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 utr:sqft

 UNITED
STATES

 SECURITIES
AND EXCHANGE COMMISSION

 WASHINGTON,
D.C. 20549

 FORM

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

 For
the fiscal year ended December 31, 2023

 or

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

 Commission
File Number 001-37428

 Qualigen
Therapeutics, Inc.

 (Exact
name of registrant as specified in its charter)

 Delaware

 26-3474527

 (State
 or other jurisdiction of

 incorporation
 or organization)

 (I.R.S.
 Employer

 Identification
 No.)

 5857
Owens Avenue, Suite 300, Carlsbad, California 92008

 (Address
of principal executive offices) (Zip Code)

 (760) 452-8111

 Registrant's
telephone number, including area code

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

 Title
 of Each Class

 Trading
 Symbol

 Name
 of Exchange on Which Registered

 Common
 Stock, par value $0.001 per share

 QLGN

 The
 Nasdaq Capital Market

registered pursuant to Section 12(g) of the Act:

 None

by check mark if the registrant is a well-known seasoned issuer, as defined in 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 Section 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 every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 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 emerging growth company. See definitions of "large accelerated filer, "accelerated filer," "smaller
reporting company," and "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 Act). Yes No

 As
of June 30, 2023, the aggregate market value of the registrant's common stock held by non-affiliates was approximately $ 4,570,535
based on the closing price for the common stock of $0.91 on that date. Shares of common stock held by the registrant's executive
officers and directors have been excluded from this calculation, as such persons may be deemed to be affiliates of the registrant. This
determination of affiliate status is not necessarily a conclusive determination for other purposes.

 As
of March 25, 2024, there were 6,307,371 shares of the registrant's common stock outstanding.

 DOCUMENTS
INCORPORATED BY REFERENCE

 None.

 TABLE
OF CONTENTS

 Page
 Number

 Item

 Business

 Item
 1A

 Risk Factors

 Item
 1B

 Unresolved Staff Comments

 Item
 1C

 Cybersecurity

 Item

 Properties

 Item

 Legal Proceedings

 Item

 Mine Safety Disclosures

 Item

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

 Item

 [Reserved]

 Item

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

 Item
 7A

 Quantitative and Qualitative Disclosure About Market Risk

 Item

 Financial Statements and Supplementary Data

 Item

 Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

 Item
 9A

 Controls and Procedures

 Item
 9B

 Other Information

 Item
 9C

 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

 Item

 Directors, Executive Officers and Corporate Governance

 Item

 Executive Compensation

 Item

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

 Item

 Certain Relationships and Related Transactions, and Director Independence

 Item

 Principal Accounting Fees and Services

 Item

 Exhibits and Financial Statement Schedules

 Item

 Form 10-K Summary

 Signatures

 CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS

 This
Annual Report on Form 10-K ("Annual Report") contains forward-looking statements by Qualigen Therapeutics, Inc. that involve
risks and uncertainties and reflect our judgment as of the date of this Report. These statements generally relate to future events or
our future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words
such as "may," "will," "should," "expects," "plans," "anticipates,"
"could," "intends," "target," or "continue" or the negative of these words or other similar
terms or expressions that concern our expectations, strategy, plans or intentions. Such forward-looking statements may relate to, among
other things, potential future development, testing and launch of products and product candidates. Actual events or results may differ
from our expectations due to a number of factors.

 These
forward-looking statements include, but are not limited to, statements about:

 our
 ability to procure sufficient working capital to continue and complete the development, testing and launch of our prospective drug
 products;

 our
 ability to successfully develop any drugs;

 our
 ability to progress our drug candidates through preclinical and clinical development;

 our
 ability to obtain the requisite regulatory approvals for our clinical trials and to begin and complete such trials according to any
 projected timeline;

 our
 ability to complete enrollment in our clinical trials as contemplated by any projected timeline;

 the
 likelihood that future clinical trial data will be favorable or that such trials will confirm any improvements over other products
 or lack negative impacts;

 our
 ability to successfully commercialize any drugs;

 the
 likelihood that patents will issue on our in-licensed patent applications;

 our
 ability to protect our intellectual property; and

 our
 ability to compete.

 By
their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare,
regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur
on longer or shorter timelines than anticipated. In light of the significant uncertainties in these
forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe
that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we caution you that forward-looking
statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and
the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Annual
Report. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which
we operate, are consistent in some future periods with the forward-looking statements contained in this Annual Report, they may not be
predictive of results or developments in other future periods. Any forward-looking statement that we make in this Annual Report speaks
only as of the date of this Annual Report, and we disclaim any intent or obligation to update these forward-looking statements beyond
the date of this Annual Report, except as required by law. This caution is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.

 Future
filings with the Securities and Exchange Commission (the "SEC"), future press releases and future oral or written statements
made by us or with our approval, which are not statements of historical fact, may also contain forward-looking statements. Because such
statements include risks and uncertainties, many of which are beyond our control, actual results may differ materially from those expressed
or implied by such forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we
undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they
are made.

 PART
I

 As
used in this Annual Report, unless the context suggests otherwise, "we," "us," "our,"or "the
Company" refer to Qualigen Therapeutics, Inc.

 Item
1. Business

 Overview

 We
are an early-clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. Our business now consists
of one early-clinical-stage therapeutic program (QN-302) and one preclinical therapeutic program (Pan-RAS).

 Our
lead program, QN-302, is an investigational small molecule G-quadruplexes (G4)-selective transcription inhibitor with strong binding
affinity to G4s prevalent in cancer cells (such as pancreatic cancer). Such binding could, by stabilizing the G4s against DNA
"unwinding," help inhibit cancer cell proliferation. QN-302 is currently undergoing a Phase 1a clinical trial at START
Midwest in Grand Rapids, Michigan, and HonorHealth in Scottsdale, Arizona.

 Our
Pan-RAS program, which is currently at the preclinical stage, consists of a family of RAS oncogene protein-protein interaction inhibitor
small molecules believed to inhibit or block mutated RAS genes' proteins from binding to their effector proteins thereby
leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment
of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers.
 The investigational compounds within our Pan-RAS portfolio are designed to suppress the interaction of endogenous RAS with c-RAF,
upstream of the KRAS, HRAS and NRAS effector pathways.

 On
May 22, 2020, we completed a "reverse recapitalization" transaction with Qualigen, Inc. (not to be confused with the Company);
pursuant to which our merger subsidiary merged with and into Qualigen, Inc. with Qualigen, Inc. surviving as a wholly owned subsidiary
of the Company. The Company, which had previously been known as Ritter Pharmaceuticals, Inc., was renamed Qualigen Therapeutics, Inc.,
and the former stockholders of Qualigen, Inc. acquired, via the recapitalization, a substantial majority of the shares of the Company.
Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol "RTTR,"
commenced trading on Nasdaq, on a post-reverse-stock-split adjusted basis, under the ticker symbol "QLGN" on May 26, 2020.
We are no longer pursuing the gastrointestinal disease treatment business on which Ritter Pharmaceuticals, Inc. had focused before the
reverse recapitalization transaction. On
July 20, 2023, we sold our Qualigen, Inc. subsidiary, which contained our former FastPack diagnostics business to Chembio
Diagnostics, Inc., an American subsidiary of French diagnostics provider Biosynex, S.A. Accordingly, our former FastPack
diagnostics business is reported as Discontinued Operations in this Annual Report.

 The
aggregate net purchase price for Qualigen, Inc. was $5.4 million in cash, of which $450,000 is being held in escrow to satisfy certain
Company indemnification obligations. Any amounts remaining in the escrow that have not been offset or reserved for claims will be released
to us within five business days following January 20, 2025.

 We
own a minority interest in NanoSynex, Ltd. ("NanoSynex"), a privately-held microbiologics diagnostic company domiciled in
Israel. NanoSynex's technology is for Antimicrobial Susceptibility Testing that aims to enable better targeting of antibiotics
for their most suitable uses to ultimately result in faster and more efficacious treatment, hence reducing hospitals' mortality
and morbidity rates. On May 26, 2022, we acquired a 52.8% interest in NanoSynex from our related party Alpha Capital Anstalt ("Alpha")
and NanoSynex, and entered into a Master Agreement for the Operational and Technological Funding of NanoSynex with NanoSynex (the "NanoSynex
Funding Agreement"). On July 20, 2023, we entered into an Amendment and Settlement Agreement with NanoSynex (the "NanoSynex
Amendment"), pursuant to which we agreed to, in exchange for eliminating all future Funding Agreement obligations for us to invest
further cash in NanoSynex (except for obligations to lend NanoSynex $560,000 on or before November 30, 2023, and $670,000 on or before
March 31, 2024), surrender 281,000 Series B Preferred Shares of NanoSynex held by us, resulting in our ownership in NanoSynex being reduced
from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex; in addition, we agreed to surrender approximately
$3.0 million of promissory notes which NanoSynex had issued to us under the Funding Agreement. On November 22, 2023 we further agreed
to eliminate our obligations to lend NanoSynex $560,000 on or before November 30, 2023, and $670,000 on or before March 31, 2024, by
instead surrendering shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced our ownership in NanoSynex voting equity
from approximately 49.97% to 39.90%. NanoSynex was deconsolidated from our financial statements as of July 20, 2023, and is reported
as Discontinued Operations in this Annual Report. Our investment in NanoSynex will be accounted for in the future as an equity method
investment.

 Product
Pipeline

 QN-302

 We
exclusively in-licensed the global rights to the G-Quadruplex ("G4") selective transcription inhibitor platform from University
College London ("UCL") in January 2022. The licensed technology comprises lead compound QN-302 (formerly known as SOP1812)
and back-up compounds that target regulatory regions of cancer genes that down-regulate gene expression in multiple cancer pathways.
Developed by Dr. Stephen Neidle and his group at UCL, the G4 binding concept is derived from nucleic acid research conducted over more
than over 30 years, including research on G4s, which are higher order DNA and RNA structures formed by sequences containing guanine-rich
repeats. G4s are overrepresented in telomeres (a region of repetitive DNA sequences at the end of a chromosome) as well as promoter sequences
and untranslated regions of many oncogenes. Their prevalence is therefore significantly greater in cancer cells compared to normal human
cells.

 G4-selective
small molecules such as QN-302 and backup compounds target the regulatory regions of cancer genes, which have a high prevalence of enriched
G4s. Stable G4-QN-302 complexes can be impediments to replication, transcription or translation of those cancer genes containing G4s,
and the drugs' binding to G4s are believed to stabilize the G4s against possible "unwinding." G4 binders like QN-302
could be efficacious in a variety of cancer types with a high prevalence of G4s.

 We
believe that QN-302 has the potential to demonstrate superior efficacy and activity against pancreatic ductal adenocarcinoma ("PDAC"),
which represents 98% of pancreatic cancers. Pancreatic cancer is the tenth most common cancer in men and the seventh most common in women,
but it is the fourth leading cause of cancer deaths in men and the third leading cause in women; it accounts for about 3% of all cancers
in the United States but is responsible for about 8% of all cancer-related deaths. It has one of the lowest rates of survival of all
cancer types.

 In-vitro
 and in-vivo studies have shown that G4 stabilization by QN-302 resulted in inhibition of target gene expression and cessation
of cell growth in various cancers, including PDAC. In in-vitro studies, QN-302 was potent in inhibiting the growth of several
PDAC cell lines at low nanomolar concentrations. Similarly, in in-vivo studies, QN-302 showed a longer survival duration in a
KPC genetic mouse model for pancreatic cancer than gemcitabine (the current standard of care for PDAC) has historically shown. Additional
preclinical in-vivo studies suggest activity in gemcitabine-resistant PDAC. Data further demonstrated that QN-302 had significant
anti-tumor activity in three patient-derived PDAC xenograft models. Early safety indicators in pancreatic cancer mouse in-vivo models
suggest no significant adverse toxic effects at proposed therapeutic doses.

 On
January 9, 2023, the U.S. Food and Drug Administration ("FDA") granted Orphan Drug Designation ("ODD") to QN-302
for the indication of pancreatic cancer. ODD provides advantages to pharmaceutical companies that are developing investigational drugs
or biological products that show promise in treating rare diseases or conditions that affect fewer than 200,000 people in the United
States, including seven-year marketing exclusivity and eligibility to receive regulatory support and guidance from the FDA in the design
of an overall drug development plan.

 There
are also economic advantages to receiving ODD, including a 25% federal tax credit for expenses incurred in conducting clinical research
on the orphan designated product within the United States. Tax credits may be applied to the prior year or applied to up to 20 years
of future taxes. ODD recipients may also have their Prescription Drug User Fee Act (PDUFA) application fees waived, a potential savings
of around $3.2 million (as of fiscal year 2023) for applications requiring covered clinical data, and may qualify to compete for research
grants from the Office of Orphan Products Development that support clinical studies.

 On
August 1, 2023 we announced that the FDA had cleared our investigational new drug ("IND") application for QN-302, and on
November 1, 2023 the first patient in our Phase 1a clinical trial for QN-302 was dosed at START Midwest in Grand Rapids, Michigan.

 We
will require additional cash resources to be able to continue and complete this Phase 1a clinical trial.

 Pan-RAS
 (formerly referred to as RAS or RAS-F)

 In
July 2020 we entered into an exclusive worldwide in-license agreement with the University of Louisville's Research Foundation ("UofL"
or "ULRF") for the intellectual property covering the "RAS" family of pan-RAS inhibitor small molecule drug candidates,
which are believed to work by blocking RAS mutations directly, thereby inhibiting tumor formation (especially in pancreatic, colorectal
and lung cancers). Pursuant to the license agreement, we will seek to identify and develop a lead drug candidate from the compound family
and, upon commercialization, will pay UofL royalties in the low-to-mid-single-digit percentages on net sales of Pan-RAS inhibitor licensed
products. The license agreement with UofL for Pan-RAS was amended in March 2021 and June 2023.

 RAS
is the most common oncogene in human cancer. Activating mutations in one of the three human RAS gene isoforms (KRAS, HRAS or NRAS) are
present in about one-fourth to one-third of all cancers. For example, mutant KRAS is found in 98% of pancreatic ductal adenocarcinomas,
52% of colon cancers, and 32% of lung adenocarcinomas. For these three cancer types, cancers with mutant KRAS are diagnosed in more than
170,000 people each year in the United States and cause more than 120,000 deaths. Drugs that target signaling downstream of RAS are available;
however, such drugs have shown disappointing clinical durability because RAS is a "hub" that activates multiple effectors,
so drugs that block a single pathway downstream may not account for the many other activated pathways.

 We
also had a sponsored research agreement with UofL for Pan-RAS research; that agreement expired in December 2023.

 We
currently do not have the resources to advance our Pan-RAS program, and so we are seeking to out-license it.

 On
February 15, 2024, we entered into a License and Sublicense Agreement with Pan-RAS Holdings, Inc., a New York corporation ("Pan-RAS
Holdings"), which contemplated an exclusive out-license of our Pan-RAS drug development program, including our rights under the
ULRF license agreement, Pan-RAS Holdings.

 Although
the License and Sublicense Agreement called for a closing by March 16, 2024, the License and Sublicense Agreement was in essence structured
as a 30-day option in favor of Pan-RAS Holdings.

 At
the contemplated closing, Pan-RAS Holdings would have paid us an upfront fee of $1,000,000 in cash. In addition, Pan-RAS Holdings would
have become responsible to pay on our behalf our in-license royalty obligations to ULRF, as and when required.

 Finally,
if the contemplated closing had occurred, Pan-RAS Holdings would have required to pay to us for our own account, on a semiannual basis,
royalties equal to 1.0% of net sales of any RAS products.

 We
would have owed certain amounts to ULRF under our in-license agreement from them, if, as and when we received any Non-Royalty Sublicensing
Income from Pan-RAS Holdings.

 Pan-RAS
Holdings did not effectuate the closing by March 16, 2024, and we and they voluntarily terminated the License and Sublicense Agreement
effective as of March 16, 2024.

 Previous
Programs

 We
have discontinued all of our efforts the following programs, and we do not plan to resume them:

 1.

 QN-247(formerly
 referred to as ALAN or AS1411-GNP) – an oligonucleotide aptamer-based, nucleolin-inhibiting anticancer drug candidate,
 consisting of QN-165 conjugated with gold nanoparticles.

 2.

 QN-165
 (formerly referred to as AS1411) – an oligonucleotide aptamer-based drug candidate for the potential broad-spectrum
 treatment of infectious diseases such as COVID-19.

 3.

 Selective
 Target Antigen Removal System (STARS) – a therapeutic blood-filtering device product concept, which would be designed
 to remove circulating tumor cells, viruses, inflammation factors and immune checkpoints.

and Development

 For
research and development of our drug candidates, we have historically leveraged the scientific and technical resources and laboratory
facilities of UofL and UCL, through technology licensing, sponsored research, and other consulting agreements. We have engaged contract
research organizations ("CROs") and clinical sites for the Phase 1a clinical trial of QN-302. We intend to focus our internal
research and development on oversight of these CROs. We currently have no internal research and development facilities.

 Regulatory
Matters

 We
have obtained FDA clearance/approval for our QN-302 Phase 1a clinical trial. We have not obtained FDA or other regulatory approval for
any other drug candidate.

 United
States—FDA Drug Approval Process

 The
research, development, testing, and manufacture of product candidates are extensively regulated by governmental authorities in the United
States and other countries. In the United States, the FDA regulates drugs under the Food, Drug and Cosmetics Act and its implementing
regulations.

 The
steps required to be completed before a drug may be marketed in the United States include, among others:

 preclinical
 laboratory tests, animal studies, and formulation studies, all performed in accordance with the FDA's Good Laboratory Practice
 ("GLP") regulations;

 submission
 to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin and
 for which progress reports must be submitted annually to the FDA;

 approval
 by an independent institutional review board ("IRB") or Ethics Committee ("EC") at each clinical trial site
 before each trial may be initiated;

 adequate
 and well-controlled human clinical trials, conducted in accordance with applicable IND regulations, Good Clinical Practices ("GCP"),
 and other clinical trial related regulations, to establish the safety and efficacy of the drug for each proposed indication to the
 FDA's satisfaction;

 submission
 to the FDA of a New Drug Application ("NDA") and payment of user fees for FDA review of the NDA (unless a fee waiver
 applies);

 satisfactory
 completion of an FDA pre-approval inspection of one or more clinical trial site(s) at which the drug was studied in a clinical trial(s)
 and/or of us as a clinical trial sponsor to assess compliance with GCP regulations;

 satisfactory
 completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the drug is produced to assess
 compliance with current GMPs regulations;

 agreement
 with the FDA on the final labeling for the product and the design and implementation of any required Risk Evaluation and Mitigation
 Strategy; and

 FDA
 review and approval of the NDA, including satisfactory completion of an FDA advisory committee review, if applicable, based on a
 determination that the drug is safe and effective for the proposed indication(s).

 Preclinical
tests include laboratory evaluation of product chemistry, toxicity, and formulation, as well as animal studies. The conduct of the preclinical
tests and formulation of the compounds for testing must comply with federal regulations and requirements, including GLP regulations.
The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of
an IND application, which must become effective before human clinical trials may begin. An IND application will automatically become
effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions about issues such as the conduct
of the trials as outlined in the IND application, and places the clinical trial(s) on a clinical hold. In such a case, the IND application
sponsor and the FDA must resolve any outstanding FDA concerns or questions before clinical trials can proceed. We cannot be certain that
submission of an IND application will result in the FDA allowing clinical trials to begin.

 Clinical
trials necessary for product approval are typically conducted in three sequential phases, but the phases may overlap or be combined.
The study protocol and informed consent information for study subjects in clinical trials must also be approved by an IRB for each institution
where the trials will be conducted, and each IRB must monitor the study until completion. Study subjects must provide informed consent
and sign an informed consent form before participating in a clinical trial. Clinical testing also must satisfy the extensive GCP regulations
for, among other things, informed consent and privacy of individually identifiable information.

 Phase
 1—Phase 1 clinical trials involve initial introduction of the study drug in a limited population of healthy human volunteers
 or patients with the target disease or condition. These studies are typically designed to test the safety, dosage tolerance, absorption,
 metabolism and distribution of the study drug in humans, evaluate the side effects associated with increasing doses, and, if possible,
 to gain early evidence of effectiveness.

 Phase
 2—Phase 2 clinical trials typically involve administration of the study drug to a limited patient population with a specified
 disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side
 effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more
 expensive Phase 3 clinical trials.

 Phase
 3—Phase 3 clinical trials typically involve administration of the study drug to an expanded patient population to further evaluate
 dosage, to provide substantial evidence of clinical efficacy and to further test for safety, generally at multiple geographically
 dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the study drug
 and to provide an adequate basis for product approval. Generally, adequate and well-controlled Phase 3 clinical trials are required
 by the FDA for approval of an NDA.

 Post-approval
trials, sometimes referred to as Phase 4 clinical trials, may be conducted after receiving initial marketing approval. These trials are
used to gain additional experience from the treatment of patients in the intended therapeutic indication and are commonly intended to
generate additional safety data regarding use of the product in a clinical setting. In certain instances, the FDA may mandate the performance
of Phase 4 clinical trials as a condition of approval of an NDA or, in certain circumstances, post-approval.

 The
FDA has various programs, including fast track designation, breakthrough therapy designation, priority review and accelerated approval,
which are intended to expedite or simplify the process for the development, and the FDA's review of drugs ( e.g., approving
an NDA on the basis of surrogate endpoints subject to post-approval trials). Generally, drugs that may be eligible for one or more of
these programs are those intended to treat serious or life-threatening diseases or conditions, those with the potential to address unmet
medical needs for those disease or conditions, and/or those that provide a meaningful benefit over existing treatments. For example,
a sponsor may be granted FDA designation of a drug candidate as a "breakthrough therapy" if the drug candidate is 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. If a drug is designated as breakthrough therapy,
the FDA will take actions to help expedite the development and review of such drug. Moreover, if a sponsor submits an NDA for a product
intended to treat certain rare pediatric or tropical diseases or for use as a medical countermeasure for a material threat, and that
meets other eligibility criteria, upon approval such sponsor may be granted a priority review voucher that can be used for a subsequent
NDA. From time to time, we anticipate applying for such programs where we believe we meet the applicable FDA criteria. A company cannot
be sure that any of its drugs will qualify for any of these programs, or even if a drug does qualify, that the review time will be reduced.

 The
results of the preclinical studies and of the clinical studies, together with other detailed information, including information on the
manufacture and composition of the drug, are submitted to the FDA in the form of an NDA requesting approval to market the product for
one or more proposed indications. The testing and approval process requires substantial time, effort and financial resources. Unless
the applicant qualifies for an exemption, the filing of an NDA typically must be accompanied by a substantial "user fee"
payment to the FDA. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety
and efficacy of the product in the proposed patient population to the satisfaction of the FDA. After an NDA is accepted for filing, the
FDA substantively reviews the application and may deem it to be inadequate, and companies cannot be sure that any approval will be granted
on a timely basis, if at all. The FDA may also refer the application to an appropriate advisory committee, typically a panel of clinicians,
for review, evaluation and a recommendation as to whether the application should be approved, but is not bound by the recommendations
of the advisory committee.

 Before
approving an NDA, the FDA usually will inspect the facility or the facilities at which the drug is manufactured and determine whether
the manufacturing and production and testing facilities are in compliance with cGMP regulations. The FDA also may audit the clinical
trial sponsor and one or more sites at which clinical trials have been conducted to determine compliance with GCPs and data integrity.
If the NDA and the manufacturing facilities are deemed acceptable by the FDA, it may issue an approval letter, and, if not, the Agency
may issue a Complete Response Letter ("CRL"). An approval letter authorizes commercial marketing of the drug with specific
prescribing information for a specific indication(s). A CRL indicates that the review cycle of the application is complete and the application
is not ready for approval. A CRL may require additional clinical data and/or an additional pivotal Phase 3 clinical trial(s), and/or
other significant, expensive and time-consuming requirements related to clinical trials, preclinical studies or manufacturing. Even if
such additional information is submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. The
FDA could also require, as a condition of NDA approval, post-marketing testing and surveillance to monitor the drug's safety or
efficacy or impose other conditions, or a Risk Evaluation and Mitigation Strategy that may include both special labeling and controls,
known as Elements to Assure Safe Use, on the distribution, prescribing, dispensing and use of a drug product. Once issued, the FDA may
withdraw product approval if, among other things, ongoing regulatory requirements are not met, certain defects exist in the NDA, or safety
or efficacy problems occur after the product reaches the market.

 Intellectual
Property

 Information
regarding our (in-licensed) issued patents and pending patent applications, as of December 31, 2023, is as follows (excluding patents
and pending patent applications which pertain to programs which we have discontinued). As of that date we did not have any directly-owned
issued patents and pending patent applications.

 Subject
 Matter

 Issued

 Pending

 Geographic
 Scope

 Patent
 Term

 In-Licensed
 Patents

 University
 College London (UCL)

 QN-302

 U.S.,
 Europe, Australia, Canada, China, Hong Kong, India, Japan, Korea, Russia

 2030-2040

 University
 of Louisville (ULRF)

 Pan-RAS

 U.S.,
 Europe, Australia, Canada, China, Hong Kong, India, Israel, Japan, Korea, Mexico, Russia, South Africa

 2039*

 TOTAL

 * Anticipated
patent term

 Human
Capital Management

 As
of March 25, 2024, we had 4 employees, all of whom were full-time. None of our employees
is represented by a labor union or covered by a collective bargaining agreement.

 Diversity
& Inclusion. With respect to our employees overall, fifty percent (50%) are women and 0% are people of color.

 Additional
Information

 Ritter
Pharmaceuticals, Inc. (our predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural
Sciences, LLC. In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals, Inc. On May
22, 2020, upon completing the "reverse recapitalization" transaction with Qualigen, Inc., Ritter Pharmaceuticals, Inc. was
renamed Qualigen Therapeutics, Inc. and Qualigen, Inc. became a wholly-owned subsidiary of the Company. On July 20, 2023 we sold Qualigen
Inc. to ChemBio Diagnostics, Inc., an American subsidiary of French diagnostics provider Biosynex S.A.

 Our
website address is www.qlgntx.com. We post links to our website to the following filings as soon as reasonably practicable after
they are electronically filed with or furnished to the SEC: annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports
on Form 8-K, proxy statements, information statements, beneficial ownership reports and any amendments to those reports or statements
filed or furnished pursuant to Sections 13(a), 14 or 15(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act").
All such filings are available through our website free of charge. However, the information contained on or accessed through our website
does not constitute part of this Annual Report, and references to our website address in this Annual Report are inactive textual references
only. All such reports are also available free of charge via EDGAR through the SEC website at www.sec.gov.

 Item
1A. Risk Factors

 An
investment in our common stock involves risks. You should carefully consider the risks described below, together with all of the other
information included in this Annual Report, as well as in our other filings with the SEC, in evaluating our business. If any of the following
risks actually occur, our business, financial condition, operating results and future prospects could be materially and adversely affected.
In that case, the trading price of our common stock may decline and you might lose all or part of your investment. The risks described
below, which are the risks we judge (rightly or wrongly) to be the most significant to investors, are not the only ones we face. Additional
risks that we currently do not judge to be among the "most significant" may also impair our business, financial condition,
operating results and prospects.

 Certain
statements below are forward-looking statements. For additional information, see the section of this Annual Report under the caption
"Cautionary Note Regarding Forward-Looking Statements."

 Risks
Related to Our Business Generally

 Our
business strategy is high-risk

 We
are focusing our resources and efforts on development of drug product candidates, which requires extensive cash needs for research and
development activities. This is a high-risk strategy because there is no assurance that that our cash resources will be adequate to develop
our product candidates, that our product candidates will ever be proven to be safe and effective or that any products will ever become
commercially viable. This makes our stock an unsuitable investment for many investors.

 We
do not currently have enough working capital to execute our strategic plan.

 We
have suffered recurring losses from operations, and we are now essentially a non-revenue company. We will need capital to maintain our
operations and to support our intended development of our therapeutics business. Future financings will be necessary in order for us
to survive as a going concern and to properly execute our strategic plan. However, there can be no assurance that such future financings
will be available to us (or, if they are, that they can be consummated on desirable terms).

 We
may, in the short and long-term, seek to raise capital through the issuance of equity securities or through other financing sources.
To the extent that we seek to raise additional funds by issuing equity or equity-linked securities, our stockholders may (as has already
occurred several times) experience significant dilution. Any debt financing, if available, may include financial and other covenants
that could restrict our use of the proceeds from such financing or impose other business and financial restrictions on us. In addition,
we may consider alternative approaches such as licensing, joint venture, or partnership arrangements to provide short term or long term
capital. Additional funding may not be available to us on acceptable terms, or at all. In addition, any future financing (depending on
the terms and conditions) may be subject to the approval of Alpha, a related party and the holder of our 8% Senior Convertible Debenture
and of our 8% Convertible Debenture (together, the "Debentures"), and/or trigger certain adjustments to the conversion prices
of the Debentures or to the exercise prices of warrants held by Alpha and/or by other persons. See Part II, Item 7 " Management's
Discussion and Analysis of Financial Condition and Results of Operations " for additional details regarding the Debentures.

 Servicing
our debt will require a significant amount of cash, and we do not expect to have sufficient cash flow from our business to pay this debt.

 Our
ability to make payments to Alpha of principal or interest on the Debentures or to make any potential
prepayments for the Debentures, to the extent applicable, depends on our future performance, which is subject to economic, financial,
competitive and other factors beyond our control. Our cash resources currently on hand, plus any anticipated near-term cash flow from
operations or dispositions, would not be sufficient to service our indebtedness and/or to make necessary expenditures.

 In
December 2022, we entered into a Securities Purchase Agreement with Alpha and in exchange for $3,000,000 in cash (less $50,000 for expense
reimbursement) issued to Alpha our 8% Senior Convertible Debenture with an original face amount of $3,300,000 due on December 22, 2025
(the "2022 Debenture"), plus 2,500,000 common stock warrants exercisable (from June 22, 2023 through June 22, 2028) at $1.65
per share. Commencing June 1, 2023 and continuing on the first day of each month thereafter until
the earlier of (i) December 22, 2025 and (ii) the full redemption of the 2022 Debenture (each such date, a "Monthly Redemption
Date"), we must redeem $110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under the 2022
Debenture (the "Monthly Redemption Amount"). The Monthly Redemption Amount must be paid in cash; provided that after the
first two monthly redemptions, we may (if the Equity Conditions, as defined in the 2022 Debenture, are then satisfied or have been waived)
elect to pay all or a portion of a Monthly Redemption Amount in shares of our common stock, based on a conversion price equal to the
lesser of (i) the then applicable conversion price of the 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined in the
2022 Debenture) for the five consecutive trading days ending on the trading day that is immediately prior to the applicable Monthly Redemption
Date.

 The
2022 Debenture accrues interest at the rate of 8% per annum, which began accruing on December 1, 2023, and will be payable on a quarterly
basis. Interest may be paid in cash or shares of common stock or a combination thereof at our option; provided that the Equity Conditions
have been satisfied.

 Alpha
has waived the Equity Conditions for certain Monthly Redemption Amounts, but Alpha is not required to continue such waivers beyond May
2024. For the foreseeable future, we do not expect to be able to satisfy the Equity Conditions; as a result, where there is no waiver
of the Equity Conditions we would not have the opportunity to make 2022 Debenture payments in the form of stock rather than in the form
of cash, even for types of payments for which payment in the form of stock would have been allowed.

 The
2022 Debenture is convertible into our common stock at any time at the holder's option; the conversion price was originally $1.32
but pursuant to a Securities Purchase Agreement amendment in December 2023 it was reduced to $0.73 and then in February 2024 it was adjusted
downward to $0.26 per share by virtue of the operation of a "ratchet" antidilution provision. (The exercise price of the
warrants issued with the 2022 Debenture was originally $1.65 but pursuant to a Securities Purchase Agreement amendment in December 2023
it was reduced to $0.73 and then in February 2024 it was adjusted downward to $0.26 per share by virtue of the operation of a "ratchet"
antidilution provision.)

 Other
than the Monthly Redemption Amounts, the 2022 Debenture does not call for scheduled payments of principal before the scheduled maturity
date.

 Both
the 2022 Debenture and the accompanying warrants provide for "ratchet" antidilution adjustments to their conversion price
and exercise price.

 Both
the 2022 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon

 We
granted Alpha resale registration rights for the common shares underlying the 2022 Debenture and the accompanying warrants.

 The
December 2023 amendment of the 2022 Debenture conversion price (and the accompanying warrants' exercise price) to be $0.73 per
share resulted in the 2022 Debenture's then current $1,528,922 principal amount thereof becoming convertible into 2,094,414 shares
of Company common stock (as opposed to the 1,158,274 shares into which such outstanding principal amount was convertible pre-adjustment).
Also, the December 2023 amendment triggered a "ratchet" antidilution adjustment in the Company's outstanding "exploding"
"Series C Warrants," resulting in such Series C Warrants becoming exercisable for 455,623 common shares (at an exercise price
of $0.73 per share), as opposed to the 251,971 common shares into which such outstanding Series C Warrants would have been exercisable
(at $1.32 per share) pre-adjustment. Finally, the $0.73 price triggered a "ratchet" antidilution adjustment in the exercise
price of other outstanding Company common stock warrants, including 7,048 warrants held by Alpha and 67,620 warrants held by other persons,
which were previously exercisable at $1.32 per share.

 In
February 2024, we entered into a Securities Purchase Agreement with Alpha and in exchange for $500,000 in cash (less $25,000 for expense
reimbursement) issued to Alpha an 8% Convertible Debenture with a face amount of $550,000 due on December 31, 2024 (the "2024 Debenture"),
plus 900,016 5-year common stock warrants exercisable at $0.26 per share. In addition, per this Securities Purchase Agreement Alpha obtained
an option to purchase additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate of $1,100,000 (and
with a proportional number of accompanying common stock warrants of like tenor, up to a total of 1,800,032 additional warrants), which
would (if and when Alpha exercises such option) provide us up to an additional $1.0 million in cash proceeds (less expense reimbursement, and not including any possible cash proceeds from any future exercise of the additional warrants).
This option is valid through July 1, 2024.

 The
2024 Debenture has a maturity date of December 31, 2024 and is convertible, at any time, and from time to time, at Alpha's option,
into shares of our common stock, at $0.6111 per share. The 2024 Debenture does not call for scheduled
payments of principal or interest before the scheduled maturity date. Interest on the 2024 Debenture accrues on its outstanding
principal balance at the rate of 8% per annum.

 Both
the 2024 Debenture and the accompanying warrants provide for "ratchet" antidilution adjustments to the Conversion Price and
Exercise Price.

 Both
the 2024 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon

 We
granted Alpha "piggyback" registration rights for the common shares underlying the 2024 Debenture and the accompanying warrants.

 The
$0.26 exercise price of the warrants issued with the 2024 Debenture triggered a "ratchet" antidilution adjustment in the
2022 Debenture, resulting in the then current $1,198,922 principal amount thereof becoming convertible into 4,611,238 shares of Company
common stock (as opposed to the 1,642,359 shares into which such outstanding principal amount were convertible pre-adjustment). Also,
the $0.26 exercise price of the warrants issued with the 2024 Debenture triggered a "ratchet" antidilution adjustment in
the Company's outstanding "exploding" "Series C Warrants," resulting in such Series C Warrants becoming
exercisable for 1,279,261 common shares (at an exercise price of $0.26 per share), as opposed to the 455,623 common shares into which
such outstanding Series C Warrants would have been exercisable (at $0.73 per share) pre-adjustment. Finally, the $0.26 exercise price
of the Warrant would trigger a "ratchet" antidilution adjustment in the exercise price of other outstanding Company common
stock warrants, including 2,507,048 warrants held by Alpha and 67,620 warrants held by other persons, all of which were previously exercisable
at $0.73 per share.

 If
we continue to lack cash resources sufficient
to service our indebtedness, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or issuing
additional equity, equity-linked or debt instruments on terms that may be onerous or highly dilutive. Our ability to refinance our indebtedness
will depend on the capital markets and our financial condition at such time. If we are unable to engage in any of these activities or
engage in these activities on desirable terms, we may be unable to meet our debt obligations, which would materially and adversely impact
our business, financial condition and operating results or even put us out of business.

 Risks
Related to Our Product Pipeline

 Our
product candidates are still in the early stages of development. Although we have begun Phase 1a clinical trials for QN-302, we might
be unable to obtain further regulatory approval for QN-302 or any other drug candidate. We may never obtain marketing approval for any
of our drug candidates.

 We
are still early in our Pan-RAS development efforts and have not yet sought approval for, or begun enrollment, in any clinical trials
evaluating Pan-RAS. There can be no assurance that any of our drug product candidates will achieve success in their clinical trials or
obtain regulatory approval.

 Our
ability to generate revenues from our drug product candidates will depend on the successful development and eventual commercialization
of such drug candidates. The success of these products will depend on several factors, including the following:

 successful
 completion of preclinical studies and clinical trials;

 acceptance
 of an IND application by the FDA or other clinical trial or similar applications from foreign regulatory authorities for our future
 clinical trials for our pipeline;

 timely
 and successful enrollment of patients in, and completion of, clinical trials with favorable results;

 demonstration
 of safety, efficacy and acceptable risk-benefit profiles of our products to the satisfaction of the FDA and foreign regulatory agencies;

 receipt
 and related terms of marketing approvals from applicable regulatory authorities, including the completion of any required post-marketing
 studies or trials;

 obtaining
 and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity for our products;

 developing
 and implementing marketing and reimbursement strategies;

 establishing
 sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone
 or in collaboration with others;

 acceptance
 of our drugs, if and when approved, by patients, the medical community and third-party payors;

 effectively
 competing with other therapies;

 obtaining
 and maintaining third-party payor coverage and adequate reimbursement; and

 maintaining
 a continued acceptable safety profile of the products following approval.

 Many
of these factors are beyond our control, and it is possible that none of our drug candidates will ever obtain regulatory approval even
if we expend substantial time and resources seeking such approval. If we do not achieve one or more of these factors in a timely manner
or at all, we could experience significant delays or an inability to successfully commercialize our drug candidates. For example, our
business could be harmed if results of the clinical trials of QN-302, Pan-RAS or any other drug candidates vary adversely from our expectations.

 Drug
development involves a lengthy and expensive process. We may incur additional costs or experience delays in completing, or ultimately
be unable to complete, the development and commercialization of our drug product candidates.

 Most
drug candidates fail, and taking a drug candidate from concept through clinical trials and regulatory approval is not easy or guaranteed.
We are unable to predict when or if our drug candidates, will prove effective or safe in humans or will obtain marketing approval. Before
obtaining marketing approval from regulatory authorities for the sale of these products, we must complete preclinical development and
then conduct extensive clinical trials to demonstrate the safety and efficacy of these products for humans. Clinical testing is expensive,
difficult to design and implement, can take many years to complete and is uncertain as to the outcome. A failure of one or more clinical
trials can occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success
of later clinical trials, and interim or preliminary results of a clinical trial do not necessarily predict final results.

 We
may experience numerous unforeseen events that could delay or prevent our ability to obtain marketing approval or commercialize our drug
candidates, including:

 we
 may not be able to obtain enough capital to begin clinical trials ort to complete any already-begun clinical trials, or to complete
 any necessary preclinical studies;

 regulators
 or IRBs or ECs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective
 trial site;

 we
 may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols
 with prospective trial sites;

 clinical
 trials for our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to
 conduct additional clinical trials, delay clinical trials or abandon product development programs;

 the
 number of patients required for clinical trials for our drug candidates may be larger than we anticipate, enrollment in these clinical
 trials may be slower than we anticipate, participants may drop out of these clinical trials at a higher rate than we anticipate or
 the duration of these clinical trials may be longer than we anticipate;

 competition
 for clinical trial participants from investigational and approved therapies may make it more difficult to enroll patients in our
 clinical trials;

 our
 third-party contractors may fail to meet their contractual obligations to us in a timely manner, or at all, or may fail to comply
 with regulatory requirements;

 we
 may have to suspend or terminate clinical trials for our drug candidates for various reasons, including a finding that the participants
 are being exposed to unacceptable health risks;

 our
 drug candidates may have undesirable or unexpected side effects or other unexpected characteristics, causing us or our investigators,
 regulators or IRBs/ECs to suspend or terminate the trials;

 the
 cost of clinical trials for our drug candidates may be greater than we anticipate; and

 the
 supply or quality of our drug candidates, or other materials necessary to conduct clinical trials may be insufficient or inadequate
 and result in delays or suspension of our clinical trials.

 Our
product development costs will increase if we experience delays in preclinical studies or clinical trials or in obtaining marketing approvals.
We do not know whether any of our planned preclinical studies or clinical trials will begin on a timely basis or at all, will need to
be restructured or will be completed on schedule, or at all. For example, the FDA may place a partial or full clinical hold on any of
our clinical trials for a variety of reasons.

 Significant
preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our
drug candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize
our drug candidates.

 Any
delays in the commencement or completion, or termination or suspension, of our current clinical trial or our future clinical trials,
if any, could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.

 Before
we can initiate clinical trials of a drug candidate, we must submit the results of preclinical studies to the FDA along with other information
as part of an IND application or similar regulatory filing, and the FDA (or corresponding foreign regulatory body) must approve the application.

 Before
obtaining marketing approval from the FDA for the sale of QN-302, Pan-RAS or any other future drug candidate, we must conduct extensive
clinical studies to demonstrate safety and efficacy. Clinical testing is expensive, time consuming and uncertain as to outcome. The FDA
may require us to conduct additional preclinical studies for any drug candidate before it allows us to initiate clinical trials under
any IND application, which may lead to additional delays and increase the costs of our preclinical development programs.

 Any
delays in the commencement or completion of our ongoing, planned or future clinical trials could significantly increase our costs, slow
down our development and approval process and jeopardize our ability to commence product sales and generate revenues. We do not know
whether our planned trials will begin on time or at all, or be completed on schedule, if at all. The commencement and completion of clinical
trials can be delayed for a number of reasons, including delays related to:

 our
 ability to pay for the costs and expenses for the clinical trials;

 the
 FDA disagreeing as to the design or implementation of our clinical trials or with our recommended dose for any of our pipeline programs;

 obtaining
 FDA authorization to commence a trial or reaching a consensus with the FDA on trial design;

 obtaining
 approval from one or more IRBs/ECs;

 IRBs/ECs
 refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects,
 or withdrawing their approval of the trial;

 changes
 to clinical trial protocol;

 clinical
 sites deviating from trial protocol or dropping out of a trial;

 failing
 to manufacture or obtain sufficient quantities of drug candidate, or, if applicable, combination therapies for use in clinical trials;

 patients
 failing to enroll or remain in our trial at the rate we expect, or failing to return for post-treatment follow-up;

 patients
 choosing an alternative treatment, or participating in competing clinical trials;

 lack
 of adequate funding to continue the clinical trial;

 patients
 experiencing severe or unexpected drug-related adverse effects;

 occurrence
 of serious adverse events in trials of the same class of agents conducted by other companies;

 selecting
 or being required to use clinical end points that require prolonged periods of clinical observation or analysis of the resulting
 data;

 a
 facility manufacturing our drug candidates, or any of their components, including without limitation, our own facilities being ordered
 by the FDA to temporarily or permanently shut down due to violations of cGMP, regulations or other applicable requirements, or infections
 or cross-contaminations in the manufacturing process;

 lack
 of stability of our clinical trial material or any quality issues that arise with the clinical trial material;

 any
 changes to our manufacturing process that may be necessary or desired;

 Our,
 or our third-party contractors, not performing data collection or analysis in a timely or accurate manner or improperly disclosing
 data prematurely or otherwise in violation of a clinical trial protocol; or

 any
 third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities
 for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use
 some or all of the data produced by such contractors in support of our marketing applications.

 We
could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs/ECs of the institutions in which such trials
are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA. Such authorities may impose such a suspension or
termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or
our clinical protocols, inspection of the clinical trial operations or trial site by the FDA resulting in the imposition of a clinical
hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using the product under investigation,
changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. In addition,
changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes.
Amendments may require us to resubmit our clinical trial protocols to IRBs/ECs for reexamination, which may impact the costs, timing
or successful completion of a clinical trial.

 If
we experience delays or difficulties enrolling patients in our ongoing or planned clinical trials, our receipt of necessary regulatory
approval could be delayed or prevented.

 We
may not be able to initiate or continue our ongoing or planned clinical trials for our products if we are unable to identify and enroll
a sufficient number of eligible patients to participate in these trials as required by the FDA. In addition, some of our competitors
may have ongoing clinical trials for products that would treat the same patients as QN-302 or Pan-RAS, and patients who would otherwise
be eligible for our clinical trials may instead enroll in clinical trials of our competitors' products. In addition, introduction
of new drugs or devices to the marketplace may have an effect on the number of patients available or timing of the availability of the
patients.

 Our
inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon
one or more clinical trials altogether.

 Adverse
side effects or other safety risks associated with our drug product candidates could delay or preclude approval, cause us to suspend
or discontinue any clinical trials or abandon further development, limit the commercial profile of an approved label, or result in significant
negative consequences following regulatory approval, if any.

 Results
of our current and planned clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected
characteristics. Undesirable side effects caused by our products could result in the delay, suspension or termination of clinical trials
by us or the FDA for a number of reasons.

 Moreover,
if our products are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may elect
to abandon or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics
are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for our
products, if approved. We may also be required to modify our study plans based on findings in our clinical trials. Many drug candidates
that initially showed promise in early stage testing have later been found to cause side effects that prevented further development.
In addition, regulatory authorities may draw different conclusions or require additional testing to confirm these determinations.

 It
is possible that as we test our drug candidates in larger, longer and more extensive clinical trials, including with different dosing
regimens, or as the use of our drug candidates becomes more widespread following any regulatory approval, illnesses, injuries, discomforts
and other adverse events that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous
trials, will be reported by patients.

 The
development and commercialization of pharmaceutical and device products are subject to extensive regulation, and we may not obtain regulatory
approvals for any product candidates, on a timely basis or at all.

 The
clinical development, manufacturing, labeling, packaging, storage, recordkeeping, advertising, promotion, export, import, marketing,
distribution, adverse event reporting, including the submission of safety and other post-marketing information and reports, and other
possible activities relating to drug product candidates such as ours are subject to extensive regulation.

 We
rely, and intend to continue to rely, on third parties to conduct our preclinical studies and clinical trials and perform some of our
research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties, fail to comply with
applicable regulatory requirements or do not meet expected deadlines, our development programs may be delayed or subject to increased
costs or we may be unable to obtain regulatory approval.

 We
are dependent on third parties to conduct our planned preclinical studies and clinical trials of our drug product candidates. The timing
of the initiation and completion of these trials will therefore be partially controlled by such third parties and may result in delays
to our development programs. We have relied heavily on UofL for preclinical studies related to Pan-RAS, and we expect to rely heavily
on CROs and sponsored academic researchers for any further preclinical studies. As to any clinical trials, we expect to rely on CROs,
sponsored academic researchers, clinical investigators and/or consultants to play a significant role in the conduct of these trials and
the subsequent collection and analysis of data. However, we will not be able to control all aspects of their activities. Nevertheless,
we are responsible for ensuring that each clinical trial is conducted in accordance with the applicable protocol and legal, regulatory
and scientific standards, including GCP, requirements, and our reliance on the CROs and other third parties does not relieve us of our
regulatory responsibilities.

 There
is no guarantee that any such CROs, clinical trial investigators and/or other third parties on which we rely will devote adequate time
and resources to our development activities or perform as contractually required. If any of these third parties fail to meet expected
deadlines, adhere to our clinical protocols or meet regulatory requirements, otherwise perform in a substandard manner, or terminate
their engagements with us, the timelines for our development programs may be extended or delayed or our development activities may be
suspended or terminated. If one of our clinical trial site terminates for any reason, we may experience the loss of follow-up information
on subjects enrolled in such clinical trial unless we are able to transfer those subjects to another qualified clinical trial site, which
may be difficult or impossible.

 If
these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct clinical trials in accordance
with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, regulatory approvals
for our drug product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our products.

 Manufacturing
pharmaceutical products is complex and subject to product loss for a variety of reasons. We contract with third parties for the manufacture
of our product candidates for preclinical testing and clinical trials and expect to continue to do so for commercialization. This reliance
on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable
cost or quality, which could delay, prevent or impair our development or commercialization efforts.

 We
rely, and expect to continue to rely, on third parties for the manufacture of our products for preclinical and any clinical testing,
as well as for future commercial manufacture if any of our product candidates obtain regulatory approval. This reliance on third parties
increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost or
quality, which could delay, prevent or impair our development or commercialization efforts.

 We
may be unable to establish any agreements with third-party manufacturers or to do so on favorable terms. Even if we are able to establish
agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

 reliance
 on the third-party for regulatory, compliance and quality assurance;

 operations
 of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including
 the bankruptcy of the manufacturer or supplier or the issuance of an FDA Form 483 notice or warning letter;

 the
 possible breach of the manufacturing agreement by the third-party; and

 the
 possible termination or nonrenewal of the agreement by the third-party at a time that is costly or inconvenient for us.

 We
do not have manufacturing agreements in place for any of our current drug candidates. We acquire many key materials on a purchase order
basis. As a result, we do not have long-term committed arrangements with respect to our product candidates and other materials. If we
obtain regulatory approval for any of our product candidates, we will need to establish an agreement for commercial manufacture with
a third-party.

 Any
performance failure on the part of our existing or future manufacturers could delay clinical development or regulatory approval. We do
not currently have arrangements in place for redundant supply or a second source for bulk drug substance for QN-302 or Pan-RAS.

 We
will need to seek and enter into out-licenses or collaborations with third parties for the development and commercialization of our products,
resulting in a limitation of our upside potential.

 We
expect that we will need third-party out-licensees or collaborators for the development and commercialization of our products.

 Our
likely collaborators for any collaboration arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical
companies and biotechnology companies. We face significant competition in seeking appropriate collaborators. Our ability to reach a definitive
agreement for a collaboration will depend, among other things, upon our assessment of the collaborator's resources and expertise,
the terms and conditions of the proposed collaboration and the proposed collaborator's evaluation of a number of factors.

 If
we do enter into any such arrangements with any third parties, we will likely have limited control over the amount and timing of resources
that such collaborators dedicate to the development or commercialization of our products. Our ability to generate revenues from these
arrangements will depend on our collaborators' abilities and efforts to successfully perform the functions assigned to them in
these arrangements.

 Any
out-license or collaboration will necessarily result in a sharing of economics with the out licensee or collaborator, which might otherwise
have been captured by us directly.

 Risks
Related to our Intellectual Property

 If
we are unable to obtain and maintain sufficient patent protection for our therapeutic product candidates, or if the scope of the patent
protection is not sufficiently broad, third parties, including our competitors, could develop and commercialize products similar or identical
to ours, and our ability to commercialize our product candidates successfully may be adversely affected.

 Our
commercial success depends significantly on our ability to protect our proprietary (and exclusively in-licensed) product candidates or
technologies that we believe are important to our business, including pursuing, obtaining and maintaining patent protection in the United
States and other countries intended to cover the composition of matter of our product candidates, the methods of use, related technologies,
and other inventions that are important to our business. In addition to patent protection, we also rely on trade secrets to protect aspects
of our business that are not amenable to, or that we do not consider appropriate for, patent protection. If we do not adequately pursue,
obtain, maintain, protect or enforce our intellectual property, third parties, including our competitors and/or collaborators, may be
able to erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability.

 Moreover,
depending on the terms of any license agreements to which we may become a party, we may not have the right to control the preparation,
filing, and prosecution of patent applications, or to maintain or defend the patents, covering technology licensed from third parties.
Therefore, these patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of
our business.

 We
cannot offer any assurances about which, if any, patents will issue, the breadth of any such patents, whether any issued patents will
be found invalid and unenforceable or will be threatened by third parties or whether any issued patents will effectively prevent others
from commercializing competing technologies and product candidates. Our licensors have not filed patent applications in every jurisdiction,
and some filings are only pending in the United States.

 Moreover,
because the issuance of a patent, although presumptive, is not conclusive as to its inventorship, scope, validity or enforceability,
our licensors' patents or pending patent applications may be challenged in the courts or patent offices in the United States and
abroad. Such challenges may result in loss of exclusivity or in the patent claims being narrowed, invalidated or held unenforceable,
in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical products and technologies
or limit the duration of the patent protection of our products and technologies. Such challenges also may result in substantial cost
and require significant time from our scientists and management, even if the eventual outcome is favorable to us.

 Our
licensors' pending and future patent applications may not result in patents being issued that protect our product candidates and
technologies, in whole or in part, or that effectively prevent others from commercializing competitive products and technologies. Even
if the patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent
competitors or other third parties from competing with us or otherwise provide us with any competitive advantage. Our competitors and
other third parties may be able to circumvent our licensors' patents by developing similar or alternative products or technologies
in a non-infringing manner. Our competitors and other third parties may also seek approval to market their own products and technologies
similar to or otherwise competitive with our products and technologies. Alternatively, our competitors or other third parties may seek
to market generic versions of any approved products by submitting abbreviated NDAs to the FDA during which process they may claim that
patents owned by us are invalid, unenforceable or not infringed. In these circumstances, we may need to defend or assert our licensors'
patents, or both, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency
with jurisdiction may find our licensors' patents invalid or unenforceable, or that our competitors are competing in a non-infringing
manner. Thus, even if we have in-licensed valid and enforceable patents, these patents still may not provide protection against competing
products or processes sufficient to achieve our business objectives.

 The
term of our in-licensed patents may be inadequate to protect our competitive position on our products.

 Given
the amount of time required for the development, testing and regulatory review of drug candidates, our in-licensed patents protecting
such candidates might expire before or shortly after such candidates are commercialized. In such an event (and if we are unable to obtain
patent term extension or the term of any such extension is less than we request), our competitors and other third parties may be able
to obtain approval of competing products following patent expiration and take advantage of our investment in development and clinical
trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case. Generic competition
usually results in serious price erosion for the original drug brand.

 Risks
Related to Employee Matters, Potential Dilution, Stock Price Variability and Other Risks Related to Our Business

 Our
future success depends on our ability to retain key employees and to attract, retain and motivate qualified personnel.

 We
are highly dependent on Michael Poirier, our Chief Executive Officer and Chairman, and Christopher Lotz, our Vice President and Chief
Financial Officer. In addition, the rest of our team has been sharply reduced due to rightsizing, voluntary departures and the disposition
of our Qualigen, Inc. diagnostics-products subsidiary – we currently have only two other employees.

 Our
ability to compete depends upon our ability to attract, retain and motivate highly skilled and experienced personnel with scientific,
clinical, regulatory, manufacturing and management skills and experience. We may not be able to attract or retain qualified personnel
in the future. Many of the companies against which we compete have greater financial and other resources, different risk profiles and
a longer history in the industry than we do. Our competitors may provide higher compensation, more diverse opportunities and/or better
opportunities for career advancement. Any or all of these competing factors (as well as our own limited resources) may limit our ability
to attract and retain high quality personnel, which could negatively affect our ability to successfully develop and commercialize our
product candidates and to grow our business and operations as currently contemplated.

 We
will need to rebuild our development and regulatory teams.

 Due
to rightsizing, voluntary departures and the disposition of Qualigen, Inc. and our former FastPack products business, we currently
have only four employees.
Although we outsource many drug development functions and may choose to continue to do so in the future, we expect that (resources allowing)
to recruit and retain more employees in all areas, and particularly in the areas of clinical development, clinical operations, and regulatory
affairs (and maybe, longer-term, in areas such as manufacturing, sales, marketing and distribution). We will also need to implement and
improve our managerial, operational and financial systems, and obtain stage-appropriate facilities. We do not currently have the cash
resources needed for any of the above.

 We
currently rely, and for the foreseeable future will continue to rely, in substantial part, on certain third-party contract research organizations
and consultants to provide certain services, including assuming substantial responsibilities for the conduct of our clinical trials.
We cannot assure that the services of such third-party contract research organizations and consultants will continue to be available
to us on a timely basis when needed, or that we can find qualified replacements. In addition, if we are unable to effectively manage
our outsourced activities or if the quality or accuracy of the services provided by our vendors or consultants is compromised for any
reason, our clinical trials may be extended, delayed or terminated. We cannot assure that we will be able to properly manage our existing
vendors or consultants or find other competent outside vendors and consultants on economically reasonable terms, or at all.

 We
may engage in strategic transactions that could impact liquidity, increase expenses and present significant distractions to management.

 From
time to time, we may consider strategic transactions, such as acquisitions of companies, businesses or assets and out-licensing or in-licensing
of products, drug candidates or technologies. Potential transactions that we may consider include a variety of different business arrangements,
including spin-offs, in-licensing, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments.
Any such transaction may require us to incur non-recurring or other charges, may increase near term or long-term expenditures and may
pose significant integration challenges or disrupt management or business, which could adversely affect our operations and financial
results. These transactions may entail
numerous operational and financial risks, including:

 exposure
 to unknown liabilities;

 disruption
 of business and diversion of management's time and attention in order to develop acquired products, drug candidates or technologies;

 incurrence
 of substantial debt or dilutive issuances of equity securities to pay for acquisitions;

 higher
 than expected acquisition and integration costs;

 write-downs
 of assets or impairment charges;

 increased
 amortization expenses;

 difficulty
 and cost in combining the operations, systems and personnel of any acquired businesses with our operations, systems and personnel;

 impairment
 of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and

 inability
 to retain key employees of any acquired businesses.

 Our
minority-interest investment in NanoSynex is illiquid and has many risks associated with it.

 Our
investment in NanoSynex has been reduced to a 39% equity interest and has a number of risks associated with it, including, among others,
the following:

 a
 history of operating losses, with no assurance of future revenues or operating profits;

 uncertainty
 as to the availability to NanoSynex of the cash resources it needs to execute its plans;

 technological
 risk;

 our
 inability, now that we are no longer a majority shareholder of NanoSynex, to control or veto NanoSynex's decisions;

 risks
 associated with the development of medical devices and NanoSynex's ability to obtain the necessary regulatory approvals for
 the development and commercialization of its antimicrobial susceptibility test platform;

 very
 limited manufacturing, marketing, distribution and sales capabilities;

 competition
 from both public and private companies and academic collaborators, many of which have significantly greater experience and financial
 resources;

 acceptance
 by life sciences research and diagnostic communities is not assured;

 commercial
 development of its antimicrobial susceptibility test platform is not assured;

 an
 inability to manufacture, market or sell its proposed products if it is unsuccessful in entering into strategic alliances or joint
 ventures with third parties; and

 risks
 related to the political, economic and military conditions in Israel.

 In
addition, NanoSynex is a privately-held company and its shares are illiquid, which means that we could not readily obtain cash in exchange
for some or all of our equity interest. We no longer hold any NanoSynex debt instruments.

 Our
reported financial condition may fluctuate significantly from quarter to quarter and year to year, which makes them difficult to predict
or understand.

 We
expect our financial condition and results of operations to fluctuate from quarter to quarter and year to year due to a variety of factors,
many of which are beyond our control. Accordingly, you should not blindly rely upon the results of any quarterly or annual periods as
indications of future financial status or operating performance. Other investors may, however, attach undue significance to reported
results which are heavily influenced by such distortions and variability, which in turn could cause our stock price to rise or fall despite
there being no corresponding change in our prospects or position as a practical matter.

 We
have a substantial amount of derivative securities outstanding.

 As
of December 31, 2023 there were 398,924 stock options outstanding under our equity incentive plans, 3,081,717 outstanding warrants, and
1,943,729 shares issuable upon voluntary conversion of principal amount of the 2022 Debenture issued to Alpha. (At December 31, 2023,
such principal amount was $1,418,922) Due to antidilution adjustments occurring as a result of the 2024 Debenture transaction in February
2024, the outstanding principal balance of the 2022 Debenture (which at March 25, 2024 was $1,088,922) is now convertible upon voluntary
conversions into 4,188,162 shares; and in addition the 2024 Debenture's principal amount is convertible upon voluntary conversions
into 900,016 shares, and the warrants issued with the 2024 Debenture are exercisable for 900,016 shares.

 The
2022 and 2024 Debentures issued to Alpha are convertible, at any time, and from time to time, at Alpha's option, into shares of
our common stock, subject to the terms and conditions described in the Debentures. Currently the conversion price for such optional conversions
is $0.26 per share for the 2022 Debenture and $0.6111 per share for the 2024 Debenture. Furthermore, subject to certain terms and conditions
described in the 2022 Debenture, we may elect to pay all or a portion of the Monthly Redemption Amount and/or interest required by the
2022 Debenture in shares of our common stock.

 The
issuance of shares upon the exercise or conversion of outstanding stock options, warrants and the Debentures (or our election to pay
amounts owed under the Debentures in shares of our common stock) could result in significant dilution to the holders of our existing
outstanding common stock.

 We
rely significantly upon information technology, and any failure, inadequacy, interruption or security lapse of that technology, including
any cyber security incidents, could harm our ability to operate our business effectively and result in a material disruption of our product
development programs.

 We
utilize information technology systems to transmit and store information, including sensitive personal information and proprietary or
confidential information, and otherwise to support our business and process. In the future, our systems may prove inadequate to our business
needs and necessary upgrades may not operate as designed, which could result in excessive costs or disruptions in portions of our business.
In particular, any disruptions, delays or deficiencies from our enterprise resource planning systems could adversely affect our ability
to, among other matters, process orders, procure supplies, manufacture and ship products, send invoices and track payments, fulfill contractual
obligations or otherwise operate our business.

 We
could also be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss
of information maintained in the information systems and networks of our company. Outside parties may attempt to penetrate our systems
or those of our partners or fraudulently induce our employees or employees of our partners to disclose sensitive information to gain
access to our data. Like other companies, we may experience threats to our data and systems, including malicious codes and computer viruses,
cyber-attacks or other system failures. Furthermore, a security breach could be facilitated by ineffective protection measures, employee
errors or omissions, and malfeasance. Despite our efforts to protect against cyber-attacks and security breaches, hackers and other cyber
criminals are using increasingly sophisticated and constantly evolving techniques, and we may need to expend substantial additional resources
to continue to protect against potential security breaches or to remediate problems caused by such attacks or any breach of our safeguards.
Any system failure, accident or security breach that causes interruptions in our operations, for us or our partners, could result in
a material disruption of our product development programs and business operations, in addition to possibly requiring substantial expenditures
of resources to remedy. For example, the loss of clinical trial data from completed clinical trials could result in delays in our regulatory
approval efforts and we could incur significant increases in costs to recover or reproduce the data. The risk o f
cyber incidents could also be increased by cyberwarfare in connection with the ongoing war in Ukraine, including potential proliferation
of malware from the conflict into systems unrelated to the conflict. To the extent that any disruption or security breach results in
a loss of, or damage to, our data or applications, or inappropriate public disclosure of confidential or proprietary information, we
may incur liabilities and the further development of our product candidates may be delayed.

 We
or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery
plans may not adequately protect us from a serious disaster.

 We
are located in southern California and are subject to risks posed by natural disasters, including wildfires, earthquakes and severe weather
that may interfere with our operations. Extreme weather events and other natural disasters could severely disrupt our operations, and
have a material adverse effect on our business, results of operations, financial condition and prospects. If a natural disaster, power
outage or other event occurred that damaged critical infrastructure, such as the facilities of our third-party clinical sites or contract
manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business
for a substantial period of time. Any disaster recovery and business continuity plans we have in place may prove inadequate in the event
of a serious disaster or similar event.

 Any
failure to develop or maintain effective internal controls over financial reporting or difficulties encountered in implementing or improving
our internal controls over financial reporting could harm our operating results and prevent us from meeting our reporting obligations.

 Effective
internal controls, particularly those related to financial reporting, are necessary for us to produce reliable financial reports. If
we cannot provide reliable financial reports, 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. In addition, investors relying
upon this misinformation could make an uninformed investment decision, and we could be subject to sanctions or investigations by the
SEC or other regulatory authorities or to stockholder class action securities litigation.

 As
previously described in our annual report on Form 10-K for the year ended December 31, 2021, in connection with the audit of our financial
statements as of and for the year ended December 31, 2021 (the "2021 audit"), our management identified a material weakness in our internal control over financial reporting related to the lack of accounting department
resources and/or policies and procedures to ensure recording and disclosure of items in compliance with U.S. GAAP. This material weakness
resulted in adjustments to our warrant valuations in connection with the 2021 audit. In response to the material weakness, we took a
number of remediation steps to enhance our internal controls, including implementing additional procedures and utilizing external consulting
resources with experience and expertise in U.S. GAAP and public company accounting and reporting requirements to assist management with
its accounting and reporting of complex and/or non-recurring transactions and related disclosures.

 In connection with the audit of our financial statements as of and for the year ended December 31, 2022 (the "2022 audit"),
our management determined that the material weakness identified in connection with the 2021 audit had not been fully remediated
and resulted in adjustments to the accounting treatment related to convertible debt, the business combination and goodwill impairment
during the 2022 audit, which resulted in the late filing of the 2022 Annual Report.

 In
connection with the audit of our financial statements as of and for the year ended December 31, 2023, our management identified material weaknesses in our internal control over financial reporting related to limited accounting
personnel and resources resulting in lack of segregation of duties, and to the fact that we have not designed and implemented effective Information Technology General Controls related
to access controls to financing accounting systems.

 We
intend to continue to take steps to enhance our internal controls, including implementing additional internal procedures and utilizing
well-established external consulting resources with experience and expertise in U.S. GAAP and public company accounting and reporting
requirements.

 If
we are unable to remediate the material weaknesses and achieve and maintain effective internal control over financial reporting and effective
disclosure controls, our business could be adversely affected.

 Our
right to use our "shelf" Form S-3 registration statement is sharply limited.

 We
filed a Form S-3 "shelf" registration statement with the SEC for the issuance of up to $150,000,000 of securities, and the
SEC declared the registration statement effective on August 5, 2022. However, due to the "baby shelf" rules adopted by the
SEC, the maximum amount of securities we can sell under this registration is now limited to one-third of our public float. Because our
public float is very modest (e.g., $2.9 million at December 31, 2023), the maximum amount we could sell using this registration statement
was under $1.0 million at that time. Therefore, the registration statement no longer constitutes an important tool for accessing the
public markets to satisfy our needs for capital.

 Our
failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock.

 If
we fail to satisfy the continued listing requirements of Nasdaq, Nasdaq may take steps to delist our common stock. Such a delisting would
likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when
you wish to do so.

 On
April 20, 2023, we received a notification letter from the Listing Qualifications Department of Nasdaq indicating that, as a result of
our delay in filing the 2022 Annual Report, we were not in compliance with the timely filing requirements for continued listing under
Nasdaq Listing Rule 5250(c)(1). The notification letter had no immediate effect on the listing or trading of our common stock on the
Nasdaq Capital Market. On May 2, 2023, the Company filed the Form 10-K with the SEC and was subsequently notified by Nasdaq on May 4,
2023 that it had regained compliance with Nasdaq's listing rule 5250(c)(1) as a result thereof and that the matter was closed.

 On
November 20, 2023, we received a letter (the "Bid Price Deficiency Notice") from The Nasdaq Stock Market ("Nasdaq")
notifying the Company that, because the closing bid price for its common stock has been below $1.00 per share for 30 consecutive business
days, it no longer complies with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing
Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share (the "Minimum Bid Price Requirement"),
and Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues for
a period of 30 consecutive business days.

 The
Bid Price Deficiency Notice has no immediate effect on the listing of the Company's common stock on The Nasdaq Capital Market.
Pursuant to Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has been provided an initial compliance period of 180 calendar days, or
until May 20, 2024 to regain compliance with the Minimum Bid Price Requirement. During the compliance period, the Company's shares
of common stock will continue to be listed and traded on The Nasdaq Capital Market. To regain compliance, the closing bid price of the
Company's common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days during the 180 calendar
day grace period.

 In
the event the Company is not in compliance with the Minimum Bid Price Requirement by May 20, 2024, the Company may be afforded a second
180 calendar day grace period.

 The
Company intends to actively monitor the bid price for its common stock between now and May 20, 2024 and will consider available options
to regain compliance with the Minimum Bid Price Requirement.

 On
November 21, 2023, the Company also received a letter (the "Equity Deficiency Letter") from Nasdaq notifying the Company
that, based on the Company's stockholders' deficit of ($1,640,552) as of September 30, 2023, as reported in the Company's
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, it is no longer in compliance with the minimum stockholders'
equity requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1), which requires listed companies
to maintain stockholders' equity of at least $2.5 million (the "Minimum Stockholders' Equity Requirement"), or
the alternative criteria of $35 million market value of listed securities or $500,000 in net income from continuing operations in the
most recent fiscal year or two or the last three fiscal years—which alternatives, as noted in the Equity Deficiency Letter, the
Company does not meet. The Company was given until January 5, 2024 to provide Nasdaq with a specific plan (the "Compliance Plan")
to achieve and sustain compliance with the Minimum Stockholders' Equity Requirement or its alternatives. If the Company's
Compliance Plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Equity Deficiency Letter for
the Company to evidence compliance.

 The
Company submitted a Compliance Plan to Nasdaq on January 5, 2024 to regain compliance with the Nasdaq Listing Rules. The Compliance Plan
was accepted by Nasdaq and the Company was granted an extension of up to 180 calendar days from
the date of the Equity Deficiency Letter (i.e., until May 20, 2024) for the Company to evidence compliance. If the Company does
not regain compliance within the requisite time period, or if the Company fails to satisfy another Nasdaq requirement for continued listing,
Nasdaq could provide notice that the Company's securities will become subject to delisting, which delisting determination the Company
has the right to appeal.

 If
we are unable to maintain compliance with Nasdaq's continued listing requirements, and in the event of a delisting, we would take
action to restore our compliance with Nasdaq's listing requirements, but we can provide no assurance that any such action taken
by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent
our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq's other
listing requirements.

 Losing
our Nasdaq other listing would seriously harm us, by undermining our ability to raise capital and decreasing our attractiveness to possible
merger partners.

 Item
1B. Unresolved Staff Comments.

 Not
applicable.

 Item
1C. Cybersecurity

 Our
processes for assessing, identifying, and managing material risks from cybersecurity threats are not advanced. None of our personnel
are trained specialists in cybersecurity; we rely on off-the-shelf" security software. We have not conducted employee training
regarding cybersecurity or conducted internal tests or simulations. Nonetheless, we believe that, due to the nature and status of our
business, our cybersecurity position is currently satisfactory for our situation. We do not believe that cybersecurity risks have materially
affected (or are reasonably likely to materially affect) us.

 We
have only four employees and so disclosure of cybersecurity events to management would occur organically, or would in the first instance
be observed by management.

 For
information of ours which resides on our CROs' computer systems, we rely on the CROs' own cybersecurity processes and systems.

 Item
2. Properties.

 None.
The lease for our previous operating facilities at 2042 Corte Del Nogal, Carlsbad, California had been in the name of our subsidiary
Qualigen, Inc. We sold Qualigen, Inc. in 2023 and the Company has no responsibility for the lease going forward. The Company had also
utilized such facility (in addition to Qualigen, Inc.'s use), but now has removed from it. The Company is currently essentially
"virtual."

 Item
3. Legal Proceedings.

 None.

 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.

 Our
common stock has been listed and traded on the Nasdaq Capital Market under the symbol "QLGN" since May 26, 2020.

 Holders

 As
of March 25, 2024, there were 287 registered holders of record of our common stock. This figure does not reflect the beneficial ownership
of shares held in nominee name.

Authorized for Issuance Under Equity Compensation Plans

 See
Part III, Item 12 "Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters" for information
relating to our equity compensation plans.

 Recent
Sales of Unregistered Securities

 No
further disclosure is required in response to this Item.

 Purchases
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.

 You
should read the following discussion and analysis of our financial condition and results of operations together with the consolidated
financial statements and related notes that are included elsewhere in this Annual Report. This discussion contains forward-looking statements
based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated
in these forward-looking statements as a result of various factors, including those set forth under "Risk Factors" or in
other parts of this Annual Report. See "Cautionary Note Regarding Forward-Looking Statements" for additional information.
Unless otherwise indicated, all information in this Annual Report on Form 10-K gives effect to a 1-for-10 reverse stock split of our
common stock that became effective on November 23, 2022, and all references to shares of common stock outstanding and per share amounts
give effect to the reverse stock split.

 Overview

 We
are an early-clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. Our business now consists
of one early-clinical-stage therapeutic program (QN-302) and one preclinical therapeutic program (Pan-RAS).

 Our
lead program, QN-302, is an investigational small molecule G-quadruplexes (G4)-selective transcription inhibitor with strong binding
affinity to G4s prevalent in cancer cells (such as pancreatic cancer). Such binding could, by stabilizing the G4s against DNA
"unwinding," help inhibit cancer cell proliferation. QN-302 is currently undergoing a Phase 1a clinical trial at START
Midwest in Grand Rapids, Michigan, and HonorHealth in Scottsdale, Arizona.

 Our
Pan-RAS program, which is currently at the preclinical stage, consists of a family of RAS oncogene protein-protein interaction inhibitor
small molecules believed to inhibit or block mutated RAS genes' proteins from binding to their effector proteins thereby
leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment
of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers.
 The investigational compounds within our Pan-RAS portfolio are designed to suppress the interaction of endogenous RAS with c-RAF,
upstream of the KRAS, HRAS and NRAS effector pathways.

 On
November 23, 2022, we effected a 1-for-10, reverse stock split of our outstanding shares of common stock (the "Reverse Stock Split").
The Reverse Stock Split reduced our shares of outstanding common stock, stock options, and warrants to purchase shares of our common
stock. Fractional shares of common stock that would have otherwise resulted from the Reverse Stock Split were rounded down to the nearest
whole share and cash in lieu of fractional shares was paid to stockholders. All share and per share data for all periods presented in
this Annual Report on Form 10-K have been adjusted retrospectively to reflect the Reverse Stock Split. The number of authorized shares
of common stock and the par value per share remains unchanged.

 We
do not expect to be profitable before products from our therapeutics pipeline are commercialized. To experience losses while therapeutic
products are still under development is, of course, typical for biotechnology companies.

 Recent
Developments

 Phase
1 Clinical Trial of QN-302

 On
August 1, 2023, we announced that the FDA has cleared our IND application for QN-302. Based on this clearance, we chose Translational Drug Development, LLC ("TD2") to serve
as our contract research organization to conduct a Phase 1 clinical trial in patients with advanced or metastatic solid tumors. The
Phase 1 trial (NCT06086522) is designed as a multicenter, open-label, dose escalation, safety, pharmacokinetic, and pharmacodynamic
study with dose expansion to evaluate safety, tolerability, and antitumor activity of QN-302 in patients with advanced solid tumors
that have not responded to or that have recurred following treatment with available therapies. On November 7, 2023, we announced
that the first patient had been enrolled and dosed in the dose escalation (Phase 1a) portion of the study. Subject to available
funding (which is, however, not all currently in hand), we anticipate that Phase 1a of the trial can be completed by the end of
2024. The exact number of patients to be enrolled in the trial will depend on the observed safety profile, which will
determine the number of patients per dose level, as well as the number of dose escalations required to meet the Maximum Tolerated
Dose ("MTD"). Once the MTD has been established in dose escalation, dose expansion will begin.

 Sale
of Diagnostics Business

 On
July 20, 2023, we sold all of the issued and outstanding shares of common stock of Qualigen, Inc., a wholly-owned subsidiary and the
legal entity operating our FastPack diagnostic business, to Chembio Diagnostics, Inc. ("Chembio"), a subsidiary of
Biosynex, S.A. As consideration for the shares of Qualigen, Inc., we received cash payments of approximately $4.9 million, which payment
is subject to post-closing adjustments. An additional $450,000 was delivered by Chembio to an escrow account to satisfy our indemnification
obligations. Any amounts remaining in the escrow account that have not been offset or reserved for claims will be released to us within
five business days following January 20, 2025. Following the consummation of the transaction, Qualigen, Inc. became a wholly-owned subsidiary
of Chembio.

 Amendment
and Settlement Agreement with NanoSynex Ltd.

 On
July 20, 2023, we entered into and effectuated the NanoSynex Amendment, by which we agreed to, among other things, forfeit 281,000 Series
B Preferred Shares of NanoSynex held by us, resulting in our ownership in NanoSynex being reduced from approximately 52.8% to approximately
49.97% of the voting equity of NanoSynex. In addition, we agreed to cancel approximately $3.0 million of promissory notes which NanoSynex
had issued to us under the NanoSynex Funding Agreement, relieving NanoSynex of any repayment obligations to us with respect to such notes.
The NanoSynex Amendment superseded any NanoSynex Funding Agreement obligations to provide funding to NanoSynex, except we agreed to provide
future loans as follows: (i) $560,000 on or before November 30, 2023, and (ii) $670,000 on or before March 31, 2024. However, on November
22, 2023, in full settlement of any additional funding obligations to NanoSynex, we forfeited certain of our shares of Series A-1 Preferred
Stock of NanoSynex in an amount that reduced our ownership in NanoSynex from approximately 49.97% to 39.90%. Accordingly, NanoSynex was
deconsolidated from our financial statements as of July 20, 2023, and is reported as Discontinued Operations in this Annual Report. Our
investment in NanoSynex will be accounted for in the future as an equity method investment.

 Critical
Accounting Policies and Estimates

 Our
consolidated financial statements historically have not separated our diagnostics-related activities from our therapeutics-related
activities. All of our historically reported revenue was diagnostics-related. Before the third quarter of 2023, our reported
expenses represented the total of our diagnostics-related and therapeutics-related expenses. In this Annual Report, all
diagnostics-related revenues and expenses have been reclassified to discontinued operations (See Note 5 - Discontinued
Operations).

 This
discussion and analysis is based on our consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The
preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of
assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements.
On an ongoing basis, we evaluate our estimates and judgments, including those related to impairment of goodwill and other intangible
assets, fair value of warrant liabilities, and stock-based compensation. We base our estimates on historical experience, known trends
and events and various other factors 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 under different assumptions or conditions.

 While
our significant accounting policies are more fully described in Note 1 to our consolidated financial statements appearing in "Item
8. Financial Statements and Supplementary Data," we believe that the following accounting policies are the most critical to aid
you in fully understanding and evaluating our financial condition and results of operations:

 and development

 Discontinued
 operations

 Impairment
 of long-lived assets

 Business
 combinations

 Derivative
 financial instruments and warrant liabilities

 Stock-based
 compensation

 taxes

 Warrant
Liabilities

 In
2004, Qualigen, Inc. issued Series C preferred stock warrants to investors and brokers in connection with a private placement. These
warrants were subsequently extended and survived the May 2020 Ritter reverse recapitalization transaction and are now exercisable
for Qualigen Therapeutics common stock. These warrants contain a provision that if the Company issues shares (except in certain
defined scenarios) at a price below the warrants' exercise price, the exercise price will be re-set to such new price and the
number of shares underlying the warrants will be increased in the same proportion as the exercise price decrease. For accounting
purposes, such warrants give rise to warrant liabilities. Accounting principles generally
accepted in the United States of America ("U.S. GAAP") require us to recognize the fair value of these warrants as
warrant liabilities on our Consolidated Balance Sheets and to reflect period-to-period changes in the fair value of the warrant
liabilities on our Consolidated Statements of Operations. The estimated fair value of these warrant liabilities was approximately
$0.1 million and $3.6 million at December 31, 2023 and 2022, respectively. There were 455,623 of these warrants outstanding at
December 31, 2023 and 1,349,571 of these warrants outstanding at December 31, 2022.

 Because
the fair value of the above liability classified warrants will be determined each quarter on a
"mark-to-market" basis, significant variability in our future quarterly and annual Consolidated Statement of Operations
and Consolidated Balance Sheets could occur based on changes in our public market common stock price. Pursuant to U.S. GAAP, a quarter-to-quarter
increase in our stock price would result in an increase in the fair value of the warrant liabilities and a quarter-to-quarter decrease
in our stock price would result in a decrease in the fair value of the warrant liabilities.

 On
December 22, 2022, as part of the 2022 Debenture financing, we issued to Alpha a common stock warrant (exercisable from June 22, 2023
through June 22, 2028) to purchase 2,500,000 shares of our common stock. The exercise price of the warrant was modified from $1.65 to
$0.73 on December 5, 2023, and was further modified to $0.26 on February 27, 2024. The warrant may be exercised by Alpha, in whole or
in part before June 22, 2028. The warrant was originally liability classified, but was modified on December 5, 2023 to allow for equity
classification. The estimated fair value of this warrant upon reclassification from warrant liabilities to equity was approximately $1.6
million and the estimated fair value of this warrant which was included in warrant liabilities-related party on December 31, 2022 was
approximately $2.8 million.

 Results
of Operations

 Comparison
of the Years Ended December 31, 2023 and 2022

 2023

 2022

 EXPENSES

 General and administrative

 $
 6,095,607

 10,274,600

 5,209,250

 4,486,120

 Total expenses

 11,304,857

 14,760,720

 LOSS FROM OPERATIONS

 (11,304,857
)

 (14,760,720
)

 OTHER EXPENSE (INCOME), NET

 Gain on change in fair value of warrant liabilities

 (2,035,469
)

 (907,203
)

 Interest expense, net

 1,524,722

 34,397

 Loss on voluntary conversion of convertible debt

 1,077,287

 —

 Loss on debt extinguishment

 625,653

 —

 Loss on fixed asset disposal

 21,747

 —

 Other income, net

 (38,994
)

 Total other expense (income), net

 1,174,946

 (872,806
)

 LOSS BEFORE (BENEFIT) PROVISION FOR INCOME TAXES

 (12,479,803
)

 (13,887,914
)

 (BENEFIT) PROVISION FOR INCOME TAXES

 (4,793
)

 6,548

 NET LOSS FROM CONTINUING OPERATIONS

 (12,475,010
)

 (13,894,462
)

 DISCONTINUED OPERATIONS

 Loss from discontinued operations, net of tax

 (683,008
)

 (7,140,181
)

 Loss on disposal of discontinued operations, net of tax

 (602,232
)

 —

 LOSS FROM DISCONTINUED OPERATIONS

 (1,285,240
)

 (7,140,181
)

 NET LOSS

 (13,760,250
)

 (21,034,643
)

 Net loss attributable to non-controlling interest from discontinued operations

 (343,038
)

 (2,394,100
)

 Net loss attributable to Qualigen Therapeutics, Inc.

 $
 (13,417,212
)

 $
 (18,640,543
)

 Net loss per common share, basic and diluted - continuing operations

 $
 (2.46
)

 $
 (3.62
)

 Net loss per common share, basic and diluted - discontinued operations

 $
 (0.19
)

 $
 (1.24
)

 Weighted—average number of shares outstanding, basic and diluted

 5,072,709

 3,840,340

 Other comprehensive loss, net of tax

 Net loss

 $
 (13,760,250
)

 $
 (21,034,643
)

 Foreign currency translation adjustment from discontinued operations

 119,473

 Other comprehensive loss

 (13,640,777
)

 (20,983,922
)

 Comprehensive loss attributable to noncontrolling interest from discontinued operations

 (304,735
)

 (2,394,100
)

 Comprehensive loss attributable to Qualigen Therapeutics, Inc.

 $
 (13,336,042
)

 $
 (18,589,822
)

 Expenses

 General
and Administrative Expenses

 General
and administrative expenses decreased from $10.3 million for the year ended December 31, 2022 to $6.1 million for the year ended
December 31, 2023. This decrease was due to a $3.8 million decrease in stock-based compensation expense, a $0.4 million decrease in
payroll related expenses, a $0.3 million decrease in insurance expenses, and a $0.2 million decrease in license fees, offset by an
increase of $0.5 million in professional fees. (The foregoing comparison, and all other comparisons presented in this Item, exclude
Qualigen, Inc. and NanoSynex, Ltd. results for both years.)

and Development Costs

and development expenses increased from $4.5 million for the year ended December 31, 2022 to approximately $5.2 million for year ended December
31, 2023. This increase in research and development expenses for the year ended December 31, 2023 compared to for the year ended December
31, 2022 was primarily due to a $2.1 million increase in pre-clinical and clinical research costs for QN-302, offset by a $1.0 million
decrease in pre-clinical research costs for QN-247 a $0.3 million decrease in preclinical research costs for Pan-RAS, and a $0.1 million decrease in preclinical research costs for QN-165.

 Other
Expense (Income)

 Change
in Fair Value of Warrant Liabilities

the year ended December 31, 2023 we experienced a $2.0 million gain in other income because of the change in fair value of the
warrant liabilities arising from our liability classified warrants described above. The estimated fair value of these warrant
liabilities decreased to $0.1 million as of December 31, 2023 from $3.6 million as of December 31, 2022 due to a reduction in fair
value of the warrant liabilities resulting from an associated decrease in the market price of our common stock, and the
reclassification at fair value of a liability classified warrant to equity of $1.6 million. For the year ended December 31, 2022,
the gain on change in fair value of warrant liabilities was $0.9 million due to an associated decrease in the market price of our
common stock. Typically, a decline in our stock price would result in a decline in the fair value of our warrant liabilities,
generating a gain, while an increase in our stock price would result in an increase in the fair value of our warrant liabilities,
generating a loss.

 The
remaining liability classified warrants expire on June 26, 2024. Because the fair value of the warrant liabilities will be determined
each quarter on a "mark-to-market" basis, this item is likely to, until then, continue to result in variability in our future
quarterly Consolidated Statements of Operations based on unpredictable changes in our public market common stock price and the number
of warrants outstanding at the end of each quarter.

(Income) Expense, Net

 There
was $1.5 million in net interest expense during the year ended December 31, 2023 compared to net interest income of $34,000 during the
year ended December 31, 2022. The increase was due to the interest on the 2022 Debenture.

 Loss
on Voluntary Conversion of Convertible Debt

the year ended December 31, 2023 we issued 841,726 shares of common stock upon Alpha's partial voluntary conversion of the
2022 Debenture at $1.32 per share for a total of $1,111,078 principal converted. Upon conversion, we recognized a loss on voluntary
conversion of convertible debt of approximately $1.1 million.

 Loss
on Debt Extinguishment

the year ended December 31, 2023, we issued 309,665 shares of common stock in lieu of cash for the October and December 2023 monthly
redemptions, for a total of $220,000 principal redeemed, pursuant to the terms of the 2022 Debenture at a weighted average share
price of $0.71. Upon redemption in shares, we recognized a loss on partial debt extinguishment of $34,315. The modification of the 2022 Debenture during the year ended December 31, 2023 met the criteria to be accounted for
as a debt extinguishment in the amount of $591,338. Accordingly, we recognized an additional loss on partial debt extinguishment of that
amount.

 Loss
on Fixed Asset Disposal

the year ended December 31, 2023, we incurred a $21,747 loss on fixed asset disposal due to disposal of research and development equipment
previously used for QN-165.

 Liquidity
and Going Concern

 Our
financial position is weak. As of December 31, 2023, we had approximately $0.4 million in cash and net accounts payable of over $2.2
million. We are in arrears on accounts payable to important partners. We have incurred recurring losses from operations and have an accumulated
deficit of $116.8 million at December 31, 2023. We expect to continue to incur losses subsequent to the consolidated balance sheet date
of December 31, 2023. For the years ended December 31, 2023 and 2022, we used cash of $10.3 million and $13.2 million, respectively, in
operations. We sold our Qualigen, Inc. FastPack diagnostics products business in 2023.

 On
February 26, 2024, we entered into a Securities Purchase Agreement ("Agreement") with Alpha. The transactions contemplated
by the Agreement closed on February 27, 2024, at which time we delivered to Alpha a new Debenture and warrant, as described in this paragraph,
and Alpha paid the Company a cash purchase price of $500,000 (less expenses). Pursuant to the Agreement, we issued to Alpha an 8% Convertible
Debenture (the "2024 Debenture") in the principal amount of $550,000. The 2024 Debenture has a maturity date of December
31, 2024 and is convertible, at any time, and from time to time, at Alpha's option, into shares of common stock of the Company,
at $0.6111 per share, subject to adjustment as described in the 2024 Debenture. The 2024 Debenture accrues interest on its outstanding
principal balance at the rate of 8% per annum, payable at maturity. Pursuant to the terms of the Agreement, we also issued to Alpha a
5-year common stock purchase warrant to purchase (at $0.26 per share) 900,016 shares of common stock of the Company. We also granted
to Alpha an option, exercisable until July 1, 2024, to purchase from us additional 8% Convertible Debentures, of like tenor, with face
amounts of up to an aggregate of $1,100,000 (and with a proportional number of accompanying common stock warrants of like tenor, up to
a total of 1,800,032 additional warrants), which would (if and when Alpha exercises such option) provide us up to an additional $1.0
million in cash proceeds (less expense reimbursement, and not including any possible cash proceeds from any future exercise of the additional warrants).

 We
currently expect our cash balances to fund operations only into the second quarter of 2024. We expect to continue to have net losses and negative cash flow from operations, which will challenge our liquidity.
These factors raise substantial doubt regarding our ability to continue as a going concern for the one-year period following the date
that the financial statements in this Annual Report were issued.

 There
is no assurance that we will ever achieve profitable operations, or, if achieved, could be sustained on a continuing basis. In order
to fully execute our business plan, we will require significant additional financing for planned research and development activities,
capital expenditures, QN-302 clinical trials, and preclinical development of Pan-RAS, as well as commercialization activities.

 Historically,
our principal sources of cash have, in addition to revenue from FastPack product sales and license revenues (see Note 5 - Discontinued
Operations), included proceeds from the issuance of common and preferred equity and proceeds from the issuance of debt. In December 2022
and February 2024 we raised approximately $3.0 million and $0.5 million, respectively from the sale of convertible debentures to Alpha. There can be
no assurance that further financing can be obtained on favorable terms, or at all. If we are unable to obtain funding, we could be required
to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, and
we could be unable to continue operations.

 To
the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our
common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect
the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting
our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise
additional funds through third-party funding, commercialization, marketing and distribution arrangements or other collaborations, strategic
alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue
streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. In addition, any future
financing (depending on the terms and conditions) may be subject to the approval of Alpha under the terms of the Debentures and/or trigger
certain adjustments to the Debentures or warrants held by Alpha.

 The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The financial statements
do not include any adjustments that would be necessary should the Company be unable to continue as a going concern, and therefore, be
required to liquidate its assets and discharge its liabilities in other than the normal course of business and at amounts that may differ
from those reflected in the accompanying financial statements.

 Our
current liabilities at December 31, 2023 include $2.2 million of accounts payable, $0.6 million of accrued expenses and other current
liabilities, $0.1 million in warrant liabilities, and $1.3 million of convertible debt to a related party.

 Contractual
Obligations and Commitments

 We
have no material contractual obligations that are not fully recorded on our consolidated balance sheets or fully disclosed in the notes
to the financial statements.

 License
and Sponsored Research Agreements

 We
have obligations under various license and sponsored research agreements to make future payments to third parties that become due and
payable on the achievement of certain development, regulatory and commercial milestones (such as the start of a clinical trial, filing
for product approval with the FDA or other regulatory agencies, product approval by the FDA or other regulatory agencies, product launch
or product sales) or on the sublicense of our rights to another party. We have not included these commitments on our balance sheet because
the achievement and timing of these events is not determinable. Certain milestones are in advance of receipt of revenue from the sale
of products and, therefore, we may require additional debt or equity capital to make such payments.

 We
have multiple license and sponsored research agreements with ULRF. Under these agreements, we have taken over development, regulatory
approval and commercialization of various drug compounds from ULRF and are responsible for maintenance of the related intellectual property
portfolio. We agreed to reimburse ULRF for sponsored research expenses of up to $2.7 million and prior patent costs of up to $112,000
for Pan-RAS. As of December 31, 2023, there were no remaining un-expensed amounts under this sponsored research agreement for Pan-RAS.
Under the terms of these agreements, we are required to make patent maintenance payments and payments based upon development, regulatory
and commercial milestones for any products covered by the in-licensed intellectual property. The maximum aggregate milestone payments
we may be obligated to make per product are $5 million. We will also be required to pay a royalty on net sales of products covered by
the in-licensed intellectual property in the low single digits. The royalty is subject to reduction for any third-party payments required
to be made, with a minimum floor in the low single digits. We have the right to sublicense our rights under these agreements, but we
will be required to pay ULRF a percentage of any sublicense income.

 We
previously had sponsored research agreements with ULRF for QN-247 and QN-165. As of December 31, 2023, there were no remaining un-expensed
amounts under these sponsored research agreements and the agreements were terminated effective August 31, 2022, and November 30, 2021
respectively.

 On
January 13, 2022, we entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a
genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College
London, including lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization
company for University College London.) We are further developing the program's lead compound under the name QN-302. The
License Agreement requires (if and when applicable) tiered royalty payments in the low to mid-single digits,
clinical/regulatory/sales milestone payments, and sharing of a percentage of any non-royalty sublicensing consideration paid to the
Company. In November 2023, we became obligated to pay $100,000 to UCL Business Limited upon the first patient dosing of QN-302,
which is included in accounts payable in our consolidated balance sheet.

 Alpha
Convertible Debt

 On
December 22, 2022, pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022 (the "Alpha Purchase Agreement"),
we issued to Alpha, in exchange for $3,000,000 in cash (less $50,000 for expense reimbursement), the 2022 Debenture with an original
face amount of $3,300,000 due on December 22, 2025, plus 2,500,000 common stock warrants exercisable (from June 22, 2023 through June
22, 2028) at $1.65 per share.

 Commencing
June 1, 2023 and continuing on the first day of each month thereafter until the earlier of (i) December 22, 2025 and (ii) the full redemption
of the 2022 Debenture, we must redeem $110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under
the 2022 Debenture. The Monthly Redemption Amount must be paid in cash; provided that after the first two monthly redemptions, we may
(if the Equity Conditions, as defined in the 2022 Debenture, are then satisfied or have been waived) elect to pay all or a portion of
a Monthly Redemption Amount in shares of our common stock, based on a conversion price equal to the lesser of (i) the then applicable
conversion price of the 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined in the 2022 Debenture) for the five consecutive
trading days ending on the trading day that is immediately prior to the applicable Monthly Redemption Date.

 The
2022 Debenture accrues interest at the rate of 8% per annum, which began accruing on December 1, 2023, and will be payable on a quarterly
basis. Interest may be paid in cash or shares of common stock or a combination thereof at our option; provided that the Equity Conditions
have been satisfied.

 Alpha
has waived the Equity Conditions for certain Monthly Redemption Amounts, but Alpha is not required to continue such waivers beyond May
2024. For the foreseeable future, we do not expect to be able to satisfy the Equity Conditions; as a result, where there is no waiver
of the Equity Conditions we would not have the opportunity to make 2022 Debenture payments in the form of stock rather than in the form
of cash, even for types of payments for which payment in the form of stock would have been allowed.

 The
2022 Debenture is convertible into our common stock at any time at the holder's option; the conversion price was originally $1.32
but pursuant to a Securities Purchase Agreement amendment it was reduced to $0.73 on December 5, 2023 and then on February 27, 2024 it
was adjusted downward to $0.26 per share by virtue of the operation of a "ratchet" antidilution provision. (The exercise
price of the warrants issued with the 2022 Debenture was originally $1.65 but pursuant to the Securities Purchase Agreement amendment
it was reduced to $0.73 on December 5, 2023 and then on February 27, 2024 it was adjusted downward to $0.26 per share by virtue of the
operation of a "ratchet" antidilution provision.)

 Both
the 2022 Debenture and the accompanying warrants provide for "ratchet" antidilution adjustments to their conversion price
and exercise price.

 Both
the 2022 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon

 We
granted Alpha resale registration rights for the common shares underlying the 2022 Debenture and the accompanying warrants.

 On
December 5, 2023, we entered into an Amendment No. 1 with regard to Securities Purchase Agreement, with Alpha, which, among other things,
revised certain provisions of the 2,500,000 warrants to clarify the intention that such 2,500,000 warrants would not be liability-classified
for GAAP purposes.

the year ended December 31, 2023, we recognized an extinguishment loss on voluntary conversion of convertible debt of approximately
$1.1 million, an extinguishment loss of $0.6 million upon October and December 2023 share redemptions and the modification of the
2022 Debenture in December 2023, and recorded accrued interest of approximately $1.5 million, in other expenses in the consolidated
statements of operations. During the year ended December 31, 2023 we paid Monthly Redemption Amounts of $550,000 in cash and
$220,000 in common stock, and as of December 31, 2023 the remaining 2022 Debenture principal balance was approximately $1.4 million,
the remaining discount was approximately $0.1 million, and the fair value of the suite of bifurcated embedded derivative features
was $0.

 Reference
is also made to the 2024 Debenture, which was issued to Alpha after the end of the 2023 fiscal year and is described above.

Funding Agreement

 As
a condition to our acquisition of a majority voting equity interest in NanoSynex from Alpha and NanoSynex, we entered into a Master Agreement
for the Operational and Technological Funding of NanoSynex (the "Funding Agreement"), on May 26, 2022, pursuant to which
we agreed to fund NanoSynex up to an aggregate of approximately $10.4 million, subject to NanoSynex's achievement of certain performance
milestones specified in the Funding Agreement and the satisfaction of other terms and conditions described in the Funding Agreement.

the year ended December 31, 2022, we funded a total of approximately $2.4 million and in February 2023 we funded an additional $0.5 million
to NanoSynex under the Funding Agreement.

 On
July 20, 2023, we entered into the NanoSynex Amendment, which amended the Funding Agreement, pursuant to which the Company agreed to,
among other things, forfeit 281,000 Series B Preferred Shares of NanoSynex held by the Company, resulting in our ownership in NanoSynex
being reduced from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex. In addition, we agreed to cancel approximately
$3.0 million of promissory notes which NanoSynex had issued to us under the NanoSynex Funding Agreement, relieving NanoSynex of any repayment
obligations to us with respect to such notes. The surrender of shares reducing our interest in NanoSynex from approximately 52.8% to
approximately 49.97% occurred on July 20, 2023. Accordingly, NanoSynex was deconsolidated from our financial statements as of July 20,
2023, and is reported as Discontinued Operations in this Annual Report.

 The
NanoSynex Amendment superseded any payment obligations contemplated by the original Funding Agreement and amended our obligations to
provide funding to NanoSynex, except we agreed to provide future funding as follows: (i) $560,000 on or before November 30, 2023,
and (ii) $670,000 on or before March 31, 2024, in each case issued in the form of a promissory note to the Company with a face value
in the amount of such funding. However, on November 22, 2023, in full settlement of any additional funding obligations to NanoSynex,
we forfeited certain of our shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced our ownership in NanoSynex
from approximately 49.97% to 39.90%. Our investment in NanoSynex will be accounted as an equity method investment
prospectively from the July 20, 2023 deconsolidation date.

 Other
Service Agreements

 We
enter into contracts in the normal course of business, including with clinical sites, contract research organizations, and other professional
service providers for the conduct of clinical trials, contract manufacturers for the production of our product candidates, contract research
service providers for preclinical research studies, professional consultants for expert advice and vendors for the sourcing of clinical
and laboratory supplies and materials. These contracts generally provide for termination on notice, and therefore are cancelable contracts.

 Cash
Flows

 The
following table sets forth the significant sources and uses of cash for the periods set forth below:

 For
 the Twelve Months Ended

 December
 31,

 2023

 2022

 Net
 cash (used in) provided by:

 Operating
 activities

 $
 (10,304,263
)

 $
 (13,247,541
)

 Investing
 activities

 4,215,943

 (183,763
)

 Financing
 activities

 (550,000
)

 2,910,515

 Effect
 of exchange rate on cash

 —

 22,639

 Net
 decrease in cash and restricted cash

 $
 (6,638,320
)

 $
 (10,498,150
)

 Net
Cash Used in Operating Activities

the year ended December 31, 2023, operating activities used $10.3 million of cash, primarily resulting from a loss from continuing
operations of $12.5 million. Cash flows from operating activities for the year ended December 31, 2023 were positively impacted by
adjustments for a $1.1 million non cash loss on voluntary conversion of convertible debt, a $0.6 million non cash loss on
convertible debt extinguishment, accretion of discount of $1.5 million on convertible debt, a $1.6 million increase in accounts
payable, and $1.1 million in non cash stock-based compensation expense. Cash flows from operating activities for the year ended December 31, 2023 were negatively impacted by adjustments for a
$2.0 million decrease in fair value of warrant liabilities, a $0.3 million increase in prepaid expenses and other assets, a $0.2
million decrease in accrued expenses and other current liabilities, and cash used in discontinued operations of $1.2 million.

the year ended December 31, 2022, operating activities used $13.2 million of cash, primarily resulting from a loss from continuing
operations of $13.9 million. Cash flows from operating activities for the year ended December 31, 2022 were positively impacted by
an adjustment for $4.8 million in non cash stock-based compensation expense. Cash
flows from operating activities for the year ended December 31, 2022 were negatively impacted by cash used in discontinued
operations of $2.6 million, a $0.9 million decrease in fair value of warrant liabilities, a $0.5 million decrease in accrued
expenses and other current liabilities, and a $0.1 million increase in prepaid expenses.

 Net
Cash Provided By Investing Activities

the year ended December 31, 2023, net cash provided by investing activities was approximately $4.2 million resulting from discontinued
operations due to $4.9 million in proceeds received from the sale of Qualigen, Inc., offset by $0.5 million advanced to NanoSynex, and
$0.2 million in purchases of property and equipment prior to deconsolidation.

 During the year ended December 31, 2022, net cash used in investing activities
was approximately $0.2 million, due to capital expenditures offset by cash acquired in the NanoSynex acquisition.

 Net
Cash Provided by Financing Activities

 Net
cash provided by financing activities for the year ended December 31, 2023, was approximately $0.6 million, due to monthly redemption
payments which we made in the form of stock (rather than in the form of cash) on the 2022 Debenture.

 Net cash provided by financing activities for the year ended December 31,
2022, was approximately $2.9 million, due to the issuance of convertible debt to Alpha.

 Item
7A. Quantitative and Qualitative Disclosures about Market Risk.

 We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise
required under this Item.

 Item
8. Consolidated Financial Statements and Supplementary Data

TO CONSOLIDATED FINANCIAL STATEMENTS

 Page

 Report of Independent Registered Public Accounting Firm (PCAOB ID: 23)

 Consolidated Balance Sheets

 Consolidated Statements of Operations and Comprehensive Loss

 Consolidated Statements of Stockholders' Equity

 Consolidated Statements of Cash Flows

 Notes to Consolidated Financial Statements

 REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 To
the Board of Directors and Stockholders of Qualigen Therapeutics, Inc.

 Opinion
on the Financial Statements

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

 Going
Concern Uncertainty

 The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 2 to the consolidated financial statements, the Company's current liquidity position and projected cash needs raise substantial
doubt about its ability to continue as a going concern. Management's plans regarding these matters are also described in Note 2.
The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 Basis
for Opinion

 These
consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion
on the Company's consolidated 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 consolidated 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 consolidated 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 consolidated 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 consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.

 Critical
Audit Matter

 The
critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated
or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial
statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of 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 separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.

 Accounting
for Financial Instruments – Modification of Convertible Debt with Warrants

 Critical
Audit Matter Description

 As described in Note 8 to the consolidated financial
statements, during the year ended December 31, 2023, the Company modified the conversion price and strike price of its convertible debenture
and common stock purchase warrants, respectively. Further, the Company modified certain terms of its stock warrant agreements that were
originally classified as liabilities enabling them to be classified as equity.

 We identified the accounting for the modification
of this complex financial instrument as a critical audit matter. This includes both the evaluation of the various features as potential
embedded derivatives and the determination of the respective fair value of the instruments and the embedded features, as well as the determination
of the appropriate classification of warrants between equity and liabilities. The application of the accounting guidance applicable to
issuing and modifying a complex financial instrument requires significant judgment.

 Determination of appropriate classification of warrants
requires management's judgments relating to the interpretations of relevant accounting guidance based on specific provisions of
the warrant agreement. Accounting for the convertible notes and embedded conversion features requires management's judgments related
to initial and subsequent recognition of the debt and related features, use of a valuation model, and key inputs used in the selected
valuation model.

 How We Addressed the Matter in Our Audit

 The
primary procedures we performed to address this critical audit matter included:

 Inspecting the agreements associated with the transactions and evaluating management's technical accounting analysis, including
the application of the relevant accounting literature.

 Utilizing an auditor's specialist to assist in assessing management's analysis of the transaction, including (i) evaluating
the contracts to identify relevant terms that affect the recognition of the financial instruments, (ii) assessing the appropriateness
of conclusions reached by management, and (iii) reviewing the valuation model for derivatives, performing independent calculations, and
examining the significant assumptions utilized in the valuation model.

 /s/
 Baker Tilly US, LLP

 We
have served as the Company's auditor since 2018.

 San
Diego, California

 April
5, 2024

 CONSOLIDATED
BALANCE SHEETS

 2023

 2022

 ASSETS

 Current assets

 Cash

 $
 401,803

 $
 3,165,985

 Prepaid expenses and other current assets

 764,964

 1,366,704

 Current assets of discontinued operations

 —

 6,287,849

 Total current assets

 1,166,767

 10,820,538

 Property and equipment, net

 —

 26,242

 Other assets

 866,481

 —

 Non-current assets of discontinued operations

 —

 8,236,711

 Total Assets

 $
 2,033,248

 $
 19,083,491

 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

 Current liabilities

 Accounts payable

 $
 2,222,983

 $
 619,568

 Accrued expenses and other current liabilities

 560,006

 864,559

 Warrant liabilities

 54,600

 788,100

 Warrant liabilities - related party

 —

 2,834,547

 Convertible debt - related party

 1,299,216

 60,197

 Current liabilities of discontinued operations

 —

 3,441,198

 Total current liabilities

 4,136,805

 8,608,169

 Non-current liabilities of discontinued operations

 —

 1,708,732

 Total liabilities

 4,136,805

 10,316,901

 Commitments and Contingencies (Note 10)

 -

 -

 Stockholders' equity (deficit)

 Qualigen Therapeutics, Inc. stockholders' equity (deficit):

 Common stock, $ 0.001 par value; 225,000,000 shares authorized; 5,362,128 and 4,210,737 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively

 43,262

 42,110

 Additional paid-in capital

 114,655,565

 110,528,050

 Accumulated other comprehensive income

 —

 Accumulated deficit

 ( 116,802,384
)

 ( 103,385,172
)

 Total Qualigen Therapeutics, Inc. stockholders' equity (deficit)

 ( 2,103,557
)

 7,235,709

 Noncontrolling interest

 —

 1,530,881

 Total Stockholders' Equity (deficit)

 ( 2,103,557
)

 8,766,590

 Total Liabilities & Stockholders' Equity (Deficit)

 $
 2,033,248

 $
 19,083,491

 The
accompanying notes are an integral part of these consolidated financial statements.

 CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

 2023

 2022

 2023

 2022

 EXPENSES

 General and administrative

 $
 6,095,607

 10,274,600

 5,209,250

 4,486,120

 Total expenses

 11,304,857

 14,760,720

 LOSS FROM OPERATIONS

 ( 11,304,857
)

 ( 14,760,720
)

 OTHER EXPENSE (INCOME), NET

 Gain on change in fair value of warrant liabilities

 ( 2,035,469
)

 ( 907,203
)

 Interest expense, net

 1,524,722

 34,397

 Loss on voluntary conversion of convertible debt

 1,077,287

 —

 Loss on debt extinguishment

 625,653

 —

 Loss on fixed asset disposal

 21,747

 —

 Other income, net

 ( 38,994
)

 —

 Total other expense (income), net

 1,174,946

 ( 872,806
)

 LOSS BEFORE (BENEFIT) PROVISION FOR INCOME TAXES

 ( 12,479,803
)

 ( 13,887,914
)

 (BENEFIT) PROVISION FOR INCOME TAXES

 ( 4,793
)

 6,548

 NET LOSS FROM CONTINUING OPERATIONS

 ( 12,475,010
)

 ( 13,894,462
)

 DISCONTINUED OPERATIONS

 Loss from discontinued operations, net of tax

 ( 683,008
)

)

 Loss on disposal of discontinued operations, net of tax

 ( 602,232
)

 —

 LOSS FROM DISCONTINUED OPERATIONS

 ( 1,285,240
)

)

 NET LOSS

 ( 13,760,250
)

 ( 21,034,643
)

 Net loss attributable to non-controlling interest from discontinued operations

 ( 343,038
)

 ( 2,394,100
)

 Net loss attributable to Qualigen Therapeutics, Inc.

 $
 ( 13,417,212
)

 $
 ( 18,640,543
)

 Net loss per common share, basic and diluted - continuing operations

 $
 ( 2.46
)

 $
 ( 3.62
)

 Net loss per common share, basic and diluted - discontinued operations

 $
 ( 0.19
)

 $
 ( 1.24
)

 Weighted-average number of shares outstanding, basic and diluted

 5,072,709

 3,840,340

 Other comprehensive loss, net of tax

 Net loss

 $
 ( 13,760,250
)

 $
 ( 21,034,643
)

 Foreign currency translation adjustment from discontinued operations

 119,473

 Other comprehensive loss

 ( 13,640,777
)

 ( 20,983,922
)

 Comprehensive loss attributable to noncontrolling interest from discontinued operations

 ( 304,735
)

 ( 2,394,100
)

 Comprehensive loss attributable to Qualigen Therapeutics, Inc.

 $
 ( 13,336,042
)

 $
 ( 18,589,822
)

 The
accompanying notes are an integral part of these consolidated financial statements.

 CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

 Amount

 Paid-In

 Capital

 Comprehensive

 Deficit

 (Deficit)

 Noncontrolling

 (Deficit)

 Common
 Stock

 Additional

 Other Comprehensive

 Total

 Qualigen

 Therapeutics,
 Inc.

 Stockholders'

 Total

 Stockholders'

 Amount

 Paid-In

 Capital

 Income (Deficit)

 Deficit

 (Deficit)

 Noncontrolling

 (Deficit)

 Balance at December 31, 2022

 4,210,737

 $
 42,110

 $
 110,528,050

 $

 $
 ( 103,385,172
)

 $
 7,235,709

 $
 1,530,881

 $
 8,766,590

 Voluntary conversion of convertible
 debt into common stock

 841,726

 1,111,740

 —

 —

 1,112,582

 —

 1,112,582

 Redemptions of convertible
 debt into common stock

 309,665

 254,006

 —

 —

 254,316

 —

 254,316

 Fair value of warrant modification
 for professional services

 —

 —

 7,945

 —

 —

 7,945

 —

 7,945

 Fair value of warrant reclassified
 from liabilities to equity

 —

 —

 1,626,694

 —

 —

 1,626,694

 —

 1,626,694

 Stock-based compensation

 —

 —

 1,098,533

 —

 —

 1,098,533

 9,297

 1,107,830

 Foreign currency translation
 adjustment

 —

 —

 28,597

 81,170

 —

 109,767

 38,303

 148,070

 Deconsolidation of discontinued
 operations

 —

 —

 —

 ( 131,891
)

 —

 ( 131,891
)

 ( 1,235,443
)

 ( 1,367,334
)

 Net
 loss

 —

 —

 —

 —

 ( 13,417,212
)

 ( 13,417,212
)

 ( 343,038
)

 ( 13,760,250
)

 Balance at December 31,
 2023

 5,362,128

 $
 43,262

 $
 114,655,565

 $
 —

 $
 ( 116,802,384
)

 $
 ( 2,103,557
)

 $
 —

 $
 ( 2,103,557
)

 Common
 Stock

 Additional

 Other

 Total

 Qualigen

 Therapeutics,
 Inc.

 Total

 Amount

 Paid-In

 Capital

 Comprehensive

 Deficit

 Stockholders'

 Noncontrolling

 Stockholders'

 Balance at December 31, 2021

 3,529,018

 $
 35,290

 $
 101,274,073

 $
 —

 $
 ( 84,744,629
)

 $
 16,564,734

 $
 —

 $
 16,564,734

 Balance

 3,529,018

 $
 35,290

 $
 101,274,073

 $
 —

 $
 ( 84,744,629
)

 $
 16,564,734

 $
 —

 $
 16,564,734

 Stock issued upon exercise
 of warrants

 332,000

 3,320

 4,711

 —

 —

 8,031

 —

 8,031

 Stock-based compensation

 —

 —

 5,484,044

 —

 —

 5,484,044

 —

 5,484,044

 Common stock and prefunded
 warrants issued for business acquisition

 350,000

 3,500

 3,740,417

 —

 —

 3,743,917

 3,882,225

 7,626,142

 Noncontrolling interest
 adjustments relating to Stock-based compensation and other

 —

 —

 ( 42,756
)

 —

 —

 ( 42,756
)

 42,756

 —

 Foreign currency translation
 adjustment

 —

 —

 —

 —

 —

 Fair value of warrant modification
 for professional services

 —

 —

 67,370

 —

 —

 67,370

 —

 67,370

 Fair value of warrant modification
 for business acquisition

 —

 —

 —

 —

 —

 Issuance of rounded shares
 as a result of the reverse stock split

 ( 281
)

 —

 ( 505
)

 —

 —

 ( 505
)

 —

 ( 505
)

 Net
 loss

 —

 —

 —

 —

 ( 18,640,543
)

 ( 18,640,543
)

 ( 2,394,100
)

 ( 21,034,643
)

 Balance at December 31,
 2022

 4,210,737

 $
 42,110

 $
 110,528,050

 $

 $
 ( 103,385,172
)

 $
 7,235,709

 $
 1,530,881

 $
 8,766,590

 Balance

 4,210,737

 $
 42,110

 $
 110,528,050

 $

 $
 ( 103,385,172
)

 $
 7,235,709

 $
 1,530,881

 $
 8,766,590

 The
accompanying notes are an integral part of these consolidated financial statements.

 CONSOLIDATED
STATEMENTS OF CASH FLOWS

 2023

 2022

 For the Years Ended December 31,

 2023

 2022

 CASH FLOWS FROM OPERATING ACTIVITIES

 Net loss

 $
 ( 13,760,250
)

 $
 ( 21,034,643
)

 Loss from discontinued operations, net of tax

 ( 1,285,240
)

)

 Loss from continuing operations

 ( 12,475,010
)

 ( 13,894,462
)

 Adjustments to reconcile loss from continuing operations to net cash used in operating activities:

 Depreciation and amortization

 4,495

 12,165

 Stock-based compensation

 1,098,533

 4,765,276

 Change in fair value of warrant liabilities

 ( 2,035,469
)

 ( 906,345
)

 Loss on voluntary conversion of convertible debt

 1,077,287

 —

 Accretion of discount on convertible debt

 1,469,640

 —

 Loss on debt extinguishment

 625,653

 —

 Loss on disposal of fixed assets

 21,747

 —

 Fair value of warrant modification for professional services

 7,945

 67,370

 Changes in operating assets and liabilities:

 Prepaid expenses and other assets

 ( 264,741
)

 ( 126,985
)

 Accounts payable

 1,603,422

 ( 43,440
)

 Accrued expenses and other current liabilities

 ( 227,101
)

 ( 472,441
)

 Net cash used in operating activities - continuing operations

 ( 9,093,599
)

 ( 10,598,862
)

 Net cash provided by (used in) operating activities - discontinued operations

 ( 1,210,664
)

 ( 2,648,679
)

 Net cash used in operating activities

 ( 10,304,263
)

 ( 13,247,541
)

 CASH FLOWS FROM INVESTING ACTIVITIES:

 Net cash provided by (used in) investing activities -
 discontinued operations

 4,215,943

 ( 183,763
)

 Net cash provided by (used in) investing activities

 4,215,943

 ( 183,763
)

 CASH FLOWS FROM FINANCING ACTIVITIES:

 Net proceeds from warrant exercises

 —

 7,173

 Proceeds from issuance of convertible debt

 —

 2,903,847

 Payments on convertible notes payable

 ( 550,000
)

 —

 Fractional share payments related to the reverse stock split

 —

 ( 505
)

 Net cash (used in)/provided by financing activities - continuing operations

 ( 550,000
)

 2,910,515

 Net cash used in financing activities - discontinued operations

 —

 —

 Net cash (used in) provided by financing activities

 ( 550,000
)

 2,910,515

 Net change in cash and restricted cash

 ( 6,638,320
)

 ( 10,520,789
)

 Effect of exchange rate changes on cash and restricted cash

 —

 22,639

 Cash and restricted cash from continuing operations -
 beginning of period

 3,165,985

 9,174,383

 Cash and restricted cash from discontinued operations - beginning of period

 3,874,138

 8,363,890

 Less: cash and restricted cash from discontinued operations - end of period

 —

 ( 3,874,138

)

 Cash from continuing operations - end of period

 $
 401,803

 $
 3,165,985

 SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION

 Cash paid during the year for:

 $
 —

 $
 —

 Taxes

 $
 5,571

 $
 5,571

 NONCASH FINANCING AND INVESTING ACTIVITIES:

 Net transfers to equipment held for lease from inventory

 $
 83,281

 $
 —

 Fair value of warrant liabilities on date of exercise

 $
 —

 $

 Redemption of convertible debt into common stock

 $
 254,316

 $
 —

 Voluntary conversion of convertible debt into common stock

 $
 1,112,582

 $
 —

 Fair value of warrant modifications pursuant to Securities Purchase
 Agreement

 $
 —

 $
 9,439

 Fair value of warrant modifications for business acquisition

 $
 —

 $
 33,543

 The
accompanying notes are an integral part of these consolidated financial statements.

 NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS

 NOTE
1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES

 Organization

 Ritter
Pharmaceuticals, Inc. (the Company's predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the
name Ritter Natural Sciences, LLC. In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals,
Inc. On May 22, 2020, upon completing a "reverse recapitalization" transaction with Qualigen, Inc., Ritter Pharmaceuticals,
Inc. was renamed Qualigen Therapeutics, Inc. (the "Company"). Qualisys Diagnostics, Inc. was formed as a Minnesota corporation
in 1996, reincorporated to become a Delaware corporation in 1999, and then changed its name to Qualigen, Inc. in 2000. Qualigen, Inc.
was a wholly-owned subsidiary of the Company. On July 20, 2023, the Company sold all of the issued and outstanding shares of common stock
of Qualigen, Inc. to Chembio Diagnostics, Inc. ("Chembio"), a wholly-owned subsidiary of Biosynex, S.A. ("Biosynex").
Following the consummation of this transaction, Qualigen, Inc. became a wholly-owned subsidiary of Chembio (see Note 5 – Discontinued
Operations).

 On
May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. ("NanoSynex") from Alpha
Capital Anstalt ("Alpha"), a related party, in exchange for 350,000 reverse split adjusted shares of the Company's
common stock and a prefunded warrant to purchase 331,464 reverse split adjusted shares of the Company's common stock at an exercise
price of $ 0.001 per share. These warrants were subsequently exercised on September 13, 2022. Concurrently with this transaction, the
Company also entered into a Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022,
with NanoSynex (the "NanoSynex Funding Agreement"), to, among other things, provide for the further funding of NanoSynex,
and purchased 381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $ 600,000. The transactions resulted
in the Company acquiring a 52.8 % interest in NanoSynex (the "NanoSynex Acquisition"). NanoSynex is a nanotechnology diagnostics
company domiciled in Israel. On July 20, 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex (the "NanoSynex
Amendment"), which amended the NanoSynex Funding Agreement, to, among other things, eliminate most of the Company obligation for
the further funding of NanoSynex. Pursuant to the terms of the NanoSynex Amendment, the Company lost its controlling interest in NanoSynex
(see Note 5 -Discontinued Operations).

 Basis
of Presentation

 The
accompanying consolidated financial statements of the Company have been prepared in conformity with accounting principles generally accepted
in the United States of America ("U.S. GAAP"), Regulation S-X and rules and regulations of the Securities and Exchange Commission
("SEC").

 Principles
of Consolidation

 The
accompanying consolidated financial statements include the accounts of the Company and its former wholly-owned and majority owned subsidiaries.
All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance
is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment. In general, the functional
currency of the Company and its subsidiaries is the U.S. dollar. For NanoSynex, the functional currency was the local currency, New Israeli
Shekels (NIS). As such, assets and liabilities for NanoSynex were translated into U.S. dollars with the effects of foreign currency translation
adjustments reflected as a component of accumulated other comprehensive loss within the Company's consolidated statements of
changes in stockholders' equity (deficit).

 As
of July 20, 2023, NanoSynex was deconsolidated from these financial statements as the transactions contemplated by the NanoSynex Amendment
resulted in a loss of control of a subsidiary that constitutes a business under ASC 810. The retained investment in NanoSynex is accounted
for prospectively as an equity method investment. See Note 5 – Discontinued Operations for further information.

 Discontinued
Operations

 On
July 20, 2023, the Company completed the sale of Qualigen, Inc. to Chembio Diagnostics, Inc. The sale of Qualigen Inc. constituted a
significant disposition and as such, the Company concluded that the disposition of ownership in Qualigen, Inc. represented a strategic
shift that had a major effect on its operations and financial results. Therefore, Qualigen, Inc. is classified as discontinued operations
for all periods presented herein.

 On
July 20, 2023, the Company entered into the NanoSynex Amendment, which amended the Master Funding Agreement
for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022, by and between the Company and NanoSynex (the "NanoSynex
Funding Agreement"), a former majority owned subsidiary of the Company, to, among other things, forfeit 281,000 Series B Preferred
Shares of NanoSynex held by the Company, resulting in the deconsolidation of NanoSynex. The disposition represents a strategic shift
that will have a material effect on the Company's operations and financial results. Accordingly, the business of NanoSynex is classified
as discontinued operations for all periods presented herein.

 See
Note 5 - Discontinued Operations for further information.

Method Investments

 Following
deconsolidation of NanoSynex on July 20, 2023, the Company accounts for its retained investment under the equity method of accounting
as it retained the ability to exercise significant influence over the operating and financial policies of the investee. Under the equity
method, the Company recognizes its proportionate share earnings or losses each reporting period with an adjustment to the carrying value
of the investment. As of December 31, 2023, the carrying value of the retained investment was zero, and therefore the Company has suspended
application of the equity method as the Company is not liable for the obligations of the investee nor otherwise committed to provide
financial support. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses
in prior periods. See Note 5 – Discontinued Operations for further information.

 Accounting
Estimates

 Management
uses estimates and assumptions in preparing its consolidated financial statements in accordance with U.S. GAAP. Those estimates and assumptions
affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues
and expenses. The most significant estimates relate to the estimated fair value of in-process research and development, goodwill, warrant
liabilities, and stock-based compensation. Actual results could vary from the estimates that were used.

 Reverse
Stock Split

 On
November 23, 2022, the Company effected a 1-for-10 reverse stock split of its outstanding shares of common stock (the "Reverse
Stock Split"). The Reverse Stock Split reduced the Company's shares of outstanding common stock, stock options, and warrants
to purchase shares of common stock. Fractional shares of common stock that would have otherwise resulted from the Reverse Stock Split
were rounded down to the nearest whole share and cash in lieu of fractional shares was paid to stockholders. All share and per share
data for all periods presented in the accompanying financial statements and the related disclosures have been adjusted retrospectively
to reflect the Reverse Stock Split. The number of authorized shares of common stock and the par value per share remains unchanged.

 Cash

 The
Company considers all highly liquid investments purchased with an initial maturity of 90 days or less and money market funds to be cash
equivalents.

 The
Company maintains the majority of its cash in government money market mutual funds and in accounts at banking institutions in the U.S.
that are of high quality. Cash held in these accounts often exceed the Federal Deposit Insurance Corporation (FDIC) insurance limits.
If such banking institutions were to fail, the Company could lose all or a portion of amounts held in excess of such insurance limitations.
In March 2023, Silicon Valley Bank and Signature Bank, and more recently in May 2023, First Republic Bank, were closed due to liquidity
concerns and taken over by the FDIC. While the Company did not have an account at any of these banks, in the event of failure of any
of the financial institutions where the Company maintains its cash and cash equivalents, there can be no assurance that the Company would
be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely
affect the Company's business and financial position.

 Impairment
of Long-Lived Assets

 The
Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate
that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows
is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between
the net book value of the assets and their estimated fair values. During the years ended December 31, 2023 and 2022, no such impairment
losses have been recorded.

 Segment
Reporting

 Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company
has viewed its operations and managed its business as one segment operating primarily within the United States (and in Israel prior to
the NanoSynex deconsolidation).

and Development

 Except
for acquired in process research and development (IPR&D), the Company expenses research and development costs as incurred including
therapeutics license costs.

 Patent
Costs

 The
Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting
expenses related to making such applications) and such costs are included in general and administrative expenses in the consolidated
statement of operations.

 Business
Combinations

 The
Company accounts for business combinations using the acquisition method pursuant to Financial Accounting Standards Board's ("FASB")
ASC Topic 805. This method requires, among other things, that results of operations of acquired companies are included in the Company's
financial results beginning on the respective acquisition date, and that assets acquired and liabilities assumed are recognized at fair
value as of the acquisition date. Intangible assets acquired in a business combination are recorded at fair value using a discounted
cash flow model. The discounted cash flow model requires assumptions about the timing and amount of future net cash flows, the cost of
capital and terminal values from the perspective of a market participant. Each of these factors can significantly affect the value of
the intangible asset. Any excess of the fair value of consideration transferred (the "purchase price") over the fair values
of the net assets acquired is recognized as goodwill. The fair value of assets acquired and liabilities assumed in certain cases may
be subject to revision based on the final determination of fair value during a period of time not to exceed 12 months from the acquisition
date. Legal costs, due diligence costs, business valuation costs and all other acquisition-related costs are expensed when incurred.

 Goodwill

 Goodwill
represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets acquired,
when accounted for using the purchase method of accounting. Goodwill has an indefinite useful life and is not amortized but is reviewed
for impairment annually and whenever events or changes in circumstances indicate that the carrying value of the goodwill may not be recoverable.
In testing for impairment, the fair value of the reporting unit is compared to the carrying value. If the net assets assigned to the
reporting unit exceed the fair value of the reporting unit, an impairment loss equal to the difference is recorded. As a result of the
annual goodwill impairment analysis, the Company recognized a $ 4,239,000 non-cash goodwill and fixed asset impairment charge in the valuation
of its business acquisition of NanoSynex for the year ended December 30, 2022.

 Derivative
Financial Instruments and Warrant Liabilities

 The
Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates
all of its financial instruments, including issued stock purchase warrants, 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 and comprehensive loss. Depending on the features of the derivative financial instrument,
the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments at inception
and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as
liabilities or as equity, is re-assessed at the end of each reporting period (See Note 7-Warrant Liabilities and Note 8- Convertible
Debt - Related Party).

 Fair
Value Measurements

 The
Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established
by accounting guidance and prioritizes the inputs used in measuring fair value. The Company discloses and recognizes the fair value of
its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy
gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level
1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements).
The guidance establishes three levels of the fair value hierarchy as follows:

 Level
 1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability
 to access at the measurement date;

 Level
 2 - Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs
 in markets that are not considered to be active; and

 Level
 3 - Inputs that are unobservable.

 Fair
Value of Financial Instruments

 Cash,
accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates
fair value due to the short-term nature of these instruments.

 Comprehensive
Loss

 Comprehensive
loss consists of net income and foreign currency translation adjustments related to the discontinued operations of NanoSynex. Comprehensive
gains (losses) have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements
of stockholders' equity (deficit) for all periods presented.

 Stock-Based

 Stock-based
compensation cost for equity awards granted to employees and non-employees is measured at the grant date based on the calculated fair
value of the award using the Black-Scholes option-pricing model, and is recognized as an expense, under the straight-line method, over
the requisite service period (generally the vesting period of the equity grant). If the Company determines that other methods are more
reasonable, or other methods for calculating these assumptions are prescribed by regulators, the fair value calculated for the Company's
stock options could change significantly. Higher volatility, lower risk-free interest rates, and longer expected lives would result in
an increase to stock-based compensation expense to employees and non-employees determined at the date of grant.

Taxes

 Deferred
income taxes are recognized for temporary differences in the basis of assets and liabilities for financial statement and income tax reporting
that arise due to net operating loss carry forwards, research and development credit carry forwards and from using different methods
and periods to calculate depreciation and amortization, allowance for doubtful accounts, accrued vacation, research and development expenses,
and state taxes. A provision has been made for income taxes due on taxable income and for the deferred taxes on the temporary differences.

 Deferred
tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all
of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws
and rates on the date of enactment. Realization of the deferred income tax asset is dependent on generating sufficient taxable income
in future years. For more information, refer to Note 14 - Income Taxes.

 In
December 2023, the FASB issued Accounting Standards Update 2023-09, Improvements to Income Tax Disclosures, which requires more detailed
income tax disclosures. The guidance requires entities to disclose disaggregated information about their effective tax rate reconciliation
as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis,
with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early
adoption permitted. The Company is evaluating the disclosure requirements related to the new standard.

 Foreign
Currency Translation

 The
functional currency for the Company is the U.S. dollar. The functional currency for the discontinued operations of NanoSynex was the
New Israeli Shekel (NIS). The financial statements of NanoSynex were translated into U.S. dollars using exchange rates in effect at each
period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical
exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex was reflected
as a separate component of other comprehensive income (loss) (see Note 5 - Discontinued Operations).

 Recent
Accounting Pronouncements

 The
Company reviewed all other recently issued accounting pronouncements and concluded that they were either not applicable or not expected
to have a significant impact to the financial statements.

 Global
Economic Conditions

 Ongoing
Wars in Ukraine and Israel

 In
February 2022, Russia invaded Ukraine. While the Company has no direct exposure in Russia and Ukraine, the Company continues to monitor
any broader impact to the global economy, including with respect to inflation, supply chains and fuel prices. The full impact of the
conflict on the Company's business and financial results remains uncertain and will depend on the severity and duration of the
conflict and its impact on regional and global economic conditions.

 In
October 2023, Hamas conducted terrorist attacks in Israel resulting in ongoing war. There continue to be hostilities between Israel and
Hezbollah in Lebanon and Hamas in the Gaza Strip, both of which have resulted in rockets being fired into Israel, causing casualties
and disruption of economic activities. In early 2023, there were a number of changes proposed to the political system in Israel by the
current government which, if implemented as planned, could lead to large-scale protests and additional uncertainty, negatively impacting
the operating environment in Israel. Popular uprisings in various countries in the Middle East over the last few years have also affected
the political stability of those countries and have led to a decline in the regional security situation. Such instability may also lead
to deterioration in the political and trade relationships that exist between Israel and these countries. Any armed conflicts, terrorist
activities or political instability involving Israel or other countries in the region could adversely affect the Company's minority
interest in NanoSynex, its results of operations, financial condition, cash flows and prospects (see Note 5 – Discontinued Operations).

 Inflation
and Global Economic Conditions

the year ended 2022 and continuing into the current fiscal year, global commodity and labor markets experienced significant inflationary
pressures attributable to government stimulus and recovery programs, government deficit spending and supply chain issues. The Company
cannot provide assurance that it will be successful in fully offsetting increased costs resulting from inflationary pressure. In addition,
the global economy suffers from slowing growth and rising interest rates, and some economists believe that there may be a global recession
in the near future. If the global economy slows, the Company's business may be adversely affected.

 Impact
of COVID-19 Pandemic

 The
COVID-19 pandemic has had a dramatic impact on businesses globally and on the Company's business as well. During the height of
the pandemic, sales of diagnostic products decreased significantly and the Company's net loss increased significantly, as clinics
and small hospitals' demand for Qualigen, Inc.'s FastPack diagnostic test kits was reduced sharply, largely due to
deferral of patients' non-emergency visits to physician offices. In July 2023 the Company sold Qualigen, Inc., its wholly-owned
subsidiary, to Chembio (see Note 5 - Discontinued Operations).

 Other
accounting standard updates are either not applicable to the Company or are not expected to have a material impact on the Company's
consolidated financial statements.

 NOTE
2 — LIQUIDITY AND GOING CONCERN

 As
of December 31, 2023, the Company had approximately $ 0.4 million in cash and an accumulated deficit of $ 116.8
 million. For the years ended December 31,
2023 and 2022, the Company used cash of $ 10.3
million and $ 13.2
 million, respectively, in operations.

 The
Company's cash balances as of the date that these financial statements were issued along with the proceeds from the above sale
to Chembio, without additional financing, are expected to fund operations only into the second quarter of 2024. The Company expects to
continue to have net losses and negative cash flow from operations, which will challenge its liquidity. These factors raise substantial
doubt about the Company's ability to continue as a going concern for the one-year period following the date that these financial
statements were issued.

 There
is no assurance that profitable operations will ever be achieved, or, if achieved, could be sustained on a continuing basis. In order
to fully execute its business plan, the Company will require significant additional financing for planned research and development activities,
capital expenditures, clinical testing for QN-302 and preclinical development of Pan-RAS, as well as commercialization activities.

 Historically,
the Company's principal sources of cash have included proceeds from the issuance of common and preferred equity and proceeds from
the issuance of debt. In December 2022 the Company raised $ 3.0
 million from the sale of an 8% Senior Convertible
Debenture (the "Debenture") to Alpha (see Note 8 - Convertible Debt - Related Party). There can be no assurance that further
financing can be obtained on favorable terms, or at all. If the Company is unable to obtain funding, the Company could be required to
delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which
could adversely affect the Company's business prospects.

 The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The financial statements
do not include any adjustments that would be necessary should the Company be unable to continue as a going concern, and therefore, be
required to liquidate its assets and discharge its liabilities in other than the normal course of business and at amounts that may differ
from those reflected in the accompanying financial statements

 NOTE
3 — PREPAID EXPENSES AND OTHER CURRENT ASSETS

 Prepaid
expenses and other current assets consisted of the following at December 31, 2023 and December 31, 2022:

 SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS

 2023

 2022

 Prepaid insurance

 $
 566,011

 $
 1,329,034

 Other prepaid expenses

 25,053

 37,670

 Receivable from sale of Qualigen, Inc.

 —

 —

 Prepaid research and development expenses

 173,900

 —

 Prepaid expenses and
 other current assets

 $
 764,964

 $
 1,366,704

 Prepaid
expenses attributable to Qualigen, Inc. and NanoSynex were deemed disposed of as discontinued operations (see Note 5 - Discontinued Operations).

 NOTE
4 — OTHER NON-CURRENT ASSETS

 Other
non-current assets consisted of the following at December 31, 2023:

OF OTHER NON CURRENT ASSETS

 2023

 Funds held in escrow

 $
 450,000

 Long-term research and development deposits

 416,481

 Other non-current assets

 $
 866,481

 NOTE
5 — DISCONTINUED OPERATIONS

 The
summary of assets and liabilities classified in discontinued operations as of December 31, 2022 are as follows:

OF BALANCE SHEETS AND INCOME STATEMENT CLASSIFIED IN DISCONTINUED OPERATIONS

 Qualigen, Inc.

 Total

 Current assets of discontinued operations

 $
 4,448,999

 $
 1,838,850

 $
 6,287,849

 Non-current assets of discontinued operations

 1,876,270

 6,360,441

 8,236,711

 Total assets of discontinued operations

 $
 6,325,269

 $
 8,199,291

 $
 14,524,560

 Current liabilities of discontinued operations

 $
 1,299,948

 $
 2,141,250

 $
 3,441,198

 Non-current liabilities of discontinued operations

 1,350,975

 357,757

 1,708,732

 Total liabilities of discontinued operations

 $
 2,650,923

 $
 2,499,007

 $
 5,149,930

 The
summary of gain (loss) from discontinued operations, net of tax, as of December 31, 2023 and 2022 are as follows:

 Year ended December 31, 2023

 Year ended December 31, 2022

 Qualigen, Inc.

 Total

 Qualigen, Inc.

 Total

 (Loss) from discontinued operations

 $
 ( 171,701
)

 $
 ( 511,307
)

 $
 ( 683,008
)

 $
 ( 2,142,763
)

 $
 ( 4,997,418
)

 $
)

 Gain (loss) on disposal of discontinued operations

 3,876,778

 ( 4,479,010
)

 ( 602,232
)

 —

 —

 —

 Total gain (loss) from discontinued operations

 $
 3,705,077

 $
 ( 4,990,317
)

 $
 ( 1,285,240
)

 $
 ( 2,142,763
)

 $
 ( 4,997,418
)

 $
)

 Sale
of Qualigen, Inc.

 On
July 20, 2023, the Company completed the sale of Qualigen, Inc., its formerly wholly-owned subsidiary, to Chembio Diagnostics, Inc.
for net cash consideration of $ 5.4 million, of which $ 4.9 million was received during the year ended December 31, 2023, and $ 450,000
is being held in escrow until January 20, 2025 to satisfy certain Company indemnification obligations.

 The
assets and liabilities classified in discontinued operations for Qualigen, Inc. as of December 31, 2022 are as follows:

 ASSETS
AND LIABILITIES CLASSIFIED IN DISCONTINUED OPERATIONS

 2022

 Cash

 $
 2,246,482

 Accounts receivable, net

 512,088

 Inventory, net

 1,586,297

 Prepaid expenses and other current assets

 104,132

 Total current assets of discontinued operations

 4,448,999

 Right-of-use assets

 1,422,538

 Property and equipment, net

 289,696

 Intangible assets, net

 145,702

 Other assets

 18,334

 Total non-current assets of discontinued operations

 1,876,270

 Total assets of discontinued operations of Qualigen, Inc.

 $
 6,325,269

 Accounts payable

 $
 236,470

 Accrued vacation

 187,906

 Accrued expenses and other current liabilities

 518,766

 Deferred revenue, current portion

 116,161

 Operating lease liability, current portion

 240,645

 Total current liabilities of discontinued operations

 1,299,948

 Operating lease liability, net of current portion

 1,301,919

 Deferred revenue, net of current portion

 49,056

 Total non-current liabilities of discontinued operations

 1,350,975

 Total liabilities of discontinued operations of Qualigen, Inc.

 $
 2,650,923

 The
Company reclassified the following statement of operations items to discontinued operations for the years ended December 31, 2023 and
2022, respectively:

 2023

 2022

 2023

 2022

 REVENUES

 Net product sales

 $
 3,661,121

 $
 4,983,556

 Total revenues

 3,661,121

 4,983,556

 EXPENSES

 Cost of product sales

 2,551,114

 4,302,755

 General and administrative

 610,559

 561,047

 206,819

 1,245,973

 Sales and marketing

 405,626

 950,420

 Goodwill and fixed asset impairment

 —

 75,000

 Total expenses

 3,774,118

 7,135,195

 OTHER EXPENSE (INCOME), NET

 Loss on disposal of equipment held for lease

 63,302

 —

 Interest (income) expense, net

 —

 ( 7,751
)

 Other expense (income), net

 ( 4,898
)

 ( 1,125
)

 Loss on fixed asset disposal

 —

 Total other expense (income), net

 58,704

 ( 8,876
)

 INCOME (LOSS) FROM DISCONTINUED OPERATIONS BEFORE DISPOSAL

 ( 171,701
)

 ( 2,142,763
)

 Gain on sale of Qualigen, Inc., net of tax

 3,876,778

 —

 INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.

 $
 3,705,077

 $
 ( 2,142,763
)

 In
connection with this transaction, the Company recorded a gain on the sale of Qualigen, Inc. in its consolidated financial statements
for the years ended December 31, 2023:

 Gain on sale of

 Qualigen, Inc.

 Fair value of consideration received

 $
 5,489,337

 Working capital adjustment

 235,402

 Total Assets of discontinued operations

 ( 4,225,562
)

 Total Liabilities of discontinued operations

 3,005,407

 Transaction expenses

 ( 627,806
)

 Gain on sale of Qualigen, Inc.

 $
 3,876,778

 In
the fourth quarter of 2023, the gain was adjusted upward by $ 17,000 upon final payment of transaction costs.

 Amendment
and Settlement Agreement with NanoSynex Ltd.

 On
July 20, 2023, the Company entered into and effectuated the NanoSynex Amendment, pursuant to which the Company agreed to, in exchange
for eliminating all future NanoSynex Funding Agreement obligations for the Company to invest further cash in NanoSynex (except for obligations
to lend NanoSynex $ 560,000 on or before November 30, 2023, and $ 670,000 on or before March 31, 2024), surrender 281,000 Series B Preferred
Shares of NanoSynex held by the Company, resulting in the Company's ownership in NanoSynex being reduced from approximately 52.8 %
to approximately 49.97 % of the voting equity of NanoSynex; in addition, the Company agreed to surrender approximately $ 3.0 million of
promissory notes which NanoSynex had issued to the Company under the NanoSynex Funding Agreement. On November 22, 2023, the Company further
agreed to eliminate the Company's obligations to lend NanoSynex $ 560,000 on or before November 30, 2023, and $ 670,000 on or before
March 31, 2024, by instead surrendering shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced the Company's
ownership in NanoSynex voting equity from approximately 49.97 % to 39.90 %.

 The
surrender of Series B Preferred Shares of NanoSynex was accounted for as a loss of control of a subsidiary that constitutes a business
under ASC 810. As a result, on July 20, 2023, the Company deconsolidated NanoSynex's related assets, liabilities, accumulated other
comprehensive income, and the noncontrolling interest. Subsequently, the retained investment in NanoSynex is accounted for as an equity
method investment. On the date of deconsolidation, the Company recognized its retained investment at fair value, which during the preparation
of these financial statements was determined to be de minimis based on various economic, industry, and other factors. As a result, the
Company has discontinued recognition of its proportionate share of equity method losses following the date of initial recognition. Future
equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses in prior periods.

 Based
upon the magnitude of the disposition and because the Company is exiting certain research and development operations, the disposition
represents a strategic shift that will have a material effect on the Company's operations and financial results. Accordingly, the
business of NanoSynex is classified as discontinued operations for all periods presented herein.

 The
assets and liabilities classified in discontinued operations for NanoSynex as of December 31, 2022 are as follows:

 ASSETS
AND LIABILITIES CLASSIFIED IN DISCONTINUED OPERATIONS

 2022

 Cash

 $
 1,621,967

 Accounts receivable, net

 26,499

 Prepaid expenses and other current assets

 190,384

 Total current assets of discontinued operations

 1,838,850

 Restricted cash

 5,690

 Property and equipment, net

 29,149

 Intangible assets, net

 5,700,000

 Goodwill

 625,602

 Total non-current assets of discontinued operations

 6,360,441

 Total assets of discontinued operations of NanoSynex

 $
 8,199,291

 Accounts payable

 $
 1,273

 Accrued vacation

 115,002

 Accrued expenses and other current liabilities

 293,571

 R&D grant liability

 780,682

 Short term debt-related party

 950,722

 Total current liabilities of discontinued operations

 2,141,250

 Deferred tax liability

 357,757

 Total non-current liabilities of discontinued operations

 357,757

 Total liabilities of discontinued operations of NanoSynex

 $
 2,499,007

 The
Company reclassified the following statement of operations items to discontinued operations for the years ended December 31, 2023 and
2022, respectively:

 2023

 2022

 2023

 2022

 EXPENSES

 $
 869,064

 $
 1,105,040

 Goodwill and fixed asset impairment

 —

 4,164,000

 Total expenses

 869,064

 5,269,040

 Loss on disposal of discontinued operations

 4,479,010

 —

 (BENEFIT) PROVISION FOR INCOME TAXES

 ( 357,757
)

 ( 271,622
)

 LOSS FROM DISCONTINUED OPERATIONS

 ( 4,990,317
)

 ( 4,997,418
)

 Loss attributable to noncontrolling interest

 ( 343,038
)

 ( 2,394,100
)

 NET LOSS ATTRIBUTABLE TO STOCKHOLDERS

 $
 ( 4,647,279
)

 $
 ( 2,603,318
)

 In
connection with this transaction, the Company recorded a loss on deconsolidation of NanoSynex in its consolidated financial statements
for the years ended December 31, 2023:

 Loss on deconsolidation of NanoSynex

 Fair value of NanoSynex interest retained

 $

 —

 Net assets deconsolidated

 ( 2,768,403
)

 Non-controlling interest share

 1,235,443

 Accumulated other comprehensive income attributable to NanoSynex

 131,891

 Forgiveness of debt

 ( 3,077,941
)

 Loss from deconsolidation of NanoSynex

 $
 ( 4,479,010
)

 NOTE
6 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

 Accrued
expenses and other current liabilities consisted of the following at December 31, 2023 and December 31, 2022:

 SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

 2023

 2022

 Board compensation

 $
 129,499

 70,000

 Interest (Convertible debt)

 10,004

 2,829

 License fees

 32,975

 150,130

 Payroll

 1,215

 1,247

 Professional fees

 121,775

 136,203

 104,402

 329,412

 Vacation

 151,286

 165,040

 Other

 8,850

 9,698

 Accrued expenses and
 other current liabilities

 $
 560,006

 $
 864,559

 Other
accrued liabilities attributable to Qualigen Inc, and NanoSynex were deemed disposed of as discontinued operations (see Note 5 – Discontinued
Operations).

 NOTE
7 – WARRANT LIABILITIES

 In
2004, the Company issued warrants to various investors and brokers for the purchase of Series C preferred stock in connection with a
private placement (the "Series C Warrants"). The Series C Warrants were subsequently extended and, upon closing of the
reverse recapitalization transaction with Ritter, exchanged for warrants to purchase common stock of the Company, at $ 7.195
per share, subject to adjustment. As of December 31, 2023, the Series C Warrants had a remaining term of 0.49
years. The Series C Warrants were determined to be liability-classified pursuant to the guidance in ASC 480 and ASC 815-40, based on
the inclusion of a leveraged ratchet provision for subsequent dilutive issuances. On April 25, 2022, the Series C warrants were
repriced from $ 7.195
per share exercise price to $ 6.00
per share exercise price with 49,318
additional ratchet Warrants issued. On May 26, 2022, the Series C warrants were repriced from $ 6.00
per share exercise price to $ 5.136
per share exercise price with 49,952
additional ratchet Warrants issued. As a result of these repricings, 247,625
warrants were forfeited and 346,896
warrants were reissued. On December 22, 2022, the Series C Warrants were repriced again from $ 5.136
per share exercise price to $ 1.32
per share exercise price with 1,002,717
additional ratchet Warrants issued.

 Additionally,
on December 22, 2022, in conjunction with the issuance of the Debenture to Alpha (see Note 8 – Convertible Debt – Related
Party), the Company issued to Alpha a warrant to purchase 2,500,000 shares of the Company's common stock (the "Alpha Warrant").
The exercise price of the Alpha Warrant was $ 1.65 (equal to 125 % of the conversion price of the Debenture on the closing date). The Alpha
Warrant may be exercised by Alpha, in whole or in part, at any time before June 22, 2028, subject to certain terms and conditions described
in the Alpha Warrant. The fair value of this warrant was included in Warrant liabilities-related party on the Company's consolidated
balance sheet as of December 31, 2022. On December 5, 2023, the Company entered into an Amendment No. 1 with regard to Securities Purchase
Agreement, with Alpha. This Amendment amended two instruments which the Company issued under the Securities Purchase Agreement dated
December 21, 2022: (a) the 8% Senior Convertible Debenture dated December 22, 2022 in favor of Alpha, and (b) the Common Stock Purchase
Warrant dated December 22, 2022 in favor of Alpha. The Amendment reduced the conversion price of the Debenture from $ 1.32 per share to
$ 0.73 per share (subject to possible future adjustment pursuant to the terms of the Debenture) and reduced the exercise price of the
Warrant from $ 1.65 per share to $ 0.73 per share (subject to possible future adjustment pursuant to the terms of the Warrant). The Amendment
also eliminated certain adjustment provisions of the Warrant. The Company determined the event resulted in equity classification for
the Warrant and, accordingly, the Company remeasured the warrant liabilities to fair value, and reclassified.

 As
a result of the Alpha Warrant repricing, on December 5, 2023 the Series C Warrants were repriced again from $ 1.32 per share exercise
price to $ 0.73 per share exercise price with 203,652 additional ratchet Series C Warrants issued, resulting in 455,623 of these Series
C Warrants outstanding and exercisable as of December 31, 2023.

 The
following table summarizes the activity in liability classified warrants for the year ended December 31, 2023:

 SCHEDULE OF WARRANTS ACTIVITY

 Common Stock Warrants

 Weighted– Average

 Price

 Price

 3,849,571

 $
 1.53

 $ 1.32 - $ 1.65

 3.9

 —

 —

 —

 —

 ( 2,751,976
)

 1.53

 —

 —

 ( 1,097,595
)

 1.32

 1.32

 —

 455,623

 0.73

 0.73

 0.49

 Total outstanding – December 31, 2023

 455,623

 $
 0.73

 $
 0.73

 0.49

 455,623

 $
 0.73

 $
 0.73

 0.49

 The
following table summarizes the activity in the Common Stock Warrants received in exchange for the Series C Warrants for the year ended
December 31, 2022:

 Common Stock Warrants

 Weighted–
Average

 Price

 Range
of

 Price

 Total outstanding –December 31, 2021

 248,162

 $
 7.20

 $
 7.20

 2.00

 ( 536
)

 7.20

 ( 247,625
)

 7.20

 —

 —

 3,849,570

 1.53

 3,849,571

 $
 1.53

 $
 1.32 - 1.65

 3.9

 1,349,571

 $
 1.32

 $
 1.32

 1.00

 The
following table presents the Company's fair value hierarchy for its Common Stock Warrant liabilities measured at fair value on
a recurring basis as of December 31, 2023:

 SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES

 Quoted

 Market

 Significant

 Prices for

 Other

 Significant

 Identical

 Observable

 Unobservable

 Assets

 Inputs

 Inputs

 Common Stock Warrant liabilities

 (Level 1)

 (Level 2)

 (Level 3)

 Total

 Balance as of December 31, 2022

 $
 —

 $
 —

 $
 3,622,647

 $
 3,622,647

 Exercises

 —

 —

 —

 —

 Fair value of warrant reclassified from liabilities to equity

 —

 —

 ( 1,626,694
)

 ( 1,626,694
)

 Loss on debt extinguishment

 —

 —

 94,116

 94,116

 Gain on change in fair value of warrant liabilities

 —

 —

 ( 2,035,469
)

 ( 2,035,469
)

 Balance as of December 31, 2023

 $
 —

 $
 —

 $
 54,600

 $
 54,600

 There
were no transfers of financial assets or liabilities between category levels for the year ended December 31, 2023.

 The
value of the warrant liabilities was based on a valuation received from an independent valuation firm determined using a Monte-Carlo
simulation. For volatility, the Company considers comparable public companies as a basis for its expected volatility to calculate the
fair value of common stock warrants and transitions to its own volatility as the Company develops sufficient appropriate history as a
public company. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected term of the common
stock warrant. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash dividends and
does not expect to pay cash dividends in the foreseeable future. Any significant changes in the inputs may result in significantly higher
or lower fair value measurements.

 The
following are the assumptions used in, and the weighted average and the range of assumptions used in estimating the fair value of warrant
liabilities (weighted average calculated based on the number of outstanding warrants on each issuance) as of December 31, 2023 and December
31, 2022:

OF ASSUMPTIONS OF WARRANT LIABILITIES

 Actual

 Range

 Weighted Average

 Risk-free interest rate

 5.13
 %

 3.906 % — 4.628 %

 4.15
 %

 Expected volatility (peer group)

 68.9
 %

 88 % — 103 %

 %

 Term of warrants (in years)

 0.49

.90 — 5.48

 3.9

 Expected dividend yield

 0.00
 %

 0.00 %

 0.00
 %

 NOTE
8 — CONVERTIBLE DEBT- RELATED PARTY

 On
December 22, 2022, the Company issued to Alpha an 8 %
Senior Convertible Debenture in the aggregate principal amount of $ 3,300,000
for a purchase price of $ 3,000,000
(less expenses) pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022. The Debenture has a maturity date
of December
22, 2025 and was initially convertible, at any time, and from time to time, until the Debenture is no longer outstanding, at
Alpha's option, into shares of common stock of the Company (the "Conversion Shares"), at a price equal to $ 1.32
per share, subject to adjustment as described in the Debenture (the "Conversion Price") and other terms and conditions
described in the Debenture, including the necessary stockholder approvals, which the Company obtained at its 2023 annual meeting of
stockholders on July 13, 2023. As a part of the same transaction, on December 22, 2022, the Company issued to Alpha a
liability classified warrant (the "Alpha Warrant") to purchase 2,500,000
shares of the Company's common stock (see Note 7 - Warrant Liabilities). The exercise price of the Alpha Warrant was initially
$ 1.65
(equal to 125 %
of the Conversion Price of the Debenture on the closing date) subject to adjustment as described in the Alpha Warrant. The Alpha
Warrant may be exercised by Alpha, in whole or in part, at any time before June 22, 2028, subject to certain terms and
conditions described in the Alpha Warrant, including the necessary stockholder approvals, which the Company obtained at its 2023
annual meeting of stockholders on July 13, 2023.

 The
proceeds from the transaction were used to advance the Company's QN-302 Investigative New Drug candidate towards clinical trials
and other working capital purposes.

 Commencing
June 1, 2023 and continuing on the first day of each month thereafter until the earlier of (i) December 22, 2025 and (ii) the full redemption
of the Debenture (each such date, a "Monthly Redemption Date"), the Company must redeem $ 110,000 plus accrued but unpaid
interest, liquidated damages and any amounts then owing under the Debenture (the "Monthly Redemption Amount"). The Monthly
Redemption Amount must be paid in cash; provided that after the first two monthly redemptions, the Company may elect to pay all or a
portion of a Monthly Redemption Amount in shares of common stock of the Company, based on a Conversion Price equal to the lesser of (i)
the then Conversion Price of the Debenture and (ii) 85 % of the average of the VWAPs (as defined in the Debenture) for the five consecutive
trading days ending on the trading day that is immediately prior to the applicable Monthly Redemption Date. The Company may also redeem
some or all of the then outstanding principal amount of the Debenture at any time for cash in an amount equal to 105 % of the then outstanding
principal amount of the Debenture being redeemed plus accrued but unpaid interest, liquidated damages and any amounts then owing under
the Debenture. The Company's election to pay monthly redemptions in Conversion Shares or to effect an optional redemption is subject
to the satisfaction (or waiver) of the Equity Conditions (as defined in the Debenture), including the necessary stockholder approvals,
which the Company obtained at its 2023 annual meeting of stockholders on July 13, 2023.

 The
Debenture accrues interest at the rate of 8 % per annum, which did not begin accruing until December 1, 2023. Interest may be paid in
cash or shares of common stock of the Company or a combination thereof at the option of the Company; provided that interest may only
be paid in shares if the Equity Conditions have been satisfied (or waived).

 Both
the Debenture and the Alpha Warrant provide for adjustments to the Conversion Price and exercise price, respectively, in connection with
stock dividends and splits, subsequent equity sales and rights offerings, pro rata distributions, and certain fundamental transactions.
Both the Debenture and the Alpha Warrant include a beneficial ownership blocker of 9.99 %, which may only be waived by Alpha upon

 Pursuant
to resale registration rights granted by the Company to Alpha in such Securities Purchase Agreement, the Company filed a
resale registration statement on Form S-3 (File Number 333-269088) on December 30, 2022 registering the resale by Alpha of
up to 5,157,087
shares of common stock of the Company which could be issued to Alpha pursuant to the Debenture and the Alpha Warrant, which
registration statement was declared effective by the SEC on January 5, 2023 (the "Original Registration Statement"). The
Company later became ineligible to update the Original Registration Statement via incorporation by reference of its future SEC
periodic and current reports as a result of its failure to timely file its annual report on Form 10-K for the fiscal year ended
December 31, 2022. Therefore, the Company filed a Post-Effective Amendment No. 1 to Form S-3 on Form S-1 (No. 333-269088)(the
"Post-Effective Amendment No. 1") on September 1, 2023 in order to maintain the registration of the resale by Alpha of up to 3,958,537
shares of common stock of the Company issuable under the Debenture and the Alpha Warrant., which Post-Effective Amendment No. 1 was
declared effective by the SEC on September 7, 2023.

 The
Company evaluated the Debenture and the Alpha Warrant and determined that the Alpha Warrant is a freestanding financial instrument. Initially,
the Alpha Warrant is not considered indexed to the Company's own stock, because the settlement amount would not equal the difference
between the fair value of a fixed number of the Company's equity shares and a fixed strike price and all of the adjustment features
in Section 3(b) of the Alpha Warrant are not down round provisions, as defined in ASU 2017-11. Accordingly, the Alpha Warrant was classified
as a liability and recognized at fair value, with subsequent changes in fair value recognized in earnings.

 The
proceeds from the Debenture were allocated to the initial fair value of the Alpha Warrant, with the residual balance allocated to the
initial carrying value of the Debenture. The Company has not elected the fair value option for the Debenture. The Debenture was recognized
as proceeds received after allocating the proceeds to the Alpha Warrant, and then allocating remaining proceeds to a suite of bifurcated
embedded derivative features (conversion option, contingent acceleration upon an Event of Default, and contingent interest upon an Event
of Default), with the resulting difference, if any, allocated to the loan host instrument. The suite of derivative features was measured
and determined to have no fair value.

 The
original issue discount of $ 0.3 million, the initial fair value of the Alpha Warrant of $ 2.8 million, the initial fair value of the suite
of bifurcated embedded derivative features of $ 0, and the fees and costs paid to Alpha and other third parties of $ 0.1 million
comprised the debt discount upon issuance. The debt discount is amortized to interest expense over the expected term of the Debenture
using the effective interest method, in accordance with ASC 835-30. The debt host instrument of the Debenture will subsequently be measured
at amortized cost using the effective interest method to accrete interest over its term to bring the Debenture's initial carrying
value to the principal balance at maturity.

 Between
January 9 and 12, 2023, the Company issued 841,726
shares of common stock upon Alpha's partial conversion of the Debenture at $ 1.32
per share for a total of $ 1,111,078
principal. Upon conversion, the Company recognized a loss on conversion of convertible debt of approximately $ 1.1
million, recorded to other expenses in the consolidated statements of operations.

 In October and December 2023, the Company issued 309,665
shares of common stock to Alpha in lieu of cash for monthly redemption payments on the Debenture at a weighted average price
of $ 0.71
per share. Upon redemption for shares, the Company recognized a loss on partial debt extinguishment of $ 34,315.

 On
September 22, 2023, the Company entered into a consent and waiver (the "Waiver") with Alpha. Pursuant to the Waiver,
Alpha consented to the Company's election to pay all of the Monthly Redemption Amount for October 2023 in Conversion Shares
(the "October Payment") and waived the requirement of satisfaction of the Equity Conditions in relation to the October and
December Payment. On October 3, 2023 the Company issued 128,595 shares of common stock to Alpha in satisfaction of the October
Payment. On December 8, 2023 the Company issued 181,070 shares of common stock to Alpha in satisfaction of the December Payment.

 On
December 5, 2023, the Company and Alpha executed Amendment No. 1 with regard to Securities Purchase Agreement (the "SPA
Amendment"), pursuant to which the Company and Alpha agreed to, among other things, reduce the Conversion Price of the
Debenture from $ 1.32
per share to $ 0.73
per share and reduce the exercise price of the Alpha Warrant from $ 1.65
per share to $ 0.73
per share, in each case subject to certain adjustments. In addition, the SPA Amendment revised certain provisions of the Alpha
Warrant to (i) limit the circumstances which would trigger a potential adjustment to the exercise price of the Alpha Warrant and
(ii) clarify the treatment of the Alpha Warrant upon a Fundamental Transaction. The purpose of these revisions was to remove the
terms that caused the Alpha Warrant to be liability-classified under U.S. GAAP. The Company performed an assessment and concluded
that all remaining adjustment features in the revised language meet the FASB's definition of a down-round feature. In
addition, the Alpha Warrant was determined to meet all of the additional requirements for equity classification. Accordingly, as of
December 5, 2023, the Company remeasured the Alpha Warrant to its fair value immediately prior to the modification and recognized
the change in fair value in earnings. The incremental fair value impact from the Alpha Warrant modification of $ 0.09
million was included in the Company's evaluation of the Debenture modification under ASC 470, discussed further below. The
Company then reclassified the Alpha Warrant liability to equity at its post-modification fair value of $ 1.6
million.

 In
accordance with ASC 470-50, the Company determined that the modified terms of the Debenture were substantially different when
compared to the original terms that existed prior to the SPA Amendment, and thus the event was required to be accounted for as a
debt extinguishment. Accordingly, the Company derecognized the net carrying value of the original Debenture, and recorded the new
debt instrument at its fair value of $ 1.4
million, and recorded a $ 0.6
million loss on debt extinguishment. The difference between the remaining Debenture principal and its fair value on December 5, 2023
was recorded as a debt discount and will be amortized to interest expense over the expected term of the Debenture using the
effective interest method, in accordance with ASC 835-30.

the year ended December 31, 2023, the Company recognized a loss on voluntary conversion of convertible debt of
approximately $ 1.1
million, recognized an extinguishment loss of $ 0.6
million upon October and December 2023 share redemptions and December 2023 modification of the Debenture, and recorded
accrued interest of approximately $ 1.5
million, in other expenses in the consolidated statements of operations. During the year ended December 31, 2023 the Company paid
Monthly Redemption Amounts of $ 550,000
in cash and $ 220,000
in common stock, and as of December 31, 2023 the remaining Debenture principal balance was approximately $ 1.4
million, the remaining discount was approximately $ 0.1
million, and the fair value of the suite of bifurcated embedded derivative features was $ 0.

 The
senior convertible debt comprises the following:

 SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT

 2023

 2022

 Senior convertible debenture

 $
 1,418,922

 $
 3,300,000

 Discount on convertible debenture

 ( 119,706
)

 ( 3,239,803
)

 Total convertible debt-related party

 $
 1,299,216

 $
 60,197

 As
of December 31, 2023, there were no unwaived events of default or violation of any covenants under the Company's financing obligations.

 NOTE
9 — EARNINGS (LOSS) PER SHARE

 Basic
loss per share ("EPS") is computed by dividing net loss by the weighted-average number of common shares outstanding. Diluted
EPS is computed based on the sum of the weighted-average number of common shares and potentially dilutive common shares outstanding during
the period. Potentially dilutive common shares consist of shares issuable from convertible debt, stock options and warrants.

 The
following potentially dilutive securities have been excluded from diluted net loss per share as of December 31, 2023 and 2022 because
their effect would be anti-dilutive:

OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE

 2023

 2022

 2023

 2022

 Net loss used for basic earnings per share

 $
 ( 13,417,212
)

 $
 ( 18,640,543
)

 Basic weighted-average common shares outstanding

 5,072,709

 3,840,340

 Dilutive potential shares issuable from convertible debt, stock options and warrants

 —

 —

 Diluted weighted-average common shares outstanding

 5,072,709

 3,840,340

 NOTE
10 — COMMITMENTS AND CONTINGENCIES

 Litigation
and Other Legal Proceedings

 On
November 9, 2021, the Company was named as a defendant in an action brought by Mediant Communications Inc. ("Mediant") in
the U.S. District Court for the Southern District of New York. The complaint alleged that Qualigen entered into an implied contract with
Mediant, whereby Qualigen retained Mediant to distribute proxy materials and subsequently conduct shareholder vote tabulations. The Company
filed a Motion to Dismiss with the District Court and on March 14, 2022 a hearing was held during which the presiding judge ruled in
favor of the Motion to Dismiss. The Company and Mediant settled the litigation on April 5, 2022 in the amount of $ 96,558, at which time
the amount was paid.

 NOTE
11 — RESEARCH AND LICENSE AGREEMENTS

 UCL
Business Limited

 In
January 2022, the Company entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a
genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London,
including lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization company for
University College London.) The program's lead compound is now being developed at the Company under the name QN-302 as a candidate
for treatment for pancreatic ductal adenocarcinoma, which represents the vast majority of pancreatic cancers. The License Agreement required
a $ 150,000 upfront payment, reimbursement of past patent prosecution expenses (approximately $ 160,000), and (if and when applicable)
tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments and a percentage of any non-royalty
sublicensing consideration paid to the Company.

 For
the years ended December 31, 2023 and 2022 there were license costs of approximately $ 128,000 and $ 338,000, respectively, related to
this agreement which are included in research and development expenses in the consolidated statements of operations and other comprehensive
loss.

 QN-302
Phase 1 Study

 In
June 2023, the Company entered into a Master Clinical Research Services Agreement with Translational Drug Development, LLC ("TD2")
whereby TD2 agreed to perform certain clinical research and development services for the Company including but not limited to trial management,
side identification and selection, site monitoring/management, medical monitoring, project management, data collection, statistical programming
or analysis, quality assurance auditing, scientific and medical communications, regulatory affairs consulting and submissions, strategic
consulting, and/or other related services. From time to time, the Company intends to enter into statements of work with TD2 for the performance
of specific services under this Master Clinical Research Services Agreement.

 In
June 2023, the Company entered into a Master Laboratory Services Agreement with MLM Medical Labs, LLC ("MLM") whereby MLM
agreed to perform certain clinical research and development services for the Company including but not limited to laboratory, supply,
testing, validation, data management, and storage services. From time to time, the Company intends to enter into work orders with MLM
for the performance of specific services under this Master Laboratory Services Agreement.

 In
June 2023, the Company entered into a Master Services Agreement with Clinigen Clinical Supplies Management, Inc. ("Clinigen")
whereby Clinigen agreed to provide certain pharmaceutical products and/or services. From time to time, the Company intends to enter into
statements of work with Clinigen for the performance of specific services under this Master Services Agreement.

 In
July 2023, pursuant to the above agreements, the Company entered into work orders and statements of work for clinical trial services
for the conduct of the QN-302 Phase 1 study. The project timeline started in July 2023 and is expected to continue until approximately
July 2026. The total amount to be paid under these work orders and statements of work is currently expected to be approximately $ 7.6
million over the term of the QN-302 Phase 1 study, subject to available funding.

 University
of Louisville Research Foundation

 In
March 2019, the Company entered into a sponsored research agreement and an option for a license agreement with University of Louisville
Research Foundation, Inc. ("ULRF") for development of several small-molecule RAS interaction inhibitor drug candidates. Under
the terms of this agreement, the Company agreed to reimburse ULRF for sponsored research expenses of initially up to $ 693,000 for this
program. This agreement was amended in February 2021, March 2022 and August 2023, with the current term of this agreement set to expire
in December 2023 and the aggregate amount that the Company would reimburse ULRF for sponsored research expenses increased to approximately
$ 2.9 million. In July 2020, the Company entered into an exclusive license agreement with ULRF for RAS interaction inhibitor drug candidates.
Under the agreement, the Company took over development, regulatory approval and commercialization of the candidates from ULRF and is
responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $112,000 for an upfront
license fee and reimbursement of prior patent costs. In addition, the Company has agreed to pay ULRF (i) royalties, on patent-covered
net sales associated with the commercialization, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative
$250,000,000), until expiration of the licensed patent, and 2.5% (on net sales for any sales not covered by Licensed Patents), (ii) 30%
to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two years of the ULRF license agreement,
40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth
year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution
and maintenance of licensed patents, incurred prior to July 2020, and (iv) payments ranging from $ 50,000 to $ 5,000,000 upon the achievement
of certain regulatory and commercial milestones. Milestone payments for the first therapeutic indication would be $ 50,000 for first dosing
in a Phase 1 clinical trial, $ 100,000 for first dosing in a Phase 2 clinical trial, $ 150,000 for first dosing in a Phase 3 clinical trial,
$ 300,000 for regulatory marketing approval and $ 5,000,000 upon achieving a cumulative $ 500,000,000 of Licensed Product sales. The Company
also must pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income
for any year is less than the applicable annual minimum (ranging from $ 20,000 to $ 100,000) for such year.

 Sponsored
research expenses related to these RAS agreements for the years ended December 31, 2023 and December 31, 2022 were approximately $ 743,000
and $ 758,000, respectively, and are recorded in research and development expenses in the Consolidated Statements of Operations. License
costs related to these agreements for the years ended December 31, 2023 and December 31, 2022 were approximately $ 133,000 and $ 40,000,
respectively, and are included in research and development expenses in the Consolidated Statements of Operations.

 Between
June 2018 and April 2022, the Company entered into license and sponsored research agreements with ULRF for QN-247, a novel aptamer-based
compound that has shown promise as an anticancer drug. Under the agreements, the Company took over development, regulatory approval and
commercialization of the compound from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return,
ULRF received a $ 50,000 convertible promissory note in payment of an upfront license fee, which was subsequently converted into the Company's
common stock, and the Company agreed to reimburse ULRF for sponsored research expenses of up to approximately $ 805,000 and prior patent
costs of up to $ 200,000. In addition, the Company agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization
of anti-nucleolin agent-conjugated nanoparticles, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative
$250,000,000), until expiration of the last to expire of the licensed patents, (ii) 30% to 50% of any non-royalty sublicensee income
received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third
or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter),
(iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred
prior to June 2018, and (iv) payments ranging from $ 100,000 to $ 5,000,000 upon the achievement of certain regulatory and commercial milestones.
Milestone payments for the first therapeutic indication would be $ 100,000 for first dosing in a Phase 1 clinical trial, $ 200,000 for
first dosing in a Phase 2 clinical trial, $ 350,000 for first dosing in a Phase 3 clinical trial, $ 500,000 for regulatory marketing approval
and $ 5,000,000 upon achieving a cumulative $ 500,000,000 of Licensed Product sales. The Company also agreed to pay another $ 500,000 milestone
payment for any additional regulatory marketing approval for each additional therapeutic (or diagnostic) indication. The Company must
also pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for
any year is less than the applicable annual minimum (ranging from $ 10,000 to $ 50,000) for such year.

 The
sponsored research agreement for QN-247 expired in August 2022. The sponsored research expenses related to these QN-247 agreements for
the years ended December 31, 2023 and December 31, 2022 were $ 0 and approximately $ 164,000, respectively, and these amounts are recorded
in research and development expenses in the consolidated statements of operations and other comprehensive loss. License costs related
to these agreements were approximately $ 23,000 and $ 94,000 for the years ended December 31, 2023 and December 31, 2022, respectively,
and are included in research and development expenses in the consolidated statements of operations and other comprehensive loss.

In June 2020, the Company entered into an exclusive license agreement with ULRF for its intellectual property in the use of QN-165 as
a treatment for COVID-19. Under the agreement, the Company took over development, regulatory approval and commercialization of the compound
(for such use) from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return, ULRF received
approximately $ 24,000 for an upfront license fee and reimbursement of prior patent costs. In addition, the Company was required to enter
into a separate sponsored research agreement with ULRF (for QN-165 as a treatment for COVID-19) for at least $ 250,000. In November 2020,
the Company executed a sponsored research agreement with ULRF (for QN-165 as a treatment for COVID-19) supporting up to approximately
$ 430,000 in research which satisfied this requirement. This sponsored research agreement expired in November 2021 and the exclusive license
agreement was terminated on October 31, 2022. There were no sponsored research expenses or license costs related to these QN-165 agreements
for the years ended December 31, 2023 and 2022.

 NOTE
12 — STOCKHOLDERS' EQUITY

 As
of December 31, 2023, and 2022 the Company had two classes of capital stock: common stock and preferred stock.

 Common
Stock

 Holders
of common stock generally vote as a class with the holders of the preferred stock and are entitled to one vote for each share held. Subject
to the rights of the holders of the preferred stock to receive preferential dividends, the holders of common stock are entitled to receive
dividends when and if declared by the Board of Directors. Following payment of the liquidation preference of the preferred stock, any
remaining assets will be distributed ratably among the holders of the common stock and, on an as-if-converted basis, the holders of any
preferred stock upon liquidation, dissolution or winding up of the affairs of the Company. The holders of common stock have no preemptive,
subscription or conversion rights and there are no redemption or sinking fund provisions.

 At
December 31, 2023, the Company has reserved 5,781,161 shares of authorized but unissued common stock for possible future issuance as
follows:

OF RESERVED SHARES

 Exercise of issued and future grants of stock options

 755,715

 Conversion of convertible debt

 1,943,729

 Exercise of stock warrants

 3,081,717

 Total

 5,781,161

 Preferred
Stock

 At
December 31, 2023 and December 31, 2022, there were no shares of preferred stock outstanding.

 Stock
Options and Equity Classified Warrants

 Stock
Options

 The
Company recognizes all compensatory stock-based payments as compensation expense over the service period, which is generally the vesting
period.

 In
April 2020, the Company adopted the 2020 Stock Incentive Plan (the "2020 Plan") which provides for the grant of incentive
or non-statutory common stock options, restricted stock, stock bonus awards, stock appreciation rights, restricted stock units and performance
awards to qualified employees, officers, directors, consultants and other service providers. At December 31, 2023 and December 31, 2022
there were 398,924 and 608,012 outstanding stock options, respectively, under the 2020 Plan and there were 356,778 and 147,690 Plan shares
available, respectively, for future grant.

 The
following represents a summary of the options granted to employees and non-employee service providers that were outstanding at December
31, 2023, and changes during the twelve months then ended:

OF STOCK OPTION ACTIVITY

 Price

 Price

 608,012

 $
 35.02

 $ 5.14 - $ 51.30

 8.09

 —

 —

 —

 —

 —

 —

 —

 —

 ( 209,088
)

 34.71

 5.14 - 51.30

 —

 Total outstanding – December 31, 2023

 398,924

 $
 35.21

 $ 5.14 — $ 51.30

 7.06

 Exercisable (vested)

 320,918

 $
 41.97

 $ 5.14 — $ 51.30

 6.77

 Non-Exercisable (non-vested)

 78,006

 $
 7.36

 $ 5.14 - $ 32.90

 8.36

 The
following represents a summary of the options granted (under the 2020 Plan and otherwise) to employees and non-employee service providers
that were outstanding at December 31, 2022, and changes during the twelve months then ended:

 Price

 Range
of

 Price

 Total outstanding – December 31, 2021

 484,186

 $
 60.70

 $ 12.40 — $ 14,657.50

 8.52

 134,469

 5.24

 5.14 — 10.50

 5.99

 ( 9,379
)

 932.75

 57.50 - 14,657.50

 —

 ( 1,264
)

 22.64

 5.14 - 49.70

 —

 608,012

 $
 35.02

 $ 5.14 — $ 51.30

 8.09

 Exercisable (vested)

 288,704

 $
 46.32

 $ 12.40 — $ 51.30

 7.59

 Non-Exercisable (non-vested)

 319,308

 $
 24.80

 $ 5.14 — $ 10.50

 8.59

 There
was approximately $ 1.1 million and $ 5.4 million of compensation costs related to outstanding options for the year ended December 31, 2023
and December 31, 2022, respectively. This cost is expected to be recognized over a weighted average period of 1.09 years.

 No
stock options were granted or exercised during the year ended December 31, 2023 or 2022.

 The
exercise price for an option issued under the 2020 Plan is determined by the Board of Directors, but will be (i) in the case of an incentive
stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the fair
market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value per share
on the date of grant; and (ii) in the case of a non-statutory stock option, no less than 100% of the fair market value per share on the
date of grant. The options awarded under the 2020 Plan will vest as determined by the Board of Directors but will not exceed a 10-year
period.

 There
were no options granted during the year ended December 31, 2023. The weighted average grant date fair value per share of the shares underlying
options granted during the year ended December 31, 2022 was $ 3.96.

 Fair
Value of Equity Awards

 The
Company utilizes the Black-Scholes option pricing model to value awards under the 2020 Plan, and for equity classified compensatory warrants.
Key valuation assumptions include:

 Expected
 dividend yield. The expected dividend is assumed to be zero, as the Company has never paid dividends and has no current plans
 to pay any dividends on the Company's common stock.

 Expected
 stock-price volatility. The Company's expected volatility is derived from the average historical volatilities of publicly
 traded companies within the Company's industry that the Company considers to be comparable to the Company's business
 over a period approximately equal to the expected term.

 Risk-free
 interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon
 U.S. Treasury notes with maturities approximately equal to the expected term.

 Expected
 term. The expected term represents the period that the stock-based awards are expected to be outstanding. The Company's
 historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of
 a lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method provided by the SEC.
 The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options.

 The
material factors incorporated in the Black-Scholes model in estimating the fair value of the options granted for the periods presented
were as follows:

OF ASSUMPTION USED IN BLACK-SCHOLES OPTION-PRICING METHOD

 For
the Years Ended December 31,

 2023

 2022

 Expected dividend yield

 n/a

 0.00 %

 Expected stock-price volatility

 n/a

 103 %

 Risk-free interest rate

 n/a

 1.58 % — 3.77 %

 Expected average term of options (in years)

 n/a

 5.99

 Stock price

 n/a

 5.14 - 10.50

 The
Company recorded stock-based compensation expense and classified it in the Consolidated Statements of Operations as follows:

OF SHARE-BASED COMPENSATION EXPENSE

 2023

 2022

 For the Years Ended December 31,

 2023

 2022

 General and administrative

 $
 939,228

 $
 4,649,649

 159,305

 834,395

 Total

 $
 1,098,533

 $
 5,484,044

Classified Compensatory Warrants

 In
connection with the $ 4.0 million equity capital raise as part of the May 2020 reverse recapitalization transaction, the Company issued
common stock warrants to an advisor and its designees for the purchase of 81,143 reverse split adjusted shares of the Company's
common stock at a reverse split adjusted exercise price of $ 11.10 per share. The issuance cost of these warrants was charged to additional
paid-in capital, and did not result in expense in the Company's consolidated statements of operations and comprehensive loss.

 In
addition, various service providers hold equity classified compensatory warrants issued in 2017 and earlier (originally exercisable to
purchase Series C convertible preferred stock, and now instead exercisable to purchase common stock) for the purchase of 66,802 reverse
split adjusted shares of Company common stock at a weighted average exercise price of $ 23.40 per share. These are to be differentiated
from the Series C Warrants described in Note 7- Warrant Liabilities.

 On
April 25, 2022, 60,000
warrants were repriced from $ 13.20
per share exercise price to a reverse split adjusted exercise price of $ 6.00
per share exercise price and extended from June
3, 2023 to September 14, 2023. The increase in fair value of $ 67,370
for the modification of these warrants was charged to general and administrative expenses in the Company's consolidated
statements of operations and comprehensive loss. These warrants expired on September 14, 2023. On April 25, 2022 and May 26, 2022 an
additional 67,620
reverse split adjusted warrants were repriced from reverse split adjusted $ 11.10
per share exercise price to $ 5.136
per share exercise price. The increase in fair value of $ 31,010
for the modification of these warrants was charged to additional paid-in capital and did not result in expense on the
Company's consolidated statements of operations and comprehensive loss. On December 22, 2022 67,620
warrants were repriced from $ 5.136
per share exercise price to $ 1.32
per share exercise price. The increase in fair value of $ 8,548
for the modification of these warrants was charged to additional paid-in capital and did not result in expense on the
Company's consolidated statements of operations and comprehensive loss. On December 5, 2023, 67,620
warrants were repriced from $ 1.32
per share exercise price to $ 0.73
per share exercise price. The increase in fair value of $ 7,945
for the modification of these warrants was charged to general and administrative expenses in the Company's consolidated
statements of operations and comprehensive loss.

 No
new compensatory warrants were issued during the year ended December 31, 2023 or 2022.

 The
following table summarizes the equity classified compensatory warrant activity for the year ended December 31, 2023:

OF WARRANT ACTIVITY

 Weighted– Average

 Price

 Exercise Price

 179,046

 $
 9.12

 $ 1.32 — $ 25.40

 1.73

 Granted to advisor and its designees

 —

 —

 —

 —

 ( 60,000
)

 6.00

 6.00

 —

 —

 Total outstanding – December 31, 2023

 119,046

 $
 10.69

 $ 0.73 — $ 25.40

 1.25

 119,046

 $
 10.69

 $ 0.73 — $ 25.40

 1.25

 Non-Exercisable

 —

 $
 —

 $
 —

 —

 The
following table summarizes the equity classified compensatory warrant activity for the year ended December 31, 2022:

 Weighted– Average

 Price

 Exercise Price

 Weighted–Average Remaining

 Total outstanding – December 31, 2021

 179,046

 $
 15.20

 $ 11.10 — $ 25.40

 2.64

 Granted to advisor and its designees

 —

 —

 —

 —

 —

 —

 —

 —

 179,046

 $
 9.12

 $ 1.32 — $ 25.40

 1.73

 179,046

 $
 9.12

 $ 1.32 - $ 25.40

 1.73

 Non-Exercisable

 —

 $
 —

 $
 —

 —

 There
was $ 7,945 in compensation costs related to outstanding warrants for the year ended December 31, 2023 and $ 67,370 for the year
ended December 31, 2022. As of December 31, 2023 and December 31, 2022, there was no unrecognized compensation cost related to nonvested
warrants.

 Noncompensatory
Equity Classified Warrants

 In
May 2020, as a commitment fee, the Company issued noncompensatory equity classified warrants to Alpha (a related party) for the
purchase of 27,048 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 11.10 per share
(of which warrants for 20,000 shares were subsequently exercised in December 2020). In July 2020 the Company issued noncompensatory equity
classified warrants to Alpha for the purchase of 78,019 reverse split adjusted shares of Company common stock at a reverse split
adjusted exercise price of $ 0.01 per share (which were subsequently exercised in July 2020), and 192,068 reverse split adjusted shares
of Company common stock at a reverse split adjusted exercise price of $ 52.50 per share. In August 2020, the Company issued noncompensatory
equity classified warrants to Alpha for the purchase of 128,783 reverse split adjusted shares of Company common stock at a reverse
split adjusted exercise price of $ 60.00 per share. In December 2020, the Company issued noncompensatory equity classified warrants to
Alpha for the purchase of 100,000 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise
price of $ 0.10 per share (which were exercised in February 2021) and 219,101 reverse split adjusted shares of Company common stock at
a reverse split adjusted exercise price of $ 40.70 per share. In May 2022, the Company issued noncompensatory equity classified warrants
to Alpha for the purchase of 331,464 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise
price of $ 0.01 per share.

 On
November 29, 2021, with the exception of the warrants to purchase 27,048 reverse split adjusted shares of the Company's common
stock at a reverse split adjusted exercise price of $ 11.10 per share, the exercise prices of all outstanding warrants to purchase a total
of 539,951 reverse split adjusted shares of the Company's common stock were modified to a reverse split adjusted exercise price
of $ 20.00 per share and each of their remaining terms extended by six months. The fair value of the modification cost of these warrant
modifications of approximately $ 2.3 million was charged to additional paid-in capital and did not result in expense on the Company's
consolidated statements of operations and comprehensive loss. In May 2022, pre-funded warrants to purchase 331,464 reverse split adjusted
shares of the Company's common stock at a reverse split adjusted exercise price of $ 0.01 per share with no expiration date were
issued to Alpha. These warrants were subsequently exercised in 2022.

 In
conjunction with the NanoSynex Acquisition, on April 25, 2022 the exercise price of 7,048
reverse split adjusted outstanding warrants at $ 11.10
was modified to a reverse split adjusted exercise price of $ 6.00.
The increase in fair value of $ 2,533,
using a Monte Carlo pricing model for the modification of these warrants, was charged to additional paid-in capital and did not
result in expense on the Company's consolidated statements of operations and comprehensive loss. On May 26, 2022, the reverse
split adjusted exercise price of these warrants was modified again to $ 5.136,
and the increase in fair value of $ 696,
using a Monte Carlo pricing model for the modification of these warrants, was included in consideration transferred in the NanoSynex
Acquisition. On December 22, 2022 the exercise price of these warrants was modified again to $ 1.32.
The increase in fair value of $ 891,
using a Monte Carlo pricing model for the modification of those warrants, was charged to additional paid-in capital and did not
result in expense on the Company's consolidated statements of operations and comprehensive loss.

 On
December 5, 2023, the Company entered into an Amendment No. 1 with regard to Securities Purchase Agreement, with Alpha. This
Amendment amended two instruments which the Company issued under the Securities Purchase Agreement dated December 21, 2022: (a) the 8%
Senior Convertible Debenture dated December 22, 2022 in favor of Alpha, and (b) the Common Stock Purchase Warrant dated December
22, 2022 in favor of Alpha. The Amendment reduced the Conversion Price of the Debenture from $ 1.32 per share to $ 0.73
per share (subject to possible future adjustment pursuant to the terms of the Debenture) and reduced the Exercise Price of the Alpha
Warrant from $ 1.65 per share to $ 0.73 per share (subject to possible future adjustment pursuant to the terms of the Alpha Warrant). The
Amendment revised certain provisions of the Warrant which resulted in reclassification of the Warrant from liabilities to equity. For
more details see Note 7 - Warrant Liabilities.

 The
following table summarizes the noncompensatory equity classified warrant activity for the year ended December 31, 2023:

OF WARRANT ACTIVITY

 Price

 Exercise Price

 Weighted– Average Remaining

 547,003

 $
 19.76

 $ 1.32 - $ 20.00

 0.33

 Legacy Ritter warrants

 —

 —

 Reclassification of Alpha Warrant from warrant liabilities to equity

 2,500,000

 0.73

 0.73

 —

 —

 ( 539,953
)

 20.00

 20.00

 —

 —

 Total outstanding – December 31, 2023

 2,507,050

 $
 0.73

 2,507,050

 $
 0.73

 0.73

 4.47

 Non-Exercisable

 —

 $
 —

 $
 —

 —

 The
following table summarizes the noncompensatory equity classified warrant activity for the year ended December 31, 2022:

 Weighted– Average Exercise
 Price

 Price

 Weighted– Average Remaining

 Total outstanding – December 31, 2021

 554,914

 $
 20.10

 11.10 — 37.78

 1.32

 Legacy Ritter warrants

 —

 —

 331,464

 0.01

 0.01

 ( 331,464
)

 0.01

 0.01

 ( 7,911
)

 37.78

 37.78

 —

 —

 547,003

 $
 19.76

 1.32 - 20.00

 0.33

 547,003

 $
 19.76

 1.32 - 20.00

 0.33

 Non-Exercisable

 —

 $
 —

 $
 —

 —

 NOTE
13 — RELATED PARTY TRANSACTIONS

 Convertible
Debt

 See
Note 8 – Convertible Debt – Related Party for additional information concerning convertible debt – related party
transactions. On December 22, 2022, the Company issued to Alpha, an 8 %
Senior Convertible Debenture in the aggregate principal amount of $ 3,300,000
for a purchase price of $ 3,000,000
pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022. As of December 31, 2023 the Debenture had a
remaining principal balance of $ 1,418,922,
and was convertible, at any time, and from time to time, at Alpha's option, into shares of common stock of the Company, at a
price equal to $ 0.73
per share, subject to adjustment as described in the Debenture and other terms and conditions described in the Debenture.

 Warrants

 Additionally,
on December 22, 2022, in conjunction with the issuance of the Debenture to Alpha, the Company issued to Alpha the Alpha
Warrant to purchase 2,500,000 shares of the Company's common stock (the "Alpha Warrant"). As of December 31, 2023,
the exercise price of the Alpha Warrant was $ 0.73. The Alpha Warrant may be exercised by Alpha, in whole or in part, at any time
before June 22, 2028, subject to certain terms and conditions described in the Alpha Warrant. The Alpha Warrant is included in equity
on the Company's consolidated balance sheets (see Note 12 – Stockholders' Equity).

 Pursuant
to a Share Purchase Agreement dated April 29, 2022, the Company acquired 2,232,861 shares of NanoSynex Series A-1 Preferred Stock from
Alpha in exchange for 350,000 reverse split adjusted shares of the Company's common stock and a prefunded warrant to purchase
 331,464 reverse split adjusted shares of the Company's common stock at an exercise price of $ 0.001 per share.

 NOTE
14 — INCOME TAXES

 The
following table presents domestic and foreign components of consolidated loss before income taxes from continuing operations for the
periods presented:

OF DOMESTIC AND FOREIGN COMPONENTS

 2023

 2022

 Domestic

 $
 ( 12,479,803
)

 $
 ( 13,887,914
)

 Foreign

 —

 —

 Loss before provision for income taxes

 $
 ( 12,479,803
)

 $
 ( 13,887,914
)

 A
reconciliation of the statutory income tax rates and the Company's effective tax rate is as follows:

OF RECONCILIATIONS OF STATUTORY INCOME TAX RATE

 Statutory federal income tax rate

 21.00
 %

 21.00
 %

 State taxes, net of federal tax benefit

 1.76
 %

 7.50
 %

 Non-deductible expenses

 - 0.64
 %

 - 2.09
 %

 NOL expiration

 - 5.26
 %

 - 19.88
 %

 Tax credit

 2.92
 %

 3.71
 %

 Goodwill impairment

 0.00
 %

 0.00
 %

 Foreign rate differential

 0.00
 %

 0.00
 %

 Change in fair value of warrant liability

 3.35
 %

 0.00
 %

 Tax impact of convertible debenture

 - 5.46
 %

 1.37
 %

 Tax impact of divestiture

 - 229.26
 %

 4.01
 %

 True-up

 - 10.65
 %

 2.24
 %

 Change in valuation allowance

 222.28
 %

 - 17.91
 %

 Income taxes provision (benefit)

 0.04
 %

 - 0.05
 %

tax expense for the year ended December 31, 2023 and 2022 consisted of the following:

OF PROVISION FOR INCOME TAXES

 Current

 U.S. Federal

 $
 ( 10,000
)

 $
 —

 U.S. State

 5,000

 7,000

 Total current provision

 ( 5,000
)

 7,000

 Deferred Benefit

 U.S. Federal

 23,128,000

 ( 236,000
)

 U.S. State

 4,697,000

 ( 2,252,000
)

 Total deferred benefit

 27,825,000

 ( 2,488,000
)

 Change in valuation allowance

 ( 27,825,000
)

 2,488,000

 Total provision (benefit) for income taxes

 $
 ( 5,000
)

 $
 7,000

 The
components of deferred tax assets and liabilities are as follows:

OF DEFERRED TAX ASSETS AND LIABILITIES

 Deferred tax assets:

 Net operating loss

 $
 8,644,000

 $
 32,587,000

 Research and development credits

 4,970,000

 7,857,000

 Accrued expenses

 68,000

 1,020,000

 Patent

 —

 —

 Stock compensation

 3,004,000

 3,069,000

 Research and development expenses

 1,102,000

 1,196,000

 Fixed assets

 —

 280,000

 Total deferred income tax assets

 17,788,000

 46,009,000

 Deferred tax liabilities:

 Intangible assets

 —

 ( 13,000
)

 Right-of-use asset

 —

 ( 382,000
)

 Total deferred income tax liabilities

 —

 ( 395,000
)

 Net deferred income tax assets

 17,788,000

 45,614,000

 Valuation allowance

 ( 17,788,000
)

 ( 45,614,000
)

 Deferred tax asset, net of allowance

 $
 —

 $
 —

 Based
on the available objective evidence, including the Company's history of cumulative losses, management believes it is likely that
the Company's U.S. federal and state net deferred tax assets will not be realizable. Accordingly, the Company provided for a full
valuation allowance against its U.S. federal and state net deferred tax assets at December 31, 2023 and December 31, 2022.

 Due
to the full valuation allowance already in place on the Company's U.S. federal and state net deferred tax assets, the Company does
not anticipate significant changes in the Company's effective tax rate. However, there is no valuation allowance recorded against
the Company's foreign net operating loss deferred tax assets, as the Company's foreign IPR&D deferred tax liabilities
and foreign net operating loss deferred tax assets are both indefinite-lived and thus they may be netted to arrive at a net foreign deferred
tax liability.

 The
Tax Cuts and Jobs Act resulted in significant changes to the treatment of research or experimental ("R&E") expenditures
under Section 174. For tax years beginning after December 31, 2021, taxpayers are required to capitalize and amortize all R&E expenditures
that are paid or incurred in connection with their trade or business which represent costs in the experimental or laboratory sense. Specifically,
costs for U.S. based R&E activities must be amortized over five years and costs for foreign R&E activities must be amortized
over 15 years; both using a midyear convention. The Company has incorporated the impact of this new tax legislation into its 2023 and
2022 consolidated financial statements, noting that the impact on the Company's consolidated financial statements was immaterial.

 At
December 31, 2023, the Company has U.S. federal and state net operating loss carryforwards of approximately $ 15,942,000 and $ 78,693,000,
respectively, which are available to offset future taxable income. U.S. federal and state net operating loss carryovers began to expire
in 2020. As a result of the May 2020 reverse recapitalization, an ownership change has occurred. The Company has not completed an Internal
Revenue Code Section 382 analysis. As a result, there could be substantial limitations on the Company's ability to utilize its
pre-ownership change net operating loss and tax credit carryforwards. These substantial limitations may result in both a permanent loss
of certain tax benefits related to net operating loss carryforwards and federal research and development credits, and an annual utilization
limitation.

 The
Company also has research and development credit carryforwards for federal and state tax purposes of approximately $ 3,560,000 and $ 1,410,000,
respectively. The research and development credit carryforwards began to expire in 2020 for federal tax purposes and have an indefinite
life for state tax purposes.

 U.S.
income tax has not been recognized on the excess of the amount for financial reporting over the tax basis of investments in foreign subsidiaries
that is indefinitely reinvested outside the United States. This amount becomes taxable upon a repatriation of assets from the subsidiary
or a sale or liquidation of the subsidiary. Determination of the amount of any unrecognized deferred income tax liability on this temporary
difference is not practicable because of the complexities of the hypothetical calculation.

 The
Company files income tax returns in the U.S. federal jurisdiction and in various states. The Company's U.S. federal income tax
returns remain subject to examination by the Internal Revenue Service. The Company's California income tax returns remain subject
to examination by the California Franchise Tax Board. Due to net operating losses, research and development credits and other tax credit
carryforwards that may be utilized in future years, all U.S. federal and state tax years are open to examination.

 Generally
accepted accounting principles clarify the accounting for uncertainty in income taxes recognized in the Company's financial statements
and prescribe thresholds for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax
return, and also provide guidance on de-recognition and measurement of a tax position taken or expected to be taken in a tax return.
The Company adopted these provisions effective April 1, 2009.

 The
Company did no t have any unrecognized tax benefits as of December 31, 2023 and December 31, 2022 and does not expect this to change significantly
over the next 12 months. In accordance with generally accepted accounting principles, the Company will recognize interest and penalties
accrued on any unrecognized tax benefits as a component of income tax expense. As of December 31, 2023, the Company has not accrued any
interest or penalties related to uncertain tax positions.

 NOTE
15 — SUBSEQUENT EVENTS

 On
February 26, 2024, the Company entered into a Securities Purchase Agreement ("Agreement") with Alpha. The transactions
contemplated by the Agreement closed on February 27, 2024, at which time the Company delivered to Alpha the 2024 Debenture and the
2024 Warrant, as described below, and Alpha paid the Company a cash purchase price of $ 500,000
(less $ 25,000
for expense reimbursement). Pursuant to the Agreement, the Company issued to Alpha an 8% Convertible Debenture (the "2024
Debenture") in the principal amount of $ 550,000.
The Debenture has a maturity date of December
31, 2024 and is convertible, at any time, and from time to time, at Alpha's option, into shares of common stock of the
Company, at $ 0.6111
per share, subject to adjustment as described in the 2024 Debenture (the "Conversion Price"). The Debenture accrues
interest on its outstanding principal balance at the rate of 8 %
per annum. The 2024 Debenture does not call for scheduled payments of principal or interest before the scheduled maturity date of
December 31, 2024. Pursuant to the terms of the Agreement, the Company also issued to Alpha a 5-year common stock purchase warrant
(the "2024 Warrant") to purchase (at $ 0.26
per share) 900,016
shares of common stock of the Company. Under the Agreement, Alpha also has an option, exercisable until July 1, 2024, to
purchase from the Company up to an additional $ 1,100,000
in principal amount of 2024 Debentures of like tenor, together with up to an additional 1,800,032
2024 Warrants of like tenor, which would (if and when Alpha exercises such option) provide us up to an additional $ 1.0
million in cash proceeds (less expense reimbursement, and not including any possible cash proceeds from any future exercise of the
additional 2024 Warrants). We granted Alpha "piggyback" registration rights for the common shares underlying the
2024 Debenture and the 2024 Warrant.

 Item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

 Not
applicable.

 Item
9A. Controls and Procedures.

 Evaluation
of Disclosure Controls and Procedures

 Our
management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of
our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2023,
the end of the year covered by this Annual Report. Based on this evaluation, our principal executive officer and principal financial
officer concluded that, as of December 31, 2023, our disclosure controls and procedures were effective. We believe that a disclosure
controls system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the disclosure controls
system are met, and no evaluation of disclosure controls can provide absolute assurance that all disclosure control issues, if any, within
a company have been detected.

 Management's
Report on Internal Control over Financial Reporting

 Our
management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f)
and 15d-15(f) under the Exchange Act. Internal control over financial reporting is a process designed under the supervision and with
the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes
in accordance with accounting principles generally accepted in the United States of America.

 As
of December 31, 2023, our management assessed the effectiveness of our internal control over financial reporting using the criteria set
forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework. Based on the
continuing material weakness described below, our management concluded that as of December 31, 2023, our internal control over financial
reporting was not effective.

 Description
of Material Weaknesses

 In connection
with the audit of our financial statements as of and for the year ended December 31, 2023, we identified material weaknesses related to a lack of sufficient number of personnel within our accounting function
to adequately segregate duties, and we have not designed and implemented effective Information Technology General Controls ("ITGC")
related to access controls to financial accounting systems.

 We lack the resources to employ
additional personnel to help mitigate these material weaknesses and we foresee that these material weaknesses will not be remediated until we
receive additional funding to support our accounting department.

 Remediation
of Material Weakness

 We cannot assure you that these
or other measures will fully remediate the material weakness in a timely manner. Notwithstanding the identified material weakness, our
management believes that the consolidated financial statements included in this report fairly represent in all material respects our financial
condition, results of operations and cash flows at and for the periods presented in accordance with U.S. GAAP.

 Changes
in Internal Control over Financial Reporting

 Other
than as described above, there were no changes in our internal control over financial reporting identified in management's evaluation
pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the year ended December 31, 2023 that materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.

 Limitation
on Effectiveness of Controls

 In
designing and evaluating our controls and procedures, management recognized that any controls and procedures, no matter how well designed
and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. No evaluation of internal
control can provide absolute assurance that all internal control issues and instances of fraud, if any, within a company are detected.
In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. There are inherent limitations to the effectiveness of any system of disclosure controls
and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. In addition,
the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be
no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may
become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because
of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 Item
9B. Other Information.

 None.

 Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

 None.

 PART
III

 Item
10. Directors, Executive Officers and Corporate Governance.

 The
Board of Directors

 Our
board of directors currently consists of six members, each of whose current term of office as a director expires at the 2024 annual meeting
of stockholders. Biographical information with respect to our directors is provided below.

 Our
directors hold office for one year or until their respective successors have been duly elected or until their death, resignation or removal.
Our amended and restated bylaws provide that the authorized number of directors comprising our board of directors will be fixed, from
time to time, by a majority of the total number of directors.

 There
are no family relationships among any of our directors or executive officers. There is no arrangement or understanding between any director
and any other person pursuant to which the director was selected.

 Name

 Position with the Company

 Age

 Director Since

 Michael Poirier

 Chairman and Chief Executive Officer

 2020

 Richard David

 2020

 Sidney Emery, Jr.

 2020

 Matthew Korenberg

 2020

 Kurt Kruger

 2020

 Ira Ritter

 2008

 Michael
S. Poirier. Mr. Poirier founded the Qualigen business in 1996 and is its Chairman and Chief Executive Officer. Before founding Qualigen,
Mr. Poirier had relevant operating, marketing and sales positions with Ashirus Technologies, Inc., EnSys, Inc., Sanofi Pasteur and Abbott
Laboratories, Inc. Before working at Abbott, Mr. Poirier served as an officer in the United States Navy, assigned to the US Atlantic
Fleet. Mr. Poirier holds a B.A. from Providence College and attended the University of Z rich, Switzerland, School of Law.

 Mr.
Poirier's commitment to our strategic goals, his long experience leading our company and his deep knowledge of its technologies
and business contributed to our board of directors' conclusion that he should serve as a director of our company.

 Richard
A. David, MD FACS. Dr. David serves as Chief Medical Officer for the Los Angeles Division of Genesis Healthcare Partners, the largest
urology group in Southern California. He also serves as medical director for Genesis' Advanced Prostate Cancer Center of Excellence.
In addition, Dr. David serves as Clinical Professor of Urology for the David Geffen School of Medicine at UCLA. Dr. David obtained his
undergraduate education at Stanford University and his medical degree at Thomas Jefferson University in Philadelphia. He also holds a
Master's degree in Medical Management (MMM) from the Marshall School of Business at the University of Southern California. He trained
in general surgery and completed his urology residency at UCLA Medical Center in Los Angeles. Dr. David is a fellow of the American College
of Surgeons.

 Dr.
David's experience as an executive of a large healthcare organization, including his background as a medical doctor, contributed
to our board of directors' conclusion that he should serve as a director of our company.

 Sidney
W. Emery, Jr. Mr. Emery is a seasoned executive in manufacturing, distribution and supply chain management. He served as Chairman
and Chief Executive Officer of MTS Systems Corporation (Nasdaq-GS: MTSC), a leading global supplier of mechanical testing systems and
high-performance industrial position sensors. Mr. Emery served on the Board of Directors of Allete, Inc. (NYSE: ALE), a Minnesota-based
utilities and energy company, from 2006 to 2018. Mr. Emery chairs the University of St. Thomas College of Engineering Board of Governors.
Mr. Emery holds a PhD in Industrial Engineering from Stanford University and a B.S. in Engineering from the US Naval Academy.

 Mr.
Emery's extensive board service with and executive leadership of major companies contributed to our board of directors' conclusion
that he should serve as a director of our company.

 Matthew
E. Korenberg. Mr. Korenberg has served as President and Chief Operating Officer of Ligand Pharmaceuticals Incorporated (Nasdaq: LGND),
a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines,
since November 2022, and before that as Executive Vice President, Finance and Chief Financial Officer of Ligand Pharmaceuticals Incorporated
since August 2015. Before joining Ligand, commencing in September 2013, Mr. Korenberg was the founder, Chief Executive Officer and a
director of NeuroCircuit Therapeutics, a company focused on developing drugs to treat genetic disorders of the brain with an initial
focus on Down syndrome. Before founding NeuroCircuit Therapeutics, Mr. Korenberg was a Managing Director and member of the healthcare
investment banking team at Goldman Sachs from July 1999 through August 2013. During his 14 year tenure at Goldman Sachs, Mr. Korenberg
was focused on advising and financing companies in the biotechnology and pharmaceutical sectors and was based in New York, London and
San Francisco. Before Goldman Sachs, Mr. Korenberg was a healthcare investment banker at Dillon, Read & Co. Inc. where he spent two
years working with healthcare companies in the biotechnology and pharmaceutical sectors and industrial companies. Mr. Korenberg holds
a B.B.A. in Finance and Accounting from the University of Michigan.

 Mr.
Korenberg's financial and accounting expertise, his experience as chief financial officer of a large public biopharmaceutical company
and his investment banking background contributed to our board of directors' conclusion that he should serve as a director of our
company.

 Kurt
H. Kruger. Mr. Kruger has enjoyed a 30-year career in medical technology. His deep involvement in the field has ranged from product
design and development as a biomedical engineer to raising capital for, and following, publicly traded medical product companies as an
equities research analyst. As a marketing manager at Guidant, now a part of Boston Scientific, he developed the launch plans for the
first-ever implantable defibrillator. As a securities analyst he led Hambrecht & Quist's efforts in providing venture funds
for, and then taking public, Ventritex, which was later acquired by St. Jude Medical/Abbott. After H&Q, Mr. Kruger worked as an analyst
for Montgomery Securities and Bank of America. Across 20 years of research work, Mr. Kruger has overseen the IPOs of over 30 medical
products companies. Later he headed up the Life Sciences banking effort for WR Hambrecht & Co. Mr. Kruger received a Sc. B. degree
in Biomedical Engineering from Brown University; a Master's degree in Bioengineering from the University of Michigan; and a business
degree (S.M.) from the Sloan School at the Massachusetts Institute of Technology (MIT). He also completed the premedical post-baccalaureate
program at Columbia University.

 Mr.
Kruger's long experience in investment banking and securities analysis with a life sciences focus contributed to our board of directors'
conclusion that he should serve as a director of our company.

 Ira
E. Ritter. Mr. Ritter served as Co-Founder, Chief Strategic Officer and Executive Chairman of the Company during its Ritter Pharmaceuticals,
Inc. phase, from its inception in 2004 through the formation of the Ritter Pharmaceuticals, Inc. corporate entity in 2008 and served
in those positions with Ritter Pharmaceuticals, Inc. from 2008 until the May 22, 2020 reverse recapitalization transaction (the "Reverse
Recapitalization Transaction") in which Ritter Pharmaceuticals, Inc. changed its name to Qualigen Therapeutics, Inc. Mr. Ritter
has extensive experience creating and building diverse business enterprises and since 1987 through Andela Corporation, of which he is
the CEO, has provided corporate management, strategic planning and financial consulting for a wide range of market segments including;
health product related national distribution and private label production, television and publishing. He assisted taking Ritter Pharmaceuticals,
Inc. public on Nasdaq and Martin Lawrence Art Galleries public on the New York Stock Exchange. Since 2010, Mr. Ritter has also acted
as a managing partner of Stonehenge Partners, LLC. Mr. Ritter has a long history of public service that includes appointments by three
Governors to several State of California Commissions including eight years as Commissioner on the California Prison Industry Authority.

 Mr.
Ritter's experience as an entrepreneur and chairman of a publicly traded development-phase therapeutics company contributed to
our board of directors' conclusion that he should serve as a director of our company. Mr. Ritter continued his service on our board
of directors, by agreement in connection with the Reverse Recapitalization Transaction, as the designated legacy member from the pre-Reverse
Recapitalization Transaction public-company board of directors.

 Committees
of the Board of Directors

 Our
board of directors has established an Audit Committee, a Compensation Committee and a Nominating and Corporate Governance Committee.
Each committee operates under a charter. Copies of each committee's charter are posted on the Investor Relations section of our
website, which is located at www.qlgntx.com.

 Audit
Committee. The current members of our Audit Committee are Mr. Kruger (Chair), Mr. Emery, and Mr. Korenberg, each of whom was
determined by our board of directors to be independent under Rule 10A-3 under the Exchange Act and the continued listing requirements
of Nasdaq, and to satisfy the other continued listing requirements of Nasdaq for audit committee membership. The Company has identified
Matthew Korenberg as an "audit committee financial expert" as such term is defined in Item 407(d)(5) of SEC Regulation S-K,
and has determined that he has the requisite level of financial sophistication required by the continued listing requirements of Nasdaq;
this identification does not constitute a determination that other members of the Audit Committee would not also be able to qualify as
an "audit committee financial expert."

 EXECUTIVE
 OFFICERS

 The
following table sets forth information about our current executive officers.

 Name

 Age

 Position with the Company

 Michael Poirier

 Chairman and Chief Executive Officer

 Christopher Lotz

 Chief Financial Officer, Vice President of Finance

 Officers
serve at the discretion of the board of directors. There are no family relationships among any of our directors or executive officers.
There is no arrangement or understanding between any executive officer and any other person pursuant to which the executive officer was
selected.

 For
the biography of Mr. Poirier, please see "Board of Directors" above.

 Christopher
L. Lotz | Chief Financial Officer, Vice President of Finance. Mr. Lotz joined Qualigen, Inc. as Director of Finance in 2002 and was
promoted to his current role of Chief Financial Officer, Vice President of Finance in 2003. He became an officer of the Company at the
time of the Reverse Recapitalization Transaction in 2020. Before joining Qualigen, Inc. Mr. Lotz spent the previous 15 years serving
in financial leadership positions with Bexcom, an Asian-based software developer, California Furniture Collections, Inc., a custom furniture
manufacturer, and Group Publishing, Inc., an educational media publisher. Mr. Lotz holds a B.S. in Business Administration from Colorado
State University.

 Delinquent
Section 16(a) Reports

 Section
16(a) of the Exchange Act requires the Company's officers and directors, and persons who own more than 10% of our common stock,
to file reports of securities ownership and changes in such ownership with the SEC. Officers, directors, and greater than 10% stockholders
also are required by SEC rules to furnish the Company with copies of all Section 16(a) forms they file.

 Based
solely on the Company's review of Forms 3, 4 and 5 filed by such persons and information provided by the Company's directors
and officers, the Company believes that during the year ended December 31, 2023, all Section 16(a) filing requirements applicable to
such persons were met in a timely manner.

 Item
11. Executive Compensation.

 Summary
Compensation Table (2023 and 2022)

 The
following table sets forth the compensation paid to or earned by our named executive officers for the periods presented.

 Name and Principal Position

 "Year"

 Salary
($)

 Bonus
($)

 Option Awards (1)
 ($)

 All Other Compensation (2)
 ($)

 Total
($)

 Michael Poirier, Chairman and Chief Executive Officer

 2023

 512,635

 118,174

 —

 1,889

 632,698

 2022

 575,000

 —

 145,274

 8,180

 728,454

 Tariq Arshad, Former Chief
 Medical Officer and Senior Vice President (3)

 2023

 356,615

 101,231

 —

 5,326

 463,172

 2022

 400,000

 —

 39,512

 439,650

 Amy Broidrick, Former President, Chief Strategy and Operating Officer (4)

 2023

 194,017

 —

 —

 371,454

 565,470

 2022

 450,000

 —

 50,359

 7,642

 508,001

 (1)
 The
 amounts reported in this column reflect the aggregate grant date fair value of the option
 awards granted during 2022, computed in accordance with Financial Accounting Standards
 Board Accounting Standards Codification Topic 718 for stock-based compensation transactions
 ("ASC 718"). Such grant date fair values do not take into account any estimated
 forfeitures related to service-based vesting conditions. Assumptions used in the calculation
 of these amounts are included in the notes to our consolidated financial statements included
 in this Annual Report. These amounts do not reflect the actual economic value that may be
 realized by the executive officers upon the exercise of the stock options or the sale of
 the common stock underlying such stock options. There were no option awards granted during 2023.

 (2)
 The amounts reported in this column represent
 401(k) matching contributions and life insurance premiums paid by us for Mr. Poirier and Dr. Arshad, and $1,316 in 401(k) matching contributions and life insurance premiums paid by us for Ms. Broidrick,
and $370,138 in severance compensation for Ms. Broidrick.

 (3)
 Dr.
 Arshad resigned from his role as Chief Medical Officer and Senior Vice President effective
 February 25, 2024.

 (4)
 Ms. Broidrick resigned from her role as President, Chief
 Strategy and Operating Officer and as a Director effective June 16, 2023. The 2023 "Salary" for Ms. Broidrick includes
 amounts we paid through June 16, 2023. The 2023 "All Other Compensation" for Ms. Broidrick includes $370,138 of severance compensation.

 Executive
Employment Agreements

 Employment
Agreement with Michael Poirier

 Mr.
Poirier is party to an Executive Employment Agreement dated February 1, 2017, as amended January 9, 2018 (the "Poirier
Employment Agreement"). The Poirier Employment Agreement had an initial three-year term and is now automatically renewed for successive
one-year periods unless either party gives notice of nonrenewal at least 90 days before the end of such a one-year period.

 Under
the terms of the Poirier Employment Agreement, Mr. Poirier is entitled to an annual base salary of at least $315,000, is eligible to
participate in the Company's bonus plans, benefit programs and medical benefits, is eligible for certain event-based bonuses (including
for "Liquidity Event" acquisition transactions), and is entitled to four weeks of vacation per year. If Mr. Poirier's
employment is terminated without Cause or he resigns for Good Reason (as such terms are defined in the Poirier Employment Agreement),
and he provides a general release to the Company, he will be entitled to one year of salary continuation plus the cost of COBRA coverage
continuation for such one year period. In May 2021, our board of directors and its compensation committee increased Mr. Poirier's
annual base salary to $575,000. On January 13, 2023, the Company's board of directors, as part of certain cost-cutting measures,
approved a temporary 20% reduction to the base salaries of all executive officers of the Company. Accordingly, on January 16, 2023, Mr.
Poirier's base salary was reduced to $460,000; it was subsequently restored in August 2023.

 Employment
Agreement with Christopher Lotz

 Mr.
Lotz is party to an Executive Employment Agreement dated February 1, 2017, as amended January 9, 2018 (the "Lotz
Employment Agreement"). The Lotz Employment Agreement had an initial three-year term and is now automatically renewed for successive
one-year periods unless either party gives notice of nonrenewal at least 90 days before the end of such a one-year period.

 Under
the terms of the Lotz Employment Agreement, Mr. Lotz is entitled to an annual base salary of at least $225,000, is eligible to participate
in the Company's bonus plans, benefit programs and medical benefits, is eligible for certain event-based bonuses (including for
"Liquidity Event" acquisition transactions), and is entitled to four weeks of vacation per year. If Mr. Lotz's employment
is terminated without Cause or he resigns for Good Reason (as such terms are defined in the Lotz Employment Agreement), and he provides
a general release to the Company, he will be entitled to 180 days of salary continuation plus the cost of COBRA coverage continuation
for such 180 day period. In May 2021, our board of directors and its compensation committee increased Mr. Lotz's annual base salary
to $300,000. On January 13, 2023, the Company's board of directors, as part of certain cost-cutting measures, approved a temporary
20% reduction to the base salaries of all executive officers of the Company. Accordingly, on January 16, 2023, Mr. Lotz's base
salary was reduced to $240,000; it was subsequently restored in August 2023.

 Offer
Letter with Tariq Arshad

 Under
the terms of his hire offer letter with the Company, dated May 17, 2021, Dr. Arshad was entitled to an annual base salary of at
least $400,000. He received a cash signing bonus of $25,000 when he joined the Company, was eligible to receive annual cash bonuses
equal to an amount up to 40% of his annualized base salary, and is entitled to four weeks of vacation per year. Under the terms of
his hire offer letter, if Dr. Arshad's employment is terminated without Cause or he resigns for Good Reason, and he provides a
general release to the Company, he will be entitled to 180 days of salary continuation plus the cost of COBRA coverage continuation
for such 180 day period.

 On
February 25, 2024, Dr. Arshad resigned from his position as the Company's Chief Medical Officer and Senior Vice President. He
did not assert that the resignation was for Good Reason and he did not provide a general release to the Company.

 Employment Agreement with Amy Broidrick

 Ms. Broidrick was party to an Executive
Employment Agreement with Qualigen, Inc., a former wholly-owned subsidiary of the Company, dated December 10, 2021. On May 16, 2023,
Ms. Broidrick resigned from all officer and director positions with the Company and its subsidiaries, which became effective June
16, 2023 (the "Separation Date"). Ms. Broidrick's departure was not related to any disagreement with the Company
on any matter relating to the Company's operations, policies, or practices. In connection with her termination of employment,
on June 20, 2023, Qualigen, Inc, entered into a separation agreement and general release with Ms. Broidrick, which became effective
after a 7 day revocation period following Ms. Broidrick's signing of it, on June 24, 2023. Under the terms of the Separation
Agreement, Qualigen, Inc. was obligated to provide Ms. Broidrick severance in the form of continued salary pay at the rate then in
effect on the Separation Date ($360,000 per annum) for a period of 12 months following the Separation Date, subject to applicable
withholding, and payment or reimbursement for the cost of COBRA continuation medical and dental insurance coverage for 12 months
following the Separation Date, less any required taxes or withholdings. Upon the July 20, 2023 closing of our sale of Qualigen,
Inc., Chembio (as the new parent company of Qualigen, Inc.) undertook the remaining severance liability to Ms. Broidrick.

 Stock
Incentive Plan

 The
material terms of our 2020 Stock Equity Incentive Plan (as amended, the "2020 Plan") are outlined below. This summary is
qualified in its entirety by reference to the complete text of the 2020 Plan, which is incorporated herein by reference.

 Authorized
Shares. We have reserved an aggregate of 755,702 shares of our common stock for issuance under the 2020 Plan. The number of shares
is subject to adjustment in the event of any recapitalization, stock split, reclassification, stock dividend or other change in our capitalization.
In addition, the following shares of our common stock will be available for grant and issuance under the 2020 Plan:

 subject to stock options or stock appreciation rights ("SARs"), granted under
 the 2020 Plan that cease to be subject to the stock option or SAR for any reason other than
 exercise of the stock option or SAR;

 subject to awards granted under the 2020 Plan that are subsequently forfeited or repurchased
 by us at the original issue price;

 subject to awards granted under the 2020 Plan that otherwise terminate without shares being
 issued;

 surrendered, canceled, or exchanged for cash or a different award (or combination thereof);
 and

 subject to awards under the 2020 Plan that are used to pay the exercise price of an award
 or withheld to satisfy the tax withholding obligations related to any award.

 Plan
Administration. The 2020 Plan will be administered by our Compensation Committee or by our board of directors acting in place of
our Compensation Committee. Our Compensation Committee will have the authority to construe and interpret the 2020 Plan, grant awards
and make all other determinations necessary or advisable for the administration of the 2020 Plan.

and Eligible Participants. The 2020 Plan authorizes the award of stock options, stock appreciation rights, restricted stock unit,
performance awards and stock bonuses. The 2020 Plan provides for the grant of awards to our employees, directors, consultants and independent
contractor service providers, subject to certain exceptions. No non-employee director may be granted awards under the 2020 Plan in any
calendar year that, taken together with any cash fees paid by us to such non-employee director during such calendar year, exceed $5,000,000
(calculating the value of any award based on the grant date fair value determined in accordance with GAAP). No more than 98,000,000 shares
of our common stock will be issued under the 2020 Plan pursuant to the exercise of incentive stock options.

 Stock
Options. The 2020 Plan permits us to grant incentive stock options and non-qualified stock options. The exercise price of stock options
will be determined by our Compensation Committee, and may not be less than 100% of the fair market value of our common stock on the date
of grant. Our Compensation Committee has the authority to reprice any outstanding stock option (by reducing the exercise price, or canceling
the stock option in exchange for cash or another equity award) under the 2020 Plan without the approval of our stockholders. Stock options
may vest based on the passage of time or the achievement of performance conditions in the discretion of our compensation committee. Our
Compensation Committee may provide for stock options to be exercised only as they vest or to be immediately exercisable with any shares
issued on exercise being subject to our right of repurchase that lapses as the shares vest. The maximum term of stock options granted
under the 2020 Plan is 10 years.

 Stock
Appreciation Rights. SARs provide for a payment to the holder, in cash or shares of our common stock, based upon the difference between
the fair market value of our common stock on the date of exercise and the stated exercise price on the date of grant, up to a maximum
amount of cash or number of shares. SARs may vest based on the passage of time or the achievement of performance conditions in the discretion
of our Compensation Committee. Our Compensation Committee has the authority to reprice any outstanding SAR (by reducing the exercise
price, or canceling the SAR in exchange for cash or another equity award) under the 2020 Plan without the approval of our stockholders.

 Restricted
Stock Awards. A restricted stock award represents the issuance to the holder of shares of our common stock, subject to the forfeiture
of those shares in the event of failure to achieve certain performance conditions or termination of employment. The purchase price, if
any, for the shares will be determined by our Compensation Committee. Unless otherwise determined by the administrator at the time of
award, vesting will cease on the date the holder no longer provides services to us and unvested shares will be forfeited to us or can
be repurchased by us.

 Restricted
Stock Units. Restricted stock units ("RSUs") represent the right on the part of the holder to receive shares of our common
stock at a specified date in the future, subject to forfeiture of that right in the event of failure to achieve certain performance conditions
or termination of employment. If a RSU has not been forfeited, then, on the specified date, we will deliver to the holder of the RSU
shares of our common stock, cash or a combination of cash and shares of our common stock, as previously determined by the Compensation
Committee at the time of the award.

 Performance
Awards. Performance awards cover a number of shares of our common stock that may be settled upon achievement of performance conditions
as provided in the 2020 Plan in cash or by issuance of the underlying common stock. These awards are subject to forfeiture before settlement
in the event of failure to achieve certain performance conditions or termination of employment.

 Stock
Bonuses. Stock bonuses may be granted as additional compensation for past or future service or performance and, therefore, no payment
will be required from a participant for any shares awarded under a stock bonus. Unless otherwise determined by our Compensation Committee
at the time of award, vesting will cease on the date the holder no longer provides services to us and unvested shares will be forfeited
to us.

 Change-in-Control.
If we are party to a merger or consolidation, sale of all or substantially all our assets or similar change-in-control transaction, outstanding
awards, including any vesting provisions, may be assumed or substituted by the successor company. In the alternative, the successor company
may issue, in place of outstanding shares held by a 2020 Plan participant, substantially similar shares or other property subject to
repurchase obligations no less favorable to the participant. Outstanding awards that are not assumed, substituted or cashed out will
accelerate in full and expire immediately before the transaction, and awards will be exercisable for a period of time determined by the
administrator.

 Amendment;
Termination. The 2020 Plan will terminate 10 years from April 8, 2020, unless it is terminated earlier by our board of directors.
Our board of directors may amend, suspend or terminate the 2020 Plan at any time, subject to compliance with applicable law.

 Federal
Income Tax Summary. The following is a brief summary of the principal federal income tax consequences to us and to an eligible person
(who is a citizen or resident of the United States for U.S. federal income tax purposes) (a "Participant") of awards that
may be granted under the 2020 Plan. The summary is not intended to be exhaustive and, among other things, does not describe state, local
or foreign tax consequences. The federal income tax consequences of an eligible person's award under the 2020 Plan are complex,
are subject to change and differ from person to person. Each person should consult with his or her own tax adviser as to his or her own
particular situation.

 This
discussion is based on the Code, Treasury Regulations promulgated under the Code, Internal Revenue Service rulings, judicial decisions
and administrative rulings as of the date of this proxy statement, all of which are subject to change or differing interpretations, including
changes and interpretations with retroactive effect. No assurance can be given that the tax treatment described herein will remain unchanged
at the time that awards under the 2020 Plan are made.

 A
Participant will not recognize income upon the grant of an option or at any time prior to the exercise of the option. At the time the
participant exercises a non-qualified option, he or she will recognize compensation taxable as ordinary income in an amount equal to
the excess of the fair market value of the common stock on the date the option is exercised over the price paid for the common stock,
and we will then be entitled to a corresponding deduction.

 A
Participant who exercises an incentive stock option will not be taxed at the time he or she exercises his or her options or a portion
thereof. Instead, he or she will be taxed at the time he or she sells the common stock purchased pursuant to the option. The Participant
will be taxed on the excess of the amount for which he or she sells the stock over the price he or she had paid for the stock. If the
Participant does not sell the stock prior to two years from the date of grant of the option and one year from the date the stock is transferred
to him or her upon exercise, the gain will be capital gain and we will not get a corresponding deduction. If the Participant sells the
stock at a gain prior to that time, the difference between the amount the Participant paid for the stock and the lesser of the fair market
value on the date of the exercise or the amount for which the stock is sold, will be taxed as ordinary income and we will be entitled
to a corresponding deduction. If the Participant sells the stock for less than the amount he or she paid for the stock prior to the one
or two year periods indicated, no amount will be taxed as ordinary income and the loss will be taxed as a capital loss.

 A
Participant generally will not recognize income upon the grant of a stock appreciation right or a restricted stock unit. At the time
a Participant receives shares or cash payment under any such award, he or she generally will recognize compensation taxable as ordinary
income in an amount equal to the cash or the fair market value of the common stock received, less any amount paid for the stock, and
we will then be entitled to a corresponding deduction. Upon a subsequent sale of the shares received under the stock appreciation right
or restricted stock unit, if any, the difference between the amount realized on the sale and the Participant's tax basis (the amount
previously included in income) is generally taxable as a capital gain or loss, which will be short-term or long-term depending on the
Participant's holding time of such shares.

 The
taxation of restricted stock is dependent on the actions taken by the Participant. Generally, absent an election to be taxed currently
under Section 83(b) of the Code, or an 83(b) election, there will be no federal income tax consequences to the Participant upon the grant
of a restricted stock award. At the lapse of the restrictions or satisfaction of the conditions on the restricted stock, the Participant
will recognize ordinary income equal to the fair market value of our common stock at that time. If the Participant makes an 83(b) election
within 30 days of the date of grant, he or she will recognize ordinary income equal to the fair market value of our common stock at the
time of grant, determined without regard to the applicable restrictions. If an 83(b) election is made, no additional income will be recognized
by the Participant upon the lapse of the restrictions or satisfaction of the conditions on the restricted stock award. We generally should
be entitled to a deduction equal to the amount of ordinary income recognized by the Participant, at the same time as the ordinary income
is recognized by the Participant. Upon a subsequent sale of the formerly restricted stock, the difference between the amount realized
on the sale and the Participant's tax basis (the amount previously included in income) is generally taxable as a capital gain or
loss, which will be short-term or long-term depending on the Participant's holding time of such shares.

 The
tax consequences to Participants who receive performance-based awards depend on the particular type of award issued. Our ability to take
a deduction for such awards similarly depends on the terms of the awards and the limitations of Section 162(m) of the Code, if applicable.
Section 162(m) of the Code currently imposes a $1 million limit on the amount that a public company may deduct for compensation paid
to an employee who is chief executive officer, chief financial officer, or another "covered employee" (as defined by Section
162(m)), or was such an employee beginning in any year after 2017. The Compensation Committee retains the discretion to establish the
compensation paid or intended to be paid or awarded to the executive officers as the Compensation Committee may determine is in the best
interest of us and our stockholders, and without regard to any limitation provided in Section 162(m). This discretion is an important
feature of the Compensation Committee's compensation practices because it provides the Compensation Committee with sufficient flexibility
to respond to specific circumstances facing us.

 Outstanding
Equity Awards at December 31, 2023

 The
following table presents the outstanding stock options and compensatory warrants held by each of the named executive officers as of December
31, 2023. There were no direct stock awards, restricted stock units or stock appreciation rights outstanding at December 31, 2023. All
pre-2020 "option" awards shown were initially issued as Qualigen, Inc. Series C Warrants, and became warrants exercisable
instead for our common stock (at an adjusted exercise price) upon the Reverse Recapitalization Transaction. The share numbers and exercise
prices in the table below reflect the reverse stock split, which was effected by the Company on November 23, 2022 (the "Reverse
Stock Split").

 Equity Awards

 Name

 Grant
 Date

 Number of
 Underlying
 Unexercised
 (#)

 Number of
 Underlying
 Unexercised
 (#)
 Unexercisable

 Price
 ($)

 Expiration
 Date

 Michael Poirier

 7/11/2022

 12,500

 25,000
 (1)

 5.14

 7/11/2032

 6/5/2020

 100,000

 —

 51.30

 6/5/2030

 9/22/2016

 1,443

 —

 25.41

 9/22/2026

 3/3/2015

 2,214

 —

 25.41

 3/2/2025

 8/2/2014

 2,984

 —

 20.66

 8/2/2024

 1/31/2014

 2,214

 —

 20.66

 1/31/2024

 Tariq Arshad

 7/11/2022

 3,400

 6,800
 (1)

 5.14

 7/11/2032

 12/8/2021

 20,000

 10,000
 (2)

 12.40

 5/17/2031

 5/17/2021

 6,667

 3,333
 (1)

 18.00

 5/17/2031

 Amy Broidrick

 7/11/2022

 —

 13,000
 (3)

 5.14

 7/11/2032

 12/8/2021

 —

 30,000
 (3)

 12.40

 12/8/2031

 12/7/2020

 —

 15,000
 (3)

 35.20

 12/7/2030

 8/27/2020

 —

 5,000
 (3)

 47.00

 8/27/2030

 (1)
 underlying the stock option vest over three years in three equal annual installments from
 the date of grant.

 (2)
 underlying the stock option vest over three years in three equal annual installments from
 the vesting commencement date of May 17, 2021.

 (3)
 Following Ms. Broidrick's termination of employment on June 16, 2023, she did not exercise any vested stock options, and all of her
equity awards were subsequently forfeited.

 Pay
Versus Performance (PVP)

 In
accordance with the SEC's disclosure requirements regarding pay versus performance, or PVP, this section presents the
SEC-defined "Compensation Actually Paid," or CAP of our principal executive officer ("PEO") and named
executive officers ("NEOs") for each of the fiscal years ended December 31, 2023, 2022, and 2021, and our financial
performance. Also as required by the SEC, this section compares CAP to various measures used to gauge performance at the Company for
each such fiscal year.

 Pay
versus Performance Table - Compensation Definitions

 Salary,
Bonus, Stock Awards, and All Other Compensation are each calculated in the same manner for purposes of both CAP and Summary Compensation
Table, or SCT values. The primary difference between the calculation of CAP and SCT total compensation is the calculation of the value
of "Stock Awards," with the table below describing the differences in how these awards are valued for purposes of SCT total
and CAP:

 SCT
 Total

 CAP

 Stock

 Grant
 date fair value of stock awards granted during the year

 Fair
 value of stock awards that are unvested as of the end of the year, or vested during the year

 Pay
Versus Performance Table

 In
accordance with the SEC's new PVP rules, the following table sets forth information concerning the compensation of our NEOs for
each of the fiscal years ended December 31, 2023, 2022, and 2021, and our financial performance for each such fiscal year:

 Year

 Summary Compensation Table Total for PEO

 Compensation Actually Paid to PEO

 Average Summary Compensation Table Total for non-PEO Named Executive Officers

 Average Compensation Actually Paid to non-PEO Named Executive Officers

 Value of Initial Fixed $100 Investment Based On Total Shareholder Return

 Net Loss Attributable to Qualigen Therapeutics, Inc. (millions)

 2023

 $
 632,698

 $
 612,865

 $
 514,321

 $
 488,856

 $
 1.83

 $
 (13.4
)

 2022

 728,454

 262,274

 473,826

 121,235

 4.29

 (18.6
)

 2021

 742,279

 (753,431
)

 811,499

 609,691

 38.21

 (17.9
)

 The principal executive officer ("PEO") in 2023, 2022, and 2021
was Michael Poirier, our Chairman and Chief Executive Officer. The Non-PEO NEOs in 2023, 2022, and 2021 were Amy Broidrick, who was our
President, Chief Strategy and Operating Officer, and Tariq Arshad, who was our Chief Medical Officer and Senior Vice President. The CAP
was calculated beginning with the NEOs SCT total. The following amounts were deducted from and added to the applicable SCT total compensation:

 SCT Total

 Stock awards deducted from SCT

 Increase for fair value of awards granted during the year that remain unvested as of year end

 Decrease in fair value from prior year-end to current year-end for awards granted in prior years and unvested as of year end

 Decrease in fair value from prior year-end to current year vesting date for awards granted in prior years

 Total CAP

 (A)

 (B)

 (C)

 (D)

 (E)

 A-B+C+D+E

 PEO

 2023

 $
 632,698

 $
 -

 $
 -

 $
 (13,650
)

 $
 (6,183
)

 $
 612,865

 2022

 728,454

 (145,274
)

 31,387

 (218,695
)

 (133,598
)

 262,274

 2021

 742,279

 -

 -

 (1,236,534
)

 (259,176
)

 (753,431
)

 Average Non-PEO NEO

 2023

 $
 514,321

 $
 -

 $
 -

 $
 (23,708
)

 $
 (1,757
)

 $
 488,856

 2022

 473,826

 (44,936
)

 9,709

 (218,541
)

 (98,823
)

 121,235

 2021

 811,499

 (363,370
)

 314,858

 (104,300
)

 (48,997
)

 609,691

 The
fair value of stock options reported for CAP purposes in columns (B), (C), (D) and (E) above was estimated using a Black-Scholes option
pricing model for the purposes of this PVP calculation in accordance with SEC rules. This model uses both historical data and current
market data to estimate the fair value of options and requires several assumptions. The assumptions used in estimating fair value for
awards granted during 2022 were as follows: volatility 102%, expected life 5.99 years, expected dividend yield 0%, risk-free rate 3.04%.
The assumptions used in estimating fair value for awards granted during 2021 and prior were as follows: volatility 102%, expected life
5.99 years, expected dividend yield 0%, risk-free rate 0.42% - 1.43%. There were no awards granted in 2023.

 Analysis
of Information Presented in the Pay versus Performance Table

 Our executive compensation program
reflects a variable pay-for-performance philosophy. While we utilize several performance measures to align executive compensation with
Company performance, all of those Company measures are not presented in the Pay versus Performance table. Moreover, we generally seek
to incentivize long-term performance, and therefore we do not specifically align our performance measures with compensation that is actually
paid (as computed in accordance with SEC rules) for a particular year. Further, we do not have the right to (without the executive's
consent) reduce an executive's salary for a particular year to an amount lower than is provided for in any employment agreement
with the executive which covers such year. In accordance with SEC rules, we provide the following narrative disclosure:

Actually Paid and Cumulative Total Stockholder Return

 Compensation actually paid to our PEO increased from ($753,431) in 2021
to $262,274 in 2022, and further increased to $612,865 in 2023. Average compensation actually paid to our named executive officers other
than our PEO decreased from $609,691 in 2021 to $121,235 in 2022, and increased to $488,856 in 2023. Over the same period, the value of
an investment of $100 in our common stock on the last trading day of 2020 decreased by $61.79 to $38.21 during 2021, further decreased
by $33.92 to $4.29 during 2022, and further decreased by $2.46 during 2023, for a total decrease over 2021, 2022, and 2023 of $98.17.

Actually Paid and Net Loss

 Compensation actually paid to our PEO increased from ($753,431) in 2021
to $262,274 in 2022, and further increased to $612,865 in 2023. Average compensation actually paid to our named executive officers other
than our PEO decreased from $609,691 in 2021 to $121,235 in 2022, and increased to $488,856 in 2023. Over the same period, our net loss
increased by $0.7 million during 2022 (from a net loss in 2021 of $17.9 million to a net loss in 2022 of $18.6 million), and decreased
by $5.2 million during 2023 (from a net loss in 2022 of $18.6 million to a net loss in 2023 of $13.4 million).

of Directors

 For
2023, our non-employee directors were eligible to receive $35,000 in annual cash compensation.
The Audit Committee chair was eligible to receive additional annual cash compensation of $15,000 and the other Board committee chairs
were eligible to receive additional annual cash compensation of $10,000. Each non-chair member of each Board committee was eligible to
receive additional annual cash compensation of $7,500 (Audit Committee) and $5,000 (other Committees). On January 13, 2023, the Company's
board of directors, as part of certain cost-cutting measures, approved a temporary 20% reduction to the compensation of all directors
of the Company effective January 1, 2023. On August 1, 2023 the Company's board of directors approved the reinstatement of the
compensation of all directors of the Company to the above amounts effective August 1, 2023. Non-employee directors did not receive stock
option grants during 2023. The amounts in the table below represent fees actually paid in cash during 2023 and include some fees earned in 2022.

paid to Mr. Poirier and Ms. Broidrick is presented as part of the "Summary Compensation Table" above, rather than here.
Our employee directors do not receive compensation for their service as directors.

 Name of Director

 Fees Paid in

 Cash ($)

 Option
($)

 All other compensation
($)

 Total
($)

 Richard David

 40,000

 —

 —

 40,000

 Sidney Emery, Jr.

 46,000

 —

 —

 46,000

 Matthew Korenberg

 42,000

 —

 —

 42,000

 Kurt Kruger

 40,000

 —

 —

 40,000

 Ira Ritter

 16,333

 —

 —

 16,333

 As of December 31, 2023, all non-employee directors had been paid for compensation earned through July 31, 2023.

 Hedging
or Offsetting Against Compensatory Securities

 We
have adopted a policy that our employees (including officers) and directors shall not purchase securities or other financial instruments,
or otherwise engage in transactions, that hedge or offset, or are designed to hedge or offset, any decrease in the market value of equity
securities granted as compensation to, or held directly or indirectly by, those persons.

 We have adopted a formal claw-back policy for the recovery of incentive-based
executive compensation erroneously awarded to executive officers based on misstated financial reporting measures.

 Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

 The
following table sets forth certain information regarding the beneficial ownership of our common stock as of March 25, 2024 by:

 our named executive officers;

 our directors;

 all of our current directors and executive officers as a group;
and

 each stockholder known by us to own beneficially more than
5% of our common stock.

 Beneficial
ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities.
Shares of common stock that may be acquired by an individual or group within 60 days after March 25, 2024, pursuant to the exercise of
options or warrants, are deemed to be outstanding for the purpose of computing the percentage ownership of such individual or group,
but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person shown in the table. The
percentage of beneficial ownership of our common stock is calculated based on an aggregate of 6,307,371 shares outstanding as of March
25, 2024.

 Except
as indicated in the footnotes to this table, we believe that the stockholders named in this table have sole voting and investment power
with respect to all shares of common stock shown to be beneficially owned by them, based on information provided to us by such stockholders.
Unless otherwise indicated, the address for each director and executive officer listed is: c/o Qualigen Therapeutics, Inc., 5857 Owens
Avenue, Suite 300, Carlsbad, California 92008 USA.

 Beneficial Owner

 Number of Shares
 Beneficially Owned

 Percentage of
 Beneficially Owned

 Five Percent Stockholders

 Alpha Capital Anstalt (1)

 700,041

 9.99
 %

 Executive Officers, Directors and Director Nominees

 Michael Poirier (2)

 142,376

 2.2
 %

 Christopher Lotz (3)

 72,353

 1.1
 %

 Richard David (4)

 7,219

 *%

 Sidney Emery, Jr. (5)

 8,302

 *%

 Matthew Korenberg (6)

 6,334

 *%

 Kurt Kruger (7)

 9,019

 *%

 Ira Ritter (8)

 6,738

 *%

 All current executive officers and directors as a group (7 persons) (9)

 252,341

 3.9
 %

 *
Represents beneficial ownership of less than 1% of the shares of common stock.

 (1)
 Includes
 shares of common stock issuable upon the exercise of warrants or conversion of its convertible
 debentures; Alpha Capital Anstalt would not be permitted to convert or exercise all or any
 portion of its warrants or debentures to the extent that such conversion or exercise would
 result in Alpha Capital Anstalt (and its affiliates) beneficially owning more than 9.99%
 of the number of shares of Company common stock outstanding immediately after giving effect
 to the issuance of shares of common stock issuable upon conversion/exercise. Konrad Ackermann
 has voting and investment power over the shares held by Alpha Capital Anstalt.

 (2)
 Includes
 112,500 shares of common stock exercisable within 60 days under outstanding stock options
 and 8,855 shares of common stock exercisable within 60 days under outstanding warrants.

 (3)
 Includes
 63,333 shares of common stock exercisable within 60 days under outstanding stock options
 and 7,766 shares of common stock exercisable within 60 days under outstanding warrants.

 (4)
 Includes 6,334 shares of common stock exercisable within 60 days under
outstanding stock options and 885 shares of common stock exercisable within 60 days under outstanding warrants.

 (5)
 Includes 6,334 shares of common stock exercisable within 60 days under
outstanding stock options.

 (6)
 Includes
 6,334 shares of common stock exercisable within 60 days under outstanding stock options.

 (7)
 Includes 6,334 shares of common stock exercisable within 60 days under
outstanding stock options and 885 shares of common stock exercisable within 60 days under outstanding warrants.

 (8)
 Includes 6,334 shares of common stock exercisable within 60 days under
outstanding stock options. Also includes shares of common stock held in a retirement plan trust of which Ira Ritter and his spouse are
trustees; and also includes shares beneficially owned by Stonehenge Partners. As a managing partner of Stonehenge Partners, Ira Ritter
may be deemed the beneficial owner of these shares.

 (9)
 Includes 207,503 shares of common stock exercisable within 60 days under
outstanding stock options and 18,391 shares of common stock exercisable within 60 days under outstanding warrants.

Compensation Plan Information

 The
following table presents information regarding securities authorized for issuance under equity compensation plans as of December 31,
2023:

 Plan Category

 Number of Securities
 to be Issued upon
 Exercise of
 Outstanding
 Options, Warrants and Rights

 Weighted-Average
 Exercise Price of Outstanding
 Options, Warrants and Rights

 Number of Securities
 Remaining Available
 for Future Issuance
 Under Equity
 Compensation Plans
 (excluding securities
 reflected in
 column (a))

 (a)

 (b)

 (c)

 Equity compensation plans approved by stockholders

 398,924

 $
 35.21

 356,791

 Equity compensation plans not approved by stockholders (1)

 119,046

 $
 10.35

 —

 Total

 517,970

 $
 29.50

 356,791

 (1)
 Consists
 of shares of common stock issuable upon the exercise of compensatory warrants granted to
 service providers.

 Item
13. Certain Relationships and Related Transactions, and Director Independence.

 Certain
Relationships and Related Party Transactions

 Our
Audit Committee is responsible for reviewing, approving and overseeing any transaction between the Company and its directors, director
nominees, executive officers, greater than 5% beneficial owners, and each of their respective immediate family members, where the amount
involved exceeds the lesser of (i) $120,000 and (ii) 1% of the average of our total assets at year-end for the prior two fiscal years.
Since January 1, 2021, there have been no such transactions except as described below.

 On
May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. ("NanoSynex") from Alpha a related party, in exchange for 350,000 reverse split adjusted shares of the Company's
common stock and a prefunded warrant to purchase 331,464 reverse split adjusted shares of the Company's common stock at an exercise
price of $0.001 per share. These warrants were subsequently exercised on September 13, 2022.

 On
December 21 and 22, 2022, we entered into a Securities Purchase Agreement with Alpha and in exchange for $3,000,000 in cash (less $50,000
for expense reimbursement) issued to Alpha the 2022 Debenture, plus 2,500,000 common stock warrants exercisable (from June 22, 2023 through
June 22, 2028) at $1.65 per share. Commencing June 1, 2023 and continuing on the first day of each month thereafter until the earlier
of (i) December 22, 2025 and (ii) the full redemption of the 2022 Debenture (each such date, a "Monthly Redemption Date"),
we must redeem $110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under the 2022 Debenture (the
"Monthly Redemption Amount"). The Monthly Redemption Amount must be paid in cash; provided that after the first two monthly
redemptions, we may (if the Equity Conditions, as defined in the 2022 Debenture, are then satisfied or have been waived) elect to pay
all or a portion of a Monthly Redemption Amount in shares of our common stock, based on a conversion price equal to the lesser of (i)
the then applicable conversion price of the 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined in the 2022 Debenture)
for the five consecutive trading days ending on the trading day that is immediately prior to the applicable Monthly Redemption Date.

 The
2022 Debenture accrues interest at the rate of 8% per annum, which began accruing on December 1, 2023, and will be payable on a quarterly
basis. Interest may be paid in cash or shares of common stock or a combination thereof at our option; provided that the Equity Conditions
have been satisfied.

 The
2022 Debenture is convertible into our common stock at any time at the holder's option; the conversion price was originally $1.32.

 Other
than the Monthly Redemption Amounts, the 2022 Debenture does not call for scheduled payments of principal before the scheduled maturity
date.

 Both
the 2022 Debenture and the accompanying warrants provide for "ratchet" antidilution adjustments to their conversion price
and exercise price.

 Both
the 2022 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon

 On
December 5, 2023, we and Alpha entered into an Amendment No. 1 with regard to Securities Purchase Agreement, under which the conversion
price of the 2022 Debenture and the exercise price of the associated warrants were reduced to $0.73 per share, in exchange for Alpha
permitting us to make certain Monthly Redemption Amount payments in the form of our stock rather than in cash even though the Equity
Conditions were not satisfied (which would otherwise have prevented payment in the form of stock). In addition, such Amendment revised
certain provisions of the 2,500,000 common stock warrants to (i) limit the circumstances which would trigger a potential adjustment to
the exercise price of the 2,500,000 common stock warrants and (ii) clarify the treatment of the 2,500,000 common stock warrants upon
a "Fundamental Transaction." (The purpose of these revisions was to remove the terms that caused the 2,500,000 common stock
warrants to be liability-classified under U.S. GAAP).

 The
new $0.73 per share conversion/exercise price triggered a "ratchet" antidilution adjustment in the Company's outstanding
"exploding" "Series C Warrants," resulting in such Series C Warrants becoming exercisable for 455,623 common
shares (at an exercise price of $0.73 per share), as opposed to the 251,971 common shares into which such outstanding Series C Warrants
would have been exercisable (at $1.32 per share) pre-adjustment. Finally, the $0.73 per share price triggered a "ratchet"
antidilution adjustment in the exercise price of other outstanding Company common stock warrants, including 7,084 warrants held by Alpha
and 67,620 warrants held by other persons, all of which were previously exercisable at $1.32 per share.

 In
February 26 and 27, 2024, we entered into a Securities Purchase Agreement with Alpha and in exchange for $500,000 in cash (less $25,000
for expense reimbursement) issued to Alpha an 8% Convertible Debenture with a face amount of $550,000 due on December 31, 2024 (the "2024
Debenture"), plus 900,016 5-year common stock warrants exercisable at $0.26 per share. In addition, per this Securities Purchase
Agreement Alpha obtained an option to purchase additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate
of $1,100,000 (and with a proportional number of accompanying common stock warrants of like tenor, up to a total of 1,800,032 additional
warrants), which would (if and when Alpha exercises such option) provide us up to an additional $1.0 million in cash proceeds (less expense
reimbursement, and not including any possible cash proceeds from any future exercise of the additional warrants). This option is valid through July 1, 2024.

 The
2024 Debenture has a maturity date of December 31, 2024 and is convertible, at any time, and from time to time, at Alpha's option,
into shares of our common stock, at $0.6111 per share. The 2024 Debenture does not call for scheduled payments of principal or interest
before the scheduled maturity date. Interest on the 2024 Debenture accrues on its outstanding principal balance at the rate of 8% per
annum.

 Both
the 2024 Debenture and the accompanying warrants provide for "ratchet" antidilution adjustments to their conversion price/exercise
price.

 Both
the 2024 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon

 We
granted Alpha "piggyback" registration rights for the common shares underlying the 2024 Debenture and the accompanying warrants.

 The
$0.26 exercise price of the warrants issued with the 2024 Debenture triggered a "ratchet" antidilution adjustment in the
2022 Debenture, resulting in the then current $1,198,922 principal amount thereof becoming convertible into 4,611,238 shares of Company
common stock (as opposed to the 1,642,359 shares into which such outstanding principal amount were convertible pre-adjustment). Also,
the $0.26 exercise price of the warrants issued with the 2024 Debenture triggered a "ratchet" antidilution adjustment in
the Company's outstanding "exploding" "Series C Warrants," resulting in such Series C Warrants becoming
exercisable for 1,279,261 common shares (at an exercise price of $0.26 per share), as opposed to the 455,623 common shares into which
such outstanding Series C Warrants would have been exercisable (at $0.73 per share) pre-adjustment. Finally, the $0.26 exercise price
of the warrant triggered a "ratchet" antidilution adjustment in the exercise price of other outstanding Company common stock
warrants, including 2,507,048 warrants held by Alpha and 67,620 warrants held by other persons, all of which were previously exercisable
at $0.73 per share.

 In
connection with her termination of employment, on June 20, 2023, Qualigen, Inc., a former wholly-owned subsidiary of the Company,
signed a separation agreement and general release (the "Separation Agreement") with Amy Broidrick, which became
effective on June 24, 2023.

 Under
the terms of the Separation Agreement, Qualigen, Inc. provided Ms. Broidrick with (i) $16,637 in cash compensation, less applicable withholdings
for federal and state income and employment taxes, which represented Ms. Broidrick's accrued but unpaid salary and vacation pay
through the Separation Date, and reimbursement of certain expenses incurred by Ms. Broidrick, (ii) severance in the form of continued
salary pay to Ms. Broidrick at the rate then in effect on the Separation Date ($360,000 per annum) for a period of 12 months following
the Separation Date, subject to applicable withholding, and (iii) payment or reimbursement for the cost of COBRA continuation medical
and dental insurance coverage for 12 months following the Separation Date, less any required taxes or withholdings. In addition, Ms.
Broidrick is entitled to any rights or benefits under Qualigen Inc.'s employee benefit plans, to the extent earned and vested,
and had three months from the Separation Date to exercise any vested stock options. Ms. Broidrick did not exercise any vested stock options.

Independence

 Under
Nasdaq's continued listing requirements, a majority of a listed company's board of directors must be comprised of independent
directors, subject to certain exceptions. In addition, Nasdaq's continued listing requirements require that, subject to certain
exceptions, each member of a listed company's audit, compensation and governance and nominating committees must be independent.
Audit Committee members must also satisfy the independence criteria set forth in Rule 10A-3 under the Exchange Act. Under Nasdaq's
continued listing requirements, a director will only qualify as an "independent director" if, in the opinion of that company's
board of directors, such person does not have a relationship that would interfere with the exercise of independent judgment in carrying
out the responsibilities of a director.

 Based
upon information requested from and provided by each director concerning their background, employment and affiliations, including family
relationships, our board of directors determined that each of Messrs. David, Emery, Korenberg, Kruger and Ritter are independent under
the applicable rules and regulations of Nasdaq. In making such determinations, the board of directors considered the relationships that
each such non-employee director has with our company and all other facts and circumstances the board of directors deemed relevant in
determining their independence.

 Item
14. Principal Accounting Fees and Services.

 Baker
Tilly US, LLP ("Baker Tilly") serves as the Company's independent registered public accounting firm and has served
in that capacity since June 2018.

 The
Audit Committee considered the independence of Baker Tilly and whether the audit services Baker Tilly provided to the Company are compatible
with maintaining that independence. The Audit Committee has adopted procedures by which the Audit Committee must approve in advance all
services provided by and fees paid to the Company's independent registered public accounting firm. The advance approval requirement
was not waived in any instance during 2023 or 2022.

 Fees
and Services of Baker Tilly US, LLP

 The
following table sets forth the aggregate fees billed to the Company by Baker Tilly for the years ended December 31, 2023 and 2022:

 2023

 2022

 Audit Fees(1)

 $
 495,955

 $
 411,362

 Audit-Related Fees

 —

 —

 Tax Fees (2)

 18,789

 35,050

 All Other Fees

 —

 —

 Total

 $
 514,744

 $
 446,412

 (1)
 Audit
 fees consisted of fees for audit work performed in the audit of financial statements, as
 well as fees for quarterly reviews and registration statements.

 (2)
 These
 fees were incurred for professional services rendered in connection with tax compliance,
 tax advice, and tax planning. These services included income tax compliance and related tax
 services.

 The
Audit Committee has adopted a formal policy on auditor independence requiring the advance approval by the Audit Committee of all audit
and non-audit services provided by our independent registered public accounting firm. In determining whether to approve any services
by our independent registered public accounting firm, the Audit Committee reviews the services and the estimated fees, and considers
whether approval of the proposed services will have a detrimental impact on the auditor's independence. On an annual basis, our
management reports to the Audit Committee all audit services performed during the previous 12 months and all fees billed by our independent
registered public accounting firm for such services.

 For
the years ended December 31, 2023 and 2022, all audit services and the corresponding fees were approved by our Audit Committee.

 PART
IV

 Item
15. Exhibits and Financial Statement Schedules

 (a)
The following documents are filed as part of this Annual Report:

 1. Financial
Statements. The following documents are included in Part II, Item 8 of this Annual Report and are incorporated by reference
herein:

 Page

 Report of Independent Registered Public Accounting Firm (PCAOB ID 23)

 Financial
 Statements:

 Consolidated Balance Sheets as of December 31, 2023 and December 31, 2022

 Consolidated Statements of Operations and Comprehensive Loss for the Year Ended December 31, 2023 and Year Ended December 31, 2022

 Consolidated Statements of Changes in Stockholders' Equity (Deficit) for the Year Ended December 31, 2023 and Year Ended December 31, 2022

 Consolidated Statements of Cash Flows for the Year Ended December 31, 2023 and Year Ended December 31, 2022

 Notes to Consolidated Financial Statements

 2.
 Financial Statement Schedules. Financial statement schedules have been omitted because they are not required or are not applicable,
or the required information is shown in the consolidated financial statements or notes thereto.

 3.
 Exhibits. See EXHIBIT INDEX

 EXHIBIT

 Exhibit
 No.

 Description

 Form

 File
 No.

 Exhibit

 Filing
 Date

 2.1

 Stock Purchase Agreement dated July 20, 2023 with Chembio Diagnostics, Inc., Biosynex, S.A. and Qualigen, Inc.

 2.1

 7/26/2023

 3.1

 Amended and Restated Certificate of Incorporation of Ritter Pharmaceuticals, Inc.

 3.1

 7/1/2015

 3.2

 Certificate of Amendment to the Amended and Restated Certificate of Incorporation

 3.1

 9/15/2017

 3.3

 Certificate of Amendment to the Amended and Restated Certificate of Incorporation

 3.1

 3/22/2018

 3.4

 Certificate of Designation of Preferences, Rights and Limitations of Series Alpha Preferred Stock of the Company, filed with the Delaware Secretary of State on May 29, 2020

 3.1

 3.5

 Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020 [reverse stock split]

 3.2

 3.6

 Certificate of Merger, filed with the Delaware Secretary of State on May 22, 2020

 3.3

 3.7

 Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020

 3.4

 3.8

 Amended and Restated Bylaws of the Company, as of August 10, 2021

 3.1

 8/13/2021

 3.9

 Certificate of Amendment to the Amended and Restated Certificate of Incorporation, filed with the Delaware Secretary of State on November 21, 2022

 3.1

 11/22/2022

 4.1

 Warrant, issued by the Company in favor of Alpha Capital Anstalt, dated May 22, 2020

 10.13

 4.2

 Form of Warrant, issued by the Company in favor of GreenBlock Capital LLC and its designees, dated May 22, 2020 [post-Merger]

 10.10

 4.3

 Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated July 10, 2020

 10.2

 7/10/2020

 4.4

 Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated August 4, 2020

 10.3

 8/4/2020

 4.5

 "Two-Year" Common Stock Purchase Warrant for 1,348,314 shares in favor of Alpha Capital Anstalt, dated December 18, 2020

 10.3

 12/18/2020

 4.6

 "Deferred" Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated December 18, 2020

 10.4

 12/18/2020

 4.7

 Form of liability classified Warrant to Purchase Common Stock

 4.13

 3/31/2021

 4.8

 Form of "service provider" compensatory equity classified Warrant

 4.14

 3/31/2021

 4.9

 Description of Common Stock

 10-K/A

 4.9

 7/7/2023

 4.10

 Amended and Restated Common Stock Purchase Warrant to GreenBlock Capital LLC, dated April 25, 2022

 4.15

 5/13/2022

 4.11

 Amended and Restated Common Stock Purchase Warrant to Christopher Nelson, dated April 25, 2022

 4.16

 5/13/2022

 4.12

 Common Stock Purchase Warrant for 2,500,000 shares in favor of Alpha Capital Anstalt, dated December 22, 2022

 4.1

 12/22/2022

 10.1+

 Executive Employment Agreement, by and between Qualigen, Inc. and Michael Poirier, dated as of February 1, 2017 and as amended on January 9, 2018

 10.1

 10.2+

 Executive Employment Agreement, by and between Qualigen, Inc. and Christopher Lotz, dated as of February 1, 2017 and as amended on January 9, 2018

 10.2

 10.4+

 2020 Stock Equity Incentive Plan

 10.20

 10.5+

 Standard template of Stock Option Agreement for use under 2020 Stock Incentive Plan

 10.1

 6/11/2020

 10.10

 Exclusive License Agreement (RAS) between the Company and University of Louisville Research Foundation, Inc., dated as of July 17, 2020

 10.4

 8/4/2020

 10.11

 Amendment 1 to the Exclusive License Agreement (RAS), by and between Qualigen, Inc. and University of Louisville Research Foundation, Inc., dated March 16, 2021

 10.11

 10.15

 Novation Agreement (RAS) among the Company, Qualigen, Inc. and University of Louisville Research Foundation, Inc. dated January 30, 2021

 10.1

 5/14/2021

 10.17+

 Hire offer letter from the Company to Tariq Arshad, dated April 22, 2021

 10.1

 8/16/2021

 10.20

 License Agreement with UCL Business Limited dated January 12, 2022

 10.55

 3/31/2022

 10.21

 First Deed of Variation to License Agreement with UCL Business Limited dated March 30, 2022

 10.21

 10.22

 Series B Preferred Share Purchase Agreement between the Company and NanoSynex Ltd. dated April 29, 2022

 10.1

 5/13/2022

 10.23

 Share Purchase Agreement between the Company and Alpha Capital Anstalt dated April 29, 2022

 10.2

 5/13/2022

 10.24

 Master Agreement for the Operational and Technological Funding of NanoSynex between Qualigen Therapeutics, Inc. and NanoSynex Ltd., dated May 26, 2022

 10.1

 6/2/2022

 10.25+

 Qualigen Therapeutics, Inc. 2022 Employee Stock Purchase Plan

 10.1

 11/14/2022

 10.26+

 Amendment No. 2 to the 2020 Stock Incentive Plan of Qualigen Therapeutics, Inc.

 10.1

 11/22/2022

 10.27+

 Amendment No. 1 to the 2022 Employee Stock Purchase Plan of Qualigen Therapeutics, Inc.

 10.2

 11/22/2022

 10.28

 Securities Purchase Agreement, dated December 21, 2022, by and between Qualigen Therapeutics, Inc. and Alpha Capital Anstalt

 10.1

 12/22/2022

 10.29

 8% Senior Convertible Debenture Due December 22, 2025 in favor of Alpha Capital Anstalt

 10.2

 12/22/2022

 10.30

 Registration Rights Agreement, dated December 22, 2022, by and between Qualigen Therapeutics, Inc. and Alpha Capital Anstalt

 10.3

 12/22/2022

 10.31+

 Letter to Michael Poirier, dated January 13, 2023, regarding compensatory changes

 10.31

 10.32+

 Letter to Amy Broidrick, dated January 13, 2023, regarding compensatory changes

 10.32

 10.33+

 Letter to Tariq Arshad, dated January 13, 2023, regarding compensatory changes

 10.33

 10.34

 Amendment No. 1 with regard to Securities Purchase Agreement dated December 5, 2023 with Alpha Capital Anstalt

 10.1

 12/7/2023

 10.35

 Amendment and Settlement Agreement dated July 19, 2023 with NanoSynex, Ltd.

 10.1

 7/26/2023

 10.36+

 Separation Agreement and General Release dated June 20, 2023 with Amy Broidrick

 10.1

 8/14/2023

 14.1

 Code of Business Conduct and Ethics

 14.1

 21.1*

 Subsidiaries of the Registrant

 23.1*

 Consent of Baker Tilly US, LLP, independent registered public accounting firm

 24.1

 Power of Attorney (included on signature page)

 31.1

 Certificate of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 31.2

 Certificate of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 32.1

 Certificate of principal executive officer and principal financial officer pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 97.1*

 Clawback Policy

 101.INS#

 101.SCH#

 101.CAL#

 101.DEF#

 101.LAB#

 101.PRE#

 Cover

 *
Filed or furnished herewith.

 **
Schedules have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedules will be furnished to the SEC
upon request.

 +
Indicates management contract or compensatory plan or arrangement.

 #
or Prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of section 18 of the
Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections.

 Item
16. Form 10-K Summary

 Not
applicable.

 SIGNATURES

 Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Annual Report
to be signed on its behalf by the undersigned, thereunto duly authorized.

 Qualigen
 Therapeutics, Inc.

 By:

 /s/
 Michael S. Poirier

 Name:

 Michael
 S. Poirier

 Title:

 Chief
 Executive Officer (Principal Executive Officer)

 Date:

 By:

 /s/
 Christopher L. Lotz

 Name:

 Christopher
 L. Lotz

 Title:

 Vice
 President of Finance, Chief Financial Officer (Principal Financial Officer and Chief Accounting Officer)

 Date:

 POWER
OF ATTORNEY

 KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Michael S. Poirier and
Christopher L. Lotz, and each of them individually, his true and lawful attorneys-in-fact and agents, with full power of substitution
and resubstitution, for him and in his name, place, and stead, in any and all capacities, to sign any and all amendments to this Annual
Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every
act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do
in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or his substitute or substitutes,
may lawfully do or cause to be done by virtue hereof.

 Pursuant
to the requirements of the Securities Exchange Act of 1934, this Annual Report has been signed below by the following persons on behalf
of the Registrant and in the capacities and on the dates indicated.

 Signature

 Title

 Date

 /s/
 Michael S. Poirier

 Chairman
 of the Board, Chief Executive Officer

 Michael
 S. Poirier

 (Principal
 Executive Officer)

 /s/
 Christopher L. Lotz

 Vice
 President of Finance, Chief Financial Officer

 Christopher
 L. Lotz

 (Principal
 Financial and Accounting Officer)

 /s/
 Richard A. David

 Richard
 A. David

 /s/
 Sidney W. Emery, Jr.

 Sidney
 W. Emery, Jr.

 /s/
 Matthew E. Korenberg

 Matthew
 E. Korenberg

 /s/
 Kurt H. Kruger

 Kurt
 H. Kruger

 /s/
 Ira E. Ritter

 Ira
 E. Ritter