MIRA Pharmaceuticals, Inc. filings document the regulatory record for a Nasdaq-listed clinical-stage pharmaceutical company developing oral therapeutics for pain, neurologic, neuropsychiatric and metabolic disorders. The company’s Form 8-K reports describe material clinical and preclinical updates for Ketamir-2 and Mira-55, including study design, safety observations, pharmacokinetics, cannabinoid-related behavioral assays and indication-focused development disclosures.
The filing record also covers capital structure and governance matters, including common stock registered on The Nasdaq Capital Market, at-the-market equity offering activity, prospectus supplement disclosures, board and compensation actions, and the completed SKNY Pharmaceuticals acquisition that added SKNY-1 to the pipeline. These filings provide formal disclosure around MIRA’s development programs, financing arrangements, executive compensation, corporate actions and related risk-sensitive events.
MIRA Pharmaceuticals (MIRA) reported initial proof-of-concept findings from an exploratory pilot study of oral SKNY-1 in diet-induced obese mice. Compared with vehicle-treated controls, SKNY-1 was associated with statistically significant reductions in body weight and fat mass, without a statistically significant decrease in food consumption. At the Day 14 body-composition assessment, SKNY-1-treated mice did not show statistically significant lean-mass loss versus vehicle controls, while the semaglutide reference group did.
During the two-week period after treatment stopped, MIRA reported slow, limited weight regain for SKNY-1-treated mice and rapid, substantial rebound for semaglutide-treated mice; food consumption increased significantly versus vehicle controls in the semaglutide group, but not in the SKNY-1 groups. MIRA says its next study will measure energy expenditure and other metabolic parameters directly, alongside continued longer-term preclinical and IND-enabling work.
MIRA Pharmaceuticals reported results from a 21-day preclinical study in which once-daily oral MIRA-55 reduced mechanical and thermal pain hypersensitivity in rats compared with vehicle (p < 0.001). At higher doses, its pain-relieving effects were comparable in magnitude to celecoxib; effects continued through the study without evidence of tolerance. MIRA-55 also reduced inflammation-associated swelling, and no adverse clinical signs were observed.
The study included 72 male and female rats. MIRA Pharmaceuticals plans to submit an Investigational New Drug application in the first quarter of 2027, subject to completing remaining required preclinical and regulatory activities. MIRA-55 remains in preclinical development, and its safety and efficacy in humans have not been established.
MIRA Pharmaceuticals, Inc. (MIRA) reported that its Phase 2a clinical program for Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) has advanced following U.S. FDA review of the study protocol. The updated Phase 2a protocol has been submitted for Institutional Review Board (IRB) review at a leading cancer research institution, moving the trial toward site initiation, which the company is targeting for the first quarter of 2027, subject to completion of IRB review and routine site-activation steps.
The randomized, double-blind, placebo-controlled, three-period crossover study will test oral Ketamir-2 at 300 mg and 600 mg versus placebo over three seven-day treatment periods separated by 13-day washouts, generating initial efficacy, dose-response, and expanded safety data in patients with persistent CIPN. The program builds on a completed Phase 1 study in healthy volunteers where Ketamir-2 showed a favorable safety, tolerability, and pharmacokinetic profile, with no serious adverse events or dose-limiting toxicities, and proceeds under an active IND. MIRA highlights CIPN as a significant unmet need, notes that Ketamir-2 is not classified as a controlled substance, and plans scientific presentations and business development activities in Japan in October 2026.
MIRA Pharmaceuticals, Inc. held its 2026 Annual Meeting of Stockholders on September 11, 2026, with 26,499,076 common shares present in person or by proxy out of 42,022,087 outstanding, representing a 63.06% quorum. Stockholders elected all five nominated directors to serve until the next annual meeting and until their successors are elected and qualified. Stockholders also approved the ratification of Salberg & Company, P.A. as independent registered public accounting firm for the year ending December 31, 2026, and approved a proposal allowing adjournment of the meeting, if necessary, to solicit additional proxies for the director and auditor proposals.
MIRA Pharmaceuticals, Inc. (MIRA) reported that 7-day dose-range finding toxicology and toxicokinetic studies of its investigational oral, non-opioid inflammatory pain candidate MIRA-55 in rats and dogs have been completed with positive results that characterize tolerability, toxicity and systemic exposure across species. Rats were identified as more sensitive, while dogs showed greater tolerance at the dose levels studied, and the data achieved the intended dose-range finding objective to guide dose selection for the next phase of the IND-enabling program. MIRA plans GLP-compliant toxicology studies and notes it has advanced manufacturing scale-up and formulation work for MIRA-55. Subject to successful completion of remaining IND-enabling studies, regulatory requirements and other development considerations, the company is targeting submission of an IND application for MIRA-55 to the FDA in the first quarter of 2027. MIRA highlights prior preclinical data showing analgesic and anti-inflammatory activity without THC-like CNS effects and states that the DEA has determined MIRA-55, Ketamir-2 and SKNY-1 are not classified as controlled substances.
MIRA Pharmaceuticals, Inc. reported no revenues for the three and six months ended June 30, 2026 and remains a clinical-stage company. The net loss was $1.2 million for the quarter and $2.4 million year-to-date, compared with $1.5 million and $3.3 million in the prior-year periods, driven by sharply lower stock-based compensation and other general and administrative costs, partially offset by higher research and development spending.
Research and development expenses rose to $0.7 million for the quarter and $1.2 million year-to-date as the company advanced Ketamir-2 toward a planned Phase 2a CIPN trial in 2027 and progressed MIRA-55 and SKNY-1 through IND-enabling work. Cash was $3.6 million at June 30, 2026, with stockholders’ equity of $8.2 million and a related-party equity investment in Telomir Pharmaceuticals of $4.5 million.
Management expects existing cash to fund operations into at least the first quarter of 2027 but states that cash is insufficient to support operations for 12 months from issuance of these financial statements, raising substantial doubt about the company’s ability to continue as a going concern. On July 27, 2026, Nasdaq notified MIRA that its share price no longer meets the $1.00 minimum bid requirement, and the company is working to regain compliance within the allowed cure period.
MIRA Pharmaceuticals, Inc. reported new preclinical data for SKNY-1, its investigational oral obesity candidate designed to promote weight loss while preserving lean body mass. In a 7-day repeated-dose study in male and female Beagle dogs, SKNY-1 showed rapid oral absorption and dose-dependent systemic exposure across the evaluated dose range, with comparable plasma concentrations between sexes.
The company states that the toxicokinetic results demonstrate dose-dependent response and systemic accumulation with repeated dosing, providing confidence in dose selection for a planned GLP toxicology program. MIRA believes these findings de-risk dose selection and support advancement toward GLP-compliant toxicology studies required for IND-enabling development, while noting that additional preclinical efficacy and safety work is needed as it advances SKNY-1 and its broader pipeline, which includes MIRA-55 and Ketamir-2.
Mira Pharmaceuticals, Inc. received a notice from Nasdaq on July 27, 2026 that its common stock no longer satisfies the Nasdaq Capital Market Minimum Bid Price Requirement, because the closing bid was below $1 per share for 30 consecutive business days ended July 24, 2026.
The stock continues to trade under the symbol MIRA while the company has 180 calendar days, until January 25, 2027, to regain compliance by maintaining a closing bid of at least $1 for at least ten consecutive business days. A second 180‑day cure period may be available if other listing standards are met and the company plans a cure, potentially including a reverse stock split. If compliance is not restored, the shares may be delisted, though the company could appeal any delisting determination to a Nasdaq Hearings Panel. Mira Pharmaceuticals plans to monitor its share price and consider options to address the deficiency, but there is no assurance compliance will be regained.
MIRA Pharmaceuticals, Inc. plans a virtual annual shareholders meeting on September 11, 2026, with holders of common stock at the July 21, 2026 record date (when 42,022,087 shares were outstanding) entitled to vote. Shareholders will vote on electing five directors, ratifying Salberg & Company, P.A. as independent auditor for 2026, and approving a possible adjournment to solicit additional proxies. The Board recommends voting FOR all three proposals.
The Board reports that four of five directors are independent under Nasdaq Listing Rules and oversees audit, compensation, and nominating/governance committees. In 2025, CEO Erez Aminov received total compensation of $5,304,174, including salary, cash bonuses tied to capital-raising and strategic goals, vested RSUs linked to market-cap milestones, and a significant stock option grant. As of the beneficial ownership date, Aminov beneficially owns 9,196,741 shares, or 19.34% of outstanding stock; all directors and officers as a group hold 19.89%. A related-party financing from the Bay Shore Trust provided up to $5,000,000 of credit, part of which converted into equity, along with a warrant for up to 1,000,000 shares at $5.00 per share, and the note has been repaid. The company also highlights its 2022 Omnibus Incentive Plan with millions of options and RSUs outstanding and a remaining share reserve for future awards.
MIRA Pharmaceuticals, Inc. reported positive preclinical results for optimized oral formulations of MIRA-55, its non-opioid drug candidate for chronic inflammatory pain. After testing multiple oral formulations, the company selected a lead version that showed favorable oral bioavailability, sustained systemic exposure, and reproducible distribution into both brain and liver tissue following oral administration, supported by an intravenous reference arm to characterize absolute oral bioavailability. These pharmacokinetic findings, together with earlier preclinical data showing oral MIRA-55 normalized pain and reduced inflammation versus injected morphine and exhibited a differentiated profile relative to THC, are described as strengthening the development profile of MIRA-55 as a differentiated oral therapy for chronic inflammatory pain.