MIRA PHARMACEUTICALS, INC. 8-K

What Happened
MIRA Pharmaceuticals, Inc. (filed 8‑K on Feb 2, 2026) announced it has initiated dosing in the final cohort of its Phase 1 multiple ascending dose (MAD) trial of Ketamir‑2, an oral NMDA receptor antagonist. To date 50 healthy volunteers have been dosed; dosing in the final cohort is underway with 6 subjects remaining. The company expects to complete the Phase 1 program by the end of Q1 2026. The trial is randomized, double‑blind and placebo‑controlled to evaluate safety, tolerability and pharmacokinetics of single and multiple doses. MIRA plans to finalize and submit a Phase 2a proof‑of‑concept protocol in chemotherapy‑induced peripheral neuropathy (CIPN) to the FDA after Phase 1 and — subject to feedback — anticipates starting the Phase 2a in Q2 2026 and pursuing FDA Fast Track designation.

Key Details

• 50 healthy volunteers dosed so far; 6 subjects remain in the final Phase 1 cohort.
• Company expects Phase 1 completion by end of Q1 2026 and Phase 2a initiation in Q2 2026 (CIPN indication).
• Plans to seek FDA Fast Track designation for Ketamir‑2 and to present Phase 1 data at AACR in April 2026; partnering discussions scheduled for BIO Summit in March 2026.
• Preclinical programs SKNY‑1 (oral, for weight loss and nicotine addiction) and MIRA‑55 (inflammatory pain) are in CMC optimization, targeting IND‑enabling status by year‑end 2026.

Why It Matters
Completing Phase 1 and moving toward a Phase 2a in CIPN are key clinical milestones that reduce early program risk and set up value‑creating data readouts. CIPN is an oncology‑related condition with no FDA‑approved therapies, so successful Phase 2 results and a Fast Track designation could accelerate development and commercialization pathways. The upcoming conference presentations and partnering efforts could help attract collaborators or funding, while progress on SKNY‑1 and MIRA‑55 expands MIRA’s pipeline toward additional indications.