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MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a $21 million market cap biotech company, announced Thursday that its proprietary marijuana analog, Mira-55, demonstrated morphine-comparable pain relief in a preclinical model of inflammatory pain without causing local inflammation. The company’s stock has shown remarkable momentum, delivering a 115% return over the past year, according to InvestingPro data.
The company reported that Mira-55, engineered to selectively activate CB2 cannabinoid receptors while minimizing CB1 receptor activation, reduced pain sensitivity approximately threefold in the formalin model, a standard preclinical method for studying inflammatory pain. While the company is not yet profitable, its strong liquidity position with a current ratio of 12.86 provides substantial runway for its development programs.
According to the preclinical data, Mira-55’s analgesic effect matched that of morphine, the opioid comparator used in the study. The company noted that no sedation or inflammatory swelling was observed with Mira-55 treatment.
The U.S. Drug Enforcement Administration has determined that Mira-55 is not classified as a controlled substance, which the company says supports the compound’s long-term clinical and commercial viability.
"Mira-55 offers the pain-relieving potential of cannabinoids without the liabilities traditionally seen in THC-based drugs," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, according to the press release.
The company is positioning Mira-55 as complementary to Ketamir-2, its clinical-stage NMDA receptor antagonist advancing through Phase 1 development for neuropathic pain.
MIRA also reported progress on its previously disclosed acquisition of SKNY Pharmaceuticals, stating that the U.S. Securities and Exchange Commission completed its review of the merger proxy without comments.
The company is advancing Mira-55 toward an Investigational New Drug submission, with ongoing activities supporting future clinical development in inflammatory pain. Analysts maintain a bullish outlook with a price target of $17.75, suggesting significant upside potential. InvestingPro subscribers have access to additional key metrics and 7 more exclusive ProTips that could help evaluate MIRA’s investment potential.
In other recent news, Mira Pharmaceuticals announced that its proprietary drug candidate, Mira-55, demonstrated pain relief comparable to morphine in a preclinical animal model without causing inflammation or sedative effects. The U.S. Drug Enforcement Administration confirmed that Mira-55 is not classified as a controlled substance, facilitating its clinical development. The company is also advancing Mira-55 toward an Investigational New Drug submission for inflammatory pain indications. Additionally, Mira Pharmaceuticals is moving forward with its planned acquisition of SKNY Pharmaceuticals, having received clearance from the SEC to proceed with shareholder approval. SKNY Pharmaceuticals’ drug candidate, SKNY-1, showed promising results in animal studies for weight loss and nicotine craving reduction. Mira Pharmaceuticals reported that Ketamir-2, another drug candidate, has been accepted for publication in a peer-reviewed journal, highlighting its differentiation from ketamine. The company is also preparing for a Phase 2a clinical trial of Ketamir-2 for neuropathic pain by the end of 2025. In a leadership update, Mira Pharmaceuticals appointed Alan Weichselbaum as the new Chief Financial Officer, effective May 15, 2025, as part of its strategic efforts to strengthen its executive team.
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