8-K

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d) of the Securities Exchange Act of 1934

Dateof Report (Date of earliest event reported): April 16, 2025

MIRA

PHARMACEUTICALS, INC.

(ExactName of Registrant as Specified in its Charter)

1200Brickell Avenue, Suite 1950 #1183Miami, Florida 33131(Address of Principal Executive Offices)

Registrant’stelephone number, including area code: (786) 432-9792

NotApplicable

(FormerName or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item8.01 Other Events

MIRAPharmaceuticals 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.