MIRA Pharmaceuticals, Inc. 8-K Filings

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 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. 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 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.

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 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 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.

MIRA Pharmaceuticals, Inc. disclosed that it filed a prospectus supplement to increase the maximum aggregate amount of common stock that may be sold under its at-the-market offering agreement with Rodman & Renshaw LLC by an additional $15,241,591.

The company previously sold $7,034,658 of common stock under this sales agreement using an earlier prospectus supplement. A legal opinion covering the additional common stock issuable under the program is included as an exhibit, supporting the continued use of this at-the-market facility.

MIRA Pharmaceuticals (NASDAQ: MIRA) reported it has initiated the multiple ascending dose (MAD) portion of its ongoing randomized, double-blind, placebo-controlled Phase 1 trial of its oral candidate, Ketamir-2, in healthy volunteers. The company also selected chemotherapy-induced peripheral neuropathy (CIPN) as the lead indication for planned Phase 2a evaluation.

This step follows completion of single ascending dose (SAD) dosing, where data reviewed to date showed no serious or dose-limiting adverse events and no clinically significant safety concerns. The MAD phase will test repeat daily oral dosing from 150 mg to 600 mg for five days to further assess safety, tolerability, and pharmacokinetics, with analyses to characterize absorption and half-life after unblinding.

MIRA highlighted preclinical data in neuropathic pain models in which Ketamir-2 outperformed ketamine, gabapentin, and pregabalin, and noted CIPN lacks FDA-approved therapies. The company believes Ketamir-2 may be considered for Fast Track designation.

MIRA Pharmaceuticals raised capital through its at-the-market facility by selling 1,751,000 shares of common stock in block trades to multiple institutional investors at an average price of $2.19 per share. The company reported gross proceeds of approximately $3,835,485 before fees and expenses.

The transaction, executed via Rodman & Renshaw on the StockBlock platform, was completed at a 66% premium to the prior day’s close and did not include any warrants. This was an issuance of new shares, providing cash to the company through its ATM program.

MIRA Pharmaceuticals reported new preclinical results showing its oral candidate Mira-55, a non-psychotropic marijuana analog, outperformed injected morphine in an established animal model of chronic inflammatory pain. The study found oral Mira-55 fully normalized pain thresholds and significantly reduced inflammation, while morphine delivered only partial, indirectly mediated swelling reduction.

This is the first time the program directly measured inflammation alongside pain. The data support a CB2 receptor–mediated anti-inflammatory mechanism and back the company’s plan to pursue an IND for chronic inflammatory pain. MIRA frames Mira-55 within the non-opioid pain space, noting a $70 billion market opportunity.

Key takeaways include pain normalization, inflammation reduction, and the potential convenience of oral administration versus injections. The company positions Mira-55’s dual approach—addressing both pain perception and inflammation—as a differentiated path in chronic inflammatory pain.

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 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.

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 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.