Welcome to our dedicated page for Mira Pharma SEC filings (Ticker: MIRA), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) SEC filings page provides direct access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. These documents detail material events, clinical and regulatory milestones, capital-raising activities, and corporate governance decisions for this Florida-incorporated, Miami-based clinical-stage biopharmaceutical company.
Through MIRA’s Forms 8-K, users can review key developments in the Ketamir-2 program, including FDA clearance of the Investigational New Drug (IND) application for neuropathic pain, favorable topline data from the single ascending dose Phase 1 study, and initiation of the multiple ascending dose portion with chemotherapy-induced peripheral neuropathy selected as the lead Phase 2a indication. Filings also summarize preclinical evidence, DEA determinations that Ketamir-2 is not a controlled substance, and its selective NMDA receptor targeting profile.
Filings further describe MIRA-55, an oral THC or marijuana analog with preclinical results in inflammatory and nociceptive pain, and the company’s intention to pursue an IND for chronic inflammatory pain. The completed acquisition of SKNY Pharmaceuticals, Inc. and addition of SKNY-1 for obesity and smoking cessation are documented in a Form 8-K, which also notes SKNY’s contribution of marketable securities and the resulting multi-program pipeline.
Investors can also examine capital markets and governance disclosures, such as at-the-market equity offerings, Nasdaq listing compliance updates, equity incentive plan amendments, shareholder voting results, and executive compensation and incentive awards tied to development, acquisition, and market capitalization milestones. Stock Titan’s interface surfaces these filings alongside AI-powered summaries that highlight the main points of lengthy documents, helping readers quickly understand clinical updates, transaction terms, and other material information contained in MIRA’s 8-Ks and related filings.
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.
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) filed its Q3 2025 report, highlighting a clinical-stage pipeline and a small acquisition that reshaped its balance sheet. The company closed the related‑party acquisition of SKNY Pharmaceuticals on September 29, issuing 19,755,738 shares and receiving 3,521,127 Telomir (TELO) shares recorded as short‑term investments.
Financials: Cash was $2.64 million as of September 30, 2025, with short‑term investments of $4.89 million. Stockholders’ equity rose to $7.55 million, up from $2.20 million at year‑end. Net loss was $1.14 million in Q3 and $4.46 million for the nine months. A $21.56 million deemed dividend was recorded from the SKNY share issuance. Operating cash outflow was $3.53 million year‑to‑date.
Capital and listing: The company sold 2.06 million shares via ATM during Q3 (net $2.71 million) and, subsequent to quarter‑end, raised about $3.7 million more through the ATM and received $0.59 million from CEO option exercises. MIRA regained compliance with Nasdaq’s equity rule; 41,876,087 shares were outstanding as of November 11, 2025. Going concern: The filing states substantial doubt about the ability to continue as a going concern without additional funding.
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.