Company: MIRA
Filing Date: 2025-10-23
Form Type: 8-K
Source: 0001493152-25-019065
Chunk: 1

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-10-23
Form: 8-K
Item: Item 8.01
Chunk 1
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ness, and burning sensations, most commonly in the hands and feet. It affects a large percentage of cancer patients during
treatment and often continues after therapy ends, frequently impacting quality of life and treatment continuity. Despite its prevalence,
there are no FDA-approved therapies for CIPN. The Company believes that Ketamir-2’s pharmacologic profile and preclinical results
support its further development as a potential non-opioid therapy for this indication.

Ketamir-2
is a novel, non-scheduled oral analog of ketamine engineered to overcome limitations associated with ketamine use, including the need
for intravenous administration, short duration of action, and undesirable psychoactive effects. The drug has good oral absorption and
is adapted for once-daily dosing without hallucinogenic or dissociative effects. Given the absence of FDA-approved treatments for chemotherapy-induced
neuropathic pain and the significant medical unmet need in oncology supportive care, the Company believes Ketamir-2 may qualify for consideration
of regulatory incentives such as Fast Track designation.

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