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. reported new preclinical results for its oral drug candidate SKNY-1, being developed for obesity and addiction-related disorders. The optimized oral formulation showed favorable oral bioavailability, reproducible systemic exposure, robust brain penetration, and substantial liver exposure, supporting the potential for convenient once-daily dosing.
The company said these pharmacokinetic findings strengthen SKNY-1’s development profile and complement earlier preclinical data showing reduced body weight, preserved lean mass, improved metabolic measures, reduced compulsive feeding and nicotine-seeking behaviors, and no anxiety-related behavioral effects despite cannabinoid receptor activity. The details were shared via a press release furnished as an exhibit.
MIRA Pharmaceuticals filed an 8-K to share new preclinical data on Mira-55, its cannabinoid analog in development for chronic inflammatory pain. In animal studies comparing Mira-55 with THC and the CB1 blocker rimonabant, Mira-55 did not show the full THC-like central nervous system pattern.
Mira-55 caused only a modest drop in body temperature, with no THC-like effects on movement or muscle rigidity, and this temperature change was not reversed by rimonabant, suggesting a mechanism distinct from classical CB1 agonism. It also reduced anxiety-like behavior, while THC did not and rimonabant increased anxiety-like behavior.
The company states that these findings, together with data reported in March 2026, support a differentiated pharmacological and mechanistic profile for Mira-55 relative to THC and support continued advancement toward an IND-enabling program for chronic inflammatory pain. The results remain preclinical and will require additional mechanistic and translational studies.
MIRA Pharmaceuticals submitted a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration for Ketamir-2, its oral NMDA receptor modulator, to treat chemotherapy-induced peripheral neuropathy (CIPN). The company received an FDA acknowledgment confirming acceptance of the Protocol Mira-002 submission.
The planned study is a randomized, double-blind, placebo-controlled, three-period crossover trial at a leading U.S. cancer center, testing 300 mg and 600 mg oral Ketamir-2 versus placebo in patients with moderate-to-severe persistent CIPN. It will focus on safety, tolerability, and dose-response effects on neuropathic pain, building on a prior Phase 1 study in 56 healthy volunteers where no serious adverse events or dose-limiting toxicities were observed.
MIRA PHARMACEUTICALS, INC. director Matthew Paul Del Giudice reported receiving a grant of stock options. He was awarded 50,000 stock options to buy common stock at an exercise price of $0.94 per share, expiring on June 12, 2036.
The options were granted under the company’s 2022 Omnibus Incentive Plan. According to the vesting schedule, 50% of the options vest six months after the June 12, 2026 grant date, and the remaining half vests on the one-year anniversary of that date.
MIRA PHARMACEUTICALS, INC. director Matthew Pratt received a grant of stock options as equity compensation. He was awarded 50,000 stock options for common stock at an exercise price of $0.94 per share, equal to the closing price on June 12, 2026.
The options were granted under the company’s 2022 Omnibus Incentive Plan. Half of the options vest six months after the grant date and the remaining half vest one year after the grant date. Following this award, the filing shows Pratt holding 50,000 stock options directly, which expire on June 12, 2036.
MIRA PHARMACEUTICALS, INC. director Edward Clouston MacPherson received a grant of 50,000 stock options for common stock. The options have an exercise price of $0.94 per share and expire on June 12, 2036.
According to the grant terms, 50% of the options vest on the six-month anniversary of the June 12, 2026 grant date, and the remaining 50% vest on the one-year anniversary. Following this award, he holds 50,000 stock options directly.
MIRA PHARMACEUTICALS, INC. reported that director Shekhat Denil Nanji received a grant of stock options to buy 50,000 shares of common stock at an exercise price of $0.94 per share on June 12, 2026. The options were granted under the company’s 2022 Omnibus Incentive Plan as compensation, not as an open‑market purchase.
According to the grant terms, 50% of the options vest six months after the grant date and the remaining 50% vest one year after the grant date. The options expire on June 12, 2036 if not exercised. After this award, Nanji holds 50,000 stock options directly.
MIRA PHARMACEUTICALS, INC. filed an initial ownership report (Form 3) for Andriy Mushak, who serves as Chief Financial Officer. The filing does not list any transactions or holdings, functioning primarily as a baseline disclosure of his status as an officer subject to insider reporting rules.
Mira Pharmaceuticals is changing its finance leadership, with Chief Financial Officer Alan Weichselbaum ending his service effective June 6, 2026. The company states his departure is not due to any disagreement over operations, policies, or practices.
On June 2, 2026, the board appointed Andriy Mushak as fractional Chief Financial Officer, effective June 6, 2026. Mushak, a 43-year-old Certified Public Accountant with over 20 years of SEC reporting and audit experience, will provide services through LMAM Consulting Group, LLC under a consulting agreement, for which he will be paid $6,000 per month. The filing notes no relevant family relationships or related-party transactions requiring disclosure.
MIRA Pharmaceuticals entered an Amended and Restated Exclusive License Agreement with MIRALOGX LLC, securing worldwide exclusive rights to its MIRA-55 and SKNY-1 programs. The agreement grants global rights to develop, manufacture, commercialize, sublicense and enforce intellectual property for these assets, consolidating ownership across MIRA’s core pipeline.
The company states the amendment does not materially change previously disclosed core economic terms of the license. MIRA-55 is an oral investigational cannabinoid analog for chronic inflammatory pain, with the DEA confirming it is not classified as a controlled substance. SKNY-1 is an oral investigational candidate targeting obesity and addiction-related disorders with preclinical evidence of dose-dependent weight and lipid effects.
Management highlights that MIRA now controls global development and commercialization rights for Ketamir-2, MIRA-55 and SKNY-1, aiming for Phase 2a advancement of Ketamir-2 and IND filings for MIRA-55 and SKNY-1 under a unified worldwide rights structure.