8-K - MIRA - Equibles

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): September 22, 2025

MIRA

PHARMACEUTICALS, INC.

(ExactName of Registrant as Specified in its Charter)

Florida	001-41765	85-3354547
(State or Other Jurisdiction<br><br> <br>of Incorporation)	(Commission<br><br> <br>File Number)	(IRS Employer<br><br> <br>Identification No.)

1200Brickell Avenue, Suite 1950 #1183

Miami,Florida 33131

(Addressof Principal Executive Offices)

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

Not

Applicable

(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:

☐	Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Title<br> of each class	Trading<br> Symbol	Name<br> of each exchange on which registered
Common<br> Stock, $0.0001 par value per share	MIRA	The<br> Nasdaq Capital Market

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 Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled KetamineAnalog

Studydemonstrated that Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with nosevere or clinically significant adverse effects observed. The drug showed rapid and predictable absorption and a favorable durationof action supporting once-daily dosing.

On September 22, 2025, MIRA Pharmaceuticals, Inc. (the “Company”) announced topline results from the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2 in healthy volunteers.

The randomized, placebo-controlled study enrolled 32 healthy adult participants across four escalating oral dose cohorts (50 mg to 600 mg). The primary endpoints were safety, tolerability, and pharmacokinetic (PK) characterization.

PharmacokineticResults

●	Dose-proportional<br> increases in exposure (Cmax and AUC) were observed across all dose levels tested.
●	Median<br> time to maximum plasma concentration (Tmax) was reached within 1–2 hours, consistent across cohorts.
●	Terminal<br> half-life (t½) of Ketamir-2 ranged from 2 to 5 hours.
●	The<br> primary active metabolite, nor-Ketamir, demonstrated a half-life of 6.5 to 8.5 hours.

Safetyand Tolerability Results

●	Ketamir-2<br> was generally safe and well tolerated across all four cohorts.
●	No<br> dose-limiting toxicities or serious adverse events were observed.
●	Reported<br> treatment-emergent adverse events were transient and resolved without intervention.
●	Central<br> nervous system (CNS) safety was monitored using validated tools (C-SSRS, Bowdle VAS, KSET). Across all SAD cohorts, no clinically<br> significant adverse effects of Ketamir-2 observed.

NextSteps

Based on the data, the Company is initiating the multiple ascending dose (MAD) portion of the Phase 1 study in healthy volunteers, to be followed by a Phase 2a trial in patients with neuropathic pain.

AdditionalInformation

The U.S. Drug Enforcement Administration’s scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations.

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.

	MIRA PHARMACEUTICALS, INC.
Dated:<br> September 22, 2025	By:	/s/ Erez Aminov
	Name:	Erez<br> Aminov
	Title:	Chief<br> Executive Officer