MIRA Pharmaceuticals, Inc. - Common Stock (MIRA)

Randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and dose-response efficacy of oral Ketamir-2 at a leading U.S. cancer center

Agreement Establishes Global Exclusivity Across MIRA's Core Therapeutic Pipeline and Enhances Strategic Flexibility for Future Licensing and Partnership Opportunities

Expanded Global Intellectual Property Portfolio Enhances Strategic Flexibility and Long-Term Value Potential for Ketamir-2

Selective oral NMDA receptor modulator demonstrated favorable safety, tolerability, and pharmacokinetic profile supporting planned Phase 2a development in chemotherapy-induced peripheral neuropathy

Peer-reviewed publication highlights preclinical findings demonstrating weight loss, lipid normalization, and reduction of compulsive feeding and nicotine-seeking behaviors

Previously shown to deliver morphine-comparable pain relief without opioid-related risks in a validated inflammatory pain model, supporting planned IND submission for inflammatory pain

Advancing a selective oral NMDA receptor modulator toward Phase 2a in chemotherapy-induced peripheral neuropathy following favorable Phase 1 safety and tolerability findings

Company to Participate in BIO Partnering Summit and Present Phase 1 Ketamir-2 Data at American Association for Cancer Research (AACR)Annual Meeting

Advancing toward Phase 2a clinical evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track consideration

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Findings show oral Mira-55 fully normalized pain and significantly reduced inflammation, supporting IND plans and reinforcing MIRA's position in a $70 billion non-opioid pain market.

Closing adds $5 million in marketable securities, strengthens financial position, and complements MIRA's advancing programs including Ketamir-2 and MIRA-55

Study demonstrated Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption, a favorable duration of action supporting once-daily dosing, and no CNS side effects typically seen with ketamine.

MIRA advances Ketamir-2 in the clinic for neuropathic pain while broadening development into neuropsychiatric disorders such as PTSD

SKNY transaction strengthens MIRA pipeline with SKNY-1, a differentiated oral candidate that has demonstrated up to 30% weight loss and nicotine craving reversal in preclinical studies.

Following FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025

Manuscript accepted for publication in Frontiers in Pharmacology, "Oral Administration of Ketamir-2, a Novel Ketamine Analog, Attenuates Neuropathic Pain in Rodent Models via Selective NMDA Antagonism" details Ketamir-2's superior performance in two validated neuropathic pain models and supports advancement to Phase 2a clinical trials by year-end 2025.

Topical Ketamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, demonstrating rapid onset, durable effect, and comparable efficacy to injected morphine across both pain phases

Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion as the Company prepares to launch U.S. Phase 2a by year-end

SKNY-1 was previously shown to achieve up to 30% weight loss, reverse nicotine craving, and preserve muscle mass in an animal model-and is designed to avoid the CNS side effects that halted earlier CB1-targeting drugs

With Mira-55 and Ketamir-2, MIRA is advancing complementary non-opioid therapies for two of the largest pain markets

Oral therapy designed to minimize CNS side effects shows dual activity in weight loss and smoking cessation models without muscle loss

MIAMI, FL / ACCESS Newswire / June 25, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new in vitro preclinical data generated by Eurofins supporting the therapeutic potential of SKNY-1, a next-generation oral drug candidate being developed by SKNY Pharmaceuticals, Inc. ("SKNY"). MIRA has signed a definitive agreement to acquire SKNY, and the proposed transaction remains subject to regulatory review and shareholder approval.

MIAMI, FL / ACCESS Newswire / June 18, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that the first manuscript describing its lead drug candidate Ketamir-2, currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, has been accepted for publication in the peer-reviewed journal Frontiers in Pharmacology.

The company will engage in BIO One-on-One Partnering™ meetings as it advances Phase 1 for Ketamir-2, prepares Phase IIa study in neuropathic pain, and finalizes filings for SKNY acquisition.