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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.
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 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 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 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.