Business Context and Reporting Period
Mira Pharmaceuticals, Inc. (MIRA), an emerging growth company incorporated in Florida, filed this Form 8-K on May 13, 2026. The filing discloses positive unblinded results from a completed Phase 1 clinical trial for Ketamir-2, a proprietary selective oral NMDA receptor modulator.
Key Financial Metrics
This filing is a Regulation FD disclosure regarding clinical trial results and does not contain financial statements. Consequently, data regarding revenue, profit, cash flow, margins, debt, and liquidity are not provided in this document.
Material Changes and Clinical Results
- Study Design: A randomized, double-blind, placebo-controlled Phase 1 study involving 57 healthy volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.
- Safety Profile: No serious adverse events or dose-limiting toxicities were reported. All participants completed the study with no withdrawals. Adverse events were predominantly mild, with a higher incidence in the placebo group than in the Ketamir-2-treated group.
- Pharmacokinetics: The drug demonstrated rapid oral absorption and dose-proportional Cmax. The half-life of Ketamir-2 ranged from 2.5 to 7 hours, while the active metabolite (nor-Ketamir-2) ranged from 7 to 9 hours, potentially supporting once-daily administration.
- Regulatory Status: The U.S. Drug Enforcement Administration (DEA) determined that Ketamir-2 is not classified as a controlled substance.
Outlook and Management Commentary
Management is advancing preparations to submit a Phase 2a clinical protocol to the U.S. Food and Drug Administration (FDA) under an active Investigational New Drug (IND) application. The planned evaluation targets chemotherapy-induced peripheral neuropathy (CIPN). Preclinical models indicated Ketamir-2 demonstrated superior efficacy compared to ketamine, pregabalin, and gabapentin.
Investor Verification Checklist
- Verify the timeline for the submission of the Phase 2a protocol to the FDA.
- Confirm the specific endpoints and design of the upcoming Phase 2a trial for CIPN.
- Review the company's cash runway and capital requirements to fund the Phase 2a trial, as this filing contains no financial data.
- Monitor for any updates on the regulatory status of Ketamir-2 beyond the initial DEA determination.