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Item 8.01 – Other Events
On February 2, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) announced that it has initiated dosing in the final cohort of its Phase 1 multiple ascending dose (MAD) clinical trial evaluating Ketamir-2, the Company’s lead oral NMDA receptor antagonist.
To date, 50 healthy volunteers have already been dosed, while dosing in the final cohort is underway, with 6 subjects remaining. The Company expects to complete the Phase 1 clinical program by the end of the first quarter of 2026.
The Phase 1 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of Ketamir-2 in healthy volunteers.
The Company is currently finalizing its Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy (CIPN), including clinical site selection, and plans to submit the Phase 2a protocol to the U.S. Food and Drug Administration following completion of Phase 1. Subject to regulatory feedback, the Company anticipates initiating the Phase 2a study in the second quarter of 2026. Given the oncology-related nature of CIPN and the lack of FDA-approved therapies, the Company intends to pursue FDA Fast Track designation for Ketamir-2 as the program advances.
The Company also announced that it plans to engage in partnering discussions at the BIO Partnering Investment & Growth Summit in March 2026 and to present Phase 1 data on Ketamir-2 at the American Association for Cancer Research (AACR) Annual Meeting in April 2026.
In addition, the Company provided an update on its preclinical pipeline programs. SKNY-1 is an orally administered small-molecule program under development for weight loss and nicotine addiction and is designed to avoid central nervous system–related adverse effects historically associated with prior CB1 receptor antagonists and muscle loss reported with certain injectable GLP-1–based therapies. MIRA-55 is a preclinical program under development for inflammatory pain, which has demonstrated analgesic and anti-inflammatory activity in preclinical models. Both programs are currently undergoing CMC optimization, with the objective of advancing each into IND-enabling status by year-end 2026.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MIRA PHARMACUTICALS, INC. | ||
| Dated: February 02, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |