Welcome to our dedicated page for Mira Pharma SEC filings (Ticker: MIRA), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) SEC filings page provides direct access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. These documents detail material events, clinical and regulatory milestones, capital-raising activities, and corporate governance decisions for this Florida-incorporated, Miami-based clinical-stage biopharmaceutical company.
Through MIRA’s Forms 8-K, users can review key developments in the Ketamir-2 program, including FDA clearance of the Investigational New Drug (IND) application for neuropathic pain, favorable topline data from the single ascending dose Phase 1 study, and initiation of the multiple ascending dose portion with chemotherapy-induced peripheral neuropathy selected as the lead Phase 2a indication. Filings also summarize preclinical evidence, DEA determinations that Ketamir-2 is not a controlled substance, and its selective NMDA receptor targeting profile.
Filings further describe MIRA-55, an oral THC or marijuana analog with preclinical results in inflammatory and nociceptive pain, and the company’s intention to pursue an IND for chronic inflammatory pain. The completed acquisition of SKNY Pharmaceuticals, Inc. and addition of SKNY-1 for obesity and smoking cessation are documented in a Form 8-K, which also notes SKNY’s contribution of marketable securities and the resulting multi-program pipeline.
Investors can also examine capital markets and governance disclosures, such as at-the-market equity offerings, Nasdaq listing compliance updates, equity incentive plan amendments, shareholder voting results, and executive compensation and incentive awards tied to development, acquisition, and market capitalization milestones. Stock Titan’s interface surfaces these filings alongside AI-powered summaries that highlight the main points of lengthy documents, helping readers quickly understand clinical updates, transaction terms, and other material information contained in MIRA’s 8-Ks and related filings.
MIRA Pharmaceuticals reports progress in testing its oral Ketamir-2 drug. The company has completed the Single Ascending Dose portion of its Phase 1 trial in healthy adults at the Hadassah Clinical Research Center in Israel. Thirty-two participants received single doses from 50 mg to 600 mg, with dosing overseen by an independent Safety Steering Committee.
Based on blinded safety data from this stage, no severe or clinically significant adverse effects were seen at any dose. MIRA is now moving to the Multiple Ascending Dose stage, testing daily oral doses of 150 mg, 300 mg, and 600 mg for five days in up to 24 participants to assess safety, tolerability, and pharmacokinetics. With prior FDA clearance of its IND for neuropathic pain, the company expects to start a U.S. Phase 2a trial in Q4 2025, subject to ongoing results and regulatory review.
MIRA Pharmaceuticals, Inc. reported continued pre-revenue operations with material financing and compensation activity. For the six months ended June 30, 2025 the company used approximately $2.4 million of cash in operations and recorded a net loss of approximately $3.3 million. At June 30, 2025 the company reported stockholders' equity of approximately $0.6 million and had 19,069,315 (or similar reported) shares outstanding.
The filing discloses recent equity financings including an at-the-market offering that generated gross proceeds of approximately $2.0 million, separate block sales and other share issuances producing net proceeds around $0.3 million and $151,023. Management highlights a $5.0 million capital infusion referenced as strengthening the balance sheet. Significant equity-based compensation was granted in 2025, including options and 500,000 RSUs, and approximately $1.4 million of stock compensation expense was recorded year-to-date. The company notes cash in excess of FDIC limits of about $0.5 million and discloses related-party license and warrant arrangements.
MIRA Pharmaceuticals announced on August 12, 2025 that a manuscript describing its lead candidate, Ketamir-2, was accepted for publication in Frontiers in Pharmacology. The paper reports that Ketamir-2 outperformed ketamine, pregabalin, or gabapentin in two validated preclinical models of neuropathic pain, restoring sensory function and reversing pain behaviors across genders and species. The company cites epidemiology that 7–10% of the population experiences neuropathic pain, equal to 36–51 million people in North America, and cites market estimates of $7.97 billion globally in 2024 growing to $16.79 billion by 2034.
MIRA states these findings support its plan to submit a Phase 2a clinical trial protocol to the FDA in Q4 2025 as a follow-up to its active IND, with the goal of initiating a neuropathic pain study by year-end. The company is also evaluating Ketamir-2 for other CNS indications including depression, anxiety, PTSD, and a topical formulation for localized pain.
MIRA Pharmaceuticals (MIRA) is asking shareholders to approve a merger with SKNY Pharmaceuticals at a virtual annual meeting on September 11, 2025. The transaction would exchange SKNY shares for MIRA common stock under an Exchange Ratio that is currently 1:1 based on valuations of SKNY at $30.5 million and MIRA at $30 million, and is structured so SKNY holders will own no more than 50% of the combined company. Approval requires a shareholder vote because the issuance will represent (or be convertible into) more than 20% of MIRA shares outstanding immediately prior to the Merger.
The proxy discloses key facts: 19,069,315 MIRA shares were outstanding as of the record date; SKNY must hold at least $5 million in cash or marketable securities at closing; Moore Financial Consulting provided valuation and a fairness opinion; and the DEA has determined Ketamir-2 and MIRA-55 will not be controlled substances. The Board unanimously recommends voting FOR all proposals but identifies material risks including SKNY’s limited operating history, lack of revenues, additional funding needs, license and royalty obligations, and director/shareholder conflicts of interest.