Material Event (Form 8-K)

Item 8.01 Other Events

MIRA Pharmaceuticals Reports Positive PTSD Data Demonstrating Ketamir-2 Restores Normalized Behavior in Stressed Animals

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) today announced results from a proof-of-concept validation study evaluating its oral drug candidate, Ketamir-2, in an animal model of post-traumatic stress disorder (PTSD). The study was conducted in a small group of rats using the Single Prolonged Stress (SPS) model, a widely accepted paradigm for inducing PTSD-like symptoms. Animals were exposed twice to a predator stressor (bobcat urine), which induced avoidance behavior, anxiety-like responses, and depressive-like symptoms that persisted and intensified over time, modeling chronic PTSD-like states.

Following the development of these symptoms, animals were dosed orally with Ketamir-2 once daily for five consecutive days. Behavioral assessments included anxiety-and coping/resilience-related behavior in the forced swim test (FST), which measures immobility versus active coping strategies. Stressed animals displayed hallmark PTSD-like behaviors, including increased despair, immobility, and avoidance of coping. Treatment with Ketamir-2 was associated with a reversal of these types of behaviors toward the level observed in non-stressed animals.

This initial validation supports the study design, and a larger follow-on PTSD study is ongoing. Ketamir-2 is also being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has demonstrated a favorable safety profile to date.

Ketamir-2 is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and has shown no significant off-target activity across a broad receptor panel. It was designed to capture the therapeutic efficacy of ketamine while minimizing dissociative and other central nervous system side effects that limit ketamine's clinical use. The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. In prior preclinical studies, Ketamir-2 demonstrated superior efficacy compared to ketamine, pregabalin, and gabapentin in neuropathic pain models.