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, Inc. entered into an amendment to its exclusive Ketamir-2 license with MIRALOGX, expanding its licensed territory from North America to all countries where patent rights exist. The amendment also adds international patent filings across major markets including the United States, Europe, China, Japan, Canada, Australia, India, Israel, Mexico, and South Korea.
The company describes this expanded intellectual property coverage as supporting its global development and commercialization strategy for Ketamir-2, which is advancing toward planned Phase 2a testing in chemotherapy-induced peripheral neuropathy. The amendment does not materially change the core economic terms of the original license, such as royalties and other financial obligations.
MIRA Pharmaceuticals, Inc. reported a first-quarter 2026 net loss of $1,150,152 with no revenue, reflecting its clinical-stage focus on Ketamir-2, MIRA-55, and SKNY-1. Research and development expenses were $524,781 and general and administrative expenses were $578,698, both key drivers of the loss.
Cash was $4,815,031 and total assets were $9,463,736 as of March 31, 2026, with stockholders’ equity of $9,348,975 and minimal liabilities. The company recorded a $91,582 loss from its equity method investment in Telomir Pharmaceuticals. It used $1,201,283 of cash in operating activities in the quarter.
Management expects existing cash to fund operations into at least the first quarter of 2027, but states that current cash and cash equivalents are insufficient to support operations for 12 months from the financial statement issuance date. This, along with ongoing losses and funding needs for future trials, raises substantial doubt about MIRA’s ability to continue as a going concern absent additional financing.
MIRA Pharmaceuticals reported positive unblinded results from a completed Phase 1 trial of Ketamir-2, its selective oral NMDA receptor modulator. In this randomized, double-blind, placebo-controlled study, 57 healthy volunteers across seven cohorts completed treatment with no withdrawals, no serious adverse events and no dose-limiting toxicities. Most side effects were mild, and adverse events were reported more often in the placebo group than in Ketamir-2 recipients.
Pharmacokinetic data showed rapid oral absorption and dose-proportional Cmax, with Ketamir-2 half-life ranging from about 2.5 to 7 hours and its active metabolite nor-Ketamir-2 from about 7 to 9 hours, suggesting potential for once-daily dosing after further evaluation. The company is preparing a Phase 2a protocol under its active IND to test Ketamir-2 in chemotherapy-induced peripheral neuropathy and noted that the DEA determined Ketamir-2 is not a controlled substance.
MIRA Pharmaceuticals filed an 8-K to highlight new preclinical data on SKNY-1, its investigational oral drug candidate for obesity and nicotine addiction. A peer-reviewed manuscript in the International Journal of Molecular Sciences describes SKNY-1’s pharmacology and effects in an MC4R-deficient zebrafish obesity model.
The study reports that oral SKNY-1 produced dose-dependent weight loss over six days, including about a 30% reduction in body weight from baseline in the higher-dose group, with no significant reduction in whole-body density. It also details improvements in cholesterol measures, liver triglycerides, appetite-related gene expression, and compulsive feeding and nicotine-seeking behaviors.
The company emphasizes these findings are from zebrafish and in vitro systems only. SKNY-1 is not FDA approved, and its safety and efficacy in humans are not established.
MIRA PHARMACEUTICALS, INC. reported an equity compensation award to its Chief Executive Officer, Erez Aminov. On March 30, 2026, he was granted 83,500 restricted stock units (RSUs), each representing the right to receive one share of common stock.
The footnotes state that all of these RSUs vested on the grant date, meaning the award became fully earned immediately. Following this grant, Aminov held 83,500 RSUs directly, with an expiration date of March 30, 2036. This is a compensation-related acquisition, not an open-market stock purchase or sale.
MIRA Pharmaceuticals, Inc. reports its annual results as a clinical-stage biotech with no revenue and a substantial accumulated deficit of $39.6 million as of December 31, 2025. The company warns of substantial doubt about its ability to continue as a going concern beyond the third quarter of 2025 without new financing.
MIRA is advancing three oral drug candidates: Ketamir-2 for neuropathic pain, MIRA-55 for inflammatory and CNS-related pain, and SKNY-1 for obesity and nicotine dependence. Ketamir-2 has completed Phase 1 dosing with no serious adverse events reported to date, and a Phase 2a trial in chemotherapy-induced peripheral neuropathy is planned for 2026, subject to regulatory review and resources.
The DEA has concluded that Ketamir-2, MIRA-55, and SKNY-1 are not currently controlled substances, which may ease development. However, operations rely heavily on external licensing (notably from MIRALOGX), at-the-market equity sales, and a very small team of two part-time employees and consultants, underscoring execution and financing risk.
MIRA Pharmaceuticals reported new preclinical results for its candidate Mira-55, showing no THC- or rimonabant-associated central nervous system side effects in established behavioral assays at oral doses of 10, 30, and 100 mg/kg.
Mira-55 did not produce cannabinoid-like psychogenic, sedative, cataleptic, motor, or anxiogenic effects and showed reduced anxiety-like behavior in the Elevated Plus Maze, while rimonabant produced anxiety-like changes. These findings build on earlier data where Mira-55 delivered morphine-comparable analgesia in a validated inflammatory pain model without opioid-related risks. The company is advancing Mira-55 toward an Investigational New Drug submission for inflammatory pain and continuing additional preclinical studies.
MIRA Pharmaceuticals reported completing dosing in its Phase 1 trial of Ketamir-2, a proprietary selective oral NMDA receptor modulator, in 56 healthy volunteers. The randomized, double-blind, placebo-controlled study included single and multiple ascending dose cohorts up to 600 mg.
Based on safety data reviewed to date, no serious adverse events, dose-limiting toxicities, or clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed. Final pharmacokinetic and safety analyses are underway.
The company intends to submit a Phase 2a proof-of-concept study to the FDA in the first half of 2026 for patients with moderate to severe chemotherapy-induced peripheral neuropathy, a condition with no FDA-approved therapies specifically indicated for it.
MIRA Pharmaceuticals, Inc. provides a clinical development update on its lead oral NMDA receptor antagonist, Ketamir-2, and its preclinical pipeline. The company has begun dosing the final cohort in its Phase 1 multiple ascending dose trial; 50 healthy volunteers have already been dosed, with 6 subjects remaining. It expects to complete the Phase 1 program by the end of the first quarter of 2026 and plans a Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy, targeting initiation in the second quarter of 2026 after regulatory review. MIRA also aims to seek FDA Fast Track designation for Ketamir-2, will discuss partnering at a March 2026 summit, and present Phase 1 data at the April 2026 AACR meeting. Preclinical programs SKNY-1 for weight loss and nicotine addiction and MIRA-55 for inflammatory pain are undergoing CMC optimization, with a goal of reaching IND-enabling status by year-end 2026.
MIRA Pharmaceuticals is updating compensation for its Chief Executive Officer, Erez Aminov, after what its board describes as significant progress in 2025, including clinical advances, capital-raising, and a strategic acquisition.
The CEO will receive a short-term incentive payout of $242,258, with an additional $80,753 only payable if the company completes its ongoing Phase 1 clinical study. In connection with negotiating and completing the acquisition of SKNY Pharmaceutical, Inc., the board approved a $915,000 transaction advisory award, deliverable in cash, equity, or a mix under the 2024 Omnibus Equity Incentive Plan, with any resulting awards vesting immediately. The board also confirmed achievement of the first market capitalization milestone under the CEO’s long-term plan and approved 62,500 performance share units, which will vest immediately.