Form 8-K

8-K — MIRA PHARMACEUTICALS, INC.

Accession: 0001493152-26-022704

Filed: 2026-05-13

Period: 2026-05-13

CIK: 0001904286

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

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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

Date

of Report: May 13, 2026

MIRA

PHARMACEUTICALS, INC.

(Exact

Name of Registrant as Specified in its Charter)

Florida

001-41765

85-3354547

(State

or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS

Employer

Identification No.)

1200

Brickell Avenue, Suite

1950 #1183

Miami,

Florida 33131

(Address

of Principal Executive Offices)

(786)

432-9792

(Registrant’s

telephone

number,

including area code)

(Former

Name 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

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement

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

of each class

Trading

Symbol

Name

of each exchange on which registered

Common

Stock, $0.0001 par value per share

MIRA

The

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 ☒

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. ☐

Item

7.01 Regulation FD Disclosure

MIRA

Pharmaceuticals, Inc. (the “Company”) today announced positive unblinded results from its completed Phase 1 clinical trial

evaluating Ketamir-2, the Company’s proprietary selective oral NMDA receptor modulator.

The

randomized, double-blind, placebo-controlled Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of orally administered

Ketamir-2 in healthy volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.

total of 57 healthy volunteers were enrolled across seven cohorts, including placebo. All participants completed the study with no withdrawals,

and all subjects were fit for discharge following final administration.

serious adverse events or dose-limiting toxicities were reported during the study. Adverse events observed were predominantly mild in

severity. The incidence of subjects reporting adverse events was higher in the placebo group than in the Ketamir-2-treated group.

Pharmacokinetic

analysis demonstrated rapid oral absorption and favorable systemic exposure, with dose-proportional Cmax observed across the evaluated

dose range. No major differences were observed in pharmacokinetic parameters for Ketamir-2 or its active metabolite, nor-Ketamir-2, between

Day 1 and Day 5 of administration.

The

half-life (t1/2) of Ketamir-2 ranged from approximately 2.5 to 7 hours, while the active metabolite nor-Ketamir-2 demonstrated

a half-life of approximately 7 to 9 hours. Based on the observed pharmacokinetic profile of the parent compound and active metabolite,

Ketamir-2 may support once-daily administration, subject to further clinical evaluation.

The

Company is advancing preparations for submission of its Phase 2a clinical protocol and supporting documentation to the U.S. Food and

Drug Administration under its active Investigational New Drug (IND) application for the planned evaluation of Ketamir-2 in chemotherapy-induced

peripheral neuropathy (CIPN).

validated preclinical models of neuropathic pain, including paclitaxel-induced neuropathy and sciatic nerve ligation, Ketamir-2 demonstrated

superior efficacy compared with ketamine and established neuropathic pain agents, including pregabalin and gabapentin.

Following

scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Ketamir-2 is not classified as a controlled substance.

The

information in this Item 7.01, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934,

as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, or incorporated by reference in

any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference

in such a filing.

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

PHARMACUTICALS, INC.

Dated:

May 13, 2026

By:

/s/

Erez Aminov

Name:

Erez

Aminov

Title:

Chief

Executive Officer

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Entity File Number

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Entity Registrant Name

MIRA

PHARMACEUTICALS, INC.

Entity Central Index Key

0001904286

Entity Tax Identification Number

85-3354547

Entity Incorporation, State or Country Code

Entity Address, Address Line One

1200

Brickell Avenue

Entity Address, Address Line Two

Suite

1950 #1183

Entity Address, City or Town

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Entity Address, State or Province

Entity Address, Postal Zip Code

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City Area Code

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Local Phone Number

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