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): March 4, 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 Approval and Initiation of Phase 1 Clinical Trial for Ketamir-2 in Neuropathic Pain

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”) today announced that it has received regulatory approval from the Israeli Ministry of Health and the Institutional Review Board (IRB) to initiate a Phase 1 clinical trial for Ketamir-2, the Company’s novel oral ketamine analog in development for neuropathic pain.

The randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of orally administered Ketamir-2 in healthy adult volunteers. The trial will be conducted at the Clinical Pharmacology Unit, Hadassah Medical Center in Jerusalem, Israel, with subject recruitment scheduled to begin in Q1 2025.

Mira continues to await the results of its neurotoxicity study, a requirement from the FDA, prior to IND enabling and initiating of patient dosing in the U.S**.** The Company anticipates receiving these results by Q2 2025 and does not expect any impact on its planned clinical development timeline.

MIRA expects Phase 1 to conclude by Q4 2025, paving the way for a Phase 2a study in neuropathic pain patients expected to be initiated by year-end.

For more information, please visit www.mirapharmaceuticals.com.

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.