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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 (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.
Denil Shekhat, a director of MIRA PHARMACEUTICALS, INC. (MIRA), reported on Form 4 that on 10/01/2025 she acquired 22,378 restricted shares of the issuer's common stock at a price of $1.35 per share. The filing shows the shares were issued as compensation in connection with the issuer's acquisition of SKNY Pharmaceuticals, Inc. Following the transaction the reporting person beneficially owns 22,378 shares in a direct ownership form. The Form 4 was signed on 10/03/2025 and was filed by one reporting person.
Erez Aminov, who is listed as both Chief Executive Officer and a Director of Mira Pharmaceuticals, Inc. (MIRA), reported an acquisition of 2,685,456 restricted shares of the issuer's common stock on 10/01/2025. The filing shows 3,530,156 shares beneficially owned following the transaction, held in a direct ownership form. The restricted shares were issued as compensation to Mira in connection with the company’s acquisition of SKNY Pharmaceuticals, Inc., per the explanatory note. The Form 4 is signed by Mr. Aminov on 10/03/2025.
MIRA Pharmaceuticals filed a Form 3 reporting initial beneficial ownership following a transaction dated 09/29/2025 involving Telomir Pharmaceuticals, Inc. (TELO). The filing shows the reporting person is identified as a director and discloses ownership of 3,521,127 shares of the issuer's common stock, no par value. The shares were acquired in connection with the reporting person’s acquisition of SKNY Pharmaceuticals, Inc. The Form 3 is signed by Erez Aminov, CEO on 10/03/2025.
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 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' CEO and director received repriced, fully vested stock options totaling 300,000 shares. The company’s board lowered the exercise price on two existing option grants—from $5.00 and $6.50—to $1.38, while leaving all other terms unchanged. Each repriced grant covers 150,000 options and remains exercisable into common stock with specified expiration dates in 2033. The disclosure shows the holdings are held directly by the reporting person and that the repricing was approved by the board, which materially changes the economic value of the previously issued awards.
MIRA Pharmaceuticals' CEO and director received repriced, fully vested stock options totaling 300,000 shares. The company’s board lowered the exercise price on two existing option grants—from $5.00 and $6.50—to $1.38, while leaving all other terms unchanged. Each repriced grant covers 150,000 options and remains exercisable into common stock with specified expiration dates in 2033. The disclosure shows the holdings are held directly by the reporting person and that the repricing was approved by the board, which materially changes the economic value of the previously issued awards.
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.