MIRA PHARMACEUTICALS, INC.

MIRA Pharmaceuticals announced positive preclinical study results for SKNY-1, its oral drug candidate for obesity and addiction-related disorders. The studies demonstrated favorable oral bioavailability, reproducible systemic exposure, robust brain penetration, and substantial liver exposure, supporting potential once-daily oral dosing. These findings strengthen SKNY-1's development profile, complementing previous efficacy studies that showed reductions in body weight and attenuation of compulsive behaviors without anxiety-related side effects.

MIRA Pharmaceuticals announced new preclinical data for Mira-55, its cannabinoid analog in development for chronic inflammatory pain. The data revealed a differentiated mechanism of action and anxiolytic activity compared to THC, without its known liabilities like psychoactivity and central nervous system side effects. Mira-55 did not cause locomotor suppression or catalepsy and showed a distinct pharmacological mechanism for its effects. These positive findings support the continued advancement of Mira-55 towards an Investigational New Drug (IND) submission for chronic inflammatory pain.

MIRA Pharmaceuticals, Inc. announced the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its proprietary oral NMDA receptor modulator, to treat chemotherapy-induced peripheral neuropathy (CIPN). The company also received an acknowledgment of receipt from the FDA, confirming acceptance of the submission. This randomized, double-blind, placebo-controlled study aims to evaluate the safety, tolerability, and dose-response efficacy of Ketamir-2 in patients with moderate-to-severe persistent CIPN, addressing a significant unmet medical need.

Mira Pharmaceuticals, Inc. announced the departure of Alan Weichselbaum as Chief Financial Officer, effective June 6, 2026. His departure was not due to any disagreement with the company. Concurrently, the board appointed Andriy Mushak as the company's fractional Chief Financial Officer, effective June 6, 2026. Mr. Mushak, a CPA with over 20 years of experience, will provide services through LMAM Consulting Group, LLC for $6,000 per month.

MIRA Pharmaceuticals, Inc. entered into an Amended and Restated Exclusive License Agreement with MIRALOGX LLC, securing worldwide exclusive rights to its MIRA-55 and SKNY-1 development programs. This agreement grants MIRA global rights to develop, manufacture, commercialize, and sublicense products covered by the licensed intellectual property, along with intellectual property enforcement rights. The amendment consolidates the company's IP portfolio and establishes a unified global rights structure across its core therapeutic assets, without materially changing the existing economic terms.

MIRA Pharmaceuticals amended its exclusive license agreement with MIRALOGX LLC for Ketamir-2, expanding its licensed territory from North America to worldwide rights in all countries with patent protection. The amendment also broadens the patent portfolio to include international filings across 10 major pharmaceutical markets. This strategic move aims to support the global development and commercialization of Ketamir-2, which is advancing towards Phase 2a development for chemotherapy-induced peripheral neuropathy (CIPN) following positive Phase 1 results.

MIRA Pharmaceuticals reported a net loss of $1.15 million for the first quarter of 2026, an improvement from $1.78 million in the same period last year, with basic and diluted loss per share narrowing to $0.03. The company's cash balance decreased to $4.82 million from $6.35 million at the end of 2025. Management expressed substantial doubt about the company's ability to continue as a going concern due to insufficient cash to fund operations for the next 12 months.

MIRA Pharmaceuticals announced positive unblinded results from its completed Phase 1 clinical trial for Ketamir-2, its proprietary oral NMDA receptor modulator. The study demonstrated favorable safety, tolerability, and pharmacokinetics in 57 healthy volunteers, with no serious adverse events reported and predominantly mild adverse events. Additionally, the U.S. Drug Enforcement Administration determined that Ketamir-2 is not classified as a controlled substance. The company is now preparing for Phase 2a clinical protocol submission to the USFDA for evaluation in chemotherapy-induced peripheral neuropathy.

MIRA Pharmaceuticals, Inc. announced the publication of a peer-reviewed manuscript in the International Journal of Molecular Sciences detailing positive preclinical findings for SKNY-1, its investigational oral drug candidate for obesity and nicotine addiction. The study reported that SKNY-1 led to dose-dependent body weight reductions, including a 30% reduction in the higher-dose group, along with lipid normalization and attenuation of reward-associated behaviors in an MC4R-deficient zebrafish model. The company emphasized that these findings are based on preclinical research and SKNY-1 has not yet been approved by the FDA for any indication.