Form 8-K

8-K — MIRA PHARMACEUTICALS, INC.

Accession: 0001493152-26-025335

Filed: 2026-05-27

Period: 2026-05-21

CIK: 0001904286

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Entry into a Material Definitive Agreement

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-10.1 (ex10-1.htm)

EX-99.1 (ex99-1.htm)

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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 21, 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

1.01 Entry into a Material Definitive Agreement.

May 21, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) entered into Amendment No. 1 (the “Amendment”) to that

certain Exclusive License Agreement, effective November 15, 2023, by and between the Company and MIRALOGX LLC.

Pursuant

to the Amendment, the parties expanded the Company’s exclusive licensed territory relating to Ketamir-2 from the United States,

Canada, and Mexico to all countries in which patent rights exist. The Amendment also expands the licensed patent portfolio to include

international patent filings and applications across multiple jurisdictions, including the United States, Europe, China, Japan, Canada,

Australia, India, Israel, Mexico, and South Korea.

The

Amendment is intended to support the continued global development and commercialization strategy for Ketamir-2 as the Company advances

the program toward planned Phase 2a development.

The

Amendment did not materially modify the previously disclosed core economic terms of the original License Agreement, including royalty

obligations and other financial consideration.

The

foregoing description of the Amendment is qualified in its entirety by reference to the full text of the Amendment, which is attached

hereto as Exhibit 10.1 and incorporated herein by reference.

Item

7.01 Regulation FD Disclosure.

May 27, 2026, the Company issued a press release announcing the execution of the Amendment. A copy of the press release is attached as

Exhibit 99.1 hereto.

The

information set forth under Item 7.01 and in Exhibit 99.1 is intended to be furnished and 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, nor shall it be deemed 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 filing.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits

10.1

Amendment No. 1 to Exclusive License Agreement, by and between the Company and MIRALOGX, dated as of May 21, 2026.

99.1

Press release, dated May 27, 2026, announcing Amendment No. 1 to Exclusive License Agreement between the Company and MIRALOGX.

104

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Page Interactive Data File (embedded within the Inline XBRL document)

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 27, 2026

By:

/s/

Erez Aminov

Name:

Erez

Aminov

Title:

Chief

Executive Officer

EX-10.1

Filename: ex10-1.htm · Sequence: 2

Exhibit 10.1

EX-99.1

Filename: ex99-1.htm · Sequence: 3

Exhibit 99.1

MIRA

Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPN

Expanded

global intellectual property portfolio enhances strategic flexibility and long-term value potential for Ketamir-2

MIAMI,

FL / ACCESS Newswire / May 27, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) (“MIRA” or the “Company”),

a clinical-stage pharmaceutical company focused on the development of proprietary therapeutics for neurologic, neuropsychiatric, inflammatory,

and metabolic disorders, today announced the execution of Amendment No. 1 to its exclusive Ketamir-2 license agreement with MIRALOGX

LLC, expanding the Company’s licensed territory from the United States, Canada, and Mexico to worldwide rights across all countries

in which patent rights exist.

The

amended agreement incorporates an expanded international patent portfolio now covering filings in the United States, Europe, China, Japan,

Canada, Australia, India, Israel, Mexico, and South Korea, representing the world’s largest pharmaceutical markets.

Ketamir-2

is MIRA’s proprietary oral NMDA receptor modulator currently advancing toward planned Phase 2a development in chemotherapy-induced

peripheral neuropathy (“CIPN”), an indication with significant unmet medical need. The Company recently announced positive

Phase 1 clinical results across 56 healthy volunteers, demonstrating favorable safety, tolerability, and pharmacokinetic findings, with

no serious adverse events or study discontinuations reported.

Management

Commentary

Erez

Aminov, Chairman and CEO of MIRA, stated:

“Securing

worldwide rights for Ketamir-2 represents an important strategic milestone for MIRA and significantly strengthens the long-term global

commercial potential of the program. As we advance toward planned Phase 2a development in CIPN, this expanded intellectual property position

strengthens our ability to pursue global licensing, co-development, or commercialization discussions with potential strategic partners.

The

amendment does not materially modify the previously disclosed core economic terms of the original license agreement.

With

worldwide IP rights secured and a completed Phase 1 data package in hand, MIRA is advancing Phase 2a protocol documentation for submission

to the FDA under its active Investigational New Drug (IND) application.

About

Ketamir-2

is a proprietary, orally bioavailable investigational new molecular entity designed to selectively modulate the NMDA receptor (PCP binding

site) with low binding affinity and limited off-target receptor activity.

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

improved 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.

Ketamir-2

has not been approved by the U.S. Food and Drug Administration for any indication, and its safety and efficacy have not been established.

About

MIRA Pharmaceuticals, Inc.

MIRA

Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of investigational

therapeutics for neurologic, neuropsychiatric, inflammatory, and metabolic disorders. The Company’s pipeline includes oral drug

candidates being evaluated for neuropathic pain (CIPN), inflammatory pain, obesity, addiction-related disorders, anxiety, and cognitive

impairment.

For

more information, please visit MIRA Pharmaceuticals.

Forward-Looking

Statements

This

press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of

1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,”

“plan,” “can,” “could,” “would,” “may,” “will,” “believe,”

“estimate,” “forecast,” “goal,” “project,” “guidance,” “potential,”

“intend,” “seek,” “target” and other words of similar meaning, although not all forward-looking statements

include these words. Forward-looking statements may include, but are not limited to, statements regarding the therapeutic potential,

mechanism of action, development plans, regulatory pathway, safety profile, clinical utility, market opportunity, and future development

of SKNY-1 and the Company’s other product candidates. These forward-looking statements are based on current expectations, estimates,

forecasts, and projections, as well as management’s beliefs and assumptions, and are subject to significant risks and uncertainties

that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties

include, among others, risks related to preclinical and clinical development, the ability to obtain regulatory approvals, the outcome

of future studies, reliance on third parties, intellectual property protection, financing needs, market conditions, and the other risks

identified in the Company’s under the heading “Risk Factors” contained in the Company’s Annual Report on Form

10-K and the Company’s other filings with the U.S. Securities and Exchange Commission (“SEC”). Forward-looking statements

contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update or revise such statements,

whether as a result of new information, future events, or otherwise, except as required by applicable law.

caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to

read our filings with the SEC, available at SEC website and in the “Investors” section of our website at MIRA Investors,

for a discussion of these and other risks and uncertainties.

Contact:

Krystina Quintana

info@mirapharma.com

(786) 432-9792

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