Company: MIRA
Filing Date: 2025-04-16
Form Type: 8-K
Source: 0001641172-25-004971
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-04-16
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Pharmaceuticals Announces Positive Study Results for Ketamir-2 in Diabetic Neuropathy Model

MIRA
Pharmaceuticals, Inc. (NASDAQ: MIRA), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic and neuropsychiatric
disorders, today announced positive results from a preclinical study evaluating its oral ketamine analog, Ketamir-2, in a validated animal
model of diabetic neuropathy.

The
study was conducted using a well-established rat model of type 2 diabetes, combining a high-fat diet with low-dose Streptozotocin (STZ)
to induce insulin resistance, hyperglycemia, and a significant reduction in pancreatic β-cell function. By week 8 following induction,
most of the animals developed neuropathic pain expressed as hyperalgesia and allodynia, confirmed experimentally through mechanical hypersensitivity
assessments using von Frey filaments.

Animals
treated orally with Ketamir-2 exhibited a statistically significant reduction in neuropathic pain symptoms compared to untreated controls.
Notably, a subset of treated animals returned to pre-diabetic baseline sensitivity levels, indicating full symptom resolution in those
cases. These results highlight the compound’s potential to reverse pain-related hypersensitivity in diabetic neuropathy.

The
study reinforces prior preclinical findings in other experimental models demonstrating Ketamir-2’s efficacy, oral bioavailability,
and non-dissociative profile. These findings support MIRA’s ongoing Phase I clinical trial in healthy volunteers and its plan to
initiate a Phase IIa trial in diabetic neuropathy patients by the end of 2025.

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:      April 16, 2025      By:                        /s/                
                                  Name:                      Erez               
                                  Title:                     Chief