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Item 8.01 Other Events
On May 28, 2025, MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) (“MIRA” or the “Company”) announced that it will participate in the BIO International Convention 2025, taking place in Boston, Massachusetts from June 16–19, 2025. The Company has scheduled a full week of BIO One-on-One Partnering™ meetings to explore potential licensing, strategic collaborations, and M&A opportunities.
Separately, the Company is providing an update on the continued advancement of its clinical and preclinical programs. MIRA’s lead candidate, Ketamir-2, a next-generation oral ketamine analog, is currently in an ongoing Phase 1 clinical trial. The second dosing cohort has been successfully completed, and the Company is preparing to initiate the third cohort. MIRA anticipates beginning a Phase IIa clinical trial in neuropathic pain by the end of 2025, advancing the development of what it believes could represent a safe and effective non-opioid alternative for chronic pain management.
The Company is also conducting preclinical studies evaluating Ketamir-2 in models of post-traumatic stress disorder (PTSD) and assessing the efficacy of a previously developed topical formulation for the treatment of localized inflammatory pain.
In addition, MIRA is finalizing regulatory filings related to its previously announced acquisition of SKNY Pharmaceuticals, Inc. (“SKNY”). The Company expects to submit the required documentation to the U.S. Securities and Exchange Commission (SEC) in the coming weeks. SKNY’s lead development candidate, SKNY-1, is an oral therapeutic targeting smoking cessation and obesity, with pharmacological activity at CB1, CB2, and MAO-B receptors.
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 PHARMACEUTICALS, INC. | ||
| Dated: May 28, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |