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 filed a Form 3 reporting initial beneficial ownership following a transaction dated 09/29/2025 involving Telomir Pharmaceuticals, Inc. (TELO). The filing shows the reporting person is identified as a director and discloses ownership of 3,521,127 shares of the issuer's common stock, no par value. The shares were acquired in connection with the reporting person’s acquisition of SKNY Pharmaceuticals, Inc. The Form 3 is signed by Erez Aminov, CEO on 10/03/2025.
MIRA Pharmaceuticals reported that it has completed the acquisition of SKNY Pharmaceuticals, buying 100% of SKNY in a stock-for-stock deal. SKNY shareholders received restricted shares of MIRA common stock based on an exchange ratio derived from independent third-party valuations of both companies. As part of the closing conditions, SKNY contributed $5 million in marketable securities to MIRA, which management says strengthens the company’s balance sheet.
The acquisition broadens MIRA’s pipeline with several programs, including Ketamir-2 for neuropathic pain with additional preclinical activity in depression and PTSD, MIRA-55 for inflammatory pain, cognitive decline and anxiety, and SKNY-1 targeting obesity and smoking cessation. Management describes the transaction as a transformational step in its growth strategy.
MIRA also disclosed that Nasdaq had previously notified it of non-compliance with the $2.5 million stockholders’ equity requirement, but Nasdaq granted an extension to October 6, 2025. Following at-the-market stock sales and the SKNY merger, the company believes it now meets this equity standard, although Nasdaq will continue to monitor compliance and could move toward delisting if future reports do not show continued compliance.
MIRA Pharmaceuticals reported favorable topline results from the single ascending dose portion of its Phase 1 trial of oral Ketamir-2 in 32 healthy volunteers across four dose levels from 50 mg to 600 mg. The drug was generally safe and well tolerated, with no dose-limiting toxicities, serious adverse events, or clinically significant central nervous system effects reported, and any treatment-emergent side effects were transient.
Pharmacokinetic data showed dose-proportional exposure, a time to maximum concentration of 1–2 hours, and a terminal half-life of 2–5 hours, while the main active metabolite, nor-Ketamir, had a half-life of 6.5 to 8.5 hours. These findings support once-daily dosing and allow the company to start a multiple ascending dose Phase 1 study in healthy volunteers, followed by a planned Phase 2a trial in neuropathic pain. The U.S. Drug Enforcement Administration also concluded Ketamir-2 is not a controlled substance or listed chemical.
MIRA Pharmaceuticals' CEO and director received repriced, fully vested stock options totaling 300,000 shares. The company’s board lowered the exercise price on two existing option grants—from $5.00 and $6.50—to $1.38, while leaving all other terms unchanged. Each repriced grant covers 150,000 options and remains exercisable into common stock with specified expiration dates in 2033. The disclosure shows the holdings are held directly by the reporting person and that the repricing was approved by the board, which materially changes the economic value of the previously issued awards.
MIRA Pharmaceuticals reported positive preclinical results for its oral drug candidate Ketamir-2 in an animal model of post-traumatic stress disorder (PTSD). In a proof-of-concept study using the Single Prolonged Stress model in rats, repeated predator exposure produced persistent PTSD-like behaviors such as increased despair, immobility, and avoidance of coping. After five days of once-daily oral Ketamir-2, these behaviors shifted back toward levels seen in non-stressed animals, suggesting a normalization of stress-related responses.
The company notes that this initial validation supports the study design and that a larger PTSD study is ongoing. Ketamir-2 is already in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile so far. The compound is a proprietary, orally bioavailable NMDA receptor modulator designed to retain ketamine-like therapeutic effects while reducing dissociative and other central nervous system side effects. A U.S. Drug Enforcement Administration scientific review concluded Ketamir-2 is not a controlled substance, and earlier preclinical work showed superior efficacy versus ketamine, pregabalin, and gabapentin in neuropathic pain models.
MIRA Pharmaceuticals, Inc. reported that shareholders approved several key items at the 2025 Annual Meeting. Stockholders ratified the acquisition of SKNY Pharmaceuticals, Inc., a deal in which SKNY will contribute $5 million in cash or assets at closing. Independent valuation work by Moore Financial Consulting assigned enterprise values of about $30.5 million for SKNY and $30 million for MIRA, supporting a combined enterprise value of more than $60 million.
Shareholders also approved amendments to MIRA’s 2022 Omnibus Incentive Plan, increasing the shares reserved under the plan from 5,000,000 to 8,000,000 and permitting repricing of options and stock appreciation rights. All nominated directors were elected and the auditor, Salberg & Company, P.A., was ratified. A quorum was reached with 10,588,211 shares represented, about 55.52% of the 19,069,315 shares of common stock outstanding as of the record date.
Erez Aminov, Chief Executive Officer and Director of MIRA Pharmaceuticals, Inc. (MIRA), reported on Form 4 that 62,500 restricted stock units (RSUs) vested and were issued to him on 08/29/2025 at a reported price of $1.37 per share. The RSUs were granted under the company's 2022 Omnibus Incentive Plan and vesting followed achievement of specified milestones under the Reporting Person's Executive Incentive Compensation Plan.
Following the issuance, Aminov beneficially owned 844,700 shares according to the filing. The Form 4 was signed on 09/03/2025.
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.