Company: MIRA
Filing Date: 2025-08-12
Form Type: 8-K
Source: 0001641172-25-023110
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-12
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Pharmaceuticals’ Second Ketamir-2 Manuscript Accepted for Peer-Reviewed Publication Demonstrating Superior Efficacy in Preclinical
Neuropathic Pain Models versus Ketamine, Gabapentin, or Pregabalin

On
August 12, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“ MIRA” or the “ Company”) announced that a new manuscript
describing its lead drug candidate, Ketamir-2 Frontiers in
Pharmacology outperformed ketamine, pregabalin, or gabapentin - depending
on the comparator used - in two validated preclinical models of neuropathic pain

Neuropathic
pain represents a significant and underserved market across North America. Epidemiology suggests Precedence Research global neuropathic pain market $7.97
billion in 2024 $16.79 billion by 2034 compound annual growth rate (CAGR) of 7.73% $3.7 - 3.9 billion annually U. S. neuropathic pain market $2.79 billion in 2024 $5.92 billion by 2034 CAGR of 7.80%

These
findings build on MIRA’s previously published characterization of Ketamir-2’s differentiated pharmacology and favorable safety
profile and support the Company’s plan to submit a Phase 2a clinical trial protocol to the U. S. Food and Drug Administration
(FDA) in Q4 2025 as a follow-up development to its active IND, with the goal of initiating the study in neuropathic pain by year-end

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