Material Event (Form 8-K)

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.