Company: MIRA
Filing Date: 2025-07-29
Form Type: 8-K
Source: 0001641172-25-021356
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Pharmaceuticals Reports New Topical Ketamir-2 shows comparable effects to Injected Morphine in Preclinical Pain Study

Topical
Ketamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, demonstrating rapid onset, durable effect, and
comparable efficacy to injected morphine across both pain phases

On
July 29, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“ MIRA” or the “ Company”) announced preclinical data
evaluating the analgesic effects of its new topical Ketamir-2 formulation in a validated rodent model of pain. The study was designed
to assess spontaneous pain-related behaviors in response to formalin injection, a well-established method that induces a biphasic pain
response: an acute phase (0 - 10 minutes) driven by direct nociceptor activation, and an inflammatory phase (15 - 60 minutes)
driven by central sensitization.

Topical
Ketamir-2 cream formulation was applied to the injected area at 30 minutes and just prior to formalin administration. Behavioral analysis
was conducted over five-minutes intervals on a 60-minute period using AI-assisted video tracking to quantify two validated endpoints:

  Paw                                                                     
  Paw                                                                     

Study
Results:

  In                                                                                                                    
  In                                                                                                                    
  Effect                                                                                                                

The
formalin test is commonly used to evaluate potential analgesic agents that target both neurogenic and inflammatory pain mechanisms. Phase
2 of the model, in particular, reflects central sensitization, a hallmark of many chronic and neuropathic pain conditions.

The
Company is currently conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers and expects to begin a Phase 2a study
in neuropathic pain later in 2025. MIRA is also continuing preclinical development of the topical formulation, including additional pharmacological
and toxicological assessments.

This
preclinical study supports continued investigation of topical Ketamir-2 as a potential non-opioid treatment for localized pain conditions,
including diabetic neuropathy, postherpetic neuralgia, chemotherapy-induced peripheral neuropathy, osteoarthritis, and other forms of
inflammatory pain.

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 unders