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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: June 3, 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 ☒
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.
Item 1.01 Entry into a Material Definitive Agreement.
On June 3, 2026, MIRA Pharmaceuticals, Inc. (the “Company”)
entered into an Amended and Restated Exclusive License Agreement (the “License Agreement”) with MIRALOGX LLC (“Miralogx”).
Pursuant to the License Agreement, Miralogx granted
the Company worldwide exclusive rights under certain intellectual property relating to the Company’s MIRA-55 and SKNY-1 development
programs. The License Agreement provides the Company with worldwide rights to develop, manufacture, use, sell, offer for sale, commercialize
and sublicense products covered by the licensed intellectual property.
The License Agreement also provides the Company with
certain intellectual property enforcement rights and worldwide sublicensing rights with respect to the licensed intellectual property.
The amended agreement does not materially modify the
previously disclosed core economic terms of the parties’ existing license arrangements.
The foregoing description of the License Agreement
is only a summary and is qualified in its entirety by reference to the full text of the License Agreement, which will be filed as an exhibit
to the Company’s next periodic report or amendment thereto and is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On June 4, 2026, the Company
issued a press release announcing the execution of the License Agreement. 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 |
|
Amended and Restated Exclusive License Agreement, by and between the Company and MIRALOGX LLC dated June 3, 2026 |
| |
|
|
| 99.1 |
|
Press release, dated June 4, 2026 |
| |
|
|
| 104 |
|
Cover 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: June 4, 2026 |
By: |
/s/ Erez Aminov |
| |
Name: |
Erez Aminov |
| |
Title: |
Chief Executive Officer |
Exhibit
99.1
MIRA
Pharmaceuticals Secures Worldwide Exclusive Rights to MIRA-55 and SKNY-1
Agreement
Establishes Global Exclusivity Across MIRA’s Core Therapeutic Pipeline and Enhances Strategic Flexibility for Future Licensing
and Partnership Opportunities
MIAMI,
FL / ACCESS Newswire / June 4, 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 an Amended and Restated Exclusive License Agreement with MIRALOGX LLC, securing
worldwide exclusive rights to MIRA-55 and SKNY-1.
The
amended agreement grants MIRA worldwide exclusive development, commercialization, sublicensing, and intellectual property enforcement
rights relating to both programs. The transaction further consolidates the Company’s intellectual property portfolio and establishes
a unified global rights structure across MIRA’s core therapeutic assets.
MIRA-55
is the Company’s proprietary oral investigational drug candidate being developed for chronic inflammatory pain. SKNY-1 is MIRA’s
oral investigational drug candidate being developed for obesity and addiction-related disorders.
Under
the terms of the amended agreement, MIRA receives worldwide exclusive rights under jointly owned intellectual property covering MIRA-55,
as well as worldwide exclusive rights covering SKNY-1. The agreement also provides MIRA with worldwide sublicensing rights and enhanced
intellectual property enforcement rights, strengthening the Company’s ability to pursue future licensing, co-development, and commercialization
opportunities.
The
amendment does not materially modify the previously disclosed core economic terms of the existing license arrangements.
Erez
Aminov, Chairman and CEO of MIRA Pharmaceuticals, stated:
“With
this agreement, MIRA now controls global development and commercialization rights across its entire pipeline — Ketamir-2, MIRA-55,
and SKNY-1. As we advance Ketamir-2 into Phase 2a and move both MIRA-55 and SKNY-1 toward IND filings, having a clean, unified worldwide
rights structure in place is exactly where we need to be. It strengthens our position with partners, with investors, and across every
market we intend to operate in.”
Dr.
Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals, commented:
“MIRA-55
and SKNY-1 each address large patient populations with significant unmet need. What sets these programs apart is their differentiated
approach — targeting pathways that existing therapies either miss or handle poorly. Securing worldwide exclusive rights ensures
we control how these assets are developed and ultimately reach patients.”
About
MIRA-55
MIRA-55
is a next-generation cannabinoid analog designed to modulate cannabinoid receptor activity, including CB1 and CB2 pathways, while minimizing
CB1-related psychoactive activity. In preclinical inflammatory pain models, MIRA-55 demonstrated analgesic activity comparable to injected
morphine in normalizing pain responses, supporting its continued development as a potential non-opioid therapeutic. The U.S. Drug Enforcement
Administration (DEA) has confirmed, following scientific review, that MIRA-55 is not classified as a controlled substance. MIRA-55 is
an investigational compound and has not been approved by the FDA or any regulatory authority.
About
SKNY-1
SKNY-1
is an orally administered investigational drug candidate designed to modulate multiple pathways associated with metabolic regulation
and reward-associated behaviors. The compound was designed to combine pathway-selective CB1 modulation, CB2 receptor activity, and selective
MAO-B inhibition. In preclinical studies, oral administration of SKNY-1 was associated with dose-dependent reductions in body weight
and lipid normalization, with no significant reduction in whole-body density observed during the treatment period — a finding relevant
in the context of ongoing clinical focus on lean body mass preservation during weight reduction. SKNY-1 has not been approved by the
U.S. Food and Drug Administration (FDA) or any other regulatory authority, and its safety and efficacy have not been established in humans.
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, 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 www.mirapharmaceuticals.com.
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 MIRA-55, 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 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.
We
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 the 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
