Material Event (Form 8-K)

Item 8.01 Other Events

MIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2

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

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company") announced that it has completed dosing in its Phase 1 clinical trial evaluating Ketamir-2, the Company's proprietary selective oral NMDA receptor modulator, in healthy volunteers.

The randomized, double-blind, placebo-controlled study enrolled 56 healthy adult volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Based on safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported at any dose level tested. In addition, no clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed. Database lock, unblinding, and final audited pharmacokinetic and safety analyses are underway.

The Phase 1 study was conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel and was designed to evaluate the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2. The SAD portion included four dose cohorts ranging from 50 mg to 600 mg (32 participants), and the MAD portion included three cohorts receiving daily oral doses of 150 mg, 300 mg, or 600 mg for five days (24 participants).

The Company intends to submit the Phase 2a clinical study and supporting documentation to the U.S. Food and Drug Administration under its active Investigational New Drug application in the first half of 2026. The planned proof-of-concept study is expected to enroll patients with moderate to severe chemotherapy-induced peripheral neuropathy (CIPN) and is being designed to generate interpretable and clinically meaningful safety and preliminary efficacy data using validated neuropathic pain assessment tools and appropriate statistical powering.

Chemotherapy-induced peripheral neuropathy is a common and often dose-limiting complication of certain chemotherapy regimens and is characterized by persistent neuropathic pain, numbness, and sensory dysfunction. There are currently no FDA-approved therapies specifically indicated for CIPN, and management typically relies on off-label pharmacologic agents or intravenous ketamine.

The Company also stated that it plans to present Phase 1 data at an upcoming scientific meeting.