Company: MIRA
Filing Date: 2025-05-06
Form Type: 8-K
Source: 0001641172-25-008748
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-05-06
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity

On
May 6, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) announced the completion of a regulatory-required neurotoxicity study of Ketamir-2,
the Company’s novel oral NMDA receptor antagonist. The study was conducted in accordance with FDA guidance as part of the Company’s
ongoing clinical development program.

The
study evaluated the potential for Ketamir-2 to produce neuropathologic changes, including Olney lesions, which have historically been
associated with certain NMDA receptor antagonists such as ketamine and MK-801. The study was conducted in sexually mature Sprague-Dawley
rats. Animals were administered high oral doses of Ketamir-2, while a separate positive control group received MK-801. All animals were
observed for clinical signs and underwent detailed histopathological brain analysis at two timepoints.

Key
findings from the study include:

  No                                                                                                                                   
  No                                                                                                                                   
  Positive                                                                                                                             

The
results of the study indicate that Ketamir-2 did not induce neurotoxic changes under the study conditions.

These
findings will be submitted to the U. S. Food and Drug Administration (FDA) as part of MIRA’s ongoing regulatory communications.

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                                          
  Dated:           By:                        /s/                
                   Name:                      Erez               
                   Title:                     Chief