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 1, 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

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”) today announced that the first subjects have been enrolled in its Phase 1 clinical trial with Ketamir-2, the Company’s novel oral ketamine analog in development for the treatment of neuropathic pain.

The trial is being conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel. This is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers. A total of 56 subjects are expected to participate in the study, divided into Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts.

The study follows favorable preclinical data demonstrating that Ketamir-2 achieved superior efficacy in validated neuropathic pain models compared to FDA-approved treatments such as pregabalin and gabapentin. The compound also demonstrated a favorable safety profile, high oral bioavailability, and no interaction with P-glycoprotein (P-gp), supporting its potential for improved brain penetration.

The Company anticipates completing the Phase 1 study by the fourth quarter of 2025 and initiating a Phase 2a clinical trial in diabetic neuropathic pain by year-end. First human efficacy data are expected in the first half of 2026.

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.