ADDED
As of March 30, 2026, there were 42,022,087 shares of common stock, par value $ 0.0001 , issued and outstanding.
Executive Compensation 68 Item 12 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 76 Item 13.
Exhibits, Financial Statement Schedules 81 Signatures 83 Unless we have indicated otherwise, or the context otherwise requires, references in this Report to MIRA, the Company, we, us and our or similar terms refer to MIRA Pharmaceuticals, Inc., a Florida corporation.
(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.
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.
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.
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.
REMOVED
As of March 28, 2025, there were 16,813,654 shares of common stock, par value $ 0.0001 , issued and outstanding.
Executive Compensation 71 Item 12 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 81 Item 13.
Form 10-K Summary 87 Signatures 88 Unless we have indicated otherwise, or the context otherwise requires, references in this Report to MIRA, the Company, we, us and our or similar terms refer to MIRA Pharmaceuticals, Inc., a Florida corporation.
However, information that is contained in and can be accessed through our website, our Facebook page, our Twitter posts and our LinkedIn posts are not incorporated into, and does not form a part of, this Report.
Summary of Principal Risks Our business is subject to numerous risks and uncertainties that represent challenges that we face in connection with the implementation of our strategy and the growth of our business.
In particular, the following are the principal risks which could cause a decline in the price of shares of our common stock: We are a development-stage, pre-clinical biotechnology company that has no revenues and has incurred losses since our inception.
We expect to incur losses for the foreseeable future and may never be able to generate revenues or achieve or maintain profitability.
Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
Our losses from operations and negative cash flows during the year ended December 31, 2024 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings.
We are dependent on the success of our product candidates, some of which may not receive regulatory approval or be successfully commercialized.