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 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

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

 For
the transition period from ________to_________

 Commission
file number 001-31361

 MIRA
Pharmaceuticals, Inc.

 (Exact
name of registrant as specified in its charter)

 Florida

 85-3354547

 (State
 or other jurisdiction of

 incorporation
 or organization)

 (I.R.S.
 Employer

 Identification
 No.)

 1200
 Brickell Avenue, Suite 1950 #1183, Miami, Florida

 33131

 (Address
 of principal executive offices)

 (Zip
 Code)

 Registrant's
telephone number, including area code: 786 - 432-9792

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

 Title
 of each class

 Trading
 Symbol(s)

 Name
 of exchange on which registered

 Common
 stock, par value $0.0001

 MIRA

 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 an emerging growth company. See definition 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
in the filing reflect the correction of an error to previously issued financial statements.

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

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

 The
aggregate market value of the voting and non-voting common equity held by non-affiliates as of June 30, 2023, was $ 0 based on the closing
sale price of the company's common stock on such date of $0.00 per share, as reported by the NASDAQ Capital Market.

 As
of March 28, 2024, there were 14,780,885 shares of common stock, par value $0.0001, issued and outstanding.

 Mira
Pharmaceuticals, Inc.

 Annual
Report on Form 10-K

 For
the fiscal year ended December 31, 2023

 TABLE
OF CONTENTS

 Cautionary Note Regarding Forward-Looking Statements

 Item
 1.

 Description of Business

 Item
 1A.

 Risk Factors

 Item
 1B.

 Unresolved Staff Comments

 Item
 1C.

 Cyber Disclosure

 Item
 2.

 Description of Property

 Item
 3.

 Legal Proceedings

 Item
 4.

 Mine Safety Disclosure

 Item
 5.

 Market for Common Equity and Related Stockholder Matters

 Item
 6.

 Reserved

 Item
 7.

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

 Item
 7A.

 Quantitative and Qualitative Disclosures About Market Risk

 Item
 8.

 Financial Statements

 Item
 9.

 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
 10.

 Directors, Executive Officers and Corporate Governance

 Item
 11.

 Executive Compensation

 Item

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

 Item
 13.

 Certain Relationships and Related Transactions, and Director Independence

 Item
 14.

 Principal Accountant Fees and Services

 Item
 15.

 Exhibits, Financial Statement Schedules

 Item
 16.

 Form 10-K Summary

 Signatures

 Unless
we have indicated otherwise, or the context otherwise requires, references in this Report to "MIRA," the "Company,"
"we," "us" and "our" or similar terms refer to Mira Pharmaceuticals, Inc., a Florida corporation.

 From
time to time, we may use our website, our Facebook page at
our Twitter at  and on our Linked In account at www.linkedin.com/company/mira-pharmaceuticals-inc to distribute
material information. Our financial and other material information is routinely posted to and accessible on the Investors section of
our website, available at www.mirapharmaceuticals.com. Investors are encouraged to review the Investors section of our website because
we may post material information on that site that is not otherwise disseminated by us. However, information that is contained in and
can be accessed through our website, our Facebook page, our Twitter posts and our Linked In posts are not incorporated into, and does
not form a part of, this Annual Report.

 i

 CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS

 This
Annual Report on Form 10-K (this "Report") contains forward-looking statements (as defined in Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act) that reflect our
current expectations and views of future events. In some cases, you can identify forward-looking statements by terms such as "may,"
"will," "should," "expect," "plan," "anticipate," "could," "intend,"
"target," "project," "contemplate," "believe," "estimate," "predict,"
"potential", or "continue" or the negative of these terms or other similar expressions. In particular, statements
about our pre-clinical and clinical trials and expectations regarding such trials, the markets in which we operate, including growth
of such markets, and our expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance
contained in this Report generally under the headings "Risk Factors," "Management's Discussion and Analysis of
Financial Condition and Results of Operations" and "Business" are forward-looking statements.

 We
have based these forward-looking statements on our current expectations, assumptions, estimates and projections. While we believe these
expectations, assumptions, estimates, and projections are reasonable, such forward-looking statements are only predictions and involve
known and unknown risks and uncertainties, many of which are beyond our control. These and other important factors, including those discussed
in this Report under the headings "Risk Factors," "Management's Discussion and Analysis of Financial Condition
and Results of Operations" and "Business," may cause our actual results, performance, or achievements to differ materially
from any future results, performance or achievements expressed or implied by these forward-looking statements, or could affect our share
price. Important factors that could cause actual results or events to differ materially from those expressed in forward-looking statements
include, but are not limited to, the following:

 our
 ability to obtain and maintain regulatory approval of our product candidates;

 our
 ability to successfully commercialize and market our product candidates, if approved;

 our
 ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately;

 the
 potential market size, opportunity, and growth potential for our product candidates, if approved;

 our
 ability to obtain additional funding for our operations and development activities;

 the
 accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;

 the
 initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs;

 the
 timing of anticipated regulatory filings;

 the
 timing of availability of data from our clinical trials;

 our
 future expenses, capital requirements, need for additional financing, and the period over which we believe that our existing cash
 and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements;

 our
 ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;

 our
 ability to advance product candidates into, and successfully complete, clinical trials;

 our
 ability to recruit and enroll suitable patients in our clinical trials;

 the
 timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives;

 the
 pricing and reimbursement of our product candidates, if approved;

 the
 rate and degree of market acceptance of our product candidates, if approved;

 the
 implementation of our business model and strategic plans for our business, product candidates, and technology;

 the
 scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

 developments
 relating to our competitors and our industry;

 the
 development of major public health concerns and the future impact of such concerns on our clinical trials, business operations and
 funding requirements; and

 other
 risks and factors listed under "Risk Factors" and elsewhere in this Report.

 Given
the risks and uncertainties set forth in this Report, you are cautioned not to place undue reliance on such forward-looking statements.
The forward-looking statements contained in this Report are not guarantees of future performance and 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 Report. In addition, even if our results of operations, financial condition and liquidity, and events in
the industry in which we operate, are consistent with the forward-looking statements contained in this Report, they may not be predictive
of results or developments in future periods.

 Any
forward-looking statement that we make in this Report speaks only as of the date of such statement. Except as required by federal securities
laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the forward-looking
statements, whether as a result of new information, future events or otherwise, after the date of this Report.

 Summary
of Principal Risks

 Our
business is subject to numerous risks and uncertainties that represent challenges that we face in connection with the implementation
of our strategy and the growth of our business. In particular, the following are the principal risks which could cause a decline in the
price of shares of our common stock:

 We
 are a development-stage, pre-clinical biotechnology company that has no revenues and has incurred losses since our inception. We
 expect to incur losses for the foreseeable future and may never be able to generate revenues or achieve or maintain profitability.

 Our
 limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future
 viability.

 Our
 losses from operations and negative cash flows of December 31, 2023 raise substantial doubt about our ability to continue as a going
 concern absent obtaining adequate new debt or equity financings.

 The
 report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2023
 contains an explanatory paragraph relating to our ability to continue as a going concern.

 We
 are dependent on the success of our product candidates, some of which may not receive regulatory approval or be successfully commercialized.

 We
 will need additional funds to complete the further development of our business plan, and there is no assurance that additional financing
 will be available or will be available on terms acceptable to us.

 of our executive officers will not be employed by us on a full-time basis.

 We
 face risks related to health, pandemics, epidemics, and outbreaks could significantly disrupt our pre-clinical studies and clinical
 trials, commercialization efforts, supply chain, regulatory and clinical development activities, and other business operations, in
 addition to the impact of a global economic slowdown.

 Results
 of pre-clinical studies and future early clinical trials are not necessarily predictive indicators of future results.

 We
 may fail to expand our anticipated outsourced manufacturing capability in time to meet market demand for our products and product
 candidates, and the FDA may refuse to accept the facilities of our contract manufacturers as being suitable to produce our products
 and product candidates. Any problems in our manufacturing process could have a material adverse effect on our business, results of
 operations and financial condition

 Our
 future success will largely depend on the success of our product candidates, which development will require significant capital resources
 and years of clinical development effort

 There
 is a high rate of failure for drug candidates proceeding through clinical trials

 We
 rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates. If these third parties
 do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not
 be able to obtain marketing approval for or commercialize our product candidates, and our business could be substantially harmed

 We
 rely on third parties to manufacture our clinical product supplies, and we intend to rely on third parties for at least a portion
 of the manufacturing process of our product candidates, if approved. Our business could be harmed if those third parties fail to
 provide us with sufficient quantities of product or fail to do so at acceptable quality levels or prices or fail to maintain or achieve
 satisfactory regulatory compliance

 Even
 if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians,
 patients, third-party payors, and others in the medical community necessary for commercial success

 If
 we are unable to obtain and maintain intellectual property protection for our technology and products, or if the scope of the intellectual
 property protection obtained is not sufficiently broad, our competitors could commercialize technology and products similar or identical
 to ours, and our ability to successfully commercialize our technology and products may be impaired

 recent initial public offerings of companies with relatively small public floats comparable to our anticipated public float have
 experienced extreme volatility that was seemingly unrelated to the underlying performance of the respective company, and our securities
 may potentially experience rapid and substantial price volatility, which may make it difficult for prospective investors to assess
 the value of our securities

 PART
I

 ITEM
1. Description of Business

 Overview

 We
are a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and
neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada and Mexico for Ketamir-2, a novel,
patent pending oral ketamine analog under pre-clinical investigation to potentially deliver ultra-rapid antidepressant effects,
providing hope for individuals battling treatment-resistant depression (or TRD), major depressive disorder with suicidal ideation
(or MDSI) and potentially post-traumatic stress disorder (or PTSD).

our novel oral pharmaceutical marijuana molecule, MIRA-55, is being studied for its potential to alleviate neuropathic pain, as well as anxiety and cognitive decline, symptoms
commonly associated with early-stage dementia.
MIRA-55, if approved by the U.S. Food and Drug Administration (or FDA), could mark a significant advancement in addressing various
neuropsychiatric, inflammatory, and neurologic diseases and disorders.

 The
U.S. Drug Enforcement Administration (DEA)'s scientific review of Ketamir-2 concluded that it would not be considered a controlled
substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations. Additionally, we have submitted
the required paperwork for MIRA-55 to be evaluated by the DEA.

 We
were incorporated under the laws of the State of Florida in September 2020 and commenced substantive operations, including our pharmaceutical
development program, in late 2020.

 Our
Product Candidates in Development

 KETAMIR-2

 Major
Depressive Disorder (or MDD) is a significant global health concern, affecting over 264 million people worldwide and ranking among the
leading causes of disability according to the World Health Organization. In the United States alone, it impacts nearly 21.1 million adults,
accounting for about 8.3 % of the adult population in 2-2021 according to data form the National Institutes of Health. This widespread
mental health disorder not only undermines the quality of life and daily functioning of individuals but also imposes a substantial economic
burden, with costs in the U.S. amounting to tens of billions of dollars annually. MDD is also a major risk factor for suicide, a leading
cause of death globally, highlighting its profound impact on public health and the urgent need for effective treatment and management
strategies. If approved by the FDA, Ketamir-2 may potentially provide antidepressant therapeutic effects.

 Despite
the fact that antidepressants have been on the market for decades, with imipramine being the first FDA-approved antidepressant in 1959,
the need for a rapid-acting antidepressant that can help patients with Treatment-Resistant Depression (or TRD) using a novel mechanism
of action (e.g. not a monoamine reuptake inhibitor) has been growing. In 2019, ketamine was introduced but required by the FDA to utilize
a Risk Evaluation and Mitigation Strategy (REMS) because of its: (1) poor oral availability requiring intravenous (or IV) or intranasal
(or IN) administration, (2) ability to cause side effects including dissociation, sedation and acute hypertension, and (3) potential
abuse liability.

is a new chemical entity, an analog of ketamine that is designed to potentially preserve the same rapid antidepressant response but with
improved bioavailability. It may also have decreased side effects, and decreased abuse liability, though such conclusions are within
the sole authority of the FDA. This combination is intended to potentially facilitate safer and less cumbersome dosing requirements,
with the goal of obtaining an orally administered pill that can be taken at home.

Chemical structures of ketamine and Ketamir-2 for comparison purposes.

 The
DEA conducted a scientific review of the Ketamir-2 in 2023 in accordance with the definitions within the CSA and its implementing regulations.
Based on this review, DEA determined that" Ketamir-2 is "not a controlled substances or listed chemical under the CSA."

 Mechanism
of Action of Ketamir-2

 Ketamir-2's
mechanism of action (or MOA) as a rapid acting antidepressant is the same as ketamine's, based on the fact that the two share a
common inhibitory effect on the N-methyl-D-aspartate (or NMDA) receptor, a type of glutamate receptor that is believed to be integral
to the antidepressant effects of both of these ketamine and Ketamir-2. In fact, Ketamir-2 and ketamine differ in less than 2% in their
antagonist activity at the GRIN1/GRIN2B receptor subunit of the NMDA receptor (based in in silico analysis, see below). This subunit
combination is prominently linked to neuroplasticity, believed to be a key factor in depression and the action of antidepressants such
as ketamine. GRIN2B-containing NMDA receptors are implicated in synaptic plasticity changes associated with depression and its treatment.

 Ketamine's
mechanism of action (or MOA) as a rapidly acting antidepressant is multifaceted and distinct from traditional antidepressants like selective
serotonin reuptake inhibitors (or SSRIs) and tricyclic antidepressants. While ketamine has shown promise as a rapid-acting antidepressant,
especially in treatment-resistant depression, its use is limited due to potential side effects and abuse potential that Ketamir-2 has
been targeted to minimize. Moreover, whereas ketamine has a poor oral bioavailability and must therefore be given IV or IN, Ketamir-2
has a much better bioavailability suggesting it may be appropriate for oral use.

 The
following is a detailed synopsis of the MOAs of both Ketamir-2 and ketamine:

 1.

 NMDA
 Receptor Antagonism: Ketamine primarily acts as a non-competitive antagonist of the NMDA. By inhibiting these receptors, ketamine
 modulates the release of the neurotransmitter glutamate. This modulation leads to an increase in glutamatergic signaling via activation
 of AMPA receptors, another type of glutamate receptor. This enhanced signaling is believed to play a crucial role in ketamine's
 rapid antidepressant effects.

 2.

 mTOR
 Pathway Activation: Ketamine activates the mammalian target of rapamycin (or mTOR) pathway, a key regulator of cell growth and
 survival. This activation is linked to increased synaptogenesis in the prefrontal cortex. The mTOR pathway plays a significant role
 in neural plasticity and has been implicated in the pathophysiology of depression.

 3.

 Effects
 on GABAergic System: Recent research indicates that ketamine may also affect the gamma-aminobutyric acid (GABAergic) system,
 which is responsible for inhibitory neurotransmission in the brain. Alterations in GABAergic signaling have been associated with
 mood disorders.

 4.

 BDNF
 Release and Synaptogenesis: The increased glutamatergic transmission leads to the activation of downstream pathways that result
 in the release of Brain-Derived Neurotrophic Factor (BDNF). BDNF is crucial for neuroplasticity – the brain's ability
 to reorganize and form new neural connections. Studies suggest that this increase in BDNF and subsequent synaptogenesis (formation
 of new synapses) in brain areas like the prefrontal cortex is a key factor in the antidepressant effects of ketamine.

 5.

 Anti-inflammatory
 Effects: Depression is increasingly linked with chronic inflammation. Ketamine has been shown to have anti-inflammatory properties,
 which might contribute to its antidepressant effects.

 6.

 Neuroendocrine
 Regulation: Ketamine may influence the hypothalamic-pituitary-adrenal (HPA) axis, which is often dysregulated in depression.
 By modulating this axis, ketamine could exert additional antidepressant effects.

 7.

 Rapid
 Onset of Action: Unlike traditional antidepressants, which typically take weeks to exert their effects, ketamine's impact
 on mood can be noticed within hours of administration. This rapid action is especially beneficial in acute management of severe depression
 and suicidal ideation.

 In
summary, while Ketamir-2's and ketamine's antidepressant MOA are still being studied and explored, current evidence suggests
a complex and involved synergistic action on various neural pathways, primarily through the modulation of glutamatergic neurotransmission,
enhancement of neuroplasticity, and potentially through anti-inflammatory and neuroendocrine mechanisms. Both drugs rapid onset and efficacy
in treatment-resistant cases make them potentially valuable tools in psychiatry, but the potentially improved side effect profile and
oral bioavailability are what differentiate Ketamir-2 and ketamine as described below.

Clinical Development Program

 The
clinical development plan for Ketamir-2 involves a series of methodically structured phases, starting with IND-enabling studies and progressing
through Phase 1 and Phase 2 clinical trials. These trials aim to establish the safety, efficacy, and optimal use of Ketamir-2 in treating
psychiatric conditions like TRD, Major Depressive Disorder with Suicidal Ideation (MDSI), and potentially PTSD. The strategy underscores
patient safety while evaluating Ketamir-2's therapeutic benefits and risks. The successful development of Ketamir-2 could significantly
impact the treatment landscape for depression, offering a novel approach that addresses the shortcomings of current therapies.

 Initially,
the development process begins with completion of all necessary IND-enabling studies. These preclinical studies, encompassing
pharmacokinetics, pharmacodynamics, toxicology, and safety pharmacology, are crucial for ensuring that the investigational drug
meets regulatory standards. The successful completion of these studies allows for the submission of an Investigational New Drug
(IND) application to the FDA, specifically targeting TRD. We anticipate that we will submit our IND for Ketamir-2 by the end of
2024. See the section below titled " Research and Testing to Date – Ketamir-2 " for more
information.

 Upon
FDA acceptance of our Ketamir-2 IND, our plan progresses to Phase 1 clinical trials. These trials are designed to assess the safety and
tolerability of Ketamir-2 in healthy volunteers. They are typically randomized, double-blind, and placebo-controlled, and aim to determine
the appropriate dosing while closely monitoring for adverse effects. Key to this phase is the collection of pharmacokinetic and pharmacodynamic
data, which guides the dosing strategies for subsequent trials.

 Phase
1: Safety and Dosage Determination in Healthy Volunteers

 1.

 Study
 Design:

 A
 randomized, double-blind, placebo-controlled trial.

 Primary
 objective: Assess safety and tolerability of Ketamir-2.

 Secondary
 objectives: Determine pharmacokinetics and pharmacodynamics.

 2.

 Participant
 Selection:

 Enroll
 healthy volunteers, ensuring a diverse demographic representation.

 Exclude
 individuals with a history of psychiatric illness, substance abuse, or significant medical conditions.

 3.

 Dosing
 and Administration:

 Start
 with a low dose, escalating gradually to higher doses.

 Monitor
 participants closely for adverse effects.

 4.

 Outcome
 Measures:

 Safety
 assessments: Vital signs, laboratory tests, ECG, adverse event monitoring.

 PK/PD
 assessments: Blood sampling for drug levels, brain imaging for receptor binding (if feasible).

 Following
the establishment of safety and initial dosing parameters in Phase 1, the development plan moves into Phase 2. This phase involves trials
with patients diagnosed with TRD. The primary goal here is to evaluate the optimal dose and tolerability of Ketamir-2 in this specific
patient population. Additionally, these trials provide preliminary data on the efficacy of Ketamir-2 for the treatment of TRD. Safety
remains a priority, with close monitoring for any adverse events and detailed assessments using depression rating scales.

 Phase
2: Dose, Tolerability, and Early Efficacy in TRD

 1.

 Study
 Design:

 A
 randomized, controlled trial with TRD patients.

 Primary
 objective: Evaluate the optimal dose and tolerability.

 Secondary
 objective: Obtain preliminary efficacy data.

 2.

 Participant
 Selection:

 Enroll
 patients diagnosed with TRD.

 Utilize
 standardized diagnostic criteria and severity scales.

 3.

 Dosing
 Regimen:

 Implement
 a dose range based on Phase 1 findings.

 Consider
 flexible dosing or fixed-dose regimen based on safety and tolerability data.

 4.

 Outcome
 Measures:

 Tolerability
 assessment: Adverse event monitoring, patient-reported outcomes.

 Efficacy
 assessment: Depression rating scales (e.g., HDRS, MADRS).

 As
the development of Ketamir-2 progresses, there is potential to expand its indications. One such area is MDSI, where Ketamir-2's
application could be particularly beneficial given ketamine's established efficacy in this domain. This would involve designing
a trial specifically targeting MDSI, with a focus on the rapid onset of action and short-term safety considerations.

 Furthermore,
given the emerging research suggesting ketamine's therapeutic potential in PTSD, a similar approach could be considered for Ketamir-2.
Developing a trial protocol for PTSD treatment requires a careful balance, considering the complexity of the disorder, potential comorbidities,
and the need for robust safety and efficacy data.

 Pursuing
Additional INDs:

 1.

 Major
 Depressive Disorder with Suicidal Ideation (MDSI):

 Following
 successful Phase 2 outcomes, pursue an IND for MDSI, leveraging existing data and research on ketamine.

 Design
 a trial specifically targeting MDSI, focusing on rapid onset of action and short-term safety.

 2.

 Post-Traumatic
 Stress Disorder (PTSD):

 Based
 on early research suggesting ketamine's efficacy in PTSD, consider developing a clinical trial protocol for Ketamir-2 in PTSD.

 Prioritize
 safety and efficacy, given the complex nature of PTSD and potential comorbidities.

 In
summary, the clinical development plan for Ketamir-2 is a meticulous, multi-phase strategy that prioritizes patient safety while exploring
the drug's potential in treating complex psychiatric conditions. Each phase is carefully designed to address specific research
questions and regulatory requirements, ensuring a thorough evaluation of Ketamir-2's therapeutic benefits and risks.

 Manufacture
of Product for Pre-Clinical and Clinical Development Activities

 Recipharm
Israel LTD, a leading global contract development and manufacturing organization (or CMDO), is currently developing a large-scale
synthesis protocol for us and will be supplying quantities of Ketamir-2 and MIRA-55 needed for our pre-clinical and clinical
development activities. We previously utilized Curia Global as our CMDO and are currently in discussions with other partners to have
Ketamir-2 and MIRA-55 formulated into solid oral dosage forms for clinical trials.

 We also utilize Frontage Laboratories and Pharmaseed LTD to conduct preclinical
studies on Ketamir-2.

 MIRA1A

 In
early February 2024, we made a significant discovery during the manufacturing and scale-up process of our patented molecule known as
"MIRA1a," which we believed was the molecule used in our pre-clinical trials and had been synthesized by contract manufacturer.
Through this process, we identified a novel and improved version of the molecule, which we call MIRA-55.

 As
part of our due diligence and subsequent testing, which began in late 2023, we discovered that the pre-clinical studies we conducted,
previously attributed to MIRA1a, were in fact performed on MIRA-55. Following this revelation, in early March 2024, we promptly filed
a provisional patent for MIRA-55, which encompasses all pre-clinical studies disclosed in our two registration statements on Form S-1,
declared effective on August 2, 2023, and December 27, 2023 (File Nos. 333-273024 and 333-276118, respectively). If such patent is issued,
we would own the patent rights to both MIRA1a and MIRA-55.

based on our pre-clinical analyses to date, we believe that MIRA-55 is an improvement over MIRA1a in that it displays enhanced potency
and potential for efficacy.

 Based on our discoveries to date, we decided to advance MIRA-55 as our
lead compound for our oral pharmaceutical marijuana drug candidate while still retaining our rights to MIRA1a. As such, we do not intend
to move MIRA1a forward as of the date of this Report.

 Our
objective is to develop and commercialize new treatment options for neuropsychiatric, inflammatory, and neurologic diseases and disorders.
Cannabinoids are a class of chemical compounds that are naturally occurring and are primarily found in cannabis plant extracts. The two
major cannabinoids found in cannabis plant extracts include tetrahydrocannabinol, a compound that is the main psychoactive ingredient
of cannabis (or THC) and cannabidiol, the second most prevalent active ingredient in cannabis which does not have psychoactive properties
(or CBD). These compounds bind to CB1 and CB2 cannabinoid receptors, which are found throughout the body. Specifically, CB1 receptors
are concentrated in the central nervous system (or CNS), while CB2 receptors are found mostly in peripheral organs and are associated
with the immune system. When the chemical compounds bind to these cannabinoid receptors, the process elicits certain physiological responses.
Physiological responses to cannabinoids may vary among individuals. Some of the effects of cannabinoids have been shown to impact nervous
system functions, immune responses, muscular motor functions, gastrointestinal maintenance, blood sugar management, and the integrity
of ocular functions. Based on pre-clinical testing, our product candidate, MIRA-55, appears to have a strong selectivity for CB2 versus
CB1, and is designed to minimize the risk of psychoactive adverse events associated with CB1 activation.

 Mechanism
of Action of MIRA-55

 We
believe that the effects of MIRA-55 at the cannabinoid receptors CB1 and CB2 is predicted to account for the majority of its
potential therapeutic effects, especially as it relates to its anti-anxiety, anti-pain and anti-inflammatory properties. For
example, the difference in the dose-response effects of MIRA-55 compared with THC on CB1 receptors appears to coincide with its
improved therapeutic profile. If approved by the FDA, MIRA-55 may potentially provide therapeutic effects and enhanced cognition for
anxiety, pain and inflammation.

 THC
has been demonstrated to have biphasic physiological effects (meaning effects in two phases), which have been described for over 40 years:
at low levels THC has positive effects while high doses cause the opposite, undesirable symptoms. Examples of biphasic effects at low
versus high levels of THC include the anti-anxiety versus pro-anxiety effects, respectively. Through pre-clinical test, we obtained the
following dose-response effects for MIRA-55 and THC at the CB1 receptor (see below). In contrast to THC, which displays an initial maximally
stimulatory and then inhibitory response at CB1, MIRA-55 appears to act as a monophasic partial agonist (meaning it has a lower intrinsic
activity than full agonists) in that it creates a stimulation throughout its dose range, achieving a moderate activation of the CB1 even
at high doses. We believe that this accounts for the potential broad therapeutic efficacy of MIRA-55 and the observed absence of negative
symptoms even at maximal doses of the drug.

 Compound activity with the selected GPCR Biosensor Assays: THC vs MIRA-55 agonist activity at the CB1 Receptor.

 In
pharmacology, "efficacy" or "Emax" refers to the maximum response that can be achieved with a drug or agent.
It represents the extent or magnitude of the response produced by the drug once it has bound to its target, typically referred to as
a receptor. The binding between a drug and its receptor is characterized by affinity, which quantifies the strength of their interaction.
Efficacy, however, assesses the action or effect of the drug following binding to the receptor.

 The
dose-response curve is a commonly used graph in pharmacology that depicts the relationship between the effect of a drug and its dosage.
The X-axis represents the increasing doses of the drug, while the Y-axis represents the response produced by the drug. In the case of
the figure above, the term "% Efficacy" on the Y-axis refers to the maximum response that can be achieved with the agonist
(MIRA-55 or THC) in relation to its ability to activate GPCR receptors (specifically CB1 receptors). GPCRs are G-protein-coupled receptors
that form a large group of proteins which are expressed on the cell surface of eukaryotic cells to detect molecules outside the cell
and activate cellular response.

 The
data presented in the figure above has been normalized to the maximal and minimal responses observed in the presence of a control compound
and vehicle, respectively. This normalization allows for a standardized comparison of the agonist's efficacy.

Pre-clinical Developments and Studies

 As
of the date of this Report, we completed several pre-clinical studies of MIRA-55, including, but not limited to, radio-ligand binding
assay, elevated plus maze (or EPM) model of anxiety and hot plate model thermal sensitivity testing.

 We
have studied the effects of acute administration of MIRA-55 on anxiety-related phenotypes in mice to model human conditions. An intraperitoneal
injection of Placebo [PBO] (e.g. saline) or MIRA-55 (e.g. 50mg/kg = Treatment) was administered to C57Bl/6 mice (n=5/group) that were
8-12 weeks old. Thirty minutes following injection, mice were tested in anxiety related measures using the Elevated Plus Maze (EPM).
The EPM is a widely used pre-clinical behavioral assay for rodents and it has been validated to assess the anti-anxiety effects of pharmacological
agents. If determined and approved by the FDA or other regulatory agencies, MIRA-55 appears to have anti-anxiety effects at doses that
lacked side effects of sedation or intoxication in mice. The EPM is a test measuring anxiety in rodents as a screening test for putative
anxiolytic compounds and as a general research tool in neurobiological anxiety research such as Generalized Anxiety Disorder (or GAD)
or Post-Traumatic Stress Disorder (or PTSD). The model is based on the animal's aversion to open spaces which are present in the
open arms (Open Arm) of the maze. Anti-anxiety effects of test agents are demonstrated by an increase in the percentage of time spent
in the Open Arm with treatment compared to placebo. The total distance traveled is a measure of the overall level of arousal and mobility
of the mice undergoing testing on the EPM and is used to rule out any sedating or intoxicating effects of the test agent.

 Pre-clinical
studies also have shown the potential of MIRA-55 for relieving pain. A number of clinically approved pharmacological agents used to treat
pain, including opioids, have been demonstrated to delay or ameliorate the onset of heat sensitivity upon paw exposure of mice to heat.
Thirty minutes after treatment with either a placebo (control) or MIRA-55, mice were placed on a heated plate to measure the time it
took for each mouse to lift its paw in response to the mild pain they felt from the heat. Mice treated with pain alleviating drugs took
significantly longer to become bothered by the heat and to lift their paws. Similarly, mice treated with MIRA-55 statistically took significantly
more time to lift their legs, indicating MIRA-55's potential effectiveness as a possible treatment for pain in this model. If approved
by the FDA, MIRA-55 may potentially provide therapeutic effects for pain control.

is a CB2 agonist which may also be an optimal treatment for neurodegenerative diseases associated with neuroinflammation caused by microglial
activation. CB2 agonism has been shown in pre-clinical studies to regulate neuroinflammatory processes, reducing the neuronal damage
characteristic of degeneration. We believe there may be a strong rationale for CB2 agonism in neurodegenerative diseases, given increased
CB2 expression in patients with these diseases as well as preliminary results from animal models. We see potential for a potent CB2 agonist
to treat a range of neurodegenerative diseases. MIRA-55, through its robust activity at CB2 compared to CB1, was designed to minimize
the risk of psychotropic adverse events associated with CB1 activation. If approved by the FDA, MIRA-55 may potentially provide therapeutic
effects for neurodegenerative and neuroinflammatory illnesses.

 Our
pre-clinical development program for MIRA-55 has included a variety of testing. Summarized below are the tests we have completed. Our
interpretation of results derived from pre-clinical data or our conclusions based on our pre-clinical data may prove inaccurate and are
not necessarily predictive indicators of future results. See the section below titled " Research and Testing to Date –
MIRA-55 " for more information.

 Our
MIRA-55 Clinical Development Program

 Following
the pre-clinical development plan outlined above, we plan to submit to the FDA an Investigational New Drug application (or IND) focused
on investigating MIRA-55 for the treatment of anxiety and cognitive decline in elderly patients.

 We
expect that our first IND application submission relating to MIRA-55 for the treatment of elderly patients suffering from anxiety with
some cognitive decline is currently planned for the end of the second quarter of 2025, as we believe this is a patient population with
unmet needs. If allowed to proceed by the FDA, a Phase I trial will be initiated 30 days post-IND submission. We expect that our second
IND for MIRA-55 will focus on investigating MIRA-55 for the treatment of neuropathic pain.

 All
development plans depend on FDA acceptance of our IND applications. As appropriate and pursuant to discussions with the FDA, we may periodically
adjust the timeline for certain filings and associated clinical trials. It is important to note that the process for conducting clinical
trials is uncertain and there is no assurance that our clinical development activities will meet the planned timelines set forth above.

 Our
Market Opportunity and Market Advantage

 Ketamir-2's
market opportunity and market advantage was analyzed by IQVIA who were contracted to perform an independent Market Characterization and
Drug Valuation Analysis. TRD and MDSI indications represent areas of high unmet medical need, with significant disease burden and limited
effective treatments available. Ketamir-2's formulation as a once-daily oral medication addresses shortcomings in existing treatments,
such as route of administration (RoA) and time to effectiveness.

 The
market opportunity for Ketamir-2 is substantial. Based on the IQVIA analysis, the U.S. has a large patient pool looking for effective
treatments, with diagnosed prevalence rates of 3.1% for MDSI and 2.4% for TRD, translating to total addressable populations of 4.9 million
and 3.8 million patients respectively. Based on total estimates of MDSI and TRD together, this represents a Total Diagnosed Prevalence
rate of 12.3 million patients and, assuming a Treatment Rate of 65%, the Total Addressable Population is 8.7 million patients This represents
a significant market, especially considering the current limitations and side effects associated with existing treatments.

 Estimates by IQVIA of the total addressable populations affected with MDSI and TRD.

 Ketamir-2's
market advantage lies in its novel profile and potential to address these unmet needs. As a synthetic ketamine derivative, we believe
it potentially offers an improved mechanism to treat disease, building on the success of existing marketed therapeutics but with differences
to the base molecules that potentially reduce unwanted side effects. Ketamir-2's oral formulation is being developed to potentially
not require health care professional supervision, potentially improving patient compliance and ease of use.

 Summary of assessment by IQVIA of valuation of Ketamir-2, including the background, commercial opportunity, and drivers of valuation
assessment.

 The
projected addressable market for Ketamir-2 are promising. If approved by the FDA and deemed safe, peak annual net sales in the U.S. are
estimated to potentially reach approximately $3 billion across both MDSI and TRD, with a base case eNPV (expected net present value)
of around $92 million. In the high case scenario, the unadjusted peak revenue opportunity could go up to about $7.8 billion by 2035,
with the eNPV potentially reaching $324 million. The estimated patient pool for Ketamir-2 treatment may reach approximately 0.2 million
patients in the U.S. by 2036. The NPV (net present value) ranges from approximately $270 million to $4.6 billion, with the base case
being around $1.4 billion.

 Actual valuation of Ketamir-2 over time, including base and peak revenue opportunities in the US.

 These
estimates are based on several key assumptions, including the market share Ketamir-2 might achieve, the years to peak sales, gross price
per dose, and the Probability of Technical & Regulatory Success (PTRS). Feedback from key opinion leaders (KOLs) and payors suggests
that there is a significant unmet need in behavioral health, particularly for treatments like Ketamir-2 with fewer adverse effects and
more consistent outcomes. However, issues such as pricing, insurance coverage, and potential DEA scheduling are important considerations
that could affect Ketamir-2's market penetration.

 As
such, we believe Ketamir-2 presents a significant market opportunity in the treatment of TRD and MDSI, with the potential in the PTSD
market, offering a novel approach with potential advantages over existing therapies in terms of efficacy, safety, and patient compliance.
The financial outlook is positive, contingent upon successful market penetration and realization of its therapeutic potential.

 MIRA-55,
if approved, will compete in three key overlapping growth markets: the anxiety, cognitive decline (CNS/dementia), and neuropathic pain
markets where multiple products with varying safety and efficacy profiles are already on the market. MIRA-55 competes at the intersection
of these three markets given the target patient profile for MIRA-55.

will compete primarily within the CNS market that encapsulates anxiety, dementia, other pain, Alzheimer's, migraines and related
conditions. Based on the market size of the CNS opportunity as set forth in IQVIA's Global Use of Medicines 2023 analysis (the
"IQVIA Report"), we estimate that by 2027, the U.S. CNS market will be worth $48 billion, growing between two and five percent
during the period from 2023 to 2027. Within that market opportunity, anxiety is worth between approximately $10 billion and $15 billion
in annual sales. If approved by the FDA, MIRA-55 may potentially provide therapeutic effects for anxiety, dementia and pain.

 Anxiety
and pain are expected to grow approximately five percent over the same period according to the IQVIA Report, while Alzheimer's
is expected to grow approximately twelve percent. This is critical given MIRA-55's focus on early-stage patients with dementia,
as according to the Alzheimer's Association 2023 Alzheimer's Disease Facts and Figures analysis (the "Alzheimer
Association"), 500,000 new Alzheimer cases emerge in the U.S. each year. According to the Alzheimer Association, about 60 to 80
percent of Alzheimer cases evolve into dementia. Thus, Alzheimer case directions are an important signal and gateway for MIRA-55-related
opportunities in dementia. Based on that epidemiology, the U.S. Center for Disease Control ("CDC") estimates that approximately
5.8 million Americans are living with Alzheimer's, with that number expected to grow to 14 million by 2060 ("CDC Alzheimer").

 MIRA-55's
other key market will be the neuropathic pain market. Developing targeted and efficient therapies for neuropathic pain stands as a priority
to address this common source of suffering and morbidity. Innovative strategies are under exploration to tackle the distinctive challenges
posed by this type of pain. According to the International Association for The Study of Pain, neuropathic pain affects approximately
7-10% of the world's population. Examples include diabetic peripheral neuropathy, postherpetic neuralgia, and multiple sclerosis
related neuropathy.

 Our
initial focus will be a dual path: potentially winning in traditional markets as well as the marijuana analog markets using a safe, effective
and, if determined by the FDA, an FDA-approved treatment option since safety and efficacy determinations are in the exclusive purview
of the FDA. According to Grandview Research, today, legal medical marijuana is a $11.6 billion industry whereas legal recreational marijuana is a $26.9
billion industry. Both are sub-sets of the traditional pain and anxiety markets. However, in many patient populations, non-U.S. legal,
and cultural settings, marijuana may not be the first or a viable option for treatment of neurological disorders. As a result, these
patients will typically use non-steroidal anti-inflammatory drugs (NSAIDs) or various mood management drugs, opening them up to a range
of non-ideal outcomes. The objective of MIRA-55 is to offer physicians and patients an approved, viable synthetic option. Thus, if approved
by the FDA, we believe that MIRA-55 may potentially provide a preferred alternative in such patient populations, as it is not derived
from the marijuana plant.

is being developed as the first manufactured prescription drug to potentially target the CB1 and CB2 receptors for neuropathic pain and
anxiety without the impurities of marijuana or its side effects, such as increased appetite and paranoia. MIRA-55 has demonstrated the
ability to rapidly and significantly improve cognitive performance with acute use—i.e. doubling cognitive performance after a single
dose in normal mice MIRA-55 is a novel synthetic cannabinoid analog directed at potentially treating patients with dementia associated
cognitive decline and anxiety diagnoses. Unlike other cannabinoids in the market, MIRA-55 is not derived from plants. Plants generate
alkaloids as a defense mechanism, and it has been speculated that plant-derived cannabinoids have adverse side effects in humans.

 Furthermore,
in animal studies conducted by us, MIRA-55 has preliminarily demonstrated more than 30-fold increased CB2 activation compared to CBD.

 Our
Strategy

 The
goal is to continue develop Ketamir-2 as an orally administered medication with potentially fewer side effects, free from the restrictions
such as those imposed by ketamine's REMS, to fill the current clinical need for a rapid acting antidepressant to manage TRD and
MDSI in patients who are able to take Ketamir-2 at home. The strategic plan for Ketamir-2's development encompasses several critical
stages, from scaling up manufacturing to exploring effective exit strategies.

 Scaling
 Up Manufacturing at Recipharm. The first step for us is to scale up the manufacturing process of Ketamir-2. Small-scale synthesis
 has already been achieved at third-party vendor Recipharm, which will be essential for refining the process and identifying potential
 challenges. This will be followed by a phase of process optimization, focusing on improving yield, purity, and cost-efficiency. We
 will then transition to pilot-scale production to validate the manufacturing process under real-world conditions. Once the process
 is established, large-scale manufacturing can commence, ensuring compliance with Good Manufacturing Practices (GMP) standards. Integral
 to this stage is the development of a robust supply chain strategy to manage the consistent availability of raw materials and distribution.

 IND-Enabling
 Research. Prior to IND submission, we must conduct comprehensive IND-enabling research, which we will undertake through third-party
 vendors. This includes pharmacokinetics/pharmacodynamics (PK/PD) studies to understand how Ketamir-2 is absorbed, distributed, metabolized,
 and excreted, along with its mechanism of action. Toxicology and tolerability studies are also crucial, encompassing both acute and
 chronic toxicology assessments in relevant animal models, including 7 and 28-day studies in rats and dogs. Additionally, the development
 of a stable and effective formulation for Ketamir-2's oral administration is necessary.

 IND
 Submission for TRD Indication. With the data from preclinical studies in hand, we will prepare and submit an IND to the FDA.
 This submission will include all preclinical data and a proposed plan for clinical trials. A well-thought-out regulatory strategy
 is essential to address potential queries and concerns from regulatory bodies.

 Trials - Phase 1 and 2. Upon IND acceptance, clinical development will proceed with Phase 1 trials, focusing on assessing
 the safety, tolerability, and optimal dosing in a small group of healthy volunteers. This will be followed by Phase 2 trials, where
 the efficacy of Ketamir-2 will be evaluated in a larger group of patients, along with further safety assessments.

 Potential
 Collaborations. We could focus on partnerships and licensing for later clinical development and commercialization of Ketamir-2.
 We can explore partnerships with larger pharmaceutical companies for further development and commercialization of Ketamir-2. Licensing
 agreements can also be considered, allowing other companies to market Ketamir-2 in different regions or for varied indications. While
 such relationship could offload a significant amount of the financial and operational burden associated with these activities, such
 a relationship would likely lead to loss of autonomy and come with high expectations for returns. The following options could be
 considered depending on the available opportunities:

 1.

 Strategic
 Partnerships and Collaborations: this can involve partnering with larger pharmaceutical companies, which brings the benefit of
 their extensive resources, global market reach, and regulatory expertise. However, such partnerships often mean sharing profits and
 relinquishing some control over the drug. Collaborations with biotechnology firms in similar therapeutic areas can also be beneficial,
 offering synergistic research efforts and niche expertise, though these firms may not provide as much financial support as larger
 pharma companies.

 2.

 Licensing
 Agreements. We could choose to license the drug to another company for further development and commercialization. Out-licensing
 can provide an immediate capital infusion and reduce the risk and investment required for later-stage trials. However, this often
 leads to losing direct control over the development and commercialization processes. Co-development and co-marketing deals are another
 form of licensing where the development, marketing, and commercialization responsibilities are shared, which can combine strengths
 and reduce individual risks but requires aligned objectives and effective collaboration.

 Additional
 Funding and Investment. Seeking additional capital through debt or equity financing could be a way to fund Phase 3 trials
 and marketing efforts but could dilute shareholders' equity. Undertaking Phase 3 clinical trials and, if approved, marketing
 activities would require substantial investments and expertise which we currently do not have and would need to develop.

the potential for an acquisition from a larger pharmaceutical company remains a viable exit strategy, especially if Ketamir-2 demonstrates
substantial promise.

 Throughout
this process, it is crucial for us to maintain a robust intellectual property strategy, regularly assess the antidepressant market landscape,
especially for TRD, and engage with key stakeholders. Implementing a risk management plan is also essential to navigate potential development
and commercialization challenges. This strategic plan must be adaptable, capable of responding to new data, regulatory feedback, and
changes in the market. Regular assessments and checkpoints will ensure the project aligns with our strategic goals and the evolving landscape
of pharmaceutical development.

 Our
goal is to develop therapeutics targeting well-characterized CB1 and CB2 receptors with optimized pharmacological properties to transform
the lives of patients with neurological diseases. Key elements of our strategy to achieve this goal include:

 Advance
 our MIRA-55 through clinical development and approval. Our product candidate, MIRA-55, is in pre-clinical studies. Existing
 treatment options for neuropsychiatric disorders and neurological diseases have significant limitations, and, if approved, we believe
 MIRA-55 would represent a major therapeutic advancement for patients.

 Continue
 pre-clinical development of MIRA-55 across a range of CNS diseases associated with neurodegeneration and progress into clinical development.
 MIRA-55 is currently in IND-enabling studies for neurobehavioral disorders such as dementia, PTSD, neuropathic pain, as well
 as neurodegenerative diseases. We believe MIRA-55 may have potential in several diseases associated with neuroinflammation.

 Identify
 additional product candidates and expand current candidates into additional neurological diseases. We see potential for our
 current product candidate to be evaluated in clinical trials outside of its initial indications and will evaluate additional indications
 to maximize the potential of our drug development program. Our current product focus is on targets that are well characterized in
 neurological diseases but for which there are limitations with currently available therapies. We also plan to continue to identify
 and develop additional novel product candidates that align with our focus.

 Explore
 strategic collaborations to maximize the value of our product candidates. We plan to explore collaborations opportunistically
 to maximize the value of our product candidates. We intend to retain significant economic and commercial rights to our programs in
 key geographic areas that are core to our long-term strategy.

 Competition

 The
principle competitor of Ketamir-2 is ketamine or ketamine analogs. Ketamine, originally known as a dissociative anesthetic, has emerged
as a significant breakthrough in the treatment of depression, particularly due to its rapid-acting antidepressant properties. The FDA
approved in 2019 esketamine delivered intranasal, developed by Janssen with the brand name Spravato. This has opened new avenues in psychiatric
treatment, especially for patients who do not respond to traditional antidepressants, have depression with suicidal ideation, or require
rapid antidepressant responses.

 In
contrast to most novel antidepressants, which are multi-billion dollar drugs annually, for 2023 Janssen reported $683 million in revenue
from Spravato. We believe the primary reason for Spravato's revenue performance versus other antidepressants is because Spravato's
REMS requires Spravato to be patient administered but clinician observed for 2 hours, with the patient unable to drive for the rest of
the day. As described further below, we believe this presents challenges for both patients and clinicians, which has restricted the use
of this form of ketamine from patients who would benefit from this treatment (e.g. those with TRD and MDSI). Ketamir-2, if ultimately
FDA approved without the requirement of a REMS, could potentially avoid these challenges.

 Niche
Filled by ketamine

 1.

 Treatment-Resistant
 Depression: Ketamine has shown efficacy in cases where conventional antidepressants fail, addressing a significant gap in mental
 health treatment.

 2.

 Rapid
 Onset of Action: Unlike traditional antidepressants that may take weeks to show effects, ketamine can produce noticeable antidepressant
 effects within hours to days, providing immediate relief in acute cases of depression.

 3.

 Suicidality:
 It has shown promise in rapidly reducing suicidal thoughts, which is crucial in acute psychiatric emergencies.

 Limitations
of ketamine Due to Side Effects

 1.

 Psychotomimetic
 Effects: Ketamine can induce dissociative symptoms, hallucinations, and other psychotomimetic effects, limiting its use to controlled
 settings.

 2.

 Potential
 for Abuse: Given its history as a recreational drug, there are concerns about its potential for abuse and addiction.

 3.

 Short
 Duration of Effect: The antidepressant effect of ketamine can be transient, requiring repeated administrations, which may increase
 the risk of side effects.

 4.

 Physical
 Side Effects: These may include increased heart rate, elevated blood pressure, nausea, and dizziness.

 Requirements
of ketamine under the REMS (Risk Evaluation and Mitigation Strategy)

 The
use of ketamine, especially Esketamine (a nasal spray form of ketamine approved for treatment-resistant depression), is regulated under
the Risk Evaluation and Mitigation Strategy (REMS) program to ensure safe use:

 1.

 Healthcare
 Setting Administration: Esketamine must be administered in a certified healthcare setting under the supervision of a healthcare
 provider.

 2.

 Patient
 Monitoring: Patients must be monitored for at least two hours after administration due to the risk of sedation and dissociation.

 3.

 Restricted
 Distribution: The drug is not available for take-home use and can only be dispensed to healthcare facilities and pharmacies enrolled
 in the REMS program.

 4.

 Patient
 Education and Consent: Patients must be informed about the risks and provide written consent.

 5.

 Follow-up
 and Reporting: Healthcare providers are required to report any serious adverse effects and ensure follow-up to monitor the patient's
 response to treatment.

 Ketamine's
possible role as a rapid-acting antidepressant could fill a crucial niche in the management of treatment-resistant depression and acute
suicidality. However, its potential use is tempered by significant side effects and the stringent requirements of the REMS program, which
necessitate careful patient selection and monitoring to optimize safety and efficacy.

 The
finding of up to 80% oral bioavailability with the potential for decreased abuse liability (e.g. because of the lack of opiate agonist
activity) and potentially decreased side effects (e.g. fewer dissociative experiences and less hypertension) puts Ketamir-2 in a situation
to potentially offer the same antidepressant effects but with fewer restrictions, perhaps even permitting patients to take it orally
at home.

 We
are subject to competition from pharmaceutical and biotechnology companies and academic and research institutions. We believe our future
success will depend, in large part, on our ability to maintain a first mover advantage and competitive lead in our industry.

 Competition
arises mainly from two sources, traditional cell-based in vitro culture approaches and traditional in vivo animal models and testing.
We also face future competition from companies developing cannabinoid therapies, as summarized in the table below:

 Sativex
(delta-9-tetrahydrocannibinol and cannabidiol in the EU) is an oromucosal spray indicated as treatment for symptom improvement in adult
patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity
medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
Sativex is not assigned a schedule in the U.S. by the DEA as it is not approved but is a Class B controlled drug under the Misuse of
Drugs Act 1971 and is placed in Schedule 4 to the Misuse of Drug Regulations 2001 in the United Kingdom.

 Marinol
(dronabinol) is an oral cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS
and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic
treatments. Marinol is a Schedule III controlled substance.

 Cesamet
(Nabilone) is a synthetic cannabinoid for oral administration that are indicated for the treatment of the nausea and vomiting associated
with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Cesamet contains nabilone,
which is a controlled in Schedule II of the Controlled Substances Act (CSA).

and Testing to Date

 Preclinical
Research Findings

 In
Silico Analysis of Targets of Ketamir-2 vs ketamine

 In
silico analysis, referring to computer-based techniques, has become an integral part of pharmaceutical research and development. 7
 This approach utilizes computational methods to analyze and predict the properties and behaviors of pharmaceutical compounds. The
use of in silico analysis is especially crucial in the early stages of drug development, as it aids in identifying potential drug targets
and elucidating differences between a new drug and its parent compound. By analyzing large datasets, such as genomic, proteomic, and
metabolomic data, researchers can predict how different compounds might interact with various biological targets. This approach helps
in understanding the mechanism of action of new drugs and can significantly reduce the time and cost associated with experimental screening.
InSilico Trials was contracted to provide a comparison between targets of Ketamir-2 vs ketamine employing their target identification
protocol. The following characterize some of the unique targets that are predicted to interact with either Ketamir-2 or ketamine, thereby
differentiating one drug from the next.

selective target:

 BRD4,
or Bromodomain-containing protein 4, is a member of the bromodomain and extra-terminal (BET) family of proteins and has been implicated
in the regulation of gene expression, particularly those involved in cell cycle progression and inflammatory responses. 8 In
the context of depression, research has started to explore the role of BRD4 and its potential impact.

 1.

 BRD4
 and Neuroinflammation: Inflammation is increasingly recognized as a significant factor in the pathophysiology of depression. BRD4
 has been found to regulate the expression of inflammatory genes. Its inhibition, therefore, might reduce neuroinflammation, which
 is thought to contribute to depressive symptoms.

 2.

 Gene
 Expression Regulation: BRD4 influences the transcription of genes involved in mood regulation and stress response. Dysregulation
 of these genes can contribute to the development of depression. 9

 3.

 Pharmacological
 Target: BRD4 is a target for new pharmacological interventions in depression. Inhibitors of BRD4, such as JQ1, have shown promise
 in preclinical studies for their antidepressant effects. These compounds can modulate the expression of genes associated with mood
 and stress response.

 4.

 Epigenetic
 Mechanisms: As an epigenetic regulator, BRD4's role in modifying the expression of genes without changing the DNA sequence
 might be crucial in understanding the long-term impact of environmental factors on depression. 10

 5.

 Animal
 Studies: Research in animal models has provided some evidence that modulation of BRD4 activity can influence behaviors related to
 depression. However, translating these findings to human depression is complex and requires more research.

 6.

 Thus,
 while BRD4 is not traditionally associated with depression like neurotransmitter systems (e.g., serotonin or dopamine), emerging
 evidence suggests that it plays a role in the disease's pathophysiology. Its involvement in regulating gene expression, particularly
 related to inflammation and stress response, positions it as a potential target for novel antidepressant therapies.

 Ketamine
selective targets:

 Alpha-2a
adrenergic receptor: Alpha-2a adrenergic receptors are G protein-coupled receptors (GPCRs) involved in the modulation of neurotransmitter
release. They are generally thought to be inhibitory, reducing the release of norepinephrine when activated, which can lead to various
physiological effects.

 Cardiovascular
 Effects: Alpha-2a receptors play a role in cardiovascular regulation, which might explain some of the blood pressure and heart rate
 changes seen with ketamine.

 Sedation:
 Activation of these receptors can lead to sedative effects, which is consistent with the tranquilizing effects that ketamine can
 produce.

 Sigma
Opioid Receptor: Ketamine is known for its dissociative anesthetic properties, which are primarily attributed to its antagonism of the
N-methyl-D-aspartate (NMDA) receptor. However, the sigma receptors, particularly the sigma-1 receptor, have also been implicated in the
psychotomimetic and dissociative effects of ketamine. Here's how ketamine's interaction with sigma opioid receptors might
contribute to its dissociative side effects:

 Cognitive
 and Perceptual Processes: Activation of has been linked to modulating cognitive and perceptual processes, which could be associated
 with the dissociative effects experienced during ketamine administration.

 Modulation
 of NMDA Receptor Activity: Sigma-1 receptors are known to interact with NMDA receptors, and this interaction might enhance or modulate
 the dissociative effects of ketamine, which primarily acts as an NMDA receptor antagonist.

 Mu-Opioid
Receptor: The Mu-opioid receptor (MOR) is one of the principal targets within the central nervous system for endogenous opioids like
endorphins and enkephalins, as well as for exogenous opioid analgesics such as morphine and fentanyl. Activation of MOR
typically results in analgesic effects, reduced gastrointestinal motility, respiratory depression, and can influence the reward system
in the brain, which is associated with the pleasurable sensations or euphoria. Activation of the MOR by ketamine could contribute to
side effects related to its abuse liability:

 Euphoria
 and Reward: MOR activation is heavily implicated in the reward pathway and can produce euphoria. This effect is a key driver of the
 abuse potential of opioids.

 Tolerance
 and Dependence: Chronic activation of the MOR leads to tolerance (the need for increasing doses to achieve the same effect) and physical
 dependence, contributing to the cycle of abuse.

 Sedation:
 MOR activation can also result in sedation, which might contribute to the overall sedative effects of ketamine, particularly at higher
 doses.

 is a newly synthesized compound analogous to ketamine. In a virtual screen, aimed at identifying potential interaction sites, no opioid receptor binding was found for Ketamir. Testing its potential
agonist or antagonist activities on mu-opioid receptors, it was found that Ketamir has no mu-opioid antagonist activity. It was found
that Ketamir has some minimal agonist activity, but at high concentrations, which are outside its therapeutic range. In this activity,
it is several folds lower than ketamine, which is believed to exert its dependency function through this activity.

 This
 much lower activity of Ketamir-2 MOP agonist activity suggests that Ketamir-2 may have less addictive properties, thus potentially improving its safety profile.

 Bioavailability:

 The
Caco-2 cell model, originating from a human colorectal adenocarcinoma cell line, plays a significant role in pharmaceutical research
for estimating the intestinal absorption and indirectly the bioavailability of drugs. Bioavailability, the proportion of a drug that
enters the systemic circulation when introduced into the body, is crucial for determining a drug's effectiveness. Traditionally,
bioavailability is determined through in vivo studies, including human and animal trials, as well as in vitro models like the Caco-2
cell model and in silico computational approaches.

 The
Caco-2 model involves culturing cells that differentiate into a monolayer mimicking the intestinal epithelium, complete with tight junctions
and microvilli. This model is pivotal in permeability studies to assess how well drugs can pass through the intestinal barrier and in
understanding both active and passive drug transport mechanisms. While primarily used for estimating drug absorption, the Caco-2 model
also serves to predict potential drug-drug interactions within the gastrointestinal system.

 The
Caco-2 model offers a high-throughput, cost-effective, and human-relevant system, making it a preferred choice for initial screening
of multiple compounds. In pharmaceutical research, the Caco-2 model often serves as an initial study to predict the absorption properties
of new drugs and is typically validated against clinical data once that becomes available. It plays a crucial role in the early stages
of drug development, influencing decisions on which compounds to advance.

 CaCO-2
cells are human epithelial colorectal adenocarcinoma cells that are widely used as an in vitro model of the intestinal barrier. The CaCO-2
assay is employed to study the absorption and transport of orally administered drugs across the intestinal epithelium. The assay evaluates
the permeability of a drug from the apical (AP) side, representative of the intestinal lumen, to the basolateral (BL) side, representative
of the blood side, and vice versa.

 The
bidirectional transport assays conducted with CaCO-2 cells can provide the following insights about two different drugs:

 1.

 Absorption
 Potential: The AP to BL (A B) transport rate can indicate a drug's ability to be absorbed through the intestines into
 systemic circulation. Higher transport rates suggest better absorption potential.

 2.

 Efflux
 Ratio: By comparing the BL to AP (B A) transport rate with the A B transport rate, one can determine the efflux ratio.
 If the efflux ratio is significantly greater than 1, this implies that there are active efflux mechanisms, such as P-glycoprotein,
 that are pumping the drug back into the intestinal lumen, thus reducing its absorption.

 3.

 Permeability
 Classification: The transport rates can be used to classify the drugs according to their permeability. High permeability drugs are
 absorbed more completely and are likely to have a more reliable and faster onset of action.

 4.

 Influence
 of Efflux and Influx Transporters: Differences in the AB-BA values between two drugs can indicate the involvement of different efflux
 or influx transporters, suggesting that the drugs have different affinities for these transporters.

 5.

 Impact
 of Metabolism: If a drug is extensively metabolized by the intestinal wall before reaching systemic circulation, this will be reflected
 in a low A B permeability.

 6.

 Predicting
 Oral Bioavailability: Generally, drugs that exhibit high permeability in CaCO-2 assays are expected to have good oral bioavailability,
 although this is not always the case due to other factors such as solubility and first-pass metabolism.

 In
summary, the CaCO-2 intestinal absorption (AB-BA) assay is a valuable tool for predicting the intestinal absorption and oral bioavailability
of drugs. Differences in the assay results between two drugs can provide important information about their absorption characteristics,
potential interactions with transporters, overall oral bioavailability, and possible drug-drug interactions.

 Model of the CaCO-2 model of drug intestinal absorption and how well it correlates with actual measures of human intestinal absorption.

 Data obtained from the CaCO-2 model of intestinal absorption. Propranolol, a commonly prescribed beta-blocker that is taken orally
and used to treat hypertension, is included as a positive control. The intestinal absorption (AB), Intestinal efflux (BA) and net absorption
(AB-BA) are shown.

 As
can be seen in in the figure above, the absorption from the intestinal lumen into the blood that is 80% greater (80.6 vs 44.5), the rate
of efflux back into the intestinal lumen that is 35% less (-38.7 vs -59.6), and the net absorption (AB-BA) rate is 3.77 fold greater
[(41.9+15.1)/15.1=3.77], respectively. Since the reported oral bioavailability of ketamine has been reported to be between 16-30% (average
of 23%), then the predicted oral bioavailability of Ketamir-2 could be as high as 87% (i.e. Ketamir-2's oral bioavailability is
3.77 fold greater than ketamine's = 23%*3.77=87%).

 This
is just an approximation, and when sufficient Ketamir-2 has been synthesized to do in vivo animal initially and then human Pharmacokinetic
(PK) studies, it will be possible to get a more precise estimate of Ketamir-2's Oral Bioavailability compared to ketamine by testing
and calculating the area under the concentration-time curve (AUCoral) for oral dosing divided by the AUC for IV dosing (i.e. AUCoral/AUCiv).
But based on the available preliminary estimates, it appears highly likely that the oral bioavailability of Ketamir-2 in humans is going
to be substantially larger than that of ketamine. Orally available Ketamir-2, as opposed to IV or IN ketamine, would be much easier to
be patient self-delivered at home, thereby improving on the ease and availability of this rapid acting antidepressant for TRD & MDSI.

 Eurofins
DiscoverX has developed a panel of cell lines stably expressing non-tagged GPCRs that signal through cyclic
adenosine monophosphate, a messenger used for intracellular signal transduction in many different organisms (or cAMP). Hit Hunter
cAMP assays are specialized tests that track the activation of a type of cell receptor known as GPCR. GPCRs play a crucial role in how
cells respond to external signals, and they are activated through two pathways: Gi and Gs secondary messenger signaling. These pathways
are like internal communication systems in cells that relay signals from the outside to trigger specific responses inside the cell. The
assay is conducted in a straightforward, uniform manner without the need for image-based analysis. This method uses a technology developed
by DiscoverX called Enzyme Fragment Complementation (or EFC). In EFC, fragments of an enzyme, specifically -galactosidase ( -Gal),
are brought together to become functional only when the GPCR is activated. -Galactosidase, the enzyme used as a functional reporter
in this assay, is typically inactive in fragmented form and becomes active when the fragments reassemble, indicating the activation of
the GPCR. In this case, the GPCR target was CB1 receptor. Compounds were tested in agonist and antagonist mode with the requested GPCR
Biosensor Assays. For agonist assays, data was normalized to the maximal and minimal response observed in the presence of control ligand
and vehicle. This Eurofins DiscoverX system was used to test THC vs MIRA-55 agonist activity at the CB1 receptor.

 Unlike
CB1 receptors that mediate many of the psychotropic effects of cannabinoids on the CNS, CB2 receptors are predominantly present on cells
of the immune system. Based on preliminary results of our GPCR biosensor assays, the CB2 receptor agonistic effects of MIRA-55 are 8-fold
more potent than THC and 30-fold more potent than CBD.

 The
study regarding the ability of MIRA-55 vs THC vs CBD to activate CB2Receptors and alter intracellular cAMP levels was performed by the
CRO Eurofins DiscoverX.

 As
can be seen in the table below, the EC50 (i.e. concentration required to induce a half maximal response) for MIRA-55 was 8 times more
potent than THC and at least 30 times more potent that CBD—i.e. it only took 1 uM of MIRA-55 to induce the same response that required
8 uM of THC and >30 uM of CBD.

 Compound
 Name

 Assay
 Name

 Assay
 Format

 Assay
 Target

 Result
 Type

 EC50

 Unit

 cAMP

 Agonist

 CNR2/CB2

 EC50

 1.008462

 uM

 THC

 cAMP

 Agonist

 CNR2/CB2

 EC50

 8.209884

 uM

 CBD

 cAMP

 Agonist

 CNR2/CB2

 EC50

 >30

 uM

 The foregoing measurements were performed as follows:

 DiscoverX
has developed a panel of cell lines that stably express non-tagged GPCRs (G-protein coupled receptors) capable of signaling through cAMP.
The Hit Hunter assay platform is used to investigate the functionality and response of these GPCRs.

 In
the case of the CB2 receptor, which is a GPCR involved in various physiological processes and has potential therapeutic implications,
the Hit Hunter assay can be employed to study the effects of drug agonists on CB2 receptor activity.

 To
measure the half maximal response (EC50) of CB2 receptor activation by a drug agonist that leads to a decrease in cAMP levels, an alternative
approach may be required. One common method involves using forskolin, an activator of adenylate cyclase, to stimulate cAMP production.
Forskolin bypasses the GPCR signaling and directly activates adenylate cyclase, resulting in increased cAMP levels.

 In
the presence of forskolin, the drug agonist at the CB2 receptor can then be tested at various concentrations to determine its ability
to inhibit the forskolin-induced cAMP production. The drug's concentration that leads to a 50% reduction in forskolin-stimulated
cAMP levels can be considered the half maximal response or EC50.

 Completed
Pre-Clinical Tests*

 EPM
 model of anxiety

 Thermal
 Sensitivity Model of Pain

 Context
 Fear Conditioning Model of Cognition—Test of learning and memory.

 Rat
 Psychomotor Vigilance Test ("PVT") of Cognition—Test of attention.

 *
 These were non-human studies that were not powered for statistical significance and as such, no p-values
are available.

 EPM
 Model of Anxiety Test:

 Method:
 We studied the effect of acute administration of MIRA-55 on anxiety-related phenotypes in mice to model human conditions.

 An
 intraperitoneal (i.p.) injection of Placebo (e.g. saline) or MIRA-55 (e.g. 50mg/kg = Treatment) was administered to C57Bl/6 mice
 (n=5/group) that were 8-12 weeks old

 minutes following injection, mice were tested in anxiety related measures using EPM

 Outcome:
 The following chart demonstrates MIRA-55's anti-anxiety effects:

 Figure: Effects of MIRA-55 vs Placebo Treatment on Mouse Behavior in the Elevated Plus Maze.

 EPM
is a widely used behavioral test to assess anxiety-like behavior in rodents. Typically, rodents tend to avoid open spaces due to their
natural aversion to potentially dangerous areas. Therefore, spending more time in the open arms of the maze indicates decreased anxiety-like
behavior. Similarly, the total distance travelled can reflect general locomotor activity and exploratory behavior, which can be influenced
by the state of anxiety and the effect of drugs.

 The
EPM apparatus consists of two open arms and two enclosed arms elevated above the floor. Blue Bars represent the percentage of time spent
in the open arms by mice in the placebo and drug-treated groups. Green Bars show the total distance travelled by mice in both groups
during the EPM test.

 Thermal
 Sensitivity Model of Pain:

 Method: We studied
 the potential for pain reduction in pre-clinical models of heat tolerance using a hot plate methodology.

 Outcome: MIRA-55
 provided significantly delayed thermal sensitivity and enhanced pain tolerance.

 In this thermal sensitivity test, mice are placed on a heated metal plate (e.g. 52-55 degrees Celsius). The time taken for the mouse
to show a pain response - licking or shaking of the paws, jumping, or trying to escape from the hot plate - is measured. This time interval
is known as the "hot-plate latency". A longer latency is indicative of reduced pain sensation or a higher pain tolerance.

 The
Thermal Sensitivity Model of Pain in mice is a widely used experimental approach to study nociception, which is the perception of pain.
In this model, thermal stimuli are applied to the hind paws of mice to assess their sensitivity to heat-induced pain. The procedure typically
involves placing the mouse on a temperature-controlled surface, such as a hot plate or a radiant heat source. The temperature is gradually
increased, and the response of the mouse is measured, such as the latency to withdraw its paw from the heat source. The withdrawal latency
is considered an indicator of pain sensitivity, with shorter latencies indicating greater sensitivity. By comparing the response of normal
mice to that of mice with altered pain sensitivity, such as genetically modified mice or mice treated with analgesic drugs, researchers
can gain insights into the mechanisms underlying pain perception and potential therapeutic interventions. The Thermal Sensitivity Model
of Pain in mice provides a controlled and reproducible method for studying thermal nociception, allowing researchers to investigate the
effects of various genetic, pharmacological, and environmental factors on pain sensitivity. This model has contributed significantly
to our understanding of pain pathways and the development of novel analgesic treatments.

 As
performed at Johns Hopkins, in our thermal sensitivity test, which measured sensitivity to thermal pain, MIRA-55 significantly increased
the time it took mice to lift their legs in comparison to placebo (p=0.006) at 75mg/kg. This indicates that MIRA-55 has an analgesic
effect and may be a potential treatment for pain. Each group (i.e. placebo and 75 mg/kg) was comprised of 9 mice, for a total of 18 mice.

 The
issue of how to test the effect of MIRA-55 on cognition was complicated by the following:1) MIRA-55 has anti-anxiety (i.e. anxiolytic)
effects, 2) anxiolytics can potentially improve cognitive assessment outcomes by reducing anxiety levels that may otherwise hinder cognitive
functioning. Thus, in commonly performed tests of cognition in mice, such as novel object recognition and Morris water maze, anxiolytic
medications can indirectly result in improved performance by decreasing anxiety rather than by directly improving cognition. In order
to separate assessments of the impact of MIRA-55 on cognitive performance from its demonstrated anti-anxiety effects, we employed a model
of context fear conditioning wherein we dosed the mice after training. Context fear conditioning in mice is a behavioral paradigm used
to measure cognitive processes related to associative learning and memory. Associative learning, where an individual learns to associate
specific stimuli or contexts with particular outcomes, in this case the mice associate being in a specific chamber with receiving a mild
foot shock that occurs during training the day before testing. This process of forming associations between stimuli, actions, and consequences
is involved in numerous skills and behaviors in everyday life: it underlies learning new skills, developing habits, and acquiring knowledge
through experiences and conditioning. The use of associating the chamber with the foot shock on day one, means that when the mice are
returned to the chamber on day 2 a measure of how much freezing they do corresponds to a read out of how well they can recall the experiences
they had during training on day 1 (i.e. the greater the freezing, the better the recollection of the association between the chamber
and food shock). Since the mice are given MIRA-55 AFTER training that takes place on day 1, and only before testing on day 2, there is
no concern about the anxiolytic effects of MIRA-55 on learning during training, but rather this model tests MIRA-55's effects on
performance only—which in this case represents memory (i.e. the ability to recognize and recall the chamber where they had previously
been shocked) and to translate that into an associated behavior (i.e. freezing). As published in the Journal of Neuropharmacology in
2023, THC and cannabis impair context fear conditioning, both when given prior to training (because of its anti-anxiety effects) and
when given prior to testing (because of its cognitive impairing effects). As demonstrated in the figure below, MIRA-55 resulted a dramatic
effect on cognitive performance in the context fear conditioning model: as shown in B, the second panel from the left, the percentage
of time spent freezing—that is a demonstration of their memory and association—in the mice who received MIRA-55 at a dose
of 75 mg/kg was more than twice that of those who received 0 mg/kg=placebo (i.e. 55% vs 25%, p<0.0001). Thus, MIRA-55 doubled the
cognitive performance of the mice compared to placebo. This degree of improvement in cognitive performance in healthy mice dosed just
prior to testing and after learning has not been demonstrated with any cannabinoid compound previously.

 Trace
 Fear Conditioning Model of Cognition:

 Method: We studied the potential for improving
 recall in healthy mice using a fear conditioning model.

 Outcome:
 MIRA-55 sharply improves cognitive recall as dosage rises.

 The Contextual Fear Conditioning Model of Cognition in mice is an experimental paradigm used to study associative learning and memory
processes. It focuses on the ability of mice to form an association between a specific environmental context and an aversive stimulus,
which leads to the acquisition and subsequent retrieval of contextual memories. During the acquisition phase of the model, mice are exposed
to a distinct context, such as a particular chamber or environment. In this context, they receive an aversive stimulus, typically a mild
foot shock. The presentation of the foot shock creates an association between the contextual cues and the aversive experience. Following
the acquisition phase, the mice undergo a testing phase to assess their memory of the association between the context where they received
the foot shock and the memory of the aversive stimulus. They are returned to the same context where the conditioning took place and their
behavioral responses, particularly fear-related behaviors such as freezing or defensive reactions, are measured.

 These
behavioral responses serve as indicators of the mice's ability to retrieve the associative memory formed during the acquisition
phase. The Contextual Fear Conditioning Model of Cognition in mice has been widely used in neuroscience research to explore the mechanisms
of associative learning, memory formation, and the neural circuits involved in fear-related associations. It has contributed to our understanding
of how animals, including humans, learn to associate environmental cues with aversive experiences, and has implications for understanding
and treating conditions related to associative learning, memory deficits, and emotional disorders.

 As
performed at Johns Hopkins, in the Contextual Fear Conditioning Model the data shows that during training (in the absence of any treatment)
the mice learned as indicated by increased freezing over time. The following day, 30 minutes after MIRA-55 administration, the mice were
tested in the context test, which showed significantly increased % freezing (p=<0.0001) in females given 50mg/kg or 75mg/kg MIRA-55.
The experiments were conducted with 10 mice in each group (placebo, 50 or 75 mg/kg MIRA-55) for a total of 30 mice.

 In
the context conditioning figure above, mice learn to associate the neutral context (the chamber) with the aversive stimulus (the foot
shock), leading to a conditioned fear response (freezing). This is indicated by 'freezing' behavior - a fear-related response
in mice characterized by immobility except for respiratory movements.

 A
timeline of the experimental procedure, indicating acclimatization, training (conditioning), and testing phases is shown above. Panel
A, the left-most panel, shows that on day 1 the pairing of a neutral context (the conditioning chamber shown in panel C) with an aversive
stimulus (a mild foot shock). With successive foot shocks the mice show increasing amounts of freezing, since they instinctively freeze
in anticipation of being shocked. Panel B, titled "Context Recognition: Fear Conditioning," shows the percentage freezing
the mice did on day 2 after receiving placebo or MIRA-55 just prior to being placed in the same chamber they had been shocked on day
1. Since mice freeze in anticipation of receiving a shock, the relative amount of freezing in those mice given 0 mg/kg (placebo) vs either
50 or 75 mg/kg MIRA-55 is a readout of (i.e. proportional to) how well the mice recalled that the chamber they were returned to was the
one in which they had been shocked. As shown in panel B, the mice who received 75 mg/kg of MIRA-55 right before being placed into the
chamber showed 200% of the freezing than did the mice who received placebo (55% vs 25%, respectively. Panel D, in the lower right corner
of the figure, shows that at 1 min after being placed in the chamber on day 2, the mice that got vehicle (=0 mg/kg MIRA-55), relative
to those that got MIRA-55, have much less freezing, and in fact have less freezing over time. The mice given MIRA-55 start off with better
recognition and recall of the chamber (demonstrated as increased freezing) at 1 minute and increase the association of the chamber with
the prior shocks (because they increase freezing over time).

 Because
MIRA-55 is an anxiolytic, we decided to test whether it could impair cognitive function. We therefore sought to determine if MIRA-55
could impair attention—a different aspect of cognition than memory, recall and associative learning, and one that is affected negatively
by sedating compounds (e.g. THC, Cannabis, benzodiazepine, etc.) and positively by stimulants (e.g. caffeine, nicotine, amphetamine)
In order to assess whether MIRA-55 affected attention as compared to THC required a different testing model—Psychomotor Vigilance
Test (PVT). The rat Psychomotor Vigilance Test (rPVT) is a widely used method to measure sustained attention in rodents. In the rPVT
model, rats are trained to respond to a visual stimulus by pressing a lever, with shorter reaction times indicative of better attentional
performance. Mice with longer reaction times or higher variability in response times may be considered to have attention deficits or
altered vigilance. Data is shown as percentage accuracy at pressing the lever within the allowed reaction time vs dose of drug used.
In the figure below, it can be seen that at doses of THC that impair attention, MIRA-55 had no negative effects on attention (i.e. their
accuracy at pressing a lever at the right amount of time after receiving a trained cue was not impaired at all).

 Rat
 PVT of Cognition

 Method: We performed a PVT to evaluate simple
 reaction time.

 Outcome: MIRA-55
 does not impair cognition. At 3 mg/kg and 10 mg/kg MIRA-55 causes minimal impairment in rat PVT whereas THC has a clear negative
 effect even at these low doses.

 Comparison of MIRA-55 versus THC on Psychomotor Vigilance Test (PVT) Performance in Rats. The figure displays the percentage accuracy
of rats in the Psychomotor Vigilance Test (PVT) following administration of MIRA-55 (blue) or THC (red). The y-axis represents the percentage
accuracy (% Accuracy), indicating the proportion of correct responses in the PVT task. The x-axis represents the treatment condition,
with increasing amount of compound being given to the rats before testing. The data shows that rats treated with MIRA-55 exhibited no
decrease in percentage accuracy compared to the THC group (p < 0.05). The results indicate that administration of MIRA-55 had no negative
impact on attention performance in the PVT task, as evidenced by the maintenance of 100% accuracy across the dosage range, compared to
THC that impaired attention leading to decreased accuracy more and more with increasing dosages.

 The
Psychomotor Vigilance Test (PVT) is a behavioral test used in rats to assess attention and speed of response, providing insights into
their vigilance and cognitive performance. It is based on the measurement of reaction times to visual stimuli, typically presented in
a simple reaction time task paradigm.

 In
the PVT, rats are typically placed in an operant chamber or testing apparatus equipped with a visual stimulus, such as a light or LED.
The rats are trained to perform a specific response, such as pressing a lever or nose-poking, when the visual stimulus appears. The timing
of the visual stimuli is randomized to prevent predictability and maintain the animals' attention.

the test, the rats are required to pay attention to the visual stimuli and respond as quickly as possible when they appear. The reaction
time, which represents the time it takes for the rat to initiate the response upon stimulus presentation, is recorded. This measure reflects
the speed of response and can provide an indication of the rat's attentional state and ability to sustain attention over time.
By analyzing the reaction time data, researchers can evaluate the rat's attentional performance, including measures such as mean
reaction time, variability in response times, and the occurrence of lapses or errors. The PVT has been widely used to investigate the
effects of different manipulations, such as pharmacological interventions that cause sedation, sleep deprivation, or experimental treatments,
on attention, alertness, and cognitive performance in rats.

 Therefore,
the combination of cognitive assessments demonstrated the following: despite having anxiolytic effects, 1) MIRA-55 significantly improved
associative learning, memory and recall in the context fear conditioning model, and 2) MIRA-55 had no negative effects on attention at
doses that THC showed significant impairment. This is the first time a cannabinoid has been shown to enhance (rather than inhibit) cognition
when given to normal healthy mice after training but before testing, demonstrating a specific cognitive improvement as a direct effect
on the brain that is independent of indirect effects—such as with acute administration by decreasing anxiety or with long term
administration by having anti-inflammatory effects in neurodegenerative diseases.

 Due
to further optimization of the manufacturing process, our pre-clinical work in 2024 will include the conduct of several other pre-clinical
studies and initiation of a 7-day maximum tolerated dose study of MIRA-55 in rats and dogs.

 Status

 Planned
 Activity

 Drug
 Substance Preparation

 Analytical
 Development and qualification

 NonGMP
 Production Refinement and optimization

 GLP/GMP
 Production Refinement

 Testing

 Acute
 toxicity study mice

 Genotoxicity
 studies

 MTD/7D
 DRF Dog

 MTD/7D
 DRF Rat

 Dog
 28-day Toxicology

 Rat
 28-day Toxicology

 Cardiovascular
 Study Dog (Telemetry)

 Respiratory
 Study Rat

 hERG
 (Manual Patch-Clamp)

 Neurobehavioral
 Evaluation Rats

 Neurobehavioral
 Evaluation Mice

 We
further plan on neurobehavioral evaluation of orally and intraperitoneally administered MIRA-55 in rats and mice, respiratory evaluation
of orally administered MIRA-55 in rats, and in vitro testing for effects of MIRA-55 on hERG (the human Ether- -go-go-Related Gene)
channel currents. The hERG is an early in vitro assay required by the FDA to alert companies of any potential cardiac abnormalities by
the product before proceeding with dose studies in humans. hERG is a gene that codes for a protein known as the alpha subunit of a potassium
ion channel. This ion channel (sometimes simply denoted as 'hERG') is best known for its contribution to the electrical activity
of the heart: the hERG channel mediates the repolarizing current in the cardiac action potential, which helps coordinate the heart's
beating. When this channel's ability to conduct electrical current across the cell membrane is inhibited or compromised, either
by application of drugs or by rare mutations in some individuals, it can result in a potentially fatal disorder called long QT syndrome.

 Testing
is anticipated to conclude in the first quarter of 2025. Additionally, a 28-day toxicology analysis for dogs and rats is expected to
begin at the end of the fourth quarter of 2024 and continue through the first quarter of 2025.

 We
have started the analytical development and manufacturing of MIRA-55 as of January 2023. By the third quarter of 2024, we anticipate
our suppliers will be developing MIRA-55 at scale and manufactured under GLP/cGMP conditions, expanding on earlier non-GMP volumes of
MIRA-55 for use in our initial testing programs. We plan to work closely with our suppliers to generate sufficient volumes of cGMP-grade
MIRA-55 materials for the planned pre-clinical toxicity programs, expanded animal testing and human trials expected to be performed in
2025, subject to FDA approval.

 Regulation

 The
FDA and comparable regulatory authorities in state and local jurisdictions impose substantial and burdensome requirements upon companies
involved in the clinical development, manufacture, marketing, and distribution of drugs. These agencies and other federal, state, and
local entities regulate, among other things, the research and development, testing, manufacture, quality control, safety, effectiveness,
labeling, storage, record keeping, approval, advertising and promotion, distribution, post-approval monitoring and reporting, sampling
and export and import of our drug candidates.

 U.S.
Government Regulation

 In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations.
The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes
and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements
at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative
or judicial sanctions, such as the FDA's refusal to approve pending New Drug Applications (or NDAs), withdrawal of an approval,
imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production
or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

 The
process required by the FDA before a drug may be marketed in the United States generally involves the following:

 completion
 of pre-clinical laboratory tests, animal studies and formulation studies in compliance with the FDA's good laboratory practice
 ("GLP") regulations;

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

 approval
 by an independent Institutional Review Board ("IRB"), at each clinical site before each trial may be initiated;

 performance
 of adequate and well-controlled human clinical trials in accordance with good clinical practices ("GCP") requirements
 to establish the safety and efficacy of the proposed drug product for each indication;

 demonstration
 that the API and finished product are manufactured under well controlled (eventually cGMP) conditions and meet all applicable standards
 of identity, strength, quality, and purity;

 submission
 to the FDA of an NDA;

 satisfactory
 completion of an FDA advisory committee review, if applicable;

 satisfactory
 completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance
 with cGMP requirements and to assure that the facilities, methods, and controls are adequate to preserve the drug's identity,
 strength, quality, and purity;

 FDA
 review and approval of the NDA, including consideration of the views of any FDA advisory committee, prior to commercial marketing
 or sale of the drug in the United States; and

 compliance
 with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy ("REMS")
 or to conduct a post-approval study.

 Pre-clinical
studies

 Before
testing any drug or biological product candidate in humans, the product candidate must undergo rigorous pre-clinical testing. The pre-clinical
developmental stage generally involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate
toxicity in animals, to assess the potential for adverse events ("AEs") and, in some cases, to establish a rationale for
therapeutic use. The conduct of pre-clinical studies is subject to federal regulations and requirements, including GLP regulations for
safety/toxicology studies. An IND sponsor must submit the results of the pre-clinical studies, together with manufacturing information,
analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.

 An
IND is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed
to proceed by the FDA before human clinical trials may begin. Some long-term pre-clinical testing, such as animal tests of reproductive
AEs and carcinogenicity, may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the
FDA, unless the FDA raises concerns or questions before that time related to one or more proposed clinical trials and places the trial
on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.
As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

trials

 The
clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the
supervision of qualified investigators, generally physicians not employed by, or under control of, the trial sponsor, in accordance with
GCPs, which include the requirement that all research patients provide their informed consent for their participation in any clinical
trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures,
subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy. Each protocol,
and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must
be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals
participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the
informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical
trial until completed. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trial results
to public registries. Information about most clinical trials must be submitted within specific timeframes for publication on the www.clinicaltrials.gov
website. Information related to the product, patient population, phase of investigation, study sites and investigators and other aspects
of the clinical trial is made public as part of the registration of the clinical trial. Sponsors are also obligated to disclose the results
of their clinical trials after completion. Disclosure of the results of these trials can be delayed in some cases for up to two years
after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress
of development programs.

 Human
clinical trials are typically conducted in three sequential phases, which may overlap or be combined:

 Phase
 I clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to
 a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism,
 pharmacologic action, side effect tolerability and safety of the drug.

 Phase
 II clinical trials involve studies in disease-affected patients to determine the dose required to produce the desired benefits. At
 the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety
 risks are identified, and a preliminary evaluation of efficacy is conducted.

 Phase
 III clinical trials generally involve a larger number of patients at multiple sites and are designed to provide the data necessary
 to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk
 relationship of the product and provide an adequate basis for product approval. These trials may include comparisons with placebo
 and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product during marketing.

 Post-approval
trials, sometimes referred to as Phase IV clinical trials, may be conducted after initial marketing approval. These trials are used to
gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow
up. In certain instances, the FDA may mandate the performance of Phase IV clinical trials as a condition of approval of an NDA or a Biologics
License Application ("BLA").

 Progress
reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if significant
adverse events ("SAEs") occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time, or the FDA may
impose other sanctions on various grounds, including a finding that the research patients are being exposed to an unacceptable health
risk. Similarly, an IRB can refuse, suspend, or terminate approval of a clinical trial at its institution if the clinical trial is not
being conducted in accordance with the IRB's requirements or if the drug has been associated with unexpected serious harm to patients.

 Concurrently
with clinical trials, companies usually complete additional pre-clinical studies and must also develop additional information about the
physical characteristics of the drug or biological product as well as finalize a process for manufacturing the product in commercial
quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches
of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength, quality, potency,
and purity of the final biological product. Additionally, appropriate packaging must be selected and tested, and stability studies must
be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf life.

 Marketing
Approval

 Assuming
successful completion of the required clinical testing, the results of the pre-clinical studies and clinical trials, together with detailed
information relating to the product's chemistry, manufacture, controls, and proposed labeling, among other things, are submitted
to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of
an NDA is subject to a substantial application user fee.

 The
review process typically takes twelve months from the date the NDA is submitted to the FDA. The FDA conducts a preliminary review of
all NDAs within the first 60 days after submission to determine whether they are sufficiently complete to permit substantive review before
accepting them for "filing." The FDA may request additional information rather than accept an NDA for filing. In this event,
the application must be resubmitted with the additional information and may be subject to an additional application user fee. The resubmitted
application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins
an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether
the facility in which it is manufactured, processed, packaged, or held meets standards designed to assure the product's continued
safety, quality and purity. Under the current guidelines in effect in the Prescription Drug User Fee Act (PDUFA), the FDA has a goal
to review and act on the submission within ten months from the completion of the preliminary review of a standard NDA for a new molecular
entity.

 The
FDA also may require submission of a REMS plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include
medication guides, physician communication plans, assessment plans, and/or elements to assure safe use, such as restricted distribution
methods, patient registries, or other risk minimization tools.

 The
FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including
clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be
approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations
carefully when making decisions.

 Before
approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve
an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate
to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may inspect
one or more clinical trial sites to assure compliance with GCP requirements.

 After
evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding
the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter.
A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of
the NDA and may require additional clinical trials or pre-clinical studies in order for FDA to reconsider the application. Even with
submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria
for approval. If and when those conditions have been met to the FDA's satisfaction, the FDA will typically issue an approval letter.
An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.

 Post-approval
requirements

 Drugs
manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among
other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion
and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications
or other labeling claims are subject to prior FDA review and approval. There also are continuing annual user fee requirements for any
marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications
with clinical data.

 Intellectual
Property

 KETAMIR-2

 We
license the U.S., Canadian, and Mexican patent rights for the use of KETAMIR-2 in human applications from MIRALOGX. MIRALOGX filed international
application no. PCT/US2024/018594 under the Patent Cooperation Treaty (PCT) on March 6, 2024, titled, ANTIDEPRESSANT COMPOUNDS, PHARMACEUTICAL
COMPOSITIONS, AND METHODS OF TREATING DEPRESSION AND OTHER DISORDERS, and in due course intends to enter the national phase in the United
States, Canada and Mexico, among other countries. These applications, if granted and subject to payment of patent maintenance fees, would
offer protection extending through at least March 6, 2044. The patent rights for KETAMIR-2 outside of the United States, Canada, and
Mexico are not included in our current patent rights.

 Our
license from MIRALOGX is set forth in the Exclusive License Agreement, dated November 15, 2023, pursuant to which the licensed field
of use includes therapeutic treatments and other medical or health uses in humans, and related preclinical studies and activities conducted
in furtherance of obtaining regulatory approval for and commercialization of human therapeutic treatments and uses (the "MIRALOGX
License Agreement"). "Licensed Product" is defined as a drug product containing as an active agent 2-(2-chlorophenyl)-2-(methylamino)cyclopentan-1-one
or a pharmaceutically acceptable salt or ester thereof. We also have the right to grant corresponding sublicenses under the licensed
patent rights. The MIRALOGX License Agreement provides for the payment to MIRALOGX of an 8% royalty (payable quarterly) on our net sales
of Licensed Products by us or our sublicensees and on non-royalty bearing milestone revenue, with the royalty obligation ceasing upon
the later of the expiration of the last-to-expire licensed patent. The agreement also provides for an up-front Cost Reimbursement of
$100,000 payable to MIRALOGX to cover the already-incurred costs associated with the patent rights. The Cost Reimbursement is the only
payment made to date under the agreement. MIRALOGX may terminate the agreement upon insolvency, an uncured breach including the failure
to make any payment owed under the agreement or the failure to use commercially reasonable efforts to develop the licensed product, or
upon a default of the November 15, 2023 Promissory Note and Loan Agreement. The MIRALOGX License Agreement provides that MIRALOGX will
have sole control over the filing, prosecution, maintenance, and management of the licensed patent rights, provided that we will be responsible
for the cost of prosecuting and maintaining the licensed patents. The agreement grants to us the primary right, but not the obligation,
to enforce the licensed patent rights.

 Besides
relying on patents, we also rely on trade secrets, proprietary know-how and continuing innovation to develop and maintain our competitive
position, especially when we do not believe that patent protection is appropriate or can be obtained. We seek protection of these trade
secrets, proprietary know-how and any continuing innovation, in part, through confidentiality and proprietary information agreements.
However, these agreements may not provide meaningful protection for, or adequate remedies to protect, our technology in the event of
unauthorized use or disclosure of information. Furthermore, our trade secrets may otherwise become known to, or be independently developed
by, our competitors. We intend to seek appropriate patent protection for technology in our research and development programs, where applicable,
and their uses by filing patent applications in the United States and other selected countries. We intend for these patent applications
to cover, where possible, claims for compositions of matter, medical uses, processes for preparation and formulations.

 We
have a pending provisional patent application directed to MIRA-55, a structure that was synthesized and isolated during the research
and development of MIRA1a titled "Synthetic Cannabinoid Analogs, Pharmaceutical Compositions and Methods of Treating Anxiety and
Other Disorders". The Company intends to pursue domestic and foreign filings based on the provisional application to seek global
patent protection for MIRA-55.

 MIRA1a

 The U.S. Patent 10,787,675 B2, titled "Purified Synthetic Marijuana and Methods of Treatment by Administering Same," which
covers the MIRA1a compound per se as a racemic mixture, an isolated R-enantiomer, or an isolated S-enantiomer, as well as pharmaceutical
formulations of the compound, was assigned to our Company by SRQ Patent Holdings II, LLC ("SRQ")
in December 2021. This patent also covers MIRA1a in methods of treating Alzheimer's disease, anxiety, depression, and
addictions. Subject to payment of patent maintenance fees, the '675 patent offers protection extending through at least
February 11, 2039. According to the assignment and royalty agreement, we owe 8% in royalty revenue on net sales price and royalty revenue and 8% of milestone
payment revenue to SRQ.

 The royalties shall continue, in each country on a product-by-product and country-by-country basis until the later of i) the date
of expiration of the last to expire patent included within the Innovation, or ii) the date of expiration of the last strategic partnership/licensing
agreement including the Innovation.

 We
currently have no plans to develop the MIRA1a compound for approval and commercialization in or outside of the United States. See "Risk
Factors— Risks Related to Our Intellectual Property— We own the rights associated with our patents in the United States,
but we do not own the rights to patents covering MIRA1a in foreign jurisdictions."

 Properties

 Our
corporate headquarters and executive offices were in Baltimore, Maryland, which lease expires on April 30, 2024. Our current business
address is 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 32183, which is a virtual office.

 Employees

 As
of March 28, 2024, we had three employees and various consultants providing support. None of our employees are represented by a labor
union or are covered by a collective bargaining agreement. We consider our relationship with our employees to be satisfactory.

 Legal
Proceedings

 From
time to time, we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions,
administrative actions, investigations, or claims are pending against us or involve us that, in the opinion of our management, could
reasonably be expected to have a material adverse effect on our business and financial condition.

 We
anticipate that we will expend significant financial and managerial resources in the defense of our intellectual property rights in the
future if we believe that our rights have been violated. We also anticipate that we will expend significant financial and managerial
resources to defend against claims that our products and services infringe upon the intellectual property rights of third parties.

 Corporation
Information

 Our
corporate headquarters is located at 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 32183. Our telephone number is 786-432-9792.

 Our
principal website address is www.mirapharmaceuticals.com. The information contained on, or that can be accessed through, our website
is deemed not to be incorporated in this Report or to be part of this Report. You should not consider information contained on our website
to be part of this Report.

 ITEM
1A. Risk Factors

 RISK
FACTORS

 Investing
in shares of our common stock is very speculative and involves a high degree of risk. You should carefully consider the risks
and uncertainties described below, the section of this Report entitled "Management's Discussion and Analysis of Financial
Condition and Results of Operations" and our financial statements and related notes included elsewhere in this Report before investing
in shares of our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties
that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. If any of the
following risks occur, our business, operating results and prospects could be materially harmed. In that event, the price of our common
stock could decline, and you could lose part or all of your investment.

 Risks
Related to Our Operations and Financial Condition

 We
are an early development-stage company with no revenues. As such, our losses from operations and negative cash flows as of December 31,
2023 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity
financings.

 As
a very early development-stage enterprise that is focused on the development of a pre-clinical pharmaceutical product, we have generated
no revenue and have an accumulated deficit of $21.3 million through December 31, 2023, and $9.3 million through December 31, 2022. We
have concluded that substantial doubt exists about our ability to continue as a going concern for the 12 months following
the issuance of the financial statements included in this Annual Report on Form 10-K. As of the issuance date of these financial statements,
we believe that we have sufficient resources available to support our development activities and business operations and timely satisfy
our obligations as they come due into the fourth quarter of 2024. We do not have sufficient cash and cash equivalents as of the date
of filing this Annual Report on Form 10-K to support our operations for at least the 12 months following the issuance of the financial
statements.

 To
alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional
capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances
and drug product collaborations, however, none of these alternatives are committed at this time. There can be no assurance that we will
be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, identify and enter
into any strategic transactions that will provide the capital that we will require or achieve the other strategies to alleviate the conditions
that raise substantial doubt about our ability to continue as a going concern. If none of these alternatives are available,
or if available, are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business
operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital
on acceptable terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability
to achieve our business objectives and our competitiveness, and our business, financial condition, and results of operations will be
materially adversely affected. In addition, the perception that we may not be able to continue as a going concern may
cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.

 The
report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2023
contains an explanatory paragraph relating to our ability to continue as a going concern.

 The
auditor's opinion on our audited financial statements for the year ended December 31, 2023 includes an explanatory paragraph stating
that we have incurred recurring losses from operations that raise substantial doubt about our ability to continue as a going concern.
While we believe that we will be able to obtain the capital we need to continue our operations, there can be no assurances that we will
be successful in these efforts or will be able to resolve our liquidity issues or eliminate our operating losses. If we are unable to
obtain sufficient funding, we would need to significantly reduce our operating plans and curtail some or all of our development efforts.
Accordingly, our business, prospects, financial condition, and results of operations will be materially and adversely affected, and we
may be unable to continue as a going concern. If we seek additional financing to fund our business activities in the future
and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources
may be unwilling to provide additional funding on commercially reasonable terms or at all.

 Because
we have a limited operating history, you may not be able to accurately evaluate our operations.

 We
have had limited operations to date. Therefore, we have a limited operating history upon which to evaluate the merits of investing in
our company. Potential investors should be aware of the difficulties normally encountered by new companies and the high rate of failure
of such enterprises. The likelihood of success must be considered in light of the problems, expenses, difficulties, complications, and
delays encountered in connection with the operations that we plan to undertake. These potential problems include, but are not limited
to, unanticipated problems relating to the ability to generate sufficient cash flow to operate our business, and additional costs and
expenses that may exceed current estimates. We expect to continue to incur significant losses into the foreseeable future. We recognize
that if the effectiveness of our business plan is not forthcoming, we will not be able to continue business operations. There is no history
upon which to base any assumption as to the likelihood that we will prove successful, and it is doubtful that we will generate any operating
revenues or ever achieve profitable operations. If we are unsuccessful in addressing these risks, our business will most likely fail.

 We
have significant and increasing liquidity needs and will require additional funding.

 Our
operations have consumed substantial amounts of cash since inception. For the year ended December 31, 2023, we reported a net operating
cash outflow of $4.5 million and a net cash inflow from investing activities of $8.8 million. For the year ended December 31, 2022,
we reported a net operating cash outflow of $5.6 million and a net cash inflow from investing activities of $3.1 million.

and development, and general and administrative expenses, and cash used for operations will continue to be significant and may increase
substantially in the future in connection with new research and development initiatives and continued product commercialization efforts.
We may need to raise additional capital to fund our operations, continue to conduct clinical trials to support potential regulatory approval
of marketing applications and to fund commercialization of our products.

 The
amount and timing of our future funding requirements will depend on many factors, including, but not limited to:

 the
 timing of FDA approval, if any;

 the
 DEA continuing to classify Ketamir-2 and MIRA1a as a substance not subject to CSA;

 the
 DEA granting the classification of MIRA-55 as a substance not subject to CSA;

 the
 timing and amount of revenue from sales of our products, or revenue from grants or other sources;

 the
 rate of progress and cost of our clinical trials and other product development programs;

 costs
 of establishing or outsourcing sales, marketing, and distribution capabilities;

 costs
 and timing of completion of expanded in-house manufacturing facilities as well as any outsourced commercial manufacturing supply
 arrangements for our product candidates;

 costs
 of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights associated with our product
 candidates;

 costs
 of operating as a U.S. public company;

 the
 effect of competing technological and market developments;

 personnel,
 facilities, and equipment requirements; and

 the
 terms and timing of any additional collaborative, licensing, co-promotion, or other arrangements that we may establish.

 While
we expect to fund our future capital requirements from a number of sources including existing cash balances, future cash flows from operations
and the proceeds from further public offerings, we cannot assure you that any of these funding sources will be available to us on favorable
terms, or at all. Further, even if we can raise funds from all of the above sources, the amounts raised may not be sufficient to meet
our future capital requirements.

 Operating
results may vary significantly in future periods.

 Our
operating and financial results are likely to fluctuate significantly in the future. Our operating and financial results are unpredictable
and may fluctuate, for among other reasons, due to:

 our
 achievement of product development objectives and milestones;

 clinical
 trial enrollment and expenses;

 research
 and development expenses; and

 the
 timing and nature of contract manufacturing and contract research payments.

 In
addition, a high portion of our costs are determined on an annual basis, due in part to our significant research and development costs.
Thus, increases in our costs could disproportionately affect financial results in a quarter. Other factors, including non-cash expenses
associated with financing activity, could also lead to fluctuations in our results of operations. Because of these factors, our operating
and financial results in one or more future quarters may fail to meet the expectations of securities analysts or investors, which could
cause our share price to decline.

 We
have yet to generate revenues or achieve a profit and may not generate revenue or achieve a profit for many years, if at all.

 We
have not yet produced any revenues or profit and may not for many years, if at all. Our ability to generate revenue is dependent on the
receipt of regulatory approval of our product candidates, which will take years to achieve and may not be obtained. We therefore cannot
assure you we will be able to ever generate sufficient revenue to pay for our expenses or achieve profitability. Our ability to continue
as a going concern in the future is dependent upon raising capital from financing transactions and keeping operating expenses below our
revenue levels in order to achieve positive cash flows, none of which can be assured.

 Conflicts
of interest may arise between us and MIRALOGX.

 MIRALOGX
licenses us the patent pending rights to KETAMIR-2. MIRALOGX is a separate intellectual property development company owned by the Bay
Shore Trust. The Bay Shore Trust is also our largest stockholder. The interests of MIRALOGX are 100% owned by the Bay Shore Trust. Our
relationship with MIRALOGX and the Bay Shore Trust may create, or may create the appearance of, conflicts of interest when we are faced
with decisions that could have different implications for MIRALOGX than the decisions have for us. Furthermore, in light of the license
agreement that we have with MIRALOGX, if a dispute were to arise between MIRALOGX and us relating to our past or future relationship
with MIRALOGX or with respect to intellectual property matters, these potential conflicts of interest may make it more difficult for
us to favorably resolve such disputes.

of our executive officers will not be employed by us on a full-time basis.

 Erez
Aminov, our Chairman and Chief Executive Officer, will not be employed by our company on full-time basis. As provided in his respective
employment agreement with our company, Mr. Aminov is expected to devote approximately fifty percent (50%) of his business time to the
affairs of our company. Because this officer will not work full time for our company, instances may occur where he may not be immediately
available to provide solutions to problems or address concerns that arise in the course of us conducting our business and thus adversely
affect our business. In addition, he can become subject to conflicts of interest because he devotes part of his working time to other
business endeavors and has responsibilities to other entities. Although such officer is aware of his duty and accountability to our company
and to applicable laws and policies relating to corporate opportunity and conflicts of interest, such conflicts of interest may include
deciding how much time to devote to our affairs, as well as what business opportunities should be presented to us.

 Risks
Relating to Our Business and Our Industry

 Our
future viability will largely depend on the positive development of Ketamir-2 and MIRA-55, and any future product candidates, which development
will require significant capital resources and years of clinical development effort.

 We
currently have no drug products on the market, and all of our drug development projects are in a pre-clinical stage of development. Our
business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory approval, and commercialization
of our product candidates, principally Ketamir-2 and MIRA-55. Investors need to be aware that substantial additional investments including
pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required before we are permitted to
undertake clinical studies and market and commercialize our product candidates, if ever. It may be several years before we can commence
clinical trials, if ever. Any clinical trial will be subject to extensive and rigorous review and regulation by numerous government authorities
in the United States and other jurisdictions where we intend, if approved, to market our product candidates. Before obtaining regulatory
approvals for any of our product candidates, we must demonstrate through pre-clinical testing and clinical trials that the product candidate
is safe and effective for its specific application. This process can take many years and may include post- marketing studies and surveillance,
which would require the expenditure of substantial resources. Of the large number of drugs in development for approval in the United
States (and the rest of the world), only a small percentage will successfully complete the FDA regulatory approval financing to fund
our planned research, development, and clinical programs, we cannot assure you that any of our product candidates will be successfully
developed or commercialized.

 We
may be unable to formulate or scale up any or all of our product candidates. There is no guarantee that any of the product candidates
will be or are able to be manufactured or produced in a manner to meet the FDA's criteria for product stability, content uniformity
and all other criteria necessary for product approval in the United States and other markets. Any of our product candidates may fail
to achieve their specified endpoints in clinical trials.

 Furthermore,
product candidates may not be approved even if they achieve their specified endpoints in clinical trials. The FDA may disagree with our
trial design and our interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed
and commented on the design for our clinical trials. The FDA may also approve a drug for fewer or more limited indications than we request
or may grant approval contingent on the performance of costly post-approval clinical trials (i.e., Phase IV trials). In addition, the
FDA may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product
candidates.

 If
we are unable to obtain regulatory approval for Ketamir-2 and MIRA-55 within the timeline we anticipate, we will not be able to execute
our business strategy effectively and our ability to substantially grow our revenues will be limited, which would have a material adverse
impact on our long-term business, results of operations, financial condition, and prospects.

 We
are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.

 Our
ability to progress our plan will depend on our ability to clinically develop, gain regulatory approval for and ultimately commercialize
our product candidates. Our ability to successfully commercialize our product candidates will depend on, among other things, our ability
to:

 successfully
 complete pre-clinical and other nonclinical studies and clinical trials in a manner that allows us to progress our studies;

 receive
 IND acceptance and regulatory approvals from the FDA;

 produce,
 through a validated process, in manufacturing facilities inspected and approved by regulatory authorities, including the FDA, sufficiently
 large quantities of product candidates to permit successful commercialization;

 obtain
 reimbursement from payers such as government health care programs and insurance companies and achieve commercially attractive levels
 of pricing;

 secure
 acceptance of our product candidates from physicians, health care payers, patients, and the medical community;

 create
 positive publicity surrounding our product candidates;

 manage
 our spending as costs and expenses increase due to clinical trials and commercialization; and

 obtain
 and enforce sufficient intellectual property for our product candidates.

 Our
failure or delay with respect to any of the factors above could have a material adverse effect on our business, results of operations
and financial condition.

 Impact
of global tensions may increase uncertainty of our future operations.

 The
global tensions arising from the Palestine-Israel war and the war in Ukraine may result in disruptions in the broader global
economic environment. The uncertain nature, magnitude, and duration of hostilities stemming from
such conflicts, including the potential effects of sanctions and countersanctions, or retaliatory cyber-attacks on the world economy
and markets, have contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic factors
that affect our business and operations, such as pre-clinical study issues, manufacturer delays or shipping delays.

the conflict between Palestine and Israel could impact future business decisions to locate potential clinical trials in Israel.
It is not possible to predict the short and long-term implications of military conflicts or wars or geopolitical tensions which could
include further sanctions, uncertainty about economic and political stability, increases in inflation rate and energy prices, cyber-attacks,
supply chain challenges and adverse effects on currency exchange rates and financial markets.

 Results
of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.

 Any
positive results from future pre-clinical testing of our product candidates and potential future clinical trials may not necessarily
be predictive of the results from Phase 1, Phase 2 or Phase 3 clinical trials. In addition, our interpretation of results derived from
clinical data or our conclusions based on our pre-clinical data may prove inaccurate. Frequently, pharmaceutical and biotechnology companies
have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical testing and early phase clinical
trials, and we cannot be certain that we will not face similar setbacks. These setbacks may be caused by the fact that pre-clinical and
clinical data can be susceptible to varying interpretations and analyses. Furthermore, certain product candidates may perform satisfactorily
in pre-clinical studies and clinical trials, but nonetheless fail to obtain FDA approval or appropriate approvals by the appropriate
regulatory authorities in other countries. If we fail to produce positive results in our clinical trials for our product candidates,
the development timeline and regulatory approval and commercialization prospects for them and as a result our business and financial
prospects, would be materially adversely affected.

 We
have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement
capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future.

 If
regulatory approval of our products is ever obtained, our ability to generate revenues ultimately depends on our ability to sell our
approved products and secure adequate third-party reimbursement. We currently have limited experience in marketing and selling our products.
We currently do not have any products approved for sale in the United States or in any other country.

 The
commercial success of our product candidates will not even be possible for the foreseeable future and will depend on a number of factors
beyond our control, including the willingness of physicians to prescribe our products to patients, payers' willingness and ability
to pay for the drugs, the level of pricing achieved, patients' response to our drugs and the ability of our marketing partners
to generate sales. There can be no guarantee that we will be able to establish or maintain the personnel, systems, arrangements and capabilities
necessary to successfully commercialize Ketamir-2 and MIRA-55 or any product candidate approved by the FDA in the future. If we fail
to establish or maintain successful marketing, sales and reimbursement capabilities or fail to enter into successful marketing arrangements
with third parties, our product revenues may suffer.

 Should
we later determine it is in our best interest to develop a sales force we may be unable to effectively train and equip our sales force,
therefore our ability to successfully commercialize our products may be harmed.

 We
will be required to expend significant time and resources to train our sales force to be credible, persuasive and compliant with applicable
laws in marketing Ketamir-2 and MIRA-55 or our other product candidates to physicians for their approved uses. In addition, we must continue
to train our sales force to ensure that a consistent and appropriate message about Ketamir-2 and MIRA-55 or our other product candidates
are being delivered to our potential customers. If we are unable to effectively train our sales force and equip them with effective materials,
including medical and sales literature to help them inform and educate potential customers about the benefits of Ketamir-2 and MIRA-55
and our product candidates and its proper administration, our efforts to successfully commercialize Ketamir-2 and MIRA-55 and our product
candidates could be jeopardized, which would negatively impact our ability to generate product revenues.

 We
will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing
our growth and executing our growth strategy.

 Our
management and personnel, systems, and facilities currently in place may not be adequate to support our business plan and future growth.
As a result, we may need to further expand certain areas of our organization.

 Our
need to effectively manage our operations, growth and various projects requires that we:

 continue
 to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures;

 attract
 and retain enough talented employees;

 manage
 our clinical trials effectively;

 manage
 our external manufacturing operations with contract research organizations effectively and in a cost-effective manner;

 manage
 our development efforts effectively while carrying out our contractual obligations to contractors and other third parties; and

 In
addition, we may utilize the services of part-time outside consultants and contractors to perform several tasks for us, including tasks
related to compliance programs, clinical trial management, regulatory affairs, formulation development and other drug development functions.
Our growth strategy may entail expanding our use of consultants and contractors to implement these and other tasks going forward. If
we are not able to effectively expand our organization by hiring new employees and expanding our use of consultants and contractors,
we may be unable to successfully implement the tasks necessary to effectively execute on our planned research, development, manufacturing,
and commercialization activities and, accordingly, may not achieve our research, development and commercialization goals.

 Our
product candidates, if approved, may be unable to achieve the expected market acceptance and, consequently, limit our ability to generate
revenue from new products.

 Even
when product development is successful and regulatory approval has been obtained, our ability to generate sufficient revenue depends
on the acceptance of our products by physicians and patients. We cannot assure you that our product candidates will achieve the expected
level of market acceptance and revenue if and when they obtain the requisite regulatory approvals. The market acceptance of any product
depends on a number of factors, including the indication statement and warnings required by regulatory authorities in the product label.
Market acceptance can also be influenced by continued demonstration of efficacy and safety in commercial use, physicians' willingness
to prescribe the product, reimbursement from third-party payers such as government health care programs and private third-party payers,
the price of the product, the nature of any post-approval risk, management activities mandated by regulatory authorities, competition,
and marketing and distribution support. Further, an ineffective or inefficient distribution model at launch may lead to the inability
to fulfill demand, and consequently a loss of revenue. Any factors preventing or limiting the market acceptance of our products could
have a material adverse effect on our business, results of operations and financial condition.

 If
the price for any future approved products decreases or if government and other third-party payers do not provide coverage and adequate
reimbursement levels, our revenue and prospects for profitability will suffer.

 Patients
who are prescribed medicine for the treatment of their conditions generally rely on third-party payers to reimburse all or part of the
costs associated with their prescription drugs. Reimbursement systems in international markets vary significantly by country and by region,
and reimbursement approvals generally must be obtained on a country-by-country basis. Coverage and adequate reimbursement from governmental
healthcare programs, such as Medicare and Medicaid, and commercial payers is critical to new product acceptance. Coverage decisions may
depend upon clinical and economic standards that disfavor new drug products when more established or lower-cost therapeutic alternatives
are already available or subsequently become available. Even if we obtain coverage for products we may market, the resulting reimbursement
payment rates may require co-payments that patients find unacceptably high. Patients may not use our products if coverage is not provided,
or reimbursement is inadequate to cover a significant portion of its cost.

 In
addition, the market for our products will depend significantly on access to third-party payers' drug formularies or lists of medications
for which third-party payers provide coverage and reimbursement. The industry competition to be included in such formularies often leads
to downward pricing pressures on pharmaceutical companies. Also, third-party payers may refuse to include a particular branded drug in
their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or other alternative is
available, even if not approved for the indications for which our products are approved.

payers or governmental or commercial entities are developing increasingly sophisticated methods of controlling healthcare costs. The
current environment is putting pressure on companies to price products below what they may feel is appropriate. Selling our products
at less than an optimized price could impact our revenues and overall success as a company. It will be difficult to determine the optimized
price for our products. In addition, in the U.S., no uniform policy of coverage and reimbursement for drug products exists among third-party
payers. Therefore, coverage and reimbursement for our products may differ significantly from payer to payer. As a result, the coverage
determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for
the use of our products to each payer separately, with no assurance that coverage will be obtained. If we are unable to obtain coverage
of, and adequate payment levels for, products we may market to third-party payers, physicians may limit how much or under what circumstances
they will prescribe or administer them, and patients may decline to purchase them. This in turn could affect our ability to successfully
commercialize products we may market, and thereby adversely impact our profitability, results of operations, financial condition, and
future success.

 In
addition, where we have chosen to collaborate with a third party on product candidate development and commercialization, our partner
may elect to reduce the price of our products in order to increase the likelihood of obtaining reimbursement approvals. In many countries,
products cannot be commercially launched until reimbursement is approved and the negotiation process in some countries can exceed 12
months. In addition, pricing and reimbursement decisions in certain countries can be affected by decisions taken in other countries,
which can lead to mandatory price reductions and/or additional reimbursement restrictions across a number of other countries, which may
thereby adversely affect our sales and profitability. In the event that countries impose prices that are not sufficient to allow us or
our partners to generate a profit, our partners may refuse to launch the product in such countries or withdraw the product from the market,
which would adversely affect sales and profitability. Events, such as price decreases, government mandated rebates or unfavorable reimbursement
decisions, could affect the pricing and reimbursement of Ketamir-2 and MIRA-55 and our other product candidates and could have a material
adverse effect on our business, reputation, results of operations and financial condition.

 We
expect to face intense competition, often from companies with greater resources and experience than we have.

 Demand
for ketamine analogs like Ketamir-2 and synthetic cannabinoids such as MIRA-55 and will likely be dependent on a number of social, political,
legislative, and economic factors that are beyond our control. While we believe that there will be a demand for such drugs, and that
the demand will grow, there is no assurance that such demand will happen, that we will benefit from any demand or that our business,
in fact, will ever generate revenues from our drug development programs or become profitable.

 The
emerging markets for product candidates like ours and related medical research and development is and will likely remain competitive.
The development and commercialization of drugs and medicines is highly competitive. We compete with a variety of multinational pharmaceutical
companies and specialized biotechnology companies, as well as products and processes being developed by universities and other research
institutions. Many of our competitors have developed, are developing, or will develop drugs and processes which may be competitive with
our drug candidates. Competitive therapeutic treatments include those that have already been approved by medicines regulators and accepted
by the medical community and any new treatments that may enter the market. For some of our drug development programs / areas of therapeutic
interest, other treatment options are currently available, under development, and may become commercially available in the future. If
any of our product candidates are approved for the diseases and conditions we are currently pursuing, they may compete with a range of
medicines or therapeutic treatments that are either in development, will be developed in the future or currently marketed.

 Established
companies may have a competitive advantage over us due to their size and experiences, financial resources, and institutional networks.
Many of our competitors may have significantly greater financial, technical, and human resources than we do. Due to these factors, our
competitors may have an advantage in marketing their approved drugs and may obtain regulatory approval of their drug candidates before
we are able to, which may limit our ability to develop or commercialize our drug candidates. Our competitors may also develop drugs /
medicines that are safer, more effective, more widely used and less expensive than ours. These advantages could materially impact our
ability to develop and, if approved, commercialize our product candidates successfully. Furthermore, some of these competitors may make
acquisitions or establish collaborative relationships among themselves or with third parties to increase their ability to rapidly gain
market share.

 Our
product candidates may compete with other synthetic cannabinoids, as well as with cannabinoid or cannabis-based drugs, in addition to
competing with state-licensed medical and recreational marijuana, in markets where the recreational and/or medical use of marijuana is
legal. There is continuing support in the U.S. for further state legalization of marijuana. In markets where recreational and/or medical
marijuana is not legal, our product candidates, once approved by regulators, may compete with marijuana or marijuana-based products purchased
in the illegal drug market. This may or may not affect the commercial price that we may be able to achieve for our synthetic regulatory-approved
medicines, should they be approved by the FDA.

as generic versions of drug products enter the market, the price for such medicines may be expected to decline rapidly and substantially.
Even if we are the first to obtain FDA approval of one of our product candidates, the future potential approval of generics could adversely
affect the price we are able to charge, and the profitability of our product(s) will likely decline.

 Mergers
and acquisitions in the pharmaceutical and biotechnology industries may result in more resources being concentrated among a smaller number
of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large and established companies.

 These
companies may compete with us in recruiting and retaining qualified scientific, management and commercial personnel, utilizing contract
manufacturing facilities or contract research organizations (CROs), or establishing clinical trial sites and subject registration for
clinical trials, as well as in acquiring technologies complementary to our research projects.

 Product
shipment delays could have a material adverse effect on our business, results of operations and financial condition.

 The
shipment, import and export of Ketamir-2 and MIRA-55 and our other product candidates require import and export licenses. In the U.S.,
FDA, U.S. Customs and Border Protection and the DEA, and in other countries similar regulatory authorities, regulate the import and export
of pharmaceutical products that contain controlled substances. Specifically, the import and export process require the issuance of import
and export licenses by the relevant controlled substance authority in both the importing and exporting country. We may not be granted,
or if granted, maintain, such licenses from the authorities in certain countries. Even if we obtain the relevant licenses, shipments
of Ketamir-2 and MIRA-55 and our product candidates may be held up in transit, which could cause significant delays and may lead to product
batches being stored outside required temperature ranges. Inappropriate storage may damage the product shipment resulting in a partial
or total loss of revenue from one or more shipments of Ketamir-2 and MIRA-55 or our other product candidates. A partial or total loss
of revenue from one or more shipments of Ketamir-2 and MIRA-55 or our other product candidates could have a material adverse effect on
our business, results of operations and financial condition. Even though the DEA has confirmed in writing that it conducted a scientific
review of the chemical structure of MIRA1a and Ketamir-2 in accordance with the definitions within the CSA and its implementing regulations
and determined that MIRA1a and Ketamir-2 is not a controlled substance or listed chemical, there is no assurance that the DEA may not
change its position. We have filed the necessary requirements with the DEA to review MIRA-55, however, there can be
no assurance that the DEA will conclude that MIRA-55 is not a controlled substance or listed chemical.

 The
manufacture of our product candidates is complex and uncertain, and until we develop a validated manufacturing process, we may encounter
difficulties in supplying our planned and future clinical trials. If we encounter such difficulties, or fail to meet quality standards,
our ability to meet clinical timelines and expand our development strategy could be impacted.

 The
processes involved in manufacturing Ketamir-2, MIRA-55 and other product candidates are complex, expensive, highly regulated and subject
to multiple risks and uncertainties. We have been faced with issues such as this in the initial synthesis of MIRA-55 (which we initially
believed was based on our patented MIRA1a molecule).

 In
addition, as product candidates are developed through early to late-stage clinical trials and then to approval and commercialization,
it is common that various aspects of the development program, such as manufacturing methods, are modified along the way to optimize the
scale, process and results. Any changes to the manufacturing processes carry the risk that they will not achieve these intended objectives,
or that the product candidates may not meet the rigorous quality standards necessary for use in our pre-clinical or clinical trials.

 Also,
if planned or future manufacturing of Ketamir-2, MIRA-55 or other product candidates fails to meet the quality standards for use in our
pre-clinical or clinical trials, or the active drug substance does not meet our quality specifications, it could impact our timelines
and limit our development strategy. For example, and as discussed above, in the first quarter of 2024, we concluded that during the manufacturing
and scale-up process of MIRA1a, the intended MIRA1a compound was in fact synthesized as MIRA-55.

our contract manufacturing organizations ("CMOs") or contract development and manufacturing
organization ("CDMOs") may be unable to successfully increase the manufacturing scale for our product candidates in
a timely or cost-effective manner and may experience delays due to limited manufacturing capacity. In addition, quality issues may arise
during manufacturing activities. If our CMOs or CDMOs are unable to successfully manufacture our product candidates in sufficient quantity
in a timely manner or produce active drug substances that do not meet our quality specifications, our planned pre-clinical or clinical
trials may be delayed or modified.

 We
may fail to expand our manufacturing capability in time to meet market demand for our products and product candidates, and the FDA may
refuse to accept our facilities or those of our contract manufacturers as being suitable for the production of our products and product
candidates. Any problems in our manufacturing process could have a material adverse effect on our business, results of operations and
financial condition.

 Before
we can begin commercial manufacture of any product candidates for sale in the U.S., we must obtain FDA regulatory approval for the product,
which requires a successful FDA inspection of our manufacturing facilities and those of our contract manufacturers, processes, and quality
systems in addition to other product-related approvals. Although we may successfully navigate this pre-approval inspection process as
it relates in the U.S., pharmaceutical manufacturing facilities are continuously subject to post-approval inspection by the FDA and foreign
regulatory authorities. Due to the complexity of the processes used to manufacture our product candidates, we may be unable to initially
or continue to pass federal, state or international regulatory inspections in a cost-effective manner. If we are unable to comply with
manufacturing regulations, we may be subject to fines, unanticipated compliance expenses, recall or seizure of any approved products,
total or partial suspension of production and/or enforcement actions, including injunctions, and criminal or civil prosecution. These
possible sanctions would adversely affect our business, results of operations and financial condition.

 Business
interruptions could delay us in the process of developing our product candidates and could disrupt our product sales.

 Our
research and development activities are conducted through outside contractors and manufacturers. Loss of our contracted manufacturing
facilities, stored inventory or laboratory facilities through fire, theft or other causes, or loss of our raw material, could have an
adverse effect on our ability to continue product development activities and to conduct our business. Failure to supply our partners
with commercial product may lead to adverse consequences, including the right of partners to take over responsibility for product supply.
We currently do not have insurance coverage to compensate us for such business interruptions. Our contract manufacturers and suppliers
provide that in their separate operations; however, such coverage may prove insufficient to fully compensate us for the damage to our
business resulting from any significant property or casualty loss to those facilities.

 If
product liability lawsuits are successfully brought against us, we will incur substantial liabilities and may be required to limit the
commercialization of Ketamir-2 and MIRA-55 and our product candidates.

 Although
we have never had any product liability claims or lawsuits brought against us, we face potential product liability exposure related to
the testing of our product candidates in human clinical trials. We may face exposure to claims by an even greater number of persons when
we begin to market and distribute our products commercially in the U.S., Europe and elsewhere. Now, and in the future, an individual
may bring a liability claim against us alleging that Ketamir-2, MIRA-55 or one of our other product candidates caused an injury. While
we continue to take what we believe are appropriate precautions, we may be unable to avoid significant liability if any product liability
lawsuit is brought against us. Large judgments have been awarded in class action or individual lawsuits based on drugs that had unanticipated
side effects. If we cannot successfully defend ourselves against product liability claims, we will incur substantial liabilities. Regardless
of merit or eventual outcome, liability claims may result in:

 decreased
 demand for Ketamir-2, MIRA-55 or our other product candidates if such product candidates are approved;

 injury
 to our reputation;

 withdrawal
 of clinical trial participants;

 costs
 of related litigation;

 substantial
 monetary awards to patients and others;

 increased
 cost of liability insurance;

 loss
 of revenue; and

 the
 inability to successfully commercialize our products.

 Counterfeit
versions of our products could harm our business.

 Counterfeiting
activities and the presence of counterfeit products in a number of markets and over the Internet continue to be a challenge for maintaining
a safe drug supply for the pharmaceutical industry. Counterfeit products are frequently unsafe or ineffective and can be life-threatening.
To distributors and users, counterfeit products may be visually indistinguishable from the authentic version. Reports of adverse reactions
to counterfeit drugs along with increased levels of counterfeiting could be mistakenly attributed to the authentic product, affect patient
confidence in the authentic product and harm the business of companies such as ours. If our products were to be the subject of counterfeits,
we could incur reputational and financial harm.

 We
depend upon our key personnel and our ability to attract and retain employees.

 Our
future growth and success depend on our ability to recruit, retain, manage, and motivate our employees. The inability to hire or retain
experienced management personnel could adversely affect our ability to execute our business plan and harm our operating results. Due
to the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified scientific,
technical, and managerial personnel. The competition for qualified personnel in the pharmaceutical field is intense. Due to this intense
competition, we may be unable to continue to attract and retain the qualified personnel necessary for the development of our business
or to recruit suitable replacement personnel.

 Our
employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

 We
are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with
FDA or foreign regulations, provide accurate information to FDA or other regulatory authorities, comply with applicable manufacturing
standards, comply with other foreign, federal, and state laws and regulations, report information or data accurately or disclose unauthorized
activities to us. Employee misconduct could also involve the improper use of information, including information obtained during clinical
trials, or illegal appropriation of drug products, which could result in government investigations and serious harm to our reputation.
The precautions we take to detect and prevent these prohibited activities may not be effective in controlling unknown or unmanaged risks
or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such
laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our
rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

 We
are subject to the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, customs laws, sanctions
laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties,
other remedial measures, and legal expenses, which could adversely affect our business, results of operations and financial condition.

 Our
operations are subject to anti-corruption laws, including the U.S. Foreign Corrupt Practices Act of 1977, as amended (the "FCPA"),
and other anti-corruption laws that apply in countries where we do business. The FCPA and these other laws generally prohibit us and
our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons
to obtain or retain business or gain some other business advantage. We and our commercial partners operate in a number of jurisdictions
that pose a high risk of potential FCPA violations, and we participate in collaborations and relationships with third parties whose actions
could potentially subject us to liability under the FCPA or local anti-corruption laws. In addition, we cannot predict the nature, scope,
or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws
might be administered or interpreted.

 We
are also subject to other laws and regulations governing our international operations, including regulations administered by the government
of the U.S. and other countries in which we operate or plan to operate, including applicable export control regulations, economic sanctions
on countries and persons, customs requirements, and currency exchange regulations, (collectively referred to as the "Trade Control
laws").

 However,
there is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including
the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the FCPA and other anti-corruption
laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures,
and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity, as
well as our reputation. Likewise, any investigation of any potential violations of the FCPA, other anti-corruption laws or Trade Control
laws by the U.S. or other authorities could also have an adverse impact on our reputation, our business, results of operations and financial
condition.

 Our
proprietary information, or that of our suppliers and business partners, may be lost or we may suffer security breaches.

 In
the ordinary course of our business, we will collect and store sensitive data, including valuable and commercially sensitive intellectual
property, clinical trial data, our proprietary business information and that of our suppliers and business partners, and personally identifiable
information of our clinical trial subjects and employees, on our networks, and with our third-party cloud service providers. The secure
processing, maintenance and transmission of this information is critical to our operations. Despite our security measures, our information
technology and infrastructure, and that of our third parties, may be vulnerable to attacks by hackers or breached due to employee error,
malfeasance, or other disruptions. Any breach could compromise our networks and the information stored there could be accessed, publicly
disclosed, lost, or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability
under laws that protect the privacy of personal information, regulatory penalties, disrupt our operations, damage our reputation, and
cause a loss of confidence in our products and our ability to conduct clinical trials, which could adversely affect our business and
reputation and lead to delays in gaining regulatory approvals for Ketamir-2 and MIRA-55 or other product candidates.

 Failure
of our information technology systems, including cybersecurity attacks or other data security incidents, could significantly disrupt
the operation of our business.

 Our
business is increasingly dependent on critical, complex, and interdependent information technology ("IT") systems, including
internet-based systems, some of which are managed or hosted by third parties, to support business processes as well as internal and external
communications. The size and complexity of our IT systems make us potentially vulnerable to IT system breakdowns, malicious intrusion,
and computer viruses, which may result in the impairment of our ability to operate our business effectively.

 We
are continuously evaluating and, where appropriate, enhancing our IT systems to address our planned growth, including to support our
planned manufacturing operations. There are inherent costs and risks associated with implementing the enhancements to our IT systems,
including potential delays in access to, or errors in, critical business and financial information, substantial capital expenditures,
additional administrative time and operating expenses, retention of sufficiently skilled personnel to implement and operate the enhanced
systems, demands on management time, and costs of delays or difficulties in transitioning to the enhanced systems, any of which could
harm our business and results of operations. In addition, the implementation of enhancements to our IT systems may not result in productivity
improvements at a level that outweighs the costs of implementation, or at all. In addition, our systems and the systems of our third-party
providers and collaborators are potentially vulnerable to data security breaches which may expose sensitive data to unauthorized persons
or to the public. Such data security breaches could lead to the loss of confidential information, trade secrets or other intellectual
property, could lead to the public exposure of personal information (including personally identifiable information or individually identifiable
health information) of our employees, clinical trial patients, customers, business partners, and others, could lead to potential identity
theft, or could lead to reputational harm. Data security breaches could also result in loss of clinical trial data or damage to the integrity
of that data. In addition, the increased use of social media by our employees and contractors could result in inadvertent disclosure
of sensitive data or personal information, including but not limited to, confidential information, trade secrets and other intellectual
property.

 Any
such disruption or security breach, as well as any action by us or our employees or contractors that might be inconsistent with the rapidly
evolving data privacy and security laws and regulations applicable within the United States and elsewhere where we conduct business,
could result in enforcement actions by U.S. states, the U.S. federal government or foreign governments, liability or sanctions under
data privacy laws, including healthcare laws such as HIPAA, that protect certain types of sensitive information, regulatory penalties,
other legal proceedings such as but not limited to private litigation, the incurrence of significant remediation costs, disruptions to
our development programs, business operations and collaborations, diversion of management efforts and damage to our reputation, which
could harm our business and operations. Because of the rapidly moving nature of technology and the increasing sophistication of cybersecurity
threats, our measures to prevent, respond to and minimize such risks may be unsuccessful.

 Security
breaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent us from accessing
critical information or expose us to liability, which could adversely affect our business and our reputation.

 In
the ordinary course of our business, we, our vendors, and our third-party cloud service providers may collect and store sensitive data,
including legally protected patient health information, credit card information, personally identifiable information about our employees
and patients, intellectual property, and proprietary business information. We manage and maintain our applications and data utilizing
cloud-based and on-site systems. These applications and data encompass a wide variety of business-critical information including research
and development information, commercial information and business and financial information.

 The
secure processing, storage, maintenance, and transmission of this critical information is vital to our operations and business strategy,
and we devote significant resources to protecting such information. Although we take measures to protect sensitive information from unauthorized
access or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers, or viruses, breaches, or
interruptions due to employee error, malfeasance or other disruptions, or lapses in compliance with privacy and security mandates. Any
such virus, breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties,
publicly disclosed, lost or stolen. We have measures in place that are designed to prevent, and if necessary to detect and respond to
such security incidents, breaches of privacy, and security mandates. However, in the future, any such access, disclosure or other loss
of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such
as HIPAA in the United States and the General Data Protection Regulation in the European Union, or GDPR, government enforcement actions
and regulatory penalties. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process
samples, provide test results, share and monitor safety data, bill payers or patients, provide customer support services, conduct research
and development activities, process and prepare company financial information, manage various general and administrative aspects of our
business and may damage our reputation, any of which could adversely affect our business, financial condition and results of operations.

 Legislative
or regulatory reform of the health care system in the U.S. may affect our ability to profitably sell our products, if approved.

 Our
ability to commercialize our future products successfully, alone or with collaborators, will depend in part on the extent to which coverage
and reimbursement for the products will be available from government and health administration authorities, private health insurers and
other third-party payers. The continuing efforts of the U.S. government, insurance companies, managed care organizations and other payers
for health care services to contain or reduce health care costs may adversely affect our ability to set prices for our products which
we believe are fair, and our ability to generate revenues and achieve and maintain profitability.

 Specifically,
in the U.S., there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect
our ability to sell our products profitably. For example, certain states in the U.S. are proposing legislation mandating publicly funded
health program coverage of medical cannabis. In addition, the 2010 Affordable Care Act, or the ACA, substantially changed the way healthcare
is financed by both governmental and private insurers. Both Congress and the U.S. President have already taken some actions that are
intended to significantly limit the ACA, and we expect efforts to further modify or repeal the ACA to continue. The success and potential
effects of these efforts to repeal or modify the ACA are not clear.

 We
expect additional federal and state legislative proposals for health care reform, which could limit the prices that can be charged for
the products we develop and may limit our commercial opportunity.

 The
continuing efforts of government and other third-party payers to contain or reduce the costs of health care through various means may
limit our commercial opportunity. It will be time-consuming and expensive for us to go through the process of seeking coverage and reimbursement
from Medicare, Medicaid, and other governmental health programs and from private payers. Our products may not be considered cost-effective,
and government and third-party private health insurance coverage and reimbursement may not be available to patients for any of our future
products or sufficient to allow us to sell our products on a competitive and profitable basis. Our results of operations could be adversely
affected by ACA, changes to the ACA, and by other health care reforms that may be enacted or adopted in the future. In addition, increasing
emphasis on managed care in the U.S. will continue to put downward pressure on the pricing of pharmaceutical products. Cost-control initiatives
could decrease the price that we or any potential collaborators could receive for any of our future products and could adversely affect
our ability to generate revenue in the U.S. market and maintain profitability.

 We
may acquire other companies which could divert our management's attention, result in additional dilution to our shareholders and
otherwise disrupt our operations and harm our operating results.

 We
may in the future seek to acquire businesses, products, or technologies that we believe could complement or expand our product offerings,
enhance our technical capabilities or otherwise offer growth opportunities. The pursuit of potential acquisitions may divert the attention
of management and cause us to incur various expenses in identifying, investigating, and pursuing suitable acquisitions, whether or not
they are consummated. If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations and technologies
successfully, effectively manage the combined business following the acquisition or realize anticipated cost savings or synergies. We
also may not achieve the anticipated benefits from the acquired business due to a number of factors, including:

 incurrence
 of acquisition-related costs;

 diversion
 of management's attention from other business concerns;

 unanticipated
 costs or liabilities associated with the acquisition;

 harm
 to our existing business relationships with collaboration partners as a result of the acquisition;

 harm
 to our brand and reputation;

 the
 potential loss of key employees;

 use
 of resources that are needed in other parts of our business; and

 use
 of substantial portions of our available cash to consummate the acquisition.

 In
the future, if our acquisitions do not yield expected returns, we may be required to take charges to our operating results arising from
the impairment assessment process. Acquisitions may also result in dilutive issuances of equity securities or the incurrence of debt,
which could adversely affect our operating results. In addition, if an acquired business fails to meet our expectations, our business,
results of operations and financial condition may be adversely affected.

 Risks
Related to Development and Regulatory Approval of Our Product Candidates

trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination. The results
of clinical trials are open to differing interpretations.

trials are expensive, time consuming and difficult to design and implement. Regulatory agencies may analyze or interpret the results
differently than us. Even if the results of our clinical trials are favorable, the clinical trials for a number of our product candidates
are expected to continue for several years and may take significantly longer to complete. In addition, we, the FDA, or other regulatory
authorities, including state and local authorities, or an Institutional Review Board, or IRB, with respect to a trial at its institution,
may suspend, delay or terminate our clinical trials at any time, require us to conduct additional clinical trials, require a particular
clinical trial to continue for a longer duration than originally planned, require a change to our development plans such that we conduct
clinical trials for a product candidate in a different order, e.g., in a step-wise fashion rather than running two trials of the same
product candidate in parallel, or the DEA could suspend or terminate the registrations and quota allotments we require in order to procure
and handle controlled substances, for various reasons, including:

 lack
 of effectiveness of any product candidate during clinical trials;

 discovery
 of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions,
 including those which cause confounding changes to the levels of other concomitant medications;

 slower
 than expected rates of subject recruitment and enrollment rates in clinical trials;

 difficulty
 in retaining subjects who have initiated a clinical trial but may withdraw at any time due to adverse side effects from the therapy,
 insufficient efficacy, fatigue with the clinical trial process or for any other reason;

 or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing
 constraints;

 inadequacy
 of or changes in our manufacturing process or product formulation;

 in obtaining regulatory authorization to commence a trial, including "clinical holds" or delays requiring suspension
 or termination of a trial by a regulatory agency, such as the FDA, before or after a trial is commenced;

 changes
 in applicable regulatory policies and regulation, including changes to requirements imposed on the extent, nature, or timing of studies;

 or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites;

 uncertainty
 regarding proper dosing;

 delay
 or failure to supply product for use in clinical trials which conforms to regulatory specification;

 unfavorable
 results from ongoing pre-clinical studies and clinical trials;

 failure
 of our contract research organizations, or CROs, or other third-party contractors to comply with all contractual requirements or
 to perform their services in a timely or acceptable manner;

 failure
 by us, our employees, our CROs or their employees to comply with all applicable FDA or other regulatory requirements relating to
 the conduct of clinical trials or the handling, storage, security, and recordkeeping;

 scheduling
 conflicts with participating clinicians and clinical institutions;

 failure
 to design appropriate clinical trial protocols;

 concerns with cannabinoid products generally and the potential for abuse;

 insufficient
 data to support regulatory approval;

 inability
 or unwillingness of medical investigators to follow our clinical protocols; or

 difficulty
 in maintaining contact with patients during or after treatment, which may result in incomplete data.

 Any
of the foregoing could have a material adverse effect on our business, results of operations and financial condition.

trials of synthetic cannabinoid drug candidates and ketamine analogs are novel with very limited or non-existing history; we face a significant
risk that the trials will not result in commercially viable drugs and treatments.

 At
present, there is only a very limited documented clinical trial history from which we can derive any scientific conclusions for our product
candidates or prove that our present assumptions for the current and planned research are scientifically compelling. The active pharmaceutical
ingredient (or API) content shown in INDs can vary from one IND to another – hence it is not necessarily possible to extrapolate
results from studies with one product and predict efficacy of safety with another product containing a similar API and different source.
Whilst the principal synthetic cannabinoid component may be similar, the APIs may differ in terms of minor cannabinoid content, impurity
profiles or degradant profiles. While we are encouraged by the results of clinical trials by others (where they exist), there can be
no assurance that any pre-clinical study or clinical trial will result in in commercially viable drugs or treatments.

trials are expensive, time consuming and difficult to design and implement. We, as well as the regulatory authorities may suspend, delay
or terminate our clinical trials at any time, may require us, for various reasons, to conduct additional clinical trials, or may require
a particular clinical trial to continue for a longer duration than originally planned, including, among others:

 lack
 of effectiveness of any API, formulation, or delivery system during clinical trials;

 discovery
 of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues;

 slower
 than expected rates of subject recruitment and enrollment rates in clinical trials;

 or inability in manufacturing or obtaining sufficient quantities of GMP-grade materials for use in clinical trials due to regulatory
 and manufacturing constraints;

 in obtaining regulatory authorization to commence a trial, including Institutional Review Board ("IRB") approvals or
 DEA approvals, licenses required for obtaining and using synthetic cannabinoids or cannabinoid-like substances for research, either
 before or after a trial is commenced;

 unfavorable
 results from ongoing pre-clinical studies and clinical trials;

 patients
 or investigators failing to comply with clinical trial protocols;

 patients
 failing to return for post-treatment follow-up at the expected rate;

 sites
 participating in an ongoing clinical trial withdraw, requiring us to engage new sites;

 third-party
 clinical investigators decline to participate in our clinical trials, do not perform the clinical trials on the anticipated schedule,
 or act in ways inconsistent with the established investigator agreement, clinical trial protocol, good clinical practices, and other
 IRB requirements;

 third-party
 entities do not perform data collection and analysis in a timely or accurate manner or at all; or

 inspections of our clinical trials require us to undertake corrective action or suspend or terminate our clinical trials.

 Any
of the foregoing could have a material adverse effect on our business, results of operations and financial condition.

 Any
failure by us to comply with existing regulations could harm our reputation and operating results.

 We
are subject to extensive regulation by U.S. federal and state governments in each of the markets where we have product candidates progressing
through the approval process.

 We
must also adhere to all regulatory requirements including FDA's Good Laboratory Practice, Good Clinical Practice, and current Good
Manufacturing Practices requirements ("cGMP") pharmacovigilance requirements, advertising, and promotion restrictions, reporting
and recordkeeping requirements. If we or our suppliers fail to comply with applicable regulations, including FDA pre-or post-approval
cGMP requirements, then FDA could sanction us. Even if a drug is FDA-approved, regulatory authorities may impose significant restrictions
on a product's indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials. Ketamir-2
and MIRA-55, and any of our product candidates that may be approved in the U.S. in the future, will be subject to ongoing regulatory
requirements for manufacturing, labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping
and submission of safety and other post-market information, including both federal and state requirements in the U.S. In addition, manufacturers
and manufacturers' facilities are required to comply with extensive FDA requirements, including ensuring that quality control and
manufacturing procedures conform to GMP. As such, we, and our contract manufacturers (in the event contract manufacturers are appointed
in the future) are subject to continual review and periodic inspections to assess compliance with GMP. Accordingly, we and others with
whom we work must continue to spend time, money, and effort in all areas of regulatory compliance, including manufacturing, production,
quality control and quality assurance. We will also be required to report certain adverse reactions and production problems, if any,
to the FDA, and to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect
to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the
product's approved label.

 If
a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency,
or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of the product,
it may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply
with applicable regulatory requirements, a regulatory agency or enforcement authority may:

 issue
 untitled or warning letters;

 seek
 to enjoin our activities;

 impose
 civil or criminal penalties;

 suspend
 regulatory approval;

 suspend
 any of our ongoing clinical trials;

 refuse
 to approve pending applications or supplements to approved applications submitted by us;

 impose
 restrictions on our operations, including by requiring us to enter into a Corporate Integrity Agreement or closing our contract manufacturers'
 facilities, if any; or

 seize
 or detain products or require a product recall.

 In
addition, any government investigation of alleged violations of law could require us to expend significant time and resources in response
and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect
our ability to commercialize and generate revenue from our product candidates. If regulatory sanctions are applied or if regulatory approval
is withdrawn, the value of our business and our operating results may be adversely affected.

 Any
action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses,
divert our management's attention from the operation of our business and damage our reputation. We expend significant resources
on compliance efforts and such expenses are unpredictable and might adversely affect our results. Changing laws, regulations and standards
might also create uncertainty, higher expenses and increase insurance costs. As a result, we intend to invest all reasonably necessary
resources to comply with evolving standards, and this investment might result in increased management and administrative expenses and
a diversion of management time and attention from revenue-generating activities to compliance activities.

 We
are subject to federal and state healthcare laws and regulations and implementation of or changes to such healthcare laws and regulations
could adversely affect our business and results of operations.

 In
the United States, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could
impact our ability to sell our product candidates. If we are found to be in violation of any of these laws or any other federal or state
regulations, we may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment, exclusion
from federal health care programs and the restructuring of our operations. Any of these could have a material adverse effect on our business
and financial results. Since many of these laws have not been fully interpreted by the courts, there is an increased risk that we may
be found in violation of one or more of their provisions. Any action against us for violation of these laws, even if we ultimately are
successful in our defense, will cause us to incur significant legal expenses and divert our management's attention away from the
operation of our business.

 We
expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage
criteria and in additional downward pressure on the price that we may receive for any approved product. There have been judicial challenges
to certain aspects of the ACA and numerous legislative attempts to repeal and/or replace the ACA in whole or in part, and we expect there
will be additional challenges and amendments to the ACA in the future. At this time, the full effect that the ACA will have on our business
in the future remains unclear. An expansion in the government's role in the U.S. healthcare industry may cause general downward
pressure on the prices of prescription drug products, lower reimbursements, or any other product for which we obtain regulatory approval,
reduce product utilization, and adversely affect our business and results of operations. Any reduction in reimbursement from Medicare
or other government programs may result in a similar reduction in payments from private payers. The implementation of cost containment
measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize products
for which we may receive regulatory approval.

 The
regulatory approval processes with the FDA are lengthy and inherently unpredictable.

 We
are not permitted to market our drug candidates as medicines in the United States or other countries until we receive approval of a New
Drug Application ("NDA") from the FDA or in any foreign countries until we receive the approval from the regulatory authorities
of such countries. Prior to submitting an NDA to the FDA for approval of our drug candidates we will need to have completed our pre-clinical
studies and clinical trials and demonstrate that our products meet all applicable standards of identity, strength, quality, and purity
throughout their expiration date. Successfully completing any clinical program and obtaining approval of an NDA is a complex, lengthy,
expensive, and uncertain process, and the FDA (or other country medicines regulatory body) may delay, limit, or deny approval of product
candidates for many reasons, including, among others, because:

 an
 inability to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA;

 results
 of clinical trials that may not meet the level of statistical or clinical significance required by the FDA;

 disagreements
 with the FDA with respect to the number, design, size, conduct or implementation of clinical trials;

 requirements
 by the FDA to conduct additional clinical trials;

 disapproval
 by the FDA of certain formulations, labeling or specifications of product candidates;

 findings
 by the FDA that the data from pre-clinical studies and clinical trials are insufficient;

 findings
 by the FDA that our API or finished products do not meet all applicable standards of identity, strength, quality, and purity;

 the
 FDA may disagree with the interpretation of data from pre-clinical studies and clinical trials; and

 the
 FDA may change their approval policies or adopt new regulations.

 Any
of these factors, many of which are beyond our control, could increase development time and / or costs or jeopardize our ability to obtain
regulatory approval for our drug candidates.

 There
is a high rate of failure for drug candidates proceeding through clinical trials.

 Generally,
there is a high rate of failure for drug candidates proceeding through clinical trials. We may suffer significant setbacks in our clinical
trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving
promising results in earlier trials. Further, even if we view the results of a clinical trial to be positive, FDA may disagree with our
interpretation of the data. In the event that we obtain negative results from clinical trials for product candidates or other problems
related to potential chemistry, manufacturing and control issues or other hurdles occur and our product candidates are not approved,
we may not be able to generate sufficient revenue or obtain financing to continue our operations, our ability to execute on our current
business plan may be materially impaired, our reputation in the industry and in the investment community might be significantly damaged
and the price of our common stock could decrease significantly. In addition, our inability to properly design, commence and complete
clinical trials may negatively impact the timing and results of our clinical trials and ability to seek approvals for our drug candidates.

 If
we are found in violation of federal or state "fraud and abuse" laws, we may be required to pay a penalty and/or be suspended
from participation in federal or state health care programs, which may adversely affect our business, financial condition, and results
of operations.

 In
the United States, we are subject to various federal and state health care "fraud and abuse" laws, including anti-kickback
laws, false claims laws and other laws intended to reduce fraud and abuse in federal and state health care programs, which could affect
us particularly upon successful commercialization of our products in the U.S. The Medicare and Medicaid Patient Protection Act of 1987,
or federal Anti-Kickback Statute, makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its
behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the referral of business,
including the purchase, order or prescription of a particular drug for which payment may be made under a federal health care program,
such as Medicare or Medicaid. Under federal law, some arrangements, known as safe harbors, are deemed not to violate the federal Anti-Kickback
Statute. Although we seek to structure our business arrangements in compliance with all applicable requirements, it is often difficult
to determine precisely how the law will be applied in specific circumstances. Accordingly, it is possible that our practices may be challenged
under the federal Anti-Kickback Statute and Federal False Claims Act. Violations of fraud and abuse laws may be punishable by criminal
and/or civil sanctions, including fines and/or exclusion or suspension from federal and state health care programs such as Medicare and
Medicaid and debarment from contracting with the U.S. government. In addition, private individuals have the ability to bring actions
on behalf of the government under the federal False Claims Act as well as under the false claims laws of several states.

 Many
states have adopted laws similar to the federal anti-kickback statute, some of which apply to the referral of patients for health care
services reimbursed by any source, not just governmental payers. There are ambiguities as to what is required to comply with these state
requirements and if we fail to comply with an applicable state law requirement, we could be subject to penalties.

 Neither
the government nor the courts have provided definitive guidance on the application of fraud and abuse laws to our business. Law enforcement
authorities are increasingly focused on enforcing these laws, and it is possible that some of our practices may be challenged under these
laws. While we believe we have structured our business arrangements to comply with these laws, it is possible that the government could
allege violations of, or convict us of violating, these laws. If we are found in violation of one of these laws, we could be required
to pay a penalty and could be suspended or excluded from participation in federal or state health care programs, and our business, results
of operations and financial condition may be adversely affected.

 Serious
adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our product candidates,
limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of products that are already
marketed.

 If
any of our product candidates prior to or after any approval for commercial sale, cause serious or unexpected side effects, or are associated
with other safety risks such as misuse, abuse or diversion, a number of potentially significant negative consequences could result, including:

 authorities may interrupt, delay or halt clinical trials;

 authorities may deny regulatory approval of our product candidates;

 authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for
 use, and/or impose restrictions on distribution in the form of a REMS in connection with approval or post-approval;

 authorities may withdraw their approval, require more onerous labeling statements, impose a more restrictive Risk Evaluation and
 Mitigation Strategy ("REMS"), or require us to recall any product that is approved;

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

 our
 relationships with our collaboration partners may suffer;

 we
 could be sued and held liable for harm caused to patients; or

 our
 reputation may suffer. The reputational risk is heightened with respect to those of our product candidates that are being developed
 for pediatric indications.

 We
may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants
or if preliminary data demonstrate that our product candidates are unlikely to receive regulatory approval or unlikely to be successfully
commercialized. Following receipt of approval for commercial sale of a product we may voluntarily withdraw or recall that product from
the market if at any time we believe that its use, or a person's exposure to it, may cause adverse health consequences or death.
To date we have not withdrawn, recalled, or taken any other action, voluntary or mandatory, to remove an approved product from the market.
In addition, regulatory agencies, IRBs, or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation
of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are
not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants.
Although we have never been asked by a regulatory agency, IRB, or data safety monitoring board to discontinue a clinical trial temporarily
or permanently, if we elect or are forced to suspend or terminate a clinical trial of any of our product candidates, the commercial prospects
for that product will be harmed and our ability to generate product revenue from that product may be delayed or eliminated. Furthermore,
any of these events may result in labeling statements such as warnings or contraindications. In addition, such events or labeling could
prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the
costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these products
either by us or by our collaboration partners.

 Risks
Related to Our Reliance Upon Third Parties

 Our
existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect
our ability to develop and commercialize our product candidates.

 We
may seek additional collaboration arrangements with pharmaceutical or biotechnology companies for the development or commercialization
of our product candidates. We may, with respect to our product candidates, enter into new arrangements on a selective basis depending
on the merits of retaining commercialization rights for ourselves as compared to entering into selective collaboration arrangements with
leading pharmaceutical or biotechnology companies for each product candidate, both in the U.S. and internationally. To the extent that
we decide to enter into collaboration agreements, we will face significant competition in seeking appropriate collaborators and the terms
of any collaboration or other arrangements that we may establish may not be favorable to us.

 Any
existing or future collaboration that we enter may not be successful. The success of our collaboration arrangements will depend heavily
on the efforts and activities of our collaborators. Collaborators generally have significant discretion in determining the efforts and
resources that they will apply to these collaborations. Disagreements between parties to a collaboration arrangement regarding development,
intellectual property, regulatory or commercialization matters can lead to delays in the development process or commercialization of
the applicable product candidate and, in some cases, termination of the collaboration arrangement. These disagreements can be difficult
to resolve if neither of the parties has final decision-making authority. Any such termination or expiration could harm our business
reputation and may adversely affect us financially.

 We
depend on a limited number of suppliers for materials and components required to manufacture our product candidates. The loss of these
suppliers, or their failure to supply us on a timely basis, could cause delays in our current and future capacity and adversely affect
our business.

 We
depend on a limited number of suppliers for the materials and components required to manufacture our product candidates. As a result,
we may not be able to obtain sufficient quantities of critical materials and components in the future. A delay or interruption by our
suppliers may also harm our business, results of operations and financial condition. In addition, the lead time needed to establish a
relationship with a new supplier can be lengthy, and we may experience delays in meeting demand in the event we must switch to a new
supplier. The time and effort to qualify for and, in some cases, obtain regulatory approval for a new supplier could result in additional
costs, diversion of resources or reduced manufacturing yields, any of which would negatively impact our operating results. Our dependence
on single-source suppliers exposes us to numerous risks, including the following: our suppliers may cease or reduce production or deliveries,
raise prices or renegotiate terms; our suppliers may become insolvent or cease trading; we may be unable to locate a suitable replacement
supplier on acceptable terms or on a timely basis, or at all; and delays caused by supply issues may harm our reputation, frustrate our
customers and cause them to turn to our competitors for future needs.

 We
maintain our cash at financial institutions, at times in balances that exceed federally insured limits. The failure of financial institutions
could adversely affect our ability to pay operational expenses or make other payments.

 Our
cash held in non-interest-bearing and interest-bearing accounts can at times exceed the Federal Deposit Insurance Corporation ("FDIC")
insurance limits. If such banking institutions were to fail, we could lose all or a portion of those amounts held in excess of such insurance
limitations. In addition, even if account holders are ultimately made whole with respect to a future bank failure, account holders'
access to their accounts and assets held in their accounts may be substantially delayed. Any material loss that we may experience in
the future or inability for a material time period to access our cash and cash equivalents could have an adverse effect on our ability
to pay our operational expenses or make other payments, which could adversely affect our business.

 We
rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates. If these third parties
do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be
able to obtain marketing approval for or commercialize our product candidates, and our business could be substantially harmed.

 We
have agreements with third-party CROs to operationalize, provide monitors for and to manage data for our ongoing clinical trials. We
rely heavily on these parties for the execution of clinical trials and control only certain aspects of their activities. As a result,
we have less direct control over the start-up, conduct, timing and competition of these clinical trials, and the management of data developed
through the clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties
can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. However, we remain responsible
for the conduct of these trials and are subject to enforcement which may include civil and criminal liabilities for any violations of
FDA rules and regulations and the comparable foreign regulatory provisions during the conduct of our clinical trials. Outside parties
may:

 have
 staffing difficulties;

 fail
 to comply with contractual obligations;

 Devote
 inadequate resources to our clinical trials;

 Experience
 regulatory compliance issues;

 Undergo
 changes in priorities or become financially distressed; or

 Form
 more favorable relationships with other entities, some of which may be our competitors.

 These
factors, among others, may materially adversely affect the willingness or ability of third parties to conduct our clinical trials and
may subject us to unexpected cost increases that are beyond our control. Nevertheless, we are responsible for ensuring that each of our
studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on CROs
does not relieve us of our regulatory responsibilities. We and our CROs are required to comply with GCPs, which are guidelines enforced
by the FDA, the competent authorities of the EU member states and equivalent competent authorities in foreign jurisdictions for any products
in clinical development. The FDA and foreign regulatory authorities enforce these regulations and GCP guidelines through periodic inspections
of clinical trial sponsors principal investigators, and trial sites, and IRBs. If we or our CROs fail to comply with applicable GCPs,
the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other equivalent competent authorities in
foreign jurisdictions may require us to perform additional clinical trials before approving our marketing applications. We cannot assure
you that, upon inspection, the FDA or foreign regulatory authorities will determine that any of our clinical trials comply with GCPs.
In addition, our clinical trials must be conducted with products produced under current Good Manufacturing Practices, or cGMPs and similar
foreign requirements. Our failure or the failure of our CROs to comply with these regulations may require us to repeat clinical trials,
which would delay the regulatory approval process and could also subject us to enforcement action up to and including civil and criminal
penalties.

 If
any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs.
If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced
or if the quality or accuracy of the clinical data they obtain are compromised due to the failure to adhere to our clinical protocols,
regulatory requirements or for other reasons, any such clinical trials may be extended, delayed or terminated, and we may not be able
to obtain regulatory approval for, or successfully commercialize, Ketamir-2, MIRA-55 or our other product candidates. As a result, our
financial results and the commercial prospects for Ketamir-2 MIRA-55 or our other product candidates would be harmed, our costs could
increase and our ability to generate revenue could be delayed.

 We
rely and expect to continue to rely on third parties to manufacture our clinical product supplies and clinical candidates, and we may
rely on third parties for at least a portion of the manufacturing process of our product candidates, if approved. Our business could
be harmed if those third parties fail to provide us with sufficient quantities of product supplies or product candidates or fail to do
so at acceptable quality levels or prices.

 We
do not currently own any facility that may be used as a clinical-scale manufacturing and processing facility, and we rely on outside
vendors and collaborators to manufacture supplies and process our product candidates. For certain of our components or product candidates,
we rely on single suppliers or manufacturers to supply or manufacture, but we plan to expand the number of suppliers and manufacturers
as we advance our product candidates through clinical development. Our product candidates are not yet manufactured or processed on a
commercial scale and we may remain unable to do so for any of our product candidates. Although in the future we may develop our own manufacturing
facilities, we may also continue to use third parties as part of our manufacturing processes and may, in any event, never be successful
in developing our own manufacturing facilities. Our anticipated reliance on third-party manufacturers exposes us to the following risks:

 We
 may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and
 the FDA must inspect any manufacturers for current cGMP.

 Non-compliance
 of our third-party manufacturers with requirements of our marketing application(s). In addition, a new manufacturer would have to
 be educated in, or develop substantially equivalent processes for, the production of our product candidates.

 manufacturers may have little or no experience with our product candidates, and therefore may require a significant amount of support
 from us in order to implement and maintain the infrastructure and processes required to manufacture our product candidates.

 manufacturers might be unable to timely manufacture our product candidates or produce the quantity and quality required to meet our
 clinical and commercial needs, if any.

 manufacturers may not be able to execute our manufacturing procedures and other logistical support requirements appropriately.

 manufacturers may not perform as agreed, may not devote sufficient resources to our product candidates or may not remain in the contract
 manufacturing business for the time required to supply our clinical trials or to successfully produce, store, and distribute our
 products, if any.

 Manufacturers
 are subject to ongoing periodic unannounced inspection by the FDA and corresponding state or foreign agencies to ensure strict compliance
 with cGMP and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers'
 compliance with these regulations and standards.

 We
 may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in
 the manufacturing processes for our product candidates.

 Our
 third-party manufacturers could breach or terminate their agreements with us, and we may be required to pay fees upon suspension
 or termination of the agreement even if the manufacturers do not deliver adequate supply of the product candidates or their components.

 Raw
 materials and components used in the manufacturing processes, particularly those for which we have no other source or supplier, may
 not be available or may not be suitable or acceptable for use due to factors beyond our control.

 Our
 third-party manufacturers may have unacceptable or inconsistent product quality success rates and yields, and we have no direct control
 over their ability to maintain adequate quality control, quality assurance and qualified personnel.

 Each
of these risks could delay or prevent the completion of our clinical trials or the approval of any of our product candidates by the FDA,
result in higher costs or adversely impact commercialization of our product candidates. In addition, we will rely on third parties to
perform certain specification tests on our product candidates prior to delivery to patients. If these tests are not appropriately done
and test data are not reliable, patients could be put at risk of serious harm and the FDA could place significant restrictions on our
company until deficiencies are remedied. Furthermore, our or a third party's failure to execute on our manufacturing requirements,
to do so on commercially reasonable terms or to comply with cGMP could adversely affect our business in a number of ways, including:

 An
 inability to initiate or continue clinical trials of our product candidates under development;

 Delay
 in submitting regulatory applications, or receiving marketing approvals, for our product candidates;

 Loss
 of the cooperation of future collaborators;

 Subjecting
 third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities;

 Requirements
 to cease development or to recall batches of our product candidates; and

 In
 the event of approval to market and commercialize our product candidates, an inability to meet commercial demands for our product
 or any other future product candidates.

 If
any CMO or CDMO with whom we contract fails to perform its obligations, we may be forced to enter into an agreement with a different
CMO or CDMO, which we may not be able to do on reasonable terms, if at all. In such scenario, our clinical trials supply could be delayed
significantly as we establish alternative supply sources. In some cases, the technical skills required to manufacture our products or
product candidates may be unique or proprietary to the original CMO or CDMO and we may have difficulty, or there may be contractual restrictions
prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all.
In addition, if we are required to change CMOs or CDMOs for any reason, we will be required to verify that the new CMO or CDMO maintains
facilities and procedures that comply with quality standards and with all applicable regulations. We will also need to verify, such as
through a manufacturing comparability study, that any new manufacturing process will produce our product candidate according to the specifications
previously submitted to the FDA or another regulatory authority. The delays associated with the verification of a new CMO or CDMO could
negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget. In addition,
changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging
studies between our prior clinical supply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstrating
the comparability of clinical supplies which could require the conduct of additional clinical trials.

 We
rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates. If these third parties
do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be
able to obtain marketing approval for or commercialize our product candidates, and our business could be substantially harmed.

 We
are dependent on third parties to conduct our clinical trials and preclinical and nonclinical studies. Specifically, we rely on, and
intend to continue to rely on, medical institutions, clinical investigators, contract research organizations, or CROs, and consultants
to conduct nonclinical studies and clinical trials, in each case in accordance with our study protocols and applicable regulatory requirements.
These CROs, investigators and other third parties play a significant role in the conduct and timing of these studies or trials and the
subsequent collection and analysis of data. Though we expect to carefully manage our relationships with our CROs, investigators and other
third parties, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges
will not have a material adverse impact on our business, financial condition and prospects. Further, while we have and will have agreements
governing the activities of our third-party contractors, we have limited influence over their actual performance. Nevertheless, we are
responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol and legal, regulatory
and scientific standards and requirements, and our reliance on our CROs and other third parties does not relieve us of our regulatory
responsibilities. In addition, we and our CROs are required to comply with GLP and GCP requirements, as applicable, which are regulations
and guidelines enforced by the FDA and comparable foreign regulatory authorities related to the conduct of nonclinical studies and clinical
trials, respectively. Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and
trial sites. If we or any of our CROs or trial sites fail to comply with applicable GLP or GCP or other requirements, the collected nonclinical
data or the clinical data generated in our clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities
may require us to perform additional nonclinical studies or clinical trials before approving our marketing applications, if ever. Furthermore,
our clinical trials must be conducted with materials manufactured in accordance with cGMP regulations. Failure to comply with these regulations
may require us to repeat clinical trials, which would delay the regulatory approval process.

 There
is a risk that our CROs, investigators or other third parties will be unable to devote adequate time and resources to such trials or
studies 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, or otherwise perform in a substandard manner, our clinical trials may be extended, delayed or terminated.
In addition, many of the third parties with whom we contract may also have relationships with other commercial entities, including our
competitors, for whom they may also be conducting clinical trials or other development activities that could harm our competitive position.
In addition, principal investigators for our clinical trials are expected to serve as scientific advisors or consultants to us from time
to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation
result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation
of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical
trial itself may be jeopardized, which could result in the delay or rejection by the FDA of any NDA we submit. Any such delay or rejection
could prevent us from receiving regulatory approval for, or commercializing, TELOIR-1 and any future product candidates.

 Our
CROs have the right to terminate their agreements with us in the event of an uncured material breach and under other specified circumstances.
If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third
parties on commercially reasonable terms, in a timely manner or at all. Switching or adding CROs, investigators and other third parties
involves additional cost and requires our management's time and focus. In addition, there is a natural transition period when a
new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.
Though we work to carefully manage our relationships with our CROs, investigators and other third parties, there can be no assurance
that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact
on our business, financial condition and prospects.

 Risks
Related to Our Intellectual Property

 We
may not be able to adequately protect our product candidates or our proprietary technology in the marketplace.

 Our
success will depend, in part, on our ability to obtain patents, protect our trade secrets and operate without infringing on the proprietary
rights of others. We may rely upon a combination of patents, trade secret protection (i.e., know-how), trademarks, licenses, and confidentiality
agreements to protect the intellectual property of our product candidates. The strengths of patents in the pharmaceutical field involve
complex legal and scientific questions and can be uncertain. Where appropriate, we seek patent protection for certain aspects of our
products and technology. However, patent protection for naturally occurring compounds is exceedingly difficult to obtain, defend and
enforce. Filing, prosecuting and defending patents throughout the world would be prohibitively expensive, so our policy is to look to
patent technologies with commercial potential in jurisdictions with significant commercial opportunities. However, patent protection
may not be available for some of the products or technology we are developing. If we must spend significant time and money protecting,
defending, or enforcing our patents, designing around patents held by others or licensing, potentially for large fees, patents or other
proprietary rights held by others, our business, results of operations and financial condition may be harmed. We may not develop additional
proprietary products that are patentable.

 The
patent positions of pharmaceutical products are complex and uncertain. The scope and extent of patent protection for our product candidates
are particularly uncertain. To date, our principal product candidates have been based on specific formulations of certain previously
known cannabinoids found in nature in the cannabis sativa plant. While we have sought patent protection, where appropriate, directed
to, among other things, composition-of-matter for our specific formulations, their methods of use, and methods of manufacture, we do
not have and will not be able to obtain composition of matter protection on these previously known cannabinoids per se. We anticipate
that the products we develop in the future will continue to be based on the same or other naturally occurring compounds, as well as additional
synthetic compounds we may discover. Although we have sought and expect to continue to seek patent protection for our product candidates,
their methods of use, and methods of manufacture, any, or all of them may not be subject to effective patent protection. If any of our
products are approved and marketed for an indication for which we do not have an issued patent, our ability to use our patents to prevent
a competitor from commercializing a non-branded version of our commercial products for that non-patented indication could be significantly
impaired or even eliminated.

 Publication
of information related to our product candidates by us, or others may prevent us from obtaining or enforcing patents relating to these
products and product candidates. Furthermore, others may independently develop similar products, may duplicate our products, or may design
around our patent rights. In addition, any of our issued patents may be opposed and/or declared invalid or unenforceable. If we fail
to adequately protect our intellectual property, we may face competition from companies who attempt to create a generic product to compete
with our product candidates. We may also face competition from companies who develop a substantially similar product to one of our product
candidates that is not covered by any of our patents.

 If
third parties claim that our intellectual property, products, processes, or anything else used by us infringes upon their intellectual
property, our operating profits could be adversely affected.

 There
is a substantial amount of litigation, both within and outside the U.S., involving patent and other intellectual property rights in the
pharmaceutical industry. We may, from time to time, be notified of claims that we are infringing upon patents, trademarks, copyrights,
or other intellectual property rights owned by third parties, and we cannot provide assurances that other companies will not, in the
future, pursue such infringement claims against us, our commercial partners or any third-party proprietary technologies we have licensed.
If we were found to infringe upon a patent or other intellectual property right, or if we failed to obtain or renew a license under a
patent or other intellectual property right from a third party, or if a third party that we were licensing technologies from was found
to infringe upon a patent or other intellectual property rights of another third party, we may be required to pay damages, including
damages of up to three times the damages found or assessed, if the infringement is found to be willful, suspend the manufacture of certain
products or reengineer or rebrand our products, if feasible, or we may be unable to enter certain new product markets. Any such claims
could also be expensive and time consuming to defend and divert management's attention and resources. Our competitive position
could suffer as a result. In addition, if we have declined or failed to enter into a valid non-disclosure or assignment agreement for
any reason, we may not own the invention or our intellectual property, and our products may not be adequately protected. Thus, we cannot
guarantee that our product candidates, or our commercialization thereof, does not and will not infringe any third party's intellectual
property.

 If
we are unable to obtain and maintain intellectual property protection for our technology and products, or if the scope of the intellectual
property protection obtained is not sufficiently broad, our competitors could commercialize technology and products similar or identical
to ours, and our ability to successfully commercialize our technology and products may be impaired.

 Our
success depends in large part on our ability to obtain and maintain patent protection in relevant countries with respect to our proprietary
technology and products. We seek to protect our proprietary position by filing patent applications in the United States and internationally
that are related to our novel technologies and product candidates. This patent portfolio includes issued patents and pending patent applications
covering pharmaceutical compositions and methods of use.

 The
patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent
applications at a reasonable cost or in a timely manner. We may choose not to seek patent protection for certain innovations and may
choose not to pursue patent protection in certain jurisdictions, and under the laws of certain jurisdictions, patents or other intellectual
property rights may be unavailable or limited in scope. It is also possible that we will fail to identify patentable aspects of our discovery
and nonclinical development output before it is too late to obtain patent protection. Moreover, in some circumstances, we may not have
the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology
that we license from third parties. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent
with the best interests of our business.

 The
patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions
and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to
the same extent as the laws of the United States. For example, India and China do not allow patents for methods of treating the human
body. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the
United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore,
we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent
applications, or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity,
enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result
in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing
competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the EU, the United States
and other countries may diminish the value of our patents or narrow the scope of our patent protection.

 The
risks described pertaining to our patents and other intellectual property rights also apply to the intellectual property rights that
we license, and any failure to obtain, maintain and enforce these rights could have a material adverse effect on our business. In some
cases, we may not have control over the prosecution, maintenance or enforcement of the patents that we license, and our licensors may
fail to take the steps that we believe are necessary or desirable in order to obtain, maintain and enforce the licensed patents. Any
inability on our part to protect adequately our intellectual property may have a material adverse effect on our business, operating results
and financial position.

 The
USPTO and various non-U.S. governmental patent agencies require compliance with several procedural, documentary, fee payment and other
similar provisions during the patent application process. In certain situations, non-compliance can result in abandonment or lapse of
the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event,
our competitors might be able to enter the market and this circumstance would have a material adverse effect on our business.

 In
addition, we acquired rights to Ketomir-2 through a license agreement with MIRALOGX and may in the future enter into other license agreements
with third parties for other intellectual property rights or assets. These license agreements may impose various diligence, milestone
payment, royalty, and other obligations on us. If we fail to comply with our obligations under these agreements, or we are subject to
a bankruptcy, we may be required to make certain payments to the licensor, we may lose the exclusivity of our license, or the licensor
may have the right to terminate the license, in which event we would not be able to develop or market products covered by the license.
Additionally, the milestone and other payments associated with these licenses will make it less profitable for us to develop our drug
candidates than if we had developed the licensed technology internally.

 In
some cases, patent prosecution of our licensed technology may be controlled solely by the licensor. If our licensors fail to obtain and
maintain patent or other protection for the proprietary intellectual property we license from them, we could lose our rights to the intellectual
property or our exclusivity with respect to those rights, and our competitors could market competing products using the intellectual
property. In certain cases, we may control the prosecution of patents resulting from licensed technology. In the event we breach any
of our obligations related to such prosecution, we may incur significant liability to our licensing partners. If disputes over intellectual
property and other rights that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable
terms, we may be unable to successfully develop and commercialize the affected product candidates.

 We
have no patent protection for MIRA-55, which could adversely impact MIRA-55's potential competitive position.

 We
have no issued patents relating to MIRA-55 and our patent application for MIRA-55 may not result in an issued patent. While we attempt
to protect our proprietary information as trade secrets through certain agreements with our employees, consultants, agents and other
organizations to which we disclose our proprietary information, we cannot give assurance that these agreements will provide effective
protection for our proprietary information in the event of unauthorized use or disclosure of such information. If other products similar
to MIRA-55 are approved and marketed, we may be unable to prevent them from competing with MIRA-55 in MIRA-55's potential marketplace.
We expect that the presence of one or more competing products could reduce our potential market share and could negatively impact potential
price levels and third-party reimbursement for MIRA-55, any of which would materially affect our business.

 Risks
Relating to the Ownership of our Common Stock

 Because
of the speculative nature of investment risk, you may lose your entire investment.

 An
investment in our securities carries a high degree of risk and should be considered as a speculative investment. We have a limited operating
history, no revenues, have not paid dividends, and are unlikely to pay dividends in the immediate or near future. The likelihood of our
success must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection
with the establishment of any business. An investment in our securities may result in the loss of an investor's entire investment.
Only potential investors who are experienced in high-risk investments and who can afford to lose their entire investment should consider
an investment in our securities.

of our founding stockholders, plus our existing officers and directors, control a substantial interest in us and thus may influence certain
actions requiring stockholder vote.

 Our
founding stockholders, which include the Bay Shore Trust, and MIRALOGX, collectively
own in excess of 30% of our issued and outstanding common stock. Our officers and
directors also own shares of our common stock. Therefore, these entities and individuals could influence the outcome of matters requiring
stockholder approval, including the election of directors and approval of significant corporate transactions.

 Sales
of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress
the market price of our common stock.

 Sales
of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur as a result
of our utilization of a universal shelf registration statement or otherwise could depress the market price of our common stock and impair
our ability to raise capital through the sale of additional equity securities. Notably, a large number of shares of our common stock
held by Bay Shore Trust and MIRALOGX have been registered for public resale and could be sold in the public market, depressing our stock
price. Moreover, we cannot in general predict the effect that future sales of our common stock or the market perception that we are permitted
to sell a significant number of our securities would have on the market price of our common stock.

 The
requirements of being a public company may strain our resources, divert management's attention and affect our ability to attract
and retain executive management and qualified board members.

 As
a reporting issuer, we are subject to the reporting requirements of applicable securities legislation of the jurisdiction in which we
are a reporting issuer, the listing requirements of Nasdaq and other applicable securities rules and regulations. Compliance with these
rules and regulations increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly
and increase demand on its systems and resources. Applicable securities laws require us to, among other things, file certain annual and
quarterly reports with respect to its business and results of operations. In addition, applicable securities laws require us to, among
other things, maintain effective disclosure controls and procedures and internal control over financial reporting.

 In
order to maintain and, if required, improve its disclosure controls and procedures and internal control over financial reporting to meet
this standard, significant resources and management oversight are required and, as a result, management's attention may be diverted
from other business concerns, which could harm our business and results of operations. To comply with these requirements, we may need
to hire more employees in the future or engage outside consultants, which will increase its costs and expenses.

 In
addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for
public companies, increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations
and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application
in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty
regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to
continue to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general
and administrative expenses and a diversion of management's time and attention from revenue-generating activities to compliance
activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing
bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us,
which could adversely affect our business and financial results.

 As
a public company subject to these rules and regulations, it may be more expensive to obtain director and officer liability insurance,
and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make
it more difficult for us to attract and retain qualified members of the Board, particularly to serve on the Audit Committee and Compensation
Committee, and qualified executive officers.

 We
are an "emerging growth company," and any decision on our part to comply only with certain reduced reporting and disclosure
requirements applicable to emerging growth companies could make shares of our common stock less attractive to investors.

 We
are an "emerging growth company," as defined in Section 2(a) of the Securities Act. For as long as we continue to be an emerging
growth company, we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies
that are not emerging growth companies, including, but not limited to, not being required to have our independent registered public accounting
firm audit our internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations
regarding executive compensation in our periodic reports and exemptions from the requirements of holding a nonbinding advisory vote on
executive compensation and shareholder approval of any golden parachute payments not previously approved. We could be an emerging growth
company until the fifth anniversary of the fiscal year end date following the completion of our initial public offering, however, our
status would change more quickly if we have more than US$1.235 billion in annual revenue, if the market value of our shares of common
stock held by non-affiliates equals or exceeds US$700 million as of June 30 of any year, or we issue more than US$1.0 billion of non-convertible
debt over a three-year period before the end of that period.

 Investors
could find our shares less attractive if we choose to rely on these exemptions. If some investors find shares less attractive as a result
of any choice to reduce future disclosure, there may be a less active trading market for our shares and our share price may be more volatile.

 For
as long as we are an "emerging growth company", our independent registered public accounting firm will not be required to
attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404. We could be an "emerging
growth company" until the fifth anniversary of the fiscal year end date following the completion of our initial public offering.
An independent assessment of the effectiveness of our internal controls could detect problems that our management's assessment
might not. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur
the expense of remediation.

 If
we identify material weaknesses in our internal control over financial reporting, or if we are unable to comply with the requirements
of Section 404 in a timely manner or assert that our internal control over financial reporting is effective, or if our independent registered
public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting when
required, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our securities
could be negatively affected, and we could become subject to investigations by the stock exchange on which our securities are listed,
the SEC, or other regulatory authorities, which could require additional financial and management resources.

we are a "smaller reporting company" as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take
advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
We will remain a smaller reporting company until the last day of any fiscal year for so long as either: (i) the market value of our shares
of common stock held by non-affiliates does not equal or exceed $250 million as of the prior June 30 th; or (ii) our annual
revenues did not equal or exceed $100 million during such completed fiscal year. To the extent we take advantage of such reduced disclosure
obligations, it may also make the comparison of our financial statements with other public companies difficult or impossible.

 If
we fail to maintain compliance with Nasdaq Listing Rules, our shares may be delisted from Nasdaq, which would result in a limited trading
market for our shares and make obtaining future debt or equity financing more difficult for the us.

 Our
common stock is listed on the Nasdaq Capital Market under the symbol "MIRA". However, there is no assurance that we will
be able to continue to maintain our compliance with the Nasdaq continued listing requirements. If we fail to do so, our securities may
lose their status on Nasdaq and they would likely be traded on the over-the-counter markets, including the Pink Sheets market. As a result,
selling our securities could be more difficult because smaller quantities of shares or warrants would likely be bought and sold, transactions
could be delayed, and security analysts' coverage of us may be reduced. In addition, in the event our securities are delisted,
broker dealers would bear certain regulatory burdens which may discourage broker dealers from effecting transactions in the securities
and further limit the liquidity of the securities. These factors could result in lower prices and larger spreads in the bid and ask prices
for the securities. Such delisting from Nasdaq and continued or further declines in the share price of the securities could also greatly
impair our ability to raise additional necessary capital through equity or debt financing and could significantly increase the ownership
dilution to shareholders caused by our issuing equity in financing or other transactions.

 If
our shares were to be delisted from Nasdaq, they may become subject to the SEC's "penny stock" rules.

 Delisting
from Nasdaq may cause our securities to become subject to the SEC's "penny stock" rules. The SEC generally defines
a penny stock as an equity security that has a market price of less than $5.00 per share or an exercise price of less than $5.00 per
share, subject to certain exemptions. One such exemption is to be listed on Nasdaq. Therefore, if shares of our common stock were to
be delisted from Nasdaq, our securities could become subject to the SEC's "penny stock" rules. These rules require,
among other things, that any broker engaging in a purchase or sale of our securities provide its customers with: (i) a risk disclosure
document, (ii) disclosure of market quotations, if any, (iii) disclosure of the compensation of the broker and its salespersons in the
transaction, and (iv) monthly account statements showing the market values of our securities held in the customer's accounts. A
broker would be required to provide the bid and offer quotations and compensation information before effecting the transaction. This
information must be contained in the customer's confirmation. Generally, brokers are less willing to effect transactions in penny
stocks due to these additional delivery requirements. These requirements may make it more difficult for shareholders to purchase or sell
the shares of our common stock. Since the broker, not us, prepares this information, we would not be able to assure that such information
is accurate, complete or current.

 Some
provisions of Florida law and our amended and restated articles of incorporation and amended and restated bylaws may have anti-takeover
effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our shareholders and may
prevent attempts by our shareholders to replace or remove our current management.

 Our
status as a Florida corporation and the anti-takeover provisions of the Florida Business Corporation Act, which we sometimes refer to
as the FBCA, may discourage, delay or prevent a change in control even if a change in control would be beneficial to our shareholders.

 The
control share acquisition statute, Section 607.0902 of the FBCA, generally provides that in the event a person acquires voting shares
of the company in excess of 20% of the voting power of all of our issued and outstanding shares, such acquired shares will not have any
voting rights unless such rights are restored by the holders of a majority of the votes of each class or series entitled to vote separately,
excluding shares held by the person acquiring the control shares or any of our officers or employees who are also directors of the company.
Certain acquisitions of shares are exempt from these rules, such as shares acquired pursuant to the laws of intestate succession or pursuant
to a gift or testamentary transfer, pursuant to a merger or share exchange effected in compliance with the FBCA if we are a party to
the agreement, or pursuant to an acquisition of our shares if the acquisition has been approved by our board of directors before the
acquisition. The control share acquisition statute generally applies to any "issuing public corporation," which means a Florida
corporation which has:

 One
 hundred or more shareholders;

 Its
 principal place of business, its principal office, or substantial assets within Florida; and

 Either
 (i) more than 10% of its shareholders are resident in Florida; (ii) more than 10% of its shares are owned by residents of Florida;
 or (iii) one thousand shareholders are resident in Florida.

 The
affiliated transaction (or so-called "business combination") statute, Section 607.0901 of the FBCA, provides that we may
not engage in certain mergers, consolidations, sales of assets, issuances of stock, reclassifications, recapitalizations, and other affiliated
transactions with any "interested shareholder" for a period of three years following the time that such shareholder became
an interested shareholder, unless:

 Prior
 to the time that such shareholder became an interested shareholder, our board of directors approved either the affiliated transaction
 or the transaction which resulted in the shareholder becoming an interested shareholder; or;

 Upon
 consummation of the transaction that resulted in the shareholder becoming an interested shareholder, the interested shareholder owned
 at least 85% of our voting shares outstanding at the time the transaction commenced; or

 At
 or subsequent to the time that such shareholder became an interested shareholder, the affiliated transaction is approved by our board
 of directors and authorized at an annual or special meeting of shareholders, and not by written consent, by the affirmative vote
 of at least two-thirds of the outstanding voting shares which are not owned by the interested shareholder.

 An
"interested shareholder" is generally defined as any person who is the beneficial owner of more than 15% of our outstanding
voting shares. Currently, Bay Shore Trust would be considered an "interested shareholder."

 The
voting requirements set forth above do not apply to a particular affiliated transaction if one or more conditions are met, including,
but not limited to, the following: if the affiliated transaction has been approved by a majority of our disinterested directors; if we
have not had more than 300 shareholders of record at any time during the three years preceding the date the affiliated transaction is
announced; if the interested shareholder has been the beneficial owner of at least 80% of our outstanding voting shares for at least
three years preceding the date the affiliated transaction is announced; or if the consideration to be paid to the holders of each class
or series of voting shares in the affiliated transaction meets certain requirements of the statute with respect to form and amount, among
other things.

 Both
the control share acquisition statute and the affiliated transactions statute may have the effect of discouraging or preventing certain
change of control or takeover transactions involving us.

 In
addition, our amended and restated articles of incorporation and amended and restated bylaws contain provisions that may make it more
difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our shareholders, including
transactions in which shareholders might otherwise receive a premium for their shares. These provisions include:

 nothing
 in our amended and restated articles of incorporation precludes future issuances without shareholder approval of the authorized but
 unissued shares of our common stock;

 advance
 notice procedures apply for shareholders to nominate candidates for election as directors or to bring matters before an annual meeting
 of shareholders;

 a
 special meeting of shareholders can only be called by our chairman of the board of directors, our chief executive officer, our president
 (in the absence of a chief executive officer), a majority of our board of directors or the holders of 10% or more of all of our votes
 entitled to be cast on any issue proposed to be considered at the special meeting of shareholders;

 no
 provision in our amended and restated articles of incorporation or amended and restated bylaws provides for cumulative voting, which
 limits the ability of minority shareholders to elect director candidates;

 directors
 will only be able to be removed for cause;

 our
 amended and restated articles of incorporation authorizes undesignated preferred stock, the terms of which may be established and
 shares of which may be issued, without the approval of the holders of our capital stock; and

 certain
 litigation against us can only be brought in Florida.

 These
provisions could discourage, delay or prevent a transaction involving a change in control of our company. These provisions could also
discourage proxy contests and make it more difficult for you and other shareholders to elect directors of your choosing and cause us
to take corporate actions other than those you desire. See "Description of Capital Stock."

 Our
amended and restated bylaws designates the state courts located within the state of Florida as the exclusive forum for substantially
all disputes between us and our shareholders and the federal district courts as the exclusive forum for Securities Act claims, which
could limit our shareholders' ability to obtain a favorable judicial forum for disputes with us.

 Our
amended and restated bylaws provide that, unless we consent in writing to the selection of an alternative forum, the sole and exclusive
forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty
owed by any of our current or former directors, officers or other employees to us or our shareholders, (iii) any action arising pursuant
to any provision of the FBCA, our amended and restated articles of incorporation or our amended and restated bylaws, or (iv) any other
action asserting a claim that is governed by the internal affairs doctrine shall be a state court located within the state of Florida
(or, if a state court located within the state of Florida does not have jurisdiction, the federal district court for the Middle District
of Florida); provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by
the Exchange Act, or to any claim for which the federal courts have exclusive jurisdiction. Our amended and restated bylaws also provide
that, unless we consent in writing to the selection of an alternative forum, the U.S. federal district courts shall be the exclusive
forum for the resolution of any claims arising under the Securities Act. Under the Securities Act, federal and state courts have concurrent
jurisdiction over all suits brought to enforce any duty or liability created by the Securities Act, and investors cannot waive compliance
with the federal securities laws and the rules and regulations thereunder. Accordingly, there is uncertainty as to whether a court would
enforce such a forum selection provision as written in connection with claims arising under the Securities Act.

 By
becoming a shareholder in our company, you will be deemed to have notice of and have consented to the provisions of our amended and restated
bylaws related to choice of forum. The choice of forum provisions in our amended and restated bylaws may limit our shareholders'
ability to obtain a favorable judicial forum for disputes with us. Additionally, the enforceability of choice of forum provisions in
other companies' governing documents has been challenged in legal proceedings, and it is possible that, in connection with any
applicable action brought against us, a court could find the choice of forum provisions contained in our amended and restated bylaws
to be inapplicable or unenforceable in such action. If so, we may incur additional costs associated with resolving such action in other
jurisdictions, which could harm our business, results of operations, and financial condition.

or industry analysts may not regularly publish reports on us, which could cause the price of our securities or trading volumes to decline.

 The
trading market for our securities could be influenced by research and reports that industry and/or securities analysts may publish us,
our business, the market or our competitors. We do not have any control over these analysts and cannot be assured that such analysts
will cover us or provide favorable coverage. If any of the analysts who may cover our business change their recommendation regarding
our securities adversely, or provide more favorable relative recommendations about our competitors, the price of our securities would
likely decline. If any analysts who may cover our business were to cease coverage or fail to regularly publish reports on us, we could
lose visibility in the financial markets, which in turn could cause the price of our securities or trading volumes to decline.

 We
will likely conduct further offerings of our equity securities in the future, in which case your proportionate interest may become diluted.

 We
will likely be required to conduct equity offerings in the future to finance our current projects or to finance subsequent projects that
we decide to undertake. If our common stock shares are issued in return for additional funds, the price per share could be lower than
that paid by our current shareholders. We anticipate continuing to rely on equity sales of our common stock shares in order to fund our
business operations. If we issue additional common stock shares or securities convertible into shares of our common stock, your percentage
interest in us could become diluted.

 We
may issue shares of preferred stock in the future, which could make it difficult for another company to acquire us or could otherwise
adversely affect holders of our common stock, which could depress the price of our common stock.

 Our
certificate of incorporation authorizes us to issue one or more series of preferred stock. Our board of directors will have the authority
to determine the preferences, limitations and relative rights of the shares of preferred stock and to fix the number of shares constituting
any series and the designation of such series, without any further vote or action by our shareholders. Our preferred stock could be issued
with voting, liquidation, dividend and other rights superior to the rights of our common stock. The potential issuance of preferred stock
may delay or prevent a change in control of us, discouraging bids for our common stock at a premium to the market price, and materially
adversely affect the market price and the voting and other rights of the holders of our common stock.

 We
have never declared or paid any cash dividends or distributions on our capital stock. We do not anticipate paying any cash dividends
on our common stock in the foreseeable future.

 We
have never declared or paid any cash dividends or distributions on our capital stock. We currently intend to retain our future earnings,
if any, to support operations and to finance expansion and therefore we do not anticipate paying any cash dividends on our common stock
in the foreseeable future.

 The
declaration, payment and amount of any future dividends will be made at the discretion of the board of directors, and will depend upon,
among other things, the results of our operations, cash flows and financial condition, operating and capital requirements, and other
factors as the board of directors considers relevant. There is no assurance that future dividends will be paid, and, if dividends are
paid, there is no assurance with respect to the amount of any such dividend.

 Item
1B. Unresolved Staff Comments.

 None.

 Item
1C. Cybersecurity.

 Cybersecurity
Risk Management and Strategy

 We
recognize the importance of assessing, identifying, and managing material risks associated with cybersecurity threats, as such term is
defined in Item 106(a) of Regulation S-K. These risks include, among other things: operational risks, intellectual property theft, fraud,
extortion, harm to employees or customers and violation of data privacy or security laws.

 Identifying
and assessing cybersecurity risk is integrated into our overall risk management systems and processes. Cybersecurity risks related to
our business, technical operations, privacy and compliance issues are identified and addressed through a multi-faceted approach including
third party assessments, internal IT Audit, IT security, governance, risk and compliance reviews. To defend, detect and respond to cybersecurity
incidents, we, among other things: conduct proactive privacy and cybersecurity reviews of systems and applications, audit applicable
data policies, conduct employee training, monitor emerging laws and regulations related to data protection and information security and
implement appropriate changes.

 Our
risk management program also assesses third party risks, and we perform third-party risk management to identify and mitigate risks from
third parties such as vendors, suppliers, and other business partners associated with our use of third-party service providers. Cybersecurity
risks are evaluated when determining the selection and oversight of applicable third-party service providers and potential fourth-party
risks when handling and/or processing our employee, business or customer data.

 To
date, we have not identified any cybersecurity threats or past incidents that have had, or are likely to have, a material impact on our
company's operations, business strategy, financial performance, or results of operations.

 Cybersecurity
Governance

 To
manage our cybersecurity governance, we use Coalition Control, a cyber risk management platform that combines insurance, technology,
and services from Coalition and its partners into an online experience. It allows us to detect, assess, and mitigate cyber risks proactively.
Coalition Control monitors and detects risks across our entire external digital footprint, including assets, apps, services, and data
leaks. The tool shows us where any potential vulnerabilities are identified and how to fix them.

 Our
CFO is responsible for the day-to-day oversight of cybersecurity risks, and who utilizes the Coalition management platform for such risk
management. Our CFO keeps the Board apprised of ongoing cybersecurity risk mitigation and any breaches if presented.

 Item
2. Description of Property.

 Refer
to Note 2, "Leases" to our consolidated financial statements included in Part IV of this Report on Form 10-K, which is incorporated
into this item by reference.

 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.

 Market
Information

 Our
common stock began trading August 3, 2023, on The Nasdaq Capital Market under the symbol "MIRA."

 Holders
of Common Stock

 As
of March 28, 2024, we had approximately 91 holders of record of our common stock. No cash
dividends have been paid on the common stock to date. We currently intend to retain earnings for further business development and do
not expect to pay cash dividends in the foreseeable future.

Authorized for Issuance Under Equity Compensation Plans

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

 Unregistered
Sales of Equity Securities and Use of Proceeds

 None

 Issuer
Purchases of Equity Securities

 None

 Item
6. Reserved

 MANAGEMENT'S
DISCUSSION AND ANALYSIS OF

 FINANCIAL
CONDITION AND RESULTS OF OPERATIONS

 The
following discussion and analysis provide information which our management believes is relevant to an assessment and understanding of
our results of operations and financial condition. You should read the following discussion and analysis of our results of operations
and financial condition together with our financial statements and related notes and other information included elsewhere in this Report.

 In
addition to historical financial information, this discussion contains forward-looking statements based upon our current expectations
that involve risks and uncertainties. Our actual results could differ materially from such forward-looking statements as a result of
various factors, including those set forth under "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements"
included elsewhere in this Report. Additionally, our historical results are not necessarily indicative of the results that may be expected
for any period in the future.

 Overview

 We
are a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and
neuropsychiatric disorders. We have an exclusive licensing agreement for Ketamir-2, a unique, patent pending novel oral ketamine analog
under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant
depression (TRD), major depressive disorder with suicidal ideation (MDSI) and potentially post-traumatic stress disorder (PTSD).

our novel oral pharmaceutical marijuana, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety
and cognitive decline, often associated with early-stage dementia. MIRA-55, if approved by the FDA, could mark a significant advancement
in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.

 The
U.S. Drug Enforcement Administration (DEA)'s scientific review of Ketamir-2 concluded that it would not be considered a controlled
substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations. Additionally, we have filed the
required paperwork for MIRA-55 to be evaluated by the U.S. DEA.

 We
had net losses of $12 million and $7.1 million for the year ended December 31, 2023 and December 31, 2022, respectively.

 Recent
Developments

 In
early February 2024, we made a significant discovery during the manufacturing and scale-up process of our patented molecule known as
"MIRA1a," which we had been utilizing with a contract manufacturer. Through this process, we identified a novel and improved
version of the molecule, MIRA-55. MIRA-55 exhibits enhanced potency and holds promise for improved efficacy compared to MIRA1a.

 As
part of our due diligence and subsequent testing, we discovered that the pre-clinical studies we conducted, previously attributed to
MIRA1a, were in fact performed on MIRA-55. Following this revelation, we promptly filed a provisional patent for MIRA-55, which encompasses
all pre-clinical studies disclosed in our two registration statements on Form S-1, declared effective on August 2, 2023 and December
27, 2023 (File Nos. 333-273024 and 333-276118, respectively).

based on our pre-clinical analyses to date, we believe that MIRA-55 is an improvement over MIRA1a in that it displays enhanced potency
and potential for efficacy. In early March 2024, we filed a provisional patent application for MIRA-55, aiming for global patent protection.
If such patent is issued, we would own the patent rights to both MIRA1a and MIRA-55.

 Based on our discoveries to date, we have decided to advance MIRA-55
as our lead compound for our oral pharmaceutical marijuana drug candidate while still retaining our rights to MIRA1a.

 Reverse
Stock Split

 Effective
June 28, 2023, we completed a 1-for-5 reverse stock split of our outstanding common stock. Unless otherwise noted, the share and per
share information in this Report reflects the reverse stock split.

 Components
of our Results of Operations

and Development Expenses

and development expenses represent costs incurred to conduct research and development of our product candidate. We recognize all research
and development costs as they are incurred. Research and development expenses consist primarily of the following:

 salaries
 and benefits;

 contracted
 research and manufacturing;

 consulting
 arrangements; and

 other
 expenses incurred to advance our research and development activities.

 Our
operating expenses have historically been the costs associated with our patent prosecution and initial investment in pre-clinical research
and development activities. We expect research and development expenses will increase in the future as we advance Ketamir-2 and MIRA-55
into and through clinical trials and pursue regulatory approvals, which will require a significant investment in costs of clinical trials,
regulatory support, and contract manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product
candidates and technologies, which may result in higher research and development expenses due to license fee and/or milestone payments,
as well as added clinical development costs.

 The
process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely
development and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be
affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we
are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue
from the commercialization and sale of our product candidates.

and Administrative Expenses

and administrative expenses consist of employee-related expenses, including salaries, benefits, and travel, and other administrative
functions, as well as fees paid for legal, accounting and tax services, consulting fees and facilities costs not otherwise included in
research and development expense. Legal costs include general corporate legal fees and patent costs. We expect to incur additional expenses
as a result of becoming a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq,
additional insurance, investor relations and other administrative expenses and professional services.

 Interest
expense

 Interest
expense, net consists of accrued interest on a related party line of credit, net of earned interest income.

 Results
of Operations for the year ended December 31, 2023 and 2022

 Year Ended
 December 31,

 2023

 2022

 Revenues

 $
 -

 $
 -

 Operating costs:

 General and administrative expenses

 6,499,537

 2,992,125

 Related party travel costs

 453,550

 1,704,350

 Research and development expenses

 1,572,963

 2,351,465

 Total operating costs

 8,526,049

 7,047,940

 Interest expense, net

 (3,456,294
)

 (10,250
)

 Net loss attributable to common stockholders

 $
 (11,982,343
)

 $
 (7,058,190
)

 Basic and diluted loss per share

 $
 (0.64
)

 $
 (0.40
)

 Weighted average common stock shares outstanding

 18,566,158

 17,566,533

and Administrative Expenses. We incurred $6.5 million and $2.9 million in general and administrative expenses during the year ended
December 31, 2023 and December 31, 2022, respectively. General and administrative expenses are composed primarily of compensation, insurance,
professional fees, stock-based compensation, administration and other related costs. The increase is primarily due to an increase in
stock-based compensation, debt issuance costs, and compensation related to the IPO efforts of the executive team.

 Related
Party Travel Costs. We incurred $0.4 million and $1.7 million in related party travel costs during the year ended December 31, 2023
and December 31, 2022 respectively. Related party travel costs consisted of a lease and use of an airplane with an entity under common
control. The decrease in related party travel costs in 2023 is due to the termination of the lease in March 2023.

 Interest
expense. We incurred $3.5 million, net in interest expense and interest income during the year ended December 31, 2023, and $0.01
million interest expense during the year ended December 31, 2022, respectively. Interest expense during 2023 included $2.8 million of
write-off of unamortized deferred financing costs, $0.44 million of debt issuance costs and $0.02 million of interest income. The remaining 2023 and 2022
interest expense consists of accrued interest on a related party line of credit.

and Development Expenses. During the year ended December 31, 2023, we incurred $1.6 million in research and development expenses,
which were primarily related to initial payments for toxicology studies, consultants and stock compensation. We incurred $2.4 million
in research and development expenses during the three months ended December 31, 2022, relating to initial payment for toxicology study
costs. Research and development expenses include pre-clinical, toxicology and consultant expenses. Major components of research and development
expenses during the year ended December 31, 2023 are as follows:

 R&D Category

 Expense

 R&D consultants

 $
 0.25 million

 R&D research

 $
 0.37 million

 R&D toxicology

 $
 0.21 million

 R&D stock compensation

 $
 0.74 million

 Liquidity
and Capital Resources

 Since
our inception in September 2020, we have financed our operations primarily through an unsecured line of credit with a major shareholder
and an affiliated company and through a private placement of shares of our common stock that occurred during the fourth quarter 2021
and during 2022. We intend to finance our clinical development programs and working capital needs from existing cash, potential new sources
of debt and equity financing, including the proceeds from our completed IPO in August 2023. We may enter into new licensing and commercial
partnership agreements.

 On
April 28, 2023, we entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by our founder,
and under which various of his family members are beneficiaries (the "Bay Shore Trust"). Under this Promissory Note and
Loan Agreement (the "Bay Shore Note"), we have the right to borrow up to an aggregate of $5,000,000 from the Bay Shore
Trust at any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of our
initial public offering. Our right to borrow funds under the Bay Shore Note is subject to the absence of a material adverse change
in our assets, operations, or prospects. The Bay Share Note, together with accrued interest, will become due and payable on the
second anniversary of the issuance of the note, provided that it may be prepaid at any time without penalty. The Bay Shore Note will
accrue interest at a rate equal 7% per annum, simple interest, during the first year that the note is outstanding and 10% per annum,
simple interest, thereafter. The Bay Shore Note is unsecured. As of December 31, 2023, the Bay Shore Note was paid in full except
for an unpaid interest balance of $.01 million. In consideration of
the loan facility provided by the Bay Shore Trust, we issued to the Bay Shore Trust a common stock purchase warrant on April 28,
2023, giving the Bay Shore Trust the right to purchase up to 1,000,000 shares of common stock at an exercise price of $5.00 per
share, which warrant will expire five years after the date of grant.

 Since
January 1, 2023, MIRALOGX, LLC, an intellectual property development and holding company owned by Bay Shore Trust ("MIRALOGX"),
has advanced funds on behalf of Bay Shore Trust to our company in order to fund operating activities. The total amount advanced and outstanding
from MIRALOGX was $1.6 million immediately prior to being consolidated into the Bay Shore Note in 2023, and such amounts become a part
of the outstanding balance of the Bay Shore Note, which as of December 31, 2023, is $0.

 On
July 20, 2023, we entered into a conversion agreement with the Bay Shore Trust under which the Bay Shore Trust agreed to convert, upon
the completion of our initial public offering, $1,100,190 of the outstanding principal balance of the Bay Shore Note into shares of our
common stock at a conversion price equal to our initial public offering price, which resulted in the issuance of 157,170 shares to the
Bay Shore Trust upon the completion of our initial public offering (the "Bay Shore Trust Conversion Agreement").

 In
August 2023, we completed our IPO of common stock selling 1,275,000 shares at an offering price of $7.00 per share, resulting in gross
proceeds of $8.9 million. Net proceeds received after underwriting fees and offering expenses were $8.1 million. We raised $3.2 million
in 2022. Substantially all our equity capital had been raised at $1.00 per share (pre-reverse split).

 We
used $3.4 million in operating activities during the year ended December 31, 2023, compared to $5.6 million in operating activities during
the year ended December 31, 2022.

 We
have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until
such time that we can generate significant revenue and profit. We had negative cash flow from operations of approximately $3.4 million
for the year ended December 31, 2023 and an accumulated deficit of approximately $21.2 million as of December 31, 2023. As of December
31, 2023, we had cash and cash equivalents of approximately $4.6 million and working capital of $4.4 million. We currently expect that
our cash and cash equivalents be sufficient to fund our operations, development plans, and capital expenditures through at least the
fourth quarter of 2024.

 We
did not have any material non-cancellable contractual obligations as of December 31, 2023.

 Cash
Flows

 The
following table provides information regarding our cash flows for the periods presented:

 Year ended December 31,

 2023

 2022

 Net cash provided by (used in):

 Operating activities

 $
 (4,532,403
)

 $
 (5,604,759
)

 Financing activities

 8,783,991

 3,146,185

 Net change in cash

 $
 4,251,588

 $
 (2,458,574
)

 Net
Cash Used in Operating Activities

 The
cash used in operating activities resulted primarily from our net losses, stock-based compensation expense, amortization of debt issuance
costs and changes in components of accounts payable and accrued liabilities.

 For the year ended December 31,
2023, operating activities used $4.5 million of cash, primarily due to a net loss of $12 million, a $0.6 million change in accounts payable,
accrued and prepaid expenses, offset by $2.5 million in stock-based compensation expense, $0.7 million in amortization of debt issuance
costs, $3.5 million of interest expense, and $1.1 million of repayments under related party line of credit. Interest expense, net
was primarily composed of warrant expense and line of credit expense, offset by interest income. Accounts payable, accrued and prepaid
expenses was primarily composed of research and development payables, consultant costs, insurance costs and investor relations expenses.

 For
the year ended December 31, 2022, operating activities used $5.6 million of cash, primarily due to a net loss of $7.1 million, a $0.06
million change in accounts payable, accrued and prepaid expenses, offset by $1.3 million in stock-based compensation expense. Accounts
payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs
and investor relations expenses.

 Net
Cash Provided by Financing Activities

 For the year ended December 31,
2023, financing activities provided $8.8 million of cash, resulting primarily from $7.7 million in proceeds from sale of common stock,
less offering costs and $2.1 million in advances from related party line of credit, offset by $1.1 million of repayments under related party line of credit.

 For
the year ended December 31, 2022, financing activities provided $3.1 million of cash, resulting primarily from $2.9 million in proceeds
from sale of common stock, less offering costs, offset by $0.16 million of repayments under related party line of credit.

 We
currently anticipate that we will seek to monetize our product candidates, Ketamir-2 and MIRA-55, at the end of our planned Phase 2 studies.
Prior to that time, we anticipate that additional capital may be required to support ongoing activities and further phases of development.
Should that be required, our available capital may be consumed more rapidly than currently anticipated, resulting in the need for additional
funding. In addition, there can be no assurance that additional funding, when and if required, will be available at commercially favorable
terms, if at all.

 Accordingly,
we may need to raise additional capital, which may be available to us through a variety of sources, including:

 public
 equity markets;

 private
 equity financings;

 commercialization
 agreements and collaborative arrangements;

 sale
 of product royalty;

 grants
 and new license revenues;

 bank
 loans; and

 public
 or private debt.

 Additional
funding, capital, or loans (including, without limitation, milestone, or other payments from potential commercialization agreements)
may be unavailable on favorable terms, if at all. If adequate funds are not available, we may be required to significantly reduce or
refocus our operations or to obtain funds through arrangements that may require us to relinquish rights to certain technologies and drug
formulations or potential markets, any of which could have a material adverse effect on us, our financial condition, and our results
of operations. To the extent that additional capital is raised through the sale of equity or convertible debt securities or exercise
of warrants and options, the issuance of such securities would result in ownership dilution to existing stockholders.

 If
we are unable to attract additional funds on commercially acceptable terms, it may adversely affect our ability to achieve our development
and commercialization goals, which could have a material and adverse effect on our business, results of operations and financial condition.

 We
believe that we have sufficient resources available to support our development activities and business operations and timely satisfy
our obligations as they become due into the fourth quarter of 2024. We do not have sufficient cash and cash equivalents as of the date
of filing this Annual Report on Form 10-K to support our operations for at least the 12 months following the date the financial statements
are issued. These conditions raise substantial doubt about our ability to continue as a going concern through 12 months after the date
that the financial statements are issued.

 To
alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional
capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances
and drug product collaborations; however, none of these alternatives are committed at this time. There can be no assurance that we will
be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, identify and enter
into any strategic transactions that will provide the capital that we will require or achieve the other strategies to alleviate the conditions
that raise substantial doubt about our ability to continue as a going concern. If none of these alternatives are available, or if available,
are not available on satisfactory terms, we will not have sufficient cash resources and liquidity to fund our business operations for
at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable
terms when needed may require us to delay, limit, or eliminate the development of business opportunities and our ability to achieve our
business objectives and our competitiveness, and our business, financial condition, and results of operations will be materially adversely
affected. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with
us due to concerns about our ability to meet our contractual obligations.

 The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of
recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a
going concern.

 Recently
Issued and Adopted Accounting Pronouncements

 A
description of recently issued and adopted accounting pronouncements that may potentially impact our financial position and results of
operations is disclosed in Note 8 to our financial statements appearing at the end of this
Report.

 Off-Balance
Sheet Arrangements

the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.

 Summary
of Critical Accounting Policies

 Income
taxes

 We
are a C corporation. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between
the financial statement carrying amount of existing assets and liabilities and their respective tax bases. Deferred tax assets are recognized
for temporary differences that will result in deductible amounts in future years and for loss carryovers. A valuation allowance is recognized
regarding deferred tax assets, if any, if it is more likely than not that some portion of the deferred tax asset will not be realized.

and development expenses

and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties, such as contract
research organizations and consultants, who conduct research and development activities on our behalf. Patent-related costs, including
registration costs, documentation costs and other legal fees associated with the application, are expensed in the period in which they
are incurred.

 Use
of estimates

 The
preparation of financial statements in accordance with generally accepted accounting principles in the United States of America requires
our company's management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the
disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the
reporting period. Actual results may differ from such estimates and such differences could be material.

 Stock-based
compensation

 We
account for stock-based compensation under the provisions of FASB ASC 718, " Compensation - Stock Compensation ", which
requires the measurement and recognition of compensation expense for all stock-based awards made to employees, directors and consultants
based on estimated fair values on the grant date. We estimate the fair value of stock-based awards on the date of grant using the Black-Scholes
model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service
periods using the straight-line method. We have elected to account for forfeiture of stock-based awards as they occur.

 Emerging
Growth Company Election

 We
are an "emerging growth company" as defined in Section 2(a) of the Securities Act and have elected to take advantage of the
benefits of the extended transition period for new or revised financial accounting standards. We expect to continue to take advantage
of the benefits of the extended transition period, although we may decide to early adopt such new or revised accounting standards to
the extent permitted by such standards. We expect to use this extended transition period for complying with new or revised accounting
standards that have different effective dates for public and non-public companies until the earlier of the date we (i) are no longer
an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.
This may make it difficult or impossible to compare our financial results with the financial results of another public company that is
either not an emerging growth company or is an emerging growth company that has chosen not to take advantage of the extended transition
period exemptions because of the potential differences in accounting standards used.

 In
addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions
set forth in the JOBS Act and compliance with applicable laws, if, as an emerging growth company, we rely on such exemptions, we are
not required to, among other things: (a) provide an auditor's attestation report on our system of internal control over financial
reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002; (b) provide all of the compensation disclosures that may be required
of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010; (c) comply with
any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement
to the auditor's report providing additional information about the audit and the financial statements (auditor discussion and analysis);
and (d) disclose certain executive compensation-related items such as the correlation between executive compensation and performance
and comparisons of the Chief Executive Officer's compensation to median employee compensation.

 We
will remain an emerging growth company under the JOBS Act until the earliest of (a) December 31,
2028, (b) the last date of our fiscal year in which we had total annual gross revenue of at least $1.07 billion, (c) the date
on which we are deemed to be a "large accelerated filer" under the rules of the SEC or (d) the date on which we have issued
more than $1.0 billion in non-convertible debt securities during the previous three years.

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

 Smaller
reporting companies are not required to provide the information required by this item.

 Item
8. Financial Statements and Supplementary Data.

 Our
Consolidated Financial Statements and Notes thereto and the report of Cherry Bekaert, our independent registered public accounting firm
 (PCAOB ID: 677), are set forth on pages F-1 through F-22
of this Report.

 Item
9. Changes In and Disagreements With Accountants on Accounting and Financial Disclosure.

 None.

 Item
9A. Controls and Procedures.

 Evaluation
of Disclosure Controls and Procedures

 We
have established disclosure controls and procedures designed to ensure that information required to be disclosed in the reports that
we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC's
rules and forms and is accumulated and communicated to management, including the principal executive officer (our Chief Executive Officer)
and principal financial officer (our Chief Financial Officer), to allow timely decisions regarding required disclosure.

 Our
management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has
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 the end of the period covered by this Annual Report on Form 10-K. Management recognizes that any disclosure
controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their
objectives. Our disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives.
Based on such evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and
procedures were not effective at the end of fiscal year 2023.

 Changes
in Internal Control over Financial Reporting

 There
were no changes in our internal control over financial reporting that occurred during the year ended December 31, 2023 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 Management's
Report on Internal Control Over Financial Reporting

 This
annual report does not include a report of management's assessment regarding internal control over financial reporting or an attestation
report of the company's registered public accounting firm due to a transition period established by rules of the Securities and Exchange
Commission for newly public companies.

 Item
9B. Other Information.

 None.

 Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

 Not
applicable.

 PART
III

 Item
10. Directors, Executive Officers and Corporate Governance.

 March
2024 Changes to Our Management and Board of Directors

 Restructuring
of the Board of Directors

 On
March 9, 2024, after a series of discussions between our board of directors (the "Board") and senior management regarding
the need to have additional scientific expertise among the members of the Board, Ms. Talhia Tuck, Mr. Brad Kroenig and Mr. Hugh McColl,
each voluntarily resigned from the Board, effective immediately. This action allowed the remaining members of the Board to appoint new
members of the Board, as discussed below. The resignations of Ms. Tuck, Mr. Kroenig, and Mr. McColl were not the result of any disagreement
with our company on any matter relating to its operations, policies or practices.

 Also
on March 9, 2024, Dr. Chris Chapman notified the Board and senior company management of his resignation both as Executive Chairman and
as an employee of our company, effective immediately, citing his desire to focus his time on his role as Chairman and Chief Executive
Officer of Telomir Pharmaceuticals, Inc., given the recent initial public offering of that company. Dr. Chapman's resignation was
not the result of any disagreement with our company on any matter relating to its operations, policies or practices.

 On
March 13, 2024, the remaining members of the Board (Erez Aminov and Michael Jerman) unanimously
approved the appointment of (i) Mr. Aminov, our Chief Executive Officer, as Chairman of the Board and (ii) Dr. Matthew P. Del Giudice,
Dr. Denil N. Shekhat and Mr. Edward MacPherson as members of the Board, to fill the vacancies on the Board occasioned by the resignations
from the Board described above, for a term expiring at our 2024 annual meeting of shareholders.

 Resignation
of Chief Science Officer

 We
are focused on strengthening our clinical and regulatory development expertise with a view towards a future IND for one of our product
candidates. As part of this development, on March 7, 2024, following discussions with our management, Adam Kaplin, M.D., Ph. D. resigned
from his position as President and Chief Scientific Officer of the company to pursue other business endeavors, effective immediately.
 As described under "Key Consultants" below, in light of Mr. Kaplin's resignation,
we expanded the role of an existing consultant to assist in clinical and regulatory affairs.

 Current
Directors and Executive Officers

 Our
directors and executive officers and their ages as of the date of this Report are as follows:

 Name

 Age

 Position

 Erez

 Chief
 Executive Officer and Chairman

 Yanez

 Chief
 Financial Officer, Secretary and Treasurer

 Michael
 Jerman

 Matthew
 Paul Del Giudice, M.D.

 Denil
 Nanji Shekhat, M.D.

 Edward
 MacPherson

 The
following is a brief biography of each of our current executive officers and directors:

 Erez
Aminov has served as a director and our Chief Executive Officer since April 2023 and our Chairman since March 2024. Mr. Aminov
is an experienced biotechnology consultant and investor and initially joined our as a consultant in 2022. Mr. Aminov's experience
in the biotech consulting sector began in 2021 when he founded Locate Venture Corp. in September 2021. Locate Venture is a strategy
and investment consulting firm focused on advancing and supporting early-stage biotech startups. Prior to founding Locate Venture Corp.,
from February 2015 to September 2020, Mr. Aminov served as the President of Finds4less Inc., a global distributor of electronics and
gaming products. In this role, Mr. Aminov provided strategic oversight and direction for all aspects of the company's operations,
while also spearheading new business development initiatives to capitalize on emerging market opportunities. Mr. Aminov's more
than two decades of experience includes experience with the biotech industry's particular challenges, including creating strategic
alliances and guiding startups toward growth and prosperity. Mr. Aminov earned a B.A. in Accounting from Touro University in New York.
We believe that Mr. Aminov is qualified to serve as one of our directors based on his finance and investment experience, particularly
with early stage life sciences companies.

Yanez, MBA has served as our Chief Financial Officer since April 2023, prior to which she served as our Corporate Controller since
May 2022. Ms. Yanez is a senior financial executive with over 25 years of experience in public and privately held biotech, pharmaceutical,
and life science companies. Ms. Yanez' experience includes a broad range of responsibilities in a highly complex and regulated
market. She also brings deep corporate governance experience through her work with corporate boards, including audit and finance committees.
Since May 2022, Ms. Yanez is part-time Corporate Controller at Telomir Pharmaceuticals, Inc., a publicly traded pre-clinical-stage pharmaceutical
company, focusing on the development and commercialization of therapeutic treatment for human stem cells (Nasdaq: TELO). From May 2002
until its acquisition in April 2022, Ms. Yanez held various positions, including the Director of Financial Reporting, of BioDelivery
Sciences International, Inc. (Nasdaq: BDSI). In her role, she led financial offerings, managed due diligence for product acquisitions
and financings and managed finance documents and filings for the tender offer, leading to the acquisition of BioDelivery Sciences in
April 2022. Ms. Yanez also serves as a non-employee director of Inhibitor Therapeutics, Inc. (OTCQB: INTI), a publicly traded pharmaceutical
development company focused on therapeutics for certain cancers and non-cancerous proliferation disorders, since December 2022.
Ms. Yanez is a member of the Institute of Management Accountants and a member of the SEC Professionals Group. Ms. Yanez received her
MBA degree cum laude from Rutgers Business School.

 Michael
Jerman, CPA joined our company as a director in December 2023. He also serves as a member of the board of directors of Inhibitor Therapeutics,
Inc. (OTC:INTI). Mr. Jerman has served as the managing partner at Hollywell Partners, a professional accounting and finance consulting
firm, since May 2019, and has provided chief financial officer and other services to multiple private equity-backed companies in the
energy, SaaS, and manufacturing industries. Prior to his role with Hollywell Partners, he was a Director with PwC in the US and UK from
January 2007 to August of 2019 and was a Captain with the United States Air Force from July 2003 to June 2015. He has led global public
and private client engagements in the industries of retail and consumer, energy, utilities and mining, and transportation and logistics.
Mr. Jerman has significant experience in client equity and debt offerings, business combinations inclusive of public listing and reporting
requirements, initial valuations and ongoing goodwill impairment analyses, share-based awards, restructuring, and global taxes, as well
as stakeholder management, specifically with board and management presentation experience to include annual and quarterly requirements,
fee negotiations, technical accounting and finance discussions, and fraud and non-compliance investigations. Mr. Jerman has specialized
in rapid project mobilization and deployment of skilled resources for emergency issues, design, and implementation of small to large
scale assurance requirements and advisory projects. Mr. Jerman's additional experience includes leading PwC's data acquisition
methods and tools, client acquisitions and systems implementations to include new SOX-compliant control plan implementations across multiple
systems, leading co-sourced internal audit projects, and time spent driving PwC's lean efficiency initiatives. Mr. Jerman was a
member of the PwC national office within the SEC PCAOB quality group supporting Europe and the EMEA regions with complex accounting and
audit consultations. He earned a B.S. in accounting from the University of South Florida, an M.S. in accounting from the University of
Tampa, and an M.B.A. from the University of Oxford.

 Dr.
Matthew Paul Del Giudice joined our company as a director in March 2024. Dr. Del Giudice has practiced as a radiologist since
2014. He currently serves as a general overnight emergency radiologist at the Cleveland Clinic and as a real estate investor with Comfort
Living, LLC. Prior to joining the Cleveland Clinic, from March 2021 to May 2022, Dr. Del Giudice was a general radiologist with Radiology
and Imaging Specialists in Lakeland, Florida. From July 2015 to February 2021, Dr. Del Giudice was a radiologist with Radiology Partners
Phoenix, and from July 2014 to June 2015, he practiced as a musculoskeletal radiologist at the University of Arizona Health Sciences
Center – Tucson. Dr. Del Giudice received his B.S. from the University of Illinois at Urbana-Champaign, his M.D. from Loyola University
Stritch School of Medicine, completed his radiology residency at Loyola University Medical Center, and his musculoskeletal radiology
fellowship at the University of Arizona Health Sciences Center – Tucson. Dr. Del Giudice is licensed to practice medicine in Florida
and Ohio.

 Dr.
Denil Nanji Shekhat joined our company as a director in March 2024. Dr. Shekhat has practiced as a radiologist since 2014 and
currently practices at DNS Teleradiology in Wellington, Florida. Prior to starting DNS Teleradiology, Dr. Shekhat was a musculoskeletal
specialist for Radiology Associates of Florida/ Radiology Partners from July 2018 to December 2023. From July 2015 to August 2018, Dr.
Shekhat practiced as a general and musculoskeletal radiologist with Bethesda Radiology Associates. Dr. Shekhat received his B.A. in economics
from Bowdoin College, his M.D. from the University of Tennessee Health Science Center, College of Medicine, completed his radiology residency
at Baptist Memorial Hospital and his musculoskeletal radiology fellowship at the University of Arizona. Dr. Shekhat is currently licensed
to practice medicine in Florida.

 Edward
MacPherson joined our company as a director in March 2024. Mr. MacPerson currently serves as Chief Growth Officer for Power Digital,
an industry leading digital marketing agency. Prior to joining Power Digital, from May 2016 to December 2023, he served as CEO and Head
of Growth for Endrock Growth & Analytics, a company he founded and sold to Power Digital. Prior to founding Endrock Growth &
Analytics, Mr. MacPherson held senior marketing and leadership positions at sunglass maker Prive Revaux (March 2018 to April 2020), curated
meal company Menud (October 2014 to April 2018) and Rejuvenetics, LLC, a distributor of health and wellness products (December 2012 to
March 2016). Mr. Macpherson holds a BA in Economics from Gettysburg College.

 Key
Consultants

 On
March 13, 2024, we entered into an Amended and Restated Consulting Agreement with Angel Pharmaceutical Consulting & Technologies
Ltd., an Israeli consulting firm ("APCT"). All services provided to our company by APCT (which began in October 2023) are
provided directly by Dr. Itzchak Angel, who shall be our Chief Scientific Advisor. Dr. Angel has over 30 years of experience in the pharmaceutical
industry, guiding strategic drug and business development initiatives in both large and emerging companies.

 Dr.
Angel has served as Head of Pharmacology of Synthelabo (Paris, France, now Sanofi) for numerous years, where he was instrumental in the
development and bringing into the market of several drugs such as Xatral (Alfuzosin), Ambien (Zolpidem) and Mizollen (Mizolastine). He
formerly served as President and Chief Executive Officer of stem-cell company Accellta (Haifa, Israel) and Vice President for Research
and Development at Proteologics Ltd, and at D-Pharm Biopharmaceuticals (Rehovot, Israel) where he developed several neurology compounds
(stroke, Alzheimer's and Parkinson's Disease) into advanced clinical development and was involved in submitting numerous
INDs of drugs under development. Dr. Angel is the author of more than 100 book chapters, papers, and abstracts as well as the named inventor
of a number of pharmaceutical patents. Dr. Angel received his B.S. and M.Sc. in Biology from Tel-Aviv University, Israel, cum laude in
1979, and received Ph. D. cum laude from the Hamburg University, Germany in 1982.

 As
part of his consulting services, Dr. Angel shall assist our company with (i) pharmaceutical regulatory affairs, toxicology, drug research
and pre-clinical and clinical testing, (ii) outsourcing and helping our company in managing third party vendors and (iii) working with
our company in our interactions with regulatory bodies.

 Board
Composition

 Our
business and affairs are managed under the direction of our board of directors, which currently consists of five members. The number
of directors is determined by our board of directors, subject to the terms of our amended and restated articles of incorporation and
bylaws that. Our directors are elected for one-year terms.

 Family
Relationships

 There
are no family relationships among any of our directors and executive officers.

Independence

 Our
board of directors has undertaken a review of the independence of each director. Based on information provided by each director concerning
his or her background, employment, and affiliations, our board of directors has determined that Michael Jerman, Dr. Matthew Del Giudice,
Dr. Denil Shekhat and Edward MacPherson do not have any relationship that would interfere with the exercise of independent judgment in carrying
out the responsibilities of a director and are independent directors under the Nasdaq Listing Rules.

 In
making these determinations, our board of directors considered the current and prior relationships that each non-employee director has
with our company and all other facts and circumstances our board of directors deemed relevant in determining their independence, including
the transactions described in the section of this Report titled "Item 13. Certain Relationships and Related Party Transactions."

 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.
The functions of these committees are described below. Members will serve on these committees until their resignation or until otherwise
determined by our board of directors. Our board of directors may establish other committees as it deems necessary or appropriate from
time to time.

 Audit
Committee

 Our
audit committee consists of Michael Jerman, Dr. Denil Shekhat and Edward MacPherson, with Michael Jerman serving as the chair of the
audit committee. Each member of the committee meets the requirements for independence under the listing standards of Nasdaq and SEC
rules and regulations, including Rule 10A-3(b)(1) under the Exchange Act. Each member of our audit committee also meets the
financial literacy requirements of the listing standards of Nasdaq. In addition, our board of directors has determined that Michael
Jerman is an audit committee financial expert within the meaning of Item 407(d) of Regulation S-K under the Securities
Act.

 The
audit committee's main purpose is to oversee our corporate accounting and financial reporting process. Our audit committee is responsible
for, among other things:

 selecting
 a qualified firm to serve as the independent registered public accounting firm to audit our financial statements;

 helping
 to ensure the independence and performance of the independent registered public accounting firm;

 discussing
 the scope and results of the audit with the independent registered public accounting firm, and reviewing, with management and the
 independent registered public accounting firm, our interim and year-end results of operations;

 developing
 procedures for employees to submit concerns anonymously about questionable accounting or audit matters;

 reviewing
 our policies on risk assessment and risk management;

 reviewing
 related party transactions;

 reviewing
 and pre-approving, as required, all audit and all permissible non-audit services to be performed by the independent registered public
 accounting firm; and

 assisting
 our board of directors in monitoring the performance of our internal audit function.

 Our
audit committee operates under a written charter that satisfies the applicable rules and regulations of the SEC and the listing standards
of Nasdaq, a copy of which is available on our website at www.mirapharmaceuticals.com.

Committee

 Our
compensation committee consists of Dr. Denil Shekhat and Edward MacPherson, with Dr. Denil Shekhat serving as the chair of the
compensation committee. Each member of the committee meets the requirements for independence under the listing standards of Nasdaq
and SEC rules and regulations. Each member of our compensation committee is also a non-employee director, as defined pursuant to
Rule 16b-3 promulgated under the Exchange Act, or Rule 16b-3. In arriving at these determinations, our board of directors examined
all factors relevant to determining whether any compensation committee member has a relationship to us that is material to that
member's ability to be independent from management in connection with carrying out such member's duties as a
compensation committee member.

 The
compensation committee's main purpose is to review and recommend policies relating to compensation and benefits of our officers
and employees. Our compensation committee is responsible for, among other things:

 reviewing,
 approving, and determining, or making recommendations to our board of directors regarding, the compensation and compensation arrangements
 of our executive officers;

 administering
 our equity compensation plans;

 reviewing
 and approving, or making recommendations to our board of directors regarding, incentive compensation and equity compensation plans;
 and

 establishing
 and reviewing general policies relating to compensation and benefits of our employees.

 Our
compensation committee operates under a written charter that satisfies the applicable rules and regulations of the SEC and the listing
standards of Nasdaq, a copy of which is available on our website.

 Nominating
and Corporate Governance Committee

 Our
nominating and corporate governance committee consists of Dr. Matthew DelGuidice and Dr. Denil Shekhat with Dr. Matthew DelGuidice
serving as the chair of the nominating and corporate governance committee. Each member of the committee meets the requirements for
independence under the listing standards of Nasdaq and SEC rules and regulations.

 Our
nominating and corporate governance committee is responsible for, among other things:

 identifying,
 evaluating, and selecting, or making recommendations to our board of directors regarding, nominees for election to our board of directors
 and its committees;

 developing
 and overseeing the annual evaluation of our board of directors and of its committees;

 considering
 and making recommendations to our board of directors regarding the composition of our board of directors and its committees;

 overseeing
 our corporate governance practices; and

 making
 recommendations to our board of directors regarding corporate governance guidelines.

 Our
nominating and corporate governance committee operates under a written charter that satisfies the applicable listing standards of Nasdaq,
a copy of which is available on our website.

Committee Interlocks and Insider Participation

 None
of the members of our compensation committee is a current or former executive officer or employee of our company. None of our executive
officers serves as a member of the compensation committee of any entity that has one or more executive officers serving on our compensation
committee.

 Risk
Oversight

 One
of the key functions of our board of directors is informed oversight of our risk management process. Our board of directors administers
this oversight function directly through our board of directors as a whole, and through various standing committees of our board of directors
that address risks inherent in their respective areas of oversight. In particular, our board of directors is responsible for monitoring
and assessing strategic risk exposure, including risks associated with cybersecurity and data protection, and our audit committee has
the responsibility to consider our major financial risk exposures and the steps our management has taken to monitor and control these
exposures, including guidelines and policies to govern the process by which risk assessment and management is undertaken. Our audit committee
will review legal, regulatory, and compliance matters that could have a significant impact on our financial statements. Our nominating
and corporate governance committee will monitor the effectiveness of our corporate governance practices, including whether they are successful
in preventing illegal or improper liability-creating conduct. Our compensation committee will assess and monitor whether any of our compensation
policies and programs has the potential to encourage excessive risk taking. While each committee is responsible for evaluating certain
risks and overseeing the management of such risks, our entire board of directors will be regularly informed through committee reports
about such risks.

 Board
Diversity

 Our
nominating and corporate governance committee is responsible for reviewing with the board of directors, on an annual basis, the appropriate
characteristics, skills, and experience required for the board of directors as a whole and its individual members. Although our board
of directors does not have a formal written diversity policy with respect to the evaluation of director candidates, in its evaluation
of director candidates, our nominating and corporate governance committee will consider factors including, without limitation, issues
of character, integrity, judgment, potential conflicts of interest, other commitments, and diversity, and with respect to diversity,
such factors as gender, race, ethnicity, experience, and area of expertise, as well as other individual qualities and attributes that
contribute to the total diversity of viewpoints and experience represented on the board of directors.

 The
nominating and corporate governance committee will ensure compliance with the new rule by Nasdaq for board diversity (the "Nasdaq
Diversity Rule"), on or before the date required under the Nasdaq Diversity Rule. The Nasdaq Diversity Rule requires, assuming
our shares of common stock are listed on the Nasdaq Capital Market and that we are a smaller reporting company, that we will have at
least two directors serving on our board of directors, at least one of which identifies as female and the second of which identifies
as female, underrepresented minority or LGBTQ+, by December 31, 2026, unless our board of directors is comprised of five or less directors.

 Code
of Business Conduct and Ethics

 Our
board of directors has adopted a code of business conduct and ethics applicable to all of our directors, officers (including our principal
executive officer, principal financial officer, and principal accounting officer) and all global employees in accordance with applicable
federal securities laws and corporate governance rules of the Nasdaq Capital Market. Our code of business conduct and ethics is available
on our website. Any amendments to the code of business conduct and ethics, or waivers of its requirements, will, if required, be disclosed
on our website.

 Insider
Trading Policy

 Our
board of directors has adopted an insider trading policy filed hereto as Exhibit 19.1 and is incorporated herein by this reference.

 Corporate
Governance Guidelines

 Our
board of directors has adopted corporate governance guidelines, a copy of which is available on our website.

 We
did not provide any cash compensation to any of our directors during the year ended December 31, 2023 in their capacity as directors.
However, on April 28, 2023, each non-employee director was granted an additional option to purchase up to 10,000 shares of our common
stock under the 2022 Omnibus Plan. Each such option was immediately vested in full upon grant and has a 10-year term.

of our former directors have received option grants as a result of their service to our company in a non-director capacity. Prior to
his appointment as Executive Chairman, Dr. Chapman was a party to a consulting agreement with our company entered into in April 2022
and was granted additional options in his capacity as a consultant on June 15, 2022. Dr. Chapman also received employee related grants
in April 2023 and August 2023. Mr. Kroenig previously provided consulting services to our company in 2022 and received an additional
option grant on June 15, 2022, under which he has the right to purchase up to 10,000 shares of our common stock. Upon his appointment
as our General Counsel, Mr. Christos Nicholoudis was granted an option to purchase shares of our common of 15,000 shares in April 2023,
and 10,000 shares in August 2023.

 Item
11. Executive Compensation

 This
section discusses the material components of the executive compensation program for the following persons: (i) all persons serving as
our principal executive officers during 2023 and (ii) the most highly compensated of our other executive officers who received compensation
during 2023 of at least $100,000 and who were executive officers on December 31, 2023. We refer to these persons as our "named
executive officers" elsewhere in this Report. Our "named executive officers" and their positions are as follows:

 Erez
 Aminov, Chief Executive Officer and Chairman;

 Yanez, MBA, Chief Financial Officer, Secretary and Treasurer and;

 Adam
 Kaplin, MD, PhD, former President and Chief Scientific Officer;

 In
April 2023, Mr. Aminov succeeded Mr. Uzonwanne as our Chief Executive Officer, and Ms. Yanez succeeded Mr. McNulty as our
Chief Financial Officer.

 Summary
Compensation Table

 The
following table shows the compensation paid by us during the 2023 and 2022 fiscal years to our named executive officers.

 Name and principal position

 Year

 Salary ($)

 Bonus ($)

 Stock Awards ($)

 Option
Awards ($) (6)

 Non-Equity Incentive Plan Compensation ($)

 Nonqualified Deferred Compensation Earnings

 ($)

 All Other Compensation ($)

 Total

 ($)

 Erez Aminov,

 2023

 83,333

 208,006 (1)

 -

 1,368,600

 -

 -

 5,625
 (2)

 1,665,564

 CEO

 2022

 -

 -

 -

 -

 -

 -

 -

 -

 Michelle Yanez,

 2023

 165,000

 88,475
 (1)

 -

 282,215

 -

 -

 5,934
 (2)

 541,624

 CFO

 2022

 110,000

 -

 36,950

 -

 -

 6,071
 (2)

 153,021

 Adam Kaplin,

 2023

 50,000

 -

 -

 149,600

 -

 -

 -

 199,600

 former President & CSO

 2022

 -

 50,001
 (3)

 -

 739,000

 -

 -

 -

 789,001

 Jude Uzonwanne,

 2023

 75,000

 -

 -

 -

 -

 -

 6,569
 (2)

 81,569

 former CEO

 2022

 125,000

 50,000
 (4)

 -

 739,000
 (5)

 -

 -

 8,385
 (2)

 922,385

 Jim McNulty,

 2023

 154,000

 -

 -

 -

 -

 -

 -

 154,000

 former CFO

 2022

 266,869

 100,000
 (3)

 -

 -

 -

 -

 -

 366,869

 (1)

 The
 amounts represent IPO bonuses paid in 2023.

 (2)

 represents health insurance premiums paid.

 (3)

 The
 amounts represent milestone payments pursuant to prior employment agreements.

 (4)

 The
 bonus represents a paid sign-on amount.

 (5)

 Of
 these 2022 option grants, 75% were cancelled and non-exercisable as of April 2023, pursuant to the termination of Mr. Uzonwanne.

 (6)

 The
 reported amounts represent the aggregate grant date fair value of the awards computed in accordance with Financial Accounting Standards
 Board Account Standards Codification Topic 718, Stock Compensation, as modified or supplemented, or FASB ASC Topic 718. The assumptions
 used in calculating the grant date fair value of the stock options reported in this column are set forth in Note 8 to our Consolidated
 Financial Statements for the year ended December 31, 2022 included in this Report. In April 2023, we entered into an agreement with
 Mr. Uzonwanne in which the number of shares subject to his option agreement was reduced from 200,000 to 40,000.

 Narrative
Disclosure to Summary Compensation Table

 Employment
Agreements

 Except
as set forth below, we currently have no written employment agreements with any of our named executive officers.

 Erez

 Effective
April 28, 2023, we entered into an employment agreement with Mr. Aminov, as amended on August 28, 2023, pursuant to which Mr. Aminov
will serve as our Chief Executive Officer. Under his employment agreement, as amended, Mr. Aminov has agreed to devote at least 50% of
his business time to the affairs of the Company. Mr. Aminov's employment agreement provides that his employment will be on an at-will
basis and can be terminated by either Mr. Aminov or our company at any time and for any reason. Under the agreement, Mr. Aminov will
receive a base salary of $0.2 million per year, effective August 1, 2023. In the event that Mr. Aminov's employment is terminated by
our company without "Cause" or is terminated by Mr. Aminov for "Good Reason", Mr. Aminov will be entitled to
severance compensation in the form of salary continuation for a period of three months (subject to Mr. Aminov executing and delivering
a customary general release in favor of the company). "Cause" is defined in the agreement to include dishonesty, misappropriation,
willful misconduct, breach of the agreement, and other customary matters. "Good Reason" is defined to include a material
adverse change in Mr. Aminov's compensation or duties and level of responsibility. The employment agreement also contains customary
confidentiality and invention-assignment covenants to which Mr. Aminov is subject.

 On
August 17, 2023, Mr. Aminov received a $0.1 million cash bonus net of federal, state, local and income taxes related to the successful completion
of the IPO.

 In
March 2024, Mr. Aminov assumed the role of Chairman and on March 25, 2024, the Compensation Committee of the Board of Directors approved
an increase to Mr. Aminov's base salary of $0.8 million, bringing his total annual base salary to $0.28 million.

Yanez

 On
April 28, 2023, we entered into an employment agreement with Ms. Yanez pursuant to which Ms. Yanez will serve as our Chief Financial
Officer on a full-time basis. Ms. Yanez's employment agreement provides that her employment will be on an at-will basis and can
be terminated by either Ms. Yanez or our company at any time and for any reason. Under the agreement, Ms. Yanez will receive an initial
base salary of $0.17 per year. In the event that her employment is terminated by our company without "Cause" or is terminated
by Ms. Yanez for "Good Reason", Ms. Yanez will be entitled to severance compensation in the form of salary continuation for
a period of three months (subject to Ms. Yanez executing and delivering a customary general release in favor of the company). "Cause"
is defined in the agreement to include dishonesty, misappropriation, willful misconduct, breach of the agreement, and other customary
matters. "Good Reason" is defined to include a material adverse change in Ms. Yanez's compensation or duties and level
of responsibility. The employment agreement also contains customary confidentiality and invention-assignment covenants to which Ms. Yanez
is subject.

 On
August 17, 2023, Ms. Yanez received a $0.05 million cash bonus net of federal, state, local and income taxes related to the successful completion
of the IPO. On March 25, 2024, the Compensation Committee of the Board of Directors approved an increase in Ms. Yanez's base salary of $0.06 million, bringing her annual
base salary to $0.23 million.

 Chris
Chapman

 On
April 28, 2023, we entered into an employment agreement with Dr. Chapman, as amended on August 28, 2023, and October 13, 2023,
pursuant to which Dr. Chapman served as our Executive Chairman. Dr. Chapman's employment agreement, as amended, provided that
his employment would be on a part-time basis whereby Dr. Chapman would devote time and effort to the business and affairs of the
company on an as needed basis, and it further provides that such employment would be on an at-will basis and could be terminated by
either Dr. Chapman or our company at any time and for any reason. Under the agreement, Dr. Chapman would receive a base salary of
$0.05 million per year for a period of 90 days following the October 13, 2023 amendment, and following the 90-day period, Dr.
Chapman's base salary will increase to $0.15 million. In the event that Dr. Chapman's employment is terminated by our company
without "Cause" or is terminated by Dr. Chapman for "Good Reason", Dr. Chapman would be entitled to severance
compensation in the form of salary continuation for a period of three months (subject to Dr. Chapman executing and delivering a
customary general release in favor of the company). "Cause" is defined in the agreement to include dishonesty,
misappropriation, willful misconduct, breach of the agreement, and other customary matters. "Good Reason" is defined to
include a material adverse change in Dr. Chapman's compensation or duties and level of responsibility. The employment
agreement also contains customary confidentiality and invention-assignment covenants to which Dr. Chapman is subject.

 On
August 17, 2023, Dr. Chapman received a $0.05 million cash bonus net of federal, state, local and income taxes related to the successful completion
of the IPO.

 On
March 9, 2024, Dr. Chapman resigned from our company as Executive Chairman, and as an employee.

 Consulting
Relationship with Adam Kaplin

 Dr.
Kaplin was a paid non-employee consultant to our company under which he provided services and consultation on an as-needed basis. Dr.
Kaplin was paid $0.01 million a month for his services. We do not currently have a written consulting agreement with Dr. Kaplin.

 Grants
of Plan-Based Awards in 2023

 Estimated
 Future Payouts Under Non-Equity Incentive Plan Awards

 Estimated
 Future Payouts Under Equity Incentive Plan Awards

 All
 Other Stock Awards: Number of Shares of Stocks or

 All
 Other Option Awards: Number of Securities Underlying

 Exercise
 or Base Price of Option

 Closing
 stock price on Award

 Grant
 Date Fair Value of Stock and

 Name

 Grant
 Date (1)

 Threshold
 ($)

 Target
 ($)

 Maximum
 ($)

 Threshold
 (#)

 Target
 (#)

 Maximum
 (#)

 Units
 (#)

 Options
 (#)

 Awards
 ($/Sh)

 date
 ($/Sh)

 Option
 Awards

 Erez
 Aminov, CEO

 4/28/2023

 -

 -

 -

 -

 -

 -

 -

 150,000
 (2)

 $
 5.00

 -
 (3)

 $
 112,200

 8/17/2023

 -

 -

 -

 -

 -

 -

 -

 150,000
 (4)

 $
 6.50

 $
 6.50

 $
 807,600

 Yanez, CFO

 4/28/2023

 -

 -

 -

 -

 -

 -

 46,667
 (2)

 $
 5.00

 -
 (3)

 $
 174,535

 8/17/2023

 -

 -

 -

 -

 -

 -

 20,000
 (4)

 $
 6.50

 $
 6.50

 $
 107,680

 Adam
 Kaplin, former President & CSO

 4/28/2023

 -

 -

 -

 -

 -

 -

 -

 40,000
 (2)

 $
 5.00

 -
 (3)

 $
 149,600

 Jude
 Uzonwanne, former CEO

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

 $
 -

 James
 McNulty, former CFO

 -

 -

 -

 -

 -

 -

 -

 -

 -

 -

 $
 -

 (1)

 The
 "Grant Date" represents the date on which the Compensation Committee of the Board took action to grant the applicable
 award.

 (2)

 The
 stock awards disclosed in this item consist of options, as issued under our 2022 Omnibus Incentive Plan, which vest ratably in thirds
 beginning April 2023.

 (3)

 There
 was no closing stock price for our common stock since our IPO did not occur until August 2023.

 (4)

 The
 stock awards disclosed in this item consist of options, as issued under our 2022 Omnibus Incentive Plan, which vested 100% at grant.

 Outstanding
equity awards

 The
following table summarizes outstanding unexercised options held by each of our named executive officers, as of December 31, 2023.

 OPTION
 AWARDS

 STOCK
 AWARDS

 Name

 of Securities Underlying Unexercised Options (#) Exercisable

 of Securities Underlying Unexercised Options (#) Unexercisable

 Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#)

 Options
 Exercise Prices ($)

 Option Expiration
 Date

 of Shares or Units of Stock That Have Not Vested (#)

 Market
 Value of Shares or Units of Stock That Have Not Vested ($)

 Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested
 (#)

 Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That
 Have Not vested (#)

 Erez

 150,000

 -

 -

 $
 6.50

 8/16/33

 -

 -

 -

 -

 50,000

 100,000

 -

 $
 5.00

 4/27/33

 -

 -

 -

 -

 Michelle Yanez

 20,000

 -

 -

 $
 6.50

 8/16/33

 -

 -

 -

 -

 15,556

 31,111

 -

 $
 5.00

 4/27/33

 -

 -

 -

 -

 6,667

 3,333

 -

 $
 5.00

 6/14/32

 -

 -

 -

 -

 Adam
Kaplin

 13,334

 26,666

 -

 $
 5.00

 4/27/33

 -

 -

 -

 -

 100,000

 100,000

 -

 $
 5.00

 6/14/32

 -

 -

 -

 -

 Jude Uzonwanne

 50,000

 -

 -

 $
 5.00

 6/14/32

 -

 -

 -

 -

 James McNulty

 -

 -

 -

 -

 -

 -

 -

 Option
Exercises and Stock Vested

 No
stock options were exercised by our executive officers during the year ended December 31, 2023:

 2022
Omnibus Incentive Plan

 Our
board of directors has adopted, and our stockholders have approved, our 2022 Omnibus Incentive Plan, or the 2022 Omnibus Plan. The 2022
Omnibus Plan authorizes the grant of incentive stock options, within the meaning of Section 422 of the Internal Revenue Code, to our
employees and any of our parent and subsidiary corporations' employees, and the grant of nonstatutory stock options, restricted
stock, restricted stock units, stock appreciation rights, performance units and performance shares to our employees, directors, and consultants
and any of our future subsidiary corporations' employees and consultants. The following is a summary of certain terms and conditions
of the 2022 Omnibus Plan. This summary is qualified in its entirety by reference to the 2022 Omnibus Plan attached as an exhibit to this
Report. You are encouraged to read the full text of the 2022 Omnibus Plan.

 As
of December 31, 2023, there are options to purchase an aggregate of 1,210,001 shares of our common stock outstanding under the 2022 Omnibus
Plan.

 Administration

 The
2022 Omnibus Plan is administered by our board of directors or our compensation committee, or any other committee or subcommittee or
one or more of our officers to whom authority has been delegated (collectively, the "Administrator"). The Administrator has
the authority to interpret the 2022 Omnibus Plan and award agreements entered into with respect to the 2022 Omnibus Plan; to make, change
and rescind rules and regulations relating to the 2022 Omnibus Plan; to make changes to, or reconcile any inconsistency in, the 2022
Omnibus Plan or any award agreement covering an award; and to take any other actions needed to administer the 2022 Omnibus Plan.

 Eligibility

 The
Administrator may designate any of the following as a participant under the 2022 Omnibus Plan: any officer or employee, or individuals
engaged to become an officer or employee, of our company or our affiliates; and consultants of our company or our affiliates, and our
directors, including our non-employee directors.

 Types
of Awards

 The
2022 Omnibus Plan permits the Administrator to grant stock options, stock appreciation rights ("SARs"), performance shares,
performance units, shares of common stock, restricted stock, restricted stock units ("RSUs"), cash incentive awards, dividend
equivalent units, or any other type of award permitted under the 2022 Omnibus Plan. The Administrator may grant any type of award to
any participant it selects, but only our employees or our subsidiaries' employees may receive grants of incentive stock options
within the meaning of Section 422 of the Internal Revenue Code. Awards may be granted alone or in addition to, in tandem with, or (subject
to the repricing prohibition described below) in substitution for any other award (or any other award granted under another plan of our
company or any affiliate, including the plan of an acquired entity).

 Shares
Reserved Under the 2022 Omnibus Incentive Plan

 The
2022 Omnibus Plan provides that 2,000,000 shares of our common stock are reserved for issuance under the 2022 Omnibus Plan, all of which
may be issued pursuant to the exercise of incentive stock options. The number of shares available for issuance under our 2022 Omnibus
Plan will also include an annual increase on the first day of each fiscal year equal to the lesser of:

 200,000
 shares;

 1.0%
 of the outstanding shares of all class of our common stock as of the last day of the immediately preceding fiscal year; or

 such
 other amount as our board of directors may determine.

 The
number of shares reserved for issuance under the 2022 Omnibus Plan will be reduced on the date of the grant of any award by the maximum
number of shares, if any, with respect to which such award is granted. However, an award that may be settled solely in cash will not
deplete the 2022 Omnibus Plan's share reserve at the time the award is granted. If (a) an award expires, is canceled, or terminates
without issuance of shares or is settled in cash, (b) the Administrator determines that the shares granted under an award will not be
issuable because the conditions for issuance will not be satisfied, (c) shares are forfeited under an award, (d) shares are issued under
any award and we reacquire them pursuant to our reserved rights upon the issuance of the shares, (e) shares are tendered or withheld
in payment of the exercise price of an option or as a result of the net settlement of outstanding stock appreciation rights or (f) shares
are tendered or withheld to satisfy federal, state or local tax withholding obligations, then those shares are added back to the reserve
and may again be used for new awards under the 2022 Omnibus Plan. However, shares added back to the reserve pursuant to clauses (d),
(e) or (f) in the preceding sentence may not be issued pursuant to incentive stock options.

 Options

 The
Administrator may grant stock options and determine all terms and conditions of each stock option, which include the number of stock
options granted, whether a stock option is to be an incentive stock option or non-qualified stock option, and the grant date for the
stock option. However, the exercise price per share of common stock may never be less than the fair market value of a share of common
stock on the date of grant and the expiration date may not be later than 10 years after the date of grant. Stock options will be exercisable
and vest at such times and be subject to such restrictions and conditions as are determined by the Administrator, including with respect
to the manner of payment of the exercise price of such stock options.

 Stock
Appreciation Rights

 The
Administrator may grant SARs, which represent the right of a participant to receive cash in an amount, or common stock with a fair market
value, equal to the appreciation of the fair market value of a share of common stock during a specified period of time. The 2022 Omnibus
Plan provides that the Administrator will determine all terms and conditions of each SAR, including, among other things: (a) whether
the SAR is granted independently of a stock option or relates to a stock option, (b) the grant price, which may never be less than the
fair market value of our common stock as determined on the date of grant, (c) a term that must be no later than 10 years after the date
of grant, and (d) whether the SAR will settle in cash, common stock or a combination of the two.

 Performance
and Stock Awards

 The
Administrator may grant awards of shares of common stock, restricted stock, RSUs, performance shares or performance units. Restricted
stock means shares of common stock that are subject to a risk of forfeiture or restrictions on transfer, which may lapse upon the achievement
or partial achievement of performance goals (as described below) or upon the completion of a period of service. An RSU grants the participant
the right to receive cash or shares of common stock the value of which is equal to the fair market value of one share of common stock,
to the extent performance goals are achieved or upon the completion of a period of service. Performance shares give the participant the
right to receive shares of common stock to the extent performance goals are achieved. Performance units give the participant the right
to receive cash or shares of common stock valued in relation to a unit that has a designated dollar value or the value of which is equal
to the fair market value of one or more shares of common stock, to the extent performance goals are achieved.

 The
Administrator will determine all terms and conditions of the awards including (a) whether performance goals must be achieved for the
participant to realize any portion of the benefit provided under the award, (b) the length of the vesting or performance period and,
if different, the date that payment of the benefit will be made, (c) with respect to performance units, whether to measure the value
of each unit in relation to a designated dollar value or the fair market value of one or more shares of common stock, and (d) with respect
to performance shares, performance units, and RSUs, whether the awards will settle in cash, in shares of common stock (including restricted
stock), or in a combination of the two.

 Cash
Incentive Awards

 The
Administrator may grant cash incentive awards. An incentive award is the right to receive a cash payment to the extent one or more performance
goals are achieved. The Administrator will determine all terms and conditions of a cash incentive award, including, but not limited to,
the performance goals (described below), the performance period, the potential amount payable, and the timing of payment. While the 2022
Omnibus Plan permits cash incentive awards to be granted under the 2022 Omnibus Plan, we may also make cash incentive awards outside
of the 2022 Omnibus Plan.

 Performance
Goals

 For
purposes of the 2022 Omnibus Plan, the Administrator may establish objective or subjective performance goals which may apply to any performance
award. Such performance goals may include, but are not limited to, one or more of the following measures with respect to our company
or any one or more of our subsidiaries, affiliates, or other business units: net sales; cost of sales; gross income; gross revenue; revenue;
operating income; earnings before taxes; earnings before interest and taxes; earnings before interest, taxes, depreciation and amortization;
earnings before interest, taxes, depreciation, amortization and exception items; income from continuing operations; net income; earnings
per share; diluted earnings per share; total stockholder return; fair market value of a share of common stock; cash flow; net cash provided
by operating activities; net cash provided by operating activities less net cash used in investing activities; ratio of debt to debt
plus equity; return on stockholder equity; return on invested capital; return on average total capital employed; return on net capital
employed; return on assets; return on net assets employed before interest and taxes; operating working capital; average accounts receivable
(calculated by taking the average of accounts receivable at the end of each month); average inventories (calculated by taking the average
of inventories at the end of each month); economic value added; succession planning; manufacturing return on assets; manufacturing margin;
and customer satisfaction. Performance goals may also relate to a participant's individual performance. The Administrator reserves
the right to adjust any performance goals or modify the manner of measuring or evaluating a performance goal.

 Dividend
Equivalent Units

 The
Administrator may grant dividend equivalent units. A dividend equivalent unit gives the participant the right to receive a payment, in
cash or shares of common stock, equal to the cash dividends or other distributions that we pay with respect to a share of common stock.
We determine all terms and conditions of a dividend equivalent unit award, except that dividend equivalent units may not be granted in
connection with a stock option or SAR, and dividend equivalent unit awards granted in connection with another award cannot provide for
payment until the date such award vests or is earned, as applicable.

 Other
Stock-Based Awards

 The
Administrator may grant to any participant shares of unrestricted stock as a replacement for other compensation to which such participant
is entitled, such as in payment of director fees, in lieu of cash compensation, in exchange for cancellation of a compensation right
or as a bonus.

 Transferability

 Awards
are not transferable, including to any financial institution, other than by will or the laws of descent and distribution, unless the
Administrator allows a participant to (a) designate in writing a beneficiary to exercise the award or receive payment under the award
after the participant's death, (b) transfer an award to a former spouse as required by a domestic relations order incident to a
divorce, or (c) transfer an award without receiving any consideration.

 Adjustments

 If
(a) we are involved in a merger or other transaction in which our shares of common stock are changed or exchanged; (b) we subdivide or
combine shares of common stock or declare a dividend payable in shares of common stock, other securities, or other property (other than
stock purchase rights issued pursuant to a stockholder rights agreement); (c) we effect a cash dividend that exceeds 10% of the fair
market value of a share of common stock or any other dividend or distribution in the form of cash or a repurchase of shares of common
stock that our board of directors determines is special or extraordinary, or that is in connection with a recapitalization or reorganization;
or (d) any other event occurs that in the Administrator's judgment requires an adjustment to prevent dilution or enlargement of
the benefits intended to be made available under the 2022 Omnibus Plan, then the Administrator will, in a manner it deems equitable,
adjust any or all of (1) the number and type of shares subject to the 2022 Omnibus Plan and which may, after the event, be made the subject
of awards; (2) the number and type of shares of common stock subject to outstanding awards; (3) the grant, purchase, or exercise price
with respect to any award; and (4) the performance goals of an award. In any such case, the Administrator may also provide for a cash
payment to the holder of an outstanding award in exchange for the cancellation of all or a portion of the award, subject to the terms
of the 2022 Omnibus Plan.

 The
Administrator may, in connection with any merger, consolidation, acquisition of property or stock, or reorganization, authorize the issuance
or assumption of awards upon terms and conditions we deem appropriate without affecting the number of shares of common stock otherwise
reserved or available under the 2022 Omnibus Plan.

 Change
of Control

 Upon
a change of control (as defined in the 2022 Omnibus Plan), the successor or surviving corporation may agree to assume some or all outstanding
awards or replace them with the same type of award with similar terms and conditions, without the consent of any participant, subject
to the following requirements:

 Each
 award that is assumed must be appropriately adjusted, immediately after such change of control, to apply to the number and class
 of securities that would have been issuable to a participant upon the consummation of such change of control had the award been exercised,
 vested, or earned immediately prior to such change of control, and other appropriate adjustment to the terms and conditions of the
 award may be made.

 If
 the securities to which the awards relate after the change of control are not listed and traded on a national securities exchange,
 then (a) each participant must be provided the option to elect to receive, in lieu of the issuance of such securities, cash in an
 amount equal to the fair value of the securities that would have otherwise been issued, and (b) no reduction may be taken to reflect
 a discount for lack of marketability, minority, or any similar consideration, for purposes of determining the fair value of such
 securities.

 If
 a participant is terminated from employment without cause, or due to death or disability, or the participant resigns employment for
 good reason (as defined in any award or other agreement between the participant and our company or an affiliate) within two years
 following the change of control, then upon such termination, all of the participant's awards in effect on the date of such
 termination will vest in full or be deemed earned in full.

 If
the purchaser, successor, or surviving entity does not assume the awards or issue replacement awards, then immediately prior to the change
of control date, unless the Administrator otherwise determines:

 Each
 stock option or SAR then held by a participant will become immediately and fully vested, and all stock options and SARs will be cancelled
 on the change of control date in exchange for a cash payment equal to the excess of the change of control price of the shares of
 common stock over the purchase or grant price of such shares under the award.

 Unvested
 restricted stock and RSUs (that are not performance awards) will vest in full.

 All
 performance shares, performance units and cash incentive awards for which the performance period has expired will be paid based on
 actual performance, and all such awards for which the performance period has not expired will be cancelled in exchange for a cash
 payment equal to the amount that would have been due under such awards, valued assuming achievement of target performance goals at
 the time of the change of control, prorated based on the number of full months elapsed in the performance period.

 All
 unvested dividend equivalent units will vest (to the same extent as the award granted in tandem with such units) and be paid.

 All
 other unvested awards will vest and any amounts payable will be paid in cash.

 Term
of Plan

 Unless
earlier terminated by our board of directors, the 2022 Omnibus Plan will terminate on, and no further awards may be granted, after the
tenth (10 th) anniversary of its effective date.

 Termination
and Amendment of Plan

 Our
board of directors or the Administrator may amend, alter, suspend, discontinue, or terminate the 2022 Omnibus Plan at any time, subject
to the following limitations:

 Our
 board of directors must approve any amendment to the 2022 Omnibus Plan if we determine such approval is required by prior action
 of our board of directors, applicable corporate law, or any other applicable law;

 Stockholders
 must approve any amendment to the 2022 Omnibus Plan, which may include an amendment to materially increase the number of shares reserved
 under the 2022 Omnibus Plan, if we determine that such approval is required by Section 16 of the Exchange Act, the Code, the listing
 requirements of any principal securities exchange or market on which the shares are then traded, or any other applicable law; and

 Stockholders
 must approve any amendment to the 2022 Omnibus Plan that would diminish the protections afforded by the participant award limits
 or repricing and backdating prohibitions.

 Amendment,
Modification, Cancellation and Disgorgement of Awards

 Subject
to the requirements of the 2022 Omnibus Plan, the Administrator may modify or amend any award or waive any restrictions or conditions
applicable to any award or the exercise of the award, or amend, modify, or cancel any terms and conditions applicable to any award, in
each case, by mutual agreement of the Administrator and the participant or any other person that may have an interest in the award, so
long as any such action does not increase the number of shares of common stock issuable under the 2022 Omnibus Plan.

 We
do not need to obtain participant (or other interested party) consent for any such action (a) that is permitted pursuant to the adjustment
provisions of the 2022 Omnibus Plan; (b) to the extent we deem the action necessary to comply with any applicable law or the listing
requirements of any principal securities exchange or market on which our common stock is then traded; (c) to the extent we deem the action
is necessary to preserve favorable accounting or tax treatment of any award for us; or (d) to the extent we determine that such action
does not materially and adversely affect the value of an award or that such action is in the best interest of the affected participant
or any other person as may then have an interest in the award.

 The
Administrator can cause a participant to forfeit any award, and require the participant to disgorge any gains attributable to the award,
if the participant engages in any action constituting, as determined by the Administrator in its discretion, cause for termination, or
a breach of a material company policy, any award agreement or any other agreement between the participant and us or one of our affiliates
concerning noncompetition, nonsolicitation, confidentiality, trade secrets, intellectual property, nondisparagement or similar obligations.

 Any awards granted under the 2022
Omnibus Plan, and any shares of common stock issued or cash paid under an award, will be subject to recoupment our Compensation Recovery
Policy (as described below), or any recoupment or similar requirement otherwise made applicable by law, regulation or listing standards
to us, or that may be provided for in any cash or equity award granted by us.

of Directors

 The
following table sets forth all compensation paid to our Board members during the year ended December 31, 2023:

 Name

 Fees
 Earned or Paid in Cash ($) (1)

 Stock
 Awards ($)

 Option
 Awards ($) (7)

 Non-Equity
 Incentive Plan Compensation ($)

 Change
 in Pension Value and Nonqualified Deferred Compensation Earnings ($)

 All
 Other Compensation ($)

 Total
 ($)

 Chris Chapman,
 PhD. (2)

 128,629

 -

 493,600

 -

 -

 -

 622,229

 Mike Jerman

 -

 -

 -

 -

 -

 -

 -

 Talhia Tuck (3)

 -

 -

 -

 -

 -

 Brad Kroenig (3)

 -

 -

 -

 -

 -

 Hugh McColl III (3)

 -

 -

 -

 -

 -

 Christos Nicholoudis, Esq.
 (4)

 74,085

 -

 109,940

 -

 -

 -

 184,025

 Dave
 Vorhoff, former
 director
 (5)

 -

 -

 -

 -

 -

 Brian Daly, former director
 (6)

 -

 -

 -

 -

 -

 -

 -

 (1)

 Cash
 payments made to Dr. Chapman and Mr. Nicholoudis are related to their employment agreements, respectively.

 (2)

 On
 March 9, 2024, Dr. Chapman resigned from our Company as Executive Chairman and as an employee.

 (3)

 On
 March 9, 2024, Ms. Tuck, Mr. Kroenig and Mr. McColl resigned from our Company as members of the Board of Directors.

 (4)

 On
 January 15, 2024, Mr. Nicholoudis resigned from our Company as General Counsel and as a member of the Board of Directors.

 (5)

 On
 October 19, 2023, Mr. Vorhoff resigned from our Company as a member of the Board of Directors.

 (6)

 On
 December 15, 2023, Mr. Daly resigned from our Company as a member of the Board of Directors.

 (7)

 The
 reported amounts represent the aggregate grant date fair value of the awards computed in accordance with Financial Accounting Standards
 Board Account Standards Codification Topic 718, Stock Compensation, as modified or supplemented, or FASB ASC Topic 718. The assumptions
 used in calculating the grant date fair value of the stock options reported in this column are set forth in Note 8 to our Consolidated
 Financial Statements for the year ended December 31, 2022 included in this Report.

Recovery Policy

 On
October 2, 2023, our Board of Directors adopted a policy (commonly known as a "clawback" policy) which provides for the recovery
of erroneously awarded incentive compensation to certain of our officers in the event that we are required to prepare an accounting restatement
due to material noncompliance by us with any financial reporting requirements under the federal securities laws. This policy is designed
to comply with Section 10D of the Securities Exchange Act of 1934, as amended, related rules and the listing standards of Nasdaq Stock
Market or any other securities exchange on which our shares are listed in the future. The policy is administered by our Board of Directors
or, if so designated by the Board of Directors, the Compensation Committee. Any determinations made by the Board shall be final and binding
on all affected individuals.

 The
individuals covered by this policy (the "Covered Officers") are any current or former employee who is or was identified as
our president, principal financial officer, principal accounting officer (or if there is no such accounting officer, the controller),
any vice-president in charge of a principal business unit, division, or function (such as sales, administration, or finance), any other
officer who performs a significant policy-making function, or any other person (including any executive officer of our subsidiaries or
affiliates) who performs similar significant policy-making functions for us.

 The
policy covers our recoupment of "Incentive-Based Compensation" (as defined in the policy) received by a person after beginning
service as a Covered Executive and who served as a Covered Officer at any time during the performance period for that Incentive Compensation.
In the event we are required to prepare an accounting restatement, the policy requires us to recover, reasonably promptly, any excess
incentive compensation (as determined by our Board of Directors or Compensation Committee) received by any Covered Officer during the
three completed fiscal years immediately preceding the date on which we are required to prepare such accounting restatement. The foregoing
description of our Compensation Recovery Policy does not purport to be complete and is qualified in its entirety by the terms and conditions
of such policy, a copy of which is filed as an exhibit to this Report and is incorporated herein by reference.

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

 The
following table sets forth, as of the date of this Report, the ownership of our securities by: (i) each of our directors, (ii) all persons
who, to our knowledge, are the beneficial owners of more than 5% of the outstanding shares of common stock, (iii) each of the executive
officers, and (iv) all of our directors and executive officers, as a group. Each person named in this table has sole investment power
and sole voting power with respect to the shares of common stock set forth opposite such person's name, except as otherwise indicated.

 Name and Address of Beneficial Owner

 and Nature of Beneficial Ownership

 Percentage of Class as of

 March 28 2024

 Directors
 and Executive Officers (1)

 Erez Aminov

 623,500

 4.15
 %

 Michelle Yanez

 57,779

 *

 Michael Jerman

 25,000

 *

 Matthew Del Giudice

 25,000

 *

 Denil Nanji Shekhat

 25,000

 *

 Edward MacPherson

 25,000

 *

 All current
 directors and officers as a group (6 persons) (2)

 781,279

 5.21
 %

 5% Stockholders

 Brian McNulty (3)

 5,110,270

 34.57
 %

 *Represents beneficial ownership of less than 1%

 (1)

 Unless
 otherwise denoted, the address of each noted person is 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 33131.

 (2)

 Includes
 shares subject to options granted under our 2022 Omnibus Plan that are exercisable as of the Beneficial Ownership Date or within
 60 days of the Beneficial Ownership Date held as follows: Mr. Aminov, 250,000 shares and Ms. Yanez, 57,779 shares, Mr. Jerman, 25,000 shares, Dr. Del Guidice, 25,000 shares, Dr. Shekhat, 25,000 shares, Mr. MacPherson, 25,000 shares, and all current
 officers and directors as a group, 407,779 shares. Excludes shares subject to options granted under our 2022 Omnibus Plan that are
 not exercisable within 60 days of the Beneficial Ownership Date.

 (3)

 Includes
 (i) 10,000 shares held directly by Mr. McNulty, (ii) 2,740,270 shares held by the Bay Shore Trust, (iii) 660,000 shares held by the
 Celeste J Williams Lifetime QTIP Trust, (iv) 1,000,000 shares issuable pursuant to warrants held by the Bay Shore Trust that are
 immediately exercisable, and (v) 700,000 shares issuable pursuant to warrants held by MIRALOGX LLC, that are immediately exercisable.
 As trustee of the Bay Shore Trust and the Celeste J Williams Lifetime QTIP Trust, Mr. McNulty has sole voting and dispositive power
 over the shares held by each trust, and, as a result is deemed to have beneficial ownership (as determined under Section 13(d) of
 the Exchange Act) of the securities held by the trusts. The address for MIRALOGX LLC and the Bay Shore Trust is 900 West Platt Street,
 Suite 200, Tampa, Florida, 33606.

 DELINQUENT
SECTION 16(A) REPORTS

 Section
16(a) of the Exchange Act requires directors and executive officers, and persons who own more than 10% of the Company's common
stock, to report to the SEC their initial ownership of the Company's common stock and any subsequent changes in that ownership.
Specific due dates for these reports have been established by the SEC and we are required to disclose in this Annual Report on Form 10-K
any late filings or failures to file.

 Based
solely on review of the copies of such reports furnished to us and written representations from reporting persons that no other reports
were required during the fiscal year ended December 31, 2023, we believe that, during the 2023 fiscal year, all of the Company's
directors and executive officers complied with all Section 16(a) filing requirements applicable to them, with the exception of one late
filing By the Bay Shore Trust, which was required to be filed on November 22, 2023, but was filed on December 27, 2023.

Authorized for Issuance Under Equity Compensation Plans

 The
following table indicates shares of common stock authorized for issuance under our 2022 Omnibus Plan as of December 31, 2023:

 Plan
 category

 of securities to be issued upon exercise of outstanding options and warrants

 Weighted-
 average exercise price of outstanding options and warrants

 of securities remaining available for future issuance

 Equity compensation plans approved by security holders

 2,973,571

 $
 4.45

 789,999

 Equity compensation plans not approved by security
 holders

 -

 -

 -

 Total

 2,973,571

 $
 4.45

 789,999

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

 The
following is a description of transactions within the last two years to which we have been a party, in which the amount involved exceeded
or will exceed $120,000, and in which any of our executive officers, directors or holders of more than 5% of our voting securities, or
an immediate family member thereof, had or will have a direct or indirect material interest. We believe the terms obtained or consideration
that we paid or received, as applicable, in connection with the transactions described below were comparable to terms available or amounts
that would be paid or received, as applicable, in arm's-length transactions with unrelated third parties.

 Line
of Credit and Promissory Note with the Bay Shore Trust

 On
April 28, 2023, we entered into the Bay Shore Note with the Bay Shore Trust, under which we have the right to borrow up to an aggregate
of $5,000,000 from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note or, if earlier,
upon the completion of our initial public offering. Our right to borrow funds under the Bay Shore Note is subject to the absence of a
material adverse change in our assets, operations, or prospects. The Bay Share Note, together with accrued interest, will become due
and payable on the second anniversary of the issuance of the note, provided that it may be prepaid at any time without penalty. The Bay
Shore Note will accrue interest at a rate equal 7% per annum, simple interest, during the first year that the note is outstanding and
10% per annum, simple interest, thereafter. The Bay Shore Note is unsecured. As of June 30, 2023, the Bay Shore Note had an outstanding
principal balance of $1.8 million and accrued and unpaid interest of $0.04 million. Under the Bay Shore Trust Conversion Agreement, the
Bay Shore Trust agreed to convert, upon the completion of our initial public offering, $1,100,190 of the outstanding principal balance
of the Bay Shore Note into shares of our common stock at a conversion price equal to our initial public offering price, which resulted
in the issuance of 157,170 shares to the Bay Shore Trust upon the completion of our initial public offering. The note was paid off as of December 31, 2023.

 In
consideration of the loan facility provided by the Bay Shore Trust, we issued to the Bay Shore Trust a common stock purchase warrant
on April 28, 2023 giving the Bay Shore Trust the right to purchase up to 1,000,000 shares of common stock at an exercise price of $5.00
per share, which warrant will expire five years after the date of grant. Pursuant to a registration rights agreement, we have granted
to Bay Shore Trust the right to require us, at any time after one year following our initial public offering, to register for resale
the shares issuable upon the exercise of the warrant, with such registration rights being in the form of demand and "piggyback"
registration rights that are subject to customary limitations and restrictions. Upon issuance, the warrant met the criteria to be classified
as equity based on an analysis under Accounting Standards Codification (480) ASC 480, " Distinguishing Liabilities from Equity "
and was measured at fair value, resulting in an initial fair value of approximately $3.5 million upon issuance of the warrant using
Black-Scholes valuation techniques.

 Transactions
with MIRALOGX LLC

 Since
January 1, 2023, MIRALOGX has advanced funds on behalf of Bay Shore Trust to our company in order to fund operating activities. The total
amount advanced and outstanding from MIRALOGX was $1.6 million immediately prior to being consolidated into the Bay Shore Note on June
30, 2023, and such amounts became a part of the outstanding balance of the Bay Shore Note as of June 30, 2023 and are payable under the
terms of the Bay Shore Note.

 We
are also a party to an Agreement for Shared Lease Costs, dated April 1, 2023, with MIRALOGX under which we have agreed to pay our pro
rata share of the operating usage costs owing by MIRALOGX under an aircraft lease agreement between MIRALOGX and Supera Aviation I LLC
("Supera Aviation") based on our usage of the leased aircraft each month. No amounts are payable by us under this agreement
unless and to the extent we choose to utilize the leased aircraft. As such, we discontinued the use of the aircraft in March 2023. Prior
to entering into this agreement, we were a party to an aircraft lease agreement with Supera Aviation from April 20, 2021, through March
31, 2023. We paid Supera Aviation an aggregate of $0.5 million during the first quarter of 2023 and $1.7 million in 2022. Supera Aviation
is a company owned by Starwood Trust.

 On
November 15, 2023, we entered into an exclusive license agreement in with MIRALOGX to develop and commercialize a drug product containing
2-(2-chlorophenyl)-2-(methylamino) cyclopentan-1-one (sometimes referred to by the Parties as "M209" or "KETAMIR-2")
as an active agent in North America. The exclusive license in the license agreement includes our right to sublicense the licensed intellectual
property. Pursuant to the terms of the license agreement, and subject to the conditions set forth therein, we paid MIRALOGX a one-time,
nonrefundable payment of $100,000 upon the signing of the Agreement and will be obligated to pay quarterly royalty payments on sales
of the Product in the Territory of 8% of net sales and 8% of other revenue (such as milestone or sublicense payments) from licensed products.
Also, in consideration of License Agreement, we issued to MIRALOGX a common stock purchase warrant to purchase up to 700,000 shares of
our common stock. The MIRALOGX Warrants are exercisable, in whole or in part, any time prior to November 15, 2028, at a cash exercise
price of $2.00 per share.

 On
November 15, 2023, we entered into a promissory note and loan agreement with MIRALOGX. Pursuant to the loan agreement, we may borrow
up to $3.0 million from MIRALOGX to fund the development of licensed products under the license agreement. Together with any advance
request, we will deliver to the Lender a budget for the requested advance. The budget may only include costs directly associated with
preparing an IND application for KETAMIR-2, exclusive of personnel costs. Any advances made by the Lender to us pursuant to this note
may be repaid by us (together with any and all interest accrued thereon) at any time without penalty or premium in accordance with the
terms hereof. Amounts repaid hereunder may not be reborrowed. The loan agreement has a one-year term, and all outstanding principal and
accrued but unpaid interest must be repaid in full on November 15, 2023. Interest on the amounts borrowed under the loan agreement accrues
at an annual fixed rate of 8%. We may prepay all or a portion of the outstanding principal and accrued unpaid interest under the loan
agreement at any time without a prepayment fee.

 Consulting
and Employment Agreements with Dr. Chris Chapman

 On
April 1, 2022, we entered into a Consulting Agreement with Dr. Chapman pursuant to which he provided regulatory and drug development
consulting services to the Company on an as-requested basis. Pursuant to the Consulting Agreement, he was to be paid a one-time fee of
$100,000 upon the completion of our initial public offering (of which $50,000 was prepaid in in the first quarter of 2022) plus a monthly
fee of $20,000 thereafter. The monthly fee was to begin upon the completion of our initial public offering. He was also reimbursed for
reasonable out-of-pocket expenses incurred in connection with his duties under the Consulting Agreement. The agreement had a term of
one year with an automatic one-year extension, provided that either party could terminate the agreement without cause upon 30-days prior
written notice.

 In
his capacity as a consultant, Dr. Chapman was also granted on June 15, 2022, an option to purchase up to 200,000 shares of our common
stock at an exercise price of $5.00 per share. Upon Dr. Chapman becoming Executive Chairman, received additional
compensation in that capacity, and his employment agreement replaced his Consulting Agreement. See "Executive
Compensation" above. Dr. Chapman resigned his positions with our company on March 9, 2024.

 Review
and Approval of Related Party Transactions

 Our
board of directors has adopted a written policy regarding the review and approval of related party transactions. Our audit committee
charter provides that the audit committee shall review and approve or disapprove any related party transactions, which are transactions
between us and related persons in which the aggregate amount involved exceeds or may be expected to exceed the lessor of $120,000 or
one percent of the average of our total assets at year end for the last two completed fiscal years and in which a related person has
or will have a direct or indirect material interest. Our policy regarding transactions between us and related persons provides that a
related person is defined as a director, executive officer, nominee for director or greater than 5% beneficial owner of our common stock,
in each case since the beginning of the most recently completed year, and any of their immediate family members.

of the foregoing disclosures are summaries of certain provisions of our related party agreements and are qualified in their entirety
by reference to all of the provisions of such agreements. Because these descriptions are only summaries of the applicable agreements,
they do not necessarily contain all of the information that you may find useful. Copies of certain of the agreements have been filed
as exhibits to this Report and are available electronically on the website of the SEC at www.sec.gov.

 As
a matter of corporate governance policy, we have not and will not make loans to officers or loan guarantees available to "promoters"
as that term is commonly understood by the SEC and state securities authorities.

 All
future transactions between us and our officers, directors or five percent stockholders, and respective affiliates will be on terms no
less favorable than could be obtained from unaffiliated third parties and will be approved by a majority of our independent directors
who do not have an interest in the transactions and who had access, at our expense, to our legal counsel or independent legal counsel.

 Item
14. Principal Accountant Fees and Services.

 Audit
Fees.

 The
aggregate fees billed by Cherry Bekaert LLP for professional services rendered for the audit of our annual financial statements, review
of the financial information included in our Forms 10-Q for the respective periods and other required filings with the SEC for the years
ended December 31, 2023 and December 31, 2022 totaled $0.06 million and $0.05 million, respectively.

 The
above amounts include interim procedures and audit fees, as well as attendance at audit committee meetings.

 Audit-Related
Fees.

 The
aggregate fees billed by Cherry Bekaert LLP for audit-related fees for the years ended December 31, 2023 and 2022 were $0.1 million and
$0.01 million, respectively. The fees were provided in consideration of services consisting of review and update procedures associated
with registration statements and other SEC filings.

 Tax
Fees.

 The
aggregate fees billed by Cherry Bekaert LLP for professional services rendered for tax compliance for the years ended December 31, 2023
were $0.02 million. There were no such fees incurred in 2022. The fees were provided in consideration of services consisting of preparation
of tax returns and related tax advice.

 All
Other Fees. None

 The
Audit Committee of our board of directors has established its pre-approval policies and procedures, pursuant to which the Audit Committee
approved the foregoing audit and non-audit services provided by Cherry Bekaert LLP in 2023. Consistent with the Audit Committee's
responsibility for engaging our independent auditors, all audit and permitted non-audit services require pre-approval by the Audit Committee.
The full Audit Committee approves proposed services and fee estimates for these services. The Audit Committee chairperson has been designated
by the Audit Committee to approve any audit-related services arising during the year that were not pre-approved by the Audit Committee.
Any non-audit service must be approved by the full Audit Committee. Services approved by the Audit Committee chairperson are communicated
to the full Audit Committee at its next regular meeting and the Audit Committee reviews services and fees for the fiscal year at each
such meeting. Pursuant to these procedures, the Audit Committee approved the foregoing services provided by Cherry Bekaert LLP.

 PART
IV

 Item
15. Exhibits, Financial Statement Schedules.

 The
information called for by this Item is incorporated herein by reference to the Exhibit Index in this Form 10-K.

 Description

 3.1

 Third
 Amended and Restated Articles of Incorporation of MIRA Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.1 to Form S-1
 filed July 28, 2023).

 3.2

 Amended
 and Restated Bylaws of MIRA Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.3 to Form S-1 filed July 28, 2023).

 4.1

 Common
 Stock Purchase Warrant, dated April 28, 2023, between MIRA Pharmaceuticals, Inc. and Bay Shore Trust (incorporated by reference to
 Exhibit 4.2 to Form S-1 filed July 28, 2023).

 4.2

 Common
 Stock Purchase Warrant from the Company to MIRALOGX, dated November 15, 2023 (incorporated by reference to Exhibit 10.2 to the Current
 Report on Form 8-K filed November 20, 2023).

 4.3

 Representative's Warrant, dated August 7, 2023 (incorporated by reference to Exhibit 4.1 of the Company's Current Report on Form 8-K filed August 7, 2023).

 4.4*

 Description of Securities of the Registrant

 10.1+

 2022
 Omnibus Incentive Plan, as amended and restated (incorporated by reference to Exhibit 10.1 to Form S-1 filed July 28, 2023).

 10.2+

 Form
 of Stock Option Award under 2022 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.2 to Form S-1 filed July 28, 2023).

 10.3

 Form
 of Indemnification Agreement (incorporated by reference to Exhibit 10.3 to Form S-1 filed July 28, 2023).

 10.4

 Confirmatory
 Patent Assignment and Royalty Agreement, dated November 1, 2021, between SRQ Patent Holdings II, LLC and MIRA Pharmaceuticals, Inc.
 (incorporated by reference to Exhibit 10.4 to Form S-1 filed July 28, 2023).

 10.5

 Amended
 and Restated Limited License Agreement, dated June 27, 2022, between MIRA Pharmaceuticals, Inc. and MyMD Pharmaceuticals, Inc. (incorporated
 by reference to Exhibit 10.5 to Form S-1 filed July 28, 2023).

 10.6

 Amendment
 No. 1, dated April 20, 2023, to Amended and Restated Limited License Agreement between MIRA Pharmaceuticals, Inc. and MyMD Pharmaceuticals,
 Inc. (incorporated by reference to Exhibit 10.6 to Form S-1 filed July 28, 2023).

 10.7+

 Employment
 Agreement, dated April 28, 2023, between MIRA Pharmaceuticals, Inc. and Erez Aminov (incorporated by reference to Exhibit 10.7 to
 Form S-1 filed July 28, 2023).

 10.8+

 Amendment
 to Employment Agreement, August 28, 2023, between MIRA Pharmaceuticals, Inc. and Erez Aminov (incorporated by reference to Exhibit
 10.1 to the Current Report on Form 8-K filed August 31, 2023).

 10.9+

 Employment
 Agreement, dated April 28, 2023, between MIRA Pharmaceuticals, Inc. and Michelle Yanez (incorporated by reference to Exhibit 10.8
 to Form S-1 filed July 28, 2023).

 10.10+

 Employment
 Agreement, dated April 28, 2023 between MIRA Pharmaceuticals, Inc. and Chris Chapman (incorporated by reference to Exhibit 10.9 to
 Form S-1 filed July 28, 2023).

 10.11+

 Amendment
 to Employment Agreement, dated August 28, 2023, between MIRA Pharmaceuticals and Dr. Chris Chapman (incorporated by reference to
 Exhibit 10.2 to the Current Report on Form 8-K filed August 31, 2023).

 10.12+

 Amendment to Employment Agreement, dated October 13, 2023, between MIRA Pharmaceuticals and Dr. Chris Chapman.

 10.13

 Promissory
 Note and Loan Agreement, dated April 28, 2023, between MIRA Pharmaceuticals, Inc. and Bay Shore Trust (incorporated by reference
 to Exhibit 10.10 to Form S-1 filed July 28, 2023).

 10.14

 Registration
 Rights Agreement, dated April 28, 2023, between MIRA Pharmaceuticals, Inc. and Bay Shore Trust (incorporated by reference to Exhibit
 10.11 to Form S-1 filed July 28, 2023).

 10.15

 Agreement
 for Shared Lease Costs, dated April 1, 2023, between MIRA Pharmaceuticals, Inc., Telomir Pharmaceuticals, Inc., and MIRALOGX LLC
 (incorporated by reference to Exhibit 10.12 to Form S-1 filed July 28, 2023).

 10.16

 Master
 Collaboration Agreement, dated November 1, 2021, between MIRA Pharmaceuticals, Inc. and The Johns Hopkins University (incorporated
 by reference to Exhibit 10.13 to Form S-1 filed July 28, 2023).

 10.17

 Conversion
 Agreement, dated July 20, 2023, between MIRA Pharmaceuticals, Inc. and the Bay Shore Trust (incorporated by reference to Exhibit
 10.14 to Form S-1 filed July 28, 2023).

 10.18

 Exclusive
 License Agreement, by and between the Company and MIRALOGX, dated as of November 30, 2023 (incorporated by reference to Exhibit 10.1
 to the Current Report on Form 8-K filed November 20, 2023).

 10.19

 Promissory
 Note and Loan Agreement, by and between the Company and MIRALOGX, dated as of November 15, 2023 (incorporated by reference to Exhibit
 10.3 to the Current Report on Form 8-K filed November 20, 2023).

 14.1

 Code
 of Business Conduct and Ethics (incorporated by reference to Exhibit 14.1 to Form S-1 filed July 28, 2023).

 19.1

 Insider Trading Policy (incorporated by reference to Exhibit 99.5 to Form S-1 filed July 28, 2023).

 21.1

 List
 of Subsidiaries of Registrant (incorporated by reference to Exhibit 21.1 to Form S-1 filed July 28, 2023).

 31.1*

 Certification of the Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 31.2*

 Certification of the Interim Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 32.1**#

 Certification of the Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 32.2**#

 Certification of the Interim Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 97.1*

 Policy Relating to Recovery of Erroneously Awarded Compensation

 99.1

 Audit
 Committee Charter (incorporated by reference to Exhibit 99.1 to Form S-1 filed July 28, 2023).

 99.2

 Nominating
 and Corporate Governance Committee Charter (incorporated by reference to Exhibit 99.2 to Form S-1 filed July 28, 2023).

 99.3

 Committee Charter (incorporated by reference to Exhibit 99.3 to Form S-1 filed July 28, 2023).

 99.4

 Corporate
 Governance Guidelines (incorporated by reference to Exhibit 99.4 to Form S-1 filed July 28, 2023).

 99.5

 Related
 Person Transaction Policy and Procedures (incorporated by reference to Exhibit 99.6 to Form S-1 filed July 28, 2023).

 101.INS

 101.SCH

 101.CAL

 101.DEF

 101.LAB

 101.PRE

 Cover

 +
Denotes management contract or compensatory plan or arrangement.

 *

 Filed
 herewith

 **

 Furnished
 herewith

 #
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company
and furnished to the Securities and Exchange Commission or its staff upon request.

 Item
16. Form 10-K

 Summary
None.

 MIRA

TO FINANCIAL STATEMENTS

 Report of Independent Registered Public Accounting Firm

 Consolidated Balance Sheets as of December 31, 2023 and 2022

 Consolidated Statements of Operations for the years ended December 31, 2023 and 2022

 Consolidated Statements of Stockholders' Equity for the years ended December 31, 2023 and 2022

 Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022

 Supplemental Cash Flow Information for the years ended December 31, 2023 and 2022

 Notes to Consolidated Financial Statements

 F- 1

 Report
of Independent Registered Public Accounting Firm

 To the Board of Directors and Stockholders

 MIRA Pharmaceuticals, Inc.

 Tampa, Florida

 Opinion on the Financial Statements

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

 Going Concern

 The accompanying financial statements have been prepared
assuming the Company will be able to continue as a going concern. As discussed in Note 2 to the financial statements, the Company has
incurred recurring net losses and negative operating cash flows since inception. These factors, among others, raise substantial doubt
about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described
in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 Basis for Opinion

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

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

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

 We have served as the Company's auditor since
2022.

 /s/
 Cherry Bekaert LLP

 Tampa, Florida

 April
1, 2024

 F- 2

 MIRA

 BALANCE
SHEETS

 2023

 2022

 December 31,

 2023

 2022

 ASSETS

 Current assets:

 Cash

 $
 4,602,566

 $
 350,978

 Deferred offering costs

 -

 143,427

 Other receivables

 11,862

 -

 Prepaid expenses

 243,802

 -

 Total current assets

 4,858,230

 494,405

 Operating lease, right of use assets

 5,061

 164,910

 Related party operating lease, right of use assets

 -

 198,759

 Operating lease, right of use assets

 -

 198,759

 Related party accounts receivable

 69,152

 -

 Total assets

 $
 4,932,443

 $
 858,074

 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

 Current liabilities:

 Trade accounts payable and accrued liabilities

 $
 538,564

 $
 811,738

 Related party accounts payable

 -

 116,350

 Related party line of credit

 -

 133,062

 Related party accrued interest

 14,472

 34,987

 Current portion of operating lease liabilities

 5,061

 75,143

 Related party current portion of operating lease liabilities

 -

 198,759

 Current portion of operating lease liabilities

 -

 198,759

 Total current liabilities

 558,097

 1,370,039

 Non-current operating lease liabilities

 -

 84,267

 Total liabilities

 558,097

 1,454,306

 Stockholders' Deficit

 Preferred Stock, $ 0.0001 par value, 10,000,000 shares authorized and none issued or outstanding.

 -

 -

 Common Stock, $ 0.0001 par value; 100,000,000 shares authorized, 14,780,885 and 13,313,000 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively.

 1,478

 6,657

 Additional paid-in capital

 25,657,930

 8,699,830

 Accumulated deficit

 ( 21,285,062
)

 ( 9,302,719
)

 Total stockholders' equity (deficit)

 4,374,346

 ( 596,232
)

 Total liabilities and stockholders' equity (deficit)

 $
 4,932,443

 $
 858,074

 See

 F- 3

 MIRA

 STATEMENTS
OF OPERATIONS

 2023

 2022

 2023

 2022

 Revenues

 $
 -

 $
 -

 Operating costs:

 General and administrative expenses

 6,499,537

 2,992,125

 Related party travel costs

 453,550

 1,704,350

 Research and development expenses

 1,572,962

 2,351,465

 Total operating costs

 8,526,049

 7,047,940

 Interest expense, net

 ( 3,456,294
)

 ( 10,250
)

 Net loss attributable to common stockholders

 $
 ( 11,982,343
)

 $
 ( 7,058,190
)

 Basic and diluted loss per share

 $
 ( 0.64
)

 $
 ( 0.40
)

 Weighted average common stock shares outstanding

 18,566,158

 17,566,533

 See

 F- 4

 MIRA

 STATEMENTS
OF STOCKHOLDERS' EQUITY

 Shares

 Capital

 Receivable

 Deficit

 Common Stock

 Additional Paid-In

 Stock Subscription

 Accumulated

 Total Stockholders'

 Shares

 Capital

 Receivable

 Deficit

 Balances, January 1, 2022

 12,673,800

 $
 6,337

 $
 4,499,550

 $
 -

 $
 ( 2,244,529
)

 $
 2,261,358

 Sale of common stock

 639,200

 2,903,680

 -

 -

 2,904,000

 Stock-based compensation

 -

 -

 1,296,600

 -

 -

 1,296,600

 Net loss

 -

 -

 -

 -

 ( 7,058,190
)

 ( 7,058,190
)

 Balances, December 31, 2022

 13,313,000

 $
 6,657

 $
 8,699,830

 $
 -

 $
 ( 9,302,719
)

 $
 ( 596,232
)

 Common Stock

 Additional Paid-In

 Stock Subscription

 Accumulated

 Total Stockholders'

 Shares

 Capital

 Receivable

 Deficit

 Deficit

 Balances, January 1, 2023

 13,313,000

 $
 6,657

 $
 8,699,830

 $
 -

 $
 ( 9,302,719
)

 $
 ( 596,232
)

 Stock-based compensation

 -

 ( 5,326
)

 2,556,272

 -

 -

 2,550,946

 Issuance of common stock at IPO, net

 1,275,000

 7,704,152

 -

 -

 7,704,279

 Issuance of common stock conversion of debt

 157,170

 1,100,080

 -

 -

 1,100,096

 Issuance of common stock

 35,715

 249,996

 -

 -

 250,000

 Issuance of Warrants

 -

 -

 5,347,600

 -

 -

 5,347,600

 Net loss

 -

 -

 -

 -

 ( 11,982,343
)

 ( 11,982,343
)

 Balances, December 31, 2023

 14,780,885

 $
 1,478

 $
 25,657,930

 $
 -

 $
 ( 21,285,062
)

 $
 4,374,346

 See

 F- 5

 MIRA

 STATEMENTS
OF CASH FLOWS

 2023

 2022

 2023

 2022

 Cash flows from Operating activities

 Net loss

 $
 ( 11,982,343
)

 $
 ( 7,058,190
)

 Adjustments to reconcile net loss to net cash from operations

 Interest expense

 3,456,294

 10,250

 Amortization of debt issuance costs

 732,292

 -

 Stock-based compensation expense

 2,550,946

 1,296,600

 Non-cash investor relations fees

 250,000

 -

 Change in operating assets and liabilities:

 Right of use lease, net

 5,500

 ( 5,500
)

 Accounts payable and accrued expenses

 ( 389,524
)

 152,081

 Prepaid expenses

 ( 243,802
)

 -

 Accounts receivable

 ( 11,862
)

 -

 Related party line of credit

 1,100,096

 -

 Net cash flows used in operating activities

 ( 4,532,403
)

 ( 5,604,759
)

 Financing activities:

 Advances (to) from affiliates

 ( 69,152
)

 445,612

 Advances received from related party line of credit

 2,147,920

 -

 Deferred offering costs

 143,427

 ( 43,427
)

 Repayments under related party line of credit

 ( 1,142,483
)

 ( 160,000
)

 Proceeds from sale of common stock, less offering costs

 7,704,279

 2,904,000

 Net cash flows provided by financing activities

 8,783,991

 3,146,185

 Net change in cash

 4,251,588

 ( 2,458,574
)

 Cash, beginning of year

 350,978

 2,809,552

 Cash, end of period

 $
 4,602,566

 $
 350,978

 Cash paid for interest

 -

 -

 See

 F- 6

 MIRA

 SUPPLEMENTAL
CASH FLOW INFORMATION

 Non-cash
Financing and Investing Activities:

 The
Company recorded the fair value of a total of 1,000,000 shares of common stock issued to Bay Shore Trust during the year ended December
31, 2023 which totaled approximately $ 3.5 million to deferred finance costs. The Company had amortized approximately $ 0.7 million of
deferred offering costs as non-cash amortization of debt issuances costs in accordance with Generally Accepted Accounting Principles.
As of December 31, 2023, this agreement was paid in full. This resulted in a write-off of unamortized deferred financing costs, in the amount of $ 2.8 million
which was recorded as interest expense.

 On
November 15, 2023, the Company entered a warrant agreement and recorded the fair value of a total of 700,000 shares of common stock issued
to MIRALOGX, LLC which totaled $ 1,832,600 to interest expense.

 The
Company recorded the fair value of a total of 157,170 shares of common stock issued to Bay Shore Trust during the year ended December
31, 2023 totaling approximately $ 1.1 million to record Bay Shore Trust conversions of a line of credit and interest to shares of common
stock.

 The
Company recorded the fair value of a total of 35,715 shares of common stock issued to the MZ Group during the year ended December 31,
2023 totaling $ 0.25 million in lieu of fees for investor relation services.

 The
Company recorded a right of use asset and a corresponding liability in the amount of $ 0.2 million in exchange for an operating lease
liability as a result of the adoption of Accounting Standards Codification, ("ASC"), Topic 842, Leases, on January 1, 2022.

 See

 F- 7

 MIRA

 NOTES
TO THE FINANCIAL STATEMENTS

 Note
1. Description of business and summary of significant accounting policies:

 Overview

 MIRA
Pharmaceuticals, Inc. ("MIRA" or the "Company" and formerly known as MIRA1a Therapeutics, Inc.) is a pre-clinical-stage
pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders.
The Company has an exclusive licensing agreement for Ketamir-2, a unique, patent pending novel oral ketamine analog under investigation
to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (TRD)
and major depressive disorder with suicidal ideation (MDSI). The Company's novel oral pharmaceutical marijuana, MIRA-55, is currently
under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia.
MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic
diseases and disorders.

 The
U.S. Drug Enforcement Administration (DEA)'s scientific review of Ketamir-2 concluded that it would not be considered a controlled
substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations. Additionally, we have submitted
the required paperwork for MIRA-55 to be evaluated by the DEA.

 The
Company was organized as a Florida corporation in September 2020 and commenced substantive operations in late 2020, at which time the
Company commenced its pharmaceutical development program.

 The
accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of America
("GAAP").

 As
used herein, the Company's Common Stock, par value $ 0.0001 per share, is referred to as the "Common Stock" and the
Company's preferred stock, par value $ 0.0001 per share, is referred to as the "Preferred Stock".

 Operating
updates

 In
early February 2024, we made a significant discovery during the manufacturing and scale-up process of our patented molecule known as
"MIRA1a," which we had been utilizing with a contract manufacturer. Through this process, we identified a novel and improved
version of the molecule, MIRA-55. MIRA-55 exhibits enhanced potency and holds promise for improved efficacy compared to MIRA1a.

 As
part of our due diligence and subsequent testing, we discovered that the pre-clinical studies we conducted, previously attributed to
MIRA1a, were in fact performed on MIRA-55. Following this revelation, we promptly filed a provisional patent for MIRA-55, which encompasses
all pre-clinical studies disclosed in our two registration statements on Form S-1, declared effective on August 2, 2023 and December
27, 2023 (File Nos. 333-273024 and 333-276118, respectively).

based on our pre-clinical analyses to date, we believe that MIRA-55 is an improvement over MIRA1a in that it displays enhanced potency
and potential for efficacy. In early March 2024, we filed a provisional patent application for MIRA-55, aiming for global patent protection.
If such patent is issued, we would own the patent rights to both MIRA1a and MIRA-55.

 Additional
testing is required to confirm our preliminary beliefs. However, based on our discoveries to date, the Company has decided to advance
MIRA-55 as our lead compound for our oral pharmaceutical marijuana drug candidate while still retaining our rights to MIRA1a. As such,
we do not intend to move MIRA1a forward as of the date of this Report.

 F- 8

 Initial
public offering

 On
August 7, 2023, the Company closed its initial public offering consisting of 1,275,000 shares at a price of $ 7.00 per share for approximately
$ 8.9 million in gross proceeds. After deducting the underwriting commission and other deferred offering expenses totaling $ 1.2 million,
the net proceeds to the Company were $ 7.7 million (the "IPO").

 The
shares were offered and sold pursuant to the Company's Registration Statement on Form S-1, as amended (File No. 333-273024), originally
filed with the Securities and Exchange Commission (the "SEC") on June 29, 2023 (the "Registration Statement")
and the final quarterly report filed with the Commission pursuant to Rule 424(b)(4) of the Securities Act of 1933, as amended. The Registration
Statement was declared effective by the Commission on August 2, 2023. The common stock began trading on The Nasdaq Capital Market on
August 3, 2023 under the symbol "MIRA". The closing of the IPO occurred on August 7, 2023.

 As
of the completion of the IPO, among other things, certain of the Company's then-outstanding convertible debt was converted into
shares of common stock. See Note 5 for more information.

 Revenue
recognition

 The
Company currently has no source of revenue. Miscellaneous income, including interest, is recognized when earned by the Company.

 Income
taxes

 The
Company is taxed as a C corporation. Deferred tax assets and liabilities are recognized for the future tax consequences attributable
to differences between the financial statement carrying amount of existing assets and liabilities and their respective tax bases. Deferred
tax assets are recognized for temporary differences that will result in deductible amounts in future years and for loss carryovers. A
valuation allowance is recognized regarding deferred tax assets, if any, if it is more likely than not that some portion of the deferred
tax asset will not be realized.

and development expenses

and development costs are expensed in the period in which they are incurred and include the expenses paid to third parties, such as contract
research organizations and consultants, who conduct research and development activities on behalf of the Company. Patent-related costs,
including registration costs, documentation costs and other legal fees associated with the application, are expensed in the period in
which they are incurred.

 F- 9

and administrative expense

and administrative expenses are primarily comprised of personnel costs, marketing expenses, amortization, insurance expenses, professional
services fees, travel and office expenses, and stock-based compensation.

 Advertising
expenses

 The
Company expenses advertising costs when incurred. Advertising expense for the years ended December 31, 2023 and 2022 is as follows:

of Advertising Expenses

 December 31, 2023

 December 31, 2022

 Advertising expenses

 $
 102,000

 $
 -

 Leases

 The
Company accounts for leases under the provisions of FASB ASC Topic 842, "Leases", which requires the Company to recognize
right-to-use (ROU) assets and lease liabilities for operating leases on the balance sheet.

 Use
of estimates

 The
preparation of financial statements in accordance with generally accepted accounting principles in the United States of America requires
the Company's management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the
disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the
reporting period. Actual results may differ from such estimates and such differences could be material.

 Cash

 The
Company maintains cash balances with financial institutions that management believes are of high credit quality. The Company's
cash account at times may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes
it is not exposed to any significant credit risk from its cash account.

 Stock-based
compensation

 The
Company accounts for stock-based compensation under the provisions of FASB ASC 718, "Compensation - Stock Compensation",
which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, directors and consultants
based on estimated fair values on the grant date. The Company estimates the fair value of stock-based awards on the date of grant using
the Black-Scholes model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the
requisite service periods using the straight-line method. The Company has elected to account for forfeiture of stock-based awards as
they occur.

 Segment
information

 ASC
Topic 280, " Disclosures about Segments of an Enterprise and Related Information," established standards for the way
that public business enterprises report information about operating segments in annual financial statements and requires those enterprises
to report selected information about operating segments in interim financial reports issued to stockholders. Management has determined
that the Company operates in one business segment, which is the research and development of neuroscience drug candidates.

 F- 10

 Recent
accounting pronouncements not yet adopted

 In
December 2023, the FASB issued Accounting Standards Update No. 2023-09, "Income Taxes (Topic 740): Improvements to Income Tax
Disclosures" ("ASU 2023-09"), which modifies the rules on income tax disclosures to require entities to disclose
(1) specific categories in the rate reconciliation, (2) the income or loss from continuing operations before income tax expense or benefit
(separated between domestic and foreign) and (3) income tax expense or benefit from continuing operations (separated by federal, state
and foreign). ASU 2023-09 also requires entities to disclose their income tax payments to international, federal, state and local jurisdictions,
among other changes. The guidance is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for
annual financial statements that have not yet been issued or made available for issuance. ASU 2023-09 should be applied on a prospective
basis, but retrospective application is permitted. The Company is currently evaluating the potential impact of adopting this new guidance
on its financial statements and related disclosures.

 Management
has considered all other recent accounting pronouncements that are issued, but not effective, and it does not believe that they will
have a significant impact on the Company's results of operations or financial position.

 Change
in accounting principle

 In
February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes existing guidance for accounting for leases under Topic
840, Leases. The FASB also subsequently issued additional ASUs which amend and clarify Topic 842. The most significant change in the
new leasing guidance is the requirement to recognize right-to-use (ROU) assets and lease liabilities for operating leases on the balance
sheet.

 The
Company adopted these ASUs effective January 1, 2022 using the modified retrospective approach. As a result of adopting these ASUs, the
Company recorded ROU assets and lease liabilities of approximately $ 0.2 million and $ 0.2 million, respectively. Adoption of the new standard
did not materially impact the Company's net income and had no impact on cash flows.

 Fair
value of financial instruments

 The
Company measures the fair value of financial instruments in accordance with GAAP which defines fair value, establishes a framework for
measuring fair value, and expands disclosures about fair value measurements.

 GAAP
defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal
or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use
of unobservable inputs when measuring fair value. The Company considers the carrying amount of deferred offering costs to approximate
fair value due to short-term nature of this instrument. GAAP describes three levels of inputs that may be used to measure fair value:

 Level
1 – quoted prices in active markets for identical assets or liabilities.

 Level
2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable.

 Level
3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions).

 Contingencies

 In
the normal course of business, the Company may be subject to loss contingencies, such as legal proceedings, amounts arising from contractual
arrangements and claims arising out of the Company's business that cover a wide range of matters, including, among others, government
investigations, shareholder lawsuits, and tax matters. In accordance with ASC Topic 450, Accounting for Contingencies, (ASC 450),
the Company records accruals for such loss contingencies when it is probable that a liability will be incurred, and the amount of loss
can be reasonably estimated. The Company, in accordance with this guidance, does not recognize gain contingencies until realized or realizable.

 F- 11

 Note
2. Liquidity and capital resources:

 In
accordance with Accounting Standards Codification 205-40, Going Concern, the Company has evaluated whether there are conditions
and events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern
within one year after the date the financial statements are issued. As of December 31, 2023, the Company had cash of approximately $ 4.6
 million. The Company used approximately $ 4.5 million of cash in operations during the year ended December 31, 2023 and had stockholders'
equity of approximately $ 4.4 million, versus stockholders' deficit of approximately $ 0.6 million at December 31, 2022

 Historically,
the Company has been primarily engaged in developing MIRA-55. During these activities, the Company sustained substantial losses. The
Company's ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on the Company's
ability to obtain significant additional external funding in the near term. Since inception, the Company financed its operations through
the sale of Common Stock, the IPO and related party financings. Additional sources of financing may be sought by the Company. The Company
expects to be able to fund operations through the fourth quarter of 2024, with available borrowings on the loan agreement
(Note 4). Additional financing will be needed by the Company to fund its operations after such date to complete clinical developments
and to commercially develop its product candidate. However, there can be no assurance that any fundraising will be achieved on commercially
reasonable terms, if at all.

 The
Company expects to continue to generate losses in the foreseeable future. The Company's liquidity needs will be determined largely
by the budgeted operational expenditures incurred in regard to the progression of its product candidates. Management believes that the
Company has sufficient resources available to support its development activities and business operations and timely satisfy its obligations
as they become due into the fourth quarter of 2024. The Company does not have sufficient cash and cash equivalents as of the date of
filing this Annual Report on Form 10-K to support its operations for at least the 12 months following the date the financial statements
are issued. These conditions raise substantial doubt about the Company's ability to continue as a going concern through 12 months
after the date the financial statements are issued.

 To
alleviate the conditions that raise substantial doubt about the Company's ability to continue as a going concern, the Company plans
to secure additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including
potential alliances and drug product collaborations; however, none of these alternatives are committed at this time. There can be no
assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to it to fund continuing operations,
if at all, identify and enter into any strategic transactions that will provide the capital that it will require or achieve the other
strategies to alleviate the conditions that raise substantial doubt about the Company's ability to continue as a going concern.
If none of these alternatives are available, or if available, are not available on satisfactory terms, the Company will not have sufficient
cash resources and liquidity to fund its business operations for at least the 12 months following the date the financial statements are
issued. The failure to obtain sufficient capital on acceptable terms when needed may require the Company to delay, limit, or eliminate
the development of business opportunities and its ability to achieve its business objectives and its competitiveness, and its business,
financial condition, and results of operations will be materially adversely affected. In addition, the perception that the Company may
not be able to continue as a going concern may cause others to choose not to deal with it due to concerns about its ability to meet its
contractual obligations.

 The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of
recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue
as a going concern.

 F- 12

 Note
3 Accounts payable and accrued liabilities:

 The
following table represents the components of accounts payable and accrued liabilities as of:

of Accounts Payable and Accrued Liabilities

 December 31, 2023

 December 31, 2022

 Trade accounts payable

 $
 538,564

 $
 789,204

 Accrued other

 -

 22,534

 Accounts
 payable and accrued liabilities

 $
 538,564

 $
 811,738

 Note
4. License agreement, related party:

 MIRALOGX

 On
November 15, 2023, the Company and MIRALOGX, LLC, a Florida limited liability company ("MIRALOGX"), entered into an exclusive
license agreement (the "License Agreement") to develop and commercialize a drug product containing 2-(2- chlorophenyl)-2-(methylamino)
cyclopentan-1-one (sometimes referred to by the Parties as "M209" or "KETAMIR-2") ("the Product")
as an active agent in North America. (the "Territory"). The exclusive license in the License Agreement includes the right
of the Company to sublicense the licensed intellectual property.

 Pursuant
to the terms of the License Agreement, and subject to the conditions set forth therein, the Company paid MIRALOGX a one-time, nonrefundable
payment of $ 0.1 million upon the signing of the Agreement and will be obligated to pay quarterly royalty payments on sales of the Product
in the Territory of 8% of net sales and 8% of other revenue (such as milestone or sublicense payments) from licensed products.

 Also,
in consideration of License Agreement, the Company issued to MIRALOGX a Common Stock Purchase Warrant to purchase up to 700,000 shares
of the Company's common stock (the "MIRALOGX Warrants"). The MIRALOGX Warrants are exercisable, in whole or in part,
any time prior to November 15, 2028 at a cash exercise price of $ 2.00 per share.

 The
Company and MIRALOGX have made customary representations and warranties in the License Agreement and have agreed to certain other customary
covenants, including confidentiality, cooperation, and indemnity provisions. Either party may terminate the License Agreement for cause
if the other party materially breaches or defaults in the performance of its obligations, and, if curable, such material breach remains
uncured for 120 days. Unless earlier terminated, the License Agreement will continue in effect until the last to expire of the Patent
Rights (the "Term"), unless earlier terminated.

 The
Company and MIRALOGX have the same founder.

 F- 13

 Note
5. Debt, related party:

 MIRALOGX

 On
November 15, 2023, the Company entered into a Promissory Note and Loan Agreement (the "Loan Agreement") with MIRALOGX.

 Pursuant
to the Loan Agreement, the Company may borrow up to $ 3.0 million from MIRALOGX to fund the development of licensed products under the
License Agreement (the "Loan").

 Together
with any Advance Request, the Company shall deliver to the Lender a budget for the requested Advance (the "Budget"). The
Budget may only include costs directly associated with preparing an Investigational New Drug ("IND") application for KETAMIR-2,
exclusive of personnel costs. Any Advances made by the Lender to the Company pursuant to this Note may be repaid by the Company (together
with any and all interest accrued thereon) at any time without penalty or premium in accordance with the terms hereof. Amounts repaid
hereunder may not be reborrowed.

 The
Loan Agreement has a one-year term, and all outstanding principal and accrued but unpaid interest must be repaid in full on November
15, 2024. Interest on the amounts borrowed under the Loan Agreement accrues at an annual fixed rate of 8 %. The Company may prepay all
or a portion of the outstanding principal and accrued unpaid interest under the Loan Agreement at any time without a prepayment fee.
The Company did not borrow any funds from the MIRALOGX loan as of December 31, 2023.

 Bay
Shore Trust

 In
May 2021, the Company entered into a revolving credit facility which allowed for borrowings of up to $ 5 million from Starwood Trust,
a shareholder of the Company. The facility had an initial term of 24 months (extended to 36 months in March 2023), with a new maturity
date of May 10, 2024, at which time all outstanding borrowings and accrued interest, if any, were due in full. Borrowings accrued interest
at a rate of 5 % per annum.

 In
April 2023, the Company entered into a Promissory Note and Loan Agreement with the Bay Shore Trust, a trust established by a shareholder
of the Company. Under this Promissory Note and Loan Agreement (the "Bay Shore Note"), the Company has the right to borrow
up to an aggregate of $ 5 million from the Bay Shore Trust at any time up to the second anniversary of the issuance of the Bay Shore Note
or, if earlier, upon the completion of the Company's IPO. The Company's right to borrow funds under the Bay Shore Note is
subject to the absence of a material adverse change in the Company's assets, operations, or prospects. The Bay Share Note, together
with accrued interest, will become due and payable on the second anniversary of the issuance of the note, provided that it may be prepaid
at any time without penalty. The Bay Shore Note will accrue interest at a rate equal 7 % per annum, simple interest, during the first
year that the note is outstanding and 10 % per annum, simple interest, thereafter. The Bay Shore Note is unsecured.

 The
Bay Shore Note replaced the revolving credit facility that the Company entered into with Starwood Trust, a separate trust established
by a shareholder of the Company, in May 2021 and pursuant to which the Company had an outstanding principal balance of $ 0.2 million as
of the date of the Bay Shore Note (which outstanding balance was retired with an advance under the Bay Shore Note).

 In
consideration of the loan facility provided by the Bay Shore Trust, in April 2023, the Company issued to the Bay Shore Trust a common
stock purchase warrant giving the Bay Shore Trust the right to purchase up to 1,000,000 shares of common stock at an exercise price of
$ 5.00 per share, which warrant will expire five years after the date of grant. Pursuant to a registration rights agreement, the Company
has granted to Bay Shore Trust the right to require the Company, at any time after one year following the Company's IPO, to register
for resale the shares issuable upon the exercise of the warrant, with such registration rights being in the form of demand and "piggyback"
registration rights that are subject to customary limitations and restrictions. See Note 8 for additional details related to these warrants.

 F- 14

 On
July 20, 2023, the Company entered into a conversion agreement with the Bay Shore Trust under which the Bay Shore Trust had agreed
to convert, upon the completion of the IPO, $ 1.1
million of the outstanding principal balance of the Bay Shore Note into shares of the Company's common stock at a conversion
price equal to the Company's IPO price, which resulted in the issuance of 157,170
shares to the Bay Shore Trust. On August 14, 2023, the Company paid $ 1.0
million in full to Bay Shore Trust, which was the amount due. The company also paid accrued interest of $ 0.03
million. Both amounts are recorded in the accompanying statement of operations for the year ended December 31, 2023 as interest
expense. There is a remaining amount of $ 0.01
in accrued interest due to Bay Shore Trust as of December 31, 2023.

 Note
6. Related party transactions:

 Due from Related Party – As of the year ended December 31, 2023, the Company paid $ 0.07 million in accounts payable on behalf
of a related party. There was no such amount during the corresponding period in 2022.

 Due to Related Party – Amounts due to related parties as of December 31, 2023 and December 31, 2022, are recorded as related
party accounts payable, in the accompanying balance sheets. As of December 31, 2022, amounts due to related parties totaled $ 0.1 million.
The balance was paid in 2023 which resulted in a $ 0.0 balance as of December 31, 2023.

 Travel
expenses – In April 2021, the Company entered into an airplane lease with an entity under common control that the Company incurs
approximately $ 0.05 million of lease charges per month. The lease was renewable, at the Company's discretion, for an additional
one to three years, however, the Company terminated the lease at March 31, 2023, without any penalties. The Company may continue to incur
related party travel-related expenses as they occur, which will be recorded in Related Party Travel Costs, in the condensed statement
of operations. During the year ended December 31, 2023, the Company incurred $ 0.5 million, for travel-related expenses to the related
party for monthly rental charges and airplane-related expenses. There was $ 1.7 million of related party travel expenses during the year
ended December 31, 2022.

 License
agreement - See Note 4.

 Line
of credit - See Note 5.

 Note
7. Leases:

 The
Company's corporate headquarters was in Baltimore, Maryland, which includes a lease for office space. This lease began in November
2021 and was amended in April 2023. This space is approximately 550 square feet and has a remaining base rent of $ 0.01 million payable
through April 2024. Rent is payable in monthly installments and is subject to yearly price increases.

 The
Company had leased an office in Tampa, Florida, for its finance and general operations, which began in March 2022 for 37 months. On December
1, 2023, the Company formally terminated the lease with the landlord. There is a remaining deposit due from the landlord to the Company
of $ 0.005 million, which is recorded in accounts receivable in the accompanying balance sheet as of December 31, 2023.

 The
Company also leased a jet (Note 5) from a related party, which terminated on March 31 2023.

 Variable
lease costs

 Variable
lease costs primarily include utilities, property taxes, and other operating costs that are passed on from the lessor. Variable lease
costs related to the aircraft include usage expenses, which includes pilot expenses, jet fuel and general flight expenses.

 F- 15

 The
components of lease expense were as follows:

 Schedule of Lease Expense

 2023

 2022

 Lease Costs

 2023

 2022

 Operating Lease Cost

 Operating Lease

 $
 200,283

 $
 333,046

 Variable Lease Costs

 311,126

 637,420

 Total Lease Cost

 $
 511,409

 $
 970,466

 Supplemental
cash flow information related to leases were as follows:

of Cash Flow Information Related to Leases

 Other Lease Information

 2023

 2022

 Other Lease Information

 2023

 2022

 Cash paid for amounts included in the measurement of lease liabilities

 Operating cash flows from operating leases

 $
 511,409

 $
 970,466

of Remaining Weighted-average Lease Term and Weighted-average Discount Rate

 2023

 2022

 Lease Term and Discount

 Weighted Average remaining lease term

.33
years

 3 years

 Weighted Average discount rate

 5.0
 %

 5.0
 %

 Maturity
of Lease Liabilities

 Future
minimum lease payments under non-cancellable leases as of December 31, 2023 were as follows:

of Maturity
 of Lease Liabilities

 Maturity
of Lease Liabilities

 December 31, 2023

 2024

 $
 5,092

 2025

 -

 Total Lease payments

 5,092

 Less: Interest

 ( 32
)

 Present Value of Lease Liabilities

 $
 5,061

 F- 16

 On
April 1, 2023 the Company entered into an Agreement For Shared Lease Costs with MIRALOGX, LLC, (the "Shared Agreement") who
is a related party for the jet usage. Under the Shared Agreement, the Company agrees to make monthly contributions or payments in accordance
with its monthly use of shared aircraft toward rent payments. However, the Company has not used the aircraft after the termination of
the lease and there are no minimum payments due without usage.

 Note
8. Income taxes:

 The
significant components of the Company's net deferred tax assets are as follows as of December 31:

of Deferred Tax Assets and Liabilities

 2023

 2022

 December 31,

 2023

 2022

 Deferred tax assets

 Net operating loss carry-forward

 $
 2,430,529

 $
 1,061,300

 Section 174 Qualified Research Expenditures

 533,159

 388,230

 Stock compensation

 650,018

 330,633

 ROU liability

 1,291

 91,333

 Other

 6,120

 Deferred
 tax assets, Gross

 3,615,201

 1,877,616

 Less: valuation allowance

 ( 3,613,901
)

 ( 1,784,880
)

 Deferred
tax assets, Net

 1,291

 92,736

 Deferred tax liabilities

 ROU asset

 ( 1,291
)

 ( 92,736
)

 Total net deferred tax asset

 $
 -

 $
 -

 Beginning
in 2022, in accordance with Internal Revenue Code Section 174, Qualified Research Expenditures are capitalized for tax purposes and amortized
over a period of five years. Accordingly, for income tax purposes, the Company has recorded a deferred tax asset totaling approximately
$ 0.5 million related to the timing difference between GAAP and Tax recognition of these expenditures.

 The
components of the provision for income taxes consist of the following:

 Schedule of Components of Income Tax Provision

 2023

 2022

 Deferred tax:

 Deferred

 ( 1,829,030
)

 ( 1,784,880
)

 Change in valuation allowance

 1,829,030

 1,784,880

 Total deferred

 -

 -

 Total provision for income taxes

 $
 -

 $
 -

 ASC
Topic 740 requires that a deferred tax amount be reduced by a valuation allowance if, based on the weight of available evidence it is
more likely than not (a likelihood of more than 50%) that some portion or all of the deferred tax assets will not be realized. The valuation
allowance should be sufficient to reduce the deferred tax asset to the amount that is more likely than not to be realized. The Company
has recorded a full valuation allowance against its deferred tax assets generated by net operating loss carryforwards as it has determined
that such amounts may not be recognizable, given the historical losses of the Company to date. As of December 31, 2023, the Company has
a cumulative federal net operating loss carryforward of approximately $ 9.5 million. The net operating loss carryforwards have no expiration
date.

 F- 17

 Note
9. Stockholders' equity:

 Capital
stock

 The
Company has the authority to issue 110,000,000 shares of capital stock, consisting of 100,000,000 shares of Common Stock and 10,000,000
shares of undesignated preferred stock (as amended and restated on June 28, 2023), whose rights and privileges will be defined by the
Board of Directors when a series of preferred stock is designated.

 Reverse
stock-split

 Effective
June 28, 2023, the Company completed a 1-for-5 reverse stock split of its outstanding common stock upon the filing of the Company's
Third Amended and Restated Articles of Incorporation with the Florida Secretary of State. No fractional shares were issued in connection
with the reverse stock split, and all such fractional shares resulting from the reverse stock split were rounded up to the nearest whole
number. The shares issuable upon the exercise of our outstanding options and warrants, and the exercise prices of such options and warrants,
have been adjusted to reflect the reverse stock split.

 Stock
issuances

 At
IPO in August 2023, 1,275,000 shares of the Company's common stock were issued at a price of $ 7.00 per share which resulted in
gross proceeds of $ 8.9 million and net proceeds of $ 7.7 million to the Company after the underwriter discount but before other IPO related
expenses.

the Company issued its investor relations firm $ 0.25 million worth of restricted common stock upon closing of the IPO, which resulted
in issuance of 35,715 shares of stock.

the year ended December 31, 2022, the Company sold 3.2 million shares of Common Stock at $ 1.00 per share, net of offering costs of $ 0.3
 million, resulting in net proceeds of $ 2.9 million.

 2022
Omnibus Incentive Plan

 In
June 2022, the Company's Board of Directors adopted, and its stockholders approved, the Company's 2022 Omnibus Incentive
Plan, as amended and restated in August 2023, ("2022 Omnibus Plan"). The 2022 Omnibus Plan authorizes the grant of incentive
stock options, within the meaning of Section 422 of the Internal Revenue Code, to the Company's employees and any of its parent
and subsidiary corporations' employees, and for the grant of nonstatutory stock options, restricted stock, restricted stock units,
stock appreciation rights, performance units and performance shares to the Company's employees, directors, and consultants and
any of its future subsidiary corporations' employees and consultants.

 The
2022 Omnibus Plan provides that 2,000,000 shares of the Company's Common Stock are reserved for issuance under the 2022 Omnibus
Plan, all of which may be issued pursuant to the exercise of incentive stock options.

 Stock-based
compensation

 The
fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected
volatility, expected dividends, expected term, and the risk-free interest rate. Expected price volatility is based on the historical
volatilities of a peer group as the Company does not have a trading history for its shares prior to its IPO. Industry peers consist of
several public companies in the biotech industry similar to the Company in size, stage of life cycle and product indications. The Company
intends to continue to consistently apply this process using the same or similar public companies until a sufficient amount of historical
information regarding the volatility of the Company's own stock price becomes available, or unless circumstances change such that
the identified companies are no longer similar to the Company, in which case, more suitable companies whose share prices are publicly
available would be utilized in the calculation.

 Expected
term of options granted is derived using the "simplified method" which computes expected term as the average of the sum of
the vesting term plus contract term. The risk-free rate is based on the 5-year U.S. Treasury yield curve in effect at the time of grant.
The Company recognizes forfeitures as they occur.

 F- 18

the year ended December 31, 2023, a total of 635,001 options to purchase Common Stock, with an aggregate fair market value of approximately
$ 2.75 million were granted to the Company's executive officers and management, and consultants of the Company. Options have a term
of 10 years from the grant date. These option vest as follows: (i) executive officer options vested 100 % on date of grant and (ii) employee
and consultant options vest 33.33 % at 6 month anniversary of date of grant, 33.33 % at 1 year anniversary at date of grant and the remaining
vest at two-year anniversary of date of grant.

 As
of December 31, 2023, there was approximately $ 1.3 million of unrecognized compensation cost related to unvested share-based compensation
awards granted. These costs will be expensed over the next two years.

 The
following is option activity during the year ended December 31, 2023:

 Schedule of Stock
Option Activity

 Number of Shares

 Weighted Average Exercise Price Per Share

 Aggregate Intrinsic Value

 Outstanding as January 1, 2022

 -

 $
 -

 $
 -

 Options granted

 750,000

 $
 5.00

 Outstanding as December 31, 2022

 750,000

 $
 5.00

 $
 -

 Options granted

 635,001

 $
 5.55

 Forfeitures

 ( 170,000
)

 $
 5.00

 Outstanding as December 31, 2023

 1,215,001

 $
 5.29

 $
 -

 Range of Exercise Prices

 Number Outstanding

 Weighted Average Remaining Contractual Life (Years)

 Weighted Average Exercise Price

 Number Exercisable

 Aggregate Intrinsic Price

 $
 1.00
- 5.00

 980,001

 8.9

 $
 5.00

 382,500

 $
 -

 $
 5.01 - 10.00

 235,000

 9.6

 $
 6.50

 230,000

 -

 1,215,001

 612,500

 $
 -

 Key
assumptions used to value stock options during the year ended December 31, 2023 are as follows:

 Schedule of Key Assumptions Used to Value Stock Options

 Expected price volatility

 88.01 - 116.64
 %

 Risk-free interest rate

 3.51 - 4.42
 %

 Weighted average fair values (grants post-split)

 $

 3.515 - $ 5.384

 Weighted average expected life in years

 5 - 6 years

 Dividend yield

 -

 On March 25, 2024, a total of
 100,000 options to purchase Common Stock, with an aggregate fair market value of approximately $ 0.1 million were granted to the Company's
Independent Board of Directors. These option vest as follows: (i) 50% on date of grant and (ii) 50% at 1 year anniversary at date of grant.

 On March 26, 2024, a total
of 450,000 options
to purchase Common Stock were granted to the Company's executive officers. These option vest as follows: (i) 50% six months
from the date of grant and (ii) 50% at 1 year anniversary at date of grant.

 Both aforementioned option grants
have a term of 10 years from the grant date.

 Warrants

 MIRALOGX
warrants

 The
Company issued to MIRALOGX a common stock purchase warrant on November 15, 2023 giving MIRALOGX the right to purchase up to 700,000 shares
of common stock at an exercise price of $ 2.00 per share. This warrant will expire five years after the date of grant.

 F- 19

 The
fair value of the warrants were estimated on the grant date using the Black-Scholes valuation model and level 3 inputs based on assumptions
for expected volatility, expected dividends, expected term, and the risk-free interest rate, which resulted in $ 1.8 million of warrant
expense. This cost was recorded as interest expense in General and Administrative expenses on the accompanying statement of operations
and additional paid in capital on the accompanying balance sheet.

 Bay
Shore Trust warrants

 In
consideration of the line of credit provided by the Bay Shore Trust, the Company issued to the Bay Shore Trust a common stock
purchase warrant on April 28, 2023 giving the Bay Shore Trust the right to purchase up to 1,000,000
shares of common stock at an exercise price of $ 5.00 per
share. This warrant will expire five
years after the date of grant. There are 1,000,000 warrants outstanding at December 31, 2023.

 The
fair value of the warrants were estimated on the grant date using the Black-Scholes valuation model and level 3 inputs based on assumptions
for expected volatility, expected dividends, expected term, and the risk-free interest rate, which resulted in $ 3.5 million of deferred
financing costs. This cost was recorded as deferred financing costs and additional paid in capital on the accompanying balance sheet
and is amortized straight-line over the term of the line of credit (which is 24 months). Associated amortization of deferred finance
costs is recorded to interest expense on the condensed income statement of operations.

 Subsequent
to the IPO, the Bay Shore Trust line of credit was paid in full early, of $ 2.8 million. These
costs were recorded as interest expense on the accompanying statement of operations with the offsetting entry clearing the balance of
amortization in deferred finance costs.

 Underwriter
warrants

 In
connection with the IPO, the Company issued 63,750 warrants to purchase common stock to the IPO underwriter (or its designees) at an
exercise price of $ 7.00 which will expire in the four-and-a-half-year period commencing six months after the commencement of sales in
the IPO. The warrants will be exercisable at any time and from time to time, in whole or in part, during the four-and-a-half-year period
commencing six months after the commencement of sales in the IPO. The warrants provide for registration rights (including a one-time
demand registration right and piggyback registration rights that expire 5 years from the commencement of sales of the offering) and customary
anti-dilution provisions as permitted under FINRA Rule 5110(g)(8).

 Key
assumptions used to value underwriter warrants in August 2023 are as follows:

 Schedule of Key Assumptions Used to Value Warrants

 Expected price volatility

 98.53
 %

 Risk-free interest rate

 4.16
 %

 Weighted average fair values

 $
 5.297

 Weighted average expected life in years

 5 years

 Dividend yield

 -

 Earnings
Per Share

the year ended December 31, 2023 and 2022, outstanding stock options and warrants of 2,915,001 and 750,000, respectively, were not included
in the computation of diluted earnings per share, because to do so would have had an antidilutive effect.

 F- 20

 Note
10. Employment Agreements:

 Erez

 On
April 28, 2023, the Company entered into an employment agreement with Mr. Erez Aminov pursuant to which Mr. Aminov serves as the Company's
Chief Executive Officer on a full-time basis. Mr. Aminov's employment agreement provides that his employment will be on an at-will
basis and can be terminated by either Mr. Aminov or the Company at any time and for any reason. Under the agreement, Mr. Aminov will
receive an initial base salary of $ 0.11 million per year. In the event that Mr. Aminov's employment is terminated by the company
without "Cause" or is terminated by Mr. Aminov for "Good Reason", Mr. Aminov will be entitled to severance compensation
in the form of salary continuation for a period of three months (subject to Mr. Aminov executing and delivering a customary general release
in favor of the company).

 On
August 17, 2023, Mr. Aminov received a $ 0.12 million cash bonus net of federal, state, local and income taxes related to the successful
completion of the IPO.

 On
August 28, 2023, the Company amended Mr. Aminov's employment agreement to increase his yearly compensation from its current
amount of $ 0.11 million
to $ 0.2
million per year, effective August 1, 2023. In March 2024, Mr. Aminov assumed the role of Chairman and on March 25, 2024, the
Compensation Committee of the Board of Directors approved increasing Mr. Aminov's annual base salary to $ 0.28
million.

Yanez

 On
April 28, 2023, the Company entered into an employment agreement with Ms. Michelle Yanez pursuant to which Ms. Yanez serves as the Company's
Chief Financial Officer on a full-time basis. Ms. Yanez's employment agreement provides that her employment will be on an at-will
basis and can be terminated by either Ms. Yanez or the company at any time and for any reason. Under the agreement, Ms. Yanez will receive
an initial base salary of $ 0.17 million per year. In the event that her employment is terminated by the company without "Cause"
or is terminated by Ms. Yanez for "Good Reason", Ms. Yanez will be entitled to severance compensation in the form of salary
continuation for a period of three months (subject to Ms. Yanez executing and delivering a customary general release in favor of the
company).

 On
August 17, 2023, Ms. Yanez received a $ 0.05 million cash bonus net of federal, state, local and income taxes related to the successful
completion of the IPO. On March 25, 2024, the Compensation Committee of the Board of Directors approved increasing Ms. Yanez' annual base salary to $ 0.23
million.

 Chris
Chapman

 On
April 28, 2023, the Company entered into an employment agreement with Dr. Chris Chapman pursuant to which Dr. Chapman served as the Company's
Executive Chairman. Dr. Chapman's employment agreement provided that his employment will be on a part-time basis whereby Dr. Chapman
would devote 50% of his full business time and effort to the business and affairs of the company, and it further provided that such employment
would be on an at-will basis and could be terminated by either Dr. Chapman or the company at any time and for any reason. Under the agreement,
Dr. Chapman would receive an initial base salary of $ 0.15 million per year. In the event that Dr. Chapman's employment is terminated
by the company without "Cause" or is terminated by Dr. Chapman for "Good Reason", Dr. Chapman would be entitled
to severance compensation in the form of salary continuation for a period of three months (subject to Dr. Chapman executing and delivering
a customary general release in favor of the company).

 On
August 17, 2023, Dr. Chapman received a $ 0.05 million cash bonus net of federal, state, local and income taxes related to the successful
completion of the IPO.

 On
August 28, 2023, the Company amended Dr. Chapman's employment agreement to indicate that he works part-time on an as needed basis
for the Corporation, rather than fifty percent (50%) of the time, effective August 1st, 2023.

 On
October 13, 2023, the Company amended Dr. Chapman's employment agreement to reflect a temporary reduction in his compensation
from $ 0.15
million per year to $ 0.05
million per year, to extend for a period of 90 days. After the 90-day period, Dr. Chapman's compensation shall be reinstated
to the amount in his employment agreement of $ 0.15 million
per year. On March 13, 2024, Dr. Chapman resigned as both an employee and as the Chairman of the Board of Directors.

 F- 21

 Christos
Nicholoudis

 On
April 28, 2023, the Company entered into an employment agreement with Christos Nicholoudis pursuant to which Mr. Nicholoudis served as
the Company's General Counsel. Under the agreement, Mr. Nicholoudis receive an initial base salary of $ 0.075 million per year.

 On
August 17, 2023, Mr. Nicholoudis received a $ 0.025 million cash bonus net of federal, state, local and income taxes related to the successful
completion of the IPO. Mr. Nicholoudis resigned on January 15, 2024, and there are no further payments due to him.

 Note
11. Subsequent Events:

 Section
16(b) disgorgement

 In
January 2024, the Company recorded a related party receivable of $ 148,703 related to the recovery of short-swing profits due from The
Bay Shore Trust, under Section 16(b) of the Securities Exchange Act of 1934, as amended. Once the receivable is paid in full, the Company
will recognize these proceeds as a capital contribution from a stockholder with an increase to additional paid-in-capital in its balance
sheet and as cash provided by financing activities in its statement of cash flows.

 Restructuring
of the Board of Directors

 On
March 9, 2024, after a series of discussions between our board of directors (the "Board") and senior management regarding
the need to have additional scientific expertise among the members of the Board, Ms. Talhia Tuck, Mr. Brad Kroenig and Mr. Hugh McColl,
each voluntarily resigned from the Board, effective immediately. This action allowed the remaining members of the Board to appoint new
members of the Board, as discussed below. The resignations of Ms. Tuck, Mr. Kroenig, and Mr. McColl were not the result of any disagreement
with our company on any matter relating to its operations, policies or practices.

 Also
on March 9, 2024, Dr. Chris Chapman notified the Board and senior company management of his resignation both as Executive Chairman and
as an employee of our company, effective immediately, citing his desire to focus his time on his role as Chairman and Chief Executive
Officer of Telomir Pharmaceuticals, Inc., given the recent initial public offering of that company. Dr. Chapman's resignation was
not the result of any disagreement with our company on any matter relating to its operations, policies or practices.

 On
March 13, 2024, the remaining members of the Board (Erez Aminov and Michael Jerman) unanimously
approved the appointment of (i) Mr. Aminov, our Chief Executive Officer, as Chairman of the Board and (ii) Dr. Matthew P. Del Giudice,
Dr. Denil N. Shekhat and Mr. Edward MacPherson as members of the Board, to fill the vacancies on the Board occasioned by the resignations
from the Board described above, for a term expiring at our 2024 annual meeting of shareholders.

 Resignation
of Chief Science Officer

 We
are focused on strengthening our clinical and regulatory development expertise with a view towards a future IND for one of our product
candidates. As part of this development, on March 7, 2024, following discussions with our management, Adam Kaplin, M.D., Ph. D. resigned
from his position as President and Chief Scientific Officer of the company to pursue other business endeavors, effective immediately.
 As described under "Key Consultants" below, in light of Mr. Kaplin's resignation,
we expanded the role of an existing consultant to assist in clinical and regulatory affairs.

 F- 22

 SIGNATURES

 In
accordance with Section 13 or 15(d) of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.

 MIRA

 Date:

 By:

 /S/
 Erez Aminov

 Name:

 Erez

 Title:

 Chief
 Executive Officer

 (Principal
 Executive Officer)

 By:

 /S/
 Michelle Yanez

 Name:

 Yanez

 Title:

 Chief
 Financial Officer

 (Principal
 Financial Officer)

 In
accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities
and on the dates indicated.

 Person

 Capacity

 Date

 /s/
 Erez Aminov

 Chief
 Executive Officer and Chairman

 Erez

 /s/
 Michelle Yanez

 Chief
 Financial Officer

 Yanez

 /s/
 Michael Jerman

 Michael
 Jerman

 /s/
 Matthew Del Giudice

 Matthew
 Del Giudice

 /s/
 Denil Shekhat

 Denil
 Shekhat

 /s/
 Edward MacPherson

 Edward
 MacPherson