MIRA Pharma initiates final cohort of Ketamir-2 Phase 1 MAD trial; 50 volunteers dosed

MIRA PHARMACEUTICALS, INC.

Phase 1 MAD trial final cohort dosing underway; 50 healthy volunteers dosed, 6 remaining; completion expected by Q1 2026.
Phase 2a proof-of-concept study for CIPN planned; protocol submission to FDA after Phase 1; targeting Q2 2026 start.
Plans to pursue FDA Fast Track designation for Ketamir-2; to present Phase 1 data at AACR April 2026.
Preclinical programs SKNY-1 (weight loss/nicotine addiction) and MIRA-55 (inflammatory pain) advancing toward IND-enabling by year-end 2026.
Engaging in partnering discussions at BIO Partnering Investment & Growth Summit in March 2026.

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