false
0001904286
0001904286
2026-05-21
2026-05-21
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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 ☒
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
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.
On
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 |
|
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:
May 27, 2026 |
By: |
/s/
Erez Aminov |
| |
Name: |
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
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
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.
In
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.
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 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
