs current standard of care in chemorefractory metastatic KRAS G12C-mutated
colorectal cancer. Again in 2023, Bexion Pharmaceuticals announced that the first adult patient has been dosed in the Phase Ib/II
placebo controlled, double blinded study on the efficacy and safety of BXQ-350 in combination with mFOLFOX7 and Bevacizumab in newly
diagnosed metastatic colorectal carcinoma. Several other companies developing biologics for the treatment of gastric and colorectal cancer
include Medivir AB (Birinapant), PDS Biotechnology Corporation, GSK plc (Jemperli) in partnership with AnaptysBio, Inc.

 COVID-19
Vaccine

 Vaccines for COVID-19 granted full FDA regulatory approval include Comirnaty
(BNT162b2), marketed by Pfizer-BioNTech, Spikevax (mRNA-1273), marketed by Moderna, Inc. and Covovax (NVX-CoV2373) marketed
by Novavax. Other vaccines have received emergency use authorization ("EUA") in international markets. Other companies developing
COVID-19 vaccines include Ocugen Inc., Invivyd, Inc. and Vaxxinity, Inc.. Ocugen's OCU500 was selected by NIH/NIAID Project NextGen
for clinical trials.

 Smallpox
and Mpox Vaccines and Antivirals

 Vaccines approved
for the prevention of smallpox include ACAM2000, marketed by Emergent BioSolutions and JYNNEOS, marketed by Bavarian Nordic.
JYNNEOS is also approved for the prevention of mpox. Approved antivirals for smallpox include TPOXX, marketed by SIGA and TEMBEXA,
marketed by Chimerix. These antivirals are not FDA approved for the treatment of mpox. Tonix is aware of other companies developing treatments
for smallpox and mpox including Moderna, EpiVax, Inc., Emergex Vaccines Holding Ltd., BioFactura, Blue Water Vaccines, NightHawk Biosciences,
Ascletis Pharma, Inc., and Hyundai Bioscience Co., Ltd.

 Intellectual
Property

 We
believe that we have an extensive patent portfolio and substantial know-how relating to Tonmya/TNX-102 SL, Zembrace, Tosymra,
TNX-1300, TNX-1500, TNX-2900, TNX-1900, TNX-801, TNX-1800 and TNX-1700, and our other product candidates. Our patent portfolio,
described more fully below, includes claims directed to various compositions and methods of use related to our product candidates.
As of March 8, 2024, the patents we are either the owner of record of or own the contractual right to include 42 issued U.S. patents
and 337 issued non-U.S. patents. We are actively pursuing an additional 23 U.S. non-provisional patent applications, 4 international
patent applications, and 237 non-U.S./non-international patent applications.

 We
strive to protect the proprietary technology that we believe is important to our business, including our proprietary technology
platform, our product candidates, and our processes. We seek patent protection in the U.S. and internationally for our products,
their methods of use and processes of manufacture, and any other technology to which we have rights, where available and when
appropriate. We also rely on trade secrets that may be important to the development of our business.

 Our
success will depend on 1) the ability to obtain and maintain patent and other proprietary rights in commercially important technology,
inventions and know-how related to our business, 2) the validity and enforceability of our patents, 3) the continued confidentiality
of our trade secrets, and 4) our ability to operate without infringing the valid and enforceable patents and proprietary rights
of third parties. We also rely on continuing technological innovation and in-licensing opportunities to develop and maintain our
proprietary position.

 We
cannot be certain that patents will be granted with respect to any of our pending patent applications or with respect to any patent
applications we may own or license in the future, nor can we be certain that any of our existing patents or any patents we may
own or license in the future will be useful in protecting our technology. For this and more comprehensive risks related to our
intellectual property, please see "Risk Factors — Risks Relating to Our Intellectual Property."

 The
term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries
in which we file, the patent term is 20 years from the date of filing the first non-provisional priority application. In the United
States, a patent's term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays
by the PTO in granting a patent or may be shortened if a patent is terminally disclaimed over another patent.

 The
term of a U.S. patent that covers a drug approved by the FDA or methods of making or using that drug may also be eligible for
patent term extension, which permits patent term restoration as compensation for the patent term lost during the FDA regulatory
review process. The Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, is a federal law
that encourages new drug research by restoring patent term lost to regulatory delays by permitting a patent term extension of
up to five years beyond the statutory 20-year term of the patent for the approved product or its methods of manufacture or use
if the active ingredient has not been previously approved in the U.S. The length of the patent term extension is related to the
length of time the drug is under regulatory review. A patent term extension cannot extend the remaining term of a patent beyond
a total of 14 years from the date of product approval and only one patent applicable to an approved drug may be extended. Similar
provisions are available in Europe and some other foreign jurisdictions to extend the term of a patent that covers an approved
drug.

 When
possible, depending upon the length of clinical trials and other factors involved in the filing of an NDA, we expect to apply
for patent term extensions for patents covering our product candidates and their methods of use.

 The
patent portfolios for our proprietary technology platform and our most advanced product candidates as of March 8, 2024 are summarized
below.

SL — Central Nervous System Conditions

 Our
patent portfolio for TNX-102 SL includes patents and patent applications directed to compositions of matter of CBP, formulations containing CBP, and methods for treating CNS conditions, such as TNX-102 SL for PTSD, for acute stress disorder,
for pain, fatigue and sleep disturbances in fibromyalgia, for alcohol abuse, for disordered sleep, for sexual dysfunction, for
depression in fibromyalgia, fatigue, e.g., CAP rates, post-acute sequelae of SARS-CoV-2 infection, and for agitation in neurodegenerative
conditions, e.g., AAD.

 Certain
eutectic compositions were discovered by development partners and are termed the "Eutectic Technology." The patent
portfolio for CBP compositions (e.g., TNX-102 SL) relating to the Eutectic Technology includes patents and patent applications
directed to eutectic compositions containing CBP, eutectic CBP formulations, methods for treating PTSD and other CNS conditions
utilizing eutectic CBP compositions and formulations, and methods of manufacturing eutectic CBP compositions. The Eutectic Technology
patent portfolio includes U.S. patents, such as U.S. Patent No. 9,636,408, U.S. Patent No. 9,956,188, U.S. Patent No. 10,117,936,
U.S. Patent No. 10,357,465, U.S. Patent No. 10,864,175, U.S. Patent No. 11,026,898, and U.S. Patent No. 11,839,594. These U.S.
patents and counterpart non-U.S. patents, and any U.S. and non-U.S. patents that issue in the future from this portfolio would
expire in 2034 or 2035, excluding any patent term adjustments or extensions.

 The
unique pharmacokinetic profile of TNX-102 SL, or the PK Technology, was discovered by Tonix and its development partners. The
patent portfolio for TNX-102 SL relating to the PK Technology includes patent applications directed to compositions of matter
of CBP, formulations containing CBP, methods for treating PTSD, agitation in neurodegenerative conditions, and other CNS conditions
utilizing these compositions and formulations. The PK Technology patent portfolio includes U.S. Patent Application No. 13/918,692.
If U.S. and non-U.S. patents claiming priority from those applications issue, those patents would expire in 2033, excluding any
patent term adjustments or extensions.

 On
May 2, 2017, U.S. Patent No. 9,636,408 entitled "Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride", issued. The patent claims recite pharmaceutical compositions comprising the eutectic. The patent claims
also recite methods of manufacturing the eutectic.

 On
September 13, 2017, European patent 2,501,234, entitled "Methods and Compositions for Treating Symptoms Associated with
PTSD Using Cyclobenzaprine", issued. This patent recites the use of CBP for the treatment of PTSD. On January 11, 2024,
the European Patent Office Technical Board of Appeal reversed the October 2019 decision of the Opposition Division of the European
Patent Office maintaining the patent in unamended form and held the patent to be invalid. No appeal may be taken from that decision.

 On
December 15, 2017, Japanese Patent No. 6259452, entitled "Compositions and Methods for Transmucosal Absorption," issued.
These claims relate to the pharmacokinetic profile of TNX-102 SL.

 On
August 3, 2022, European Patent No. 2861223, entitled "Compositions and Methods for Transmucosal Absorption," issued.
These claims relate to the pharmacokinetic profile of TNX-102 SL.

 On
March 20, 2018, U.S. Patent No. 9,918,948 entitled "Methods and Compositions for Treating Symptoms Associated with PTSD
Using Cyclobenzaprine," issued. The claims recite a method of using TNX-102 SL's active ingredient cyclobenzaprine
to treat PTSD and provides TNX-102 SL with US market exclusivity until 2030, excluding any patent term extensions.

 On
March 23, 2018, Japanese Patent No. 6310542 entitled "Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride", issued. The claims recite pharmaceutical compositions comprising the eutectics and methods of manufacturing
these eutectic formulations.

 On
May 1, 2018, U.S. Patent No. 9,956,188, entitled "Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride", issued. The claims recite a eutectic of cyclobenzaprine hydrochloride and mannitol and methods of making
those eutectics.

 On
November 6, 2018, U.S. Patent No. 10,117,936, entitled "Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride", issued. The claims recite pharmaceutical compositions of eutectics of cyclobenzaprine hydrochloride and
mannitol and methods of making those compositions.

 On
April 16, 2019, Chinese Patent No. ZL 201480024011.1 entitled "Eutectic Formulations of Cyclobenzaprine Hydrochloride and
Amitriptyline Hydrochloride", issued. The claims recite pharmaceutical compositions comprising eutectics of cyclobenzaprine
hydrochloride and mannitol and methods of making those compositions.

 On
July 23, 2019, U.S. Patent No. 10,357,465 entitled "Eutectic Formulations of Cyclobenzaprine Hydrochloride", issued.
The claims recite a eutectic of cyclobenzaprine hydrochloride and mannitol and methods of making those eutectics.

 On
December 11, 2019, European patent 2968992, entitled "Eutectic Formulations of Cyclobenzaprine Hydrochloride", issued.
This patent recites pharmaceutical compositions comprising a eutectic of mannitol and Cyclobenzaprine HCl and methods of making
the same. In response to an opposition filed in September 2020 by Hexal AG, the European Patent Office's Opposition Division
upheld the patent in unamended form in the January 2022 oral proceedings. Hexal AG did not appeal that decision.

 On
December 25, 2019, European patent 2,683,245, entitled "Methods and Compositions for Treating Depression Using Cyclobenzaprine",
issued. The claims recite the use of CBP for the treatment of depression in a FM patient. This patent provides TNX-102 SL with
European market exclusivity until March 2032 and may be extended based on the timing of the European marketing authorization of
TNX-102 SL for depression in a FM patient. In September 2020, Hexal AG filed an opposition against this patent. The European Patent
Office's Opposition Division upheld the patent claims in unamended form at the February 2022 oral proceedings. Hexal AG
did not appeal that decision.

 On
December 15, 2020, U.S. Patent No. 10,864,175 entitled "Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride", issued. The claims recite a eutectic comprising cyclobenzaprine hydrochloride and beta-mannitol.

 On
December 12, 2023, U.S. Patent No. 11,839,594 entitled "Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride", issued. The claims recite a method of manufacturing a eutectic comprising cyclobenzaprine hydrochloride
and beta-mannitol comprising mixing or milling.

 On
February 14, 2024, European Patent No. 3,650,081, entitled "Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride", issued. The claims recite a eutectic of mannitol and cyclobenzaprine hydrochloride and methods of manufacturing
a eutectic.

 On
April 8, 2021, U.S. non-provisional Patent Application No. 17/226,058 and International Patent Application No. PCT/US2021/026492,
entitled "Cyclobenzaprine Treatment for Sexual Dysfunction" were filed. The PCT application is now nationalized in
Australia, Canada, China, European Patent Office, Japan, and Hong Kong. On October 5, 2022, International Patent Application No.
PCT/US2022/045791, entitled "Cyclobenzaprine Treatment for Sexual Dysfunction" was filed. The claims of these applications
are directed to methods using pharmaceutical compositions and combinations for treating sexual dysfunction with cyclobenzaprine
or pharmaceutically acceptable salts of cyclobenzaprine.

 On
October 25, 2016 and July 28, 2020, U.S. Patent No. 9,474,728 and U.S. Patent No. 10,722,478, entitled "Methods and Compositions
for Treating Fatigue Associated with Disordered Sleep Using Very Low Dose Cyclobenzaprine", issued, respectively. The claims
are directed to a method for monitoring the effectiveness of cyclobenzaprine treatment for disordered sleep and method for reducing
CAP rates A2 or A3 by treating a subject with a pharmaceutical composition comprising cyclobenzaprine.

 On
December 11, 2018, International Patent Application No. PCT/IB2018/001509, entitled "Cyclobenzaprine Treatment for Agitation,
Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions," was filed. The PCT application is now nationalized
in 16 countries. The claims are directed to methods for treating or preventing agitation, cognitive decline, psychosis, and associated
symptoms thereof using pharmaceutical compositions and combinations with cyclobenzaprine or pharmaceutically acceptable salts
of cyclobenzaprine.

 On
November 28, 2023, U.S. Patent No. 11,826,321, entitled "Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive
Decline in Dementia and Neurodegenerative Conditions," issued. The claims are directed to a method for treating or preventing
one or more agitation associated symptoms comprising administering a eutectic of cyclobenzaprine HCl and mannitol.

 On
August 20, 2019, International Patent Application No. PCT/IB2019/000940, entitled "Methods of Treating Acute Stress Disorder
and Posttraumatic Stress Disorder," was filed. The PCT application is now nationalized in 18 countries. The claims are directed
to methods of treating acute stress disorder or post-traumatic stress disorder in a subject who has experienced a traumatic event
using pharmaceutical compositions with cyclobenzaprine, amitriptyline or pharmaceutically acceptable salts of cyclobenzaprine
or amitriptyline.

 On
November 19, 2021, International Patent Application No. PCT/US2021/060011, entitled "Cyclobenzaprine Treatment for Alcohol
Use Disorder," was filed. The PCT application is now nationalized in 13 countries. The claims are directed to methods for
treating alcohol use disorder and associated symptoms using pharmaceutical compositions with cyclobenzaprine or pharmaceutically
acceptable salts of cyclobenzaprine.

 On
December 7, 2021, International Patent Application No. PCT/US2021/062244, entitled, "Cyclobenzaprine Treatment for Fibromyalgia,"
was filed. The PCT is now nationalized in 15 countries. The claims are directed to methods for treating fibromyalgia and its associated
symptoms of pain, sleep disturbance and/or fatigue by transmucosally administering a eutectic of cyclobenzaprine hydrochloride
and mannitol in dosage units with a basifying agent.

 On
June 21, 2023, U.S. non-provisional Patent Application No. 18/212,500 and International Patent Application No. PCT/US2023/025895,
entitled "Cyclobenzaprine Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)," were filed. The claims
are directed to methods of treating PASC or one or more associated symptoms comprising administering cyclobenzaprine or a pharmaceutically
acceptable salts of cyclobenzaprine.

 TNX-1900
— Oxytocin-Based Treatments for Obesity, Eating Disorders, Pain, Insulin Resistance, and Diabetes

 We
have acquired the migraine and pain treatment technologies of Trigemina, Inc., and have assumed its license rights to related
technologies from The Board of Trustees of the Leland Stanford Junior University. TNX-1900, an enhanced formulation of nasal oxytocin,
has demonstrated activity in several non-clinical studies in pain, including migraine.

 As
part of our acquisition, we acquired International Patent Application No. PCT/US2016/012512, filed on January 7, 2016, entitled
"Magnesium-Containing Oxytocin Formulations and Methods of Use" (nationalized in 13 countries). We also acquired U.S.
Patent Nos. 9,629,894 and 11,389,473, entitled "Magnesium-Containing Oxytocin Formulations and Methods of Use", which
will expire in January 2036, excluding any patent term extensions. On October 4, 2023, European Patent No. 3242676, entitled "Magnesium-Containing
Oxytocin Formulations and Methods of Use," issued.

 We
also have rights to International Patent Application No. PCT/US2019/020419, filed on April 12, 2017, entitled "Labeled Oxytocin
and Method of Manufacture and Use" (nationalized in the U.S., European Patent Office and Japan).

 We
have entered into an exclusive license to the University of Geneva's technology for using oxytocin to treat insulin resistance
and related syndromes, including obesity. This license expands our intranasal potentiated oxytocin development program, TNX-1900,
into cardiometabolic syndromes. Under the license, we have rights to European Patent No. EP2571511B1, entitled "New Uses
of Oxytocin-like Molecules and Related Methods." We also have rights to U.S. Patent No. 9,101,569, entitled "Methods
for the Treatment of Insulin Resistance." The U.S. and non-U.S. patents expire in May 2031, excluding any patent term adjustments
or extensions.

 TNX-2900
— Oxytocin-Based Therapeutics Treatments for Prader-Willi Syndrome (PWS)

 We
have licensed technology using oxytocin-based therapeutics for the treatment of PWS and non-organic failure
to thrive disease from the French National Institute of Health and Medical Research (INSERM). The co-exclusive license relates
to TNX-2900, an intranasal potentiated oxytocin, for the treatment of Prader-Willi syndrome and other feeding disorders. Under
the license, we have rights to European Patent No. EP2575853B1, entitled "Methods and Pharmaceutical Composition for the
Treatment of a Feeding Disorder with Early-Onset in a Patient"; U.S. Patent No. 8,853,158, entitled "Methods for the
Treatment of a Feeding Disorder with Onset During Neonate Development Using an Agonist of the Oxytocin Receptor"; and U.S.
Patent No. 9,125,862, entitled "Methods for the Treatment of Prader-Willi-like Syndrome or Non-Organic Failure to Thrive
(NOFITT) Feeding Disorder Using an Agonist of the Oxytocin Receptor." The U.S. and non-U.S. patents expire in May 2031,
excluding any patent term extensions.

 TNX-1300
— Cocaine Intoxication Treatment

 We
have licensed rights from The Trustees of Columbia University in the City of New York, The Regents of the University of Michigan,
and University of Kentucky Research Foundation to develop a potential product, TNX-1300, for the treatment of cocaine intoxication.
The licensed patents are directed to mutant cocaine esterase polypeptides and methods of using these polypeptides as anti-cocaine
therapeutics. They include U.S. Patent Nos. 8,318,156 and 9,200,265, entitled "Anti-Cocaine Compositions and Treatment"
and various counterpart patents outside of the U.S (e.g., European Patent 2046368). These patents provide TNX-1300 with US market
exclusivity until February 2029, and market exclusivity outside of the U.S. until July 10, 2027, subject to any patent term extensions.

 TNX-1500
— anti-CD40L Therapeutics

 We
are developing TNX-1500, a humanized mAb that targets CD40L for the prevention and treatment of organ transplant rejection. In
this regard, we filed International Application No. PCT/EP2020/068589, entitled "Anti-CD154 antibodies and uses thereof"
on July 1, 2020 (nationalized in 15 countries). We also filed International Patent Application No. PCT/US2020/028002 on April
13, 2020, entitled "Inhibitors of CD40-CD154 Binding" (nationalized in U.S., Canada, China, European Patent Office
and Japan). We also filed International Patent Application No. PCT/US2022/011404, entitled "Methods of Inducing Immune Tolerance
with Modified Anti-CD154 Antibodies" on January 6, 2022 (nationalized in 14 countries).

 TNX-801
— Live Horsepox Vaccine for Prevention of Smallpox and Mpox

 We
own the rights to develop a potential biodefense technology, TNX-801, a live horsepox that is being developed as a new smallpox
and mpox preventing vaccine, we have filed patent applications directed to synthetic chimeric poxviruses and methods of using
these poxviruses to protect individuals against smallpox. These applications include U.S. non-provisional Patent Application No.
15/802,189 and International Patent Application No. PCT/US2017/059782 (nationalized in 15 countries and filed in 4 non-PCT countries).
We also own the rights to develop other vaccine candidates against smallpox. With respect to these vaccine candidates, we own
International Patent Application No. PCT/US2019/030486 and the non-convention and national phase applications related thereto
(nationalized in 17 countries and filed in 2 non-PCT countries). The smallpox vaccine technologies relate to proprietary forms
of live horsepox and vaccinia vaccines which may be safer than ACAM2000, the only currently available replication competent, live
vaccinia vaccine to protect against smallpox disease. We believe that this technology, after further development, may be of interest
to biodefense agencies in the U.S. and other countries.

 On
May 31, 2022, U.S. Patent No. 11,345,896 was issued. The claims recite a synthetic chimeric orthopoxvirus (scOPV), a synthetic
chimeric horsepox virus (scHPXV), methods of generating the scOPV and scHPXV, and compositions comprising the scOPV or scHPXV.

 TNX-1800
and TNX-1850 — Live Modified Horsepox Vaccine for Prevention of COVID-19

 We
are developing TNX-1800 and TNX-1850, live attenuated modified HPXVs, as a COVID-19 preventing vaccine against different strains
of SARS-CoV-2. On February 26, 2021, we filed International Patent Application No. PCT/US2021/020119, entitled "Recombinant
Poxvirus Based Vaccine Against SARS-CoV-2." On the same date, we also filed applications in Argentina and Taiwan and we
filed U.S. Application No. 17/187,678. The PCT application is not nationalized in 19 countries. These applications are directed
to synthetic poxviruses comprising a SARS-CoV-2 virus protein, poxvirus delivery vectors for SARS-CoV-2 virus proteins and methods
of using these modified poxviruses to protect individuals against COVID-19.

 On
March 1, 2023, we filed International Patent Application No. PCT/US2023/063503, entitled "Recombinant Poxvirus Based Vaccine
Against the Omicron Strain of SARS-CoV-2 Virus and Variants Thereof." This application is directed to synthetic poxviruses
comprising a SARS-CoV-2 virus protein of an omicron strain, poxvirus delivery vectors for SARS-CoV-2 virus proteins of an omicron
strain and methods of using these modified poxviruses to protect individuals against the SARS-CoV-2 virus of an omicron strain.

 TNX-1700
— Recombinant Trefoil Family Factor 2 (rTFF2) to Treat Gastric and Pancreatic Cancers

 We
have licensed rights from The Trustees of Columbia University in the City of New York to develop a potential product, TNX-1700,
for the treatment of gastric and pancreatic cancers. The licensed patents are directed to rTFF2 compositions and methods of treatment.
The licensed patents U.S. Patent No. 10,124,037 and U.S. Patent No. 11,167,010. The licensed patents provide TNX-1700 with US
market exclusivity until April 2033, subject to any patent term extensions. On August 27, 2020, we filed International Patent
Application No. PCT/IB2020/000699 entitled "Modified TFF2 Polypeptides." The PCT application is now nationalized in
12 countries.

 TNX-1600
— Triple Reuptake Inhibitor to Treat PTSD

 We
have licensed rights from Wayne State University to develop a potential product, TNX-1600, for PTSD treatment. The licensed patents
directed to pyran-based derivatives and analogues.

 They
include U.S. Patent Nos. 7,915,433, 8,017,791, 8,519,159, 8,841,464, and 8,937,189, entitled "Tri-substituted 2-benzhydryl
5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel 3,6 disubstituted
pyran derivatives" and U.S. Patent No. 9,458,124, entitled "Substituted Pyran Derivatives". These patents provide
TNX-1600 with US market exclusivity between April 2024 and February 2034, respectively, subject to any patent term extensions.

 TNX-3900
— Antiviral Drugs

 We
have acquired the intellectual property rights of Healion Bio, Inc. to develop antiviral drugs. These rights include International
Patent Application No. PCT/US2021/032461 (nationalized in 6 countries) and U.S. Patent Application No. 18/055,596, both entitled
"Compositions and Methods for Increasing Efficacy of a Drug."

and Tosymra — Sumatriptan

 We have acquired the intellectual
property rights of Zembrace SymTouch and Tosymra and their uses in treating migraine from Upsher-Smith Laboratories, LLC. These rights
include U.S. Patent No. 9,211, 282, U.S. Patent No. 9,610,280, U.S. Patent No. 9,974,770, U.S. Patent No. 10,603,305, U.S. Patent No.
11,337,962, U.S. Patent No. 10,537,554, and U.S. Patent No. 11,364, 224. These rights also include International Patent Application No.
PCT/US2016/015961, entitled "Pharmaceutical Composition Comprising Sumatriptan for Treating Migraine," (nationalized in 7
countries, excluding rights in Brazil and China) and International Patent Application No. PCT/IB2010/001708, entitled "Formulations
Comprising Triptan Compounds," (nationalized in 11 countries, excluding rights in Brazil, Russia, India, and China).

 Trade
Secrets

 In
addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. For example, significant
aspects of our proprietary technology platform are based on unpatented trade secrets and know-how. Trade secrets and know-how
can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by confidentiality agreements
and invention assignment agreements with our employees, consultants, scientific advisors, contractors, and commercial partners.
These agreements are designed to protect our proprietary information and, in the case of the invention assignment agreements,
to grant us ownership of technologies that are developed through a relationship with a third party. We also seek to preserve the
integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and
electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems,
agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade
secrets may otherwise become known or be independently discovered by competitors. To the extent that our contractors use intellectual
property owned by others in their work for us, disputes may arise as to rights in related or resulting inventions and know-how.

 Issued
Patents

 Our
current patents owned or licensed include:

 Anti-Cocaine
Therapeutics

 No.

 Title

 Date

 8,318,156

 February 14, 2029

 9,200,265

 December 30, 2027

 2007272955

 2014201653

 2657246

 612929

 2046368 (602007045044.6
 in Germany; 502016000056543 in Italy)

 Office – Germany, Spain, France, United Kingdom, and Italy

 2009/00197

 305483

 196411

 Mutants of Cocaine
 Esterase (CocE) Polypeptide, Nucleic Acids Encoding Them, Pharmaceutical Compositions Comprising Them and Uses Thereof

 Sublingual
CBP/Amitriptyline

 No.

 Title

 Date

 6259452

 Japan

 631144

 I590820

 2013274003

 I642429

 726488

 I683660

 2018241128

 2876902

 IDP000076019

 382516

 2861223

 Office – Italy, Albania, Austria, Belgium, Bulgaria, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece,
 Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
 Slovenia, Spain, Sweden, Switzerland, United Kingdom, San Marino, Serbia, Croatia, North Macedonia and Turkey

 236268

 Compositions for
 Transmucosal Delivery and Uses Thereof

 2015/00288

 BR112014031394-6

 1209361

 398632

 A059897

 Venezuela

 MY-194495-A

 CBP
– Depression

 No.

 Title

 Date

 2012225548

 2016222412

 2018204633

 2020203874

 614725

 714294

 2,829,200

 2683245

 (AL/P/2020/15
 in Albania; MK/P/2020/68 in North Macedonia; 602012066717.6 in Germany; 3103147 in Greece; 502020000014740 in Italy; SM-T-202000083
 in San Marino; 60240 in Serbia; 202000139T4 in Turkey)

 Methods
 and Compositions for Treating Depression Using Cyclobenzaprine

 Office – Albania, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czechia, Germany, Denmark, Estonia, Spain, Finland,
 France, United Kingdom, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Monaco, Republic
 of North Macedonia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovakia, San Marino,
 and Turkey

 CBP
– PTSD

 No.

 Title

 Date

 9,918,948

 for Treating Symptoms Associated with Post-Traumatic Stress Disorder Using Cyclobenzaprine

 November 18, 2030

 CBP
Fatigue

 No.

 Title

 Date

 9,474,728

 for Treating Fatigue Associated with Disordered Sleep Using Very Low Dose Cyclobenzaprine

 June 9, 2031

 10,722,478

 for Treating Fatigue Associated with Disordered Sleep Using Very Low Dose Cyclobenzaprine

 June 9, 2031

 CBP
– Agitation in Neurodegenerative Condition

 No.

 Title

 Date

 11,826,321

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 December 11, 2038

 275289

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 December 11, 2038

 CBP/Amitriptyline

 No.

 Title

 Date

 631152

 747040

 9,636,408

 9,956,188

 10,117,936

 and Amitriptyline Hydrochloride

 10,322,094

 and Amitriptyline Hydrochloride

 10,357,465

 10,736,859

 10,864,175

 10,864,176

 11,026,898

 11,737,991

 11,839,594

 6310542

 Japan

 6614724

 Japan

 6717902

 Japan

 6088

 ZL201480024011.1

 China

 ZL.201580050140.2

 China

 2014233277

 2015317336

 I661825

 I740136

 Eutectic
 Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

 Taiwan
 R.O.C.

 March
 14, 2034

 IDP000055516

 and Amitriptyline Hydrochloride

 IDP000063221

 IDP000076872

 and Amitriptyline Hydrochloride

 2968992

 (1211591 in Austria, CZ2014-762323 in Czechia, 602014058260.5 in Germany,
E018723 in Estonia, P20200055 in Croatia, 201361792757 P in Ireland, 2020.67 in Monaco, P-2020/0094 in Serbia, 201431487 in Slovenia,
33269 in Slovakia, 2020000045 in San Marino, AL/P/2019/906 in Albania, MK/P/2020/67 in Republic of North Macedonia, 3102655 in Greece,
502020000007756 in Italy)

 Office - Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Republic of North
 Macedonia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway,
 Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom

 March
 14, 2034

 3650081

 Office - Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Republic of North
 Macedonia, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Norway,
 Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom

 241353

 251218

 of Cyclobenzaprine Hydrochloride and Methods of Producing Same

 277814

 of Cyclobenzaprine Hydrochloride and Methods of Producing Same

 September 18, 2034

 370021

 387402

 388137

 2015/07443

 2017/01637

 BR112015022095-9

 Pharmaceutical Composition,
 Method of Fabrication, Eutectic Composition and Use of Compositions Containing Cyclobenzaprine HCl and Mannitol

 2904812

 HK1218727

 MY-186047-A

 398845

 India

 441374

 India

 MY-196014-A

 ZL201910263541.6

 China

 2020289838

 HK40047283

 ZL202011576351.9

 China

 730379

 768064

of CBP

 No.

 Title

 Date

 11,517,557

 Analogs of Cyclobenzaprine
 and Amitryptilene

 July 13, 2037

 Oxytocin
therapeutics

 No.

 Title

 Date

 9,629,894

 11,389,473

 11201705591P

 388286

 253347

 7030517

 Japan

 ZL201680013809.5

 China

 3242676

 Europe – (Albania,
 Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
 Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Monaco, Netherlands, North Macedonia, Norway, Poland, Portugal, Romania,
 San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom)

 2017/05176

 1252942

 7093559

 Japan

 April 12, 2037

 2017250505

 April 12, 2037

 ZL201780036185.3

 China

 April 12, 2037

 40005263

 April 12, 2037

 2575853

 Methods and Pharmaceutical
 Composition for the Treatment of a Feeding Disorder with Early-Onset in a Patient

 Europe – (Spain,
 France, and United Kingdom)

 May 25, 2031

 8,853,158

 Methods for the
 Treatment of a Feeding Disorder with Onset During Neonate Development Using an Agonist of the Oxytocin Receptor

 May 25, 2031

 9,125,862

 Methods for the
 Treatment of Prader-Willi-like Syndrome or Non-Organic Failure to Thrive (NOFITT) Feeding Disorder Using an Agonist of the
 Oxytocin Receptor

 May 25, 2031

 2571511

 New Uses of Oxytocin-like
 Molecules and Related Methods

 Europe – (Switzerland,
 Spain, France, United Kingdom, and Ireland)

 May 17, 2031

 9,101,569

 Methods for the
 Treatment of Insulin Resistance

 June 22, 2031

 Nociceptin/Orphanin
FQ therapeutics

 No.

 Title

 Date

 8,551,949

 August 11, 2031

 9,238,053

 October 12, 2030

 2010281436

 ZL 201080042858.4

 China

 2459183 (602010028120.5
 in Germany)

 Europe – (Switzerland,
 Germany, Denmark, France, and United Kingdom)

 1169804

 329837

 597763

 10201406930U

 201200584

 2,769,347

 413642

 India

 Tianeptine
– Neurocognitive Dysfunction

 No.

 Title

 Date

 9,314,469

 Method for Treating
 Neurocognitive Dysfunction

 September 24, 2030

 2723688

 Method for Treating
 Neurodegenerative Dysfunction

 April 30, 2029

 2299822 (602009047361.1
 in Germany and E911827 in Austria)

 Method for Treating
 Neurodegenerative Dysfunction

 Office – Austria, Belgium, Switzerland, Germany, Spain, France, United Kingdom, Ireland, Luxembourg, Monaco, and Portugal

 April 30, 2029

 3246031 (602009057284.9
 in Germany)

 Method for Treating
 Neurocognitive Dysfunction

 Office – Austria, Belgium, Switzerland, Germany, Spain, France, United Kingdom, Ireland, Luxembourg, Monaco, and Portugal

 April 30, 2029

 Triple
reuptake inhibitor therapeutics

 No.

 Title

 Date

 7,915,433

 2-benzhydryl 5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel

 U.S.A

 March
 10, 2028

 8,017,791

 2-benzhydryl 5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel

 April 14, 2024

 8,519,159

 2-benzhydryl 5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel

 U.S.A

 December 7, 2025

 8,841,464

 2-benzhydryl 5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel

 U.S.A

 April 15, 2025

 8,937,189

 2-benzhydryl 5-benzlamino-tetrahydro-pyran-4-OL and 6-benzhydryl-4-benzylamino-tetrahydro-pyran-3-OL analogues, and novel

 U.S.A

 January 12, 2027

 9,458,124

 Substituted Pyran Derivatives

 U.S.A

 February 6, 2034

 TFF2
therapeutics

 No.

 Title

 Date

 10,124,037

 Trefoil family factor
 proteins and uses thereof

 U.S.A

 April 2, 2033

 11,167,010

 Trefoil family factor
 proteins and uses thereof

 U.S.A

 April 2, 2033

 No.

 Title

 Date

 11,345,896

 U.S.A

 November 2, 2037

 397516

 November 2, 2037

 2019/02868

 November 2, 2037

 MY-200354-A

 November 2, 2037

 Triptan
Compound – Formulations

 No.

 Title

 Date

 9,211,282

 U.S.A

 July 19, 2031

 9,610,280

 U.S.A

 June 16, 2030

 9,974,770

 U.S.A

 June 16, 2030

 10,603,305

 U.S.A

 June 16, 2030

 11,337,962

 June 16, 2030

 2010299607

 2775404

 2480197

 (502016000000073
in Italy

 Office - Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Spain, Switzerland, and United Kingdom

 5845183

 Japan

 101646079

 Republic of Korea

 338110

 599344

 2012/02168

 Triptan
Compound – Migraine

 No.

 Title

 Date

 10,537,554

 for Treating Migraine

 U.S.A

 January 29, 2036

 11,364,224

 for Treating Migraine

 U.S.A

 January 29, 2036

 385725

 Comprising Sumatriptan for Treating Migraine

 February 1, 2036

 2994748

 Comprising Sumatripan for Treating Migraine

 February 1, 2036

 Pending
Patent Applications

 Our
current pending patent applications are as follows:

 CD40
and anti-CD154 Therapeutics

 No.

 Title

 17/623,710

 2020300002

 BR112021026410-8

 3145453

 202080059891.1

 China

 20764933.6

 and uses thereof (Allowed)

 202217004870

 India

 P00202200763

 289354

 2021-578262

 Japan

 PI 2021007835

 MX/a/2022/000133

 784548

 11202114433Y

 2022/01378

 62022063693.5

 62022062573.0

 18/271,098

 2022205313

 BR112023013285-1

 3207098

 202280019221.6

 China

 22701768.8

 P00202307159

 304253

 2023-541043

 Japan

 PI 2023003993

 MX/a/2023/008055

 801414

 11202305000R

 2023/06791

 3136725

 20787970.1

 2021-560713

 Japan

 17/603,260

 202080033531.4

 China

 CBP/Amitriptyline

 No.

 Title

 18/385,468

 BR112017005231-8

 BR122020020968-2

 2,961,822

 3,119,755

 of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride (Allowed)

 15841528.1

 18101200.4

 42020003105.2

 of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride (Allowed)

 42020019748.1

 2023-188486

 Japan

 2023-116057

 Japan

 No.

 Title

 PI 20233000078

 517381123

 10201707528W

 10201902203V

 Eutectic
Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline Hydrochloride

 Eutectic
Formulations of Cyclobenzaprine Hydrochloride

 2014-000391

 Venezuela

 Sublingual
CBP/Amitriptyline

 No.

 Title

 13/918,692

 P20130102101

 20230100254

 3,118,913

 and Methods for Transmucosal Absorption (Allowed)

 202010024102.2

 China

 2013/24661

 2013/37088

 Gulf
Cooperation

 Gulf
Cooperation

 2013/40660

 42020020336.2

 P-00
 2021 01421

 2021-100154

 Japan

 10201605407T

 CBP
– Agitation in Neurodegenerative Condition

 No.

 Title

 18/382,262

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 2018383098

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 BR112020011345-0

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 3,083,341

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions (Allowed)

 201880079917.1

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 China

 18847270.8

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 P00202004178

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 202017023747

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 India

 2020-531611

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 Japan

 MX/a/2020/006140

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions (Allowed)

 PI2020002800

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 765792

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 520412146

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 2020/03243

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 6202002246.2

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 62021029558.5

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 523442519

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 10202303446R

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 2023-186441

 Treatment for Agitation, Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions

 Japan

 CBP
– Depression

 No.

 Title

 13/412,571

 for Treating Depression Using Cyclobenzaprine (Allowed)

of CBP

 No.

 Title

 18/075,386

 CA3069699

 201880050758.2

 EP18831505.5

of Cyclobenzaprine and Amitriptyline

of Cyclobenzaprine and Amitriptyline

of Cyclobenzaprine and Amitriptyline

of Cyclobenzaprine and Amitriptyline

 China

 European
Patent Office

 2020-526592

 Analogs of Cyclobenzaprine
 and Amitriptyline

 Japan

 CBP
– ASD and PTSD

 No.

 Title

 2019/38140

 108129709

 17/269,106

 2019323764

 PI2021000802

 772889

 BR112021003107-3

 3109258

 201980062283.3

 China

 19802247.7

 62021045278.0

 62022046260.5

 202117011223

 India

 P00202101716

 280921

 or Amitriptyline Containing Compositions for Use in Treating Stress Disorders

 2021-509201

 Japan

 MX/a/2021/002012

 11202101443W

 2021/01121

 CBP
– Fibromyalgia

 No.

 Title

 18/265,525

 2021396509

 3204202

 202180089897.8

 China

 21844438.8

 202317044026

 India

 P00202306147

 303497

 2023-542924

 Japan

 PI 2023003286

 MX/a/2023/006720

 800700

 523441103

 11202304340U

 2023/06139

 CBP
– Alcohol Use Disorder

 No.

 Title

 18/037,815

 2021382668

 112023009731-2

 3202722

 202180088339.X

 China

 21827298.7

 202317038485

 India

 303050

 2023-530204

 Japan

 MX/a/2023/005899

 800112

 11202303835Y

 2023/05747

 CBP
– Sexual dysfunction

 No.

 Title

 PCT/US2022/045791

 PCT

 17/226,058

 U.S.A

 2021253592

 3179754

 202180040673.8

 China

 21721779.3

 2022-562023

 Japan

 62023077251.4

 62023078964.1

 CBP
– Post-Acute Sequelae of SARS-CoV-2 (PASC)

 No.

 Title

 PCT/US2023/025895

 Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

 PCT

 18/212,500

 Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC)

 Oxytocin
therapeutics

 No.

 Title

 2020286221

 BR1120170145456

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 Trademarks
and Service Marks

 Tonix
Pharmaceuticals, Inc.

 We
seek trademark and service mark protection in the United States and outside of the United States where available and when appropriate.
We are the owner of the following U.S. federally registered mark: TONIX PHARMACEUTICALS (Reg. No. 4656463, issued December 16,
2014).

 We
are the owner of the following marks for which applications for U.S. federal registration are currently pending: FYMRALIN (Serial
No. 98/327953, filed December 22, 2023), MODALTIN (Serial No. 97/424052, filed May 23, 2022), RAPONTIS (Serial No. 97/424058,
filed May 23, 2022), PROTECTIC (Serial No. 97/424071, filed May 23, 2022), TONIX PHARMACEUTICALS (Serial No. 88/896150, filed
April 30, 2020), ANGSTRO-TECHNOLOGY (Serial No. 98/006538, filed May 22, 2023) and TONMYA (Serial No. 97/185424, filed December
22, 2021).

 Tonix
Medicines, Inc.

 We
seek trademark and service mark protection in the United States and outside of the United States where available and when appropriate.
We are the owner of the following U.S. federally registered marks: NOTIME4MIGRAINES (Reg. No. 5392512, issued January 30, 2018);
SYMTOUCH (Reg. No. 5186988, issued April 18, 2017); TOSYMRA (Reg. No. 5981221, issued February 11, 2020); TOSYMRA & DROPLET
Design (Reg. No. 6142333, issued August 11, 2020); ZEMBRACE (Reg. No. 5186989, issued April 18, 2017); ZEMBRACE SYMTOUCH (Reg.
No.5478282, issued May 29, 2018); DROPLET Design (Reg. No. 6117797, issued August 4, 2020). We are the owner of the following
International Registrations under the Madrid Protocol: TOSYMRA (Reg. No. 1501060, issued October 16, 2019 – Extensions of
Protection to: Canada, European Union, Japan, Republic of Korea, United Kingdom); ZEMBRACE (Reg. No. 1683288, issued August 17,
2022 – Extensions of Protection to: Canada (still pending), China, European Union, Israel, Mexico, United Kingdom); DROPLET
Design (Reg. No. 1545038, issued June 29, 2020 – Extensions of Protection to: Canada, European Union, Israel, Japan, Norway,
Republic of Korea, Switzerland, Turkey, United Kingdom).

and Development

 We
have approximately 71 employees dedicated to research and development. Our research and development operations are located in
Chatham, NJ, Dartmouth, MA, Frederick, Maryland, Dublin, Ireland and Montreal, Canada. We have used, and expect to continue to
use, third parties to conduct our nonclinical and clinical studies. We acquired the RDC in Frederick, Maryland consisting of two
buildings totaling approximately 48,000 square feet. The acquisition closed in October 2021 and is operational.

 Marketing

 We have two employees supporting
sales administration and marketing initiatives. We also have three sales employees who are focused on customer service
requests and top-tier headache specialists. We utilize third party vendors to support trade, managed markets, marketing initiatives,
and promotional compliance programs.

 Manufacturing

 We have contracted with third-party
cGMP-compliant contract manufacturer organizations("CMOs"), for the manufacture of TNX-102 SL drug substance and drug products
for clinical and commercial supply. Our manufacturing operations are managed and controlled out of our Dublin, Ireland offices.

 All
of our small molecules drug candidates are synthesized using industry standard processes, and our drug products are formulated
using commercially available pharmaceutical grade excipients.

 We
own a 45,000 square foot facility in Massachusetts, to house our new Advanced Development Center for accelerated development and manufacturing
of vaccines and biologics. As of October 1, 2022, the facility was ready for its intended use and is operational. This facility, in addition
to contract CMOs, is currently used for the manufacture of nonclinical and clinical investigational products for our Immunology and Infectious
Disease portfolio. The current focus of which is TNX-1500 for Organ Transplant Rejection/Autoimmune Disorders, TNX-01 a Smallpox and
Monkeypox Preventing Vaccine and TNX-1800 a COVID vaccine selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials.

 We
own an approximately 44-acre site in Hamilton, Montana, for the construction of a vaccine development and commercial scale manufacturing
facility. As of December 31, 2023, the facility was not ready for its intended use.

 Our two marketed products,
Zembrace and Tosymra, are manufactured at cGMP compliant, FDA audited, U.S. based CMOs with expertise in pre-filled syringe and inhalation
expertise.

 Government
Regulations

 The
FDA and other federal, state, local and foreign regulatory agencies impose substantial requirements upon the clinical development,
approval, labeling, manufacture, marketing and distribution of drug products. These agencies regulate, among other things, research
and development activities and the testing, approval, manufacture, quality control, safety, effectiveness, labeling, storage,
record keeping, advertising and promotion of our product candidates. The regulatory approval process is generally lengthy and
expensive, with no guarantee of a positive result. Moreover, failure to comply with applicable requirements by the FDA or other
requirements may result in civil or criminal penalties, recall or seizure of products, injunctive relief including partial or
total suspension of production, or withdrawal of a product from the market.

 The
FDA regulates, among other things, the research, manufacture, promotion and distribution of drugs in the U.S. under the FDCA and
other statutes and implementing regulations. The process required by the FDA before prescription drug product candidates may be
marketed in the U.S. generally involves the following:

 completion
 of extensive nonclinical laboratory tests, animal studies and formulation studies, all performed in accordance with the FDA's
 Good Laboratory Practice regulations;

 submission
 to the FDA of an IND, which must become effective before human clinical trials may begin;

 performance
 of adequate and well-controlled human clinical trials in accordance with the FDA's regulations, including Good Clinical
 Practices, to establish the safety and efficacy of the product candidate for each proposed indication;

 submission
 to the FDA of an NDA for drug products, or a Biologics License Application, or BLA, for biologic products;

 satisfactory
 completion of a preapproval inspection by the FDA of the manufacturing facilities at which the product is produced to assess
 compliance with cGMP regulations; and

 the
 FDA's review and approval of the NDA or BLA prior to any commercial marketing, sale or shipment of the drug.

 The
testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals
for our product candidates will be granted on a timely basis, if at all.

 Nonclinical
tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity
in animals and other animal studies. The results of nonclinical tests, together with manufacturing information and analytical
data, are submitted as part of an IND to the FDA. Some nonclinical testing may continue even after an IND is submitted. The IND
also includes one or more protocols for the initial clinical trial or trials and an investigator's brochure. An IND automatically
becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions
relating to the proposed clinical trials as outlined in the IND and places the clinical trial on a clinical hold. In such cases,
the IND sponsor and the FDA must resolve any outstanding concerns or questions before any clinical trials can begin. Clinical
trial holds also may be imposed at any time before or during studies due to safety concerns or non-compliance with regulatory
requirements. An independent Institutional Review Board, or IRB, at each of the clinical centers proposing to conduct the clinical
trial must review and approve the plan for any clinical trial before it commences at that center. An IRB considers, among other
things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated
benefits. The IRB also approves the consent form signed by the trial participants and must monitor the study until completed.

Trials

trials involve the administration of the product candidate to human subjects under the supervision of qualified medical investigators
according to approved protocols that detail the objectives of the study, dosing procedures, subject selection and exclusion criteria,
and the parameters to be used to monitor participant safety. Each protocol for a U.S. study is submitted to the FDA as part of
the IND.

 Human
clinical trials are typically conducted in three sequential phases, but the phases may overlap, or be combined.

 Phase
 1 clinical trials typically involve the initial introduction of the product candidate into healthy human volunteers. In Phase
 1 clinical trials, the product candidate is typically tested for safety, dosage tolerance, absorption, metabolism, distribution,
 excretion and pharmacodynamics.

 Phase
 2 clinical trials are generally conducted in a limited patient population to gather evidence about the efficacy of the product
 candidate for specific, targeted indications; to determine dosage tolerance and optimal dosage; and to identify possible adverse
 effects and safety risks. Phase 2 clinical trials, in particular Phase 2b trials, can be undertaken to evaluate clinical efficacy
 and to test for safety in an expanded patient population at geographically dispersed clinical trial sites.

 Phase
 3 clinical trials are undertaken to evaluate clinical efficacy and to test for safety in an expanded patient population at
 geographically dispersed clinical trial sites. The size of Phase 3 clinical trials depends upon clinical and statistical considerations
 for the product candidate and disease. Phase 3 clinical trials are intended to establish the overall risk-benefit ratio of
 the product candidate and provide an adequate basis for product labeling.

 Post-approval
clinical trials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial approval. These clinical trials
are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for
long-term safety follow-up.

testing must satisfy the extensive regulations of the FDA. Reports detailing the results of the clinical trials must be submitted
at least annually to the FDA and safety reports must be submitted for serious and unexpected adverse events. Success in early-stage
clinical trials does not assure success in later-stage clinical trials. The FDA, an IRB or we may suspend a clinical trial at
any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health
risk.

 New
Drug Applications

 Assuming
successful completion of the required clinical trials, the results of product development, nonclinical studies and clinical trials
are submitted to the FDA as part of an NDA (or BLA, in the case of a biologic product). An NDA or BLA also must contain extensive
manufacturing information, as well as proposed labeling for the finished product. An NDA or BLA applicant must develop information
about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in accordance
with cGMP. The manufacturing process must be capable of consistently producing quality product within specifications approved
by the FDA. The manufacturer must develop methods for testing the quality, purity and potency of the final product. In addition,
appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product does
not undergo unacceptable deterioration over its shelf life. Prior to approval, the FDA will conduct an inspection of the manufacturing
facilities to assess compliance with cGMP.

 The
FDA reviews all NDAs and BLAs submitted before it accepts them for filing. The FDA may request additional information rather than
accept an NDA for filing. In this event, the NDA or BLA must be resubmitted with the additional information and is subject to
review before the FDA accepts it for filing. After an application is filed, the FDA may refer the NDA or BLA to an advisory committee
for review, evaluation and recommendation as to whether the application should be approved and under what conditions. The FDA
is not bound by the recommendations of an advisory committee, but it considers them carefully when making decisions. The FDA may
deny approval of an NDA or BLA if the applicable regulatory criteria are not satisfied. Data obtained from clinical trials are
not always conclusive and the FDA may interpret data differently than we interpret the same data.

 The
FDA may issue a complete response letter, which may require additional clinical or other data or impose other conditions that
must be met in order to secure final approval of the NDA or BLA. If a product receives regulatory approval, the approval may be
significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict
the commercial value of the product. In addition, the FDA may require us to conduct Phase 4 testing which involves clinical trials
designed to further assess a drug's safety and effectiveness after NDA or BLA approval, and may require surveillance programs
to monitor the safety of approved products which have been commercialized. Once issued, the FDA may withdraw product approval
if ongoing regulatory requirements are not met or if safety or efficacy questions are raised after the product reaches the market.

 Section
505(b) NDAs

 There
are two types of NDAs: the Section 505(b)(1) NDA, or full NDA, and the Section 505(b)(2) NDA. We intend to file Section 505(b)(2)
NDAs for TNX-102 SL for FM, and FM-type Long COVID, and TNX-2900 for Prader Willi Syndrome and for certain other
products, that might, if accepted by the FDA, save time and expense in the development and testing of our product candidates. We may
need to file a Section 505(b)(1) NDA for certain other products in the future. A full NDA is submitted under Section 505(b)(1) of
the FDCA, and must contain full reports of investigations conducted by the applicant to demonstrate the safety and effectiveness of
the drug. A Section 505(b)(2) NDA may be submitted for a drug for which one or more of the investigations relied upon by the
applicant was not conducted by or for the applicant and for which the applicant has no right of reference from the person by or for
whom the investigations were conducted. A Section 505(b)(2) NDA may be submitted based in whole or in part on published literature
or on the FDA's finding of safety and efficacy of one or more previously approved drugs, which are known as reference drugs.
Thus, the filing of a Section 505(b)(2) NDA may result in approval of a drug based on fewer clinical or nonclinical studies than
would be required under a full NDA. The number and size of studies that need to be conducted by the sponsor depends on the amount
and quality of data pertaining to the reference drug that are publicly available, and on the similarity of and differences between
the applicant's drug and the reference drug. In some cases, extensive, time-consuming, and costly clinical and nonclinical
studies may still be required for approval of a Section 505(b)(2) NDA.

 Our
drug approval strategy for our new formulations of approved chemical entities is to submit Section 505(b)(2) NDAs to the FDA.
As such, we plan to submit an NDA under Section 505(b)(2) for TNX-102 SL for FM, FM-type Long COVID, and TNX-2900
for Prader Willi Syndrome. The FDA may not agree that these product candidates are approvable as a Section 505(b)(2) NDA. If the
FDA determines that a Section 505(b)(2) NDA is not appropriate and that a full NDA is required, the time and financial resources
required to obtain FDA approval could substantially and materially increase and be less likely to be approved. If the FDA requires
a full NDA or requires more extensive testing and development for some other reason, our ability to compete with alternative products
that arrive on the market more quickly than our product candidates would be adversely impacted. If reference listed products are
withdrawn from the market by the FDA for a safety reason, we may not be able to reference such products to support our anticipated
505(b)(2) NDAs, and we may be required to follow the requirements of Section 505(b)(1).

Protections

 An
applicant submitting a Section 505(b)(2) NDA must certify to the FDA with respect to the patent status of the reference drug upon
which the applicant relies in support of approval of its drug. With respect to every patent listed in the FDA's Orange Book,
which is the FDA's list of approved drug products, as claiming the reference drug or an approved method of use of the reference
drug, the Section 505(b)(2) applicant must certify that: (1) there is no patent information listed in the orange book for the
reference drug; (2) the listed patent has expired; (3) the listed patent has not expired, but will expire on a particular date;
(4) the listed patent is invalid or will not be infringed by the manufacture, use, or sale of the product in the Section 505(b)(2)
NDA; or (5) if the patent is a use patent, that the applicant does not seek approval for a use claimed by the patent. If the applicant
files a certification to the effect of clause (1), (2) or (5), FDA approval of the Section 505(b)(2) NDA may be made effective
immediately upon successful FDA review of the application, in the absence of marketing exclusivity delays, which are discussed
below. If the applicant files a certification to the effect of clause (3), the Section 505(b)(2) NDA approval may not be made
effective until the expiration of the relevant patent and the expiration of any marketing exclusivity delays.

 If
the Section 505(b)(2) NDA applicant provides a certification to the effect of clause (4), referred to as a paragraph IV certification,
the applicant also must send notice of the certification to the patent owner and the holder of the NDA for the reference drug.
The filing of a patent infringement lawsuit within 45 days of the receipt of the notification may prevent the FDA from approving
the Section 505(b)(2) NDA for 30 months from the date of the receipt of the notification unless the court determines that a longer
or shorter period is appropriate because either party to the action failed to reasonably cooperate in expediting the action. However,
the FDA may approve the Section 505(b)(2) NDA before the 30 months have expired if a court decides that the patent is invalid
or not infringed, or if a court enters a settlement order or consent decree stating the patent is invalid or not infringed.

 Notwithstanding
the approval of many products by the FDA pursuant to Section 505(b)(2), over the last few years certain brand-name pharmaceutical
companies and others have objected to the FDA's interpretation of Section 505(b)(2). If the FDA's interpretation of
Section 505(b)(2) is successfully challenged in court, the FDA may be required to change its interpretation of Section 505(b)(2)
which could delay or even prevent the FDA from approving any Section 505(b)(2) NDA that we submit. The pharmaceutical industry
is highly competitive, and it is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA
seeking to delay approval of, or impose additional approval requirements for, pending competing products. If successful, such
petitions can significantly delay, or even prevent, the approval of the new product. Moreover, even if the FDA ultimately denies
such a petition, the FDA may substantially delay approval while it considers and responds to the petition.

 Marketing
Exclusivity

 Market
exclusivity provisions under the FDCA can delay the submission or the approval of Section 505(b)(2) NDAs, thereby delaying a Section
505(b)(2) product from entering the market. The FDCA provides five-year marketing exclusivity to the first applicant to gain approval
of an NDA for an NCE, meaning that the FDA has not previously approved any other drug containing the same active moiety. This
exclusivity prohibits the submission of a Section 505(b)(2) NDA for any drug product containing the active ingredient during the
five-year exclusivity period. However, submission of a Section 505(b)(2) NDA that certifies that a listed patent is invalid, unenforceable,
or will not be infringed, as discussed above, is permitted after four years, but if a patent infringement lawsuit is brought within
45 days after such certification, FDA approval of the Section 505(b)(2) NDA may automatically be stayed until 7 years
after the NCE approval date. The FDCA also provides three years of marketing exclusivity for the approval of new and supplemental
NDAs for product changes, including, among other things, new indications, dosage forms, routes of administration or strengths
of an existing drug, or for a new use, if new clinical investigations, other than bioavailability studies, that were conducted
or sponsored by the applicant are deemed by FDA to be essential to the approval of the application.

 Five-year
and three-year exclusivity will not delay the submission or approval of another full NDA; however, as discussed above, an applicant
submitting a full NDA under Section 505(b)(1) would be required to conduct or obtain a right of reference to all of the nonclinical
and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

 Other
types of exclusivities in the United States include orphan drug exclusivity and pediatric exclusivity. The FDA may grant orphan
drug designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects
fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there
is no reasonable expectation that the cost of developing and making available in the United States a drug for this type of disease
or condition will be recovered from sales in the United States for that drug. Seven-year orphan drug exclusivity is available
to a product that has orphan drug designation and that receives the first FDA approval for the indication for which the drug has
such designation. Orphan drug exclusivity prevents approval of another application for the same drug for the same orphan indication,
for a period of seven years, regardless of whether the application is a full NDA or a Section 505(b)(2) NDA, except in limited
circumstances, such as a showing of clinical superiority to the product with orphan exclusivity. Pediatric exclusivity, if granted,
provides an additional six months to an existing exclusivity or statutory delay in approval resulting from a patent certification.
This six-month exclusivity, which runs from the end of other exclusivity protection or patent delay, may be granted based on the
voluntary completion of a pediatric study in accordance with an FDA-issued "Written Request" for such a study.

 Section
505(b)(2) NDAs are similar to full NDAs filed under Section 505(b)(1) in that they are entitled to any of these forms of exclusivity
if they meet the qualifying criteria. They also are entitled to the patent protections described above, based on patents that
are listed in the FDA's Orange Book in the same manner as patents claiming drugs and uses approved for NDAs submitted as
full NDAs.

 Breakthrough
Therapy Designation

 The
Food and Drug Administration Safety and Innovation Act, or FDASIA, Section 902 provides for Breakthrough Therapy designation.
A Breakthrough Therapy is a drug:

 intended
 alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and

 preliminary
 clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically
 significant endpoints, such as substantial treatment effects observed early in clinical development.

 Fast
Track Designation

 A
Fast Track is a designation by the FDA of an investigational drug which:

 intended
 alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition; and

 non-clinical
 or clinical data demonstrate the potential to address an unmet medical need

 Fast
track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill
an unmet medical need. The benefits of a Fast Track designation include rolling submission of portions of the NDA for the drug
candidate and eligibility for priority review of the NDA. Additionally, more frequent meetings and written communication with
the FDA regarding the development plan and trial design for the drug candidate are encouraged throughout the entire drug development
and review process, with the goal of having earlier drug approval and access for patients.

 Material
Threat Medical Countermeasures

 In
2016, the 21 st Century Cures Act, or Act, was signed into law to support ongoing biomedical innovation. One part of
the Act, Section 3086, is aimed at "Encouraging Treatments for Agents that Present a National Security Threat." The
Act created a new priority review voucher program for approved "material threat medical countermeasure applications."
The Act defines such countermeasures as drug or biological products, including vaccines intended to treat biological, chemical,
radiological, or nuclear agents that present a national security threat or to treat harm from a condition that may be caused by
administering a drug or biological product against such an agent. The Department of Homeland Security has identified 13 such threats,
including anthrax, smallpox, Ebola/Marburg, tularemia, botulinum toxin, and pandemic influenza, which includes the SARS coronavirus
2, known as SARS-CoV-2.

 Other
Regulatory Requirements

 Maintaining
substantial compliance with appropriate federal, state and local statutes and regulations requires the expenditure of substantial
time and financial resources. Drug manufacturers are required to register their establishments with the FDA and certain state
agencies, and after approval, the FDA and these state agencies conduct periodic unannounced inspections to ensure continued compliance
with ongoing regulatory requirements, including cGMPs. In addition, after approval, some types of changes to the approved product,
such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review and approval.
The FDA may require post-approval testing and surveillance programs to monitor safety and the effectiveness of approved products
that have been commercialized. Any drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing
regulation by the FDA, including:

 record-keeping
 requirements;

 reporting
 of adverse experiences with the drug;

 providing
 the FDA with updated safety and efficacy information;

 reporting
 on advertisements and promotional labeling;

 drug
 sampling and distribution requirements; and

 complying
 with electronic record and signature requirements.

 In
addition, the FDA strictly regulates labeling, advertising, promotion and other types of information on products that are placed
on the market. There are numerous regulations and policies that govern various means for disseminating information to health-care
professionals as well as consumers, including to industry sponsored scientific and educational activities, information provided
to the media and information provided over the Internet. Drugs may be promoted only for the approved indications and in accordance
with the provisions of the approved label.

 The
FDA has very broad enforcement authority and the failure to comply with applicable regulatory requirements can result in administrative
or judicial sanctions being imposed on us or on the manufacturers and distributors of our approved products, including warning
letters, refusals of government contracts, clinical holds, civil penalties, injunctions, restitution and disgorgement of profits,
recall or seizure of products, total or partial suspension of production or distribution, withdrawal of approvals, refusal to
approve pending applications, and criminal prosecution resulting in fines and incarceration. The FDA and other agencies actively
enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted
off-label uses may be subject to significant liability. In addition, even after regulatory approval is obtained, later discovery
of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product
from the market.

 Coverage
and Reimbursement

 Sales
of our product candidates, if approved, will depend, in part, on the extent to which such products will be covered by third-party
payors, such as government health care programs, commercial insurance and managed healthcare organizations. These third-party
payors are increasingly limiting coverage or reducing reimbursements for medical products and services. In addition, the U.S.
government, state legislatures and foreign governments have continued implementing cost-containment programs, including price
controls, restrictions on reimbursement and requirements for substitution of generic products. Third-party payors decide which
therapies they will pay for and establish reimbursement levels. Third-party payors often rely upon Medicare coverage policy and
payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage
and amount of reimbursement to be provided for any drug candidates that we develop will be made on a payor-by-payor basis.
Each payor determines whether or not it will provide coverage for a therapy, what amount it will pay the manufacturer for the
therapy, and on what tier of its formulary it will be placed. The position on a payor's list of covered drugs, or formulary,
generally determines the co-payment that a patient will need to make to obtain the therapy and can strongly influence
the adoption of such therapy by patients and physicians. Adoption of price controls and cost-containment measures, and adoption
of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results.
Decreases in third-party reimbursement for our product candidates or a decision by a third-party payor to not cover our product
candidates could reduce physician usage of our product candidates, once approved, and have a material adverse effect on our sales,
results of operations and financial condition.

 Other
Healthcare Laws

of our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party
payors, we will also be subject to healthcare regulation and enforcement by the federal government and the states and foreign
governments in which we will conduct our business, including our clinical research, proposed sales, marketing and educational
programs. Failure to comply with these laws, where applicable, can result in the imposition of significant civil penalties, criminal
penalties, or both.

 The
U.S. laws that may affect our ability to operate, among others, include: the federal Health Insurance Portability and Accountability
Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the
conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; certain
state laws governing the privacy and security of health information in certain circumstances, some of which are more stringent
than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance
efforts; the federal healthcare programs' Anti-Kickback Statute, which prohibits, among other things, persons from knowingly
and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either
the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made
under federal healthcare programs such as the Medicare and Medicaid programs; federal false claims laws which prohibit, among
other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare,
Medicaid, or other third-party payors that are false or fraudulent; federal criminal laws that prohibit executing a scheme to
defraud any healthcare benefit program or making false statements relating to healthcare matters; the Physician Payments Sunshine
Act, which requires manufacturers of drugs, devices, biologics, and medical supplies to report annually to the U.S. Department
of Health and Human Services information related to payments and other transfers of value to physicians (defined to include doctors,
dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and ownership and investment interests held by
physicians and their immediate family members; and state law equivalents of each of the above federal laws, such as anti-kickback
and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.

 In
addition, many states have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope
and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs. Additionally,
to the extent that our product is sold in a foreign country, we may be subject to similar foreign laws.

 The
Impact of New Legislation and Amendments to Existing Laws

 The
FDCA is subject to routine legislative amendments with a broad range of downstream effects. In addition to new legislation, such
as the FDA Reauthorization Act of 2017 or the FDASIA in 2012, Congress introduces amendments to reauthorize drug user fees and
address emerging concerns every five years. We cannot predict the impact of these new legislative acts and their implementation
of regulations on our business. The programs established or to be established under the legislation may have adverse effects upon
us, including increased regulation of our industry. Compliance with such regulation may increase our costs and limit our ability
to pursue business opportunities. In addition, the FDA's regulations, policies and guidance are often revised or reinterpreted
by the agency or the courts in ways that may significantly affect our business and our products.

 We
expect that additional federal and state, as well as foreign, healthcare reform measures will be adopted in the future, any of
which could result in reduced demand for our products or additional pricing pressure.

 Human
Capital Resources

 As
of April 1, 2024, we had 103 full-time employees, of whom 16 hold M.D. or Ph. D. degrees. We have 71 employees dedicated to research
and development. We have two employees supporting sales administration and marketing initiatives and three sales employees who are focused on customer service requests and top-tier headache specialists. None of our employees are represented by a collective bargaining agreement. We believe that the skills, experience
and industry knowledge of our key employees significantly benefit our operations and performance. Our research and development
operations are located in Chatham, NJ, Dartmouth, MA, Frederick, Maryland, Dublin, Ireland and Montreal, Canada. We have used,
and expect to continue to use, third parties to conduct our nonclinical and clinical studies as well as part-time employees.

 Employee
health and safety in the workplace is one of our core values.

 Employee
levels are managed to align with the pace of business and management believes it has sufficient human capital to operate its business
successfully.

 Corporate
Information

 We
lease the space for our principal executive offices, which are located at 26 Main Street, Suite 101, Chatham, New Jersey 07928,
and our telephone number is (862) 799 8599. Our website address is www.tonixpharma.com. We do not incorporate the information
on our websites into this annual report, and you should not consider such information part of this annual report.

 We
were incorporated on November 16, 2007 under the laws of the State of Nevada as Tamandare Explorations Inc. On October 11, 2011,
we changed our name to Tonix Pharmaceuticals Holding Corp.

 ITEM
1A. Risk Factors

 Summary
of Risk Factors

 Our
 prospects are dependent on the continued successful commercialization of Tosymra and
 Zembrace.

 Our
 prospects are dependent on the success of Tonmya.

 We
 are exposed to cybersecurity and data privacy risks that, if realized, could expose us to legal liability, damage our
 reputation and harm our business.

 We
 have a history of operating losses and may never achieve profitability.

 We
 expect our operating results to fluctuate, which may make it difficult to predict our future performance.

 Our
 product candidates are novel and still in development.

 We
 do not expect revenues from product sales to offset our expenses in the foreseeable future, if at all.

 We
 are largely dependent on the success of our product candidates and cannot be certain that our product candidates will receive
 regulatory approval or be successfully commercialized.

 studies required for our product candidates are expensive and time-consuming, and their outcome is uncertain.

 We
 are subject to extensive and costly government regulation.

 We
 have never submitted an NDA before, and may be unable to do so for our product candidates we are developing.

 Our
 product candidates may cause serious adverse events or undesirable side effects which may delay or prevent marketing approval,
 or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise
 limit their sales.

 We
 may be unable to meet our anticipated development and commercialization timelines for approval of any of our product candidates.

 Any
 breakthrough, fast track or orphan drug designation or grant of priority review status by the FDA may not actually lead to
 a faster development or regulatory review or approval process, nor assure FDA approval of our product candidates.

 Even
 if approved, our products may not be accepted by the market.

 We
 may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize
 on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.

 Our
 independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as
 a going concern in its report on our audited financial statements. We may be unable to continue to operate without the threat
 of liquidation for the foreseeable future.

 We
 will need additional capital. If additional capital is not available or is available at unattractive terms, we may be forced
 to delay, reduce the scope of or eliminate our research and development programs, reduce our commercialization efforts or
 curtail our operations.

 Outbreaks
 of communicable diseases may materially and adversely affect our business, financial condition and results of operations.

 Competition
 and technological change may make our product candidates and technologies less attractive or obsolete.

 If
 we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products
 would be negatively affected.

 We
 may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming.

 If
 we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and defend against
 litigation.

 We
 rely on third parties to conduct, supervise and monitor our clinical studies, and if those third parties perform in an unsatisfactory
 manner, it may harm our business.

 We
 will need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth.

 Our
 executive officers and other key personnel are critical to our business, and our future success depends on our ability to
 retain them.

 If
 we are unable to hire additional qualified personnel, our ability to grow our business may be harmed.

 We
 rely on third parties to manufacture the compounds used in our studies, and we intend to rely on them for the manufacture
 of any approved products for commercial sale. If these third parties do not manufacture our product candidates in sufficient
 quantities and at an acceptable cost, clinical development and commercialization of our product candidates could be delayed,
 prevented or impaired.

 Failure
 by our third-party manufacturers to comply with the regulatory guidelines set forth by the FDA with respect to our product
 candidates could delay or prevent the completion of clinical studies, the approval of any product candidates or the commercialization
 of our products.

 Adverse
 global conditions, including economic uncertainty, may negatively impact our financial results.

 Our
 internal computer systems, or those of our CRO's or other contractors or consultants, may fail or suffer security breaches,
 which could result in a material disruption of our product development programs.

 Corporate
 and academic collaborators may take actions to delay, prevent, or undermine the success of our products.

 Data
 provided by collaborators and others upon which we rely that has not been independently verified could turn out to be false,
 misleading, or incomplete.

 Our
 product candidates may face competition sooner than expected.

 If
 we fail to establish marketing, sales and distribution capabilities, or fail to enter into arrangements with third parties,
 we will not be able to create a market for our product candidates.

 Our
 relationships with customers, physicians, and third-party payors will be subject, directly or indirectly, to federal and state
 healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws
 and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

 Coverage
 and adequate reimbursement may not be available for our current or any future drug candidates, which could make it difficult
 for us to sell profitably, if approved.

 Healthcare
 legislative reform measures may have a negative impact on our business and results of operations.

 If
 we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with
 international operations could materially adversely affect our business.

 We
 face the risk of product liability claims and may not be able to obtain insurance.

 We
 use hazardous chemicals in our business. Potential claims relating to improper handling, storage or disposal of these chemicals
 could affect us and be time consuming and costly.

 If
 we retain collaborative partners and our partners do not satisfy their obligations, we will be unable to develop our partnered
 product candidates.

 We
 may be unsuccessful in obtaining a priority review voucher for material threat medical countermeasures.

 Government
 entities may take actions that directly or indirectly have the effect of limiting opportunities for our vaccines for COVID-19.

 If
 technology developed for the purposes of developing new medicines or vaccines can be applied to the creation or development
 of biological weapons, then our technology may be considered "dual use" technology and be subject to limitations
 on public disclosure or export.

 We
 face risks in connection with existing and future collaborations with respect to the development, manufacture, and commercialization
 of our product candidates.

 We
 face risks in connection with the testing, production and storage of our vaccine product candidates.

 An
 active trading market for our common stock may not be sustained.

 The
 market price of our common stock has been extremely volatile and may continue to be volatile due to numerous circumstances
 beyond our control.

 We
 could be delisted from Nasdaq, which could seriously harm the liquidity of our stock and our ability to raise capital.

 We
 do not anticipate paying dividends on our common stock and, accordingly, shareholders must rely on stock appreciation for
 any return on their investment.

 We
 expect that our quarterly results of operations will fluctuate, and this fluctuation could cause our stock price to decline.

 If
 we fail to comply with the rules under the Sarbanes-Oxley Act of 2002 related to accounting controls and procedures, or if
 we discover material weaknesses and deficiencies in our internal control and accounting procedures, our stock price could
 decline significantly and raising capital could be more difficult.

 If
 securities or industry analysts do not publish research or reports about our business, or if they change their recommendations
 regarding our stock adversely, our stock price and trading volume could decline.

 Other
 companies may have difficulty acquiring us, even if doing so would benefit our stockholders, due to provisions under our corporate
 charter and bylaws, as well as Nevada law.

 Other
 companies may have difficulty acquiring us, even if doing so would benefit our stockholders, due to provisions under our corporate
 charter and bylaws, as well as Nevada law.

 Our
 bylaws designate the Eighth Judicial District Court of Clark County, Nevada as the sole and exclusive forum for certain types
 of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders' ability to
 obtain a favorable judicial forum for disputes with us or our directors, officers, employees or agents.

 RISKS
RELATED TO OUR BUSINESS

 Our
prospects are dependent on the continued successful commercialization of Zembrace and Tosymra. To the extent we cannot maintain
or increase sales of Zembrace and Tosymra, our business, financial condition and results of operations may be materially adversely
affected and the price of our common stock may decline.

and Tosymra are our only drugs that have been approved for sale. Continued successful commercialization of Zembrace and Tosymra
is subject to many risks, and there is no guarantee that we will be able to maintain or increase sales of Zembrace and Tosymra.
While we have established our commercial team and have hired our U.S. sales force, we may need to further expand and develop the
team in order to continue to successfully grow the business. Even if we are successful in developing our commercial team, there
are many factors that could negatively impact sales of Zembrace and Tosymra or cause the continued commercialization of Zembrace
and Tosymra to be unsuccessful, including several factors that are outside our control. If the continued commercialization of
Zembrace and Tosymra or future sales are less successful than expected or perceived as disappointing, our stock price could decline
significantly, and the long-term success of the product and our company could be harmed.

 Additionally,
our strategy in the U.S. includes distributing Zembrace and Tosymra solely through a limited network of third-party specialty
distributors and specialty pharmacies. While we have entered into agreements with each of these distributors and pharmacies to
distribute Zembrace and Tosymra in the U.S., they may not perform as agreed or they may terminate their agreements with us. Also,
we may need to enter into agreements with additional distributors or pharmacies, and there is no guarantee that we will be able
to do so on commercially reasonable terms or at all. In the event we are unable to maintain, or expand, if needed, our commercial
team, including our U.S. sales force, or maintain and, if needed, expand, our network of third-party specialty distributors and
specialty pharmacies, our ability to continue commercializing Zembrace and Tosymra would be limited, and Zembrace and Tosymra
may not be profitable.

 Our
prospects are dependent on the success of Tonmya. To the extent regulatory approval of Tonmya is delayed or not granted or, if
approved, Tonmya is not commercially successful, our business, financial condition and results of operations may be materially
adversely affected and the price of our common stock may decline.

 The
research, testing, manufacturing, labeling, approval, sale, import, export, marketing, and distribution of pharmaceutical product
candidates are subject to extensive regulation by the FDA. We have focused a significant portion of our activities and resources
on the development of Tonmya, and we believe our prospects are also dependent on our ability to obtain regulatory approval for
and successfully commercialize Tonmya in the U.S. The regulatory approval and successful commercialization of Tonmya is subject
to many risks, including those discussed in other risk factors, and Tonmya may not receive approval from the FDA. If the results
or timing of regulatory filings, the regulatory process, regulatory developments, commercialization, or other activities, actions
or decisions related to Tonmya do not meet our or others' expectations, the market price of our common stock could decline
significantly.

 In
December 2023, we announced positive results from our pivotal Phase 3 RESILIENT study. The study demonstrated a statistically
significant improvement over placebo for both primary endpoints as well as key secondary endpoints.

 The
FDA retains complete discretion in deciding whether to approve the NDA for Tonmya and there are many components to an NDA filing
beyond the efficacy and safety data provided to the FDA. No assurances can be given that the FDA will approve Tonmya for the treatment
of FM, or that if approved, we will successfully commercialize Tonmya.

 We
have a history of operating losses and expect to incur losses for the foreseeable future. We may never achieve profitability.

 We
are focused on product development, and we started generating revenues from product sales in the third quarter of 2023. We have
incurred losses in each year of our operations, and we expect to continue to incur operating losses for the foreseeable future.
These operating losses have adversely affected and are likely to continue to adversely affect our working capital, total assets
and shareholders' equity.

 We
and our prospects should be examined in light of the risks and difficulties frequently encountered by new and early-stage companies
in new and rapidly evolving markets. These risks include, among other things, the speed at which we can scale up operations, our
complete dependence upon development of our product candidates that currently have no market acceptance, our ability to establish
and expand our brand name, our ability to expand our operations to meet the commercial demand of our clients, our development
of and reliance on strategic and customer relationships and our ability to minimize fraud and other security risks.

 The
process of developing our products requires significant clinical, nonclinical and CMC development, laboratory testing and clinical
studies. In addition, commercialization of our product candidates will require that we obtain necessary regulatory approvals and
establish sales, marketing and manufacturing capabilities, either through internal hiring or through contractual relationships
with others. We expect to incur substantial losses for the foreseeable future as a result of anticipated increases in our research
and development costs, including costs associated with conducting preclinical and nonclinical testing and clinical studies, and
regulatory compliance activities.

 We
expect to incur substantial additional operating expenses over the next several years as our research, development, preclinical
and nonclinical testing, and clinical study activities increase, and if and when we acquire rights to additional product
candidates. The amount of future losses and when, if ever, we will achieve profitability are uncertain. We have two products that
have generated commercial revenue starting in the third quarter of 2023, but we do not expect revenues from the commercial sale
of products to exceed expenses in the near future. Our ability to generate revenue and achieve profitability will depend on, among
other things, successful completion of the development of our product candidates; obtaining necessary regulatory approvals from
the FDA; establishing manufacturing, sales, and marketing arrangements with third parties; successfully commercializing our products;
establishing a favorable competitive position; and raising sufficient funds to finance our activities. Many of these factors will
depend on circumstances beyond our control. We might not succeed at any of these undertakings. If we are unsuccessful at some
or all of these undertakings, our business, prospects, and results of operations may be materially adversely affected.

 We
expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult
to predict our future performance.

 We
are a development-stage biopharmaceutical and our operations to date have been primarily limited to developing our technology
and undertaking preclinical and nonclinical testing and clinical studies of our latest stage product candidate, TNX-102 SL for
FM, Long COVID and potentially other CNS conditions. We have not yet obtained regulatory approvals for TNX-102 SL or any of our
other product candidates. Consequently, any predictions made about our future success or viability may not be as accurate as they
could be if we had a longer operating history or commercialized products. Our financial condition has varied significantly in
the past and will continue to fluctuate from quarter-to-quarter or year-to-year due to a variety of factors, many of which are
beyond our control. Factors relating to our business that may contribute to these fluctuations include other factors described
elsewhere in this annual report and also include, among other things:

 our
 ability to obtain additional funding to develop our product candidates;

 delays
 in the commencement, enrollment and timing of clinical studies;

 the
 success of our clinical studies through all phases of clinical development, including studies of our most advanced product
 candidate, TNX-102 SL for FM, FM-type Long COVID and potentially other CNS indications;

 any
 delays in regulatory review and approval of product candidates in clinical development;

 our
 ability to obtain and maintain regulatory approval for our product candidate TNX-102 SL for FM and FM-type Long COVID, or
 any of our other product candidates in the United States and foreign jurisdictions;

 potential
 nonclinical toxicity and/or side effects of our product candidates that could delay or prevent commercialization, limit the
 indications for any approved drug, require the establishment of REMS, or cause an approved drug to be taken off the market;

 our
 ability to establish or maintain collaborations, licensing or other arrangements;

 market
 acceptance of our product candidates;

 competition
 from existing products or new products that may emerge;

 the
 ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for our products;

 our
 ability to leverage our proprietary technology platform to discover and develop additional product candidates;

 our
 ability and our licensors' abilities to successfully obtain, maintain, defend and enforce intellectual property rights
 important to our business; and

 potential
 product liability claims;

 Accordingly,
the results of any quarterly or annual periods should not be relied upon as indications of future operating performance.

 We
are exposed to cybersecurity and data privacy risks that, if realized, could expose us to legal liability, damage our reputation
and harm our business.

 We
face risks of cyber-attacks, computer hacks, theft, viruses, malicious software, phishing, employee error, denial-of-service attacks
and other security breaches that could jeopardize the performance of our software and expose us to financial and reputational
harm. Any of these occurrences could create liability for us, put our reputation in jeopardy and harm our business. Such harm
could be in the form of theft of our or our customers' confidential information, the inability to access our systems. In
some cases, we rely on the safeguards put in place by third parties to protect against security threats. These third parties,
including vendors that provide products and services for our operations, could also be a source of security risk to us in the
event of a failure or a security incident affecting their own security systems and infrastructure. Our network of partners could
also be a source of vulnerability to the extent their applications interface with ours, whether unintentionally or through a malicious
backdoor. We do not review the software code included in third-party integrations in all instances. Because the techniques used
to obtain unauthorized access or to sabotage systems change frequently and generally are not recognized until launched against
a target, we or these third parties may be unable to anticipate these techniques or to implement adequate preventative measures.
We have internal controls designed to prevent cyber-related frauds related to authorizing the transfer of funds, but such internal
controls may not be adequate. With the increasing frequency of cyber-related frauds to obtain inappropriate payments and other
threats related to cyber-attacks, we may find it necessary to expend resources to remediate cyber-related incidents or to enhance
and strengthen our cybersecurity. Our remediation efforts may not be successful and could result in interruptions, delays or cessation
of service. Although we have insurance coverage for losses associated with cyber-attacks, as with all insurance policies, there
are coverage exclusions and limitations, and our coverage may not be sufficient to cover all possible claims, and we may still
suffer losses that could have a material adverse effect on our reputation and business.

 The
increase in remote working arrangements by our employees, vendors, and other third parties also increase the risk of a data security
compromise and the possible attack surfaces. Although we conduct training as part of our information security, cybersecurity,
and data privacy efforts, that training cannot be completely effective in preventing those attacks from being successful. There
can be no assurance that our cybersecurity risk management program and processes, including our policies, controls, or procedures,
will be fully implemented, complied with or effective in protecting our systems and information.

 RISKS
RELATED TO PRODUCT DEVELOPMENT, REGULATORY APPROVAL, MANUFACTURING AND COMMERCILAIZATION

 Our
product candidates are novel and still in development.

 We
are a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent
human disease and alleviate suffering. Our drug development methods may not lead to commercially viable drugs for any of several
reasons. For example, we may fail to identify appropriate targets or compounds, our drug candidates may fail to be safe and effective
in clinical studies, or we may have inadequate financial or other resources to pursue development efforts for our drug candidates.
Our drug candidates will require significant additional development, clinical studies, regulatory clearances and additional investment
by us or our collaborators before they can be commercialized.

 Further, we and our product
candidates are subject to extensive regulation by the FDA and comparable regulatory authorities in other countries governing, among other
things, research, testing, clinical studies, manufacturing, labeling, promotion, selling, adverse event reporting and recordkeeping. We
are not permitted to market any of our product candidates in the United States until we receive approval of an NDA for a product candidate
from the FDA or the equivalent approval from a foreign regulatory authority. Obtaining FDA approval is a lengthy, expensive and uncertain
process. We currently have one product candidate, Tonmya, for the management of fibromyalgia and have completed two successful Phase 3
trials and for which we are preparing an NDA. We also have TNX-102 SL in Phase 2 development for the treatment of FM-type Long COVID,
and we have two other products in Phase 2 development: TNX-1300 for the treatment of cocaine intoxication, and TNX-1900 for the treatment
of binge eating disorder, adolescent obesity, social anxiety disorder and bone loss associated with autism. TNX-2900 is in development
for Prader Willi Syndrome and has a cleared IND, orphan drug designation and Pediatric Rare Disease Designation. The success of our business
currently depends on the successful development, approval and commercialization of our product candidates and TNX-102 SL. Any projected
sales or future revenue predictions are predicated upon FDA approval and market acceptance. If projected sales do not materialize for
any reason, it would have a material adverse effect on our business and our ability to continue operations.

 As
we have two approved products on the market, we do not expect revenues from product sales to exceed expenses in the foreseeable
future, if at all.

 To
date, we have two approved products on the market and have started generating product revenues in the second half of 2023. However,
we have primarily funded our operations from sales of our securities. We expect to rely on investment capital for the foreseeable
future.

 To
obtain revenues from sales of our product candidates, we must succeed, either alone or with third parties, in developing, obtaining
regulatory approval for, manufacturing and marketing drugs with commercial potential. We may never succeed in these activities,
and we may not generate sufficient revenues to continue our business operations or achieve profitability.

 We
are largely dependent on the success of our lead product candidates, and we cannot be certain that these product candidates will
receive regulatory approval or be successfully commercialized.

 We
have not yet submitted an NDA or foreign equivalent or received marketing approval for our lead product candidates anywhere in
the world. The clinical development programs may not lead to commercial products for a number of reasons, including if we fail
to obtain necessary approvals from the FDA or foreign regulatory authorities because our clinical studies fail to demonstrate
to their satisfaction that this product candidate is safe and effective or a clinical program may be put on hold due to unexpected
safety issues. We may also fail to obtain the necessary approvals if we have inadequate financial or other resources to advance
our product candidates through the clinical study process. Any failure or delay in completing clinical studies or obtaining regulatory
approvals for our lead product candidates in a timely manner would have a material adverse impact on our business and our stock
price.

 We
may not commence or advance clinical trials for COVID-related products if the COVID-19 disease outbreak subsides.

 Disease
outbreaks are unpredictable. For example, the SARS virus disappeared just four months after it caused a global panic. In the event
that COVID-19 has a similar disease cycle, we may be forced to abandon or delay the development of our COVID-related products
due to a lack of patients or government funding.

 Successful
development of our products is uncertain.

 Our
development of current and future product candidates is subject to the risks of failure and delay inherent in the development
of new pharmaceutical products, including: delays in product development, clinical testing, or manufacturing; unplanned expenditures
in product development, clinical testing, or manufacturing; failure to receive regulatory approvals; emergence of superior or
equivalent products; inability to manufacture on its own, or through any others, product candidates on a commercial scale; and
failure to achieve market acceptance.

of these risks, our research and development efforts may not result in any commercially viable products. If a significant portion
of these development efforts are not successfully completed, required regulatory approvals are not obtained or any approved products
are not commercially successfully, our business, financial condition, and results of operations may be materially harmed.

studies required for our product candidates are expensive and time-consuming, and their outcome is uncertain.

 In
order to obtain FDA approval to market a new pharmaceutical product, we must demonstrate proof of safety and effectiveness in
humans. To meet these requirements, we must conduct "adequate and well controlled" clinical studies. Conducting clinical
studies is a lengthy, time-consuming, and expensive process. The length of time may vary substantially according to the type,
complexity, novelty, and intended use of the product candidate, and often can be several years or more per study. Delays associated
with products for which we are directly conducting clinical studies may cause us to incur additional operating expenses. The commencement
and rate of completion of clinical studies may be delayed by many factors, including, for example: inability to manufacture sufficient
quantities of stable and qualified materials under cGMP, for use in clinical studies; slower than expected rates of patient recruitment;
failure to recruit a sufficient number of patients; modification of clinical study protocols; changes in regulatory requirements
for clinical studies; the lack of effectiveness during clinical studies; the emergence of unforeseen safety issues; delays, suspension,
or termination of the clinical studies due to the IRB responsible for overseeing the study at a particular study site; and government
or regulatory delays or "clinical holds" requiring suspension or termination of the studies.

 The
results from early clinical studies are not necessarily predictive of results obtained in later clinical studies. Accordingly,
even if we obtain positive results from early clinical studies, we may not be able to confirm the results in future clinical studies.
In addition, clinical studies may not demonstrate sufficient safety and effectiveness to obtain the requisite regulatory approvals
for product candidates.

 Our
clinical studies may be conducted in patients with CNS conditions, and in some cases, our product candidates are expected to be
used in combination with approved therapies that themselves have significant adverse event profiles. During the course of treatment,
these patients could suffer adverse medical events or die for reasons that may or may not be related to our product candidates.
We cannot ensure that safety issues will not arise with respect to our product candidates in clinical development.

 The
failure of clinical studies to demonstrate safety and effectiveness for the desired indications could harm the development of
that product candidate and other product candidates. This failure could cause us to abandon a product candidate and could delay
development of other product candidates. Any delay in, or termination of, our clinical studies would delay the filing of our NDAs
with the FDA and, ultimately, our ability to commercialize our product candidates and generate product revenues. Any change in,
or termination of, our clinical studies could materially harm our business, financial condition, and results of operations.

 We
are subject to extensive and costly government regulation.

 Product
candidates employing our technology are subject to extensive and rigorous domestic government regulation including regulation
by the FDA, the Centers for Medicare and Medicaid Services, other divisions of the United States Department of Health and Human
Services, the United States Department of Justice, state and local governments, and their respective foreign equivalents. The
FDA regulates the research, development, preclinical and nonclinical testing and clinical studies, manufacture, safety, effectiveness,
record-keeping, reporting, labeling, storage, approval, advertising, promotion, sale, distribution, import, and export of biopharmaceutical
products. The FDA regulates small molecule chemical entities as drugs, subject to an NDA under the FDCA. The FDA applies the same
standards for biologics, requiring an IND application, followed by a Biologic License Application, or BLA, prior to licensure.
Other products, such as vaccines, are also regulated under the Public Health Service Act. FDA has conflated the standards for
approval of NDAs and BLAs so that they require the same types of information on safety, effectiveness, and CMCs. If products employing
our technologies are marketed abroad, they will also be subject to extensive regulation by foreign governments, whether or not
they have obtained FDA approval for a given product and its uses. Such foreign regulation may be equally or more demanding than
corresponding United States regulation.

 Government
regulation substantially increases the cost and risk of researching, developing, manufacturing, and selling our products. The
regulatory review and approval process, which includes preclinical and nonclinical testing and clinical studies of each product
candidate, is lengthy, expensive, and uncertain. We or our collaborators must obtain and maintain regulatory authorization to
conduct clinical studies. We or our collaborators must obtain regulatory approval for each product we intend to market, and the
manufacturing facilities used for the products must be inspected and meet legal requirements. Securing regulatory approval requires
the submission of extensive preclinical, nonclinical and clinical data and other supporting information for each proposed therapeutic
indication in order to establish the product's safety and efficacy, and in the case of biologics also potency and purity,
for each intended use. The development and approval process takes many years, requires substantial resources, and may never lead
to the approval of a product.

 Even
if we are able to obtain regulatory approval for a particular product, the approval may limit the indicated medical uses for the
product, may otherwise limit our ability to promote, sell, and distribute the product, may require that we conduct costly post-marketing
surveillance, and/or may require that we conduct ongoing post-marketing studies. Material changes to an approved product, such
as, for example, manufacturing changes or revised labeling, may require further regulatory review and approval. Once obtained,
any approvals may be withdrawn, including, for example, if there is a later discovery of previously unknown problems with the
product, such as a previously unknown safety issue.

 If
we, our collaborators, or our CMOs fail to comply with applicable regulatory requirements at any stage during the regulatory process,
such noncompliance could result in, among other things delays in the approval of applications or supplements to approved applications;
refusal of a regulatory authority, including the FDA, to review pending market approval applications or supplements to approved
applications; warning letters; fines; import and/or export restrictions; product recalls or seizures; injunctions; total or partial
suspension of production; civil penalties; withdrawals of previously approved marketing applications or licenses; recommendations
by the FDA or other regulatory authorities against governmental contracts; and/or criminal prosecutions.

 We
do not have, and may never obtain, the regulatory approvals we need to market our product candidates.

 Following
completion of clinical studies, the results are evaluated and, depending on the outcome, submitted to the FDA in the form of an
NDA or BLA in order to obtain FDA approval of the product and authorization to commence commercial marketing. In responding to
an NDA, the FDA may require additional testing or information, may require that the product labeling be modified, may impose post-approval
study and other commitments or reporting requirements or other restrictions on product distribution, or may deny the application.
The FDA has established performance goals for review of NDAs or BLAs: six months for priority applications and ten months for
standard applications. However, the FDA is not required to complete its review within these time periods. The timing of final
FDA review and action varies greatly but can take years in some cases and may involve the input of an FDA advisory committee of
outside experts. Product sales in the United States may commence only when an NDA or BLA is approved.

 To
date, we have not applied for or received the regulatory approvals required for the commercial sale of any of our products in
the United States or in any foreign jurisdiction. None of our product candidates have been determined to be safe and effective,
and we have not submitted an NDA or BLA to the FDA or an equivalent application to any foreign regulatory authorities for any
of our product candidates.

 It
is possible that none of our product candidates will be approved for marketing. Failure to obtain regulatory approvals, or delays
in obtaining regulatory approvals, may adversely affect the successful commercialization of any drugs or biologics that we or
our partners develop, may impose additional costs on us or our collaborators, may diminish any competitive advantages that we
or our partners may attain, and/or may adversely affect our receipt of revenues or royalties.

 We
have never submitted an NDA before, and may be unable to do so for our product candidates we are developing.

 The
conduct of pivotal clinical studies and the submission of a successful NDA is a complicated process. Although members of our management
team have extensive industry experience, including in the development and clinical testing of drug candidates and the commercialization
of drug, have limited experience in preparing, submitting and prosecuting regulatory filings, and have not submitted an NDA before.
Consequently, we may be unable to successfully and efficiently execute and complete this planned clinical study in a way that
leads to NDA submission and approval of our product candidates we are developing. We may require more time and incur greater costs
than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop. Failure to commence
or complete, or delays in, our planned clinical studies would prevent or delay commercialization of TNX-102 SL and other product
candidates we are developing.

 Our
product candidates may cause serious adverse events, or SAEs, or undesirable side effects which may delay or prevent marketing
approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise
limit their sales.

 SAEs
or undesirable side effects from any of our other product candidates could arise either during clinical development or, if approved,
after the approved product has been marketed. The results of future clinical studies may show that our product candidates cause
SAEs or undesirable side effects, which could interrupt, delay or halt clinical studies, resulting in delay of, or failure to
obtain, marketing approval from the FDA and other regulatory authorities.

 If
any of our other product candidates cause SAEs or undesirable side effects or suffer from quality control issues:

 regulatory
 authorities may impose a clinical hold or risk evaluation and mitigation strategies, or REMS, which could result in substantial
 delays, significantly increase the cost of development, and/or adversely impact our ability to continue development of the
 product;

 regulatory
 authorities may require the addition of statements, specific warnings, or contraindications to the product label, or restrict
 the product's indication to a smaller potential treatment population;

 we
 may be required to change the way the product is administered or conduct additional clinical studies;

 we
 may be required to implement a risk minimization action plan, which could result in substantial
 cost increases and have a negative impact on our ability to commercialize the product;

 we
 may be required to limit the participants who can receive the product;

 we
 may be subject to limitations on how we promote the product;

 we
 may, voluntarily or involuntarily, initiate field alerts for product recall, which may result in shortages;

 sales
 of the product may decrease significantly;

 regulatory
 authorities may require us to take our approved product off the market;

 we
 may be subject to litigation or product liability claims; and

 our
 reputation may suffer.

 Any
of these events could prevent us from achieving or maintaining market acceptance of the affected product or could substantially
increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from
the sale of our products.

 If
we are unable to file for approval of TNX-102 SL under Section 505(b)(2) of the FDCA or if we are required to generate additional
data related to safety and efficacy in order to obtain approval under Section 505(b)(2), we may be unable to meet our anticipated
development and commercialization timelines.

 Our
current plans for filing NDAs for our most advanced product candidate, TNX-102 SL, include efforts to minimize the data we will
be required to generate in order to obtain marketing approval and therefore reduce the development time. We intend to file Section
505(b)(2) NDAs for TNX-102 SL for FM, Long COVID and for other proposed indications, that might, if accepted by the FDA, save
time and expense in the development and testing of TNX-102 SL.

 Tonmya or TNX-102 SL for FM is our most advanced development product candidate which has completed two successful Phase 3 trials in FM and for which we are submitting the NDA under Section 505(b)(2) of the
FDCA, which would enable us to rely in part on data in the public domain or elsewhere. We have not yet filed an NDA under Section
505(b)(2) for any of our product candidates. Depending on the data that may be required by the FDA for approval, some of the data
may be related to products already approved by the FDA. If the data relied upon is related to products already approved by the
FDA and covered by third-party patents, we would be required to certify that we do not infringe the listed patents or that such
patents are invalid or unenforceable. As a result of the certification, the third-party would have 45 days from notification of
our certification to initiate an action against us. In the event that an action is brought in response to such a certification,
the approval of our NDA could be subject to a stay of up to 30 months or more while we defend against such a suit. Approval of
our product candidates under Section 505(b)(2) may therefore be delayed until patent exclusivity expires or until we successfully
challenge the applicability of those patents to our product candidates. Alternatively, we may elect to generate sufficient additional
clinical data so that we no longer rely on data which triggers a potential stay of the approval of our product candidates. Even
if no exclusivity periods apply to our applications under Section 505(b)(2), the FDA has broad discretion to require us to generate
additional data on the safety and efficacy of our product candidates to supplement third-party data on which we may be permitted
to rely. In either event, we could be required, before obtaining marketing approval for any of our product candidates, to conduct
substantial new research and development activities beyond those we currently plan to engage in order to obtain approval of our
product candidates. Such additional new research and development activities would be costly and time-consuming.

 We
may not be able to realize a shortened development timeline for TNX-102 SL for FM, Long COVID (or other proposed indications under
TNX-102 SL), and the FDA may not approve our NDA based on their review of the submitted data. If cyclobenzaprine-containing products
are withdrawn from the market by the FDA for any safety reason, we may not be able to reference such products to support a 505(b)(2)
NDA for TNX-102 SL, and we may need to fulfill the more extensive requirements of Section 505(b)(1). If we are required to generate
additional data to support approval, we may be unable to meet our anticipated development and commercialization timelines, may
be unable to generate the additional data at a reasonable cost, or at all, and may be unable to obtain marketing approval of our
lead product candidate.

 Any
breakthrough, fast track or orphan drug designation or grant of priority review status by the FDA may not actually lead to a faster
development or regulatory review or approval process, nor will it assure FDA approval of our product candidates. Additionally,
our product candidates may treat indications that do not qualify for priority review vouchers.

 If
a product candidate offers major advances in treatment, the FDA may designate it eligible for priority review. The FDA has broad
discretion whether or not to grant these designations, so even if we believe a particular product candidate is eligible for these
designations, we cannot assure you that the FDA would decide to grant them. Even if we do receive fast track designation or priority
review, we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA
may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development
program.

 Even
if approved, our product candidates will be subject to extensive post-approval regulation.

 Once
a product is approved, numerous post-approval requirements apply. Among other things, the holder of an approved NDA is subject
to periodic and other FDA monitoring and reporting obligations, including obligations to monitor and report adverse events and
instances of the failure of a product to meet the specifications in the NDA. Application holders must submit new or supplemental
applications and obtain FDA approval for certain changes to the approved product, product labeling, or manufacturing process.
Application holders must also submit advertising and other promotional material to the FDA and report on ongoing clinical studies.

 Depending
on the circumstances, failure to meet these post-approval requirements can result in criminal prosecution, fines, injunctions,
recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals,
or refusal to allow us to enter into supply contracts, including government contracts. In addition, even if we comply with FDA
and other requirements, new information regarding the safety or effectiveness of a product could lead the FDA to modify or withdraw
product approval.

 Even
if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market.

 Even
if the FDA approves one or more of our product candidates, physicians and patients may not accept it or use it. Even if physicians
and patients would like to use our products, our products may not gain market acceptance among healthcare payors such as managed
care formularies, insurance companies or government programs such as Medicare or Medicaid. Acceptance and use of our products
will depend upon a number of factors including: perceptions by members of the health care community, including physicians, about
the safety and effectiveness of our drug or device product; cost-effectiveness of our product relative to competing products;
availability of reimbursement for our product from government or other healthcare payors; and effectiveness of marketing and distribution
efforts by us and our licensees and distributors, if any.

 The
degree of market acceptance of any pharmaceutical product that we develop will depend on a number of factors, including:

 cost-effectiveness;

 the
 safety and effectiveness of our products, including any significant potential side effects (including drowsiness and dry mouth),
 as compared to alternative products or treatment methods;

 the
 timing of market entry as compared to competitive products;

 the
 rate of adoption of our products by doctors and nurses;

 product
 labeling or product insert required by the FDA for each of our products;

 reimbursement
 policies of government and third-party payors;

 effectiveness
 of our sales, marketing and distribution capabilities and the effectiveness of such capabilities of our collaborative partners,
 if any; and

 unfavorable
 publicity concerning our products or any similar products.

we expect sales of our current product candidates, if approved, to generate substantially all of our product revenues for the
foreseeable future, the failure of these products to find market acceptance would harm our business and could require us to seek
additional financing.

 We
may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize
on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.

we have limited financial and human resources, we are currently focusing on development of our lead product candidates. As a result,
we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have
greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products
or profitable market opportunities. Our spending on existing and future product candidates for specific indications may not yield
any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular
product candidate, we may relinquish valuable rights to that product candidate through strategic alliance, licensing or other
royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization
rights to such product candidate, or we may allocate internal resources to a product candidate in a therapeutic area in which
it would have been more advantageous to enter into a partnering arrangement.

 RISKS
RELATED TO OUR FINANCIAL CONDITION AND CAPITAL REQUIREMENTS; COMPETITION

 Our
independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going
concern in its report on our audited financial statements. We may be unable to continue to operate without the threat of liquidation
for the foreseeable future.

 In
connection with our management's assessment, our report from our independent registered public accounting firm for the fiscal
year ended December 31, 2023 includes an explanatory paragraph stating that our recurring losses from operations and net
capital deficiency raise substantial doubt about our ability to continue as a going concern. If we are unable to obtain sufficient
funding, our business, prospects, financial condition and results of operations will be materially and adversely affected and
we may be unable to continue as a going concern. For example, we anticipate that our existing cash and cash equivalents will enable
us to maintain our current operations into the second quarter of 2024, but not beyond. If we are unable to continue as a going
concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our consolidated
financial statements, and investors will likely lose all or a part of their investment. Future reports from our independent registered
public accounting firm may also contain statements expressing substantial doubt about our ability to continue as a going concern.
If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability
to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially
reasonable terms or at all.

 We
will need additional capital. If additional capital is not available or is available at unattractive terms, we may be forced to
delay, reduce the scope of or eliminate our research and development programs, reduce our commercialization efforts or curtail
our operations.

 In
order to develop and bring our product candidates to market, we must commit substantial resources to costly and time-consuming
research, preclinical and nonclinical testing, clinical studies and marketing activities and the buildout of our research and
development and manufacturing facilities. We anticipate that our existing cash and cash equivalents will enable us to maintain
our current operations into the second quarter of 2024, but not beyond. We anticipate using our cash and cash equivalents to fund
further research and development with respect to our lead product candidate. We will, however, need to raise additional funding
sooner if our business or operations change in a manner that consumes available resources more rapidly than we anticipate. Our
requirements for additional capital will depend on many factors, including:

 increased sales of our two commercialized products;

 successful
 commercialization of our product candidates;

 the
 time and costs involved in obtaining regulatory approval for our product candidates;

 costs
 associated with protecting our intellectual property rights;

 development
 of marketing and sales capabilities;

 payments
 received under future collaborative agreements, if any; and

 market
 acceptance of our products.

 To
the extent we raise additional capital through the sale of equity securities, the issuance of those securities could result in
dilution to our shareholders. In addition, if we obtain debt financing, a substantial portion of our operating cash flow may be
dedicated to the payment of principal and interest on such indebtedness, thus limiting funds available for our business activities.
If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate our research and development
programs, reduce our commercialization efforts or curtail our operations. In addition, we may be required to obtain funds through
arrangements with collaborative partners or others that may require us to relinquish rights to technologies, product candidates
or products that we would otherwise seek to develop or commercialize ourselves or license rights to technologies, product candidates
or products on terms that are less favorable to us than might otherwise be available.

 We
will require substantial additional funds to support our research and development activities, and the anticipated costs of preclinical
and nonclinical testing and clinical studies, regulatory approvals and eventual commercialization. Such additional sources of
financing may not be available on favorable terms, if at all. If we do not succeed in raising additional funds on acceptable terms,
we may be unable to commence or complete clinical studies or obtain approval of any product candidates from the FDA and other
regulatory authorities. In addition, we could be forced to discontinue product development, forego sales and marketing efforts
and forego attractive business opportunities. Any additional sources of financing will likely involve the issuance of our equity
securities, which will have a dilutive effect on our shareholders.

 There
is no assurance that we will be successful in raising the additional funds needed to fund our business plan. If we are not able
to raise sufficient capital in the near future, our continued operations will be in jeopardy and we may be forced to cease operations
and sell or otherwise transfer all or substantially all of our remaining assets.

 Outbreaks
of communicable diseases may materially and adversely affect our business, financial condition and results of operations.

 We
may face risks related to health epidemics or outbreaks of communicable diseases. The outbreak of such communicable diseases,
such as COVID-19, has and may result in future widespread health crisis that adversely affect general commercial activity and
the economies and financial markets of many countries. An outbreak of communicable diseases, or the perception that such an outbreak
could occur, and the measures taken by the governments of countries affected could adversely affect our business, financial condition
or results of operations. For example, an outbreak could significantly disrupt our business by limiting our ability to travel
or ship materials within or outside of an affected country and forcing temporary closure of facilities or service providers that
we rely upon. An outbreak could also impact our ability to conduct our ongoing multicenter clinical trials if trial participant
attendance at requisite study visits is substantially reduced and if a significant percentage of study participants and study
staff are adversely affected by coronavirus or other infections and the resulting disease course. Moreover, government or community
shutdowns such as those caused by the COVID-19 pandemic, may impair our ability to analyze and submit the results from our clinical
and preclinical trials, leading to further delays in the development and approval of our product candidates.

 Competition
and technological change may make our product candidates and technologies less attractive or obsolete.

 We
compete with established pharmaceutical and biotechnology companies that are pursuing other forms of treatment for the same or
similar indications we are pursuing and that have greater financial and other resources. Other companies may succeed in developing
products earlier than us, obtaining FDA approval for products more rapidly, or developing products that are more effective than
our product candidates. Research and development by others may render our technology or product candidates obsolete or noncompetitive,
or result in treatments or cures superior to any therapy we develop. We face competition from companies that internally develop
competing technology or acquire competing technology from universities and other research institutions. As these companies develop
their technologies, they may develop competitive positions that may prevent, make futile, or limit our product commercialization
efforts, which would result in a decrease in the revenue we would be able to derive from the sale of any products.

 There
can be no assurance that any of our product candidates will be accepted by the marketplace as readily as these or other competing
treatments. Furthermore, if our competitors' products are approved before ours, it could be more difficult for us to obtain
approval from the FDA. For example, at least three vaccines for the prevention of COVID-19 have been approved to date, and we
expect that other vaccines will be approved prior to the approval of our COVID-19 vaccine candidate, if it is approved at all.
Even if our products are successfully developed and approved for use by all governing regulatory bodies, there can be no assurance
that physicians and patients will accept our product(s) as a treatment of choice.

 Additionally,
if a competitor receives FDA approval before we do for a drug that is similar to one of our product candidates, FDA approval for
our product candidate may be precluded or delayed due to periods of non-patent exclusivity and/or the listing with the FDA by
the competitor of patents covering its newly-approved drug product. Periods of non-patent exclusivity for new versions of existing
drugs such as our current drug product candidate, TNX-102 SL, can extend up to three and one-half years.

 Furthermore,
the pharmaceutical research industry is diverse, complex, and rapidly changing. By its nature, the business risks associated therewith
are numerous and significant. The effects of competition, intellectual property disputes, market acceptance, and FDA regulations
preclude us from forecasting revenues or income with certainty or even confidence.

 RISKS
RELATED TO OUR INTELLECTUAL PROPERTY RIGHTS AND REGULATORY EXCLUSIVITY

 If
we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would
be negatively affected.

 Our
success will depend in part on our ability to obtain patents and maintain adequate protection of our technologies and products.
If we do not adequately protect our intellectual property, competitors may be able to use our technologies to produce and market
drugs using our technologies and patents in direct competition with us and erode our competitive advantage. Some foreign countries
lack rules and methods for defending intellectual property rights and do not protect proprietary rights to the same extent as
the United States. Many companies have had difficulty protecting their proprietary rights in these foreign countries. We may not
be able to prevent misappropriation of our proprietary rights and intellectual property rights in these and other countries.

 We
have received, and are currently seeking, patent protection for numerous compounds and methods of treating diseases. However,
the patent process is subject to numerous risks and uncertainties, and there can be no assurance that we will be successful in
protecting our products by obtaining and defending patents related to them. These risks and uncertainties include the following:
patents that may be issued or licensed may be challenged, invalidated, or circumvented, or otherwise may not provide us any competitive
advantage; our competitors, many of which have substantially greater resources than we and many of which have made significant
investments in competing technologies, may seek, or may already have obtained, patents that will limit, interfere with, or eliminate
our ability to make, use, and sell our potential products either in the United States or in international markets; there may be
significant pressure on the United States government and other international governmental bodies to limit the scope of patent
protection both inside and outside the United States for treatments that prove successful as a matter of public policy regarding
worldwide health concerns; and countries other than the United States may have less robust patent laws than those upheld by United
States courts, allowing foreign competitors the ability to exploit these laws to create, develop, and market competing products
using our technologies and patents.

 Moreover,
any patents issued to us may not provide us with meaningful protection, or others may challenge, circumvent or narrow our patents.
Third parties may also independently develop products similar to our products, duplicate our unpatented products or design around
any patents or propriety technologies on products we develop. Additionally, extensive time is required for development, testing
and regulatory review of a potential product. While extensions of patent term due to regulatory delays may be available, it is
possible that, before any of our product candidates can be commercialized, any related patent, even with an extension, may expire
or remain in force for only a short period following commercialization, thereby reducing any advantages to us of the patent.

 In
addition, the PTO and patent offices in other jurisdictions have often required that patent applications concerning pharmaceutical
and/or biotechnology-related inventions be limited or narrowed substantially to cover only the innovations specifically exemplified
in the patent application, thereby limiting the scope of protection against competitive challenges. Thus, even if we or our licensors
are able to obtain patents, the patents may be substantially narrower than anticipated.

 Our
success depends on our patents and patent applications that may be licensed exclusively to us and other patents and patent applications
to which we may obtain assignment or licenses. We may not be aware, however, of all patents, published applications or published
literature that may affect our business either by blocking our ability to commercialize our product candidates, by preventing
the patentability of our product candidates to us or our licensors, or by covering the same or similar technologies. These patents,
patent applications, and published literature may limit the scope of our future patent claims or adversely affect our ability
to market our product candidates.

 In
addition to patents, we rely on a combination of trade secrets, confidentiality, nondisclosure and other contractual provisions,
and security measures to protect our confidential and proprietary information. These measures may not adequately protect our trade
secrets or other proprietary information. If they do not adequately protect our rights, third parties could use our technology,
and we could lose any competitive advantage we may have. In addition, others may independently develop similar proprietary information
or techniques or otherwise gain access to our trade secrets, which could impair any competitive advantage we may have.

protection and other intellectual property protection is crucial to the success of our business and prospects, and there is a
substantial risk that such protections will prove inadequate.

 We
may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming.

 The
pharmaceutical industry has been characterized by extensive litigation regarding patents and other intellectual property rights,
and companies have employed intellectual property litigation to gain a competitive advantage. We may become subject to infringement
claims or litigation arising out of present and future patents and other proceedings of our competitors. The defense and prosecution
of intellectual property suits are costly and time-consuming to pursue, and their outcome is uncertain. Litigation may be necessary
to determine the enforceability, scope, and validity of the proprietary rights of others. An adverse determination in litigation
to which we may become a party could subject us to significant liabilities, require us to obtain licenses from third parties,
or restrict or prevent us from selling our products in certain markets. Although patent and intellectual property disputes might
be settled through licensing or similar arrangements, the costs associated with such arrangements may be substantial and could
include our paying large fixed payments and ongoing royalties. Furthermore, the necessary licenses may not be available on satisfactory
terms or at all.

 Competitors
may infringe our patents, and we may file infringement claims to counter infringement or unauthorized use. Third parties may assert
that our patents are invalid and/or unenforceable in these proceedings. Such litigation can be expensive, particularly for a company
of our size, and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid
or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents
do not cover its technology. An adverse determination of any litigation or defense proceedings could put one or more of our patents
at risk of being invalidated or interpreted narrowly.

 Third
parties may also assert that our patents are invalid in patent office administrative proceedings. These proceedings include oppositions
in the European Patent Office and inter partes review and post-grant review proceedings in the PTO. The success
rate of these administrative challenges to patent validity in the United States is higher than it is for validity challenges in
litigation.

 Interference
or derivation proceedings brought before the PTO may be necessary to determine priority of invention with respect to innovations
disclosed in our patents or patent applications. During these proceedings, it may be determined that we do not have priority of
invention for one or more aspects in our patents or patent applications and could result in the invalidation in part or whole
of a patent or could put a patent application at risk of not issuing. Even if successful, an interference or derivation proceeding
may result in substantial costs and distraction to our management.

 Furthermore,
because of the substantial amount of discovery required in connection with intellectual property litigation or interference or
derivation proceedings, there is a risk that some of our confidential information could be compromised by disclosure. In addition,
there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If investors
perceive these results to be negative, the price of our common stock could be adversely affected.

 Except
for the oppositions to European Patents 2501234, 2968992, and 2683245 (the Opposition Division in each of those oppositions maintained
our claims in unamended form; Opponent has appealed that decision in the '234 Opposition and we expect the opponents to
appeal the decisions in the '992 and '245 oppositions), there are no unresolved communications, allegations, complaints
or threats of litigation related to the possibility that our patents are invalid or unenforceable. Any litigation or claims against
us, whether or not merited, may result in substantial costs, place a significant strain on our financial resources, divert the
attention of management and harm our reputation. An adverse decision in litigation or administrative proceedings could result
in inadequate protection for our product candidates and/or reduce the value of any license agreements we have with third parties.

 If
we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and defend against
litigation.

 If
our products, methods, processes and other technologies infringe the proprietary rights of other parties, we could incur substantial
costs and we may have to: obtain licenses, which may not be available on commercially reasonable terms, if at all; abandon an
infringing product candidate; redesign our products or processes to avoid infringement; stop using the subject matter claimed
in the patents held by others; pay damages; and/or defend litigation or administrative proceedings which may be costly whether
we win or lose, and which could result in a substantial diversion of our financial and management resources.

 There
are risks to our intellectual property based on our international business initiatives.

 We
may face risks to our technology and intellectual property as a result of our conducting strategic business discussions outside
of the United States, and particularly in jurisdictions that do not have comparable levels of protection of corporate proprietary
information and assets such as intellectual property, trademarks, trade secrets, know-how and customer information and records.
While these risks are common to many companies, conducting business in certain foreign jurisdictions, housing technology, data
and intellectual property abroad, or licensing technology to joint ventures with foreign partners may have more significant exposure.
For example, we have shared intellectual properties with entities in China pursuant to confidentiality agreements in connection
with discussions on potential strategic collaborations, which may expose us to material risks of theft of our proprietary information
and other intellectual property, including technical data, manufacturing processes, data sets or other sensitive information.
For example, our technology may be reverse engineered by the parties or other parties, which could result in our patents being
infringed or our know-how or trade secrets stolen. The risk can be by direct intrusion wherein technology and intellectual property
is stolen or compromised through cyber intrusions or physical theft through corporate espionage, including with the assistance
of insiders, or via more indirect routes.

 GENERAL
COMPANY-RELATED RISKS

 If
preclinical and nonclinical testing or clinical studies for our product candidates are unsuccessful or delayed, we will be unable
to meet our anticipated development and commercialization timelines.

 We
rely and expect to continue to rely on third parties, including contract research organizations, or CROs, and outside consultants,
to conduct, supervise or monitor some or all aspects of preclinical and nonclinical testing and clinical studies involving our
product candidates. We have less control over the timing and other aspects of these preclinical and nonclinical testing activities
and clinical studies than if we performed the monitoring and supervision entirely on our own. Third parties may not perform their
responsibilities for our preclinical and nonclinical testing and clinical studies on our anticipated schedule or, for clinical
studies, consistent with a clinical study protocol. Delays in preclinical and nonclinical testing, and clinical studies could
significantly increase our product development costs and delay product commercialization. In addition, many of the factors that
may cause, or lead to, a delay in the clinical studies may also ultimately lead to denial of regulatory approval of a product
candidate.

 The
commencement of clinical studies can be delayed for a variety of reasons, including delays in:

 demonstrating
 sufficient safety and efficacy to obtain regulatory approval to commence a clinical study;

 reaching
 agreement on acceptable terms with prospective CROs and study sites;

 developing
 a stable formulation of a product candidate;

 manufacturing
 sufficient quantities of a product candidate; and

 obtaining
 institutional review board, or IRB, approval to conduct a clinical study at a prospective site.

 Once
a clinical study has begun, it may be delayed, suspended or terminated by us or the FDA or other regulatory authorities due to
a number of factors, including:

 ongoing
 discussions with the FDA or other regulatory authorities regarding the scope or design of our clinical studies;

 failure
 to conduct clinical studies in accordance with regulatory requirements;

 lower
 than anticipated recruitment or retention rate of patients in clinical studies;

 inspection
 of the clinical study operations or study sites by the FDA or other regulatory authorities resulting in the imposition of
 a clinical hold;

 lack
 of adequate funding to continue clinical studies;

 negative
 results of clinical studies;

 investigational
 drug product out-of-specification; or

 nonclinical
 or clinical safety observations, including adverse events and SAEs.

 If
clinical studies are unsuccessful, and we are not able to obtain regulatory approvals for our product candidates under development,
we will not be able to commercialize these products, and therefore may not be able to generate sufficient revenues to support
our business.

 We
rely on third parties to conduct, supervise and monitor our clinical studies, and if those third parties perform in an unsatisfactory
manner, it may harm our business.

 We
rely on CROs and clinical study sites to ensure the proper and timely conduct of our clinical studies. While we have agreements
governing their activities, we will have limited influence over their actual performance. We will control only certain aspects
of our CROs' activities. Nevertheless, we will be responsible for ensuring that our clinical studies are conducted in accordance
with the applicable protocol, legal, regulatory and scientific standards and our reliance on the CROs does not relieve us of our
regulatory responsibilities.

 We
and our CROs are required to comply with the FDA's cGCP for conducting, recording and reporting the results of clinical
studies to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality
of clinical study participants are protected. The FDA enforces these cGCPs through periodic inspections of study sponsors, principal
investigators and clinical study sites. If we or our CROs fail to comply with applicable cGCPs, the clinical data generated in
our clinical studies may be deemed unreliable and the FDA may require us to perform additional clinical studies before approving
any marketing applications. Upon inspection, the FDA may determine that our clinical studies did not comply with cGCPs. Accordingly, if our CROs fail to comply with these
regulations, we may be required
to repeat such clinical studies, which would delay the regulatory approval process.

 Our
CROs are not our employees, and we are not able to control whether or not they devote sufficient time and resources to our clinical
studies. These CROs may also have relationships with other commercial entities, including our competitors, for whom they may also
be conducting clinical studies, or other drug development activities which could harm our competitive position.

 If
our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality
or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory
requirements, or for any other reasons, our clinical studies may be extended, delayed or terminated, and we may not be able to
obtain regulatory approval for, or successfully commercialize our product candidates. As a result, our financial results and the
commercial prospects for such product candidates would be harmed, our costs could increase, and our ability to generate revenues
could be delayed.

 We
also rely on other third parties to store and distribute drug products for our clinical studies. Any performance failure on the
part of our distributors could delay clinical development or marketing approval of our product candidates or commercialization
of our products, if approved, producing additional losses and depriving us of potential product revenue.

 In addition, we currently
rely on foreign CROs and CMOs, including WuXi Biologics, and will likely continue to rely on foreign CROs and CMOs in the future. Foreign
CMOs may be subject to U.S. legislation, including the proposed BIOSECURE Act, sanctions, trade restrictions and other foreign
regulatory requirements which could increase the cost or reduce the supply of material available to us, delay the procurement or supply
of such material or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential
therapies.

 For example, the biopharmaceutical
industry in China is strictly regulated by the Chinese government. Changes to Chinese regulations or government policies affecting biopharmaceutical
companies are unpredictable and may have a material adverse effect on our collaborators in China which could have an adverse effect on
our business, financial condition, results of operations and prospects. Evolving changes in China's public health, economic, political,
and social conditions and the uncertainty around China's relationship with other governments, such as the United States and the
U.K., could also negatively impact our ability to manufacture our product candidates for our planned clinical trials or have an adverse
effect on our ability to secure government funding, which could adversely affect our financial condition and cause us to delay our clinical
development programs.

 We
will need to expand our operations and increase the size of our company, and we may experience difficulties in managing growth.

 As
we advance our product candidates through preclinical and nonclinical testing and clinical studies, and develop new product candidates, buildout of our research and development and manufacturing facilities, and develop our commercialization organization, we will need to increase our product development, scientific,
regulatory and compliance and administrative headcount to manage these programs. In addition, to meet our obligations as a public
company, we will need to increase our general and administrative capabilities. Our management, personnel and systems currently
in place may not be adequate to support this future growth. Our need to effectively manage our operations, growth and various
projects requires that we:

 successfully
 attract and recruit new employees with the expertise and experience we will require;

 manage
 our clinical programs effectively, which we anticipate being conducted at numerous clinical sites;

 maintain a marketing, distribution and sales infrastructure in addition
to a post-marketing surveillance program; and

 continue
 to improve our operational, manufacturing, quality assurance, financial and management controls, reporting systems and procedures.

 If
we are unable to successfully manage this growth and increased complexity of operations, our business may be adversely affected.

 Our
executive officers and other key personnel are critical to our business, and our future success depends on our ability to retain
them.

 Our
success depends to a significant extent upon the continued services of Dr. Seth Lederman, our President and Chief Executive Officer
and Dr. Gregory M. Sullivan, our Chief Medical Officer. Dr. Lederman has overseen Tonix Pharmaceuticals, Inc., a wholly-owned
subsidiary, since inception and provides leadership for our growth and operations strategy as well as being an inventor on many
of our patents. Dr. Sullivan has served as our Chief Medical Officer since 2014 and directed the Phase 2 AtEase study, Phase 3
HONOR study, the Phase 3 RECOVERY study, Phase 3 RELIEF study, the Phase 3 RALLY study and the Phase 3 RESILIENCE study. Loss
of the services of Drs. Lederman or Sullivan would have a material adverse effect on our growth, revenues, and prospective business.
The loss of any of our key personnel, or the inability to attract and retain qualified personnel, may significantly delay or prevent
the achievement of our research, development or business objectives and could materially adversely affect our business, financial
condition and results of operations.

 Any
employment agreement we enter into will not ensure the retention of the employee who is a party to the agreement. In addition,
we have only limited ability to prevent former employees from competing with us.

 Furthermore,
our future success will also depend in part on the continued service of our key scientific and management personnel and our ability
to identify, hire, and retain additional personnel. We experience intense competition for qualified personnel and may be unable
to attract and retain the personnel necessary for the development of our business. Moreover, competition for personnel with the
scientific and technical skills that we seek is extremely high and is likely to remain high. Because of this competition, our
compensation costs may increase significantly.

 If
we are unable to hire additional qualified personnel, our ability to grow our business may be harmed.

 Over
time we will need to hire additional qualified personnel with expertise in drug development, product registration, clinical, preclinical
and nonclinical research, quality compliance, government regulation, formulation and manufacturing, financial matters and sales
and marketing. We compete for qualified individuals with numerous biopharmaceutical companies, universities and other research
institutions. Competition for such individuals is intense, and we cannot be certain that our search for such personnel will be
successful. Attracting and retaining qualified personnel will be critical to our success.

 We rely on third parties to manufacture
our marketed products and the compounds used in our studies, and we intend to rely on them in the future. If these third parties do not
manufacture our products and product candidates in sufficient quantities and at an acceptable cost, clinical development and commercialization
of our products and product candidates could be delayed, prevented or impaired.

 We have no experience in the
clinical or commercial-scale manufacture of drugs or in designing drug manufacturing processes. We rely on CMOs to manufacture all of
our product candidates in clinical studies and our commercial products. Completion of our clinical studies and commercialization of our
products requires the manufacture of a sufficient supply of our products. We have contracted with outside sources to manufacture our development
compounds and commercial products. If, for any reason, we become unable to rely on our current manufacturing sources, either for clinical
studies or for commercial quantities, then we would need to identify and contract with additional or replacement third-party manufacturers.
Although we are in discussions with other manufacturers we have identified as potential alternative CMOs of TNX-102 SL, we may not be
successful in negotiating acceptable terms with any of them.

 We believe that there are
a variety of manufacturers that we may be able to retain to produce these products. However, once we retain a manufacturing source, if
our manufacturers do not perform in a satisfactory manner, we may not be able to develop or commercialize our products as planned. Certain
specialized manufacturers are expected to provide us with modified and unmodified pharmaceutical compounds, including finished products,
for use in our preclinical and nonclinical testing and clinical studies and final product. Some of these materials are available from
only one supplier or vendor. Any interruption in or termination of service by such sole source suppliers could result in a delay or interruption
in manufacturing until we locate an alternative source of supply. Any delay or interruption in manufacturing operations (or failure to
locate a suitable replacement for such suppliers) could materially adversely affect our business, prospects, or results of operations.
We do not have any short-term or long-term manufacturing agreements with many of these manufacturers. If we fail to contract for manufacturing
on acceptable terms or if third-party manufacturers do not perform as we expect, our development programs could be materially adversely
affected, and our efforts to commercialize our marketed products will be materially impaired. This may result in delays in filing for
and receiving FDA approval for one or more of our products and impair our revenues from sales. Any such delays could cause our prospects
and financial condition to suffer significantly.

 Failure
by our third-party manufacturers to comply with the regulatory guidelines set forth by the FDA with respect to our products and product candidates
could delay or prevent the completion of clinical studies, the approval of any product candidates or the commercialization of
our products.

 Third-party manufacturers must be inspected by FDA for cGMP compliance before they can produce commercial product. We may be in
competition with other companies for access to these manufacturers' facilities and may be subject to delays in manufacture
if the manufacturers give other clients higher priority than they give to us. If we are unable to secure and maintain third-party
manufacturing capacity, the development and sales of our products and our financial performance may be materially affected.

 Manufacturers
are obligated to operate in accordance with FDA-mandated requirements. A failure of any of our third-party manufacturers to establish
and follow cGMP requirements and to document their adherence to such practices may lead to significant delays in the availability
of material for clinical studies, may delay or prevent filing or approval of marketing applications for our products, and may
cause delays or interruptions in the availability of our products for commercial distribution following FDA approval. This could
result in higher costs to us or deprive us of potential product revenues.

 Drug
manufacturers are subject to ongoing periodic unannounced inspections by the FDA, the Drug Enforcement Administration, or DEA,
and corresponding state and foreign agencies to ensure strict compliance with cGMP requirements and other requirements under Federal
drug laws, other government regulations and corresponding foreign standards. If we or our third-party manufacturers fail to comply
with applicable regulations, sanctions could be imposed on us, including fines, injunctions, civil penalties, failure by the government
to grant marketing approval of drugs, delays, suspension or withdrawal of approvals, seizures or recalls of product, operating
restrictions and criminal prosecutions.

 Adverse
global conditions, including economic uncertainty, may negatively impact our financial results.

 Global
conditions, dislocations in the financial markets, or inflation could adversely impact our business. In addition, the global macroeconomic
environment has been and may continue to be negatively affected by, among other things, instability in global economic markets,
increased U.S. trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain weaknesses,
instability in the geopolitical environment as a result of the Russian invasion of the Ukraine, the withdrawal of the United Kingdom
from the European Union, and other political tensions, and foreign governmental debt concerns. Such challenges have caused, and
may continue to cause, uncertainty and instability in local economies and in global financial markets, which may adversely affect
our business.

 Our
internal computer systems, or those of our CROs or other contractors or consultants, may fail or suffer security breaches, which
could result in a material disruption of our product development programs.

 Despite
the implementation of security measures, our internal computer systems and those of our CROs and other contractors and consultants
are vulnerable to damage or disruption from computer viruses, software bugs, unauthorized access, natural disasters, terrorism,
war, and telecommunication, equipment and electrical failures.

 While
we have not, to our knowledge, experienced any significant system failure, accident or security breach to date, if such an event
were to occur and cause interruptions in our operations, it could result in a material disruption of our programs. For example,
the loss of clinical trial data from completed or ongoing clinical trials for any of our product candidates could result in delays
in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Moreover, our information
security systems and those of our CROs are also subject to laws and regulations requiring that we take measures to protect the
privacy and security of certain information gathered and used in our business. For example, HIPAA and its implementing regulations
impose, among other requirements, certain regulatory and contractual requirements regarding the privacy and security of personal
health information. In the European Union the General Data Protection Regulation, or GDPR, is even more restrictive with respect
to all personal information, including information masked by a coding system. In addition to HIPAA and GDPR, numerous other federal
and state laws, including, without limitation, state security breach notification laws, state health information privacy laws
and federal and state consumer protection laws, govern the collection, use, disclosure and storage of personal information. To
the extent that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate
disclosure or theft of confidential or proprietary information, we could incur liability, the further development of our product
candidates could be delayed, our competitive position could be compromised, or our business reputation could be harmed.

 Corporate
and academic collaborators may take actions to delay, prevent, or undermine the success of our products.

 Our
operating and financial strategy for the development, clinical testing, manufacture, and commercialization of drug candidates
is heavily dependent on our entering into collaborations with corporations, academic institutions, licensors, licensees, and other
parties. Our current strategy assumes that we will successfully establish these collaborations, or similar relationships; however,
there can be no assurance that we will be successful establishing such collaborations. Some of our existing collaborations are,
and future collaborations may be, terminable at the sole discretion of the collaborator. Replacement collaborators might not be
available on attractive terms, or at all. The activities of any collaborator will not be within our control and may not be within
our power to influence. There can be no assurance that any collaborator will perform its obligations to our satisfaction or at
all, that we will derive any revenue or profits from such collaborations, or that any collaborator will not compete with us. If
any collaboration is not pursued, we may require substantially greater capital to undertake development and marketing of our proposed
products and may not be able to develop and market such products effectively, if at all. In addition, a lack of development and
marketing collaborations may lead to significant delays in introducing proposed products into certain markets and/or reduced sales
of proposed products in such markets.

 Data
provided by collaborators and others upon which we rely that has not been independently verified could turn out to be false, misleading,
or incomplete.

 We
rely on third-party vendors, scientists, and collaborators to provide us with significant data and other information related to
our projects, clinical studies, and our business. If such third parties provide inaccurate, misleading, or incomplete data, our
business, prospects, and results of operations could be materially adversely affected.

 Our
product candidates may face competition sooner than expected.

 We
intend to seek data exclusivity or market exclusivity for our product candidates provided under the FDCA and similar laws in other
countries. We believe that TNX-801 could qualify for 12 years of data exclusivity under the Biologics Price Competition and Innovation
Act of 2009, or BPCIA, which was enacted as part of the PPACA. Under the BPCIA, an application for a biosimilar product or BLA
cannot be submitted to the FDA until four years, or if approved by the FDA, until 12 years, after the original brand product identified
as the reference product is approved under a BLA. The BPCIA provides an abbreviated pathway for the approval of biosimilar and
interchangeable biological products. The new abbreviated regulatory pathway establishes legal authority for the FDA to review
and approve biosimilar biologics, including the possible designation of a biosimilar as "interchangeable" based on
its similarity to an existing brand product. The new law is complex and is only beginning to be interpreted and implemented by
the FDA. While it is uncertain when any such processes may be fully adopted by the FDA, any such processes could have a material
adverse effect on the future commercial prospects for any of our product candidates that are biologics. There is also a risk that
BPCIA could be repealed or amended to shorten this exclusivity period, potentially creating the opportunity for biosimilar competition
sooner than anticipated after the expiration of our patent protection. Although there is no current discussion of repeal or modification
of the BPCIA, the future remains uncertain. Moreover, the extent to which a biosimilar, once approved, will be substituted for
any reference product in a way that is similar to traditional generic substitution for non-biological products is not yet clear,
and will depend on a number of marketplace and regulatory factors that are still developing.

 Our product candidates that are not, or
are not considered, biologics that would qualify for exclusivity under the BPCIA may be eligible for market exclusivity as drugs
under the FDCA. The FDCA provides a five-year period of non-patent marketing exclusivity within the U.S. to the first applicant
to gain approval of an NDA for an NCE. A drug is an NCE if the FDA has not previously approved any other new drug containing the
same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period,
the FDA may not accept for review an abbreviated new drug application, or ANDA, or a 505(b)(2) NDA, submitted by another company
for another version of such drug where the applicant does not own or have a legal right of reference to all the data required
for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or
non-infringement. The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing
NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are
deemed by the FDA to be essential to the approval of the application, for example, for new indications, dosages, or strengths
of an existing drug. This three-year exclusivity covers only the conditions associated with the new clinical investigations and
does not prohibit the FDA from approving ANDAs for drugs containing the original active agent.

 Even
if, as we expect, our product candidates are considered to be reference products eligible for 12 years of exclusivity under the
BPCIA or five years of exclusivity under the FDCA, another company could market competing products if the FDA approves a full
BLA or full NDA for such product containing the sponsor's own preclinical data and data from adequate and well-controlled
clinical trials to demonstrate the safety, purity and potency of the products. Moreover, an amendment or repeal of the BPCIA could
result in a shorter exclusivity period for our product candidates, which could have a material adverse effect on our business.

 If
we fail to establish marketing, sales and distribution capabilities, or fail to enter into arrangements with third parties, we
will not be able to create a market for our product candidates.

 Our
strategy for our marketed products and our product candidates is to control, directly or through contracted third parties, all or most aspects of the product
development process, including marketing, sales and distribution.

 We are in the process of establishing
sales, marketing or distribution capabilities. In order to successfully generate and increase sales of our marketed products or any of
our product candidates that receive regulatory approval, we must either acquire or develop an internal marketing and sales force with
technical expertise and with supporting distribution capabilities or make arrangements with third parties to perform these services for
us. The acquisition or development of a sales and distribution infrastructure, which we have commenced, requires substantial resources,
which may divert the attention of our management and key personnel and defer our product development efforts.

 To
the extent that we enter into marketing and sales arrangements with other companies, our revenues will depend on the efforts of
others. These efforts may not be successful. If we fail to develop sales, marketing and distribution channels, or enter into arrangements
with third parties, we will experience delays in product sales and incur increased costs.

 Sales
of pharmaceutical products largely depend on the reimbursement of patients' medical expenses by government health care programs
and private health insurers. Without the financial support of the government or third-party payors, the market for our products
will be limited. These third-party payors are increasingly challenging the price and examining the cost effectiveness of medical
products and services. Recent proposals to change the health care system in the United States have included measures that would
limit or eliminate payments for medical products and services or subject the pricing of medical treatment products to government
control. Significant uncertainty exists as to the reimbursement status of newly approved health care products. Third-party payors
may not reimburse sales of our products or enable our collaborators to sell them at profitable prices.

 Our
business strategy might involve out-licensing product candidates to or collaborating with larger firms with experience in marketing
and selling pharmaceutical products. There can be no assurance that we will be able to successfully establish marketing, sales,
or distribution relationships; that such relationships, if established, will be successful; or that we will be successful in gaining
market acceptance for our products. To the extent that we enter into any marketing, sales, or distribution arrangements with third
parties, our product revenues will be lower than if we marketed and sold our products directly, and any revenues we receive will
depend upon the efforts of such third-parties. If we are unable to establish such third-party sales and marketing relationships,
or choose not to do so, we will have to establish and rely on our own in-house capabilities.

 We,
as a company, have no experience in marketing or selling pharmaceutical products and currently have no sales, marketing, or distribution
infrastructure. To market any of our products directly, we would need to develop a marketing, sales, and distribution force that
both has technical expertise and the ability to support a distribution capability. The establishment of a marketing, sales, and
distribution capability would significantly increase our costs, possibly requiring substantial additional capital. In addition,
there is intense competition for proficient sales and marketing personnel, and we may not be able to attract individuals who have
the qualifications necessary to market, sell, and distribute our products. There can be no assurance that we will be able to establish
internal marketing, sales, or distribution capabilities. If we are unable to, or choose not to establish these capabilities, or
if the capabilities we establish are not sufficient to meet our needs, we will be required to establish collaborative marketing,
sales, or distribution relationships with third parties.

 Our
relationships with customers, physicians, and third-party payors is subject, to federal and state
healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and
regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

 Healthcare providers, physicians
and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of our products.
Our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors
subject us to various federal and state fraud and abuse laws and other health care laws, including, without limitation, the federal Anti-Kickback
Statute, the federal civil and criminal false claims laws and the law commonly referred to as the Physician Payments Sunshine Act and
regulations. These laws will impact, among other things, our clinical research, sales, marketing and educational programs. In addition,
we may be subject to patient privacy laws by both the federal government and the states in which we conduct or may conduct our business.
The laws that will affect our operations include, but are not limited to:

 the
 federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting,
 receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly
 or covertly, in cash or in kind, in return for the purchase, recommendation, leasing or furnishing of an item or service reimbursable
 under a federal healthcare program, such as the Medicare and Medicaid programs;

 federal
 civil and criminal false claims laws, including, without limitation, the False Claims Act, and civil monetary penalty laws
 which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims
 for payment or approval from Medicare, Medicaid or other government payors that are false or fraudulent or making a false
 statement to avoid, decrease or conceal an obligation to pay money to the federal government;

 the
 federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes
 that prohibit a person from knowingly and willfully executing a scheme or making false or fraudulent statements to defraud
 any healthcare benefit program, regardless of the payor (e.g., public or private);

 HIPAA,
 as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations,
 and as amended again by the final HIPAA omnibus rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach
 Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act; Other Modifications to HIPAA, published
 in January 2013, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable
 health information without appropriate authorization by entities subject to the rule, such as health plans, health care clearinghouses
 and health care providers, and their respective business associates;

 federal
 transparency laws, including the federal Physician Payments Sunshine Act, which is part of PPACA, that require certain manufacturers
 of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's
 Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services,
 or CMS, information related to: (i) payments or other "transfers of value'' made to physicians and
 teaching hospitals; and (ii) ownership and investment interests held by physicians and their immediate family members;

 state
 and foreign law equivalents of each of the above federal laws, state laws that require manufacturers to report information
 related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, and
 state laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines
 and the relevant compliance guidance promulgated by the federal government or to adopt compliance programs as prescribed by
 state laws and regulations, or that otherwise restrict payments that may be made to healthcare providers; and

 state
 and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from
 each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some
of our business activities could be subject to challenge under one or more of such laws.

 It
is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes,
regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found
to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant
civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion of drugs from government funded
healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a
corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws and the
curtailment or restructuring of our operations.

 The
risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted
by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Efforts to ensure
that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial
costs. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant
legal expenses and divert our management's attention from the operation of our business. The shifting compliance environment
and the need to build and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance
and/or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements.

 Coverage
and adequate reimbursement may not be available for our products, which could make it difficult for us to sell profitably.

 Market
acceptance and sales of any of our products depends in part on the extent to which reimbursement for these drugs and related treatments
will be available from third-party payors, including government health administration authorities, managed care organizations and other
private health insurers. Third-party payors decide which therapies they will pay for and establish reimbursement levels. Third-party payors
often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions
regarding the extent of coverage and amount of reimbursement to be provided for any drug is made on a payor-by-payor basis.
One payor's determination to provide coverage for a drug does not assure that other payors will also provide coverage, and adequate
reimbursement, for the drug. Additionally, a third-party payor's decision to provide coverage for a therapy does not imply that
an adequate reimbursement rate will be approved. Each payor determines whether or not it will provide coverage for a therapy, what amount
it will pay the manufacturer for the therapy, and on what tier of its formulary it will be placed. The position on a payor's list
of covered drugs, or formulary, generally determines the co-payment that a patient will need to make to obtain the therapy and
can strongly influence the adoption of such therapy by patients and physicians. Patients who are prescribed treatments for their conditions
and providers prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs.
Patients are unlikely to use our drugs unless coverage is provided and reimbursement is adequate to cover a significant portion of the
cost of our drugs.

 A
primary trend in the U.S. healthcare industry and elsewhere is cost containment. Third-party payors have attempted to control costs by
limiting coverage and the amount of reimbursement for particular medications. We cannot be sure that coverage and reimbursement will be
available or continue to be available for any drug that we commercialize and, if reimbursement is available, what the level of reimbursement
will be. Inadequate coverage and reimbursement may impact the demand for, or the price of, any drug we commercialize. If coverage and
adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our
current and any future drug products.

 Healthcare
legislative or regulatory reform measures, including government restrictions on pricing and reimbursement, may have a negative
impact on our business and results of operations.

 In
the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes
and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict
or regulate post-approval activities, and affect our ability to profitably sell any of our commercialized products.

 Among
policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare
systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States,
the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative
initiatives. For example, in the United States, the PPACA substantially changed the way healthcare is financed by both the government
and private insurers, and significantly affects the pharmaceutical
industry. Many provisions of the ACA impact the biopharmaceutical industry, including that in order for a biopharmaceutical product
to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to U.S. government agencies,
the manufacturer must extend discounts to entities eligible to participate in the drug pricing program under the Public Health
Services Act, or PHS.

 Additionally,
the Inflation Reduction Act of 2022, which took effect in 2023, includes policies that are designed to have a direct impact on
drug prices and reduce drug spending by the federal government. This legislation contains substantial drug pricing reforms, including
the establishment of a drug price negotiation program within the U.S. Department of Health and Human Services that would require
manufacturers to charge a negotiated "maximum fair price" for certain selected drugs covered by Medicare or pay an
excise tax for noncompliance, the establishment of rebate payment requirements on manufacturers of certain drugs payable under
Medicare Parts B and D to penalize price increases that outpace inflation, and requires manufacturers to provide discounts on
Part D drugs.

 Legislative,
administrative, and private payor efforts to control drug costs span a range of proposals, including drug price negotiation, Medicare
Part D redesign, drug price inflation rebates, international mechanisms, generic drug promotion and anticompetitive behavior,
manufacturer reporting, and reforms that could impact therapies utilizing the accelerated approval pathway. We cannot predict
the ultimate content, timing or effect of any changes to the ACA, the Inflation Reduction Act, or other federal and state healthcare
policy reform efforts including those aimed at drug pricing. There is no assurance that federal or state health care reform will
not adversely affect our future business and financial results, and we cannot predict how future federal or state legislative,
judicial or administrative changes relating to healthcare policy will affect our business.

 At
the federal level, the now-departed Trump administration proposed numerous prescription drug cost control measures. Similarly,
the new Biden administration has made lowering prescription drug prices one of its priorities. The Biden administration
has not yet proposed any specific plans, but we expect that these will be forthcoming in the near term. At the state level, legislatures
are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing,
including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure
and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Other
examples of proposed changes include, but are not limited to, expanding post-approval requirements, changing the Orphan Drug Act,
and restricting sales and promotional activities for pharmaceutical products.

 We
cannot be sure whether additional legislative changes will be enacted, or whether government regulations, guidance or interpretations
will be changed, or what the impact of such changes would be on the marketing approvals, sales, pricing, or reimbursement of our
drug candidates or products, if any, may be. We expect that these and other healthcare reform measures that may be adopted in
the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for
any approved drug. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction
in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from
being able to generate revenue, attain profitability, or commercialize our drugs.

 In
addition, FDA regulations and guidance may be revised or reinterpreted by the FDA in ways that may significantly affect our business
and our products. Any new regulations or guidance, or revisions or reinterpretations of existing regulations or guidance, may
impose additional costs or lengthen FDA review times for our product candidates. We cannot determine how changes in regulations,
statutes, policies, or interpretations when and if issued, enacted or adopted, may affect our business in the future. Such changes
could, among other things, require:

 additional
 clinical trials to be conducted prior to obtaining approval;

 changes
 to manufacturing methods;

 recalls,
 replacements, or discontinuance of one or more of our products; and

 additional
 recordkeeping.

 Such
changes would likely require substantial time and impose significant costs, or could reduce the potential commercial value of
our product candidates. In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any other
products would harm our business, financial condition, and results of operations.

 If
we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international
operations could materially adversely affect our business.

 If
TNX-102 SL or any of our other product candidates are approved for commercialization outside of the United States, we intend to
enter into agreements with third parties to market them on a worldwide basis or in more limited geographical regions. We expect
that we will be subject to additional risks related to entering into international business relationships, including:

 different
 regulatory requirements for drug approvals;

 reduced
 protection for intellectual property rights, including trade secret and patent rights;

 unexpected
 changes in tariffs, trade barriers and regulatory requirements;

 economic
 weakness, including inflation, or political instability in particular foreign economies and markets;

 compliance
 with tax, employment, immigration and labor laws for employees living or traveling abroad;

 foreign
 taxes, including withholding of payroll taxes;

 foreign
 currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident
 to doing business in another country;

 workforce
 uncertainty in countries where labor unrest is more common than in the United States;

 production
 shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

 business
 interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes,
 hurricanes, floods and fires; and

 difficulty
 in importing and exporting clinical study materials and study samples.

 We
face the risk of product liability claims and may not be able to obtain insurance.

 Our business exposes
us to the risk of product liability claims that are inherent in the sale and development of drugs. If the use of one or more of our or
our collaborators' drugs harms people, we may be subject to costly and damaging product liability claims brought against us by clinical
study participants, consumers, health care providers, pharmaceutical companies or others selling our products. Our inability to obtain
sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit
the commercialization of pharmaceutical products we develop, alone or with collaborators. While we currently carry clinical study insurance
and product liability insurance, we cannot predict all of the possible harms or side effects that may result and, therefore, the amount
of insurance coverage we hold now or in the future may not be adequate to cover all liabilities we might incur. We expanded our insurance
coverage to include the sale of our commercial products Tosymra and Zembrace Symtouch. We intend to further expand our insurance coverage
to include the sale of Tonmya upon receiving FDA approval for marketing. If we are unable to obtain insurance at an acceptable cost or
otherwise protect against potential product liability claims, we will be exposed to significant liabilities, which may materially and
adversely affect our business and financial position. If we are sued for any injury allegedly caused by our or our collaborators'
products, our liability could exceed our total assets and our ability to pay the liability. A product liability claim or series of claims
brought against us would decrease our cash and could cause our stock price to fall.

 We
use hazardous chemicals in our business. Potential claims relating to improper handling, storage or disposal of these chemicals
could affect us and be time-consuming and costly.

 Our
research and development processes and/or those of our third party contractors may involve the controlled use of hazardous materials
and chemicals. These hazardous chemicals are reagents and solvents typically found in a chemistry laboratory. Our operations also
produce hazardous waste products. Federal, state and local laws and regulations govern the use, manufacture, storage, handling
and disposal of hazardous materials. While we attempt to comply with all environmental laws and regulations, including those relating
to the outsourcing of the disposal of all hazardous chemicals and waste products, we cannot eliminate the risk of contamination
from or discharge of hazardous materials and any resultant injury. In the event of such an accident, we could be held liable for
any resulting damages and any liability could materially adversely affect our business, financial condition and results of operations.

 Compliance
with environmental laws and regulations may be expensive. Current or future environmental regulations may impair our research,
development or production efforts. We might have to pay civil damages in the event of an improper or unauthorized release of,
or exposure of individuals to, hazardous materials. We are not insured against these environmental risks.

 If
we enter into collaborations with third parties, they might also work with hazardous materials in connection with our collaborations.
We may agree to indemnify our collaborators in some circumstances against damages and other liabilities arising out of development
activities or products produced in connection with these collaborations.

 In
addition, the federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of
hazardous or radioactive materials and waste products may require us to incur substantial compliance costs that could materially
adversely affect our business, financial condition and results of operations.

 Our
insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured
liabilities.

 We
carry insurance for most categories of risk that our business may encounter, however, we may not have adequate levels of coverage.
We currently maintain general liability, clinical study, property, workers' compensation, products liability and directors'
and officers' insurance, along with an umbrella policy, which collectively costs approximately $2,000,000 per annum. We
cannot provide any assurances that we will be able to maintain existing insurance at current or adequate levels of coverage. Any
significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash position and
results of operations.

 If
we retain collaborative partners and our partners do not satisfy their obligations, we will be unable to develop our partnered
product candidates.

 In
the event we enter into any collaborative agreements, we may not have day-to-day control over the activities of our collaborative
partners with respect to any of these product candidates. Any collaborative partner may not fulfill its obligations under these
agreements. If a collaborative partner fails to fulfill its obligations under an agreement with us, we may be unable to assume
the development of the products covered by that agreement or enter into alternative arrangements with a third party. In addition,
we may encounter delays in the commercialization of the product candidate that is the subject of the agreement. Accordingly, our
ability to receive any revenue from the product candidates covered by these agreements will be dependent on the efforts of our
collaborative partner. We could also become involved in disputes with a collaborative partner, which could lead to delays in or
termination of our development and commercialization programs and time-consuming and expensive litigation or arbitration. In addition,
any such dispute could diminish our collaborators' commitment to us and reduce the resources they devote to developing and
commercializing our products. Conflicts or disputes with our collaborators, and competition from them, could harm our relationships
with our other collaborators, restrict our ability to enter future collaboration agreements and delay the research, development
or commercialization of our product candidates. If any collaborative partner terminates or breaches its agreement, or otherwise
fails to complete its obligations in a timely manner, our chances of successfully developing or commercializing these product
candidates would be materially and adversely affected. We may not be able to enter into collaborative agreements with partners
on terms favorable to us, or at all. Our inability to enter into collaborative arrangements with collaborative partners, or our
failure to maintain such arrangements, would limit the number of product candidates that we could develop and ultimately, decrease
our sources of any future revenues.

 We
may be unsuccessful in obtaining a priority review voucher for material threat medical countermeasures.

 In
2016, the 21 st Century Cures Act, or the Act, was signed into law to support ongoing biomedical innovation. One part
of the Act, Section 3086, is aimed at "Encouraging Treatments for Agents that Present a National Security Threat."
The Act created a new priority review voucher program for approved "material threat medical countermeasures." The
Act defines such countermeasures as drug or biologic products, including vaccines, intended to treat biological, chemical, radiological,
or nuclear agents that present a national security threat or to treat harm from a condition that may be caused by administering
a drug or biological product against such an agent. The Department of Homeland Security has identified 13 such threats, including
anthrax, smallpox, Ebola/Marburg, tularemia, botulinum toxin, and pandemic influenza, which includes the SARS coronavirus 2 known
as SARS-CoV-2. A priority review voucher can be applied to any other product; it shortens the FDA review timeline for a new application
from 10 to 12 months to 6 months. The recipient of a priority review voucher may transfer it.

 There
may not be market interest in TNX-801.

 The
government is the only market for most medical countermeasures. This is because unlike other drugs and vaccines, these products
are not sold to doctors, hospitals, or pharmacies. The BioShield Special Reserve Fund, or SRF, has been the sole medical countermeasures
market for the last decade. The SRF is now appropriated annually and has not kept pace with the need for purchasing products ready
for stockpiling. During 2020, $735 million was appropriated to SRF. As such, even if TNX-801 were to receive FDA licensure, the
commercial success of TNX-801 remains uncertain.

 Government
entities may take actions that directly or indirectly have the effect of limiting opportunities for our vaccine candidates for
COVID-19.

 Various
government entities, including the U.S. government, are offering incentives, grants and contracts to encourage additional investment
by commercial organizations into preventative and therapeutic agents against COVID-19, which may have the effect of increasing
the number of competitors and/or providing advantages to competitors. Accordingly, there can be no assurance that we will be able
to successfully establish a competitive market share if we ultimately receive regulatory approval for our vaccines as a vaccine
for COVID-19. COVID-19 vaccines may also be subject to government pricing controls, which could adversely affect the profitability
of any COVID-19 vaccine we are able to develop and commercialize.

 If
technology developed for the purposes of developing new medicines or vaccines can be applied to the creation or development of
biological weapons, then our technology may be considered "dual use" technology and be subject to limitations on public
disclosure or export.

 Our
research and development of synthetic poxviruses is dedicated not only to creating tools that better protect public health but
also to safeguarding any information with broad, dual-use potential that could be inappropriately applied. "Dual use research"
is research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be
reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose
a significant threat to public health, agricultural crops, or national security. Because variola, the agent that causes smallpox,
is a pox virus, the technology we created could be considered dual use and could be subject to export control, for example under
the Wassenaar Arrangement. Further, if federal authorities determine that our research is subject to institutional oversight,
we will need to implement a risk-management plan developed in collaboration with the institutional review entity. Failure to comply
with the plan may result in suspension, limitation, or termination of federal funding or loss of future federal funding opportunities
for any of our research.

 We
face risks in connection with existing and future collaborations with respect to the development, manufacture, and commercialization
of our product candidates.

 We
face a number of risks in connection with our current collaborations. Our collaboration agreements are subject to termination
under various circumstances. Our collaborators may change the focus of their development and commercialization efforts or may
have insufficient resources to effectively assist in the development of our products. Any future collaboration agreements may
have the effect of limiting the areas of research and development that we may pursue, either alone or in collaboration with third
parties. Further, disagreements with collaborators, including disagreements over proprietary rights, contract interpretation,
or the preferred course of development, might cause delays, might result in litigation or arbitration, or might result in termination
of the research, development or commercialization of our products. Any such disagreements would divert management attention and
resources and be time-consuming and costly.

 We
face risks in connection with the testing, production and storage of our vaccine product candidates.

 Developing
our TNX-1850 and TNX-801 vaccine candidates each require testing of challenges with mpox or SARS-CoV-2 viruses under controlled
experimental conditions. The testing of TNX-1850 and TNX-801 may carry risk of infection and harm to individuals.

 In
addition, our TNX-1850 and TNX-801 vaccine candidates are both live forms of the horsepox. We have initiated vaccine-manufacturing
activities to support further nonclinical testing of TNX-801. The production and storage of the synthesized horsepox virus stock
and, once initiated, TNX-1850 virus stock, may carry risk of infection and harm to individuals. Any such infection could expose
us to product and general liability claims, and may carry risk of infection and harm to individuals.

 RISKS
RELATED TO OUR STOCK

 Sales
of additional shares of our common stock could cause the price of our common stock to decline.

 Sales
of substantial amounts of our common stock in the public market, or the availability of such shares for sale, by us or others,
including the issuance of common stock upon exercise of outstanding options and warrants, could adversely affect the price of
our common stock. We and our directors and officers may sell shares into the market, which could adversely affect the market price
of shares of our common stock.

 An
active trading market for our common stock may not be sustained.

 Although
our common stock is listed on the NASDAQ Capital Market, the market for our shares has demonstrated varying levels of trading
activity. Furthermore, the current level of trading may not be sustained in the future. The lack of an active market for our common
stock may impair investors' ability to sell their shares at the time they wish to sell them or at a price that they consider
reasonable, may reduce the fair market value of their shares and may impair our ability to raise capital to continue to fund operations
by selling shares and may impair our ability to acquire additional intellectual property assets by using our shares as consideration.

 The
market price of our common stock has been extremely volatile and may continue to be volatile due to numerous circumstances beyond
our control.

 The
market price of our common stock has fluctuated, and may continue to fluctuate, widely, due to many factors, some of which may
be beyond our control. These factors include, without limitation:

 "short
 squeezes";

 comments
 by securities analysts or other third parties, including blogs, articles, message boards and social and other media;

 large
 stockholders exiting their position in our common stock or an increase or decrease in the short interest in our common stock;

 actual
 or anticipated fluctuations in our financial and operating results;

 the
 timing and allocations of new product candidates;

 public
 perception of our product candidates and competitive products;

 changes
 in financial estimates or recommendations by securities analysts;

 changes
 in the reimbursement policies of third party insurance companies or government agencies; and

 overall
 general market fluctuations.

 Stock
markets in general and our stock price in particular have experienced extreme price and volume fluctuations that have often been
unrelated or disproportionate to the operating performance of those companies and our company. Broad market fluctuations may adversely
affect the trading price of our common stock. In particular, a proportion of our common stock has been and may continue to be
traded by short sellers which may put pressure on the supply and demand for our common stock, further influencing volatility in
its market price. Additionally, these and other external factors have caused and may continue to cause the market price and demand
for our common stock to fluctuate, which may limit or prevent investors from readily selling their shares of common stock and
may otherwise negatively affect the liquidity of our common stock.

 A
"short squeeze" due to a sudden increase in demand for shares of our common stock that largely could lead to extreme
price volatility in shares of our common stock.

 Investors
may purchase shares of our common stock to hedge existing exposure or to speculate on the price of our common stock. Speculation
on the price of our common stock may involve long and short exposures. To the extent aggregate short exposure exceeds the number
of shares of our common stock available for purchase on the open market, investors with short exposure may have to pay a premium
to repurchase shares of our common stock for delivery to lenders of our common stock. Those repurchases may in turn, dramatically
increase the price of our common stock until additional shares of our common stock are available for trading or borrowing. This
is often referred to as a "short squeeze." A proportion of our common stock has been and may continue to be traded
by short sellers which may increase the likelihood that our common stock will be the target of a short squeeze. A short squeeze
could lead to volatile price movements in shares of our common stock that are unrelated or disproportionate to our operating performance
or prospectus and, once investors purchase the shares of our common stock necessary to cover their short positions, the price
of our common stock may rapidly decline. Investors that purchase shares of our common stock during a short squeeze may lose a
significant portion of their investment.

 We
could be delisted from Nasdaq, which could seriously harm the liquidity of our stock and our ability to raise capital.

 On
October 17, 2023, we received a written notice from the Nasdaq staff indicating that, based upon the closing bid price of our
common stock, we no longer met the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing
Rule 5550(a)(2) (the "Minimum Bid Price Requirement"). In accordance with Nasdaq listing rules, we have a period of
180 calendar days, or until April 15, 2024, in which to regain compliance. In order to regain compliance with the Minimum Bid
Price Requirement, the closing bid price of our common stock must be at least $1 per share for a minimum of ten consecutive business
days during this 180-day period. In the event we do not regain compliance within this 180-day period, we may be eligible to seek
an additional compliance period of 180 calendar days if we meet the continued listing requirement for market value of publicly
held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price
Requirement. However, if it appears to the Nasdaq staff that we will not be able to cure the deficiency, or if we are otherwise
not eligible, our common stock will be subject to delisting. If we are unable to maintain compliance with the Minimum Bid Price
or other listing requirements, we could lose eligibility for continued listing on the Nasdaq Capital Market or any comparable
trading market. In such event:

 We
 may have to pursue trading on a less recognized or accepted market, such as the OTC Bulletin Board or the "pink sheets."

 Shares
 of our common stock could be less liquid and marketable, thereby reducing the ability of stockholders to purchase or sell
 our shares as quickly and as inexpensively as they have done historically. If our stock is traded as a "penny stock,"
 transactions in our stock would be more difficult and cumbersome.

 We
 may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as
 less attractive investments with higher associated risks, such that existing or prospective institutional investors may be
 less interested in, or prohibited from, investing in our common stock. This may also cause the market price of our common
 stock to decline.

 We
do not anticipate paying dividends on our common stock and, accordingly, shareholders must rely on stock appreciation for any
return on their investment.

 We
have never declared or paid cash dividends on our common stock and do not expect to do so in the foreseeable future. The declaration
of dividends is subject to the discretion of our board of directors and will depend on various factors, including our operating
results, financial condition, future prospects and any other factors deemed relevant by our board of directors. You should not
rely on an investment in our company if you require dividend income from your investment in our company. The success of your investment
will likely depend entirely upon any future appreciation of the market price of our common stock, which is uncertain and unpredictable.
There is no guarantee that our common stock will appreciate in value.

 We
expect that our quarterly results of operations will fluctuate, and this fluctuation could cause our stock price to decline.

 Our
quarterly operating results are likely to fluctuate in the future. These fluctuations could cause our stock price to decline.
The nature of our business involves variable factors, such as the timing of the research, development and regulatory pathways
of our product candidates, which could cause our operating results to fluctuate.

 Due
to the possibility of fluctuations in our revenues and expenses, we believe that quarter-to-quarter comparisons of our operating
results are not a good indication of our future performance.

 The
rights of the holders of common stock may be impaired by the potential issuance of preferred stock.

 Our
articles of incorporation give our board of directors the right to create new series of preferred stock. As a result, the board
of directors may, without stockholder approval, issue preferred stock with voting, dividend, conversion, liquidation or other
rights which could adversely affect the voting power and equity interest of the holders of common stock. Preferred stock, which
could be issued with the right to more than one vote per share, could be utilized as a method of discouraging, delaying or preventing
a change of control. The possible impact on takeover attempts could adversely affect the price of our common stock. Although we
have no present intention to issue any shares of preferred stock or to create a series of preferred stock, we may issue such shares
in the future.

 If
we fail to comply with the rules under the Sarbanes-Oxley Act of 2002 related to accounting controls and procedures, or if we
discover material weaknesses and deficiencies in our internal control and accounting procedures, our stock price could decline
significantly and raising capital could be more difficult.

 If
we fail to comply with the rules under the Sarbanes-Oxley Act of 2002 related to disclosure controls and procedures, or, if we
discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline
significantly and raising capital could be more difficult. Section 404 of the Sarbanes-Oxley Act requires annual management assessments
of the effectiveness of our internal control over financial reporting. If material weaknesses or significant deficiencies are
discovered or if we otherwise fail to achieve and maintain the adequacy of our internal control, we may not be able to ensure
that we can conclude on an ongoing basis that we have effective internal controls over financial reporting in accordance with
Section 404 of the Sarbanes-Oxley Act. Moreover, effective internal controls are necessary for us to produce reliable financial
reports and are important to helping prevent financial fraud. If we cannot provide reliable financial reports or prevent fraud,
our business and operating results could be harmed, investors could lose confidence in our reported financial information, and
the trading price of our common stock could drop significantly.

 If
securities or industry analysts do not publish research or reports about our business, or if they change their recommendations
regarding our stock adversely, our stock price and trading volume could decline.

 The
trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish
about us or our business. Our research coverage by industry and financial analysts is currently limited. Even if our analyst coverage
increases, if one or more of the analysts who cover us downgrade our stock, our stock price would likely decline. If one or more
of these analysts cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial
markets, which in turn could cause our stock price or trading volume to decline.

 Other
companies may have difficulty acquiring us, even if doing so would benefit our stockholders, due to provisions under our corporate
charter and bylaws, as well as Nevada law.

 Provisions
in our articles of incorporation, our bylaws, and under Nevada law could make it more difficult for other companies to acquire
us, even if doing so would benefit our stockholders. Our articles of incorporation and bylaws contain the following provisions,
among others, which may inhibit an acquisition of our company by a third party:

 advance
 notification procedures for matters to be brought before stockholder meetings

 a
 limitation on who may call stockholder meetings

 a
 limitation on the removal of directors

 the
 ability of our board of directors to issue up to 5,000,000 shares of preferred stock without a stockholder vote

 We
are also subject to provisions of Nevada law that prohibit us from engaging in any business combination with any "interested
stockholder," meaning generally that a stockholder who beneficially owns 10 percent or more of our stock cannot acquire
us for a period of time after the date this person became an interested stockholder, unless various conditions are met, such as
approval of the transaction by our board of directors and stockholders.

 Our
bylaws designate the Eighth Judicial District Court of Clark County, Nevada as the sole and exclusive forum for certain types
of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders' ability to obtain
a favorable judicial forum for disputes with us or our directors, officers, employees or agents.

 Our
bylaws require that, to the fullest extent permitted by law, and unless the Company consents in writing to the selection of an
alternative forum, the Eighth Judicial District Court of Clark County, Nevada, will, to the fullest extent permitted by law, be
the sole and exclusive forum for each of the following:

 any
derivative action or proceeding brought in the name or right of the Company or on its behalf,

 any
action asserting a claim for breach of any fiduciary duty owed by any director, officer, employee or agent of the Company to the
Company or the Company's stockholders,

 any
action arising or asserting a claim arising pursuant to any provision of NRS Chapters 78 or 92A or any provision of our articles
of incorporation or bylaws, or

 any
action asserting a claim governed by the internal affairs doctrine, including, without limitation, any action to interpret, apply,
enforce or determine the validity of our articles of incorporation or bylaws.

the applicability of the exclusive forum provision is limited to the extent permitted by law, we believe that the exclusive forum
provision would not apply to suits brought to enforce any duty or liability created by the Securities Exchange Act of 1934, as
amended (Exchange Act), or any other claim for which the federal courts have exclusive jurisdiction, and that federal courts have
concurrent jurisdiction over all suits brought to enforce any duty or liability created by the Securities Act of 1933, as amended
(Securities Act). We note that there is uncertainty as to whether a court would enforce the provision and that investors cannot
waive compliance with the federal securities laws and the rules and regulations thereunder. Although we believe this provision
benefits us by providing increased consistency in the application of Nevada law in the types of lawsuits to which it applies,
the provision may have the effect of discouraging lawsuits against our directors and officers.

 ITEM
1B – UNRESOLVED STAFF COMMENTS

 There
are no unresolved staff comments at December 31, 2023.

 ITEM 1C. Cybersecurity
Disclosures

 Cybersecurity
Risk Management

 We, like other companies in our industry, face several cybersecurity risks in connection with our business.
Our business strategy, results of operations, and financial condition have not, to date, been affected by risks from cybersecurity threats.
During the reporting period, we have not experienced any material cyber incidents, nor have we experienced a series of immaterial incidents,
which would require disclosure.

 In
the ordinary course of our business, we use, store and process data including data of our employees, partners, collaborators, and vendors.
To effectively prevent, detect, and respond to cybersecurity threats, we maintain a cyber risk management program, which is comprised
of a wide array of policies, standards, architecture, and processes. The cyber risk management program falls under the responsibility of
our Director of Information Technology ("IT"), who has cross-functional expertise in IT, computer science, cyber security,
and more than 20 years of experience. The IT Director leads a team of IT specialists with similar IT and cybersecurity backgrounds. Under
the guidance of our IT Head, we develop, maintain, and evidence the policies, standards, and processes in a manner consistent with applicable
legal requirements. We also utilize a variety of cybersecurity software from reputable vendors in cybersecurity.

 We have implemented a cybersecurity
risk management program that is designed to identify, assess, and mitigate risks from cybersecurity threats to this data and our systems
and ensure the effectiveness of our security controls. Our cybersecurity risk management program is intended to address applicable NIST
800-171 & CMMC requirements for our business. Our cybersecurity risk management program incorporates several components, including
information security program assessments, continuous monitoring of critical risks from cybersecurity threats using automated tools, backup
testing, periodic threat testing, and documented standards, policies, and procedures. We deploy a wide range of security tools across
the environment, and implement access control policies to further limit access to data within the systems.

 We periodically engage third
parties to conduct risk assessments, including penetration testing, tabletops and other system vulnerability analyses. As a result of
these assessments and testing, we have not identified any material cybersecurity risks and are constantly hardening our environment. Additionally,
our program includes annual cybersecurity training for all employees.

 Cybersecurity Governance

 Our Board of Directors ("Board")
is responsible for the oversight of cybersecurity risk management. The Board delegates oversight of the cybersecurity risk management
program to the Information Security Oversight Committee ("ISOC"). The Chief Financial Officer ("CFO"), who serves
on ISOC, provides updates to the Audit Committee on our cybersecurity risk management program, including any critical cybersecurity risks,
ongoing cybersecurity initiatives and strategies, and applicable regulatory requirements and industry standards on a quarterly basis.
The CFO also notifies the Board and Audit Committee of any cybersecurity incidents (suspected or actual) and provides updates on the incidents
as well as cybersecurity risk mitigation activities as appropriate.

 ITEM
2 – PROPERTIES

 We
maintain our principal office at 26 Main Street, Suite 101, Chatham, New Jersey 07928. Our telephone number at that office is
(862) 799-8599 and our fax number is (212) 923-5700. On August 28, 2020, we entered into a lease, whereby we agreed to lease new
office space, commencing September 2020 and expiring December 2025. In connection therewith, we maintain a letter of credit, which
has a remaining balance of $142,407 as of December 31, 2023, and such amount is deposited into the restricted cash account maintained
at the bank that issued the letter of credit.

 We
own a research and development facility in Maryland used for process development activities. As of August, 1 2022, the asset was
operational and the asset was ready for its intended use.

 We
own an approximately 44-acre site in Hamilton, Montana, for the construction of a vaccine development and commercial scale manufacturing
facility. As of December 31, 2023, the facility was not ready for its intended use.

 We
own a 45,000 square foot facility in Massachusetts that houses our Advanced Development Center for accelerated development and
manufacturing of vaccines. As of October 1, 2022, the facility was operational and ready for its intended use.

 Future
minimum lease payments are as follows (in thousands):

 Year Ending December 31,

 2024

 $

 2025

 2026

 2027

 2028
 and beyond

 Included
 interest

 (90

)

 $

 We
believe that our existing facilities are suitable and adequate to meet our current business requirements.

 ITEM
3 – LEGAL PROCEEDINGS

 From
time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business.
However, litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time
to time that may harm our business. We are currently not aware of any such legal proceedings or claims that we believe will have,
individually or in the aggregate, a material adverse effect on our business, financial condition, operating results or cash flows.

 ITEM 4 – MINE SAFETY DISCLOSURES

 Not
applicable.

 PART
II

 ITEM
5 – MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 Market
Information

 Our
common stock is listed on The NASDAQ Capital Market under the symbol "TNXP".

 Holders

 On
March 28, 2024, the closing sale price of our common stock, as reported by The NASDAQ Stock Market, was $0.19 per share. On March 28, 2024, there were 228 holders of record of our common stock. Because many of our shares of common
stock are held by brokers and other institutions on behalf of stockholders, we are unable to estimate the total number of stockholders
represented by these record holders.

 Dividend
Policy

 We
have never paid any cash dividends on our capital stock and do not anticipate paying any cash dividends on our common stock in
the foreseeable future. We intend to retain future earnings to fund ongoing operations and future capital requirements of
our business. Any future determination to pay cash dividends will be at the discretion of the Board and will be dependent upon
our financial condition, results of operations, capital requirements and such other factors as the Board deems relevant.

 Recent
Sales of Unregistered Securities

 None.

 Repurchases
of Equity Securities by the Issuer and Affiliated Purchasers

 None.

 ITEM
6 – RESERVED

 ITEM
7 – MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 This
Management's Discussion and Analysis of Financial Condition and Results of Operations includes a number of forward-looking
statements that reflect Management's current views with respect to future events and financial performance. You can identify
these statements by forward-looking words such as "may" "will," "expect," "anticipate,"
"believe," "estimate" and "continue," or similar words. Those statements include statements
regarding the intent, belief or current expectations of us and members of its management team as well as the assumptions on which
such statements are based and should be read together with the "Risk Factors" section of this Annual Report on Form 10-K
for a discussion of important factors that could cause actual results to differ materially from the results described in or implied
by the forward-looking statements contained in the following discussion and analysis. Our actual results could differ materially
from those anticipated in these forward-looking statements as a result of various factors, including those discussed below and
elsewhere in this Annual Report and in other reports we file with the Securities and Exchange Commission, particularly those under
"Risk Factors.".

 We are a fully-integrated
biopharmaceutical company focused on developing and commercializing therapeutics to treat and prevent human disease and alleviate suffering.

 Our near-term priority is
to submit a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for Tonmya TM *
(also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablet) for the management of fibromyalgia ("FM").
FM is a chronic pain disorder characterized by chronic widespread pain, non-restorative sleep, fatigue and impaired cognition. Tonmya
is a non-opioid analgesic designed for long-term bedtime use and has completed two positive Phase 3 studies. Tonix announced the positive
results of the second Phase 3 study in December of 2023. Tonmya treatment resulted in highly statistically significant improvement in
the primary endpoint of pain reduction (p=0.00005) and statistical significance in all six of the key secondary endpoints. Tonmya was
well tolerated. Systemic adverse events were similar between Tonmya and placebo. No serious adverse events were reported. The FDA conditionally
accepted Tonmya as the trade name for TNX-102 SL for the management of fibromyalgia in January 2024. We have scheduled a type B pre-NDA
meeting with the FDA in the first half of 2024, plan to submit an NDA for the approval of Tonmya in the second half of 2024 and expect
an FDA decision on the NDA in the second half of 2025. We are preparing for a commercial launch of Tonmya conditional on FDA approval.

 Tonmya is a proprietary sublingual
tablet formulation of cyclobenzaprine ("CBP") designed for bedtime administration. In December 2020, we reported positive
results from the Phase 3 RELIEF study of Tonmya 5.6 mg for the management of FM. In July 2021, we had disappointing results from a second
Phase 3 study, RALLY. In December 2023, we reported positive results from the third Phase 3 RESILIENT study, which met its pre-specified
endpoint by significantly reducing daily pain compared to placebo in patients with fibromyalgia.

 In preparation for the launch
of Tonmya, we have built a team of professionals to market and distribute our products. Our commercial portfolio consists of two FDA-approved
prescription products for the treatment of migraine which were acquired from Upsher-Smith Laboratories ("Upsher Smith") in June 2023:
Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10
mg. Zembrace SymTouch and Tosymra are both indicated for the treatment of acute migraine with or without aura in adults. Zembrace SymTouch
is the only branded sumatriptan autoinjector professionally promoted in the United States and is designed for ease of use and favorable
tolerability with a low 3 mg dose. Tosymra is a novel intranasal sumatriptan product formulated with a permeation enhancer that provides
rapid and efficient absorption of sumatriptan. Tosymra was approved on the basis of bioequivalence to subcutaneous ( s.c.) sumatriptan.
Our commercial team is engaged in marketing and distributing our products, and also engaged in planning the launch of Tonmya.

 In addition to Tonmya and
our marketed products, we have a pipeline of products in development that include therapeutics and vaccines which are based on small molecules
and biologics. Our pipeline has been generated from internal discovery, as well as licenses, acquisitions and collaborations with academic
institutions and non-profit organizations.

 Our portfolio is focused on
central nervous system, or CNS, disorders, but also consists of rare disease, immunology, and infectious disease product candidates. The
CNS portfolio includes small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Our immunology portfolio
includes TNX-1500*, a biologic to address organ transplant rejection and autoimmune diseases. Finally, our infectious disease portfolio
includes a vaccine in development to prevent smallpox and mpox (formerly known as monkeypox), TNX-801*. TNX-801 also serves as the live
virus vaccine platform or recombinant pox vaccine ("RPV") platform for vaccines to protect against other infectious diseases,
including TNX-1800* and TNX-1850* for COVID-19.

 In addition to fibromyalgia,
TNX-102 SL* is being developed as a potential treatment for a type of Long COVID, the symptoms of which overlap with fibromyalgia, that
we term fibromyalgia-type Long COVID. TNX-102 SL has completed a Phase 2 proof-of-concept study. Long COVID also known as PASC, (post-acute
sequelae of SARS-CoV-2 infection) is a chronic post-acute COVID-19 condition. We initiated enrollment in the Phase 2 PREVAIL study, in
August 2022, and topline results were reported in September 2023. The study did not meet the primary endpoint of change in mean pain from
baseline but did show activity in improving fatigue, a hallmark symptom of Long COVID.

 TNX-102 SL also is being developed also as a treatment for acute stress reaction
("ASR") and to prevent acute stress disorder ("ASD") and posttraumatic stress disorder ("PTSD") under an investigator-initiated
Investigational New Drug Application ("IND") in partnership with the University of North Carolina ("UNC") Institute
for Trauma Recovery. The Phase 2 OASIS study at UNC is supported by the U.S. Department of Defense ("DoD"). We expect enrollment
in the OASIS study to begin in the second quarter of 2024. The UNC-led OASIS study will build upon the existing AURORA initiative, a major
national research initiative to improve the understanding, prevention, and recovery of individuals who have experienced a traumatic event.

 In addition, TNX-102 SL has active INDs for PTSD, agitation in Alzheimer's
disease ("AAD"), and alcohol use disorder ("AUD"). TNX-102 SL for AAD has been granted Fast Track designation
by the FDA. We are not currently actively studying TNX-102 SL in PTSD, AAD or AUD.

 Another CNS candidate in development is TNX-1300* (double-mutant cocaine esterase)
which is in Phase 2 for the treatment of cocaine intoxication. TNX-1300 has been granted Breakthrough Therapy designation by the FDA.
TNX-1300 was licensed from Columbia University in 2019 after a Phase 2 study showed that it rapidly and efficiently disintegrates cocaine
in the blood of volunteers who received intravenous cocaine. In August of 2022, we received a Federal Grant from the National Institute
on Drug Abuse ("NIDA") to advance the development of TNX-1300 as a treatment for cocaine intoxication. We expect to initiate
enrollment in a potentially pivotal Phase 2 study of TNX-1300 in emergency rooms in the second quarter of 2024.

 Our rare disease
portfolio includes TNX-2900* (intranasal potentiated oxytocin) for Prader-Willi syndrome ("PWS"), a genetic disorder characterized by
complex symptoms. The formulation technology for TNX-2900 was acquired from Trigemina, Inc. and licensed from Stanford University in
2020. The potentiated formulation includes magnesium, which has been shown in animal studies to potentiate binding of oxytocin to
the oxytocin receptor. The therapeutic technology was licensed from Inserm, the French National Institute of Health and Medical
Research. TNX-2900 was granted Orphan-Drug Designation by the FDA in the second half of 2023 and the IND was cleared by the FDA in
the fourth quarter of 2023 and Rare Pediatric Disease Designation was granted in March 2024. PWS, an orphan condition, is a rare
genetic disorder of failure to thrive in infancy, associated with uncontrolled appetite beginning in childhood with complications of
obesity and diabetes. We have sponsored a research program at Inserm to study oxytocin on suckling behavior in mice that have been
engineered to express one of the PWS genes.

 We are developing a different intranasal oxytocin product, TNX-1900* (intranasal
potentiated oxytocin with magnesium) for several CNS disorders through investigator-initiated studies. TNX-1900 is in development through
investigator-initiated studies for the treatment of BED, adolescent obesity, social anxiety disorder ("SAD"), and bone health
in pediatric autism. We received IND clearance from the FDA in the fourth quarter of 2021 to study TNX-1900 in chronic migraine and we
initiated the Phase 2 PREVENTION study for the prevention of migraine headaches in chronic migraineurs in the first quarter of 2023. Topline
results from the study, reported in December 2023, showed that TNX-1900 did not meet the primary endpoint as measured by a reduction from
28-day run-in baseline in the mean number of migraine headache days during the last 28 days of the treatment phase. PREVENTION was a small
proof-of-concept study with 88 patients enrolled across three arms (TNX-1900 30 IU QD, TNX-1900 30 IU BID, and placebo), and was not powered
to result in a statistically significant outcome. In the trial, TNX-1900 was generally well-tolerated with no treatment-emergent serious
or severe adverse events. We have discontinued development of TNX-1900 in chronic migraine.

 Our lead candidate in the immunology pipeline is TNX-1500, an Fc-modified humanized
mAb, directed against CD40-ligand (CD40L, also known as CD154). TNX-1500 was engineered to modulate binding to Fc receptors. TNX-1500
is being developed as a prophylaxis against organ transplant rejection as well as to treat autoimmune conditions. The IND was cleared
and a Phase 1 study of TNX-1500 in healthy volunteers was initiated in the second quarter of 2023 and completed the clinical phase in
the first quarter of 2024. TNX-1500 is being studied in combination with other immunosuppressive agents in allogeneic and xenogeneic organ
transplants in non-human primates at Massachusetts General Hospital, a teaching hospital of Harvard Medical School ("MGH").
In experiments at MGH, TNX-1500 is being studied as monotherapy or in combination with other immunosuppressive agents in heart and kidney
allogeneic organ transplants in non-human primates. Results from experiments in kidney and heart transplants indicate that TNX-1500 appears
to have comparable efficacy to historical experiments using the chimeric mouse/human IgG1 version (5c8H1) of the anti-CD40L mAb 5c8. Some
results from this collaboration were published in the peer-reviewed journal, American Journal of Transplantation in 2023.

 TNX-1500 also is being studied in combination with other immunosuppressive agents
in xenogeneic organ transplants in non-human primates at MGH. In some of these studies, genetically engineered (GE) pigs in baboon transplants
were treated with cold perfused ischemia minimization and a novel costimulation-based immunosuppressive regimen including TNX-1500. The
results of these preclinical studies were encouraging and demonstrated the potential of genetically engineered pig hearts in the context
of a clinically applicable regimen. The multi-GE pigs were provided by eGenesis and Revivicor. Revivicor is a subsidiary of United Therapeutics.
Some results from the collaboration with MGH and eGenesis were published in the peer-reviewed journal, Nature in 2023. In
March of 2024, MGH announced the first GE pig kidney transplant into a living recipient supported in part by the pre-clinical work with
TNX-1500. TNX-1500 therapy was not used in the human transplant recipient.

 Our immunology pipeline also includes TNX-1700*, a recombinant Trefoil Factor Family
2 ("rTFF2") fusion protein that was licensed from Columbia University in 2019. TNX-1700 consists of TFF2 fused to human serum
albumin (HAS) and is a biologic being developed to treat gastric and colorectal cancers by an immune-oncology mechanism, in combination
with PD1 blockers, and is in the preclinical stage of development. We presented data that show a murine version of TNX-1700 consisting
of a fusion protein with murine serum albumin was able to evoke anti-tumor immunity in the MC38 mouse model of colorectal cancer as monotherapy
and that TNX-1700 augmented the efficacy of anti-PD1 therapy in both the MC38 model and the CT26.wt mouse models of colorectal cancer.

 Our infectious disease portfolio includes vaccines based on our live virus vaccine
or RPV platform. Live virus vaccines are believed to protect against poor clinical outcomes of infectious diseases by eliciting T cell
responses in addition to antibody responses. TNX-801, a live attenuated vaccine based on synthesized horsepox, is in the pre-IND stage
of development to protect against smallpox and mpox. Mpox has become endemic in the U.S. since it spread in the U.S. and other countries
outside of Africa, mostly in populations of men who have sex with men. Non-human primates vaccinated with TNX-801 were protected from
mpox in studies reported in the first quarter of 2020. These data were published in the peer-reviewed journal Vaccines in 2023.
In October 2023, at the World Vaccine Congress - Europe, we reported that the TNX-801 vaccine was shown to be greater than 10 to 1,000
fold more attenuated than older vaccinia-based smallpox vaccines in both human primary cell lines and immunocompromised mice. That work
has been posted on BioRxiv, which is not peer-reviewed. TNX-801 also serves as the live virus vaccine platform for other infectious
diseases for which subsequent products will be designed by expressing other viral antigens in the horsepox vector.

 TNX-1800 is a live virus vaccine on the
RPV platform that expresses the SARS-CoV-2 spike protein from the ancestral Wuhan strain, which has shown encouraging results in non-human
primates. In the third quarter of 2023, TNX-1800 was selected by the National Institute of Allergy and Infectious Diseases, a part of
the National Institutes of Health, to be included in their Project NextGen initiative, an initiative to advance a pipeline of new, innovative
vaccines and therapeutics for COVID-19. The COVID-19 vaccines approved for use in the U.S. have provided significant health benefits to
the vaccinated population; however, they have shown limitations in the durability of protection conferred and in their ability to block
forward transmission. Live virus vaccines that protect against other viral diseases by eliciting T cell responses have shown durability
of protection that lasts years to decades, and some live virus vaccines have significantly inhibited forward transmission. With respect
to TNX-1800 vaccination, we reported positive efficacy data from animal challenge studies using live SARS-CoV-2 in the first quarter of
2021. These data were published in the peer-reviewed journal Vaccines in 2023. In this study, TNX-1800 vaccinated, SARS-CoV-2 challenged
animals had undetectable SARS-CoV-2 in the upper airways, which we believe relates to potential inhibition of forward transmission of
this respiratory pathogen.

 Tonix has three pre-clinical research
and development programs developing broad spectrum antivirals. The DoD announced in December 2022 a plan to move beyond a 'one bug,
one drug' approach and are seeking broad-spectrum drugs since it may be hard to predict which or how many viruses may be deployed
on the battlefield. TNX-3900* are broad-spectrum small molecule oral antivirals which inhibit essential cathepsins required by viruses
such as coronaviruses and filoviruses to infect cells. TNX-4200* are orally available CD45 antagonists in preclinical development. We
believe that partial inhibition of CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations and
a lower dose, and therefore will have a higher safety window. Tonix plans to leverage previous research on phosphatase inhibitors, specifically
compounds that target CD45, to optimize lead compounds for therapeutic intervention of biothreat agents. TNX-4000* are viral glycan-targeted
engineered biologics. These antivirals are currently in preclinical development.

 Relating to our development programs, we own and operate the Research and
Development Center ("RDC") in Frederick, Maryland consisting of one building totaling approximately 48,000 square feet. The
RDC conducts research on CNS, immunology, and infectious disease candidates. The RDC facility is mostly biosafety level 2 (BSL-2), with
some components designated BSL-3. We also own and operate an Advanced Development Center (ADC) located in the New Bedford business park
in Dartmouth, Massachusetts. This approximately 45,000 square foot BSL-2 facility is intended to accelerate development and clinical scale
manufacturing of live-virus vaccines and biologics to support clinical trials. We have engaged CBRE, an international real estate brokerage
firm, to find a strategic partner for, or buyer of, ADC.

 *Tonix's product development
candidates are investigational new drugs or biologics and have not been approved for any indication.

 We are led by a management team with significant industry experience in drug development.
We complement our management team with a network of scientific, clinical, and regulatory advisors that includes recognized experts in
their respective fields.

 Results
of Operations

 We anticipate that our results
of operations will fluctuate for the foreseeable future due to several factors, such as the sale of our commercialized assets, progress
of our research and development efforts and the timing and outcome of regulatory submissions. Due to these uncertainties, accurate predictions
of future operations are difficult or impossible to make. Since the acquisition of Zembrace and Tosymra on June 30, 2023, we are now reporting
product revenue and related costs.

 Fiscal
year Ended December 31, 2023 Compared to Fiscal year Ended December 31, 2022

 The
following table sets forth our operating expenses for the fiscal years ended December 31, 2023 and 2022 (in thousands):

 Year
 ended December 31,

 2023

 2022

 REVENUE

 Product
 revenue, net

 $

 7,768

 $

 —

 COSTS
 AND EXPENSES:

 Cost
 of sales

 $

 4,741

 $

 —

 and development

 86,655

 81,876

 General
 and administrative

 34,752

 30,215

 Total operating
 expenses

 126,148

 112,091

 Operating
 loss

 (118,380

)

 (112,091

)

 Other
 income, net

 1,722

 1,873

 Net
 loss

 $

 (116,658

)

 $

 (110,218

)

 Revenues. The
Company recognized revenue beginning in the year ended December 31, 2023, as a result of the acquisition of two marketed products.
See discussion at Note 12 to our financial statements appearing in this Annual Report on Form 10-K. Revenue recognized for the
year ended December 31, 2023 was $7.8 million.

 The
Company's net product revenues are summarized below:

 Year
 Ended December 31,

 2023

 2022

 Symtouch

 $

 6,304

 $

 —

 Tosymra

 1,464

 $

 —

 Total
 product revenues

 $

 7,768

 $

 —

 Cost
of Sales. The Company recognized cost of sales beginning in the year ended December 31, 2023 as a result of the
acquisition of Zembrace and Tosymra from Upsher Smith. See discussion at Note 12 to our financial statements appearing in this Annual Report on Form 10-K. Cost of sales
recognized for the year ended December 31, 2023, was $4.7 million.

and Development Expenses. Research and development expenses for the fiscal year ended December 31, 2023, were $86.7
million, an increase of $4.8 million, or 6%, from $81.9 million for the fiscal year ended December 31, 2022. This increase is
predominately due to increased employee-related expenses of $4.3 million, predominately related to new hires at the RDC and ADC,
lab supplies of $1.6 million, and office-related expenses of $3.5 million related to our new facilities offset by a decrease in
regulatory expenses of $1.0 million and a decrease in non-clinical expenses of $4.7 million. In August 2022, we received a Cooperative
Agreement grant from the National Institute on Drug Abuse ("NIDA"), part of the National Institutes of Health, to
support the development of its TNX-1300 product candidate for the treatment of cocaine intoxication. During the year ended December
31, 2023, we recorded $2.9 million in funding as a reduction of related research and development expenses.

 The
table below summarizes our direct research and development expenses for our product candidates and development platform for the
years ended December 31, 2023, and 2022.

 December
31,

 2023

 2022

 Change

 Research and development expenses:

 Direct expenses – TNX
 - 102 SL

 $

 12,250

 $

 13,530

 $

 (1,280

)

 Direct expenses – TNX - 1800

 1,608

 3,819

 (2,211

)

 Direct expenses – TNX - 601
 ER

 8,531

 1,308

 7,223

 Direct expenses – TNX - 801

 2,931

 2,111

 Direct expenses – TNX - 1500

 7,044

 11,510

 (4,466

)

 Direct expenses – TNX - 1900

 5,254

 4,155

 1,099

 Direct expenses – Other programs

 6,826

 13,741

 (6,915

)

 Internal staffing,
 overhead and other

 42,211

 31,702

 10,509

 Total research
 & development

 $

 86,655

 $

 81,876

 $

 4,779

 Our
direct research and development expenses consist principally of external costs for clinical, nonclinical, and manufacturing, such
as fees paid to contractors, consultants and CROs in connection with our development work. Included in "Internal Staffing,
Overhead and Other" is overhead, supplies, research and development employee costs (including stock option expenses), travel,
regulatory and legal.

 General and Administrative
Expenses. General and administrative expenses for the fiscal year ended December 31, 2023, were $34.8 million, an increase
of $4.6 million, or 15%, from $30.2 million incurred in the fiscal year ended December 31, 2022. The increase is primarily due to an increase
in sales and marketing of $1.8 million, and transition services agreement fees payable to Upsher Smith of $1.5 million, and office-related expenses
of $1.0 million.

 Net
Loss. As a result of the foregoing, the net loss for the year ended December 31, 2023, was $116.7 million, compared to
a net loss of $110.2 million for the year ended December 31, 2022.

 License
Agreements

 On
February 13, 2023, we exercised an option to obtain an exclusive license from Columbia University ("Columbia") for
the development of a portfolio of fully human and murine mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including
our TNX-3600 and TNX-4100 product candidates, respectively. The licensed mAbs were developed as part of a research collaboration
and option agreement between us and Columbia. As of December 31, 2023, other than the upfront fee, no payments have been accrued
or paid in relation to this agreement.

 On
December 12, 2022, we entered into an exclusive license agreement with Curia for the development of three humanized murine mAbs
for the treatment or prophylaxis of SARS-CoV-2 infection. As consideration for entering into the License Agreement, we paid a
license fee of approximately $0.4 million to Curia. The license agreement also provides for single-digit royalties and contingent
milestone payments. As of December 31, 2023, other than the upfront fee, no payments have been accrued or paid in relation to
this agreement.

 On
May 18, 2022, we entered into an exclusive license agreement with the University of Alberta focused on identifying and testing
broad-spectrum antiviral drugs against future variants of SARS-CoV-2 and other emerging viruses. As consideration for entering
into the license agreement, we paid a low-five digit license fee to University of Alberta. The license agreement also provides
for single-digit royalties and contingent milestone payments. As of December 31, 2023, other than the upfront fee, no payments
have been accrued or paid in relation to this agreement.

 Asset
Purchase Agreements

 On June 23, 2023, we entered into an asset
purchase agreement with Upsher Smith for the acquisition of certain assets related to Zembrace SymTouch (sumatriptan injection) 3 mg ("Zembrace")
and Tosymra (sumatriptan nasal spray) 10 mg ("Tosymra") products (such businesses collectively, the "Business")
and certain inventory related to the Business for an aggregate purchase price of approximately $26.5 million, including certain deferred
payments (such transaction, the "USL Acquisition"). The transaction closed on June 30, 2023.

 Additionally, in connection with the acquisition
from Upsher Smith, we and Upsher Smith entered into a transition services agreement pursuant to which Upsher Smith agreed to provide certain
transition services to us for base fees equal to $100,000 per month for the first six months, and $150,000 per month for the seventh through
ninth months, plus additional monthly fees for each service category totaling up to $150,000 per month. We have signed an amendment to
the transitional services agreement with Upsher Smith so that Upsher Smith will continue to provide administrative services.

 As the assets acquired from Upsher Smith
met the definition of a business under the current accounting guidance, the total purchase price was allocated to the acquired inventory
and other tangible assets, and the developed technology intangible assets related to Zembrace and Tosymra based on their estimated fair
values on the acquisition date. The excess of the purchase price over the fair value of the acquired assets was recorded as goodwill.

 We have assumed certain obligations of Upsher Smith, including the payment of quarterly
earn-out payments on annual net sales from the Business in the U.S. as follows: for Tosymra, 4% for net sales of $0 to $30 million, 7%
of net sales of $30 to $75 million; 9% for net sales of $75 to $100 million; 12% for net sales of $100 to $150 million; and 15% for net
sales greater than $150 million. Earn-out payments with respect to Tosymra are payable until the expiration or termination of the product's
Orange Book listed patent(s) with respect to the United States or, outside the United States, the expiration of the last valid claim covering
the product in the relevant country of the territory. For Zembrace, earn-out payments on annual net sales in the U.S. are 3% for net sales
of $0 to $30 million, 6% of net sales of $30 to $75 million; 12% for net sales of $75 to $100 million; 16% for net sales of greater than
$100 million. Such earn-out payments are payable until July 19, 2025. Upon the entry of a generic version of the relevant product, the
applicable earn-out rates will be reduced by 90% percent for Zembrace, and by 66.7% percent for Tosymra.

 In
addition, we have assumed the obligation to pay an additional 3% royalty on net sales of Tosymra, plus an additional 3% if a patent
containing certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra in the
applicable country or for as long as the manufacture, use or sale of Tosymra in such country is covered by a valid claim of a
licensed patent, and up to $15 million per Tosymra product on the achievement of sales milestones.

 On
February 2, 2023, we entered into an asset purchase agreement (the "Healion Purchase Agreement") with Healion
Bio Inc., pursuant to which we acquired all the pre-clinical infectious disease assets of
Healion for $1.2 million. Because the Healion intellectual property was acquired prior to FDA approval, the $1.2 million
cash consideration was expensed as research and development costs since there is no alternative future use and the acquired intellectual
property does not constitute a business.

 Liquidity
and Capital Resources

 As
of December 31, 2023, we had working capital of $28.9 million, comprised primarily of cash and cash equivalents of $24.9 million
inventory of $13.6 million, and prepaid expenses and other of $9.2 million, offset by $3.8 million of accounts payable, $12.5
million of accrued expenses and other current liabilities, $2.4 million of term loan payable, short term and $0.3 million of lease
liabilities, short term. A significant portion of the accounts payable and accrued expenses are due to work performed in relation
to our clinical programs, and the acquisition of Zembrace and Tosymra.

 The
following table provides a summary of operating, investing, and financing cash flows for the years ended December 31, 2023, and
2022, respectively (in thousands):

 2023

 2022

 Net
 cash used in operating activities

 $

 (102,003

)

 $

 (98,053

)

 Net
 cash used in investing activities

 (29,070

)

 (48,147

)

 Net
 cash provided by financing activities

 36,517

 87,844

 For
the years ended December 31, 2023, and 2022, we used approximately $102.0 million and $98.1 million of cash in operating activities,
respectively, which represents cash outlays for research and development and general and administrative expenses in such periods.
The increase in cash outlays principally resulted from an increase in research and development and general and administrative
activities.

 Cash
used by investing activities for the year ended December 31, 2023, was approximately $29.1 million related to the purchase of
Zembrace and Tosymra assets and property and equipment. Cash used in investing activities for the year ended December 31, 2022, was $48.1 million,
related to the purchase of property and equipment. A significant portion of capital expenditure in 2022 is related to the build-out of the
RDC and ADC.

 For
the year ended December 31, 2023, net proceeds from financing activities were $36.5 million, primarily related to the sale of
common stock and warrants; and debt raised which was offset by repurchase of common stock. For the year ended December 31, 2022, net proceeds
from financing activities were $87.8 million, predominately from the sale of our common stock.

 We
believe that our cash resources at December 31, 2023 and the proceeds that we raised from equity offerings in the first quarter
of 2024, will meet our operating and capital expenditure requirements into the second quarter of 2024, but not beyond.

 We
continue to face significant challenges and uncertainties and, as a result, our available capital resources may be consumed more
rapidly than currently expected due to changes we may make in our research and development spending plans. These factors raise
substantial doubt about our ability to continue as a going concern for the one-year period from the date of filing of this Form
10-K. We must obtain additional funding through public or private financing or collaborative arrangements with strategic partners
to increase the funds available to fund operations. Without additional funds, we may be forced to delay, scale back or eliminate
some of our research and development activities, or other operations and potentially delay product development to provide sufficient
funds to continue our operations. If any of these events occurs, our ability to achieve our development and commercialization
goals would be adversely affected and we may be forced to cease operations.

 Future
Liquidity Requirements

 We
expect to incur losses from operations for the near future. We expect to incur increasing research and development expenses, including
expenses related to additional clinical trials and the build out of our research and development operations and manufacturing.
We will not have enough resources to meet our operating requirements for the one-year period from filing date of this report.

 Our
future capital requirements will depend on a number of factors, including the progress of our research and development of product
candidates, the timing and outcome of regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining,
defending and enforcing patent claims and other intellectual property rights, the status of competitive products, the availability
of financing and our success in developing markets for our product candidates.

 We
will need to obtain additional capital in order to fund future research and development activities. Future financing may include
the issuance of equity or debt securities, obtaining credit facilities, or other financing mechanisms. Even if we are able to
raise the funds required, it is possible that we could incur unexpected costs and expenses, fail to collect significant amounts
owed to us, or experience unexpected cash requirements that would force us to seek alternative financing. Furthermore, if we issue
additional equity or debt securities, shareholders may experience additional dilution or the new equity securities may have rights,
preferences or privileges senior to those of existing holders of our common stock.

 If
additional financing is not available or is not available on acceptable terms, we may be required to delay, reduce the scope of
or eliminate our research and development programs, reduce our commercialization efforts or obtain funds through arrangements
with collaborative partners or others that may require us to relinquish rights to certain product candidates that we might otherwise
seek to develop or commercialize independently.

 Share
Repurchase Program

 Since
January 1, 2023, the Company has repurchased 2,512,044
 of its shares of common stock outstanding under a $12.5 million share purchase program at
prices ranging from $2.75 to $8.61 per share for a gross aggregate cost of approximately
$12.5 million. In addition, we incurred expenses of $0.3 million.

 In
January 2023, the Board of Directors approved a new share repurchase program pursuant
to which the Company may repurchase up to an additional $12.5 million in value of its outstanding common stock from
time to time on the open market and in privately negotiated transactions subject to market conditions, share price and other factors. Since
January 1, 2023, the Company has repurchased 160,000 of its shares of common stock
outstanding under the new share repurchase program at $7.12 per share for a gross aggregate cost of $1.1 million.

 Debt
Financing

 On
December 8, 2023, we executed a Loan and Guaranty Agreement (the "Loan Agreement") to issue a 36-month term loan (the
"Term Loan") in the principal amount of $11.0 million with a maturity date of December 8, 2026 (the "Maturity
Date"). The Term Loan was funded with an original issue discount of 9% of the principal amount of the Term Loan, or $1.0
million, which is being amortized over the term of the debt as an adjustment to the effective interest rate on the outstanding
borrowings.

 Borrowings
under the Term Loan bear interest at a fluctuating rate equal to the greater of (i) the prime rate as defined in the Loan Agreement
plus 3.5% and (ii) 12%. Interest is payable monthly in arrears commencing in December 2023. In connection with the Term Loan,
we deposited into a reserve account $1.8 million to be used exclusively to fund interest payments related to the Term Loan. The
deposit is reflected as prepaid and other current assets on the consolidated balance sheet.

 Commencing
on March 8, 2024 and continuing monthly through the Maturity Date, the outstanding principal will be due and payable in monthly
installments of $0.2 million, with the final remaining balance of unpaid principal and interest due and payable on the Maturity
Date. In addition, we must pay a monthly collateral monitoring charge equal to 0.23% of the outstanding principal amount of the
term loan as of the date of payment. We incurred $1.1 million in issuance costs, which is being amortized over the term of
the debt as an adjustment to the effective interest rate on the outstanding borrowings.

 The
Loan Agreement provides for voluntary prepayments of the Term Loan, in whole or in part, subject to a prepayment premium. The
Loan Agreement contains customary affirmative and negative covenants by us, which among other things, will require us to provide
certain financial reports to the lenders, to maintain a deposit account to fund interest payments, and limit the ability of us
to incur or guarantee additional indebtedness, pay dividends or make other equity distributions, sell assets, engage in certain
transactions, and effect a consolidation or merger. Our obligations under the Loan Agreement may be accelerated upon customary
events of default, including non-payment of principal, interest, fees and other amounts, covenant default, insolvency, material
judgements, inaccuracy of representations and warranties, invalidity of guarantees. The Term Loan is secured by first priority
security interests in our R&D Center in Frederick, Maryland, the Advanced Development Center in North Dartmouth, Massachusetts,
and substantially all of the relevant deposit accounts.

 As
of December 31, 2023, the carrying amount of the Term Loan approximated its fair value as the contractual interest rate for the
Term Loan was representative of the then market interest rate.

 April 2024 Financing

 On
March 28, 2024, we sold 10,766,666 shares of common stock, pre-funded warrants to purchase up to 3,900,000 shares of common stock, and
accompanying Series E warrants to purchase up to 14,666,666 shares of common stock with an exercise price of $0.33 per share and expiring
five and a half years from date of issuance in a public offering, which closed on April 1, 2024. The offering price per share of common
stock was $0.30, accompanying warrants was $0.33, and the offering price per share of pre-funded warrants was $0.2999.

 We incurred offering
expenses of approximately $0.5 million, including placement agent fees of approximately $0.3 million. We received net proceeds of approximately
$3.9 million, after deducting the underwriting discount and other offering expenses.

 Additionally, we entered into warrant amendments with certain holders of its Common
Warrants. The exercise price of each Existing Warrant will be amended to $0.33 upon approval by the Company's stockholders of a
proposal to allow the Existing Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635, or as otherwise provided in
the Amendment if stockholder approval is not obtained by October 1, 2024. Upon stockholder approval, the termination date for Common Warrants
to purchase up to an aggregate of 6,950,000 shares will be amended to April 1, 2029; the termination date for Series A Warrants to purchase
up to an aggregate of approximately 8,900,000 shares will be April 1, 2029; the termination date for Series B Warrants to purchase up
to an aggregate of approximately 8,900,000 shares will be April 1, 2029; the termination date for Series C Warrants to purchase up to
an aggregate of approximately 34,823,928 shares will be the earlier of (i) April 1, 2026 and (ii) 10 trading days following notice by
the Company to the Series C Warrant holder of the Company's public announcement of the FDA's acknowledgement and acceptance
of our NDA relating to TNX-102 SL in patients with Fibromyalgia; the termination date for Series D Warrants to purchase up to an aggregate
of approximately 34,823,928 shares will be April 1, 2029. The other terms of the Existing Warrants will remain unchanged. If stockholder
approval is not obtained on or by October 1, 2024, then the Company has agreed to automatically amend the exercise price of the Existing
Warrants to the Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) of the Common Stock on October 1, 2024 if and only if the Minimum
Price is below the then current exercise price.

 December
2023 Financing

 On
December 20, 2023, we issued (i) 25,343,242 shares of our common stock, (ii) pre-funded warrants (the "Pre-Funded Warrants")
to purchase up to 28,710,812 shares of common stock and (iii) Series C warrants to purchase up to 81,081,081 shares of common
stock (the "Series C Warrants"), and (iv) Series D warrants to purchase up to 81,081,081 shares of common stock (the
"Series D Warrants" and, together with the Series C Warrants, the "Common Warrants") in a registered direct
offering. The securities were sold in fixed combinations as units. The offering price per share of common stock and accompanying
Common Warrants was $0.555, and the offering price per Pre-Funded Warrant and accompanying Common Warrants was $0.5549. The offering
closed on December 22, 2023, generating gross proceeds of approximately $30.0 million, before deducting offering expenses of $2.3
million payable by us.

 The
Pre-Funded Warrants have an exercise price of $0.0001 per share, are immediately exercisable subject to certain ownership limitations,
and can be exercised at any time until exercised in full. The Series C Warrants have an exercise price of $0.555 per share, and
are exercisable on the later of approval by the Company's stockholders of (i) a proposal to approve the filing of an amendment
to the Company's Articles of Incorporation, increasing the number of authorized shares of common stock from 160,000,000
to 1,000,000,000 and (ii) a proposal to allow the Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635 (the
later of such events, the "Approval Date") and will expire on the later of (a) 10 trading days following the Approval
Date and (b) the earlier of (x) the two year anniversary of the Approval Date and (y) 10 trading days following the public announcement
of the FDA's acknowledgement and acceptance of the NDA relating to TNX-102 SL in patients with fibromyalgia. The Series
D Warrants have an exercise price of $0.85 per share and are exercisable beginning on the Approval Date through the five-year
anniversary of the Approval Date.

 September
2023 Financing

 On
September 28, 2023, we sold 4,050,000 shares of common stock; pre-funded warrants to purchase up to 4,950,000 shares of common
stock, and accompanying common warrants to purchase up to 9,000,000 shares of common stock with an exercise price of $0.50 per
share and expiring one year from date of issuance, and common warrants to purchase up to 9,000,000 shares of common stock with
an exercise price of $0.50 per share and expiring five years from date of issuance in a public offering which closed on October
3, 2023. The offering price per share of common stock and accompanying common warrant was $0.50, and the offering price per share
of pre-funded warrant and accompanying common warrant was $0.4999.

 We
incurred other offering expenses of approximately $0.5 million, including a placement agent discount. We received net proceeds
of approximately $4.0 million, after deducting the underwriting discount and other offering expenses.

 July
2023 Financing

 On
July 27, 2023, we sold securities consisting of 2,530,000 shares of common stock; pre-funded warrants to purchase up to 4,470,000
shares of common stock and common warrants to purchase up to 7,000,000 shares of common stock in a public offering that closed
on August 1, 2023. The offering price per share of common stock and accompanying common warrant was $1.00, and the offering price
per pre-funded warrant and accompanying common warrant was $0.9999.

 We
incurred offering expenses of approximately $0.7 million, including placement agent fees of approximately $0.5 million. We received
net proceeds of approximately $6.3 million, after deducting the underwriting discount and other offering expenses.

 Convertible
Redeemable Preferred stock

 On
October 26, 2022, we issued 1,400,000 shares of Series A Preferred Stock and 100,000 shares of Series B Preferred Stock to certain
institutional investors in a private placement. The Preferred Stock had an aggregate stated value of $15,000,000. Each share of
the Preferred Stock had a purchase price of $9.50, representing an OID of 5% of the stated value. The shares of the preferred
stock were convertible into shares of our common stock, upon the occurrence of certain events, at a conversion price of $6.25
per share.

 All
outstanding shares of the Series A Convertible Redeemable Preferred Stock and Series B Convertible Redeemable Preferred Stock
were redeemed in December 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $15.8 million in the aggregate.

 On
June 24, 2022, we issued 2,500,000 shares of Series A Preferred Stock and 500,000 shares of Series B Preferred Stock to certain
institutional investors in a private placement. The Preferred Stock had an aggregate stated value of $30,000,000. Each share of
the Preferred Stock had a purchase price of $9.50, representing an OID of 5% of the stated value. The shares of the preferred
stock were convertible into shares of our common stock, upon the occurrence of certain events, at a conversion price of $25.00
per share.

 All
outstanding shares of the Series A Convertible Redeemable Preferred Stock and Series B Convertible Redeemable Preferred Stock
were redeemed in August 2022 at 105% of the $10.00 stated value of the Preferred Stock, or $31.5 million in the aggregate.

 2022
Lincoln Park Transaction

 On
August 16, 2022, we entered into a purchase agreement (the "2022 Purchase Agreement") and a registration rights agreement
with Lincoln Park, pursuant to which Lincoln Park agreed to purchase from us up to $50,000,000 of our common stock (subject to
certain limitations) from time to time. We filed a registration statement to register for resale the shares that have been or
may be issued to Lincoln Park under the 2022 Purchase Agreement.

 We
issued 100,000 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock
under the 2022 Purchase Agreement. The commitment shares were valued at $1,000,000 and recorded as an addition to equity for the
issuance of the common stock and treated as a reduction to equity as a cost of capital to be raised under the 2022 Purchase Agreement.

the year ended December 31, 2023, we sold 0.1 million shares of common stock under the 2022 Purchase Agreement, for net proceeds
of approximately $0.4 million. During the year ended December 31, 2022, we sold 0.2 million shares of common stock under
the 2022 Purchase Agreement for net proceeds of approximately $0.5 million.

 2021
Lincoln Park Transaction

 On
December 3, 2021, we entered into a purchase agreement (the "2021 Purchase Agreement") and a registration rights agreement
with Lincoln Park, pursuant to which Lincoln Park has agreed to purchase from us up to $80,000,000 of our common stock (subject
to certain limitations) from time to time. We filed a registration statement to register for resale the shares that have been
or may be issued to Lincoln Park under the 2021 Purchase Agreement.

 We
issued 14,546 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock
under the 2021 Purchase Agreement with Lincoln Park. The commitment shares were valued at $1.6 million and recorded as an addition
to equity for the issuance of the common stock and treated as a reduction to equity as a cost of capital to be raised under the
Purchase Agreement with Lincoln Park.

the year ended December 31, 2022, we sold 0.5 million shares of common stock under the 2021 Purchase Agreement for net proceeds
of approximately $8.7 million. No sales occurred in 2023, and we may not sell any additional shares under the 2021 Purchase Agreement.

 At-the-Market
Offerings

 On
April 8, 2020, we entered into a sales agreement (the "Sales Agreement") with AGP pursuant to which we may issue and
sell, from time to time, shares of our common stock having an aggregate offering price of up to $320.0 million in at-the-market
offerings ("ATM") sales. AGP will act as sales agent and will be paid a 3% commission on each sale under the Sales
Agreement. Our common stock will be sold at prevailing market prices at the time of the sale, and, as a result, prices will vary.
During the year ended December 31, 2023, we sold approximately 1.0 million shares of common stock under the Sales Agreement, for
net proceeds of approximately $3.0 million. During the year ended December 31, 2022, we sold approximately 9.1 million shares
of common stock under the Sales Agreement, for net proceeds of approximately $85.3 million.

 Stock

 On
May 1, 2020, our stockholders approved the Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive Plan
("Amended and Restated 2020 Plan").

 Under
the terms of the Amended and Restated 2020 Plan, we may issue (1) stock options (incentive and nonstatutory), (2) restricted stock,
(3) stock appreciation rights ("SARs"), (4) restricted stock units, (5) other stock-based awards, and (6) cash-based
awards. The Amended and Restated 2020 Plan initially provided for the issuance of up to 50,000 shares of common stock, which amount will
be increased to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise
provided in the Amended and Restated 2020 Plan). In addition, the Amended and Restated 2020 Plan contains an "evergreen
provision" providing for an annual increase in the number of shares of our common stock available for issuance under the
Amended and Restated 2020 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on
(and including) January 1, 2030, in an amount equal to the difference between (x) twenty percent (20%) of the total number of
shares of common stock outstanding on December 31 st of the preceding calendar year, and (y) the total number of shares
of common stock reserved under the Amended and Restated 2020 Plan on December 31 st of such preceding calendar year
(including shares subject to outstanding awards, issued pursuant to awards or available for future awards). The Board of Directors
determines the exercise price, vesting and expiration period of the grants under the Amended and Restated 2020 Plan. However,
the exercise price of an incentive stock option may not be less than 110% of fair value of the common stock at the date of the
grant for a 10% or more shareholder and 100% of fair value for a grantee who is not a 10% shareholder. The fair value of the common
stock is determined based on quoted market price or in absence of such quoted market price, by the Board of Directors in good
faith. Additionally, the expiration period of grants under the Amended and Restated 2020 Plan may not be more than ten years.
As of December 31, 2023, 1,071,599 options were available for future grants under the Amended and Restated 2020 Plan.

 We
measure the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions
discussed below, and the closing market price of the Company's common stock on the date of the grant. The fair value of
the award is measured on the grant date. One-third of most stock options granted pursuant to the Plans vest 12 months from the
date of grant and 1/36 th each month thereafter for 24 months and expire ten years from the date of grant. In addition,
the Company issues options to directors which vest over a one-year period. The Company also issues premium options to executive
officers which have an exercise price greater than the grant date fair value and has issued performance-based options which vest
when target parameters are met or probable of being met, subject in each case to a one year minimum service period prior to vesting.
Stock-based compensation expense related to awards is amortized over the applicable service period using the straight-line method.

 The
risk-free interest rate is based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of
the options as of the grant date. The expected term of options is determined using the simplified method, as provided in
an SEC Staff Accounting Bulletin, and the expected stock price volatility is based on the Company' historical stock
price volatility.

 The
weighted average fair value of options granted during the year ended December 31, 2023, was $3.99 per share. The weighted average
fair value of options granted during the year ended December 31, 2022, was $32.81 per share.

 Stock-based
compensation expense relating to options granted of $9.3 million, of which $6.4 million and $2.9 million, related to General and
Administration and Research and Development, respectively was recognized for the year ended December 31, 2023. Stock-based compensation
expense relating to options granted of $10.9 million, of which $7.9 million and $3.0 million, related to General and Administration
and Research and Development, respectively was recognized for the year ended December 31, 2022.

 As
of December 31, 2023, the Company had approximately $6.1 million of total unrecognized compensation cost related to non-vested
awards granted under the Plans, which the Company expects to recognize over a weighted average period of 1.70 years.

 Employee
Stock Purchase Plan

 On
May 6, 2022, our stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2022 Employee Stock Purchase Plan (the "2022
ESPP"), which was replaced by the Tonix Pharmaceuticals Holdings Corp. 2023 Employee Stock Purchase Plan (the "2023
ESPP", and together with the 2022 ESPP, the "ESPP Plans"), which was approved by the Company's stockholders
on May 5, 2023.

 The
2023 ESPP allows eligible employees to purchase up to an aggregate of 800,000 shares of the Company's common stock.
Under the 2023 ESPP, on the first day of each offering period, each eligible employee for that offering period has the option
to enroll for that offering period, which allows the eligible employees to purchase shares of the Company's common stock
at the end of the offering period. Each offering period under the 2023 ESPP is for six months, which can be modified from time-to-time.
Subject to limitations, each participant will be permitted to purchase a number of shares determined by dividing the employee's
accumulated payroll deductions for the offering period by the applicable purchase price, which is equal to 85 percent of
the fair market value of our common stock at the beginning or end of each offering period, whichever is less. A participant must
designate in his or her enrollment package the percentage (if any) of compensation to be deducted during that offering period
for the purchase of stock under the 2023 ESPP, subject to the statutory limit under the Code. As of December 31, 2023, 800,000
shares were available for future sales under the 2023 ESPP.

 The
ESPP Plans are considered compensatory plans with the related compensation cost expensed over the six-month offering period. For
the year ended December 31, 2023 and 2022, $34,000 and $46,000, respectively, was expensed. In January 2022, 646 shares that were
purchased as of December 31, 2021, under the 2020 ESPP, were issued. Accordingly, during the first quarter of 2022, approximately
$40,000 of employee payroll deductions accumulated at December 31, 2021, related to acquiring such shares, was transferred from
accrued expenses to additional paid in capital. The remaining $30,000 was returned to the employees. In January 2023, 14,999 shares
that were purchased as of December 31, 2022, under the 2022 ESPP, were issued. Accordingly, during the first quarter of 2023,
approximately $29,000 of employee payroll deductions accumulated at December 31, 2022, related to acquiring such shares, was transferred
from accrued expenses to additional paid in capital. The remaining $14,000 was returned to the employees. As of December 31, 2023,
approximately $44,000 of employee payroll deductions have accumulated and have been recorded in accrued expenses. In January
2024, 66,359 shares that were purchased as of December 31, 2023, under the 2022 ESPP, were issued. Accordingly, during the first
quarter of 2024, approximately $24,000 of employee payroll deductions accumulated at December 31, 2023, related to acquiring such
shares, was transferred from accrued expenses to additional paid in capital. The remaining $20,000 was returned to the employees.

 Commitments

and Development Contracts

 We
have entered into contracts with various contract research organizations with outstanding commitments aggregating approximately
$23.2 million at December 31, 2023 for future work to be performed.

 Operating
leases

 As
of December 31, 2023, future minimum lease payments are as follows (in thousands):

 Year
 Ending December 31,

 2024

 $

 2025

 2026

 2027

 2028
 and beyond

 Included
 interest

 (90

)

 $

 Critical
Accounting Policies and Estimates

 Our
discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements,
which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of
these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities
and expenses. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and
on assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ
from these estimates.

 We
believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation
of our consolidated financial statements.

 Business
Combinations. We apply the acquisition method of accounting for business combinations. Under the acquisition method, the acquiring
entity recognizes all of the identifiable assets acquired and liabilities assumed at their acquisition date fair values. We use
our best estimates and assumptions to estimate the fair values of these tangible and intangible assets. Any excess of the purchase
price over amounts allocated to the assets acquired is recorded as goodwill. The acquired intangible assets are amortized using
the straight-line method over the estimated useful lives of the respective assets. Goodwill is reviewed for impairment on an annual
basis, or more frequently if events or changes in circumstances indicate that the carrying amount of goodwill may be impaired.

 Revenue
Recognition. Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in
the same period that the revenues are recognized. Such variable consideration represents chargebacks, rebates, prompt pay and
other sales discounts, and product returns. These deductions represent estimates of the related obligations and, as such, knowledge
and judgment are required when estimating the impact of these revenue deductions on gross sales for a reporting period. We began
recognizing revenue following the completion of the USL Acquisition, beginning July 1, 2023, and required variable consideration
estimates are currently primarily based on the acquired products historical results. Adjustments to these estimates to reflect
actual results or updated expectations will be assessed each period. If any of our ratios, factors, assessments, experiences,
or judgments are not indicative or accurate estimates of our future experience, our results could be materially affected. The
potential of our estimates to vary differs by program, product, type of customer and geographic location. In addition, estimates
associated with U.S. Medicare and Medicaid governmental rebate programs are at risk for material adjustment because of the extensive
time delay.

and Development. We outsource certain of our research and development efforts and expense the related costs as incurred, including
the cost of manufacturing product for testing, licensing fees and costs associated with planning and conducting clinical trials.
The value ascribed to patents and other intellectual property acquired was expensed as research and development costs, as it related
to particular research and development projects and had no alternative future uses.

 We
estimate our accrued expenses. Our clinical trial accrual process is designed to account for expenses resulting from our obligations
under contracts with vendors, consultants and clinical research organizations and clinical site agreements in connection with
conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract
and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts.
We account for trial expenses according to the progress of the trial as measured by participant progression and the timing of
various aspects of the trial. We determine accrual estimates that take into account discussions with applicable personnel and
outside service providers as to the progress or state of completion of trials, or the services completed. During the course of
a clinical trial, we adjust our clinical expense recognition if actual results differ from our estimates. We make estimates of
our accrued expenses as of each balance sheet date based on the facts and circumstances known to us at that time. Our clinical
trial accruals and prepaid assets are dependent upon the timely and accurate reporting of contract research organizations and
other third-party vendors.

 Stock-Based
Compensation. All stock-based payments to employees and to nonemployee directors for their services as directors consisted of
grants of restricted stock and stock options, which are measured at fair value on the grant date and recognized in the consolidated
statements of operations as compensation expense over the relevant vesting period. In addition, for awards that vest immediately
and are nonforfeitable, the measurement date is the date the award is issued.

 Deferred
financing costs. Deferred financing costs represent the cost of obtaining financing arrangements and are amortized over the term
of the related debt agreement using the effective interest method. Deferred financing costs related to term debt arrangements
are reflected as a direct reduction of the related debt liability on the consolidated balance sheet. Amortization of deferred
financing costs is included in interest expense on the consolidated statements of operations.

 Original
issue discount. Certain term debt issued by the Company provides the debt holder with an original issue discount. Original issue
discounts are reflected as a direct reduction of the related debt liability on the consolidated balance sheets and are amortized
over the term of the related debt agreement using the effective interest method. Amortization of original issue discounts are
included in interest expense on the consolidated statements of operations.

 Derivative
Instruments and Warrant Liabilities. The Company evaluates all of its financial instruments, including issued warrants to purchase
common stock under ASC 815 – Derivatives and Hedging, to determine if such instruments are derivatives or contain features
that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative
instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value
reported in the consolidated statements of operations. The Company uses the Black-Scholes option pricing model to value the derivative
instruments at inception and subsequent valuation dates, which is adjusted for instrument-specific terms as applicable.

 From
time to time, certain equity-linked instruments may be classified as derivative liabilities due to the Company having insufficient
authorized shares to fully settle the equity-linked financial instruments in shares. In such a case, the Company has adopted a
sequencing approach under ASC 815-40, Derivatives and Hedging - Contracts in Entity's Own Equity to determine the classification
of its contracts at issuance and at each subsequent reporting date. If reclassification of contracts between equity and assets
or liabilities is necessary, the Company first allocates remaining authorized shares to equity on the basis of the earliest issuance
date of potentially dilutive instruments, with the earliest issuance date receiving the first allocation of shares. In the event
of identical issuance dates, shares are then allocated to equity beginning with instruments with the latest maturity date first.

 Redeemable
Convertible Preferred Stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are
measured at fair value. The Company classifies conditionally redeemable preferred shares, which includes preferred shares that
feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain
events not solely within the Company's control, as temporary equity ("mezzanine") until such time as the conditions
are removed or lapse.

 Other
than contractual obligations incurred in the normal course of business, we do not have any off-balance sheet financing arrangements
or liabilities, guarantee contracts, retain or contingent interests in transferred assets or any obligation arising out of a material
variable interest in an unconsolidated entity.

 Recently
Adopted Accounting Pronouncements

 In
August 2020, the Financial Accounting Standards Board ("FASB" issued Accounting Standards Update ("ASU")
No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts
in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own
Equity, which simplifies accounting for convertible instruments by removing major separation models required under current
GAAP. The ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative
scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. We adopted ASU 2020-06 on
January 1, 2023, under the modified retrospective method of transition. The adoption of ASU 2020-06 did not impact the Company's
financial position, results of operations or cash flows.

 In
June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments. The main objective
of ASU 2016-13 is to provide financial statement users with more decision-useful information about an entity's expected credit
losses on financial instruments and other commitments to extend credit at each reporting date. To achieve this objective, the
amendments in this update replace the incurred loss impairment methodology currently used today with a methodology that reflects
expected credit losses and requires consideration of a broader range of reasonable and supportable information to develop credit
loss estimates. ASU 2016-13 will be effective for us for fiscal years beginning after December 15, 2022, including interim
periods within those fiscal years, using a modified retrospective approach. Early adoption is permitted. We adopted ASU 2016-13 and
related updates as of January 1, 2023. The adoption of ASU 2016-13 did not impact the Company's financial position,
results of operations or cash flows.

 ITEM
7A – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 Not
required under Regulation S-K for "smaller reporting companies.

 ITEM 8 – FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 Report of Independent Registered Public Accounting Firm

 Consolidated balance sheets as of December 31, 2023 and 2022

 Consolidated statements of operations for the years ended December 31, 2023 and 2022

 Consolidated statements of comprehensive loss for the years ended December 31, 2023 and 2022

 Consolidated statements of stockholders' equity for the years ended December 31, 2023 and 2022

 F-6 – F-7

 Consolidated statements of cash flows for the years ended December 31, 2023 and 2022

 Notes to consolidated financial statements

 F-9 – F-30

 F- 1

 REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM

 To the Board of Directors and Stockholders of

 Tonix Pharmaceuticals Holding Corp.

 Opinion on the Financial Statements

 We have audited the accompanying consolidated balance
sheets of Tonix Pharmaceuticals Holding Corp. and Subsidiaries (the "Company") as of December 31, 2023 and 2022, and the
related consolidated statements of operations, comprehensive loss, stockholders' equity, and cash flows for each of the years then
ended, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements
present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2023 and 2022, and the
consolidated results of their operations and their cash flows for each of the years then ended, in conformity with accounting principles
generally accepted in the United States of America.

 Going Concern

 The accompanying financial statements have been prepared
assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has continuing
losses and negative cash flows from operating activities that raise substantial doubt about its ability to continue as a going concern.
Management's plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments
that might result from the outcome of this uncertainty.

 Basis for Opinion

 These financial statements are the responsibility
of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB")
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.

 We conducted our audits in accordance with the standards
of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements
are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform,
an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal
control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
control over financial reporting. Accordingly, we express no such opinion.

 Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

 Critical Audit Matters

 The critical audit matters communicated below are
matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the
audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially
challenging, subjective, or complex judgments. The communication of the critical audit matters does not alter in any way our opinion on
the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion
on the critical audit matters or on the accounts or disclosures to which they relate.

 Accrual and prepaid balance for clinical trial expenses

 As described in Note 2 to the consolidated financial
statements, at each balance sheet date the Company estimates its expenses resulting from its obligations under contracts with vendors,
clinical research organizations and under clinical site agreements in connection with conducting clinical trials. The Company accounts
for trial expenses according to the timing of various aspects of the trial. The Company's accrual for clinical trial expenses of
approximately $3.0 million is included in accrued expenses and other current liabilities in the December 31, 2023 consolidated balance
sheet. The Company also recorded prepaid clinical trial expenses of approximately $4.6 million within prepaid expenses and other in the
December 31, 2023 consolidated balance sheet. The amounts recorded for clinical trial expenses represent the Company's estimates
of the unpaid and prepaid clinical trial expenses based on facts and circumstances known to the Company at that time, and are dependent
upon the timely and accurate reporting of contract research organizations and other third-party vendors. The estimation of clinical trial
expenses was also identified as a critical accounting estimate by management.

 We identified the accrual for clinical trial expenses
as a critical audit matter due to the significant judgment and estimation required by management in determining progress or state of completion
of clinical trials or services completed. This in turn led to a high degree of auditor subjectivity, and significant audit effort was
required in performing our procedures and evaluating audit evidence relating to estimates made by management.

 Addressing the matter involved performing procedures
and evaluating audit evidence, in connection with forming our overall opinion on the consolidated financial statements. We obtained an
understanding of Management's process and evaluated the design of controls over developing its estimate of accrued and prepaid clinical
trial expenses, including the process of estimating the expenses incurred to date based on the status of the clinical trials. Our procedures
also included, among others, reading agreements and contract amendments with vendors, consultants and clinical research organizations
and clinical site agreements in connection with conducting clinical trials, and evaluating the significant assumptions described above
and the methods used in developing the clinical trial estimates and re-calculating the amounts that were unpaid and prepaid at the balance
sheet date. We confirmed contractual commitments and amounts completed, paid and unpaid directly with the third parties involved in performing
the clinical trial services on behalf of the Company. We also made direct inquiries of financial and clinical Company personnel regarding
the contract amount including change orders, status and progress to completion of clinical trials, amounts paid to date under each contract,
and description of future commitments. We also assessed the historical accuracy of management's estimates by comparing current expenses
to prior-period expenses to identify unusual fluctuations, if any.

 Valuation of intangible assets acquired in a business combination

 As described in Note 12 to the consolidated financial
statements, the Company acquired certain assets from Upsher-Smith Laboratories LLC, which was accounted for as a business combination
using the acquisition method of accounting. The acquired intangible assets consisted of developed technology related to Zembrace and Tosymra,
including the value associated with the acquired patents, customer relationships, and trademarks and tradenames associated with the technology.
The developed technology intangible assets were valued as composite assets under the premise that each asset is reliant on one another
to generate cash flow, and is not considered separable from the technology. The intangible assets had an estimated acquisition date fair
value of $10.1 million. The accounting for business combinations, including valuation of intangible assets, was also identified as a critical
accounting estimate by management.

 We identified valuation of intangible assets acquired
in a business combination as a critical audit matter due to the significant judgment and estimation required by management in the use
of fair valuation methodologies, including sensitive significant assumptions such as revenue growth rates and risk premium. This in turn
led to a high degree of auditor subjectivity, and significant audit effort was required in performing our procedures and evaluating audit
evidence relating to estimates made by management.

 Addressing the matter involved performing procedures
and evaluating audit evidence, in connection with forming our overall opinion on the consolidated financial statements. We obtained an
understanding of Management's process and evaluated the design of controls over developing its estimate of the purchase price allocation.
Our procedures also included, among others, assessing the appropriateness of the valuation methodology utilized, testing of significant
assumptions, and ensuring completeness and accuracy of the underlying data used by the Company. We involved our valuation specialist to
assist in evaluating the valuation methodologies and risk premium used in the purchase price allocation valuation.

 We have served as the Company's auditor since
2010.

 EISNERAMPER LLP

 Iselin, New Jersey

 F- 2

 CONSOLIDATED BALANCE SHEETS

 DECEMBER 31, 2023 AND 2022

 (In Thousands, Except Par Value and Share
Amounts)

 2023

 2022

 ASSETS

 Current assets:

 Cash and cash equivalents

 $

 24,948

 $

 120,229

 Inventory, net

 13,639

 —

 Prepaid expenses and other current assets

 9,181

 10,548

 Total current assets

 47,768

 130,777

 Property and equipment, net

 94,028

 93,814

 Intangible assets, net

 9,743

 Goodwill

 —

 Operating lease right-to-use assets

 Other non-current assets

 1,129

 Total assets

 $

 154,457

 $

 225,690

 LIABILITIES AND STOCKHOLDERS' EQUITY

 Current liabilities:

 Accounts payable

 $

 3,782

 $

 8,068

 Accrued expenses and other current liabilities

 12,482

 9,680

 Term loan payable, short term

 2,350

 —

 Lease liability, short term

 Total current liabilities

 18,884

 18,180

 Term loan payable, long term

 6,561

 —

 Series C Warrant liabilities

 14,595

 —

 Series D Warrant liabilities

 8,260

 —

 Lease liability, long term

 Total liabilities

 48,932

 18,508

 Commitments (See Note 21)

 Stockholders' equity:

 Preferred stock, $ 0.001 par value; 5,000,000 shares authorized

 Series B Convertible Preferred stock, 0 shares designated as of both December 31, 2023 and 2022; issued and outstanding - None

 —

 —

 Series A Convertible Preferred stock, 0 shares designated as of both December 31, 2023 and December 31, 2022; issued and outstanding - none

 —

 —

 Common stock, $ 0.001 par value; 160,000,000 shares authorized; 58,614,593 and 12,368,620 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively and 66,329 and 14,999 shares to be issued as of December 31, 2023 and December 31, 2022, respectively

 Additional paid in capital

 706,356

 677,375

 Accumulated deficit

 ( 600,658

)

 ( 470,038

)

 Accumulated other comprehensive loss

 ( 232

)

 ( 167

)

 Total stockholders' equity

 105,525

 207,182

 Total liabilities and stockholders' equity

 $

 154,457

 $

 225,690

 See the accompanying notes to the consolidated

 F- 3

 CONSOLIDATED STATEMENTS OF OPERATIONS

 (In Thousands, Except Share and Per Share
Amounts)

 Year ended December 31,

 2023

 2022

 REVENUES:

 Product revenue, net

 $

 7,768

 $

 —

 COSTS AND EXPENSES:

 Cost of sales

 4,741

 —

 Research and development

 86,655

 81,876

 General and administrative

 34,752

 30,215

 Total Operating Expenses

 126,148

 112,091

 Operating loss

 ( 118,380

)

 ( 112,091

)

 Other income, net

 1,722

 1,873

)

)

 Preferred stock deemed dividend

 —

 6,659

 Net loss available to common stockholders

 $

)

 $

 ( 116,877

)

 Net loss to common stockholders per common share, basic and diluted

 $

 ( 6.85

)

 $

 ( 20.01

)

 Weighted average common shares outstanding, basic and diluted

 17,039,309

 5,841,447

 See the accompanying notes to the consolidated

 F- 4

 CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS

 (In Thousands)

 Year ended December 31,

 2023

 2022

 $

)

 $

)

 Other comprehensive loss:

 Foreign currency translation loss

 ( 65

)

 ( 75

)

 Comprehensive loss

 $

 ( 116,723

)

 $

 ( 110,293

)

 See the accompanying notes to the consolidated

 F- 5

 CONSOLIDATED STATEMENTS OF STOCKHOLDERS'
EQUITY

 (In Thousands, Except Share and Per Share
Amounts)

 Accumulated

 Additional

 Other

 Common stock

 Paid in

 Comprehensive

 Accumulated

 Shares

 Amount

 Capital

 Gain (loss)

 Deficit

 Total

 Balance, December 31, 2022

 12,368,620

 $

 $

 677,375

 $

 ( 167

)

 $

 ( 470,038

)

 $

 207,182

 Repurchase of common stock under Share Repurchase Program, including transactional expenses of $ 334

 ( 2,672,044

)

 ( 3

)

 —

 —

 ( 13,962

)

 ( 13,965

)

 Issuance of common stock under 2022 Purchase agreement

 96,000

 —

 —

 —

 Issuance of common stock under At-the-market offering, net of transactional expenses of $ 137

 954,766

 3,023

 —

 —

 3,024

 Issuance of common stock and warrants under AGP Financing, net of transactional expenses of $ 2,663

 31,923,242

 16,230

 —

 —

 16,262

 Issuance of common stock upon exercise of prefunded common warrants

 15,929,010

 ( 17

)

 —

 —

 —

 Employee stock purchase plan

 14,999

 —

 —

 —

 —

 —

 9,275

 —

 —

 9,275

 Foreign currency transaction gain

 —

 —

 —

 ( 65

)

 —

 ( 65

)

 —

 —

 —

 —

)

)

 Balance, December 31, 2023

 58,614,593

 $

 $

 706,356

 $

 ( 232

)

 $

 ( 600,658

)

 $

 105,525

 See the accompanying notes to the consolidated

 F- 6

 CONSOLIDATED STATEMENTS OF STOCKHOLDERS'
EQUITY

 (In Thousands, Except Share and Per Share
Amounts)

 Accumulated

 Additional

 Other

 Common stock

 Paid in

 Comprehensive

 Accumulated

 Shares

 Amount

 Capital

 Gain (loss)

 Deficit

 Total

 Balance, December 31, 2021

 2,634,110

 $

 $

 578,626

 $

 ( 92

)

 $

 ( 359,820

)

 $

 218,717

 Issuance of common stock under At-the-market offering, net of transactional expenses of $ 3,078

 9,017,307

 85,284

 —

 —

 85,293

 Issuance of commitment shares under 2022 Purchase agreement

 100,000

 —

 —

 —

 —

 —

 Issuance of common stock under 2022 Purchase agreement

 160,000

 —

 —

 —

 Issuance of common stock under 2021 Purchase agreement

 456,557

 —

 8,682

 —

 —

 8,682

 Preferred stock deemed dividend

 —

 —

 ( 6,659

)

 —

 —

 ( 6,659

)

 Employee stock purchase plan

 —

 —

 —

 —

 —

 10,914

 —

 —

 10,914

 Foreign currency transaction gain

 —

 —

 —

 ( 75

)

 —

 ( 75

)

 —

 —

 —

 —

)

)

 Balance, December 31, 2022

 12,368,620

 $

 $

 677,375

 $

 ( 167

)

 $

 ( 470,038

)

 $

 207,182

 See the accompanying notes to the
consolidated financial statements

 F- 7

 CONSOLIDATED STATEMENTS OF CASH FLOWS

 (In Thousands)

 Year ended December 31,

 2023

 2022

 CASH FLOWS FROM OPERATING ACTIVITIES:

 $
)

 $
)

 Adjustments to reconcile net loss to net cash used in operating activities:

 Depreciation and amortization

 4,291

 1,253

 9,275

 10,914

 Change in fair value of warrant liabilities

 —

 Offering costs allocated to warrant liabilities

 —

 Gain on sale of property and equipment

 ( 62
)

 —

 Changes in operating assets and liabilities:

 Inventory

 —

 Prepaid expenses and other

 1,573

 ( 164
)

 Accounts payable

 ( 3,490
)

 ( 1,045
)

 Operating lease liabilities and ROU asset, net

 Accrued expenses and other current liabilities

 1,786

 1,205

 Net cash used in operating activities

 ( 102,003
)

 ( 98,053
)

 CASH FLOWS FROM INVESTING ACTIVITIES:

 Purchase of property and equipment

 ( 7,895
)

 ( 48,147
)

 Disposal of property and equipment

 —

 Purchase of a business

 ( 22,174
)

 —

 Net cash used in investing activities

 ( 29,070
)

 ( 48,147
)

 CASH FLOWS FROM FINANCING ACTIVITIES:

 Proceeds from ESPP

 Proceeds, net of $ 6,659 expenses, from sale of convertible redeemable preferred stock

 —

 40,591

 Redemption of convertible preferred stock

 —

 ( 47,250
)

 Proceeds from debt financing

 8,942

 —

 Proceeds, net of $ 2,800 and $ 3,078 expenses, from sale of common stock and warrants

 18,939

 94,463

 Proceeds from allocated warrant liabilities

 22,572

 —

 Repurchase of common stock

 ( 13,965
)

 —

 Net cash provided by financing activities

 36,517

 87,844

 Effect of currency rate change on cash

 ( 65
)

 ( 74
)

 Net decrease in cash, cash equivalents and restricted cash

 ( 94,621
)

 ( 58,430
)

 Cash, cash equivalents and restricted cash beginning of the period

 120,470

 178,900

 Cash, cash equivalents and restricted cash end of period

 $
 25,849

 $
 120,470

 Supplemental disclosures of cash flow information:

 Purchases of property and equipment included in accounts payable and accrued liabilities

 $

 $
 3,092

 Debt financing costs included in accrued liabilities and other current liabilities

 $

 $
 -

 Issuance costs included in accrued liabilities and other current liabilities

 $

 -

 Preferred stock deemed dividend

 $
 —

 $
 6,659

 New operating leases and lease amendments

 $

 See the accompanying notes to consolidated

 F- 8

 NOTE 1 – BUSINESS

 Tonix Pharmaceuticals Holding
Corp., through its wholly owned subsidiary Tonix Pharmaceuticals, Inc. ("Tonix Sub"), is a fully-integrated biopharmaceutical
company focused on developing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. The therapeutics
under development include both small molecules and biologics. Tonix, through its recent acquisition, markets Zembrace SymTouch
(sumatriptan injection) 3 mg ("Zembrace") and Tosymra (sumatriptan nasal spray) 10 mg ("Tosymra"). Zembrace
and Tosymra, which were acquired as of June 30, 2023 (See Note 12), are each indicated for the treatment of acute migraine with or without
aura in adults. All other drug product and vaccine candidates are still in development and are not approved or marketed.

 The consolidated financial statements
include the accounts of Tonix Pharmaceuticals Holding Corp. and its wholly owned subsidiaries, Tonix Sub, Krele LLC, Tonix Pharmaceuticals
(Canada), Inc., Tonix Medicines, Inc., Jenner Institute LLC, Tonix R&D Center LLC, Tonix Pharma Holdings Limited and Tonix Pharma
Limited (collectively hereafter referred to as the "Company" or "Tonix"). All intercompany balances and transactions
have been eliminated in consolidation.

 Going Concern

 The accompanying financial
statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates
the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has suffered
recurring losses from operations and negative cash flows from operating activities. At December 31, 2023, the Company had working
capital of approximately $ 28.9 million. At December 31, 2023, the Company had an accumulated deficit of approximately $600.7 million.
The Company held cash and cash equivalents of approximately $24.9 million as of December 31, 2023.

 The Company believes
that its cash resources at December 31, 2023 and the proceeds that it raised from equity offerings in the first quarter of 2024
(See Note 23), will not meet its operating and capital expenditure requirements through the second quarter of 2024.

 These factors raise
substantial doubt about the Company's ability to continue as a going concern. The Company continues to face significant challenges
and uncertainties and must obtain additional funding through public and private financing and collaborative arrangements with strategic
partners to increase the funds available to fund operations. However, the Company may not be able to raise capital on terms acceptable
to the Company, or at all. Without additional funds, it may be forced to delay, scale back or eliminate some of its research and
development activities, or other operations and potentially delay product development in an effort to provide sufficient funds
to continue operations. If any of these events occurs, its ability to achieve our development and commercialization goals would
be adversely affected and the Company may be forced to cease operations. The financial statements do not include any adjustments
that might result from the outcome of this uncertainty.

 NOTE 2 – SIGNIFICANT ACCOUNTING
POLICIES

 Reverse Stock Split

 On May 9, 2023, the
Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023. Pursuant to the Certificate of
Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common stock. The Company
accounted for the reverse stock split on a retrospective basis pursuant to ASC 260, Earnings Per Share. All authorized, issued
and outstanding common stock, common stock warrants, stock option awards, exercise prices and per share data have been adjusted
in these consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods presented.
Authorized preferred stock was not adjusted because of the reverse stock split.

 Risks and uncertainties

 The Company's
primary efforts are devoted to conducting research and development of innovative pharmaceutical and biological products to address
public health challenges. The Company has experienced net losses and negative cash flows from operations since inception and expects
these conditions to continue for the foreseeable future. Further, the Company now has commercial products available for sale, and
generates revenue from the sale of its Zembrace SymTouch and Tosymra products, with no assurance that the Company
will be able to generate sufficient cash flow to fund operations from its commercial products or products in development if and
when approved. In addition, there can be no assurance that the Company's research and development will be successfully completed
or that any product will be approved or commercially viable.

 F- 9

 Use of estimates

 The preparation of
financial statements in accordance with Generally Accepted Accounting Principles ("GAAP") requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities
at the date of the financial statements, and the reported amounts of expenses during the reporting period. Actual results could
differ from those estimates. Significant estimates include, but are not limited to, provisions for product returns, coupons, rebates,
chargebacks, discounts, allowances, inventory realization, the assumptions used in the fair value of stock-based compensation and
other equity instruments, the percent of completion of research and development contracts, fair value estimates for assets acquired
in business combinations, and assessment of useful lives of acquired intangible assets.

 Business Combinations

 The Company accounts
for business combinations in accordance with the provisions of ASC 805, Business Combinations and ASU No. 2017-01, Business Combinations
(Topic 805): Clarifying the Definition of a Business. Business combinations are accounted for using the acquisition method, whereby
the consideration transferred is allocated to the net assets acquired based on their respective fair values measured on the acquisition
date. The difference between the fair value of these assets and the purchase price is recorded as goodwill. Transaction costs other
than those associated with the issue of debt or equity securities, and other direct costs of a business combination are not considered
part of the business acquisition transaction and are expensed as incurred.

 Segment Information and Concentrations

 Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the
chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.
The Company views its operations and manages its business in one segment.

 The
Company has two products that each accounted for more than 10 % of total revenues during the year ended December 31, 2023. These
products collectively accounted for 100 % of revenues during the year ended December 31, 2023.

 As
of December 31, 2023, accounts receivable from five customers accounted for 26 %, 21 %, 16 %, 14 % and 13 % of total accounts receivable.
For the year ended December 31, 2023, revenues from five customers accounted for 23 %, 21 %, 19 %, 17 % and 10 % of net product revenues,
respectively. As of December 31, 2022, and for the year ended December 31, 2022, the Company had no commercialized products and
therefore had no accounts receivable or revenues.

 Cash, Cash Equivalents and Restricted Cash

 The
Company considers cash equivalents to be those investments which are highly liquid, readily convertible to cash and have an original
maturity of three months or less when purchased. At December 31, 2023, and December 31, 2022, cash equivalents, which consisted
of money market funds, amounted to approximately $ 23,000 and $ 116.3 million, respectively. Restricted cash, which is included
in Other non-current assets on the consolidated balance sheet, at December 31, 2023, of approximately $ 0.9 million, collateralizes
a letter of credit issued in connection with the lease of office space in Chatham, New Jersey (see Note 20) and restricted cash
held by vendors in escrow accounts for patient support services. Restricted cash at December 31, 2022, of approximately $ 241,000,
collateralizes a letter of credit issued in connection with the lease of office space in Chatham, New Jersey and New York, New
York.

provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum
to the total of the same amounts shown in the consolidated statement of cash flows:

2023

 2022

 Cash and cash equivalents

 $

 24,948

 $

 120,229

 Restricted cash

 Total

 $

 25,849

 $

 120,470

 Accounts Receivable, net

 Accounts receivable
consists of amounts due from our wholesale and other third-party distributors and pharmacies and have standard payment terms that
generally require payment within 30 to 90 days. For certain customers, the accounts receivable for the customer is net of prompt
payment or specialty pharmacy discounts. We do not adjust our receivables for the effects of a significant financing component
at contract inception if we expect to collect the receivables in one year or less from the time of sale. We provide reserves against
accounts receivable for estimated losses that may result from a customer's inability to pay. Amounts determined to be uncollectible
are charged or written-off against the reserve. However, during the period covered by the Transition Services Agreement, the Seller
has agreed to collect the accounts receivable on behalf of the Company and net settle within 45 days from each month-end. See Note
12 for further details. The Company had no accounts receivable as of December 31, 2022.

 F- 10

 As of December
31, 2023, the Company did not have an allowance for doubtful accounts. An allowance for doubtful accounts is determined
based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends
expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected
to be collected. The payment history of the Company's customers will be considered in future assessments of collectability
as these patterns are established over a longer period.

 Concentration of Credit Risk

 Financial instruments
that potentially subject us to concentrations of credit risk include cash and cash equivalents, and accounts receivable. We attempt
to minimize the risks related to cash and cash equivalents by investing in a broad and diverse range of financial instruments,
and we have established guidelines related to credit ratings and maturities intended to safeguard principal balances and maintain
liquidity. Concentrations of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due
to the wide variety of customers using our products, as well as their dispersion across different geographic areas.

 We monitor the financial
performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile.
We continue to monitor these conditions and assess their possible impact on our business.

 Inventories

 Inventories are recorded
at the lower of cost or net realizable value, with cost determined by the weighted average cost method. The Company periodically
reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking
into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand. If non-saleable
items are observed and there are no alternate uses for the inventory, the Company records a write-down to net realizable value
in the period that the decline in value is first recognized. Although the Company makes every effort to ensure the accuracy of
forecasts of future product demand, any significant unanticipated decreases in demand could have a material impact on the carrying
value of inventories and reported operating results. The Company's reserves were approximately $ 21,000 as of December 31,
2023. The Company did not have inventory on hand prior to the acquisition of Zembrace and Tosymra on June 30, 2023.

 Property and equipment

 Property and equipment
are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the asset's
estimated useful life, which ranges from 20 to 30 years for buildings, 15 years for land improvements and laboratory equipment,
 three years for computer assets, five years for furniture and all other equipment and the shorter of the useful life or term of
lease for leasehold improvements. Depreciation on assets begins when the asset is placed in service. Depreciation and amortization
expense for the years ended December 31, 2023, and 2022, were $ 3.8 million and $ 1.3 million, respectively. All property and equipment
are located in the United States.

 Intangible assets, net

 Intangible assets deemed
to have finite lives are carried at acquisition-date fair value less accumulated amortization and impairment, if any. Finite-lived
intangible assets consist of developed technology intangible assets acquired in connection with the acquisition of certain products
from Upsher Smith Laboratories, LLS ("Upsher Smith") consummated on June 30, 2023 (See Note 5). The acquired intangible
assets are amortized using the straight-line method over the estimated useful lives of the respective assets. Amortization expense
for the year ended December 31, 2023, was $ 477,000. The annual impairment assessment date will be June 30. No triggering events
were identified during the period of July 1, 2023 through December 31, 2023.

 During the year ended
December 31, 2015, the Company purchased certain internet domain rights, which were determined to have an indefinite life. Identifiable
intangibles with indefinite lives, which are included in Intangible assets, net on the consolidated balance sheet, are not amortized
but are tested for impairment annually or whenever events or changes in circumstances indicate that their carrying amount may be
less than fair value. As of December 31, 2023, the Company believed that no impairment existed.

 F- 11

 Goodwill

 Goodwill represents
the excess of the aggregate purchase price over the fair value of the net tangible and intangible assets acquired in a business
combination. Goodwill is reviewed for impairment on an annual basis, or more frequently if events or changes in circumstances indicate
that the carrying amount of goodwill may be impaired. As of December 31, 2023, the Company has recognized goodwill in connection
with the USL Acquisition consummated on June 30, 2023 (See Note 5). The annual impairment assessment date will be June 30. No triggering
events were identified during the period of July 1, 2023 through December 31, 2023.

 Leases

 The Company determines
if an arrangement is, or contains, a lease at inception. Operating leases are included in operating lease right-of-use ("ROU")
assets, operating lease liabilities, current and operating lease liabilities, noncurrent in the Company's consolidated balance
sheets. ROU assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent
its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement
date based on the present value of lease payments over the lease term. As the Company's leases do not provide an implicit
rate, the Company uses an incremental borrowing rate based on the information available at the transition date and subsequent lease
commencement dates in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing
on a collateralized basis over a similar term to each lease. The operating lease ROU asset excludes lease incentives. The Company's
lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that
option. Lease expense for lease payments made under operating leases is recognized on a straight-line basis over the lease term.

 Deferred financing costs

 Deferred financing
costs represent the cost of obtaining financing arrangements and are amortized over the term of the related debt agreement using
the effective interest method. Deferred financing costs related to term debt arrangements are reflected as a direct reduction of
the related debt liability on the consolidated balance sheet. Amortization of deferred financing costs are included in interest
expense on the consolidated statements of operations.

 Original issue discount

 Certain term debt issued
by the Company provides the debt holder with an original issue discount. Original issue discounts are reflected as a direct reduction
of the related debt liability on the consolidated balance sheets and are amortized over the term of the related debt agreement
using the effective interest method. Amortization of original issue discounts are included in interest expense on the consolidated
statements of operations.

 Convertible Preferred Stock

 Preferred shares subject
to mandatory redemption are classified as liability instruments and are measured at fair value. The Company classifies conditionally
redeemable preferred shares, which includes preferred shares that feature redemption rights that are either within the control
of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company's control, as
temporary equity ("mezzanine") until such time as the conditions are removed or lapse.

 Revenue Recognition

 The Company records
and recognizes revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects
the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company's revenues
primarily result from contracts with customers, which are generally short-term and have a single performance obligation - the delivery
of product. The Company's performance obligation to deliver products is satisfied at the point in time that the goods are
received by the customer, which is when the customer obtains title to and has the risks and rewards of ownership of the products,
which is generally upon shipment or delivery to the customer as stipulated by the terms of the sale agreements. The transaction
price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods to
a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Our
contractual payment terms are typically 30 to 90 days.

 Revenues from product sales, net of gross-to-net
deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not probable
of occurring and when the uncertainty associated with gross-to-net deductions is subsequently resolved. Taxes assessed by governmental
authorities and collected from customers are excluded from product sales. Shipping and handling activities are considered to be
fulfillment activities and not a separate performance obligation.

 F- 12

 Many of the Company's
products sold are subject to a variety of deductions. Revenues are recognized net of estimated rebates and chargebacks, cash discounts,
distributor fees, sales return provisions and other related deductions. Deductions to product sales are referred to as gross-to-net
deductions and are estimated and recorded in the period in which the related product sales occur. Accruals for these provisions
are presented in the consolidated financial statements as reductions to gross sales in determining net sales, and as a contra asset
within accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). Amounts recorded for revenue
deductions can result from a complex series of judgements about future events and uncertainties and can rely heavily on estimates
and assumptions. The following section briefly describes the nature of the Company's provisions for variable consideration
and how such provisions are estimated:

 Chargebacks -
The Company sells a portion of its products indirectly through wholesaler distributors, and enters into specific agreements with
these indirect customers to establish pricing for the Company's products, and in-turn, the indirect customers and entities
independently purchase these products. Because the price paid by the indirect customers and/or entities is lower than the price
paid by the wholesaler, the Company provides a credit, called a chargeback, to the wholesaler for the difference between the contractual
price with the indirect customers and the wholesale customer's purchase price. The Company's provision for chargebacks
is based on expected sell-through levels by the Company's wholesale customers to the indirect customers and estimated wholesaler
inventory levels as well as historical chargeback rates. The Company continually monitors its reserve for chargebacks and adjusts
the reserve accordingly when expected chargebacks differ from actual experience.

 Rebates - The
Company participates in certain government and specific sales rebate programs which provides discounted prescription drugs to qualified
recipients, and primarily relate to Medicaid and managed care rebates in the U.S., pharmacy rebates, Tri-Care rebates and discounts,
specialty pharmacy program fees and other governmental rebates or applicable allowances.

 Managed Care Rebates are processed in the quarter following the quarter in which they are earned. The managed care reporting entity submits utilization data after the end of the quarter and the Company processes the payment in accordance with contract terms. All rebates earned but not paid are estimated by the Company according to historical payments trended for market growth assumptions.

 Medicaid and State Agency rebates are based upon historical experience of claims submitted by various states. The Company monitors Medicaid legislative changes to determine what impact such legislation may have on the provision for Medicaid rebates. The accrual of State Agency reserves is based on historical payment rates. There is an approximate three-month lag from the time of product sale until the rebate is paid.

 Tri-Care represents a regionally managed health care program for active duty and retired members, dependents and survivors of the US military. The Tri-Care program supplements health care resources of the US military with civilian health care professionals for greater access and quality healthcare coverage. Through the Tri-Care program, the Company provides pharmaceuticals on a direct customer basis. Prices of pharmaceuticals sold under the Tri-Care program are pre-negotiated and a reserve amount is established to represent the proportionate rebate amount associated with product sales.

 Coverage Gap refers to the Medicare prescription drug program and represents specifically the period between the initial Medicare Part D prescription drug program coverage limit and the catastrophic coverage threshold. Applicable pharmaceutical products sold during this coverage gap timeframe are discounted by the Company. Since the nature of the program is that coverage limits are reset at the beginning of the calendar year; the payments escalate each quarter as the participants reach the coverage limit before reaching the catastrophic coverage threshold. The Company has determined that the cost of this reserve will be viewed as an annual cost. Therefore, the accrual will be incurred evenly during the year with quarterly review of the liability based on payment trends and any revision to the projected annual cost.

 Prompt-Pay and other
Sales Discounts - The Company provides for prompt pay discounts, which early payments are recorded as a reduction of revenue
and as a reduction in the accounts receivable at the time of sale based on the customer's contracted discount rate. Consumer
sales discounts represent programs the Company has in place to reduce costs to the patient. This includes copay buy down and eVoucher
programs.

 Product Returns
- Consistent with industry practice, the Company offers customers a right to return any unused product. The customer's right
of return commences typically six months prior to product expiration date and ends one year after product expiration date. Products
returned for expiration are reimbursed at current wholesale acquisition cost or indirect contract price. The Company estimates
the amount of its product sales that may be returned by the Company's customers and accrues this estimate as a reduction
of revenue in the period the related product revenue is recognized. The Company estimates products returns as a percentage of sales
to its customers. The rate is estimated by using historical sales information, including its visibility and estimates into the
inventory remaining in the distribution channel. Adjustments are made to the current provision for returns when data suggests product
returns may differ from original estimates.

 Research and Development Costs

 The Company outsources
certain of its research and development efforts and expenses these costs as incurred, including the cost of manufacturing products
for testing, as well as licensing fees and costs associated with planning and conducting clinical trials. The value ascribed to
patents and other intellectual property acquired has been expensed as research and development costs, as such property is related
to particular research and development projects and had no alternative future uses.

 F- 13

 The Company estimates its expenses resulting from its
obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in
connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from
contract to contract and may result in payment flows that do not match the periods over which materials or services are provided
under such contracts. The Company accounts for trial expenses according to the timing of various aspects of the trial. The Company
determines accrual estimates taking into account discussion with applicable personnel and outside service providers as to the progress
or state of consummation of trials, or the services completed.

 During the course of
a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company
makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that
time. The Company's clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations
and other third-party vendors.

 Government Grants

 From time to time,
the Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development
activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities
included in the grant application approved by the government authority. The Company classifies government grants received under
these arrangements as a reduction to the related research and development expense in the same period as the relevant expenses are
incurred. In August 2022, the Company announced that it received a Cooperative Agreement grant from the National Institute on Drug
Abuse ("NIDA"), part of the National Institutes of Health, to support the development of its TNX-1300 product candidate
for the treatment of cocaine intoxication. During the year ended December 31, 2023, we received $ 2.7 million in funding as a reduction
of related research and development expense. Included in Prepaid expenses and other is an additional $ 0.2 million which was not received until January 2024. No funding was received during 2022.

 Stock-based Compensation.

 All stock-based payments
to employees and to nonemployees for their services, including grants of restricted stock units ("RSUs"), and stock
options, are measured at fair value on the grant date and recognized in the consolidated statements of operations as compensation
expense over the requisite service period. The Company accounts for share-based awards in accordance with the provisions of the
Accounting Standards Codification ("ASC") 718, Compensation – Stock Compensation.

 Foreign Currency Translation

 Operations of the Company's
Canadian subsidiary, Tonix Pharmaceuticals (Canada), Inc., are conducted in local currency, which represents its functional currency.
The U.S. dollar is the functional currency of the other foreign subsidiaries. Balance sheet accounts of the Canadian subsidiary
were translated from foreign currency into U.S. dollars at the exchange rate in effect at the balance sheet date and income statement
accounts were translated at the average rate of exchange prevailing during the period. Translation adjustments resulting from this
process were included in accumulated other comprehensive loss on the consolidated balance sheets.

 Comprehensive Income (Loss)

 Comprehensive income
(loss) is defined as the change in equity of a business during a period from transactions and other events and circumstances from
non-owners sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions
to owners. Other comprehensive income (loss) represents foreign currency translation adjustments.

 Income Taxes

 Deferred income tax
assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards
and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured
at the current enacted tax rates. The Company records a valuation allowance on its deferred income tax assets if it is not more
likely than not that these deferred income tax assets will be realized.

 The Company recognizes
a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination
by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial
statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized
upon ultimate settlement. As of December 31, 2023, the Company has not recorded any unrecognized tax benefits. The Company's
policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.

 F- 14

 Derivative Instruments and Warrant Liabilities

 The Company evaluates
all of its financial instruments, including issued warrants to purchase common stock under ASC 815 – Derivatives and Hedging,
to determine if such instruments are derivatives or contain features that qualify as embedded derivatives (See Note 17). For derivative
financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value
and is then re-valued at each reporting date, with changes in the fair value reported in the consolidated statements of operations.
The Company uses the Black-Scholes option pricing model to value the derivative instruments at inception and subsequent valuation
dates, which is adjusted for instrument-specific terms as applicable.

 From time to time,
certain equity-linked instruments may be classified as derivative liabilities due to the Company having insufficient authorized
shares to fully settle the equity-linked financial instruments in shares. In such case, the Company has adopted a sequencing approach
under ASC 815-40, Derivatives and Hedging - Contracts in Entity's Own Equity to determine the classification of its contracts
at issuance and at each subsequent reporting date. In the event that reclassification of contracts between equity and assets or
liabilities is necessary, the Company first allocates remaining authorized shares to equity on the basis of the earliest issuance
date of potentially dilutive instruments, with the earliest issuance date receiving the first allocation of shares. In the event
of identical issuance dates, shares are then allocated to equity beginning with instruments with the latest maturity date first.

 Per Share Data

 The computation of
basic and diluted loss per share for the year ended December 31, 2023, and 2022 excludes potentially dilutive securities when their
inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during
the period.

 All warrants and preferred
stock issued participate on a one-for-one basis with common stock in the distribution of dividends, if and when declared by the
Board of Directors, on the Company's common stock. For the purposes of computing EPS, these warrants and preferred stock
are considered to participate with common stock in earnings of the Company. Therefore, the Company calculates basic and diluted
EPS using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders
and participating securities according to dividends declared and participation rights in undistributed earnings. The weighted average
number of outstanding shares of common stock used in the denominator for the calculation of basic loss per share for the year ended
December 31, 2023, include pre-funded warrants that are accounted for as equity instruments, beginning with their respective issuance
dates, as their stated exercise price of $ 0.0001 is non-substantive and there are no further vesting conditions or limitations
on exercise. No income was allocated to the warrants and preferred stock for the year ended December 31, 2023, and 2022, as results
of operations were a loss for the periods.

 Potentially dilutive
securities excluded from the computation of basic and diluted net loss per share, as of December 31, 2023, and 2022, are as follows:

 2023

 2022

 Warrants to purchase common stock

 209,364,707

 3,196

 Options to purchase common stock

 1,375,539

 392,643

 Totals

 210,740,246

 395,839

 Recently Adopted Accounting Pronouncements

 In August 2020, the
Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2020-06, Debt—Debt
with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity's Own Equity (Subtopic
815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which simplifies accounting
for convertible instruments by removing major separation models required under current GAAP. The ASU also removes certain settlement
conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it also simplifies
the diluted earnings per share calculation in certain areas. The Company adopted ASU 2020-06 on January 1, 2023, under the modified
retrospective method of transition. The adoption of ASU 2020-06 did not impact the Company's financial position, results
of operations or cash flows.

 In June 2016, the FASB
issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments. The main objective of ASU 2016-13 is to provide
financial statement users with more decision-useful information about an entity's expected credit losses on financial instruments
and other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace
the incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires
consideration of a broader range of reasonable and supportable information to develop credit loss estimates. ASU 2016-13 will be
effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years,
using a modified retrospective approach. Early adoption is permitted. The Company adopted ASU 2016-13 and related updates as of
January 1, 2023. The adoption of ASU 2016-13 did not impact the Company's financial position, results of operations or cash
flows.

 F- 15

 Recent Accounting Pronouncements Not
Yet Adopted

 In November 2023, the
Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-07, Segment
Reporting--Improvements to Reportable Segment Disclosures, which requires incremental disclosures about a public entity's
reportable segments but does not change the definition of a segment or the guidance for determining reportable segments. The new
guidance requires disclosure of significant segment expenses that are (1) regularly provided to (or easily computed from information
regularly provided to) the chief operating decision maker and (2) included in the reported measure of segment profit or loss. The
new standard also allows companies to disclose multiple measures of segment profit or loss if those measures are used to assess
performance and allocate resources. The guidance will first be effective in our annual disclosures for the year ending December
31, 2024, and will be adopted retrospectively unless impracticable. Early adoption is permitted. The Company is in the process
of assessing the impact of ASU 2023-07 on our disclosures.

 In December 2023, the
FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires disaggregated information about our effective
tax rate reconciliation as well as information on income taxes paid. The guidance will first be effective in our annual disclosures
for the year ending December 31, 2025, and should be applied on a prospective basis with the option to apply retrospectively. Early
adoption is permitted. The Company is in the process of assessing the impact of ASU 2023-09 on our disclosures.

 In March 2024, the
SEC adopted new rules relating to the disclosure of a range of climate-change-related physical and transition risks, data, and
opportunities. The adopted rule contains several new disclosure obligations, including, (i) disclosure on how the board of directors
and management oversee climate-related risks and certain climate-related governance items, (ii) disclosure of information related
to a registrant's climate-related targets, goals, and/or transition plans, and (iii) disclosure on whether and how climate-related
events and transition activities impact line items above a threshold amount on a registrant's consolidate financial statements,
including the impact of the financial estimates and the assumptions used. This new rule will first be effective in the Company's
disclosures for the year ending December 31, 2027. The Company is in the process of assessing the impact on our consolidated financial
statements and disclosures.

 NOTE 3 – INVENTORY

 The components of inventory
consisted of the following as of December 31, 2023:

 2023

 2022

 Raw Materials

 $

 3,611

 $

 —

 Work-in-process

 2,539

 —

 Finished Goods

 7,510

 —

 Inventory gross

 13,660

 $

 —

 Less: Inventory reserves

 ( 21

)

 —

 Total Inventory

 $

 13,639

 $

 —

 NOTE 4 – PROPERTY AND EQUIPMENT,
NET

 Property and equipment,
net consisted of the following (in thousands):

 2023

 2022

 Property and equipment, net:

 Land

 $

 8,011

 $

 8,011

 Land improvements

 Buildings

 66,749

 65,644

 Office furniture and equipment

 2,366

 1,893

 Laboratory equipment

 21,904

 18,440

 Leasehold improvements

 Construction in progress

 —

 1,366

 Property and equipment gross

 99,390

 95,467

 Less: Accumulated depreciation and amortization

 ( 5,362

)

 ( 1,653

)

 Property and equipment, net

 $

 94,028

 $

 93,814

 F- 16

 On
October 1, 2021, the Company completed the acquisition of its approximately 45,000 square foot research and development facility
in Frederick, Maryland totaling $ 17.5 million, to process development activities. Of the total purchase price, $ 2.1 million was
allocated to the value of land acquired, and $ 13.9 million was allocated to buildings, and approximately $ 1.5 million was allocated
to office furniture and equipment and laboratory equipment. As of August 1, 2022, the assets became ready for the intended use
and were placed in service.

 On
September 28, 2020, the Company completed the purchase of its approximately 45,000 square foot facility in Dartmouth, Massachusetts
for $ 4.0 million, to house its new Advanced Development Center for the development and manufacturing of vaccines. Of the total
purchase price, $ 1.2 million was allocated to the value of land acquired, and $ 2.8 million was allocated to buildings. Additionally,
the Company incurred approximately $ 38.8 million of costs during the year ended December 31, 2022, bringing total costs incurred-to-date
to $ 61.6 million, of which the majority related to the build-out of the facility. As of October 1, 2022, the assets became ready
for the intended use and were placed in service.

 On
December 23, 2020, the Company completed the purchase of its approximately 44 -acre site in Hamilton, Montana for $ 4.5 million,
for the construction of a vaccine development and commercial scale manufacturing facility. As of December 31, 2023, the asset
was not ready for its intended use.

the year ended December 31, 2023, property and equipment with a net book value of approximately $ 0.9 million were sold for net
proceeds of approximately $ 1.0 million.

 NOTE 5 – GOODWILL AND INTANGIBLE ASSETS

provides the gross carrying value of goodwill as follows:

 Amounts

 Balance at December 31, 2022

 $

 —

 Acquired during the period (see Note 12)

 Balance at December 31, 2023

 $

provides the gross carrying amount and accumulated amortization for each major class of intangible asset:

 2023

 2022

 Intangible assets subject to amortization

 Developed technology

 $

 10,100

 $

 —

 Less: Accumulated amortization

 —

 Total

 $

 9,623

 $

 —

 Intangible assets not subject to amortization

 Internet domain rights

 $

 $

 Total intangible assets, net

 $

 9,743

 $

 During the year ended December 31, 2023,
the Company recorded amortization of $ 477,000.

 At December 31, 2023,
the related amortization for each of the next five years ended December 31 is as follows (in thousands):

 Year Ending December 31,

 2024

 $

 2025

 2026

 2027

 2028 and beyond

 5,811

 Total

 $

 9,623

 F- 17

 NOTE 6 – FAIR VALUE MEASUREMENTS

 Fair value measurements
affect the Company's accounting for certain of its financial assets. Fair value is defined as the price that would be received
to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date
and is measured according to a hierarchy that includes:

 Level 1:

 Observable inputs, such as quoted prices in active markets.

 Level 2:

 Inputs, other than quoted prices in active markets, that are observable either directly or indirectly. Level 2 assets and liabilities include debt securities with quoted market prices that are traded less frequently than exchange-traded instruments. This category includes U.S. government agency-backed debt securities and corporate-debt securities.

 Level 3:

 Unobservable inputs in which there is little or no market data.

 As of December 31,
2023, and December 31, 2022, the Company used Level 1 quoted prices in active markets to value cash equivalents of $ 0.1 million
and $ 116.3 million, respectively. The Company did not have any Level 2 or Level 3 assets or liabilities as of December 31, 2022.
As of December 31, 2023, Level 3 liabilities include a portion of the Series D Warrants and all Series C Warrants issued on December
22, 2023, which did not meet the criteria for equity classification due to insufficient authorized shares to settle the instruments
and are therefore accounted for as liabilities at fair value.

 The Company estimates
the fair value of the Series D Warrants and the Series C Warrants using significant unobservable inputs, which represent Level
3 measurements within the fair value hierarchy. The Company estimated the fair value of these instruments using the Black-Scholes
option pricing model, which was then adjusted by applying a discount for lack of marketability ("DLOM") based on the
expected timing of receipt of stockholder approval to increase the number of authorized shares and to allow the Warrants to become
exercisable in accordance with Nasdaq Listing Rule 5635.

 The significant unobservable
inputs used in the valuation models at issuance and as of December 31, 2023, to measure the fair value of the Series D Warrants
and the Series C Warrants are as follows:

 Series C Warrants

 Series D Warrants

 Valuation Date:

 December 22, 2023

 December 31, 2023

 December 22, 2023

 December 31, 2023

 Common stock price

 $
 0.398

 $
 0.403

 $
 0.398

 $
 0.403

 Risk-free rate

 4.31
 %

 4.23
 %

 3.87
 %

 3.84
 %

 Expected term (in years)

 1.80

 1.78

 5.18

 5.15

 Expected volatility

 108.0
 %

 108.0
 %

 108.0
 %

 108.0
 %

 Dividend yield

 0.0
 %

 0.0
 %

 0.0
 %

 0.0
 %

 Discount for lack of marketability

 5.0
 %

 5.0
 %

 5.0
 %

 5.0
 %

 The liability-classified
Series D Warrants and the Series C Warrants were recognized at their aggregate issuance date fair values totaling $ 22.5 million.
From the date of issuance to December 31, 2023, the Company recognized a change in fair value resulting in a loss of $0.3 million
related to the liability-classified warrants. Changes in the fair value of the liability-classified warrants are recognized as
a component of other income, net in the consolidated statement of operations.

 F- 18

 NOTE 7 – OTHER BALANCE SHEET INFORMATION

 Components of selected
captions in the consolidated balance sheets consist of:

 2023

 2022

 Prepaid expenses and other:

 Contract-related

 $

 4,590

 $

 8,043

 Debt interest and fees

 1,513

 —

 Inventory

 —

 Insurance

 1,275

 Other

 2,427

 1,230

 $

 9,181

 $

 10,548

 Accrued expenses and other current liabilities:

 Contract-related

 $

 2,980

 $

 3,273

 Upsher Smith obligation

 3,000

 —

 Compensation and compensation-related

 4,361

 3,645

 Product returns

 —

 Construction in progress

 —

 2,103

 Professional fees and other

 1,398

 $

 12,482

 $

 9,680

 NOTE 8 – DEBT FINANCING

 Long-term debt consists of the following:

 2023

 Term Loan

 $
 11,000

 Less: current portion

 ( 2,350
)

 Total long-term debt

 8,650

 Less: unamortized debt discount and deferred financing costs

 ( 2,089
)

 Total long-term debt, net

 $
 6,561

 On
December 8, 2023, the Company entered into a Loan and Guaranty Agreement (the "Loan Agreement") by and among the Company,
Krele LLC, Tonix Pharmaceuticals, Inc., Jenner and Tonix R&D Center ("Loan Parties"), with JGB Capital, LP, JGB
Partners, LP, JGB (Cayman) Port Ellen Ltd., and any other lender from time to time party hereto (collectively, the "Lenders"),
and JGB Collateral LLC, as administrative agent and collateral agent for the Lenders (in such capacity, "JGB Agent")
for a 36 -month term loan (the "Term Loan") in the aggregate principal amount of $ 11.0 million, with a maturity date
of December 8, 2026 (the "Maturity Date"). The Term Loan was funded with an original issue discount of 9 % of the principal
amount of the Term Loan, or $ 1.0 million, which is being amortized over the term of the debt as an adjustment to the effective
interest rate on the outstanding borrowings.

 Borrowings under the
Term Loan bear interest at a fluctuating rate equal to the greater of (i) the prime rate as defined in the Loan Agreement plus
 3.5 % and (ii) 12 %. Interest is payable monthly in arrears commencing in December 2023. In connection with the Term Loan, the Company
deposited into a reserve account $ 1.8 million to be used exclusively to fund interest payments related to the Term Loan. The deposit
is reflected in Prepaid expenses and other current assets on the consolidated balance sheet.

 Commencing on March
8, 2024 and continuing monthly through the Maturity Date, the outstanding principal will be due and payable in monthly installments
of $ 0.2 million, with the final remaining balance of unpaid principal and interest due and payable on the Maturity Date. In addition,
the Company must pay a monthly collateral monitoring charge equal to 0.23 % of the outstanding principal amount of the term loan
as of the date of payment. The Company incurred $ 1.1 million in issuance costs, which is being amortized over the term of
the debt as an adjustment to the effective interest rate on the outstanding borrowings.

 The Loan Agreement
provides for voluntary prepayments of the Term Loan, in whole or in part, subject to a prepayment premium. The Loan Agreement contains
customary affirmative and negative covenants by the Company, which among other things, will require the Borrowers to provide certain
financial reports to the lenders, to maintain a deposit account to fund interest payments, and limit the ability of the Company
to incur or guarantee additional indebtedness, pay dividends or make other equity distributions, sell assets, engage in certain
transactions, and effect a consolidation or merger. The obligations of the Company under the Loan Agreement may be accelerated
upon customary events of default, including non-payment of principal, interest, fees and other amounts, covenant default, insolvency,
material judgements, inaccuracy of representations and warranties, invalidity of guarantees. The Term Loan is secured by first
priority security interests in the Company's R&D Center in Frederick, Maryland, the Advanced Development Center in North
Dartmouth, Massachusetts, and substantially all of the relevant deposit accounts.

 As of December 31,
2023, the carrying amount of the Term Loan approximated its fair value as the contractual interest rate for the Term Loan was representative
of the then market interest rate.

 F- 19

 Annual future principal
payments due on the Term Loan as of December 31, 2023 are as follows (in thousands):

 Fiscal years ending

 2024

 $

 2,350

 2025

 2,820

 2026

 5,830

 $

 11,000

 NOTE 9 – STOCKHOLDERS' EQUITY

 On
May 9, 2023, the Company filed a Certificate of Change with the Nevada Secretary of State, effective May 10, 2023. Pursuant to
the Certificate of Change, the Company effected a 1-for-6.25 reverse stock split of its issued and outstanding shares of common
stock, whereby 64,627,246 outstanding shares of the Company's common stock were exchanged for 10,340,506 shares of the Company's
common stock. In connection with the reverse stock split, the Company issued an additional 131,902 shares of the Company's
common stock due to fractional shares. Furthermore, pursuant to the Certificate of Change, the number of authorized shares of
common stock was reduced from 1,000,000,000 to 160,000,000. All per share amounts and number of shares in the consolidated financial
statements and related notes have been retroactively restated to reflect the reverse stock split.

 On
October 17, 2023, the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market LLC ("Nasdaq")
indicating that, based upon the closing bid price of the Company's common stock for the last 30 consecutive business days,
the Company no longer meets the requirement to maintain a minimum bid price of $ 1 per share, as set forth in Nasdaq Listing Rule
55450(a)(1) (the "Minimum Bid Price Requirement").

 The
Company was initially provided with a 180 calendar day period, or until April 15, 2024, in which to regain compliance. In the
event that the Company does not regain compliance within this 180 -day period, the Company may be eligible to seek an additional
 180 day compliance period if it meets the continued listing requirement for market value of publicly held shares and all other
initial listing standards for the Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and provides
written notice to Nasdaq of its intent to cure the deficiency during this second compliance period, by effecting a reverse stock
split, if necessary.

 On January 25, 2024,
the Company filed a Certificate of Amendment to its Articles of Incorporation, as amended, with the Secretary of State of the State
of Nevada to increase the number of authorized shares of the Company's common stock from 160,000,000 to 1,000,000,000 shares
(the "Charter Amendment"). The Charter Amendment was approved by the Company's shareholders at a special meeting
of shareholders held on January 25, 2024.

 NOTE 10 – TEMPORARY EQUITY

 On October 26, 2022,
the Company closed on an offering ("the October offering") with certain institutional investors (the "Investors"),
pursuant to which the Company issued and sold, in a private placement, 1,400,000 shares of the Company's Series A Convertible
Redeemable Preferred Stock, par value $ 0.001 per share (the "Series A Preferred Stock"), and 100,000 shares of the
Company's Series B Convertible Redeemable Preferred Stock, par value $ 0.001 per share (the "Series B Preferred Stock,"
and together with the Series A Preferred Stock, the "Preferred Stock"), at an offering price of $ 9.50 per share, representing
a 5 % original issue discount ("OID) to the stated value of $ 10.00 per share, for gross proceeds of $ 14.3 million in the aggregate
for the October offering, before the deduction of fees and offering expenses. The shares of Preferred Stock were convertible, at
a conversion price of $ 6.25 per share (subject in certain circumstances to adjustments), into shares of the Company's common
stock, at the option of the holders and, in certain circumstances, by the Company.

 On
December 13, 2022, an amendment (the "December Amendment") to the Company's Articles of Incorporation, as amended,
to increase the Company's authorized shares of common stock from 24,000,000 to 160,000,000, as adjusted for the reverse
split, was approved at a special meeting of shareholders. The Series A Preferred Stock had the right to vote on such December
Amendment on an as-converted to common stock basis. The shares of the Series B Preferred Stock were automatically voted in a manner
that "mirrored" the proportions on which the shares of common stock (excluding any shares of common stock that were
not voted) and Series A Preferred Stock were voted to increase the Authorized Shares. The December Amendment required the approval
of the majority of the votes associated with the Company's outstanding stock entitled to vote on the proposal. Because the
Series B Preferred Stock were automatically and without further action of the purchaser voted in a manner that "mirrored"
the proportions on which the shares of common stock (excluding any shares of common stock that were not voted) and Series A Preferred
Stock were voted on the December Amendment, abstentions by common stockholders did not have any effect on the votes cast by the
holders of the Series B Preferred Stock. The Certificates of Designation for the Preferred Stock provides that the Preferred Stock
have no voting rights other than the right to vote on the December Amendment and as a class on certain other specified matters,
and, with respect to the Series B Certificate of Designation, the right to cast 2,500 votes per share of Series B Preferred Stock
on the December Amendment.

 The
holders of Preferred Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any,
on shares of common stock. The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by
the Company, into shares of common stock at a conversion price of $ 6.25 per share. The holders of the Preferred Stock had the
right to require the Company to redeem their shares of preferred stock for cash at 105 % of the stated value of such shares through
January 23, 2023. The Company had the option to redeem the Preferred Stock for cash at 105 % of the stated value, subject to the
holders' rights to convert the shares prior to such redemption.

 The
 $ 14.3 million in gross proceeds of the October offering was held in an escrow account, along with an additional $ 1.5 million deposited
by the Company to cover the aggregate OID as well as the additional amount that would be necessary to fund the 105 % redemption
price until the expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment to
redeeming holders. Upon expiration of the redemption period, any proceeds remaining in the escrow account would be disbursed to
the Company.

 F- 20

 Since the Preferred
Stock had a redemption feature at the option of the holder, it was classified as temporary equity. The Series A Preferred Stock
and Series B Preferred Stock was recorded at redemption value of approximately $ 14.7 million and $1.1 million, respectively, as
calculated in the following table (in thousands):

 Series A

Preferred

Stock

 Series B

Preferred

Stock

 Gross Proceeds

 $

 13,300

 $

 Less:

 Preferred stock issuance costs

 ( 844

)

 ( 60

)

 Plus:

 Accretion of carrying value to redemption value

 2,244

 Preferred stock subject to possible redemption

 $

 14,700

 $

 1,050

 During December 2022,
the Company received redemption notices for all outstanding shares of Preferred Stock. The Preferred Stock was redeemed during
December 2022 at 105 % of the $ 10.00 stated value of the Preferred Stock, or $ 15.8 million in the aggregate.

 On June 24, 2022, the
Company closed on an offering ("the Offering") with certain institutional investors (the "Investors"),
pursuant to which the Company issued and sold, in a private placement, 2,500,000 shares of the Company's Series A Convertible
Redeemable Preferred Stock, par value $ 0.001 per share (the "Series A Preferred Stock"), and 500,000 shares of the
Company's Series B Convertible Redeemable Preferred Stock, par value $ 0.001 per share (the "Series B Preferred Stock,"
and together with the Series A Preferred Stock, the "Preferred Stock"), at an offering price of $ 9.50 per share, representing
a 5 % OID to the stated value of $ 10.00 per share, for gross proceeds of $ 28.5 million in the aggregate for the Offering, before
the deduction of fees and offering expenses. The shares of Preferred Stock were convertible, at a conversion price of $ 25.00 per
share (subject in certain circumstances to adjustments), into shares of the Company's common stock, at the option of the
holders and, in certain circumstances, by the Company.

 On
August 5, 2022, an amendment (the "Amendment") to the Company's Articles of Incorporation, as amended, to increase
the Company's authorized shares of common stock from 8,000,000 to 24,000,000, as adjusted for the reverse split, was approved
at a special meeting of shareholders. The Series A Preferred Stock had the right to vote on such Amendment on an as-converted to
common stock basis. The shares of the Series B Preferred Stock were automatically voted in a manner that "mirrored"
the proportions on which the shares of common stock (excluding any shares of common stock that were not voted) and Series A Preferred
Stock were voted to increase the Authorized Shares. The Amendment required the approval of the majority of the votes associated
with the Company's outstanding stock entitled to vote on the proposal. Because the Series B Preferred Stock were automatically
and without further action of the purchaser voted in a manner that "mirrored" the proportions on which the shares of
common stock (excluding any shares of common stock that were not voted) and Series A Preferred Stock were voted on the Amendment,
abstentions by common stockholders did not have any effect on the votes cast by the holders of the Series B Preferred Stock. The
Certificates of Designation for the Preferred Stock provides that the Preferred Stock have no voting rights other than the right
to vote on the Amendment and as a class on certain other specified matters, and, with respect to the Series B Certificate of Designation,
 the right to cast 2,500 votes per share of Series B Preferred Stock on the Amendment.

 The holders of Preferred
Stock were entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of common stock.
The Preferred Stock was convertible, at the option of the holders and, in certain circumstances, by the Company, into shares of
common stock at a conversion price of $ 25.00 per share. The holders of the Preferred Stock had the right to require the Company
to redeem their shares of preferred stock for cash at 105 % of the stated value of such shares through September 22, 2022. The Company
had the option to redeem the Preferred Stock for cash at 105 % of the stated value, subject to the holders' rights to convert
the shares prior to such redemption.

 The
 $ 28.5 million in gross proceeds of the Offering was held in an escrow account, along with an additional $ 3.0 million deposited
by the Company to cover the aggregate OID as well as the additional amount that would be necessary to fund the 105 % redemption
price until the expiration of the redemption period for the Preferred Stock, as applicable, subject to the earlier payment to
redeeming holders. Upon expiration of the redemption period, any proceeds remaining in the escrow account would be disbursed to
the Company.

 Since the Preferred
Stock had a redemption feature at the option of the holder, it was classified as temporary equity. The Series A Preferred Stock
and Series B Preferred Stock was recorded at redemption value of approximately $26.3 million and $5.2 million, respectively, as
calculated in the following table (in thousands):

 Series A

Preferred

Stock

 Series B

Preferred

Stock

 Gross Proceeds

 $

 23,750

 $

 4,750

 Less:

 Preferred stock issuance costs

 ( 1,046

)

 ( 209

)

 Plus:

 Accretion of carrying value to redemption value

 3,546

 Preferred stock subject to possible redemption

 $

 26,250

 $

 5,250

 During August 2022,
the Company received redemption notices for all outstanding shares of Preferred Stock. The Preferred Stock was redeemed during
August 2022 at 105 % of the $ 10.00 stated value of the Preferred Stock, or $ 31.5 million in the aggregate.

 F- 21

 NOTE 11 – REVENUES

 Disaggregation of Net Revenues

 The Company's net product revenues
are summarized below:

 2023

 2022

 Zembrace Symtouch

 $

 6,304

 $

 —

 Tosymra

 1,464

 —

 Total product revenues

 $

 7,768

 $

 —

 All sales are generated
in the United States.

 Gross-to-Net Sales Accruals

 We record gross-to-net
sales accruals for chargebacks, rebates, sales and other discounts, and product returns, which are all customary to the pharmaceutical
industry.

 Our provision for gross-to-net allowances
was $ 2.9 million at December 31, 2023, $ 0.6 million of which was recorded as a reduction to accounts receivable and $ 2.3 million
recorded as a component of accrued expenses.

 NOTE 12 – ASSET PURCHASE AGREEMENT WITH UPSHER-SMITH

 On June 30, 2023, the Company completed
the acquisition of certain assets from Upsher Smith related to Zembrace SymTouch (sumatriptan injection) 3 mg ("Zembrace")
and Tosymra (sumatriptan nasal spray) 10 mg ("Tosymra") products (such businesses collectively, the "Business")
and certain inventory related to the Business for an aggregate purchase price of approximately $ 26.5 million, including certain deferred
payments and subject to customary adjustments (such transaction, the "USL Acquisition").

 On June 30, 2023, in connection with the USL Acquisition, the Company and
Upsher Smith entered into a Transition Services Agreement (the "Transition Services Agreement"), pursuant to which Upsher Smith will provide
certain transition services to the Company for base fees equal to $ 100,000 per month for the first six months, and $ 150,000 per months
for the seventh through ninth months, plus additional monthly fees for each service category totaling up to $ 150,000 per month. The Company
has amended the transitional services agreement with Upsher Smith so that Upsher Smith can continue to provide administrative services.

 The
Company has assumed certain obligations of Seller, including the payment of quarterly earn-out payments on annual net sales from
the Business in the U.S. as follows: for Tosymra, 4 % for net sales of $ 0 to $ 30 million, 7 % of net sales of $ 30 to $ 75 million;
 9 % for net sales of $ 75 to $ 100 million; 12 % for net sales of $ 100 to $ 150 million; and 15 % for net sales greater than $ 150 million.
Earn-out payments with respect to Tosymra are payable until the expiration or termination of the product's Orange Book listed
patent(s) with respect to the United States or, outside the United States, the expiration of the last valid claim covering the
product in the relevant country of the territory. For Zembrace, earn-out payments on annual net sales in the U.S. are 3 % for net
sales of $ 0 to $ 30 million, 6 % of net sales of $ 30 to $ 75 million; 12 % for net sales of $ 75 to $ 100 million; 16 % for net sales
of greater than $ 100 million. Such earn-out payments are payable until July 19, 2025. Upon the entry of a generic version of the
relevant product, the applicable earn-out rates shall be reduced by 90 % percent with respect to Zembrace, and by 66.7 % percent
for Tosymra. Prior to Purchaser or a licensee filing an application for marketing authorization for either of the products in
a permitted country outside the U.S., the parties will negotiate in good faith the earn-out payment rates annual net sales tiers
that will apply for such country, based on the market opportunity for the product in such country. If the parties fail to agree,
then the earn-out payment rates and annual net sales tiers described above will apply.

 In
addition, the Company has assumed the obligation to pay an additional 3 % royalty on net sales of Tosymra, plus an additional 3 %
if a patent containing certain claims related to Tosymra issues in the U.S., for 15 years from the first commercial sale of Tosymra
in the applicable country or for as long as the manufacture, use or sale of Tosymra in such country is covered by a valid claim
of a licensed patent, and up to $ 15 million per Tosymra product on the achievement of sales milestones.

 As consideration for
acquisition of the Business and certain product-related inventories, the Company paid approximately $ 23.5 million in cash upfront.
On the earlier of March 2024 and the completion of the transition services to be provided by Upsher Smith, as described above, the Company
agreed to pay an additional deferred payment of $ 3.0 million in cash, which is included in Accrued expenses and other current liabilities
on the accompanying balance sheet. The following table summarizes the components of the purchase consideration (in thousands):

 Purchase consideration

 Amount

 Closing cash consideration

 $

 22,174

 Inventory adjustment payment liability

 1,348

 Deferred payment liability

 3,000

 Purchase price to be allocated

 $

 26,522

 The USL Acquisition
was accounted for as a business combination using the acquisition method, in accordance with the provisions of ASC 805, Business
Combinations and ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. The tangible
and intangible assets acquired were recorded at their estimated fair values on the acquisition date, and the difference between
the fair value of these assets and the purchase price has been recorded as goodwill. The purchase price allocation is based upon
preliminary valuations and estimates and assumptions which are subject to change. As the Company receives additional information
about facts and circumstances that existed at the acquisition date, the fair values of the acquired inventory and intangible assets
may be adjusted, with the offset recorded to goodwill.

represents the allocation of the purchase price to the assets acquired by the Company in the USL Acquisition recognized in the
Company's consolidated balance sheets (in thousands):

 F- 22

 Preliminary purchase price allocation

 Amount

 Inventory

 $

 13,700

 Prepaid expenses and other

 1,757

 Intangible assets, net

 10,100

 Goodwill

 Fair value of assets acquired

 $

 26,522

 The acquired inventory
consists of Upsher Smith's raw materials, semi-finished goods, and finished goods inventory as of the Closing date. The fair value
was determined based on the estimated selling price of the inventory, less the estimated total costs to complete, disposal effort
and holding costs.

 The
$ 1.0 million of goodwill arising from the USL Acquisition represents expected synergies from combining operations, intangible
assets that do not qualify for separate recognition, and other factors, of which all is expected to be deductible for tax purposes,
subject to any limitations.

 Intangible assets eligible
for recognition separate from goodwill were those that satisfied either the contractual or legal criterion or the separability
criterion in the accounting guidance. The identifiable intangible assets acquired and their estimated useful lives for amortization
are as follows (in thousands):

 Fair Value

 Useful Life
 (years)

 Developed technology - Tosymra

 $

 3,400

 Developed technology - Zembrace

 6,700

 Total

 $

 10,100

 The developed technology
intangible assets related to Zembrace and Tosymra includes the value associated with the acquired patents, customer relationships,
and trademarks and trade names associated with the technology. The developed technology intangible assets were valued as composite
assets under the premise that each asset is reliant on one another to generate cash flow, is not considered separable from the
technology, and are assumed to have similar useful lives. The composite intangible assets were valued using a multi-period excess
earnings method and are being amortized over their estimated useful lives using the straight-line method of amortization. The key
assumptions used in estimating the fair values of intangible assets include forecasted financial information, the weighted average
cost of capital, customer retention rates, and certain other assumptions.

 The fair values assigned
to the assets acquired are based on reasonable assumptions and estimates that market participants would use. Actual results may
differ from these estimates and assumptions.

 Supplemental Pro Forma Information

 The
following unaudited pro forma consolidated financial information reflects the results of operations of the Company for the year
ended December 31, 2023 and 2022 as if the USL Acquisition had occurred as of January 1, 2022 and gives effect to
transactions that are directly attributable to the acquisition. These amounts are based on financial information of the acquired
business and are not necessarily indicative of what the Company's operating results would have been had the acquisition taken
place on the date presented, nor is it indicative of the Company's future operating results. The net loss of USL acquisition
is included in the Company's consolidated results since the date of acquisition. The revenue and net loss of the USL
Acquisition business reflected in the consolidated statements the year ended December 31, 2023 would have been $ 7.6
million and $ 2.4
million, respectively.

 December 31

 December 31

 2023

 2022

 Net Product Sales

 $
 15,389

 $
 11,591

 Net Loss

 $
 ( 119,905
)

 $
 ( 130,342
)

 The pro forma information
for all periods presented include additional amortization expense related to the fair value of the acquired intangible assets as
if such assets were acquired on January 1, 2022. The pro forma financial information for the year ended December 31, 2022 also
reflects an increase in Cost of Sales related to the preliminary acquisition-date fair value adjustment to inventory.

 As described above,
in connection with the USL Acquisition, the Company and Upsher Smith entered into a Transition Services Agreement with the Seller related
to providing ongoing services associated with the assets acquired, such as procuring and selling migraine therapy products, providing
accounting and billing services and collecting accounts receivable and paying trade payables. The Seller collected and will continue
to collect cash on behalf of Tonix for revenue generated by sales of the assets acquired from June 30, 2023 through the transition
period and the Seller is obligated to transfer cash generated by such sales to the Buyer.

 The amount due to Upsher Smith
for reimbursement of services performed under the transition services agreement was $ 0.5 million as of December 31, 2023. The transition
service fees were netted against the receivables collected of $ 5.1 million and liabilities paid of $ 4.4 million, including gross-to-net
on behalf of the Company with the net amount due to the Company of $ 0.2 million recorded within prepaid expenses and other on the consolidated
balance sheet as of December 31, 2023.

 NOTE 13 – ASSET PURCHASE AGREEMENT WITH HEALION

 On February 2, 2023,
the Company entered into an asset purchase agreement (the "Healion Asset Purchase Agreement") with Healion Bio Inc.,
("Healion") pursuant to which the Company acquired all the pre-clinical infectious disease assets of Healion, including
its portfolio of next-generation antiviral technology assets. Healion's drug portfolio includes a class of broad-spectrum
small molecule oral antiviral drug candidates with a novel host-directed mechanism of action, including TNX-3900, formerly known
as HB-121. As consideration for entering into the Healion Asset Purchase Agreement, the Company paid $ 1.2 million to Healion. Because
the Healion intellectual property was acquired prior to U.S. Food and Drug Administration (FDA) approval, the cash consideration
totaling $ 1.2 million, was expensed as research and development costs since there is no alternative future use and the acquired
intellectual property does not constitute a business.

 F- 23

 NOTE 14 – LICENSE AGREEMENT WITH CURIA

 On December 12, 2022,
the Company entered into an exclusive license agreement with Curia for the development of three humanized murine mAbs for the treatment
or prophylaxis of SARS-CoV-2 infection. We believe that the licensing of these mAbs strengthens our pipeline of next-generation
therapeutics to treat COVID-19, which is caused by SARS-CoV-2. As consideration for entering into the License Agreement, we paid
a license fee of approximately $ 0.4 million to Curia. The License Agreement also provides for single-digit royalties and contingent
milestone payments. As of December 31, 2023, other than the upfront fee, no payments have been accrued or paid in relation to this
agreement.

 NOTE 15 – LICENSE AGREEMENT WITH
UNIVERSITY OF ALBERTA

 On May 18, 2022, the
Company entered into an exclusive License Agreement with the University of Alberta focused on identifying and testing broad-spectrum
antiviral drugs against future variants of SARS-CoV-2 and other emerging viruses. As consideration for entering into the License
Agreement, Tonix paid a low-five digit license fee to University of Alberta. The License Agreement also provides for single-digit
royalties and contingent milestone payments. As of December 31, 2023, other than the upfront fee, no milestone payments have been
accrued or paid in relation to this agreement.

 NOTE 16 – LICENSE AGREEMENTS WITH COLUMBIA UNIVERSITY

 On February 13, 2023,
Tonix exercised an option to obtain an exclusive license from Columbia University ("Columbia) for the development of a portfolio
of both fully human and murine mAbs for the treatment or prophylaxis of SARS-CoV-2 infection, including our TNX-3600 and TNX-4100
product candidates, respectively. The licensed mAbs were developed as part of a research collaboration and option agreement between
Tonix and Columbia. As of December 31, 2023, other than the upfront fee, no payments have been accrued or paid in relation to this
agreement.

 NOTE 17 – SALE OF COMMON STOCK

 December 2023 Financing

 On
December 20, 2023, the Company entered into a securities purchase agreement (the "Purchase Agreement") with certain
institutional investors, pursuant to which the Company sold and issued (i) 25,343,242 shares of the Company's common stock,
(ii) pre-funded warrants (the "Pre-Funded Warrants") to purchase up to 28,710,812 shares of common stock and (iii)
Series C warrants to purchase up to 81,081,081 shares of common stock (the "Series C Warrants"), and (iv) Series D
warrants to purchase up to 81,081,081 shares of common stock (the "Series D Warrants" and, together with the Series
C Warrants, the "Common Warrants"). The securities sold in the offering were sold in fixed combinations as units.
The offering price per share of common stock and accompanying Common Warrants was $ 0.555, and the offering price per Pre-Funded
Warrant and accompanying Common Warrants was $ 0.5549. The offering closed on December 22, 2023, generating gross proceeds of approximately
$ 30.0 million, before deducting offering expenses of $ 2.3 million payable by the Company. At the closing of the offering, 6,509,010
Pre-Funded Warrants were immediately exercised into shares of common stock for nominal proceeds.

 The
Pre-Funded Warrants have an exercise price of $ 0.0001
per share, are immediately exercisable subject to certain ownership limitations, and can be exercised at any time until exercised in
full. The Series C Warrants have an exercise price of $ 0.555
per share, and are exercisable on the later of approval by the Company's stockholders of (i) a proposal to approve the filing
of an amendment to the Company's Articles of Incorporation, increasing the number of authorized shares of common stock from 160,000,000
to 1,000,000,000
and (ii) a proposal to allow the Warrants to become exercisable in accordance with Nasdaq Listing Rule 5635 (the later of such
events, the "Approval Date") and will expire on the later of (a) 10
trading days following the Approval Date and (b) the earlier of (x) the two
year anniversary of the Approval Date and (y) 10
trading days following the public announcement of the U.S. Food and Drug Administration's ("FDA") acknowledgement and
acceptance of the New Drug Application ("NDA") relating to the Company's TNX-102 SL product candidate in patients with fibromyalgia. The Series D
Warrants have an exercise price of $ 0.85
per share and are exercisable beginning on the Approval Date through the five-year
anniversary of the Approval Date.

 Upon
the closing of the offering, the Company determined that certain of the Common Warrants did not meet the criteria for equity classification
due to the lack of sufficient authorized and unissued shares to settle the instruments. The Company has adopted a sequencing approach
under ASC 815-40, Derivatives and Hedging - Contracts in Entity's Own Equity to determine the classification of its contracts
at issuance and at each subsequent reporting date, whereby shares are allocated based on the earliest issuance date of potentially
dilutive instruments, with the earliest issuance date receiving the first allocation of shares. In the event of identical issuance
dates, shares are then allocated beginning with instruments with the latest maturity date first. Pursuant to this sequencing approach,
the Company's authorized and unissued shares were applied to the Pre-Funded Warrants and the Common Warrants in the following
order: (i) the Pre-Funded Warrants, (ii) the Series D Warrants, and (iii) the Series C Warrants. Based on this analysis, the Company
determined that the authorized shares are sufficient to settle the remaining Pre-Funded Warrants and 50,933,271 Series D Warrants
and were therefore classified in equity. The remaining 30,147,810 Series D Warrants and the Series C Warrants associated with
the deficit shares were classified as liabilities and are accounted for at fair value.

 The
$ 30.0 million in gross proceeds received by the Company were first allocated to the Series C Warrants and the liability-classified
Series D Warrants at their respective fair values of approximately $ 14.4 million and $ 8.1 million, respectively. The residual
proceeds of approximately $ 7.5 million were allocated to the shares of common stock, the Pre-Funded Warrants, and the equity-classified
Series D Warrants on a relative fair value basis. The issuance costs totaling $ 2.3 million were allocated between the equity and
liability-classified instruments on a relative fair value basis. Issuance costs of $ 1.4 million allocated to the shares, the Pre-Funded
Warrants, and the equity-classified Series D Warrants were recognized as a discount to the proceeds allocated to the equity-classified
instruments. Issuance costs of $ 0.9 million were allocated to the liability-classified Series D Warrants and the Series C Warrants
and expensed within Selling, general and administrative expense on the consolidated statements of operations.

 F- 24

 The liability-classified
Series D Warrants and all of the Series C Warrants are presented within non-current liabilities on the consolidated balance sheets
as of December 31, 2023, and will be adjusted to fair value at each subsequent balance sheet date until the warrants are reclassified
to equity or settled. Changes in the fair value of the liability-classified warrants are recognized as a component of other income,
net in the consolidated statement of operations.

 On January 25, 2024,
the Company's stockholders approved the proposal to file an amendment to the Company's Articles of Incorporation to
increase the number of authorized shares of common stock from 160,000,000 to 1,000,000,000.

 September 2023 Financing

 On
September 28, 2023, the Company sold 4,050,000 shares of common stock; pre-funded warrants to purchase up to 4,950,000 shares
of common stock, and accompanying Series A warrants to purchase up to 9,000,000 shares of common stock with an exercise price
of $ 0.50 per share and expiring five years from date of issuance, and Series B warrants to purchase up to 9,000,000 shares of
common stock with an exercise price of $ 0.50 per share and expiring one year from date of issuance in a public offering, which
closed on October 3, 2023. The offering price per share of common stock and accompanying warrants was $ 0.50, and the offering
price per share of pre-funded warrant and accompanying warrants was $ 0.4999.

 The
Company incurred offering expenses of approximately $ 0.5 million, including placement agent fees of approximately $ 0.3 million.
The Company received net proceeds of approximately $ 4.0 million, after deducting the underwriting discount and other offering
expenses.

 July 2023 Financing

 On
July 27, 2023, the Company sold 2,530,000 shares of common stock; pre-funded warrants to purchase up to 4,470,000 shares of common
stock and accompanying common warrants to purchase up to 7,000,000 shares of common stock with an exercise price of $ 1.00 per
share in a public offering that closed on August 1, 2023. The offering price per share of common stock and accompanying common
warrant was $ 1.00, and the offering price per share of pre-funded warrant and accompanying common warrant was $ 0.9999.

 The
Company incurred offering expenses of approximately $ 0.7 million, including placement agent fees of approximately $ 0.5 million.
The Company received net proceeds of approximately $ 6.3 million, after deducting the underwriting discount and other offering
expenses.

 2022 Lincoln Park Transaction

 On
August 16, 2022, the Company entered into an equity line of credit with Lincoln Park Capital Fund, LLC ("Lincoln Park"),
pursuant to which Lincoln Park agreed to purchase up to $ 50,000,000 of the Company's common stock (subject to certain limitations)
from time to time. The Company filed with the SEC a registration statement to register for resale under the Securities Act the
shares that have been or may be issued to Lincoln Park under the 2022 Purchase Agreement. The Company issued 100,000 shares of
common stock to Lincoln Park as consideration for its commitment to purchase shares of the Company's common stock. The commitment
shares were valued at $ 1,000,000 and recorded as an addition to equity for the issuance of the common stock and treated as a reduction
to equity as a cost of capital to be raised under the equity line of credit.

 During the year ended
December 31, 2023, the Company sold 0.1 million shares of common stock under the equity line of credit with Lincoln Park, for net
proceeds of approximately $ 0.4 million. During the year ended December 31, 2022, the Company sold 0.2 million shares of common
stock under the equity line of credit with Lincoln Park, for net proceeds of approximately $ 0.5 million.

 Purchase Agreement with Lincoln Park

 On
December 3, 2021, the Company entered into a purchase agreement (the "Purchase Agreement with Lincoln Park") and a
registration rights agreement (the "Lincoln Park Registration Rights Agreement") with Lincoln Park Capital Fund, LLC
("Lincoln Park"). Pursuant to the terms of the Purchase Agreement with Lincoln Park, Lincoln Park agreed to purchase
from the Company up to $ 80,000,000 of the Company's common stock (subject to certain limitations) from time to time during
the term of the Purchase Agreement with Lincoln Park. Pursuant to the terms of the Lincoln Park Registration Rights Agreement,
the Company filed with the SEC a registration statement to register for resale under the Securities Act the shares that have been
or may be issued to Lincoln Park under the Purchase Agreement with Lincoln Park.

 Pursuant
to the terms of the Purchase Agreement with Lincoln Park, at the time the Company signed the Purchase Agreement with Lincoln Park
and the Lincoln Park Registration Rights Agreement, the Company issued 14,546 shares of common stock to Lincoln Park as consideration
for its commitment to purchase shares of our common stock under the Purchase Agreement with Lincoln Park. The commitment shares
were valued at $ 1.6 million and recorded as an addition to equity for the issuance of the common stock and treated as a reduction
to equity as a cost of capital to be raised under the Purchase Agreement with Lincoln Park.

the year ended December 31, 2022, the Company sold 0.5 million shares of common stock under the Purchase Agreement with Lincoln
Park, for net proceeds of approximately $ 8.7 million. No sales occurred in 2023.

 Under applicable rules
of the NASDAQ Global Market, the Company could not issue or sell more than 19.99 % of the shares of its common stock outstanding
immediately prior to the execution of the Purchase Agreement with Lincoln Park (approximately 0.5 million shares) to Lincoln Park
under the Purchase Agreement with Lincoln Park without stockholder approval, unless the average price of all applicable sales of
its common stock to Lincoln Park under the Purchase Agreement with Lincoln Park equals or exceeds a threshold amount. As the Company
has issued approximately 0.5 million shares to Lincoln Park, by December 31, 2022, under the Purchase Agreement with Lincoln Park
at less than the threshold amount, the Company will not sell any additional shares under the Purchase Agreement with Lincoln Park
without shareholder approval.

 F- 25

 At-the-Market Offerings

 On
April 8, 2020, the Company entered into a sales agreement with AGP pursuant to which the Company may issue and sell shares of
its common stock having an aggregate offering price of up to $ 320.0 million in at-the-market offerings ("ATM") sales
at prevailing market prices at the time of the sale, and, as a result, prices will vary. AGP receives a 3 % commission on each
ATM sale under the Sales Agreement.

the year ended December 31, 2023, the Company sold approximately 1.0 million shares of common stock under the Sales Agreement,
for net proceeds of approximately $ 3.0 million. During the year ended December 31, 2022, the Company sold approximately 9.1 million
shares of common stock under the Sales Agreement, for net proceeds of approximately $ 85.3 million.

 Stock Repurchases

the first quarter of 2023, the Company has repurchased 2,512,044 of its shares of common stock outstanding under the 2022 share
repurchase program for up to $ 12.5 million at prices ranging from $ 2.75 to $ 8.61 per share for a gross aggregate cost of approximately
$ 12.5 million. In addition, the Company incurred expenses of $ 0.3 million.

 In
January 2023, the Board of Directors approved a new 2023 share repurchase program pursuant to which the Company may repurchase up
to an additional $ 12.5 million in value of its outstanding common stock from time to time on the open market and in privately
negotiated transactions subject to market conditions, share price and other factors. During the first quarter of 2023, the
Company has repurchased 160,000 of our shares of common stock outstanding under the new 2023 share repurchase program at $ 7.12
per share for a gross aggregate cost of $ 1.1 million. No additional repurchases have occurred since the first quarter of 2023.

 The timing and amount
of any shares repurchased will be determined based on the Company's evaluation of market conditions and other factors
and the New Share Repurchase Program may be discontinued or suspended at any time. Repurchases will be made
in accordance with the rules and regulations promulgated by the Securities and Exchange Commission and certain other legal requirements
to which the Company may be subject. Repurchases may be made, in part, under a Rule 10b5-1 plan, which allows stock repurchases when
the Company might otherwise be precluded from doing so.

 NOTE 18 – STOCK-BASED COMPENSATION

 On May 1, 2020, the
Company's stockholders approved the Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive Plan ("Amended
and Restated 2020 Plan").

 Under the terms of
the Amended and Restated 2020 Plan, the Company may issue (1) stock options (incentive and nonstatutory), (2) restricted stock,
(3) stock appreciation rights ("SARs"), (4) RSUs, (5) other stock-based awards, and (6) cash-based awards. The Amended
and Restated 2020 Plan initially provided for the issuance of up to 50,000 shares of common stock, which amount will be increased
to the extent that awards granted under the Plans are forfeited, expire or are settled for cash (except as otherwise provided in
the Amended and Restated 2020 Plan). In addition, the Amended and Restated 2020 Plan contains an "evergreen provision"
providing for an annual increase in the number of shares of our common stock available for issuance under the Amended and Restated
2020 Plan on January 1 of each year for a period of ten years, commencing on January 1, 2021 and ending on (and including) January
1, 2030, in an amount equal to the difference between (x) twenty percent ( 20 %) of the total number of shares of common stock outstanding
on December 31st of the preceding calendar year, and (y) the total number of shares of common stock reserved under the Amended
and Restated 2020 Plan on December 31 st of such preceding calendar year (including shares subject to outstanding awards,
issued pursuant to awards or available for future awards). The Board of Directors determines the exercise price, vesting and expiration
period of the grants under the Amended and Restated 2020 Plan. However, the exercise price of an incentive stock option may not
be less than 110 % of fair value of the common stock at the date of the grant for a 10% or more shareholder and 100 % of fair value
for a grantee who is not a 10% shareholder. The fair value of the common stock is determined based on quoted market price or in
absence of such quoted market price, by the Board of Directors in good faith. Additionally, the expiration period of grants under
the Amended and Restated 2020 Plan may not be more than ten years. As of December 31, 2023, 1,071,599 options were available for
future grants under the Amended and Restated 2020 Plan.

 General

 A summary of the stock
option activity and related information for the Plans for the year ended December 31, 2023 is as follows:

 Shares

 Weighted-

Average

Exercise Price

 Weighted-Average Remaining Contractual Term

 Aggregate Intrinsic Value

 Outstanding at December 31, 2021

 101,754

 $

 487.63

 8.83

 $

 —

 Grants

 298,657

 $

 67.46

 —

 —

 Exercised

 —

 —

 Forfeitures or expirations

 ( 7,768

)

 8,238.07

 Outstanding at December 31, 2022

 392,643

 $

 334.08

 8.70

 $

 —

 Grants

 1,019,130

 $

 4.64

 —

 $

 —

 Exercised

 —

 —

 Forfeitures or expirations

 ( 36,234

)

 $

 345.92

 Outstanding at December 31, 2023

 1,375,539

 $

 89.62

 8.75

 $

 —

 Exercisable at December 31, 2023

 259,991

 $

 381.80

 7.51

 $

 —

 F- 26

 The
weighted average fair value of options granted during the year ended December 31, 2023, and December 31, 2022 was $ 3.99 per share
and $ 32.81, respectively.

 The Company measures
the fair value of stock options on the date of grant, based on the Black Scholes option pricing model using certain assumptions
discussed below, and the closing market price of the Company's common stock on the date of the grant. The fair value of the
award is measured on the grant date. One-third of most stock options granted pursuant to the Plans vest 12 months from the date
of grant and 1/36th each month thereafter for 24 months and expire ten years from the date of grant. In addition, the Company issues
options to directors which vest over a one-year period. The Company also issues premium options to executive officers which have
an exercise price greater than the grant date fair value and has issued performance-based options which vest when target parameters
are met or probable of being met, subject in each case to a one-year minimum service period prior to vesting. Stock-based compensation
expense related to awards is amortized over the applicable service period using the straight-line method.

 The assumptions used
in the valuation of stock options granted during the year ended December 31, 2023 and 2022 were as follows:

 December 31, 2023

 December 31, 2022

 Risk-free interest rate

 3.42 % to 4.35

 %

 1.67 % to 3.05

 %

 Expected term of option

 5.0 to 10 years

 5.5 to 10 years

 Expected stock price volatility

 122.19 % - 142.72

 %

 120.32 % - 133.22

 %

 Expected dividend yield

 0.0

 0.0

 The risk-free interest
rate is based on the yield of Daily U.S. Treasury Yield Curve Rates with terms equal to the expected term of the options as of
the grant date. The expected term of options is determined using the simplified method, as provided in an SEC Staff Accounting
Bulletin, and the expected stock price volatility is based on the Company' historical stock price volatility.

expense relating to options granted of $ 9.3 million, of which $ 6.4 million and $ 2.9 million, related to General and Administration
and Research and Development, respectively was recognized for the year ended December 31, 2023. Stock-based compensation expense
relating to options granted of $ 10.9 million, of which $ 7.9 million and $ 3.0 million, related to General and Administration and
Research and Development, respectively was recognized for the year ended December 31, 2022.

 As of December 31,
2023, the Company had approximately $ 6.1 million of total unrecognized compensation cost related to non-vested awards granted under
the Plans, which the Company expects to recognize over a weighted average period of 1.70 years.

 Employee Stock Purchase Plans

 On May 6, 2022, the
Company's stockholders approved the Tonix Pharmaceuticals Holdings Corp. 2022 Employee Stock Purchase Plan. (the "2022
ESPP"), which was replaced by the Tonix Pharmaceuticals Holdings Corp. 2023 Employee Stock Purchase Plan (the "2023
ESPP", and together with the 2022 ESPP, the "ESPP Plans"), which was approved by the Company's stockholders on
May 5, 2023.

 The 2023 ESPP allows
eligible employees to purchase up to an aggregate of 800,000 shares of the Company's common stock. Under the 2023
ESPP, on the first day of each offering period, each eligible employee for that offering period has the option to enroll for that
offering period, which allows the eligible employees to purchase shares of the Company's common stock at the end of the offering
period. Each offering period under the 2023 ESPP is for six months, which can be modified from time-to-time. Subject to limitations,
each participant will be permitted to purchase a number of shares determined by dividing the employee's accumulated
payroll deductions for the offering period by the applicable purchase price, which is equal to 85 percent of the fair
market value of our common stock at the beginning or end of each offering period, whichever is less. A participant must designate
in his or her enrollment package the percentage (if any) of compensation to be deducted during that offering period for the purchase
of stock under the 2023 ESPP, subject to the statutory limit under the Code. As of December 31, 2023, 800,000 shares were available
for future sales under the 2023 ESPP.

 The
ESPP Plans are considered compensatory plans with the related compensation cost expensed over the six-month offering period. For
the year ended December 31, 2023 and 2022, $ 34,000 and $ 46,000, respectively, was expensed. In January 2022, 646 shares that were
purchased as of December 31, 2021, under the 2020 ESPP, were issued. Accordingly, during the first quarter of 2022, approximately
$ 40,000 of employee payroll deductions accumulated at December 31, 2021, related to acquiring such shares, was transferred from
accrued expenses to additional paid in capital. The remaining $ 30,000 was returned to the employees. In January 2023, 14,999 shares
that were purchased as of December 31, 2022, under the 2022 ESPP, were issued. Accordingly, during the first quarter of 2023,
approximately $ 29,000 of employee payroll deductions accumulated at December 31, 2022, related to acquiring such shares, was transferred
from accrued expenses to additional paid in capital. The remaining $ 14,000 was returned to the employees. As of December 31, 2023,
approximately $ 44,000 of employee payroll deductions have accumulated and have been recorded in accrued expenses. In January
2024, 66,359 shares that were purchased as of December 31, 2023, under the 2022 ESPP, were issued. Accordingly, during the first
quarter of 2024, approximately $ 24,000 of employee payroll deductions accumulated at December 31, 2023, related to acquiring such
shares, was transferred from accrued expenses to additional paid in capital. The remaining $ 20,000 was returned to the employees.

 F- 27

 NOTE 19 – STOCK WARRANTS

summarizes information with respect to outstanding warrants to purchase common stock of the Company at December 31, 2023:

 Exercise

 Number

 Price

 Outstanding

 Date

 $

 0.0001

 22,201,802

 N/A

 $

 0.555

 81,081,081

 December 2025

 $

 0.85

 81,081,081

 December 2028

 $

 0.50

 18,000,000

 August 2028

 $

 1.00

 7,000,000

 August 2028

 $

 November 2024

 $

 114.00

 February 2025

 209,364,707

 In connection with
the July 2023 Financing, the Company issued 4,470,000 prefunded common warrants with an exercise price of $ 0.0001. All prefunded
common warrants were exercised during the year ended December 31, 2023. Additionally, the Company issued common warrants to purchase up
to an aggregate of 7,000,000 shares of the Company's common stock. The common warrants are exercisable at $ 1.00 per share, expire
 five years from the date of issuance.

 In connection with the September
2023 Financing, the Company issued 4,950,000
 prefunded common warrants with an exercise price of $ 0.0001.
All prefunded common warrants were exercised during the year ended December 31, 2023. Additionally, the Company issued common warrants
to purchase up to an aggregate of 18,000,000
 shares of the Company's common stock. The common warrants are exercisable at $ 0.50
 per share, expire five
years from the date of issuance.

 In connection with the
December 2023 Financing, the Company issued 28,710,812
prefunded common warrants with an exercise price of $ 0.0001.
Only 6,509,010
prefunded common warrants were exercised during the year ended December 31, 2023. Subsequent to December 31, 2023, 15,043,244
prefunded common warrants were exercised. Additionally, the Company issued Series C common warrants to purchase up to an
aggregate of 81,081,081
shares of the Company's common stock. The common warrants are exercisable at $ 0.555
per share, expire two
years from the date of issuance. Additionally, the Company issued Series D common warrants to purchase up to an
aggregate of 81,081,081
shares of the Company's common stock. The common warrants are exercisable at $ 0.85
per share, expire five
years from the date of issuance.

 No warrants were exercised
during the year ended December 31, 2022.

 For the year ended
December 31, 2023, 2,453 warrants with an exercise price of $ 7,000.00 expired.

 On April
1, 2024, the Company issued 3,900,000 pre-funded common warrants with an exercise price of $ 0.0001. Additionally, the Company issued Series
E warrants to purchase up to 14,666,666 shares of common stock with an exercise price of $ 0.33 per share and expiring five and a half
years from date of issuance.

 Additionally, the Company entered
into warrant amendments with certain holders of its Common Warrants. The exercise price of each Existing Warrant will be amended to $ 0.33
upon approval by the Company's stockholders of a proposal to allow the Existing Warrants to become exercisable in accordance with
Nasdaq Listing Rule 5635, or as otherwise provided in the Amendment if stockholder approval is not obtained by October 1, 2024. Upon stockholder
approval, the termination date for Common Warrants to purchase up to an aggregate of 6,950,000 shares will be amended to April 1, 2029;
the termination date for Series A Warrants to purchase up to an aggregate of approximately 8,900,000 shares will be April 1, 2029; the
termination date for Series B Warrants to purchase up to an aggregate of approximately 8,900,000 shares will be April 1, 2029; the termination
date for Series C Warrants to purchase up to an aggregate of approximately 34,823,928 shares will be the earlier of (i) April 1, 2026
and (ii) 10 trading days following notice by the Company to the Series C Warrant holder of the Company's public announcement of
the FDA's acknowledgement and acceptance of the Company's NDA relating to TNX-102 SL in patients with Fibromyalgia; the termination
date for Series D Warrants to purchase up to an aggregate of approximately 34,823,928 shares will be April 1, 2029. The other terms of
the Existing Warrants will remain unchanged. If stockholder approval is not obtained on or by October 1, 2024, then the Company
has agreed to automatically amend the exercise price of the Existing Warrants to the Minimum Price (as defined in Nasdaq Listing Rule
5635(d)) of the Common Stock on October 1, 2024 if and only if the Minimum Price is below the then current exercise price.

 NOTE 20 – LEASES

 The
Company has various operating lease agreements, which are primarily for office space. These agreements frequently include one
or more renewal options and require the Company to pay for utilities, taxes, insurance and maintenance expense. No lease agreement
imposes a restriction on the Company's ability to engage in financing transactions or enter into further lease agreements.
At December 31, 2023, the Company has right-of-use assets of $ 0.8 million and a total lease liability for operating leases of
$ 0.9 million of which $ 0.6 million is included in long-term lease liabilities and $ 0.3 million is included in current lease liabilities.
During the year ended December 31, 2023, the Company exited a lease which had a right-of-use assets, net of $ 0.2 million and a
total lease liability for operating leases of $ 0.2 million.

 At December 31, 2023,
future minimum lease payments for operating leases with non-cancelable terms of more than one year were as follows (in thousands):

 Year Ending December 31,

 2024

 $

 2025

 2026

 2027

 2028 and beyond

 Included interest

 ( 90

)

 $

 During the year ended
December 31, 2023, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing an
additional operating lease liability of approximately $ 898,000 based on the present value of the minimum rental payments. The Company
also recognized a corresponding increase to ROU assets of approximately $ 898,000, which represents a non-cash operating activity.

 During the year ended
December 31, 2022, the Company entered into new operating leases and lease amendments, resulting in the Company recognizing an
additional operating lease liability of approximately $ 386,000 based on the present value of the minimum rental payments. The Company
also recognized a corresponding increase to ROU assets of approximately $ 386,000, which represents a non-cash operating activity.

 Other information related to leases is as follows:

 Operating lease expense
was $ 0.6 million for both the years ended December 31, 2023 and 2022.

 F- 28

 Other information related to leases is as follows:

 Cash paid for amounts included in the measurement of lease liabilities:

 December 31, 2023

 December 31, 2022

 Operating cash flow from operating leases (in thousands)

 $

 $

 Weighted Average Remaining Lease Term

 Operating leases

 3.78 years

 2.20 years

 Weighted Average Discount Rate

 Operating leases

 4.53

 %

 2.19

 %

 NOTE 21 – COMMITMENTS

 Contractual agreements

 The Company has entered
into contracts with various contract research organizations with outstanding commitments aggregating approximately $ 23.2 million
at December 31, 2023 for future work to be performed.

 Defined contribution plan

 The
Company has a qualified defined contribution plan (the "401(k) Plan") pursuant to Section 401(k) of the Code, whereby
all eligible employees may participate. Participants may elect to defer a percentage of their annual pretax compensation
to the 401(k) Plan, subject to defined limitations. The Company is required to make contributions to the 401(k) Plan equal to
 100 percent of each participant's pretax contributions of up to six percent of his or her eligible compensation, and the
Company is also required to make a contribution equal to three percent of each participant's salary, on an annual basis,
subject to limitations under the Code. The Company charged operations $ 1.3 million and $ 0.9 million for the year ended December
31, 2023 and 2022, respectively, for contributions under the 401(k) Plan.

 NOTE 22 – INCOME TAXES

 Components of the net loss consist of the
following (in thousands):

 Year ended December 31,

 2023

 2022

 Foreign

 $

 ( 98,204

)

 $

 ( 88,478

)

 Domestic

 ( 18,454

)

 ( 21,740

)

 Total

 $

)

 $

)

 In
2023, the foreign losses are primarily comprised of $ 98.4 million related to the Irish operations netted against
$ 0.2 million related to Canada operations of Tonix International Holding. In 2022, the foreign losses are primarily comprised
of the $ 86.7 million related to the Irish operations and $ 1.5 million related to the Bermudan operations of Tonix International
Holding.

 A reconciliation of
the effect of applying the federal statutory rate to the net loss and the effective income tax rate used to calculate the Company's
income tax provision is as follows:

 Year Ended December 31,

 2023

 2022

 Statutory federal income tax

 ( 21.0

)%

 ( 21.0

)%

 Change in valuation allowance

 11.7

 %

 9.6

 %

 Foreign loss not subject to income tax

 7.2

 %

 7.0

 %

 Attribute reduction from control change

 0.9

 %

 4.0

 %

 Other

 1.2

 %

 0.4

 %

 Income Tax Provision

 0.0

 %

 0.0

 %

 Deferred tax assets
(liabilities) and related valuation allowance as of December 31, 2023 and 2022 were as follows (in thousands):

 2023

 2022

 Deferred tax assets/(liabilities):

 Net operating loss carryforward

 $

 32,997

 $

 21,642

 10,276

 7,353

 Other

 2,211

 1,997

 Total deferred assets

 45,484

 30,992

 Valuation allowance

 ( 45,484

)

 ( 30,992

)

 Net deferred tax assets

 $

 —

 $

 —

 The Company has incurred
research and development ("R&D") expenses, a portion of which qualifies for tax credits. The Company conducted
an R&D credit study to quantify the amount of credits and has claimed an R&D credit on its 2014-2017 tax returns. A portion
of these R&D credit carryforwards are subject to annual limitations in their use in accordance with Internal Revenue Service
Code ("IRC") section 383. The R&D credit carryforwards at December 31, 2023 have been reduced to $ 0.0 million to
reflect IRC section 383 ownership changes through December 31, 2023 and the resulting inability to utilize a portion of the R&D
credit prior to its expiration.

 F- 29

 At
December 31, 2023, the Company has $ 263.4 million of Ireland NOL carryforwards that do not expire. As of December 31, 2023, the
Company's Federal NOL carryforwards of $ 0.2 million, which do not expire. The Company has New Jersey NOL carryforwards of $ 0.2
million, Massachusetts NOL carryforwards of $ 0.01 million, and Montana NOL carryforwards of $ 0.05 million, all of which expire
in 20 years, are subject to annual limitations in their use in accordance with IRC section 382. The NOL carryforwards at December
31, 2023 have been reduced to reflect IRC section 382 ownership changes through December 31, 2023 and the resultant inability
due to annual limitations, to utilize a portion of the NOL prior to its expiration.

 Management
assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use
the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred
over the three-year period ended December 31, 2023. Such objective evidence limits the ability to consider other subjective evidence
such as our projections for future growth. As such, the Company has determined that it is not more likely than not that the deferred
tax assets will be realized and accordingly, has provided a full valuation allowance against its gross deferred tax assets. The
increase/(decrease) in the valuation allowance for the years ended December 31, 2023 and 2022 were $ 14.5 million, and $ 9.5 million
respectively.

 The Company recognizes
interest accrued related to unrecognized tax benefits and penalties as income tax expense. However, as of December 31, 2023 there
are no unrecognized tax benefits recorded. The Company is subject to taxation in the United States and various states and foreign
jurisdictions. As of December 31, 2023, the Company's tax returns remain open and subject to examination by the tax authorities
for the tax years 2020 and after.

 NOTE 23 – SUBSEQUENT EVENTS

 On January 25, 2024, the
Company filed a Certificate of Amendment to its Articles of Incorporation, as amended, with the Secretary of State of the State of Nevada
to increase the number of authorized shares of the Company's common stock from 160,000,000 to 1,000,000,000 shares. The Amendment
was approved by the Company's shareholders at a special meeting of shareholders held on January 25, 2024.

 On February 27, 2024,
the Company granted options to purchase an aggregate of 4,261,104 shares of the Company's common stock to employees with
an exercise price of $ 0.37, with a term of ten years, vesting 1/3 on the first anniversary and 1/36 th each month thereafter
for 24 months. Additionally, the Company granted options to purchase 2,860,680 shares of the Company's common stock to certain
employees with an exercise price of $ 0.46, with a term of ten years, vesting 1/3 on the first anniversary and 1/36 th each
month thereafter for 24 months. Finally, the Company granted options to purchase 1,309,911 shares of the Company's common
stock to an employee with an exercise price of $ 0.37, with a term of ten years, vesting in 6 months.

 On March
28, 2024, the Company sold 10,766,666 shares of common stock, pre-funded warrants to purchase up to 3,900,000 shares of common stock,
and accompanying Series E warrants to purchase up to 14,666,666 shares of common stock with an exercise price of $ 0.33 per share and expiring
 five and a half years from date of issuance in a public offering, which closed on April 1, 2024. The offering price per share of common
stock was $ 0.30, accompanying warrants was $ 0.33, and the offering price per share of pre-funded warrants was $ 0.2999.

 The Company
incurred offering expenses of approximately $ 0.5 million, including placement agent fees of approximately $ 0.3 million. The Company received
net proceeds of approximately $ 3.9 million, after deducting the underwriting discount and other offering expenses.

 Additionally, the Company entered
into warrant amendments with certain holders of its Common Warrants. The exercise price of each Existing Warrant will be amended to $ 0.33
upon approval by the Company's stockholders of a proposal to allow the Existing Warrants to become exercisable in accordance with
Nasdaq Listing Rule 5635, or as otherwise provided in the Amendment if stockholder approval is not obtained by October 1, 2024. Upon stockholder
approval, the termination date for Common Warrants to purchase up to an aggregate of 6,950,000 shares will be amended to April 1, 2029;
the termination date for Series A Warrants to purchase up to an aggregate of approximately 8,900,000 shares will be April 1, 2029; the
termination date for Series B Warrants to purchase up to an aggregate of approximately 8,900,000 shares will be April 1, 2029; the termination
date for Series C Warrants to purchase up to an aggregate of approximately 34,823,928 shares will be the earlier of (i) April 1, 2026
and (ii) 10 trading days following notice by the Company to the Series C Warrant holder of the Company's public announcement of
the FDA's acknowledgement and acceptance of the Company's NDA relating to TNX-102 SL in patients with Fibromyalgia; the termination
date for Series D Warrants to purchase up to an aggregate of approximately 34,823,928 shares will be April 1, 2029. The other terms of
the Existing Warrants will remain unchanged. If stockholder approval is not obtained on or by October 1, 2024, then the Company
has agreed to automatically amend the exercise price of the Existing Warrants to the Minimum Price (as defined in Nasdaq Listing Rule
5635(d)) of the Common Stock on October 1, 2024 if and only if the Minimum Price is below the then current exercise price.

 F- 30

 ITEM 9 - CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON
ACCOUNTING AND FINANCIAL DISCLOSURES

 None.

 ITEM 9A – CONTROLS AND PROCEDURES

 Management's evaluation of disclosure
controls and procedures.

 Our management, with
the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls
and procedures pursuant to Rule 13a-15 under the Exchange Act. In designing and evaluating the disclosure controls and procedures,
management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance
of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact
that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible
controls and procedures relative to their costs.

 Based on management's
evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are designed
at a reasonable assurance level and are effective to provide reasonable assurance that information we are required to disclose
in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods
specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our chief
executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure.

 Changes in internal control over financial
reporting.

 The acquisition of
marketed products from Upsher Smith has had a material impact on the Company's internal control over financial reporting as we are
now required and have implemented controls related to revenue and inventory management. Management established controls to mitigate
the risk over financial reporting as it relates to the services provided by Upsher Smith under the transition services agreement.

 Except as otherwise
described above, there was no change in our internal control over financial reporting that occurred during the year ended December
31, 2023, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 Management's report on internal
control over financial reporting.

 Our management is responsible
for establishing and maintaining adequate internal control over financial reporting for our company. Internal control over financial
reporting is defined in Rule 13a-15(f) and 15d-15(f) promulgated under the Exchange Act, as a process designed by,
or under the supervision of, a company's principal executive and principal financial officer and effected by the our board
of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and
includes those policies and procedures that:

 (1)

 pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;

 (2)

 provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made in accordance with authorizations of management and directors of the company; and

 (3)

 provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company's assets that could have a material effect on the financial statements.

 Because of its inherent
limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or
that the degree of compliance with the policies or procedures may deteriorate. Management recognizes that any controls and procedures,
no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily
applies its judgment in evaluating the cost-benefit relationship of possible enhancements to controls and procedures.

 We conducted an evaluation
of the effectiveness of internal control over financial reporting based on the framework in Internal Control — Integrated
Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, our
principal executive officer and principal financial officer conclude that, at December 31, 2022, our internal control over
financial reporting was effective.

 This annual report
does not include an attestation report by EisnerAmper LLP, our independent registered public accounting firm regarding internal
control over financial reporting. As a smaller reporting company, our management's report was not subject to attestation
by our registered public accounting firm pursuant to rules of the Securities and Exchange Commission that permit us to provide
only management's report in this annual report.

 ITEM 9B – OTHER INFORMATION

 None.

 ITEM 9C – DISCLOSURE REGARDING FOREIGN JURISDICTIONS
THAT PREVENT INSPECTIONS

 Not Applicable.

 ITEM 10 – DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE
GOVERNANCE

 The Board of Directors
elects our executive officers annually. A majority vote of the directors who are in office is required to fill vacancies. Each
director shall be elected for the term of one year and until his successor is elected and qualified or until his earlier resignation
or removal. Our directors and executive officers are as follows:

 NAME

 AGE

 CURRENT POSITION

 President, CEO and Chairman of the Board of Directors

 James Treco

 Lead Director

 Chief Operating Officer

 Chief Financial Officer and Treasurer

 Chief Medical Officer and Secretary

 The following information
with respect to the principal occupation or employment of each nominee for director, the principal business of the corporation
or other organization in which such occupation or employment is carried on, and such nominee's business experience during
the past five years, as well as the specific experiences, qualifications, attributes and skills that have led the Board to determine
that such Board members should serve on our Board, has been furnished to the Company by the respective director nominees:

 Seth Lederman,
MD became our President, Chief Executive Officer, Chairman of the Board and a Director in October 2011. Dr. Lederman
founded Tonix Pharmaceuticals, Inc., a wholly-owned subsidiary of us ("Tonix Sub") in 2007 and has acted as its Chairman
of the Board of Directors since its inception and as President since 2010. Dr. Lederman is an inventor on key patents and patent
applications underlying our programs including: TNX-102 SL's eutectic composition; and TNX-102 SL's pharmacokinetic
profile and related therapeutic properties. Dr. Lederman served as an Associate Professor at Columbia University, between 1996
and 2017. As an Assistant Professor at Columbia, Dr. Lederman discovered and characterized the CD40-ligand, or CD154 and invented
therapeutic candidates to treat autoimmune diseases and transplant rejection. TNX-1500 is a mAb directed against CD154 invented
by Dr. Lederman. Dr. Lederman has been a Manager of L&L Technologies LLC, or L&L, since 1996. In addition, Dr. Lederman
has been the Managing Member of Seth Lederman Co, LLC since 2007 and the Managing Member of Lederman & Co, LLC, or Lederman
& Co, since 2002, both of which are biopharmaceutical consulting and investing companies. Dr. Lederman has also been the Managing
Member of Targent Pharmaceuticals, LLC, or Targent, since 2000, and Managing Member of Plumbline LLC since 2002. Targent was a
founder of Targent Pharmaceuticals Inc. on which Board of Directors Dr. Lederman served from inception in 2001 until the sale of
its assets to Spectrum Pharmaceuticals Inc. in 2006. Between January 2007 and November 2008, Dr. Lederman was a Managing Partner
of Konanda Pharma Partners, LLC, a Director of Konanda Pharma Fund I, LP, and a Managing Partner of Konanda General Partner, LLC,
which were related private growth equity fund entities. As well, between 2007 and 2008, Dr. Lederman was Chairman of Validus Pharmaceuticals,
Inc. and Fontus Pharmaceuticals, Inc., which were portfolio companies of the Konanda private growth equity funds. Since 2011, Dr.
Lederman has served as CEO and Chairman of Leder Laboratories Inc., or Leder Labs, and Starling Pharmaceuticals Inc., or Starling,
which are biopharmaceutical development companies. Dr. Lederman was the chairman of Leder Laboratories, Ltd., a wholly-owned subsidiary
of Leder Laboratories Inc., between 2013 and 2018, when the entity was dissolved. In 2015, Dr. Lederman served as a member of the
US – Japan Business Council. Between 2006 and 2011, Dr. Lederman was a director of Research Corporation, a New York-based
non-profit organization. Dr. Lederman received his BA degree in Chemistry from Princeton University in 1979 and his MD from Columbia
University in 1983. Dr. Lederman's significant experience with our patent portfolio and his experience as an entrepreneur,
seed capital investor, fund manager, and director of start-up biopharmaceutical companies were instrumental in his selection as
a member of the Board.

 became a Director in June 2020. Mr. Bagger has been a Partner and Executive Director of Christie 55 Solutions, LLC, a New
Jersey based consulting firm, since January 2020. Mr. Bagger has also been an Adjunct Faculty member at the Rutgers University
Eagleton Institute since 2018. From 2012 through 2019, Mr. Bagger was Executive Vice President of Corporate Affairs and Market
Access for Celgene Corporation (NASDAQ: CELG), a global biopharmaceutical company, as well as a member of its Executive Committee.
From 1993 to 2010, Mr. Bagger held roles of increasing responsibility with Pfizer Inc. (NYSE: PFE), a global pharmaceutical company,
and served as Senior Vice President, Worldwide Public Affairs and Policy, from 2006 to 2009. Prior to joining Pfizer, Mr. Bagger
was Assistant General Counsel of Blue Cross and Blue Shield of New Jersey, a health insurer, and practiced law with the law firm
of McCarter & English. Mr. Bagger served as Board Chair of the National Pharmaceutical Council for 2019 and is a member of
the Board of Directors of the U.S. Chamber of Commerce. He is also on the advisory board for the Lerner Center for the Study of
Pharmaceutical Management Issues at Rutgers University Business School. Mr. Bagger received an A.B. degree from Princeton University's
School of Public and International Affairs and a J.D. degree from Rutgers University Law School. Mr. Bagger's extensive healthcare
and public policy experience were instrumental in his selection as a member of the Board.

 Margaret Smith
Bell became a Director in September 2017. Ms. Bell has been retired for the last ten years. Previously, Ms. Bell was a
Vice President at Standard Life Investments where she was a portfolio manager and health care equity analyst. Ms. Bell was also
a Managing Director at Putnam Investments, and served as a senior health care analyst and a portfolio manager of the Putnam Health
Sciences Trust. Ms. Bell was an analyst and vice president at State Street Research and a research analyst at Alex. Brown &
Sons, Inc. Ms. Bell is a past member of the Board of Overseers at Beth Israel Deaconess Medical Center. Ms. Bell holds a B.A. from
Wesleyan University and an M.B.A. from the Wharton School at the University of Pennsylvania. Ms. Bell's extensive healthcare
and investment banking experience were instrumental in her selection as a member of the Board.

 Major General
David Grange (U.S. Army, retired) became a director in February 2018. MG Grange has been President and founder of Osprey
Global Solutions, LLC ("OGS"), a Service Disabled Veterans Organization, since 2011. MG Grange was Chief Executive
Officer of Pharm-Olam International, Ltd. ("Pharm-Olam"), a contract research organization, from April 2017 to October
2019. Prior to founding OGS, MG Grange was a member of the Board of Pharmaceutical Product Development, Inc. (Nasdaq: PPDI), a
contract research organization, from 2003 to 2009, and Chief Executive Officer from 2009 to 2011.

 Prior to PPDI he served
in the McCormick Tribune Foundation for 10 years most recently as Chief Executive Officer and President, where he also oversaw
the support of Veteran Programs. MG Grange served 30 years in the U.S. Army as a Ranger, Green Beret, Aviator, Infantryman and
a member of special operating units. At the Pentagon, he was Director of Army Current Operations, Readiness, and Mobilization.
MG Grange commanded the Ranger Regiment and the First Infantry Division (the Big Red One). MG Grange holds a master's degree
in Public Service from Western Kentucky University. MG Grange's extensive experience in the pharmaceutical industry and service
with the U.S. military was instrumental in his selection as a member of our Board.

 Adeoye Olukotun, MD became
a Director in September 2018. Dr Olukotun is a member of management of Genesis Unicorn Corporation, a special acquisition company recently
listed on Nasdaq (GENQU). Dr. Olukotun has been the Chief Executive Officer of CR Strategies, LLC, a medical products consulting company,
since 2000, and was the Chief Executive Officer of EpiGen Pharmaceuticals, Inc., a pharmaceutical company, from 2014 to January of 2018.
Dr. Olukotun served as Vice Chairman of CardoVax, Inc., a pharmaceutical company, from 2012 to 2016, and as its Chief Executive Officer
from 2006 to 2012. He is also co-founder of VIA Pharmaceuticals, Inc., a pharmaceutical company, and served as the company's Chief
Medical Officer from 2004 to 2008. Dr. Olukotun is a member of the board of directors of Arrowhead Pharmaceuticals. Dr. Olukotun's
extensive medical background and experience in the pharmaceutical industry was instrumental in his selection as a member of our Board.

 N ewcomb Stillwell
became a director in March 2023. Mr. Stillwell has held positions of varying responsibility at the law firm of Ropes & Gray
LLP from 1984 to 2021, including, most recently, as co-managing partner of the Ropes & Gray Boston office. Mr. Stillwell graduated
from Harvard Law School and earned an A.B. from Princeton University. Mr. Stillwell's extensive advisory experience on numerous
transactions in the life science and healthcare sectors was instrumental in his selection as a member of the Board.

 became a Director in July 2021. Ms. Taylor was general counsel of Strike Protocols Inc., a financial technology company,
from 2019 to 2020, and held positions of varying responsibility, including partner, and most recently, of counsel, at the law firm
of Covington & Burling LLP from 1989 to 2000 and 2004 to 2015. From 2000 to 2003, Ms. Taylor served as Executive Vice President
and General Counsel of Longitude, Inc., a financial services company. Ms. Taylor graduated from Columbia Law School and earned
a B.A. from Brown University. Ms. Taylor's broad transactional experience was instrumental in her selection as a member of
the Board.

 James Treco became
a director in February 2019 and has been our Lead Director since March 2020. Mr. Treco has been a Managing Partner at First Chicago
Advisors, Inc., a boutique financial advisory firm where he advises executives and boards of directors of a wide range of companies,
from global, large-cap companies to emerging companies, from 2009 to 2012 and from 2014 to the present. From 2012 to 2013 Mr. Treco
was an investment banker with Gleacher & Company, a company that previously operated an investment banking business, providing
corporate and institutional clients with strategic and financial advisory services. Mr. Treco held various positions of increasing
responsibility at Salomon Brothers/Citigroup from 1984 to 2008, where he used his extensive experience in the global capital markets
to advise a wide range of clients. Mr. Treco holds a B.A. from Yale University and an M.B.A. from the Stanford University Graduate
School of Business. Mr. Treco's extensive healthcare and investment banking experience were instrumental in his selection
as a member of the Board.

 Jessica Morris is
our Chief Operating Officer and has worked for the Company since April 2013, first as a consultant (April 2013 – September
2013), then as SVP of Finance (September 2013 – October 2015), followed by Chief Administrative Officer (October 2015 –
January 2016), Acting Chief Financial Officer (January 2016 – February 2016), and Executive Vice President, Operations (February
2016 – January 2018). Prior to joining the Company, Ms. Morris was a Vice President in investment management at Zhong Rong
Group. Previously, Ms. Morris was a Senior Associate in the Sponsor Finance Group at American Capital, a Vice President of the
mezzanine debt fund at Calvert Street Capital Partners, an Associate in the commercial finance department of Silicon Valley Bank,
and a Financial Analyst in the investment banking group at Deutsche Bank. Ms. Morris earned a B.S. in Commerce and a B.A. in Music
from the University of Virginia, where she was an Echols Scholar.

 Bradley Saenger,
CPA became our Chief Financial Officer in February 2016. Mr. Saenger has worked for us since May 2014, as the Director
of Accounting (May 2014 – December 2015) and VP of Accounting (January 2016 – February 2016). Between June 2013 and
March 2014, Mr. Saenger worked for Shire Pharmaceuticals as a consultant in the financial analyst research and development group.
Since November 2015, Mr. Saenger has been a director of Tonix Pharma Holdings Limited. Between February 2013 and May 2013, Mr.
Saenger worked for Stewart Health Care System as a financial consultant. Between October 2011 and December 2012, Mr. Saenger was
an Associate Director of Accounting at Vertex Pharmaceuticals, Inc. Between January 2005 and September 2011, Mr. Saenger worked
for Alere Inc., as a Manager of Corporate Accounting and Consolidations (2007 – 2011) and Manager of Financial Reporting
(2005 – 2006). Mr. Saenger also worked for PricewaterhouseCoopers LLP, Shifren Hirsowitz, public accountants and auditors
in Johannesburg, South Africa, Investec Bank in Johannesburg, South Africa and Norman Sifris and Company, public accountants and
auditors in Johannesburg, South Africa. Mr. Saenger received his Bachelor's and Honors' degrees in Accounting Science
from the University of South Africa. Mr. Saenger is a Chartered Accountant in South Africa and a Certified Public Accountant in
the Commonwealth of Massachusetts.

 Gregory Sullivan,
MD became our Chief Medical Officer on June 3, 2014 and our Secretary in March 2017. Prior to becoming our Chief Medical
Officer, he served on our Scientific Advisory Board since October 2010, and had also provided ad hoc consulting
services. Previously, Dr. Sullivan had been a member of the faculty of Columbia University since July 1999, where he served as
an Assistant Professor of Psychiatry in the Department of Psychiatry at Columbia University Medical Center (CUMC) until June 2014.
Between June 1997 and August 2014, Dr. Sullivan maintained a part-time psychiatry practice. He served as a Research Scientist at
the New York State Psychiatric Institute (NYSPI) from December 2006 to June 2014. He also served as a member of the Institutional
Review Board of the NYSPI from January 2009 to June 2014. As Principal Investigator and Co-Investigator on several human studies
of PTSD, Dr. Sullivan has administered the recruitment, biological assessments, treatment, and safety of participants with PTSD
in clinical trials of the disorder. He has published more than 50 articles and chapters on research topics ranging from stress
and anxiety disorders to abnormal serotonin receptor expression in depression, PTSD and panic disorder. He is a recipient of grants
from the National Institute of Mental Health (NIMH), the Anxiety Disorders Association of America, NARSAD, the Dana Foundation,
and the American Foundation for Suicide Prevention. Dr. Sullivan received a BA in Biology from the University of California, Berkeley,
and received his MD from the College of Physicians & Surgeons at Columbia University. He completed his residency training in
psychiatry at CUMC, and then a two-year NIMH-sponsored research fellowship in anxiety and affective disorders before joining the
faculty at Columbia.

 Directors serve until
the next annual meeting of shareholders or until their successors are elected and qualified. Officers serve at the discretion of
the Board.

 Board Independence

 The Board has determined
that (i) Seth Lederman has a relationship which, in the opinion of the Board, would interfere with the exercise of independent
judgment in carrying out the responsibilities of a director and is not an "independent director" as defined in the
Marketplace Rules of The NASDAQ Stock Market and (ii) Richard Bagger, Margaret Smith Bell, David Grange, Adeoye Olukotun, Newcomb
Stillwell, Carolyn Taylor and James Treco are each an independent director as defined in the Marketplace Rules of The NASDAQ Stock
Market.

 Board
Diversity Matrix

 The following matrix is
provided in accordance with applicable Nasdaq listing requirements:

 Board
 Diversity Matrix as of March 18, 2024

 Total
 Number of Directors

 Part
 I: Gender Identity

 Female

 Male

 Non-Binary

 Did
 Not Disclose

 Gender

 Directors

 —

 Part
 II: Demographic Background

 African
 American or Black

 —

 —

 —

 Alaskan
 Native or Native American

 —

 —

 —

 —

 Asian

 —

 —

 —

 —

 Hispanic
 or Latinx

 —

 —

 —

 —

 White

 —

 Two
 or More Races or Ethnicities

 —

 —

 —

 —

 LGBTQ+

 Did
 Not Disclose Demographic Background

 Board Leadership Structure

 Our CEO also serves
as the chairman of the Board. An independent director serves as the Board's lead director. This structure allows one
person to speak for and lead both the Company and the Board, while also providing for effective independent board oversight
through an independent lead director. Having Dr. Lederman, our CEO, serve as Chairman creates clear and unambiguous authority,
which is essential to effective management. Our Board and management can respond more effectively to a clearer line of authority.
By designating our CEO as its Chairman, our Board also sends as an important signal to our employees and shareholders about who
is accountable. Further, since Dr. Lederman is the founder of our Company and is an inventor on key patents and patent applications
underlying our programs, we believe that Dr. Lederman is best-positioned to set our Board's agenda and provide leadership.

 We have established the position
of lead director, which has been held by Mr. Treco since March 2021. The lead director has the following responsibilities, as detailed
in the Lead Director charter, adopted by the Board (and also performs any other functions the Board may request):

 Board leadership — provides leadership to the Board in any situation where the chairman's role may be, or may be perceived to be, in conflict, and also chairs meetings when the chairman is absent;

 Leadership of independent director meetings — leads independent director meetings, which take place without any management directors or Tonix employees present;

 Additional meetings — calls additional independent director meetings as needed;

 Chairman-independent director liaison — regularly meets with the chairman and serves as liaison between the chairman and the independent directors;

 Stockholder communications — makes himself available for direct communication with our stockholders;

 Board agenda, schedule & information — works with the chairman regarding meeting agendas, meeting schedules and information sent to directors for Board meetings, including the quality, quantity, appropriateness and timeliness of such information; and

 Advisors and consultants — recommends to the Board the retention of outside advisors and consultants who report directly to the Board on Board-wide issues.

 Board Role in Risk Oversight

 Risk is an integral
part of the Board and Board committee deliberations throughout the year. While the Board has the ultimate oversight responsibility
for the risk management process, various committees of the Board also have responsibility for risk management. In particular, the
Audit Committee focuses on financial risk, including internal controls, and receives financial risk assessment reports from management.
Risks related to the compensation programs are reviewed by the Compensation Committee. The Board is advised by these committees
of significant risks and management's response through periodic updates.

 Stockholder Communications with the
Board

 The Company's
stockholders may communicate with the Board, including non-executive directors or officers, by sending written communications addressed
to such person or persons in care of Tonix Pharmaceuticals Holding Corp., Attention: Secretary, 26 Main Street, Suite 101, Chatham,
New Jersey 07928. All communications will be compiled by the Secretary and submitted to the addressee. If the Board modifies this
process, the revised process will be posted on the Company's website.

 Meetings and Committees of the Board

 During the fiscal year ended
December 31, 2023, the Board held 13 meetings, the Audit Committee held eight meetings, the Compensation Committee held six meetings and
the Nominating and Corporate Governance Committee held five meetings. The Board and Board committees also approved certain actions by
unanimous written consent.

 Each
of the directors attended at least 75% of the aggregate of the total number of meetings of our Board (held during the period for which
such directors served on the Board). Each of the directors attended at least 75% of the total number of meetings of all committees of
our Board on which the director served (during the periods for which the director served on such committee or committees). Dr. Lederman
was the only member of the Board who attended last year's annual meeting of stockholders. The Company does not have a formal policy
requiring members of the Board to attend our annual meetings.

 Board Committees

 The Board has standing
Audit, Compensation, and Nominating and Corporate Governance Committees. Information concerning the membership and function of
each committee is as follows:

 Board Committee Membership

 Name

 Audit Committee

Committee

 Nominating and

Corporate Governance

Committee

 *

 **

 *

 **

 *

 *

 *

 *

 *

 James Treco

 **

 *

 *

 Member of Committee

 **

 Chairman of Committee

 Audit Committee

 Our Audit Committee
consists of James Treco, Chair of the Committee, Richard Bagger, Margaret Smith Bell and Newcomb Stillwell. Our Board has determined
each of the members are "independent" as that term is defined under applicable SEC rules and under the current listing
standards of the NASDAQ Stock Market. Mr. Treco is our audit committee financial expert.

 Our Audit Committee's
responsibilities include: (i) reviewing the independence, qualifications, services, fees, and performance of the independent auditors,
(ii) appointing, replacing and discharging the independent auditor, (iii) pre-approving the professional services provided by the independent
auditor, (iv) reviewing the scope of the annual audit and reports and recommendations submitted by the independent auditor, and (v) reviewing
our financial reporting and accounting policies, including any significant changes, with management and the independent auditor. The
Audit Committee reviewed and discussed with management the Company's audited financial statements for the year ended December 31,
2023. Our Board has adopted a written charter for the Audit Committee, a copy of which
is posted under the "Investors" tab under "Governance" on our website, which is located at www.tonixpharma.com.

 Compensation Committee

 Our Compensation Committee
consists of Margaret Smith Bell, Chair of the Committee, David Grange, Adeoye Olukotun and Carolyn Taylor. Our Board has determined
that all of the members are "independent" under the current listing standards of the NASDAQ Stock Market. Our Board
has adopted a written charter setting forth the authority and responsibilities of the Compensation Committee.

 Our Compensation Committee
has responsibility for, among other things, evaluating and making decisions regarding the compensation of our executive officers, assuring
that the executive officers are compensated effectively in a manner consistent with our stated compensation strategy, producing an annual
report on executive compensation in accordance with the rules and regulations promulgated by the SEC and periodically evaluating and
administering the terms and administration of our incentive plans and benefit programs. In addition, our Compensation Committee reviews
and makes recommendations to the Board regarding incentive compensation plans that require shareholder approval, director compensation
and the related executive compensation information for inclusion in the Company's Annual Report on Form 10-K and proxy statement,
and employment and severance agreements relating to the chief executive officer. Our Compensation Committee has engaged Aon plc, an independent
executive compensation consultant, to provide guidance with respect to the development and implementation of our compensation programs. Our Board has adopted a written charter for the Compensation Committee, a copy of which is posted under the "Investors" tab under "Governance" on our website, which is located at www.tonixpharma.com.

 Nominating and Corporate Governance
Committee

 Our Nominating and Corporate
Governance Committee consists of Richard Bagger, Chair of the Committee, David Grange, Newcomb Stillwell and James Treco. The Board has
determined that all of the members are "independent" under the current listing standards of the NASDAQ Stock Market.

 Our Nominating and
Corporate Governance Committee has responsibility for assisting the Board in, among other things, effecting the organization,
membership and function of the Board and its committees. The Nominating and Corporate Governance Committee identifies and evaluates
the qualifications of all candidates for nomination for election as directors, and seeks director nominees that complement and
enhance the effectiveness of the existing Board to ensure that its members have varied and relevant backgrounds, skills, knowledge,
perspectives and experiences. Our Board currently includes two female directors, one director who contributes racial/ethnic
diversity, and one who identifies as LGBTQ+. In addition, the Nominating and Corporate Governance Committee is responsible for
developing, recommending and evaluating corporate governance standards and a code of business conduct and ethics. In addition, the
Nominating and Corporate Governance Committee is responsible for developing, recommending and evaluating corporate governance
standards and a code of business conduct and ethics. Our Board has adopted a written charter for the Nominating and Corporate
Governance Committee, a copy of which is posted under the "Investors" tab under "Governance" on our website,
which is located at www.tonixpharma.com.

 Nomination of Directors

 As provided in its
charter and our Company's corporate governance principles, the Nominating and Corporate Governance Committee is responsible
for identifying individuals qualified to become directors. The Nominating and Corporate Governance Committee seeks to identify
director candidates based on input provided by a number of sources, including (1) the Nominating and Corporate Governance Committee
members, (2) our other directors, (3) our shareholders, (4) our Chief Executive Officer or Chairman, and (5) third parties such
as professional search firms. In evaluating potential candidates for director, the Nominating and Corporate Governance Committee
considers the entirety of each candidate's credentials.

 Qualifications for
consideration as a director nominee may vary according to the particular areas of expertise being sought as a complement to the
existing composition of the Board. However, at a minimum, candidates for director must possess:

 high personal and professional ethics and integrity;

 the ability to exercise sound judgment;

 the ability to make independent analytical inquiries;

 a willingness and ability to devote adequate time and resources to diligently perform Board and committee duties; and

 the appropriate and relevant business experience and acumen.

 In addition to these
minimum qualifications, the Nominating and Corporate Governance Committee also takes into account when considering whether to nominate
a potential director candidate the following factors:

 whether the person possesses specific industry expertise and familiarity with general issues affecting our business;

 whether the person's nomination and election would enable the Board to have a member that qualifies as an "audit committee financial expert" as such term is defined by the SEC in Item 401 of Regulation S-K;

 whether the person would qualify as an "independent" director under the listing standards of the Nasdaq Stock Market;

 the importance of continuity of the existing composition of the Board to provide long term stability and experienced oversight; and

 the importance of diversified Board membership, in terms of both the individuals involved and their various experiences and areas of expertise.

 The Nominating and
Corporate Governance Committee will consider director candidates recommended by shareholders provided such recommendations are
submitted in accordance with the procedures set forth below. In order to provide for an orderly and informed review and selection
process for director candidates, the Board has determined that shareholders who wish to recommend director candidates for consideration
by the Nominating and Corporate Governance Committee must comply with the following:

 The recommendation must be made in writing to the Corporate Secretary at Tonix Pharmaceuticals Holding Corp.;

 The recommendation must include the candidate's name, home and business contact information, detailed biographical data and qualifications, information regarding any relationships between the candidate and the Company within the last three years and evidence of the recommending person's ownership of the Company's common stock;

 The recommendation shall also contain a statement from the recommending shareholder in support of the candidate; professional references, particularly within the context of those relevant to board membership, including issues of character, judgment, diversity, age, independence, expertise, corporate experience, length of service, other commitments and the like; and personal references; and

 A statement from the shareholder nominee indicating that such nominee wants to serve on the Board and could be considered "independent" under the Rules and Regulations of the Nasdaq Stock Market and the SEC, as in effect at that time.

 All candidates submitted
by shareholders will be evaluated by the Nominating and Corporate Governance Committee according to the criteria discussed above
and in the same manner as all other director candidates.

 Prohibition Against
Certain Transactions

 All
of our employees and directors are prohibited from hedging or pledging Tonix stock, or engaging in short sales or trading in standardized
options under our Insider Trading Policy.

 Insider Trading
Policies and Procedures

 We
have adopted a Policy on Insider Trading and a Policy Regarding Special Trading Procedures. These policies and procedures apply to all
of our directors, officers and employees.

 Code of Ethics

 We have adopted a Code of
Business Conduct and Ethics that applies to all of our directors, officers and employees which
can be found on our website at

 Involvement in Certain Legal Proceedings

 Our directors and executive
officers have not been involved in any of the following events during the past ten years:

 1.

 any bankruptcy petition filed by or against such person or any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time;

 2.

 any conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);

 3.

 being subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining him from or otherwise limiting his involvement in any type of business, securities or banking activities or to be associated with any person practicing in banking or securities activities;

 4.

 being found by a court of competent jurisdiction in a civil action, the Securities and Exchange Commission or the Commodity Futures Trading Commission to have violated a Federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;

 5.

 being subject of, or a party to, any Federal or state judicial or administrative order, judgment decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of any Federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or

 6.

 being subject of or party to any sanction or order, not subsequently reversed, suspended, or vacated, of any self-regulatory organization, any registered entity or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.

 ITEM 11 - EXECUTIVE COMPENSATION

 Compensation Philosophy and Practices

 We believe that the
performance of our executive officers significantly impacts our ability to achieve our corporate goals. We, therefore, place considerable
importance on the design and administration of our executive officer compensation program. This program is intended to enhance
stockholder value by attracting, motivating and retaining qualified individuals to perform at the highest levels and to contribute
to our growth and success. Our executive officer compensation program is designed to provide compensation opportunities that are
tied to individual and corporate performance.

 Our compensation packages
are also designed to be competitive in our industry. The Compensation Committee from time-to-time consults with compensation consultants,
legal counsel and other advisors in designing our compensation program, including in evaluating the competitiveness of individual
compensation packages and in relation to our corporate goals.

 Our overall compensation
philosophy has been to pay our executive officers an annual base salary and to provide opportunities, through cash and equity incentives,
to provide higher compensation if certain key performance goals are satisfied. We believe that many of our key practices and programs
demonstrate good governance. The main principles of our fiscal year 2023 compensation strategy included the following:

 An emphasis on pay for performance. A significant portion of our executive officers' total compensation is variable and at risk and tied directly to measurable performance, including pre-specified corporate, strategic or developmental goals, which aligns the interests of our executives with those of our stockholders;

 Performance results are linked to Company and individual performance. When looking at performance over the year, we equally weigh individual performance as well as that of the Company as a whole. Target annual compensation is positioned to allow for above-median compensation to be earned through an executive officer's and the Company's extraordinary performance;

 Equity as a key component to align the interests of our executives with those of our stockholders. Our Compensation Committee believes that keeping executives interests aligned with those of our stockholders is critical to driving toward achievement of long-term goals of both our stockholders and the Company. Accordingly, a significant portion of our executives' compensation are stock based, including stock options that are exercisable at a percentage above market value at the time of grant; and

 Peer group positioning. While the Compensation Committee considers the level of compensation paid by the companies in our peer group as a reference point that provides a framework for its compensation decisions, in order to maintain competitiveness and flexibility, the Compensation Committee does not target compensation at a particular level relative to the peer group; nor does the Compensation Committee employ a formal benchmarking strategy or rely upon specific peer–derived targets.

 In 2023, we also continued
practices that demonstrate good governance and careful stewardship of corporate assets, including:

 Limited personal benefits. Our executive officers are eligible for the same benefits as our non-executive salaried employees, and they do not receive any additional perquisites.

 No retirement benefits. We do not provide our executive officers with a traditional retirement plan, or with any supplemental deferred compensation or retirement benefits.

 No tax gross-ups. We do not provide our executive officers with any tax gross-ups.

 No single-trigger cash change in control benefits. We do not provide cash benefits to, or accelerate the vesting of unvested equity grants issued to, our executives upon a change in control, absent an actual termination of employment.

 At our annual meeting
in May 2022, we conducted our tri-annual advisory vote on executive compensation, commonly referred to as a "say-on-pay"
vote. At that time, a majority of the votes affirmatively cast on the advisory say-on-pay proposal were voted in favor of the compensation
of our named executive officers. The Compensation Committee understood this level of approval to indicate strong stockholder support
for our executive compensation policies and programs generally, and as a result, our Compensation Committee made no fundamental
changes to our executive compensation programs. We will hold our next say-on-pay vote at the 2025 annual meeting. Our Compensation
Committee and our Board will consider shareholder feedback through the say-on-pay vote and remains committed to engaging with shareholders
and are open to feedback from shareholders.

 Summary Compensation Table

provides certain summary information concerning compensation awarded to, earned by or paid to our Chief Executive Officer, and
the two next most highly paid executive officers for fiscal years 2023 and 2022.

 Name & Principal
 Position

 Year

 Salary
 ($)

 Bonus
 ($)

 Stock
 Awards
 ($)

 Option
 Awards
 ($) (1)(2)

 Non-Equity
 Incentive Plan
 ($)

 Change in
 Pension Value and
 Non-Qualified
 Deferred
 Earnings ($)

 All Other
 ($)

 Total
 ($)

 2023

 675,000

 —

 —

 1,375,065

 —

 —

 —

 2,050,065

 Chief Executive Officer

 2022

 675,000

 355,000

 —

 3,550,167

 —

 —

 —

 4,580,167

 2023

 475,000

 179,550

 —

 274,049

 —

 —

 —

 928,599

 Chief Operations Officer

 2022

 455,175

 155,000

 —

 781,037

 —

 —

 —

 1,391,212

 2023

 465,000

 175,770

 —

 264,143

 —

 —

 —

 904,913

 Chief Financial Officer

 2022

 445,400

 152,000

 —

 639,030

 —

 —

 —

 1,236,430

 2023

 480,000

 181,440

 —

 290,558

 —

 —

 —

 951,998

 Chief Medical Officer

 2022

 461,120

 130,000

 —

 887,541

 —

 —

 —

 1,478,661

 (1)

 Represents the aggregate grant date fair
 value of options granted in accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or
 ASC, Topic 718, "Stock Compensation." For the relevant assumptions used in determining these amounts, refer to Note
 18 to our audited financial statements.

 (2)

 In lieu of a cash award, Dr. Lederman's bonus shall be paid in the form of a stock option award granted pursuant to the 2020 Plan, with 100% of such options vesting on the six-month anniversary of issuance, expiring 10 years from date of issuance and having an exercise price per share equal to the closing price of the Company's common stock on February 27, 2024.

 Grants of Plan-Based Awards in Fiscal 2023

 The following table provides information
with regard to each grant of plan-based award made to a named executive officer under any plan during the fiscal year ended December
31, 2023.

 Name

 Grant Date

 All Other Option Awards:
 Number of Securities
 Underlying Options (#)

 Exercise or
 Base Price of
 Option Awards ($/Share)

 Grant Date Fair Value of
 Stock and Option Awards
 ($) (1)

 112,000

 4.57

 465,003

 112,000

 5.71

 (2)

 459,499

 32,000

 4.57

 137,840

 32,000

 5.71

 (2)

 136,209

 33,200

 4.57

 132,858

 33,200

 5.71

 (2)

 131,285

 35,200

 4.57

 146,144

 35,200

 5.71

 (2)

 144,414

 (1)

 Represents the aggregate grant date fair value of options granted in accordance with FASB ASC Topic 718.

 (2)

 Represents an exercise price at a 125% premium of the closing price of the Company's common stock on the grant date.

 Outstanding Equity Awards at December 31, 2023

presents information regarding outstanding equity awards held by our named executive officers as of December 31, 2023.

 Name

 Number of
 Securities
 underlying
 Unexercised
 Options (#)
 Exercisable

 Number of
 Securities
 underlying
 Unexercised
 Options (#)
 Unexercisable

 Option
 Exercise
 Price ($/Sh)

 Option
 Date

 —

 $

 3,176,000.00

 2/11/2024

 —

 $

 1,974,000.00

 6/17/2024

 —

 $

 1,336,000.00

 10/29/2024

 —

 $

 —

 $

 —

 $

 —

 (1)

 $

 —

 $

 110,000.00

 3/1/2027

 —

 $

 68,000.00

 —

 $

 85,000.00

 —

 $

 3,780.00

 —

 $

 4,720.00

 —

 $

 4,100.00

 —

 $

 5,120.00

 —

 $

 80.00

 —

 $

 10,000

 —

 $

 154.00

 10,000

 —

 $

 192.00

 14,174

 (2)

 $

 244.00

 14,174

 (2)

 $

 306.00

 15,284

 9,716

 (3)

 $

 41.38

 2,500

 22,500

 (3)

 $

 82.75

 2,500

 22,500

 (3)

 $

 124.06

 2,500

 22,500

 (3)

 $

 165.44

 —

 112,000

 (4)

 $

 4.57

 —

 112,000

 (4)

 $

 5.71

 —

 $

 3,176,000.00

 2/11/2024

 —

 $

 1,974,000.00

 6/17/2024

 —

 $

 1,336,000.00

 10/29/2024

 —

 $

 —

 $

 —

 (1)

 $

 —

 $

 110,000.00

 3/1/2027

 —

 $

 68,000.00

 —

 $

 85,000.00

 —

 $

 3,780.00

 —

 $

 4,720.00

 —

 $

 4,100.00

 —

 $

 5,120.00

 —

 $

 80.00

 —

 $

 1,800

 —

 $

 154.00

 1,800

 —

 $

 192.00

 2,550

 (2)

 $

 244.00

 2,550

 (2)

 $

 306.00

 3,364

 2,136

 (3)

 $

 41.38

 4,950

 (3)

 $

 82.75

 4,950

 (3)

 $

 124.06

 4,950

 (3)

 $

 165.44

 —

 33,200

 (4)

 $

 4.57

 —

 33,200

 (4)

 $

 5.71

 —

 $

 1,974,000.00

 6/17/2024

 —

 $

 1,336,000.00

 10/29/2024

 —

 $

 —

 $

 —

 (1)

 $

 484,000.00

 5/27/2026

 —

 $

 484,000.00

 5/27/2026

 —

 $

 110,000.00

 3/1/2027

 —

 $

 68,000.00

 —

 $

 85,000.00

 —

 $

 3,780.00

 —

 $

 4,720.00

 —

 $

 4,100.00

 —

 $

 5,120.00

 —

 —

 $

 80.00

 —

 —

 $

 1,800

 —

 —

 $

 154.00

 1,800

 —

 —

 $

 192.00

 2,550

 (2)

 $

 244.00

 2,550

 (2)

 $

 306.00

 2,750

 1,750

 (3)

 $

 41.38

 4,050

 (3)

 $

 82.75

 4,050

 (3)

 $

 124.06

 4,050

 (3)

 $

 165.44

 —

 32,000

 (4)

 $

 4.57

 —

 32,000

 (4)

 $

 5.71

 —

 $

 1,974,000.00

 6/17/2024

 —

 $

 1,336,000.00

 10/29/2024

 —

 $

 —

 $

 —

 (1)

 $

 —

 $

 110,000.00

 3/1/2027

 —

 $

 68,000.00

 —

 $

 85,000.00

 —

 $

 3,780.00

 —

 $

 4,720.00

 —

 $

 4,100.00

 —

 $

 5,120.00

 —

 $

 80.00

 —

 $

 2,500

 —

 $

 154.00

 2,500

 —

 $

 192.00

 3,550

 (2)

 $

 244.00

 3,550

 (2)

 $

 306.00

 3,824

 2,427

 (3)

 $

 41.38

 5,625

 (3)

 $

 82.75

 5,625

 (3)

 $

 124.06

 5,625

 (3)

 $

 165.44

 —

 35,200

 (4)

 $

 4.57

 —

 35,200

 (4)

 $

 5.71

 (1)

 The shares subject to this stock option vest 1/3rd upon the date(s) that certain stock price goals are achieved. The stock price goals are such date(s) when the Company's common stock has an average closing sales price equal to or exceeding each of $1,200,000.00, $1,400,000.00 and $1,600,000.00 per share for 20 consecutive trading days, subject to a one year minimum service period prior to vesting.

 (2)

 The shares subject to this stock option vested as to 1/3 of the shares on February 23, 2022, with the remaining shares vesting on an equal monthly basis over the following 24 months.

 (3)

 The shares subject to this stock option vested as to 10% of the shares on February 15, 2023, 10% of the shares on February 15, 2024, 40% of the shares on February 15, 2025 and 40% of the shares on February 15, 2026.

 (4)

 The shares subject to this stock option vested as to 1/3 of the shares on February 23, 2024, with the remaining shares vesting on an equal monthly basis over the following 24 months.

 Option Exercises and Stock Vested

 No options were exercised by any of the
named executive officers and no named executive officers held restricted stock units during the fiscal year ended December 31,
2023.

 Equity Compensation Plan Information

 The following table provides certain information
with respect to our equity compensation plans in effect as of December 31, 2023.

 Plan Category

 Number of

securities to be

issued upon

exercise of

outstanding

options,

warrants and

rights (A)

 Weighted-

average exercise

price of

outstanding

options,

warrants and

rights (B)

 Number of

securities

remaining

available for

future issuance

under equity

compensation

plans (excluding

securities

reflected in

column A) (2) (C)

 Equity compensation plans approved by security holders (1)

 1,375,539

 $

 89.62

 1,805,240

 Equity compensation plans not approved by security holders

 —

 —

 —

 Total

 1,375,539

 $

 89.62

 1,805,240

 (1)

 Consists of the Company's 2012 Amended and Restated Incentive Stock Option Plan, the 2014 Stock Incentive Plan, the 2016 Stock Incentive Plan, the 2017 Stock Incentive Plan, the 2018 Equity Incentive Plan, the 2019 Stock Incentive Plan, the 2020 Stock Incentive Plan, the Amended and Restated 2020 Stock Incentive Plan and the 2019 Employee Stock Purchase Plan, the 2020 Employee Stock Purchase Plan, and the 2022 Employee Stock Purchase Plan (the "ESPP").

 (2)

 Consists of shares available for future issuance under the Amended and Restated 2020 Plan and our ESPP. As of December 31, 2023, 1,071,599 shares of common stock were available for issuance under the Amended and Restated 2020 Plan and 733,641 shares of common stock were available for issuance under the ESPP.

 Employment Contracts and Termination of Employment and Change-In-Control
Arrangements

 Employment Agreement with Seth Lederman

 On February 11, 2014,
the Company entered into an employment agreement (the "Lederman Agreement") with Dr. Seth Lederman to continue to serve
as our President, Chief Executive Officer and Chairman of the Board.

 The base salary for Dr. Lederman
under the Lederman Agreement was $425,000 per annum and as of January 1, 2024, the base salary is $675,000. The Lederman Agreement
has an initial term of one year and automatically renews for successive one year terms unless either party delivers written notice not
to renew at least 60 days prior to the end of the current term.

 Pursuant to the Lederman Agreement,
if the Company terminates Dr. Lederman's employment without Cause (as defined in the Lederman Agreement) or Dr. Lederman resigns
for Good Reason (as defined in the Lederman Agreement), Dr. Lederman is entitled to the following payments and benefits: (1) his
fully earned but unpaid base salary through the date of termination at the rate then in effect, plus all other benefits, if any, under
any group retirement plan, nonqualified deferred compensation plan, equity award plan or agreement, health benefits plan or other group
benefit plan to which Dr. Lederman may be entitled to under the terms of such plans or agreements; (2) a lump sum cash payment in
an amount equal to 12 months of his base salary as in effect immediately prior to the date of termination; (3) continuation
of health benefits for Dr. Lederman and his eligible dependents for a period of 12 months following the date of termination; and
(4) the automatic acceleration of the vesting and exercisability of outstanding unvested stock awards as to the number of stock awards
that would have vested over the 12-month period following termination had Dr. Lederman remained continuously employed by the Company during
such period.

 Pursuant to the Lederman Agreement,
if Dr. Lederman's employment is terminated as a result of death or permanent disability, Dr. Lederman or his estate, as applicable,
is entitled to the following payments and benefits: (1) his fully earned but unpaid base salary through the date of termination at
the rate then in effect; (2) a lump sum cash payment in an amount equal to six months of his base salary as in effect immediately
prior to the date of termination; and (3) the automatic acceleration of the vesting and exercisability of outstanding unvested stock
awards.

 If Dr. Lederman is terminated
without Cause or resigns for Good Reason during the period commencing 90 days prior to a Change in Control (as defined below) or
12 months following a Change in Control, Dr. Lederman shall be entitled to receive, in lieu of the severance benefits described
above, the following payments and benefits: (1) a lump sum cash payment in an amount equal to 36 months of his base salary
as in effect immediately prior to the date of termination, except that, if and while Dr. Lederman is still entitled to the Sale Bonus
(as defined below), it will only be 18 months; (2) continuation of health benefits for Dr. Lederman and his eligible dependents
for a period of 24 months following the date of termination, except that, if and while Dr. Lederman is still entitled to the Sale
Bonus it will only be 12 months; and (3) the automatic acceleration of the vesting and exercisability of outstanding unvested stock
awards.

 If during the term
of the Lederman Agreement or within 120 days after Dr. Lederman is terminated without Cause or resigns for Good Reason, following
a Change in Control, the Company consummates a Change in Control transaction in which the Enterprise Value (as defined below) equals
or exceeds $50 million, Dr. Lederman shall be entitled to receive a lump sum payment equal to 4.4% of the Enterprise Value (the
"Sale Bonus"). The Sale Bonus provision of the Lederman Agreement will terminate upon the Company granting
Dr. Lederman long-term incentive compensation mutually agreed to by the Board and Dr. Lederman.

 For purposes of the Lederman
Agreement, "Cause" generally means (1) commission of an act of fraud, embezzlement or dishonesty or some other
illegal act that has a demonstrable material adverse impact on the Company or any successor or affiliate of the Company, (2) conviction
of, or entry into a plea of "guilty" or "no contest" to, a felony, (3) unauthorized use or disclosure
of the Company's confidential information or trade secrets or any successor or affiliate of the Company that has, or may
reasonably be expected to have, a material adverse impact on any such entity; (4) gross negligence, failure to follow a material,
lawful and reasonable request of the Board or material violation of any duty of loyalty to the Company or any successor or affiliate
of the Company, or any other demonstrable material willful misconduct by Dr. Lederman, (5) ongoing and repeated failure or
refusal to perform or neglect of his duties as required by his employment agreement, which failure, refusal or neglect continues
for 30 days following Dr. Lederman's receipt of written notice from the Board stating with specificity the nature of
such failure, refusal or neglect, provided that such failure to perform is not as a result of illness, injury or medical incapacity,
or (6) material breach of any Company policy or any material provision of the Lederman Agreement.

 For purposes of the Lederman
Agreement, "Good Reason" generally means (1) a material diminution in Dr. Lederman's title, authority, duties
or responsibilities, (2) a material diminution in Dr. Lederman's base compensation, unless such a reduction is imposed
across-the-board to the Company's senior management, and such reduction is not greater than 15%, (3) a material change
in the geographic location at which Dr. Lederman must perform his duties, (4) any other action or inaction that constitutes
a material breach by the Company or any successor or affiliate of the Company's obligations to Dr. Lederman under the Lederman
Agreement, or (5) the Company elects not to renew the Lederman Agreement for another term.

 For purposes of the Lederman
Agreement, "Change in Control" generally means:

 A transaction or series of transactions (other than public offerings) that results in any person or entity or related group of persons or entities (other than the Company, its subsidiaries, an employee benefit plan maintained by the Company or any of its subsidiaries or a person or entity that, prior to such transaction, directly or indirectly controls, is controlled by, or is under common control with, the Company) of beneficial ownership (within the meaning of Rule 13d-3 under the Exchange Act) of more than 40% of the total combined voting power of the Company's securities outstanding immediately after such acquisition;

 (1) a merger, consolidation, reorganization, or business combination or (2) the sale, exchange or transfer of all or substantially all of the Company's assets in any single transaction or series of transactions or (3) the acquisition of assets or stock of another entity, in each case other than a transaction:

 which results in the Company's voting securities outstanding immediately before the transaction continuing to represent, directly or indirectly, at least 60% of the combined voting power of the successor entity's outstanding voting securities immediately after the transaction, and

 after which no person or group beneficially owns voting securities representing 40% or more of the combined voting power of the Company or its successor; provided, however, that no person or group is treated as beneficially owning 40% or more of combined voting power of the Company or its successor solely as a result of the voting power held in the Company prior to the consummation of the transaction.

 For purposes of the Lederman
Agreement, "Enterprise Value" generally means (1) in a Change in Control in which consideration is received by the
Company, the total cash and non-cash consideration, including debt assumed, received by the Company, net of any fees and expenses
in connection with the transaction and (2) in a Change in Control in which consideration is payable to the stockholders of the
Company, the total cash and non-cash consideration, including debt assumed, payable to the Company's stockholders net of
any fees and expenses in connection with the transaction. Enterprise Value also includes any cash or non-cash consideration
payable to the Company or to the Company's stockholders on a contingent, earnout or deferred basis.

 Employment Agreement with Gregory Sullivan

 On June 3, 2014, the
Company entered into an employment agreement (the "Sullivan Agreement") with Dr. Gregory Sullivan to serve as our Chief
Medical Officer. The base salary for Dr. Sullivan under the Sullivan Agreement was $225,000 per annum and as of January
1, 2024, the base salary is $499,200. The Sullivan Agreement had an initial term of one year and automatically renews
for successive one year terms unless either party delivers written notice not to renew at least 60 days prior to the end of the
current term.

 Pursuant to the Sullivan
Agreement, if the Company terminates Dr. Sullivan's employment without Cause (as defined below) or Executive resigns for
Good Reason (as defined below), Dr. Sullivan is entitled to the following payments and benefits: (1) his fully earned but
unpaid base salary through the date of termination at the rate then in effect, plus all other benefits, if any, under any
group retirement plan, nonqualified deferred compensation plan, equity award plan or agreement, health benefits plan or other group
benefit plan to which Dr. Sullivan may be entitled to under the terms of such plans or agreements; (2) a lump sum cash payment
in an amount equal to 12 months of his base salary as in effect immediately prior to the date of termination; (3) continuation
of health benefits for Dr. Sullivan and his eligible dependents for a period of 12 months following the date of termination;
and (4) the automatic acceleration of the vesting and exercisability of outstanding unvested stock awards as to the number
of stock awards that would have vested over the 12-month period following termination had Dr. Sullivan remained continuously employed
by the Company during such period.

 Pursuant to the Sullivan
Agreement, if Dr. Sullivan's employment is terminated as a result of death or permanent disability, Dr. Sullivan or his estate,
as applicable, is entitled to his fully earned but unpaid base salary through the end of the month in which termination occurs at the
rate then in effect.

 For purposes of the Sullivan
Agreement, "Cause" generally means (1) commission of an act of fraud, embezzlement or dishonesty or some other
illegal act that has a demonstrable material adverse impact on the Company or any successor or affiliate of the Company, (2) conviction
of, or entry into a plea of "guilty" or "no contest" to, a felony, (3) unauthorized use or disclosure
of the Company's confidential information or trade secrets or any successor or affiliate of the Company that has, or may
reasonably be expected to have, a material adverse impact on any such entity, (4) gross negligence, failure to follow a material,
lawful and reasonable request of the Company or material violation of any duty of loyalty to the Company or any successor or affiliate
of the Company, or any other demonstrable material misconduct by Dr. Sullivan, (5) ongoing and repeated failure or refusal
to perform or neglect of his duties as required by his employment agreement, which failure, refusal or neglect continues for 30 days
following Dr. Sullivan's receipt of written notice from the Company stating with specificity the nature of such failure,
refusal or neglect, or (6) material breach of any Company policy or any material provision of the Sullivan Agreement.

 For purposes of the Sullivan
Agreement, "Good Reason" generally means (1) a material diminution in Dr. Sullivan's title, authority, duties
or responsibilities, (2) a material diminution in the executive officer's base compensation, unless such a reduction
is imposed across-the-board to the Company's senior management and such reduction is not greater than 15%, (3) a material
change in the geographic location at which the executive officer must perform his duties, (4) any other action or inaction
that constitutes a material breach by the Company or any successor or affiliate of the Company's obligations to Dr. Sullivan
under the Agreement, or (5) the Company elects not to renew the Agreement for another term.

 Employment Agreement with Bradley Saenger

 On February 23, 2021, the
Company entered into an employment agreement (the "Saenger Agreement") with Mr. Bradley Saenger to serve as our Chief Financial
Officer. The base salary for Mr. Saenger under the Saenger Agreement was $483,600 per annum as of January 1, 2024. The
Saenger Agreement has an initial term of one year and automatically renews for successive one year terms unless either party delivers
written notice not to renew at least 60 days prior to the end of the current term.

 Pursuant to the Saenger Agreement,
if the Company terminates Mr. Saenger's employment without Cause (as defined below) or Executive resigns for Good Reason (as defined
below), Mr. Saenger is entitled to the following payments and benefits: (1) his fully earned but unpaid base salary through the
date of termination at the rate then in effect, plus all other benefits, if any, under any group retirement plan, nonqualified deferred
compensation plan, equity award plan or agreement, health benefits plan or other group benefit plan to which Mr. Saenger may be entitled
to under the terms of such plans or agreements; (2) a lump sum cash payment in an amount equal to 12 months of his base salary
as in effect immediately prior to the date of termination; (3) continuation of health benefits for Mr. Saenger and his eligible
dependents for a period of 12 months following the date of termination; and (4) the automatic acceleration of the vesting and
exercisability of outstanding unvested stock awards as to the number of stock awards that would have vested over the 12-month period
following termination had Mr. Saenger remained continuously employed by the Company during such period.

 Pursuant to the Saenger Agreement,
if Mr. Saenger's employment is terminated as a result of death or permanent disability, Mr. Saenger or his estate, as applicable,
is entitled to his fully earned but unpaid base salary through the end of the month in which termination occurs at the rate then in effect.

 For purposes of the Saenger
Agreement, "Cause" generally means (1) commission of an act of fraud, embezzlement or dishonesty or some other
illegal act that has a demonstrable material adverse impact on the Company or any successor or affiliate of the Company, (2) conviction
of, or entry into a plea of "guilty" or "no contest" to, a felony, (3) unauthorized use or disclosure
of the Company's confidential information or trade secrets or any successor or affiliate of the Company that has, or may
reasonably be expected to have, a material adverse impact on any such entity, (4) gross negligence, failure to follow a material,
lawful and reasonable request of the Company or material violation of any duty of loyalty to the Company or any successor or affiliate
of the Company, or any other demonstrable material misconduct by Mr. Saenger, (5) ongoing and repeated failure or refusal
to perform or neglect of his duties as required by his employment agreement, which failure, refusal or neglect continues for 30 days
following Mr. Saenger's receipt of written notice from the Company stating with specificity the nature of such failure, refusal
or neglect, or (6) material breach of any Company policy or any material provision of the Saenger Agreement.

 For purposes of the Saenger
Agreement, "Good Reason" generally means (1) a material diminution in Mr. Saenger's title, authority, duties
or responsibilities, (2) a material diminution in the executive officer's base compensation, unless such a reduction
is imposed across-the-board to the Company's senior management and such reduction is not greater than 15%, (3) a material
change in the geographic location at which the executive officer must perform his duties, (4) any other action or inaction
that constitutes a material breach by the Company or any successor or affiliate of the Company's obligations to Mr. Saenger
under the Agreement, or (5) the Company elects not to renew the Agreement for another term.

 Employment Agreement with Jessica Morris

 On February 23, 2021, the
Company entered into an employment agreement (the "Morris Agreement") with Ms. Jessica Morris to serve as our Chief Operating
Officer. The base salary for Ms. Morris under the Morris Agreement was $494,000 per annum as of January 1, 2024. The
Morris Agreement has an initial term of one year and automatically renews for successive one year terms unless either party delivers written
notice not to renew at least 60 days prior to the end of the current term.

 Pursuant to the Morris Agreement,
if the Company terminates Ms. Morris's employment without Cause (as defined below) or Executive resigns for Good Reason (as defined
below), Ms. Morris is entitled to the following payments and benefits: (1) her fully earned but unpaid base salary through the date
of termination at the rate then in effect, plus all other benefits, if any, under any group retirement plan, nonqualified deferred
compensation plan, equity award plan or agreement, health benefits plan or other group benefit plan to which Ms. Morris may be entitled
to under the terms of such plans or agreements; (2) a lump sum cash payment in an amount equal to 12 months of her base salary
as in effect immediately prior to the date of termination; (3) continuation of health benefits for Ms. Morris and her eligible dependents
for a period of 12 months following the date of termination; and (4) the automatic acceleration of the vesting and exercisability
of outstanding unvested stock awards as to the number of stock awards that would have vested over the 12-month period following termination
had Ms. Morris remained continuously employed by the Company during such period.

 Pursuant to the Morris Agreement,
if Ms. Morris's employment is terminated as a result of death or permanent disability, Ms. Morris or her estate, as applicable,
is entitled to her fully earned but unpaid base salary through the end of the month in which termination occurs at the rate then in effect.

 For purposes of the Morris
Agreement, "Cause" generally means (1) commission of an act of fraud, embezzlement or dishonesty or some other
illegal act that has a demonstrable material adverse impact on the Company or any successor or affiliate of the Company, (2) conviction
of, or entry into a plea of "guilty" or "no contest" to, a felony, (3) unauthorized use or disclosure
of the Company's confidential information or trade secrets or any successor or affiliate of the Company that has, or may
reasonably be expected to have, a material adverse impact on any such entity, (4) gross negligence, failure to follow a material,
lawful and reasonable request of the Company or material violation of any duty of loyalty to the Company or any successor or affiliate
of the Company, or any other demonstrable material misconduct by Ms. Morris, (5) ongoing and repeated failure or refusal to
perform or neglect of her duties as required by her employment agreement, which failure, refusal or neglect continues for 30 days
following Ms. Morris's receipt of written notice from the Company stating with specificity the nature of such failure, refusal
or neglect, or (6) material breach of any Company policy or any material provision of the Morris Agreement.

 For purposes of the Morris
Agreement, "Good Reason" generally means (1) a material diminution in Ms. Morris's title, authority, duties
or responsibilities, (2) a material diminution in the executive officer's base compensation, unless such a reduction
is imposed across-the-board to the Company's senior management and such reduction is not greater than 15%, (3) a material
change in the geographic location at which the executive officer must perform her duties, (4) any other action or inaction
that constitutes a material breach by the Company or any successor or affiliate of the Company's obligations to Ms. Morris
under the Agreement, or (5) the Company elects not to renew the Agreement for another term.

 Directors Compensation Table

 Each
of our non-employee directors, other than the lead director, receives an annual cash retainer of $55,000; the retainer for the
lead director is $75,000. In addition, during 2023, each of our non-employee directors received stock options to purchase shares
of our common stock valued at $27,475 as determined by the Black Scholes method on the date of grant, which vest on the next annual
meeting of stockholders. The following table sets forth summary information concerning the total compensation paid to our non-employee
directors in 2023 for services to our Company.

 Name

 Cash Compensation ($)

 Option Awards ($) (1)

 Total ($)

 $

 $

 $

 $

 $

 $

 $

 $

 $

 $

 $

 $

 $

 43,542

 $

 69,511

 $

 113,053

 $

 $

 $

 James Treco (2)

 $

 75,000

 $

 $

 102,475

 Total:

 $

 393,542

 $

 234,361

 $

 627,903

 (1)

 Represents the aggregate grant date fair value of stock options granted in accordance with FASB ASC Topic 718. For the relevant assumptions used in determining these amounts, refer to Note 14 to our audited financial statements. These amounts do not necessarily correspond to the actual value that may be recognized from the stock option grant.

 (2)

 Mr. Treco received additional cash compensation for serving as lead director.

 ITEM 12 - SECURITY OWNERSHIP OF
CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

sets forth certain information regarding beneficial ownership of our common stock as of March 27, 2024:

 by each person who is known by us to beneficially own more than 5% of our common stock;

 by each of our officers and directors; and

 by all of our officers and directors as a group.

 Unless otherwise indicated
in the footnotes to the following table, each person named in the table has sole voting and investment power and that person's
address is c/o Tonix Pharmaceuticals Holding Corp., 26 Main Street, Suite 101, Chatham, New Jersey 07928.

 NAME OF OWNER

 TITLE OF CLASS

 NUMBER OF

SHARES
 OWNED(1)

 PERCENTAGE OF

 COMMON
 STOCK (2)

 5% Holders

 Sabby Management, LLC

 5,205,348

 (3)

 6.4

 Directors and Executive Officers

 176,003

 (4)

 *

 42,631

 (5)

 *

 40,247

 (6)

 *

 48,916

 (7)

 *

 22,008

 (8)

 *

 22,037

 (9)

 *

 22,008

 (10)

 *

 22,032

 (11)

 *

 22,880

 (12)

 *

 21,446

 (13)

 *

 James Treco

 22,274

 (14)

 *

 Officers and Directors as a Group
 (11 persons)

 462,482

 (15)

 *

 %

 * Denotes less than 1%

 (2) Percentage based upon 80,882,754 shares of common stock issued and
outstanding as of March 27, 2024, including 7,158,558 shares underlying prefunded warrants.

 (3) Based solely on a Schedule 13G filed with the SEC on January
3, 2024, by Sabby Volatility Warrant Master Fund Ltd., Sabby Management LLC and Hal Mintz share voting and dispositive power over
these shares. The mailing address for Sabby Management, LLC and Mr. Mintz is 115 Hidden Hills Drive, Spicewood TX 78669. The mailing
address for Sabby Volatility Warrant Master Fund Ltd. is 89 Nexus Way, Camana Bay, Grand Cayman KY1-9007, Cayman Islands.

 (4) Includes 171,557 shares of common
stock underlying options which are currently exercisable or become exercisable within 60 days, 2 shares of common stock owned
by Lederman & Co, 1 share of common stock owned by L&L, 1 share of common stock owned by Targent, 1 share of common stock
owned by Leder Laboratories, Inc. (Leder Labs), 1 share of common stock owned by Starling, 3,878 shares owned through an IRA account
and 1 share owned by Dr. Lederman's spouse. Seth Lederman, as the Managing Member of Lederman & Co and Targent, the
Manager of L&L and the Chairman of Leder Labs and Starling, has investment and voting control over the shares held by these
entities.

 (5) Includes 42,630 shares of common stock
underlying options which are currently exercisable or become exercisable within 60 days.

 (6) Includes 40,148 shares of common stock
underlying options which are currently exercisable or become exercisable within 60 days.

 (7) Includes 48,419 shares of common stock
underlying options which are currently exercisable or become exercisable within 60 days.

 (8) Includes 21,957 shares of common stock
underlying options and restricted stock units which are currently exercisable or vested or become exercisable within 60 days.

 (9) Includes 22,009 shares of common stock
underlying options and restricted stock units which are currently exercisable or vested or become exercisable within 60 days.

 (10) Includes 22,008 shares of common
stock underlying options and restricted stock units which are currently exercisable or vested or become exercisable within 60
days.

 (11) Includes 22,005 shares of common
stock underlying options and restricted stock units which are currently exercisable or vested or become exercisable within 60
days.

 (12) Includes 22,880 shares of common
stock underlying options and restricted stock units which are currently exercisable or vested or become exercisable within 60
days.

 (13) Includes 21,446 shares of common
stock underlying options which are currently exercisable or become exercisable within 60 days

 (14) Includes 22,223 shares of common stock
underlying options which are currently exercisable or become exercisable within 60 days

 (15) Includes 457,282 shares of common
stock underlying options which are currently exercisable or vested or become exercisable within 60 days, 2 shares of common stock
owned by Lederman & Co, 1 share of common stock owned by L&L, 1 share of common stock owned by Targent, 1 share of common
stock owned by Leder Labs, 1 share of common stock owned by Starling, 3,878 shares owned through an IRA account of Dr. Lederman,
and 1 share owned by Dr. Lederman's spouse.

 ITEM 13 - CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE

 We have adopted a written
related-person transactions policy that sets forth our policies and procedures regarding the identification, review, consideration and
oversight of "related-party transactions." For purposes of our policy only, a "related-party transaction" is
a transaction, arrangement or relationship (or any series of similar transactions, arrangements or relationships) in which we and any
"related party" are participants involving an amount that exceeds the lesser of $120,000
or one percent of the average of our total assets at year end for the last two completed fiscal years.

 A related party is
any executive officer, director or a holder of more than five percent of our common stock, including any of their immediate family
members and any entity owned or controlled by such persons.

 Where a transaction
has been identified as a related-party transaction, our Chief Compliance Officer must present information regarding the proposed
related-party transaction to our Nominating and Corporate Governance Committee for review. The presentation must include a description
of, among other things, the material facts, the direct and indirect interests of the related parties, the benefits of the transaction
to us and whether any alternative transactions are available. To identify related-party transactions in advance, we rely on information
supplied by our executive officers, directors and certain significant stockholders. In considering related-party transactions,
our Nominating and Corporate Governance Committee will take into account the relevant available facts and circumstances including,
but not limited to:

 whether the transaction was undertaken in the ordinary course of our business;

 whether the related party transaction was initiated by us or the related party;

 whether the transaction with the related party is proposed to be, or was, entered into on terms no less favorable to us than terms that could have been reached with an unrelated third party;

 the purpose of, and the potential benefits to us from the related party transaction;

 the approximate dollar value of the amount involved in the related party transaction, particularly as it relates to the related party;

 the related party's interest in the related party transaction, and

 any other information regarding the related party transaction or the related party that would be material to investors in light of the circumstances of the particular transaction.

 The Nominating and
Corporate Governance Committee shall then make a recommendation to the Board, who will determine whether or not to approve of the
related party transaction, and if so, upon what terms and conditions. In the event a director has an interest in the proposed transaction,
the director must recuse himself or herself from the deliberations and approval.

 During the last two
fiscal years, there have been no related party transactions.

 ITEM 14 – PRINCIPAL ACCOUNTING FEES AND SERVICES

 Our independent registered public accounting
firm is EisnerAmper LLP, Iselin, New Jersey, PCAOB ID: 274.

 (1) Audit Fees

 The aggregate fees
billed by our independent registered public accounting firm, for professional services rendered for the audit of our annual financial
statements for the years ended December 31, 2023 and 2022, including review of our interim financial statements as well as registration
statement filings with the SEC and comfort letters issued to underwriters were $522,533 and $383,880, respectively.

 (2) Audit-Related Fees

 We did not incur fees
to our independent registered public accounting firm for audit related fees during the fiscal years ended December 31, 2023 and
2022.

 (3) Tax Fees

 We did not incur fees
to our independent registered public accounting firm for tax services during the fiscal years ended December 31, 2023 and 2022.

 (4) All Other Fees

 None.

 Pre-Approval Policies and Procedures

 Consistent with SEC
policies and guidelines regarding audit independence, the Audit Committee is responsible for the pre-approval of all audit and
permissible non-audit services provided by our principal accountants on a case-by-case basis. Our Audit Committee has established
a policy regarding approval of all audit and permissible non-audit services provided by our principal accountants. Our Audit Committee
pre-approves these services by category and service. Our Audit Committee has pre-approved all of the services provided by our principal
accountants.

 ITEM 15 – EXHIBITS, FINANCIAL STATEMENT SCHEDULES

 (c)

 Index to Exhibits

 The Exhibits listed
below are identified by numbers corresponding to the Exhibit Table of Item 601 of Regulation S-K. The Exhibits designated by an
asterisk (*) are management contracts or compensatory plans or arrangements required to be filed pursuant to Item 15.

 EXHIBIT INDEX

 Exhibit

No.

 Description

 3.01

 Articles of Incorporation, filed as an exhibit to the Registration Statement on Form S-1, filed with the Securities and Exchange Commission (the "Commission") on April 9, 2008 and incorporated herein by reference.

 3.02

 Articles of Merger between Tamandare Explorations Inc. and Tonix Pharmaceuticals Holding Corp., effective October 11, 2011, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on October 17, 2011 and incorporated herein by reference.

 3.03

 Third Amended and Restated Bylaws, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 3, 2016 and incorporated herein by reference.

 3.04

 Certificate of Change of Tonix Pharmaceuticals Holding Corp., dated March 13, 2017 and effective March 17, 2017, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on March 16, 2017 and incorporated herein by reference.

 3.05

 Certificate of Amendment to Articles of Incorporation, effective June 16, 2017, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 16, 2017 and incorporated herein by reference.

 3.06

 Certificate of Amendment to Tonix Pharmaceuticals Holding Corp.'s Articles of Incorporation, as amended, filed with the Secretary of State of the State of Nevada on May 3, 2019.

 3.07

 Form of Certificate of Designation of Series A Convertible Preferred Stock, filed as an exhibit to the Current Report on Form 8-K, filed
with the Commission on October 25, 2022 and incorporated herein by reference.

 3.08

 Form of Certificate of Designation of Series B Convertible Preferred Stock, filed as an exhibit to the Current Report on Form 8-K, filed
with the Commission on October 25, 2022 and incorporated herein by reference.

 3.09

 Certificate of Amendment to Tonix Pharmaceuticals Holding Corp.'s Articles of Incorporation, filed as an exhibit to the Current
Report on Form 8-K, filed with the Commission on May 16, 2022 and incorporated herein by reference.

 4.01

 Specimen Common Stock Certificate of the Registrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on May 24, 2018 and incorporated herein by reference.

 4.02

 Form of Warrant, filed as an exhibit to the Registration Statement on Form S-1, filed with the Commission on November 14, 2019 and incorporated herein by reference.

 4.03

 Form of Warrant Agency Agreement, filed as an exhibit to the Registration Statement on Form S-1, filed with the Commission on November 14, 2019 and incorporated herein by reference.

 4.04

 Form of Warrant, filed as an exhibit to the Registration Statement on Form S-1, filed with the Commission on February 6, 2020 and incorporated herein by reference

 4.05

 Form of Warrant Agency Agreement, filed as an exhibit to the Registration Statement on Form S-1, filed with the Commission on February 6, 2020 and incorporated herein by reference.

 4.06

 Description of Registrant's Securities, filed herewith.

 10.01

 Tonix Pharmaceuticals Holding Corp. 2012 Amended and Restated Incentive Stock Option Plan, incorporated herein by reference to Appendix B to our Definitive Proxy Statement on Schedule 14A (File No. 000-54879), filed with the Commission on April 3, 2013.*

 10.02

 Employment Agreement, between Tonix Pharmaceuticals Holding Corp. and Seth Lederman, dated February 11, 2014, filed as an exhibit to the Current Report on Form 8-K filed with the Commission on February 14, 2014 and incorporated herein by reference.*

 10.03

 Tonix Pharmaceuticals Holding Corp. 2014 Stock Incentive Plan, incorporated herein by reference to Annex A to our Definitive Proxy Statement on Schedule 14A (File No. 001-36019), filed with the Commission on May 2, 2014.*

 10.04

 Lease Amendment and Expansion Agreement, dated February 11, 2014, by and between 509 Madison Avenue Associates, L.P. and Tonix Pharmaceuticals, Inc., filed as an exhibit to the Annual Report on Form 10-K filed with the Commission on February 27, 2015 and incorporated herein by reference.

 10.05

 Employment Agreement, between Tonix Pharmaceuticals Holding Corp. and Gregory Sullivan, dated June 3, 2014, filed as an exhibit to the Current Report on Form 8-K filed with the Commission on June 3, 2014 and incorporated herein by reference.*

 10.06

 Tonix Pharmaceuticals Holding Corp. 2016 Stock Incentive Plan, incorporated herein by reference to Annex A to our Definitive Proxy Statement on Schedule 14A (File No. 001-36019), filed with the Commission on March 25, 2016.*

 10.07

 Tonix Pharmaceuticals Holding Corp. 2017 Stock Incentive Plan, incorporated herein by reference to Appendix A to our Definitive Proxy Statement on Schedule 14A (File No. 001-36019), filed with the Commission on May 2, 2017.*

 10.08

 Tonix Pharmaceuticals Holding Corp. 2018 Equity Incentive Plan, incorporated herein by reference to our Definitive Proxy Statement on Schedule 14A (File No. 001-36019), filed with the Commission on April 19, 2018.*

 10.09

 Purchase Agreement, dated October 18, 2018, between Tonix Pharmaceuticals Holding Corp. and Lincoln Park Capital Fund, LLC, filed as an exhibit to the Current Report on Form 8-K filed with the Commission on October 24, 2018 and incorporated herein by reference.

 10.10

 Tonix Pharmaceuticals Holding Corp. 2019 Stock Incentive Plan, incorporated herein by reference to Appendix A to our Definitive Proxy Statement on Schedule 14A (File No. 001-36019), filed with the Commission on March 18, 2019.*

 10.11

 Tonix Pharmaceuticals Holding Corp. 2019 Employee Stock Purchase Plan, incorporated herein by reference to Appendix B to our Definitive Proxy Statement on Schedule 14A (File No. 001-36019), filed with the Commission on March 18, 2019.*

 10.12

 License Agreement, dated May 20, 2019, between Tonix Pharmaceuticals Holding Corp. and The Trustees of Columbia University in the City of New York, filed as an exhibit to the Quarterly Report on Form 10-Q filed with the Commission on August 12, 2019 and incorporated herein by reference.

 10.13

 Purchase Agreement, dated August 20, 2019, between Tonix Pharmaceuticals Holding Corp. and Lincoln Park Capital Fund, LLC, filed as an exhibit to the Current Report on Form 8-K filed with the Commission on August 23, 2019 and incorporated herein by reference.

 10.14

 Asset Purchase Agreement, dated August 19, 2019, between Tonix Pharmaceuticals Holding Corp. and TRImaran Pharma, Inc., filed as an exhibit to the Quarterly Report on Form 10-Q filed with the Commission on November 8, 2019 and incorporated herein by reference.

 10.15

 First Amended and Restated Exclusive License Agreement, dated August 19, 2019, between Tonix Pharmaceuticals Holding Corp. and Wayne State University, filed as an exhibit to the Quarterly Report on Form 10-Q filed with the Commission on November 8, 2019 and incorporated herein by reference.

 10.16

 Exclusive License Agreement, dated September 16, 2019, between Tonix Pharmaceuticals Holding Corp. and The Trustees of Columbia University in the City of New York, filed as an exhibit to the Quarterly Report on Form 10-Q filed with the Commission on November 8, 2019 and incorporated herein by reference.

 10.17

 Tonix Pharmaceuticals Holding Corp. 2020 Stock Incentive Plan, incorporated herein by reference to Appendix A to our Definitive Proxy Statement on Schedule 14A (File No. 001-36019), filed with the Commission on December 13, 2019.*

 10.18

 Research Collaboration Agreement between Tonix Pharmaceutical, Inc. and Southern Research Institute, dated November 7, 2018, filed as an exhibit to the Annual Report on Form 10-K, filed with the Commission on March 24, 2020 and incorporated herein by reference.

 10.19

 License Agreement, dated May 5, 2020, between Tonix Pharmaceuticals (Canada) Inc. and The Governors of the University of Alberta, filed as an exhibit to the Quarterly Report on Form 10-Q, filed with the Commission on August 10, 2020 and incorporated herein by reference.

 10.20

 Asset Purchase Agreement, dated June 11, 2020, between Tonix Pharmaceuticals, Inc. and Trigemina, Inc., filed as an exhibit to the Quarterly Report on Form 10-Q, filed with the Commission on May 12, 2020 and incorporated herein by reference.

 10.21

 Amended and Restated Exclusive License Agreement, dated June 11, 2020, between Tonix Pharmaceuticals, Inc. and The Board of Trustees of the Leland Stanford Junior University, filed as an exhibit to the Quarterly Report on Form 10-Q, filed with the Commission on August 10, 2020 and incorporated herein by reference.

 10.22

 Assignment and Agreement, dated June 11, 2020, between Tonix Pharmaceuticals, Inc. and The Board of Trustees of the Leland Stanford Junior University, filed as an exhibit to the Quarterly Report on Form 10-Q, filed with the Commission on August 10, 2020 and incorporated herein by reference.

 10.23

 Purchase and Sale Agreement, dated July 1, 2020, between Tonix Pharmaceuticals Holding Corp. and Seller named therein, filed as an exhibit to the Quarterly Report on Form 10-Q, filed with the Commission on August 10, 2020 and incorporated herein by reference.

 10.24

 Real Property Purchase and Sale Agreement, dated October 14, 2020, between Tonix Pharmaceuticals Holding Corp. and the Seller named therein, filed as an exhibit to the Quarterly Report on Form 10-Q, filed with the Commission on November 9, 2020 and incorporated herein by reference.

 10.25

 Tonix Pharmaceuticals Holding Corp. Amended and Restated 2020 Stock Incentive Plan, incorporated herein by reference to Appendix A to our Definitive Proxy Statement on Schedule 14A (File No. 001-36019), filed with the Commission on March 30, 2020.*

 10.26

 Employment Agreement, between Tonix Pharmaceuticals Holding Corp. and Jessica Morris, dated February 23, 2021, filed as an exhibit to the Current Report on Form 8-K filed with the Commission on February 26, 2021 and incorporated herein by reference.*

 10.27

 Employment Agreement, between Tonix Pharmaceuticals Holding Corp. and Bradley Saenger, dated February 23, 2021, filed as an exhibit to the Current Report on Form 8-K filed with the Commission on February 26, 2021 and incorporated herein by reference.*

 10.28

 Purchase and Sale Agreement, dated March 5, 2021, between Tonix Pharmaceuticals Holding Corp. and the Seller named therein, filed as an exhibit to the Annual Report on Form 10-K, filed with the Commission on March 15, 2021 and incorporated herein by reference.

 10.29

 License Agreement, dated April 14, 2021, between the Company and OyaGen, Inc., filed as an exhibit to the Quarterly Report on Form 10-Q filed with the Commission on May 10, 2021 and incorporated herein by reference

 10.30

 Purchase Agreement, dated May 14, 2021, by and between Tonix Pharmaceuticals Holding Corp. and Lincoln Park Capital Fund, LLC, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on May 14, 2021, and incorporated herein by reference.

 10.31

 Purchase and Sale Agreement, dated July 26, 2021, between the Company and Southern Research, filed as an exhibit to the Quarterly Report on Form 10-Q filed with the Commission on August 9, 2021, and incorporated herein by reference.

 10.32

 Purchase Agreement, dated August 16, 2022, by and between Tonix Pharmaceuticals Holding Corp. and Lincoln Park Capital Fund, LLC, filed as an exhibit to the Current Report on Form 8-K filed with the Commission on August 17, 2022, and incorporated herein by reference.

 10.33

 Tonix Pharmaceuticals Holding Corp. 2022 Employee Stock Purchase Plan, incorporated herein by reference to Appendix A to our Definitive Proxy Statement on Schedule 14A, filed with the Commission on March 18, 2022.*

 10.34

 Form of Securities Purchase Agreement between Tonix Pharmaceuticals Holding Corp. and the investors thereto, dated October 25, 2022, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on October 25, 2022, and incorporated herein by reference.

 10.35

 Form of Side Letter between Tonix Pharmaceuticals Holding Corp. and the investors thereto, dated October 25, 2022, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on October 25, 2022, and incorporated herein by reference.

 10.36

 Form of Registration Agreement between Tonix Pharmaceuticals
 Holding Corp. and the investors thereto, dated October 25, 2022, filed as an exhibit to the Current Report on Form 8-K, filed with the
 Commission on October 25, 2022, and incorporated herein by reference.

 10.37

 Asset Purchase Agreement, dated as of June 23, 2023, by and among Upsher-Smith Laboratories, LLC, Tonix Medicines, Inc. and Tonix Pharmaceuticals Holding Corp., filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on June 26, 2023, and incorporated herein by reference.

 10.38

 Transition Services Agreement, dated as of June 30,
 2023, by and among Upsher-Smith Laboratories, LLC and Tonix Medicines Inc., filed as an exhibit to the Current Report on Form 8-K, filed
 with the Commission on July 3, 2023, and incorporated herein by reference.

 10.39

 Placement Agent Agreement, dated July 27, 2023, among Tonix Pharmaceuticals Holding Corp., A.G.P./Alliance Global Partners and Brookline Capital Markets, a division of Arcadia Securities, LLC, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on July 28, 2023, and incorporated herein by reference.

 10.40

 Form of Pre-Funded Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on July 18, 2023 and incorporated herein by reference.

 10.41

 Form of Common Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on July 28, 2023 and incorporated herein by reference.

 10.42

 Placement Agent Agreement, dated September 28, 2023,
 among Tonix Pharmaceuticals Holding Corp., A.G.P./Alliance Global Partners and Brookline Capital Markets, a division of Arcadia Securities,
 LLC, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on September 29, 2023, and incorporated herein by
 reference.

 10.43

 Form of Pre-Funded Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on September 29, 2023, and incorporated herein by reference

 10.44

 Form of Series A Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on September 29, 2023, and incorporated herein by reference

 10.45

 Form of Series B Warrant, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on September 29, 2023, and incorporated herein by reference

 10.46

 Loan and Guaranty Agreement, dated as of December 8, 2023, by and among the Loan Parties, the Lenders and the JGB Agent, filed with the Commission on December 8, 2023, and incorporated herein by reference

 10.47

 Placement Agent Agreement, dated December 20, 2023,
 between Tonix Pharmaceuticals Holding Corp. and A.G.P./Alliance Global Partners, filed as an exhibit to the Current Report on Form 8-K,
 filed with the Commission on December 21, 2023 and incorporated herein by reference.

 10.48

 Form of Pre-Funded Warrant. filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on December 21, 2023 and incorporated herein by reference.

 10.49

 Form of Series C Warrant. filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on December 21, 2023 and incorporated herein by reference.

 10.50

 Form of Series D Warrant. filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on December 21, 2023 and incorporated herein by reference.

 14.01

 Code of Business Conduct and Ethics for Employees, Executive Officers and Directors, filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on February 16, 2016, and incorporated herein by reference.

 19.01

 Tonix Pharmaceuticals Holding Corp. Insider Trading Policy, filed herewith.

 21.01

 List of Subsidiaries, filed herewith.

 23.01

 Consent of Independent Registered Public Accounting Firm, filed herewith.

 31.01

 Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, filed herewith.

 31.02

 Certification of Chief Financial Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, filed herewith.

 32.01

 Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, filed herewith.

 97.01

 Tonix Pharmaceuticals Holding Corp. Compensation Recovery Policy, filed herewith.

 Certain portions of this exhibit, that are
 not material and would likely cause competitive harm to the registrant if publicly disclosed, have been redacted pursuant to Item 601(b)(10)
 of Regulation S-K.

 * Denotes a management compensatory agreement or arrangement.

 SIGNATURES

 Pursuant to the requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.

 Date: April 1, 2024

 By:

 /s/ SETH LEDERMAN

 Chief Executive Officer (Principal Executive Officer)

 Date: April 1, 2024

 By:

 /s/ BRADLEY SAENGER

 Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

 POWER OF ATTORNEY

 KNOW ALL PERSONS BY
THESE PRESENTS, that each person whose signature appears below constitutes and appoints Seth Lederman and Bradley Saenger, jointly
and severally, his or her attorney-in-fact, with the power of substitution, for him or her in any and all capacities, to sign any
amendments to this Annual Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith,
with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his or
her substitute or substitutes, may do or cause to be done by virtue hereof.

 Pursuant to the requirements
of the Securities Exchange Act of 1934, this Annual Report on Form 10-K has been signed below by the following persons on behalf
of the Registrant and in the capacities and on the dates indicated.

 Name

 Position

 Date

 /s/ SETH LEDERMAN

 Chief Executive Officer, President and Director (Principal Executive Officer)

 /s/ BRADLEY SAENGER

 Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

 /s/ RICHARD BAGGER

 /s/ MARGARET SMITH BELL

 /s/ DAVID GRANGE

 /s/ ADEOYE OLUKOTUN

 /s/ NEWCOMB STILLWELL

 /s/ CAROLYN TAYLOR

 /s/ JAMES TRECO

 James Treco