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 13, 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”), a clinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced the successful formulationof Ketamir-2 into a topical treatment for localized neuropathic and inflammatory pain. This advancement expands the Company’s pain management pipeline beyond its ongoing Ketamir-2 oral treatment for neuropathic pain, offering a targeted approachfor localized pain relief.

The topical formulation of Ketamir-2 is designed for slow release, enabling targeted pain relief at the site of applicationwhile minimizing systemic exposure. The Company is currently conducting an ongoing preclinical study to assess the efficacyof this new topical formulation in treating inflammatory pain, with results expected to further guide development.

As a clinical-stage company, MIRA is advancing the development of Ketamir-2’s topical treatment for potential future clinicaltrials while continuing progress on its ongoing Phase 1 clinical trial for the oral formulation. The Company is also preparing for a Phase 2a study in diabetic neuropathy by year-end, with the goal of obtaining first human efficacy data by Q1 2026.

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.