Filing Analysis
MIRA Pharmaceuticals announced the submission of a Phase 2a clinical trial protocol (Protocol Mira-002) to the FDA for its proprietary oral NMDA receptor modulator, Ketamir-2, targeting chemotherapy-induced peripheral neuropathy (CIPN). The company also confirmed receipt of an acknowledgment from the FDA accepting the submission.
📋 Key Facts
- Submission date: June 17, 2026
- Drug candidate: Ketamir-2 (oral NMDA receptor modulator)
- Indication: Chemotherapy-induced peripheral neuropathy (CIPN)
- Trial Stage: Phase 2a
- Protocol Identifier: Protocol Mira-002
- FDA status: Acknowledgment of receipt confirmed
Mira Pharmaceuticals announced the departure of CFO Alan Weichselbaum and the appointment of Andriy Mushak as Fractional CFO effective June 6, 2026. Mr. Mushak is a partner at LMAM Consulting Group, LLC, and will provide services via a consulting agreement.
🚩 Red Flags
- Transition from a full-time CFO to a 'Fractional' CFO often indicates budget constraints or a reduction in the scale of financial operations in micro-cap companies.
📋 Key Facts
- Alan Weichselbaum ceased serving as CFO effective June 6, 2026.
- Andriy Mushak appointed as Fractional CFO effective June 6, 2026.
- Mr. Mushak is a CPA and Partner at LMAM Consulting Group, LLC.
- The Company will pay Mr. Mushak $6,000 per month for his services under a Consulting Agreement with LMAM.
- The departure of Mr. Weichselbaum was reportedly not due to any disagreement with the Company.
MIRA Pharmaceuticals entered into an Amended and Restated Exclusive License Agreement with MIRALOGX LLC on June 3, 2026. The agreement secures worldwide exclusive rights to intellectual property for the MIRA-55 and SKNY-1 development programs.
📋 Key Facts
- Agreement date: June 3, 2026
- Counterparty: MIRALOGX LLC
- Scope: Worldwide exclusive rights to develop, manufacture, use, sell, and commercialize products related to MIRA-55 and SKNY-1
- The company explicitly stated that the amended agreement does not materially modify previously disclosed core economic terms
MIRA Pharmaceuticals entered into Amendment No. 1 to its Exclusive License Agreement with MIRALOGX LLC on May 21, 2026, expanding the licensed territory for Ketamir-2 from North America to all countries where patent rights exist, including Europe, China, Japan, and others.
📋 Key Facts
- Amendment date: May 21, 2026
- Territory expansion: From US, Canada, and Mexico to all countries with patent rights
- Patent portfolio expansion: Now includes international filings in Europe, China, Japan, Canada, Australia, India, Israel, Mexico, and South Korea
- Strategic goal: Support global development and commercialization of Ketamir-2 heading toward Phase 2a development
- Financial terms: No material modification to core economic terms, royalty obligations, or financial consideration
MIRA Pharmaceuticals announced positive Phase 1 clinical trial results for Ketamir-2, its oral NMDA receptor modulator, demonstrating safety and tolerability in 57 healthy volunteers. The company is now preparing for Phase 2a trials and has received confirmation from the DEA that the drug is not a controlled substance.
📋 Key Facts
- Phase 1 study included 57 healthy volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.
- No serious adverse events or dose-limiting toxicities were reported; adverse events were predominantly mild.
- Pharmacokinetic data showed a half-life of 2.5 to 7 hours for Ketamir-2 and 7 to 9 hours for its active metabolite, supporting potential once-daily dosing.
- The U.S. DEA determined Ketamir-2 is not classified as a controlled substance.
- The company is advancing to Phase 2a clinical protocol submission for chemotherapy-induced peripheral neuropathy (CIPN).
MIRA Pharmaceuticals announced the publication of a peer-reviewed manuscript in the International Journal of Molecular Sciences detailing preclinical results for its drug candidate SKNY-1. The study demonstrated that SKNY-1, a THCV analog, produced significant weight loss and reduced nicotine-seeking behaviors in a zebrafish model.
🚩 Red Flags
- The data is strictly preclinical (zebrafish), which has a high rate of failure when transitioning to human clinical trials.
📋 Key Facts
- The manuscript is titled 'SKNY-1, a THCV Analog, Produces Weight Loss, Lipid Normalization and Attenuation of Reward-Associated Behaviors in an mc4r(G894C) Zebrafish Model of Obesity.'
- SKNY-1 showed a 30% reduction in body weight relative to baseline in the higher-dose group over a six-day treatment period.
- The drug candidate demonstrated selective in vitro inhibition of monoamine oxidase B (MAO-B) and engagement of CB1 and CB2 receptors.
- Preclinical findings included normalization of cholesterol (LDL/HDL), reduction of hepatic triglycerides, and attenuation of compulsive feeding and nicotine-seeking behaviors.
- The research is currently limited to preclinical zebrafish models and in vitro systems; human safety and efficacy have not been established.
MIRA Pharmaceuticals reported positive preclinical data for its drug candidate Mira-55, demonstrating a lack of cannabinoid-related CNS side effects and reduced anxiety-like behavior. The company is leveraging these results to support an upcoming Investigational New Drug (IND) submission for inflammatory pain.
📋 Key Facts
- Preclinical study conducted in collaboration with Pharmaseed evaluated Mira-55 at doses of 10, 30, and 100 mg/kg.
- Mira-55 showed no evidence of sedation, catalepsy, or motor impairment, unlike THC or rimonabant.
- The drug candidate demonstrated a dose-dependent increase in time spent in open arms during Elevated Plus Maze (EPM) testing, suggesting reduced anxiety.
- Previous data indicated Mira-55 provides morphine-comparable analgesic effects without opioid-related risks.
- The company is currently advancing Mira-55 toward an IND submission for inflammatory pain.
MIRA Pharmaceuticals announced the completion of Phase 1 dosing for Ketamir-2, its proprietary oral NMDA receptor modulator. The study in 56 healthy volunteers showed no serious adverse events or dissociative effects, clearing the path for a Phase 2a submission in the first half of 2026.
📋 Key Facts
- Completed Phase 1 dosing for Ketamir-2 in 56 healthy adult volunteers at Hadassah Medical Center.
- The study included Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts with doses up to 600 mg.
- No serious adverse events (SAEs), dose-limiting toxicities (DLTs), or dissociative/psychotomimetic effects were reported.
- Company plans to submit Phase 2a clinical study documentation to the FDA in H1 2026.
- The upcoming Phase 2a study will target moderate to severe chemotherapy-induced peripheral neuropathy (CIPN).