MIRA PHARMACEUTICALS, INC. — Form 8-K

MIRA Pharmaceuticals announced that its Ketamir-2 Phase 2a protocol for chemotherapy-induced peripheral neuropathy (CIPN) was submitted for IRB review at a leading cancer research institution following FDA feedback. The randomized, double-blind, placebo-controlled crossover study will enroll adults with moderate-to-severe persistent CIPN receiving Ketamir-2 at 300 mg and 600 mg doses plus placebo across three 7-day periods with 13-day washouts. Site initiation is targeted for Q1 2027, subject to IRB approval and routine activation requirements; this represents the first clinical evaluation of Ketamir-2 in CIPN patients, advancing from completed Phase 1 healthy volunteer work that showed favorable safety and no serious adverse events.