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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.
MIRA Pharmaceuticals (MIRA) is asking shareholders to approve a merger with SKNY Pharmaceuticals at a virtual annual meeting on September 11, 2025. The transaction would exchange SKNY shares for MIRA common stock under an Exchange Ratio that is currently 1:1 based on valuations of SKNY at $30.5 million and MIRA at $30 million, and is structured so SKNY holders will own no more than 50% of the combined company. Approval requires a shareholder vote because the issuance will represent (or be convertible into) more than 20% of MIRA shares outstanding immediately prior to the Merger.
The proxy discloses key facts: 19,069,315 MIRA shares were outstanding as of the record date; SKNY must hold at least $5 million in cash or marketable securities at closing; Moore Financial Consulting provided valuation and a fairness opinion; and the DEA has determined Ketamir-2 and MIRA-55 will not be controlled substances. The Board unanimously recommends voting FOR all proposals but identifies material risks including SKNY’s limited operating history, lack of revenues, additional funding needs, license and royalty obligations, and director/shareholder conflicts of interest.