Business Context and Reporting Period
MIRA Pharmaceuticals, Inc. (MIRA), an emerging growth company incorporated in Florida, filed this Form 8-K on September 22, 2025. The filing reports Item 8.01 Other Events, specifically the announcement of favorable topline results from the single ascending dose (SAD) portion of a Phase 1 clinical trial for its investigational drug, oral Ketamir-2.
Key Financial Metrics
This filing is a current report 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
The filing details the completion of the SAD study involving 32 healthy adult participants across four escalating oral dose cohorts (50 mg to 600 mg). Key findings include:
- Safety and Tolerability: Ketamir-2 was safe and well tolerated at all dose levels. No severe, clinically significant adverse effects, dose-limiting toxicities, or serious adverse events were observed. Treatment-emergent adverse events were transient and resolved without intervention.
- Pharmacokinetics (PK): The drug demonstrated dose-proportional increases in exposure (Cmax and AUC). Median time to maximum plasma concentration (Tmax) was 1–2 hours. The terminal half-life ranged from 2 to 5 hours, while the primary active metabolite, nor-Ketamir, had a half-life of 6.5 to 8.5 hours.
- Regulatory Status: The U.S. Drug Enforcement Administration (DEA) concluded that Ketamir-2 is not a controlled substance or listed chemical under the Controlled Substances Act.
Outlook and Next Steps
Based on the favorable SAD data, MIRA is initiating the multiple ascending dose (MAD) portion of the Phase 1 study in healthy volunteers. Following the MAD study, the Company plans to conduct a Phase 2a trial in patients with neuropathic pain. The PK profile supports the potential for once-daily dosing.
Investor Verification Checklist
- Verify the timeline and enrollment criteria for the upcoming Multiple Ascending Dose (MAD) study.
- Confirm the specific endpoints and patient population for the planned Phase 2a neuropathic pain trial.
- Review the Company's cash runway and capital requirements to fund the transition from Phase 1 to Phase 2 trials, as this filing contains no financial data.
- Monitor for any updates regarding the formal regulatory pathway for Ketamir-2 following the DEA's non-controlled substance determination.