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): July 29, 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 Reports New Topical Ketamir-2 shows comparable effects to Injected Morphine in Preclinical Pain Study

TopicalKetamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, demonstrating rapid onset, durable effect, andcomparable efficacy to injected morphine across both pain phases

On July 29, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”) announced preclinical data evaluating the analgesic effects of its new topical Ketamir-2 formulation in a validated rodent model of pain. The study was designed to assess spontaneous pain-related behaviors in response to formalin injection, a well-established method that induces a biphasic pain response: an acute phase (0–10 minutes) driven by direct nociceptor activation, and an inflammatory phase (15–60 minutes) driven by central sensitization.

Topical Ketamir-2 cream formulation was applied to the injected area at 30 minutes and just prior to formalin administration. Behavioral analysis was conducted over five-minutes intervals on a 60-minute period using AI-assisted video tracking to quantify two validated endpoints:

StudyResults:

The formalin test is commonly used to evaluate potential analgesic agents that target both neurogenic and inflammatory pain mechanisms. Phase 2 of the model, in particular, reflects central sensitization, a hallmark of many chronic and neuropathic pain conditions.

The Company is currently conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers and expects to begin a Phase 2a study in neuropathic pain later in 2025. MIRA is also continuing preclinical development of the topical formulation, including additional pharmacological and toxicological assessments.

This preclinical study supports continued investigation of topical Ketamir-2 as a potential non-opioid treatment for localized pain conditions, including diabetic neuropathy, postherpetic neuralgia, chemotherapy-induced peripheral neuropathy, osteoarthritis, and other forms of inflammatory pain.

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.