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MIRA PHARMACEUTICALS, INC.

MIRA PHARMACEUTICALS, INC.MIRA決算レポート

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MIRA Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical firm focused on researching, developing, and commercializing novel prescription therapies for rare diseases and unmet medical needs. It primarily serves global patient populations, prioritizing therapeutic areas with limited existing treatment options to improve patient outcomes.

What changed in MIRA PHARMACEUTICALS, INC.'s 10-K — 2024 vs 2025

Top changes in MIRA PHARMACEUTICALS, INC.'s 2025 10-K

268 paragraphs added · 400 removed · 140 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

29 edited+84 added−145 removed45 unchanged
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.
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. 12 U.S.
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.
The Company intends to pursue domestic and foreign filings based on the provisional application to seek global patent protection for MIRA-55. 16 MIRA1a The U.S.
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. 20 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.
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. 17 Corporation Information Our corporate headquarters is located at 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 33131. Our telephone number is 786-432-9792. Our principal website address is www.mirapharmaceuticals.com.
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.
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.
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.
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.
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.
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.
Clinical 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.
As a result, submission of an IND may not result in the FDA allowing clinical trials to commence. 13 Clinical 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.
An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. 18 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.
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.
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 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 intend for these patent applications to cover, where possible, claims for compositions of matter, medical uses, processes for preparation and formulations. 19 MIRA-55 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”.
MIRA-55 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”.
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.
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. 14 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.
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. 16 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.
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.
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.
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.
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”). 17 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.
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.
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.
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”).
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.
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.
Employees As of March 28, 2025, we had five part time 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.
Properties Our current business address is 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 33131, which is a virtual office. Employees As of March 28, 2026, we had two part time employees and various consultants providing support. None of our employees are represented by a labor union or are covered by a collective bargaining agreement.
Drug Enforcement Administration (DEA) has completed its scientific review of both Ketamir-2 and MIRA-55, determining that neither compound will be classified as a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations.
Drug Enforcement Administration (DEA) has completed its scientific review of Ketamir-2, MIRA-55, and SKNY-1 and concluded that each compound is not currently considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and applicable regulations. This regulatory distinction may facilitate clinical development and commercialization by avoiding certain regulatory requirements applicable to controlled substances.
Its primary metabolite, Nor-Ketamir, also binds to the PCP-site and also does not exhibit affinity for NMDA site, with an IC50 of approximately 300 µM. This targeted receptor interaction differentiates Ketamir-2 from ketamine, which exhibits broader receptor binding, including opioid and monoaminergic receptors, and binds to NMDA receptors with significantly higher affinity (0.5–1 µM).
This targeted receptor interaction differentiates Ketamir-2 from ketamine, which exhibits broader receptor binding, including opioid and monoaminergic receptors, and binds to NMDA receptors with significantly higher affinity. Efficacy in Animal Models The pharmacological activity of Ketamir-2 has been evaluated in preclinical neuropathic pain and behavioral models.
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.
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. 15 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.
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 current business address is 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 32183, which is a virtual office.
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.” SKNY-1 We hold a license in the U.S. and its territories, Mexico and Canada from MIRALOGX for the use of SKNY-1 in human applications.
We are collaborating closely with our suppliers to generate sufficient cGMP-grade MIRA-55 materials for planned preclinical toxicity programs, expanded animal testing, and potential human trials, which will be conducted pending regulatory approval. 15 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.
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 studies, performed in accordance with ICH and FDA regulatory guidelines, include in vitro and in vivo assessments to evaluate receptor binding, efficacy, selectivity, pharmacokinetics, metabolism, general pharmacology and toxicology. Mechanism of Action and Receptor Selectivity Ketamir-2 has been identified as a low-affinity NMDA receptor antagonist, selectively binding to the PCP-site with an IC50 of approximately 100 µM.
Mechanism of Action and Receptor Selectivity Ketamir-2 has been identified as a low-affinity NMDA receptor antagonist that selectively binds to the phencyclidine (PCP) site, with an IC50 of approximately 100 µM. Its primary metabolite, nor-Ketamir-2, also interacts with the PCP site and does not exhibit meaningful affinity for other receptor systems evaluated.
The IC 50 is ~300 µM. Evaluation of therapeutic efficacy of Ketamir-2 in animal models of depression, anxiety and neuropathic pain (i.e., Chung model) indicate that treatment with Ketamir-2 results in anti-anxiolytic and anti-depressive behavior in behavioral assessments such as the open-field test, elevated plus maze, and the forced swim test.
In neuropathic pain models, including the Chung model, treatment with Ketamir-2 was associated with improvements in pain thresholds at multiple dose levels. In behavioral assessments, including the open-field test, elevated plus maze, and forced swim test, Ketamir-2 demonstrated activity consistent with modulation of anxiety- and depression-related pathways.
Clinical Manufacturing and Drug Supply Recipharm Israel Ltd., a leading global contract development and manufacturing organization (CDMO), has successfully completed the upscaling, development, and GMP manufacturing for clinical and preclinical supplies of Ketamir-2. 6 MIRA-55: A Novel Oral THC Analog Our objective is to develop and commercialize new treatment options for neuropsychiatric, inflammatory, and neurologic diseases and disorders.
Clinical Manufacturing and Supply Recipharm Israel Ltd., a contract development and manufacturing organization (CDMO), has completed development and GMP manufacturing of Ketamir-2 for use in preclinical and clinical studies. Preclinical Development of Mira-55 The Company has conducted a series of in vitro and in vivo preclinical studies to characterize the pharmacological activity of MIRA-55.
ITEM 1. Description of Business Overview MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical development company advancing two neuroscience programs targeting neurologic and neuropsychiatric disorders. The company holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2 and MIRA-55, two novel drug candidates designed to address unmet medical needs in pain management, depression, PTSD and cognitive function.
ITEM 1. Description of Business Overview MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA, the “Company”, “we”, “us”) is a clinical-stage pharmaceutical development company advancing a pipeline of novel oral therapeutics targeting neurologic, neuropsychiatric, metabolic, and addiction-related disorders.
Results of in vitro assessments which evaluated the pharmacological activity of Ketamir-2 indicate that Ketamir is a low affinity NMDA receptor antagonist that selectively binds to the PCP-site with an IC 50 of ~100 µM on this receptor site. Nor-Ketamir, the primary metabolite of Ketamir-2, selectively binds to the PCP-site with no affinity for NMDA.
Preclinical Research and Pharmacology Ketamir-2 Ketamir-2 has been evaluated in a series of in vitro and in vivo preclinical studies designed to characterize its pharmacological activity, receptor selectivity, and therapeutic potential. Preclinical studies indicate that Ketamir-2 is a low-affinity NMDA receptor antagonist that selectively binds to the phencyclidine (PCP) site, with reduced off-target receptor interactions compared to ketamine.
Market Opportunity and Competitive Advantage of Ketamir-2 in Neuropathic Pain Treatment Market Opportunity Neuropathic pain is a significant and growing health concern in the United States, affecting approximately 10% of adults ( PMC5677393 ).
These findings are consistent with the compound’s proposed mechanism targeting appetite regulation and reward processing. Preclinical results may not be predictive of clinical outcomes. Market Opportunity and Competitive Positioning Ketamir-2 – Neuropathic Pain Neuropathic pain is a significant and growing health concern in the United States, affecting an estimated 7–10% of adults based on published epidemiological data.
The North American neuropathic pain market was valued at approximately $2.60 billion in 2022 and is projected to reach $5.20 billion by 2030, growing at a 9.0% compound annual growth rate (CAGR) during this period (Data Bridge Market Research). This growth is driven by an aging population, increasing prevalence of diabetes, chemotherapy-induced neuropathy, and post-surgical nerve injuries.
According to third-party market research, the North American neuropathic pain market is estimated in the multi-billion-dollar range and is expected to grow significantly over the remainder of the decade, driven by an aging population, increasing prevalence of diabetes, chemotherapy-induced peripheral neuropathy (CIPN), and post-surgical nerve injuries. There are currently no therapies approved by the U.S.
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Ketamir-2: A Novel Oral Ketamine Analog Ketamir-2 is a patent-pending, oral ketamine analog currently being evaluated for the treatment of diabetic neuropathy and is in an ongoing Phase I clinical trial. The compound is designed to overcome the limitations of existing ketamine-based treatments, offering the potential for enhanced safety, improved tolerability, and better oral bioavailability.
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The Company holds exclusive rights in the United States, Canada, and Mexico to Ketamir-2, MIRA-55, and SKNY-1, three drug candidates designed to address significant unmet medical needs across neuropathic and inflammatory pain, central nervous system disorders, and metabolic and behavioral conditions. Ketamir-2 is a next-generation oral NMDA receptor modulator that has completed a Phase 1 clinical trial in healthy volunteers.
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If approved, Ketamir-2 could provide a safer, more effective option for patients suffering from neuropathic pain, treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD), with the possibility of additional Phase I studies exploring these indications.
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The study included both single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts, and dosing has been completed across all cohorts. Based on preliminary safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported; however, the database remains blinded and final audited safety and pharmacokinetic analyses are ongoing.
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Neuropathic pain is a complex, chronic condition resulting from damage or dysfunction in the nervous system, leading to abnormal sensations or pain responses. Common symptoms include burning, coldness, “pins and needles” sensations, numbness, itching, and sudden electric shock-like pain.
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The Company is preparing to initiate a Phase 2a clinical trial in chemotherapy-induced peripheral neuropathy (CIPN) in the first half of 2026, subject to regulatory feedback and site readiness. MIRA-55 is a novel oral, non-psychoactive cannabinoid analog under preclinical development for inflammatory pain and central nervous system–related conditions, including anxiety and cognitive impairment.
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Neuropathic pain can arise from metabolic disorders (such as diabetic neuropathy), viral infections (like post-herpetic neuralgia), autoimmune diseases, chemotherapy-induced neuropathy, traumatic nerve injury, stroke, or spinal cord injury. Existing treatment options include antidepressants (tricyclic antidepressants and serotonin-norepinephrine reuptake inhibitors), anticonvulsants (gabapentin and pregabalin), topical agents (lidocaine patches and capsaicin), and opioids.
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In validated preclinical models, MIRA-55 has demonstrated both analgesic and anti-inflammatory activity, including restoration of pain thresholds and reduction of inflammation in inflammatory pain models. In comparative studies, the compound produced analgesic effects comparable to morphine, while also demonstrating direct anti-inflammatory activity not observed with opioid treatment under the conditions evaluated.
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However, these therapies often provide incomplete relief, have significant side effects, and, in the case of opioids, carry a high risk of addiction. Ketamine has demonstrated efficacy for neuropathic pain, but its poor oral bioavailability and high risk of side effects have limited its widespread use.
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In a series of behavioral and safety assessments, MIRA-55 did not demonstrate cannabinoid-like central nervous system adverse effects, including sedation, catalepsy, or anxiogenic responses, at tested doses in preclinical models. These findings support a differentiated pharmacological profile designed to minimize CB1-mediated effects while maintaining therapeutic activity.
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Ketamir-2 aims to address these challenges, offering a treatment with fewer side effects, lower abuse potential, and more convenient oral dosing. MIRA-55: A Novel Oral Pharmaceutical Marijuana Analog MIRA-55 is a preclinical-stage investigational drug designed to support cognitive function and enhance memory. It is currently being evaluated in preclinical studies for its potential benefits in neuropsychiatric, inflammatory, and neurologic disorders.
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The Company is advancing MIRA-55 through IND-enabling development activities and is targeting an Investigational New Drug (IND) submission for inflammatory pain, subject to completion of required preclinical studies, manufacturing readiness, regulatory interactions, and available capital resources. The U.S.
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If approved, MIRA-55 could provide a breakthrough treatment for patients experiencing cognitive decline, including those with early neurodegenerative conditions. Regulatory and DEA Classification The U.S.
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Drug Enforcement Administration (DEA) has completed its scientific review of Ketamir-2, MIRA-55, and SKNY-1 and concluded that each compound is not currently considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and applicable regulations. 3 On September 29, 2025, MIRA acquired SKNY Pharmaceuticals, Inc., a Delaware corporation (“SKNY”), a private company and related party, developing SKNY-1, a preclinical-stage oral therapeutic candidate designed to modulate CB1 and CB2 receptor signaling and selectively inhibit monoamine oxidase B (MAO-B).
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This regulatory distinction significantly enhances their commercial and clinical viability, removing potential barriers associated with controlled substances and positioning both compounds for streamlined clinical development and commercialization.
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SKNY-1 is being developed to target pathways involved in energy balance, lipid metabolism, appetite regulation, reward, and craving-related behaviors. SKNY-1 has been evaluated in preclinical behavioral and metabolic models. In validated animal models that simulate obesity and reward-driven behavior, oral administration of SKNY-1 was associated with reductions in body weight, food consumption, and nicotine-seeking behavior compared with controls.
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MIRA Pharmaceuticals remains committed to advancing Ketamir-2 and MIRA-55 through clinical development with a focus on addressing major unmet medical needs and improving patient outcomes. 3 Preclinical Studies and Pharmacology of Ketamir-2 MIRA has conducted extensive preclinical studies to characterize the pharmacological profile, safety, and therapeutic potential of Ketamir-2, an investigational compound targeting neuropathic pain, treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD).
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In these studies, weight reduction was not accompanied by measurable loss of muscle mass under the conditions evaluated. Additional findings demonstrated improvements in metabolic parameters and modulation of craving-related behaviors. In behavioral assessments, SKNY-1 did not demonstrate anxiety-like or other adverse central nervous system–related behavioral effects in the models studied, and in certain conditions mitigated CB1-related behavioral responses.
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Efficacy in Animal Models The therapeutic potential of Ketamir-2 was evaluated in preclinical neuropathic pain and depression models, demonstrating significant effects: ● In neuropathic pain models (Chung model), animals treated with 30–300 mg/kg Ketamir-2 exhibited improved pain thresholds, with the most notable effects observed at 100 and 300 mg/kg at 15- and 22- days post treatment . ● Behavioral assessments such as the open-field test, elevated plus maze, and forced swim test showed anti-anxiolytic and antidepressant properties ● These improvements occurred without off-target receptor interactions, supporting the compound’s high specificity and potential safety advantages over ketamine.
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These observations support a differentiated pharmacological profile relative to prior CB1-targeting agents. The Company is conducting additional preclinical studies to further characterize SKNY-1 in models of obesity and nicotine dependence and is advancing the program toward IND-enabling development activities.
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Recent Developments Executive Incentive Compensation Program On March 26, 2025, the compensation committee (the “Committee”) of MIRA Pharmaceuticals, Inc. (the “Company”) adopted the Company’s Executive Incentive Compensation Plan (the “EICP”) for Erez Aminov, its Chairman and Chief Executive Officer.
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Subject to completion of required studies, manufacturing readiness, regulatory interactions, and available capital resources, the Company is targeting an Investigational New Drug (IND) submission for SKNY-1 in 2026. Ketamir-2: Selective Oral NMDA Receptor Modulator Ketamir-2 is a patent-pending, orally bioavailable NMDA receptor modulator being developed for neuropathic pain, with an initial focus on chemotherapy-induced peripheral neuropathy (CIPN).
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The EICP was approved by the Committee following greater presentation of the EICP to the board of directors of the Company (the “Board”). The specific terms of the EICP were prepared by the Board’s independent compensation consultant. Under the EICP, Mr.
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The Company has completed dosing in a Phase 1 clinical trial in healthy volunteers, including both single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts. Database lock, unblinding, and final safety and pharmacokinetic analyses are ongoing.
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Aminov is eligible to receive an annual target bonus of $242,500, with a maximum bonus of up to $485,000 (the “Annual Target Bonus”).
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Ketamir-2 is designed to selectively modulate the NMDA receptor (PCP binding site) with low binding affinity and limited off-target receptor activity, with the goal of improving tolerability relative to ketamine. Subject to regulatory interactions and operational readiness, the Company plans to advance Ketamir-2 into a Phase 2a clinical trial in CIPN in the first half of 2026.
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The Annual Target Bonus is equally weighted (though as adjusted as appropriate) based on the following three components: (i) achievement of clinical milestones for the Company’s drug candidates, (ii) entering into certain strategic partnerships, and (iii) achieving capital raise milestones.
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MIRA-55: Oral Cannabinoid Analog MIRA-55 is a novel oral cannabinoid analog in preclinical development for inflammatory pain and central nervous system–related conditions, including anxiety and cognitive impairment. The compound has been designed to preferentially modulate CB2 receptor activity while minimizing CB1-mediated central nervous system effects.
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Each component under the 2025 Program may be achieved and a corresponding payout made independent of the other components, but only after such component meets the minimum threshold of $40,017 is reached before any bonus payments will be made. Under the EICP, Mr.
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In preclinical models, MIRA-55 has demonstrated analgesic and anti-inflammatory activity, including restoration of pain thresholds and reduction of inflammation in inflammatory pain models. In behavioral assessments, the compound did not demonstrate cannabinoid-like central nervous system adverse effects under the conditions evaluated.
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Aminov will be eligible for certain long-term awards of up to 500,000 performance-based units of the Company’s common stock, par value $0.001 upon the Company achieving specified milestones based upon the Company reaching certain market capitalization values and the progress of the Company’s drug candidates. Mr.
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The Company is advancing MIRA-55 through IND-enabling development activities and is targeting an IND submission for inflammatory pain, subject to completion of required studies and regulatory interactions. 4 SKNY-1: Oral Therapeutic Candidate for Metabolic and Addiction-Related Indications SKNY-1 is a preclinical-stage oral therapeutic candidate designed to modulate CB1 and CB2 receptor signaling and selectively inhibit monoamine oxidase B (MAO-B).
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Aminov will also be entitled to an amount equal to 3% of the total value of any mergers and acquisition or strategic transaction completed by the Company. All awards under the EICP are subject to the approval of the Board and the Committee.
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The compound is being developed to target pathways involved in energy balance, appetite regulation, reward, and craving-related behaviors, with initial focus on weight management and nicotine dependence. In preclinical metabolic and behavioral models, SKNY-1 has demonstrated reductions in body weight, food intake, and nicotine-seeking behavior.
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Furthermore, the Board and the Committee, each in its sole discretion, generally retain the right to amend, supplement, supersede or cancel any awards under the EICP for any reason, and reserve the right to determine whether and when to pay out any bonus amounts pursuant to or outside of the EICP, regardless of the achievement of the performance targets.
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In these studies, weight reduction was not associated with measurable loss of muscle mass under the conditions evaluated. Behavioral assessments did not demonstrate adverse central nervous system–related effects in the models studied.
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In addition, the Committee approved an increase of Mr. Aminov’s salary to $485,000 effective April 1 st . Binding Letter of Intent with SKNY Pharmaceuticals Inc. On March 19, 2025, the Company entered into a binding letter of intent (the “LOI”) with SKNY Pharmaceuticals, Inc.
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The Company is conducting additional preclinical studies and is advancing SKNY-1 toward IND-enabling development activities, with a targeted IND submission in 2026, subject to completion of required studies and regulatory interactions. Regulatory and DEA Classification The U.S.
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(“SKNY”), a privately held Delaware corporation, to acquire SKNY through a stock exchange transaction (the “SKNY Acquisition”). The acquisition will bring SKNY-1, a novel oral drug candidate targeting weight loss and smoking cessation—two of the leading causes of preventable death—into MIRA’s development pipeline.
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Preclinical Studies and Pharmacology of Ketamir-2 We have conducted preclinical studies to characterize the pharmacological profile, safety, and therapeutic potential of Ketamir-2, an investigational compound targeting neuropathic pain and related conditions. These studies include in vitro and in vivo assessments evaluating receptor binding, efficacy, selectivity, pharmacokinetics, metabolism, general pharmacology, and toxicology.
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As part of the agreement, SKNY will provide a $5 million capital infusion in cash or cash equivalents, further strengthening MIRA’s financial position and supporting future growth initiatives. SKNY holds exclusive rights to its compounds in the United States, Canada, and Mexico.
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These effects were observed without evidence of significant off-target receptor activity in the models evaluated. Preclinical findings may not be predictive of clinical outcomes. Phase 1 Clinical Evaluation Ketamir-2 has been evaluated in a randomized, double-blind, placebo-controlled Phase 1 clinical trial in healthy volunteers, including both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.
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Under the terms of the LOI, SKNY will merge into the Company through a stock exchange, with each outstanding share of SKNY’s common stock being exchanged for shares of MIRA’s common stock. The exact exchange ratio will be determined by an independent third-party valuation firm (the “Independent Valuator”) based on the relative values of both companies.
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Dosing has been completed across all cohorts, and database lock and final analyses are ongoing. 5 Based on safety data reviewed to date, Ketamir-2 has been observed to be generally well tolerated at the dose levels evaluated, with no serious adverse events or dose-limiting toxicities reported. No clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed.
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The completion of the SKNY Acquisition is contingent upon the Independent Valuator determining that SKNY’s valuation is at least equal to or greater than that of the Company. The SKNY Acquisition will be subject to shareholder approval of both companies.
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These observations are preliminary, and final safety, tolerability, and pharmacokinetic results remain subject to completion of data analysis. Preclinical Studies and Pharmacology of MIRA-55 We have conducted preclinical studies to evaluate the pharmacological activity of MIRA-55, a cannabinoid analog under development for inflammatory pain and central nervous system–related conditions. These studies include receptor-binding assays, behavioral models, and inflammatory pain models.
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Safety and Toxicology Studies Cardiovascular, CNS, and Respiratory Safety A GLP-compliant safety pharmacology program evaluated the effects of Ketamir-2 on the cardiovascular, central nervous system (CNS), and respiratory function using standard nonclinical models. ● The hERG assay assessed cardiac ion channel inhibition, while CNS functional observational battery (FOB) studies measured motor function, coordination, and behavioral changes. ● Mild, reversible changes in blood pressure and heart rate were observed at higher doses, with no significant adverse effects on CNS function or respiratory parameters.
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In preclinical models, MIRA-55 demonstrated activity consistent with modulation of inflammatory pathways and pain responses, including reductions in inflammation and normalization of pain thresholds in validated inflammatory pain models. In comparative studies, MIRA-55 demonstrated analgesic activity in these models without evidence of opioid-like or cannabinoid-like central nervous system adverse effects under the conditions evaluated.
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Toxicology and Dose Tolerability Comprehensive toxicology studies were conducted in Sprague Dawley rats and Beagle dogs to assess systemic exposure, metabolism, and dose tolerability. ● Systemic exposure was dose-proportional in females but increased more than dose-proportionally in males at certain doses. ● The No Observed Adverse Effect Level (NOAEL) was determined at 300 mg/kg/day in rats and 200 mg/kg/day in dogs, with a safety margin of 67–156 times the intended initial human dose. ● Genotoxicity assessments, including the Ames test, micronucleus assay, and COMET assay, confirmed no mutagenic or genotoxic risk associated with Ketamir-2. 4 Pharmacokinetics and Metabolism A series of in vivo pharmacokinetics (PK) and toxicokinetic (TK) studies assessed the absorption, metabolism, and systemic exposure of Ketamir-2. ● Ketamir-2 crosses the blood-brain barrier, with higher CNS exposure relative to plasma levels. ● It exhibits rapid absorption, a short half-life, and high clearance following oral administration. ● Metabolism studies confirmed that Ketamir-2 is not a substrate for P-glycoprotein (P-gp), suggesting improved oral bioavailability compared to ketamine. ● Metabolism is primarily mediated by CYP2B6 and CYP3A4, with N-demethylation identified as the primary metabolic pathway. ● High-affinity NMDA receptor antagonists, such as MK-801, PCP, ketamine, and tiletamine, have been associated with Olney Lesions, typically binding to the PCP-site in the nanomolar range. ● Low-affinity NMDA receptor antagonists, such as memantine, amantadine, and hydroxy-nor-ketamine, have not demonstrated this effect. ● Ketamir-2, with an IC50 of ~100 µM for the PCP-site, has significantly lower receptor affinity than ketamine (0.5–1 µM), reducing the likelihood of neurotoxicity.
Added
These findings are based on preclinical studies, and their relevance to human clinical outcomes has not been established. Preclinical Studies and Pharmacology of SKNY-1 We have conducted preclinical studies to evaluate the pharmacological activity of SKNY-1, a therapeutic candidate targeting metabolic and addiction-related pathways, including appetite regulation and reward-driven behaviors.
Removed
Ketamir-2 Clinical Development Program The clinical development program for Ketamir-2 follows a structured, multi-phase approach, beginning with IND-enabling studies and progressing through Phase I and Phase IIa clinical trials. The objective is to evaluate the safety, efficacy, and optimal use of Ketamir-2 for the treatment of diabetic neuropathy, with a focus on patient safety and regulatory compliance.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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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; ● delays 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; 37 ● delays 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 regulations, including changes to requirements imposed on the extent, nature, or timing of studies; ● delays 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; ● regulatory 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.
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; ● delays 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; ● delays 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 regulations, including changes to requirements imposed on the extent, nature, or timing of studies; ● delays 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; ● regulatory 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.
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; 38 ● 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; ● delays or inability in manufacturing or obtaining sufficient quantities of GMP-grade materials for use in clinical trials due to regulatory and manufacturing constraints; ● delays 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 ● regulatory inspections of our clinical trials require us to undertake corrective action or suspend or terminate our clinical trials.
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; ● delays or inability in manufacturing or obtaining sufficient quantities of GMP-grade materials for use in clinical trials due to regulatory and manufacturing constraints; ● delays 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 ● regulatory inspections of our clinical trials require us to undertake corrective action or suspend or terminate our clinical trials.
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; 54 ● 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 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.
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; 41 ● 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.
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.
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; 26 ● 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 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 product candidates; ● 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.
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.
Currently, Bay Shore Trust would be considered an “interested shareholder.” 51 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.
Conducting clinical trials outside the United States also exposes us to additional risks, including risks associated with: ● additional foreign regulatory requirements; ● foreign exchange fluctuations; ● compliance with foreign manufacturing, customs, shipment and storage requirements; ● cultural differences in medical practice and clinical research; ● diminished protection of intellectual property in some countries; and ● interruptions or delays in our trials resulting from geopolitical events, such as war or terrorism.
Conducting clinical trials outside the United States also exposes us to additional risks, including risks associated with: ● additional foreign regulatory requirements; ● foreign exchange fluctuations; ● compliance with foreign manufacturing, customs, shipment and storage requirements; 36 ● cultural differences in medical practice and clinical research; ● diminished protection of intellectual property in some countries; and ● interruptions or delays in our trials resulting from geopolitical events, such as war or terrorism.
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.
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. 45 We have no patent protection for MIRA-55, which could adversely impact MIRA-55’s potential competitive position.
To comply with these requirements, we may need to hire more employees in the future or engage outside consultants, which will increase our costs and expenses. 51 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.
To comply with these requirements, we may need to hire more employees in the future or engage outside consultants, which will increase our 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.
Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition. Clinical 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.
Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition. 34 Clinical 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.
The control share acquisition statute generally applies to any “issuing public corporation,” which means a Florida corporation which has: ● One hundred or more shareholders; 53 ● 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 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.
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.
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. Mr.
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.
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. 52 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.
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. 55 Securities or industry analysts may not regularly publish reports on us, which could cause the price of our securities or trading volumes to decline.
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. Securities or industry analysts may not regularly publish reports on us, which could cause the price of our securities or trading volumes to decline.
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.
This patent portfolio includes issued patents and pending patent applications covering pharmaceutical compositions and methods of use. 44 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.
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.
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. 48 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.
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. 24 Operating results may vary significantly in future periods. Our operating and financial results are likely to fluctuate significantly in the future.
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.
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.
We are dependent on SKNY’s current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized. Our ability to progress SKNY’s plan will depend on SKNY’s ability to clinically develop, gain regulatory approval for and ultimately commercialize SKNY’s product candidates.
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. 27 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 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. 24 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.
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; 32 ● 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.
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; 28 ● 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.
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. 45 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.
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. 40 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.
The auditor’s opinion on our audited financial statements for the year ended December 31, 2024 includes an explanatory paragraph stating that we have no revenue and incurred recurring losses from operations and cash used in operations that raise substantial doubt about our ability to continue as a going concern.
The auditor’s opinion on our audited financial statements for the year ended December 31, 2025 includes an explanatory paragraph stating that we have no revenue and incurred recurring losses from operations and cash used in operations that raise substantial doubt about our ability to continue as a going concern.
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. 34 We are continuously evaluating and, where appropriate, enhancing our IT systems to address our planned growth, including to support our planned manufacturing operations.
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. 30 We are continuously evaluating and, where appropriate, enhancing our IT systems to address our planned growth, including to support our planned manufacturing operations.
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. 33 We are subject to the U.S.
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. 29 We are subject to the U.S.
Aminov is aware of his duties 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.
Weichselbaum is aware of his duties 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.
Because she does not work full time for our company, instances may occur where she 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.
Because he does 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.
The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2024 contains an explanatory paragraph relating to our ability to continue as a going concern .
The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025 contains an explanatory paragraph relating to our ability to continue as a going concern .
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.
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.
Risks Relating to Our Business and Our Industry Our future success will largely depend on the success of Ketamir-2 and MIRA-55 and any future product candidates, which development will require significant capital resources and years of clinical development effort.
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.
Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in more resources being concentrated among a smaller number of our competitors.
Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in more resources being concentrated among a smaller number of SKNY’s competitors.
Risks Related to Development and Regulatory Approval of Our Product Candidates Clinical 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. Clinical trials are expensive, time consuming and difficult to design and implement.
Risks Related to Development and Regulatory Approval of Our Product Candidates Clinical 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.
For the year ended December 31, 2024, we reported a net operating cash outflow of $5.6 million and a net cash inflow from financing activities of $3.8 million. For the year ended December 31, 2023, we reported a net operating cash outflow of $4.5 million and a net cash inflow from financing activities of $8.8 million.
For the year ended December 31, 2025, we reported a net operating cash outflow of $4.6 million and a net cash inflow from financing activities of $8.2 million. For the year ended December 31, 2024, we reported a net operating cash outflow of $5.6 million and a net cash inflow from financing activities of $3.8 million.
Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. 30 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.
Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. 47 These companies may compete with SKNY 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 SKNY’s research projects.
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.
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. 49 Investors could find our shares less attractive if we choose to rely on these exemptions.
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 $29.1 million through December 31, 2024, and $21.3 million through December 31, 2023.
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 $39.6 million through December 31, 2025, and $29.1 million through December 31, 2024.
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.
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. 39 We rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates.
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.
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 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. 46 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.
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. 41 ● 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.
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 as a substance not subject to CSA; ● the DEA continuing to classify 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.
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 as a substance not subject to CSA; ● the DEA continuing to classify 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. 21 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.
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.
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.
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.
We may not develop additional proprietary products that are patentable. 43 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.
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.
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.
In addition, she can become subject to conflicts of interest because she devotes part of her working time to other business endeavors and may have responsibilities to other entities. Although Mrs.
In addition, he can become subject to conflicts of interest because he devotes part of his working time to other business endeavors and may have responsibilities to other entities. Although Mr.
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.
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.
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.
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.
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.
If we are unable to obtain regulatory approval for Ketamir-2, MIRA-55 and SKNY-1 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. 23 We are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.
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.
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. 25 Third-party payers or governmental or commercial entities are developing increasingly sophisticated methods of controlling healthcare costs.
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. 36 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.
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.
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.
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. 31 Legislative or regulatory reform of the health care system in the U.S. may affect our ability to profitably sell our products, if approved.
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.
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.
The FDA may not accept data from trials conducted in such locations, and the conduct of trials outside the United States could subject us to additional delays and expense. We plan to conduct one or more clinical trials with one or more trial sites that are located outside the United States.
We plan to conduct clinical trials at sites outside the United States. The FDA may not accept data from trials conducted in such locations, and the conduct of trials outside the United States could subject us to additional delays and expense.
However, although we have received net proceeds of $3.6 million during 2024 from the ATM, there are no assurances that we will be successful in raising any additional capital from the ATM.
However, although we have received net proceeds of $6.7 million for the year ended December 31, 2025 and $3.6 million for the year ended December 31, 2024 from the ATM, there are no assurances that we will be successful in raising any additional capital from the ATM.
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. 48 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.
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.
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.
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.
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.
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. 50 If our shares were to be delisted from Nasdaq, they may become subject to the SEC’s “penny stock” rules.
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.
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. 27 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.
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.
The reputational risk is heightened with respect to those of our product candidates that are being developed for pediatric indications. 38 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.
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. 23 We may not be successful in the integration of our potential acquisition of SKNY.
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. 20 Because we have a limited operating history, you may not be able to accurately evaluate our operations.
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. 35 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.
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.
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.
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 acceptance by the FDA or other regulatory authorities of study data from clinical trials conducted outside their jurisdiction may be subject to certain conditions or may not be accepted at all.
We plan to conduct one or more clinical trials with one or more trial sites that are located outside the United States. The acceptance by the FDA or other regulatory authorities of study data from clinical trials conducted outside their jurisdiction may be subject to certain conditions or may not be accepted at all.
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.
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.
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. 50 Risks Relating to the Ownership of our Common Stock Because of the speculative nature of investment risk, you may lose your entire investment.
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.
As such, our losses from operations and negative cash flows as of December 31, 2024 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings.
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, 2025 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings.
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 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. 37 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.
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.
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.
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.
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.
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.
Any of the foregoing could have a material adverse effect on our business, results of operations and financial condition. 35 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.
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. 29 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 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 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. 42 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.
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.
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.
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. 53 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.
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.
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.
We rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates.
We depend on a limited number of suppliers for materials and components required to manufacture our product candidates. We rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates.
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.
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.
Failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process. 47 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.
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.
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. 43 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.
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.
Third-party 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.
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.
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.
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. Moreover, as generic versions of drug products enter the market, the price for such medicines may be expected to decline rapidly and substantially.
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. 31 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.
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.
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. 52 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.
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. 19 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.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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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. 56 Identifying and assessing cybersecurity risk is integrated into our overall risk management systems and processes.
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.
To date, we have no t 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.
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.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Securities 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
Securities 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
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock has been public traded on The Nasdaq Capital Market under the symbol “MIRA” since August 3, 2023.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock has been public traded on The Nasdaq Capital Market under the symbol “MIRA” since August 3, 2023. Prior to that date, there was no public trading market for our common stock.
We currently intend to retain earnings for further business development and do not expect to pay cash dividends in the foreseeable future.
Holders of Common Stock As of March 31, 2026, we had approximately 69 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.
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Prior to that date, there was no public trading market for our common stock. 57 Holders of Common Stock As of March 28, 2025, we had approximately 55 holders of record of our common stock. No cash dividends have been paid on the common stock to date.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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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.
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Item 6. Reserved 55 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 55 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 61 Item 8. Financial Statements F-1 Item 9. Changes In and Disagreements with Accountants on Accounting and Financial Disclosure 62 Item 9A. Controls and Procedures 62 Item 9B. Other Information 63
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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.
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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 MIRA Pharmaceuticals, Inc.
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(NASDAQ: MIRA) is a clinical-stage pharmaceutical development company advancing two neuroscience programs targeting neurologic and neuropsychiatric disorders. The company holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2 and MIRA-55, two novel drug candidates designed to address unmet medical needs in pain management, depression, PTSD and cognitive function. The U.S.
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Drug Enforcement Administration (DEA)’s scientific review of Ketamir-2 and MIRA-55 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations. We had net losses of $7.9 million and $12.0 million for the year ended December 31, 2024 and December 31, 2023, respectively.
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Reverse Stock Split Effective June 28, 2023, we completed a 1-for-5 reverse stock split of our outstanding common stock.
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Unless otherwise noted, the share and per share information in this Report reflects the reverse stock split. 58 Components of our Results of Operations Research and Development Expenses Research 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.
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Research and development expenses consist primarily of the following: ● contracted research and manufacturing; ● patent-related costs; ● 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.
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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.
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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.
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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.
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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.
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General and Administrative Expenses General 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.
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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.
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Interest expense Interest expense, net consists of accrued interest on a related party line of credit, net of earned interest income. 59 Results of Operations for the year ended December 31, 2024 and 2023 Year Ended December 31, 2024 2023 Revenues $ - $ - Operating costs: General and administrative expenses 4,712,753 6,499,537 Related party travel costs - 453,550 Research and development expenses 3,305,575 1,572,963 Total operating costs 8,018,328 8,526,049 Interest income (expense), net 165,669 (3,456,294 ) Net loss attributable to common stockholders $ (7,852,659 ) $ (11,982,343 ) Basic and diluted loss per share $ (0.51 ) $ (0.85 ) Weighted average common stock shares outstanding 15,444,149 13,924,619 General and Administrative Expenses .
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We incurred $4.7 million and $6.5 million in general and administrative expenses during the year ended December 31, 2024 and December 31, 2023, respectively.
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General and administrative expenses in 2024 consisted of stock compensation expense of $1.9 million, payroll expense of $0.9 million, accounting and legal expenses of $0.4 million, marketing, investor relations, advertising, and general corporate expenses of $1.0 million and insurance expenses of $0.5 million.
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The decrease in general and administrative expenses during 2024 relate primarily to a decrease in personnel in 2024 compared to 2023 and a concerted effort to conserve cash until the shelf registration statement and at-the-market offering was put into place in August 2024. Related Party Travel Costs .
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We incurred $0.5 million in related party travel costs during the year ended December 31, 2023. There were no related party travel costs incurred during the year ended December 31, 2024. Related party travel costs consisted of a lease and use of an airplane with an entity under common control.
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The airplane lease was terminated in March 2023, and hence, we ceased use of the airplane and there were no further costs incurred. Interest income (expense) . We earned $0.2 million, in interest income (expense) net, during the year ended December 31, 2024, which consisted of income earned from funds in a money market account.
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We incurred $3.5 million, in interest income (expense) net, during the year ended December 31, 2023, which consisted of $2.8 million of write-off of unamortized deferred financing costs, $0.7 million of debt issuance costs, offset by $0.02 million of interest income. Research and Development Expenses.
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During the year ended December 31, 2024, we incurred $3.3 million in research and development expenses, which were primarily related to pre-IND submission work, consultants and stock compensation. 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.
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The increase in research and development expenses during 2024 are related to the IND enabling studies and submission.
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Major components of research and development expenses during the year ended December 31, 2024 are as follows: R&D Category Expense R&D consultants $ 0.53 million R&D research $ 0.96 million R&D toxicology $ 1.72 million R&D stock compensation $ 0.10 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.
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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, and through proceeds of an ATM offering.
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We may also enter into new licensing and commercial partnership agreements. 60 On August 12, 2024, the Company filed a shelf registration statement on Form S-3 with the SEC.
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The terms of any offering under the shelf registration statement will be established at the time of such offering and will be described in a prospectus supplement filed with the SEC prior to completion of any such offering 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”).
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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.
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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.
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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, 2024, the Bay Shore Note was paid in full.
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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.
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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.
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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.
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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”).
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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).
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We used $5.6 million in operating activities during the year ended December 31, 2024, compared to $4.5 million in operating activities during the year ended December 31, 2023. 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.
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We had negative cash flow from operations of approximately $5.6 million for the year ended December 31, 2024 and an accumulated deficit of approximately $29.1 million as of December 31, 2024. As of December 31, 2024, we had cash and cash equivalents of approximately $2.8 million.
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We currently expect that our cash and cash equivalents be sufficient to fund our operations, development plans, and capital expenditures through at least the third quarter of 2025.
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We did not have any material non-cancellable contractual obligations as of December 31, 2024. 61 Cash Flows The following table provides information regarding our cash flows for the periods presented: Year ended December 31, 2024 2023 Net cash provided by (used in): Operating activities $ (5,560,606 ) $ (4,532,403 ) Financing activities 3,790,971 8,783,991 Net change in cash $ (1,769,635 ) $ 4,251,588 Net Cash Used in Operating Activities The cash used in operating activities resulted primarily from our net losses, stock-based compensation expense and changes in components of accounts payable and accrued liabilities.
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For the year ended December 31, 2024, operating activities used $5.6 million of cash, primarily due to a net loss of $7.9 million, offset by $1.9 million in stock-based compensation expense, and a $0.4 million change in accounts payable, accrued and prepaid expenses.
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Accounts payable, accrued and prepaid expenses was primarily composed of research and development payables, consultant costs, insurance costs and investor relations expenses.
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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.
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Interest income (expense), net was primarily composed of debt issuance costs, 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.
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Net Cash Provided by Financing Activities For the year ended December 31, 2024, financing activities provided $3.8 million of cash, resulting primarily from $3.6 million in proceeds from sale of common stock, less offering costs, $0.1 million from the Bay Shore Trust short-swing disgorgement, and $0.03 million in advances from related party.
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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.
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We currently anticipate that we will seek to monetize our product candidates, Ketamir-2 and MIRA-55, at the end of our planned Phase II studies. Prior to that time, we anticipate that additional capital may be required to support ongoing activities and further phases of development.
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Should that be required, our available capital may be consumed more rapidly than currently anticipated, resulting in the need for additional funding.
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In addition, there can be no assurance that additional funding, when and if required, will be available at commercially favorable terms, if at all. 62 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.
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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.
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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.
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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.
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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.
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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 third quarter of 2025.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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. 63 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 1 to our financial statements appearing at the end of this Report.
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Off-Balance Sheet Arrangements During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.
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Summary of Critical Accounting Policies and Estimates Research and development expenses Research 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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In addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act.
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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.
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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. 64