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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 (Date of earliest event reported): June 25, 2026
MIRA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in its Charter)
| Florida |
|
001-41765 |
|
85-3354547 |
| (State
or Other Jurisdiction |
|
(Commission |
|
(IRS
Employer |
| of
Incorporation) |
|
File
Number) |
|
Identification
No.) |
1200
Brickell Avenue, Suite 1950 #1183
Miami,
Florida 33131
(Address
of Principal Executive Offices)
Registrant’s
telephone number, including area code: (786) 432-9792
Not
Applicable
(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
7.01 Regulation FD Disclosure.
On
June 25, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release reporting new preclinical data demonstrating
Mira-55’s differentiated mechanism of action and anxiolytic activity relative to THC. Mira-55 is the Company’s cannabinoid
analog in development for chronic inflammatory pain, designed to act on the same cannabinoid receptors as compounds found in cannabis,
including THC, without carrying THC’s known liabilities, such as psychoactivity, and central nervous system side effects.
Using
standard preclinical models that researchers use to characterize THC-like compounds, the data showed that Mira-55 did not produce the
locomotor suppression or catalepsy associated with THC. Mira-55 produced a modest reduction in body temperature, but unlike the corresponding
THC effect, this was not reversed by rimonabant, a CB1 receptor antagonist, suggesting a mechanism distinct from classical CB1 agonism.
In a separate assay, Mira-55 demonstrated anxiolytic activity, in contrast to anxiogenic activity observed with rimonabant.
The
Company believes these findings, together with preclinical data reported in March 2026, support a pharmacological profile for Mira-55
that is differentiated from THC. These findings are based on preclinical pharmacology studies, and additional research will be required
to further characterize Mira-55’s receptor-level activity as the Company advances its IND-enabling program. A copy of the press
release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The
information in this Item 7.01, including Exhibit 99.1, is being 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 expressly set forth by specific reference in such filing.
Item
9.01 Financial Statements and Other Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release of MIRA Pharmaceuticals, Inc., dated June 25, 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 PHARMACEUTICALS, INC. |
| |
|
|
| Dated:
June 25, 2026 |
By: |
/s/
Erez Aminov |
| |
Name: |
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
Exhibit 99.1
MIRA
Pharmaceuticals Reports New Preclinical Data Demonstrating Mira-55’s Differentiated Mechanism of Action and Anxiolytic Activity
Relative to THC
Data
show Mira-55 does not produce the central nervous system effects associated with THC and acts through a distinct pharmacological mechanism,
while demonstrating anxiolytic activity, which THC does not produce, supporting continued development for chronic inflammatory pain
MIAMI,
FLORIDA / ACCESS Newswire / June 25, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”),
a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders, today announced
new preclinical pharmacology data on Mira-55, the Company’s cannabinoid analog in development for chronic inflammatory pain. Mira-55
is designed to act on the same cannabinoid receptors as compounds found in cannabis, including THC. A central pharmacological question
for the program is whether Mira-55 can deliver therapeutic activity through that receptor system without carrying THC’s known liabilities,
including psychoactivity and central nervous system side effects. This new study addresses that question directly.
Using
a standard test researchers rely on to characterize THC-like compounds, Mira-55 showed a pharmacological profile that sets it apart from
THC, including a meaningful anxiolytic effect that THC does not produce.
These
findings build on data MIRA reported in March 2026, which showed Mira-55 did not produce THC-like side effects and demonstrated anxiety-reducing
activity in animal testing, in contrast to rimonabant, a drug that blocks the same receptor THC acts on. Together, the two studies form
a consistent picture: Mira-55 engages the cannabinoid system differently than THC does, and that difference shows up at both the behavioral
and mechanistic levels.
Study
Overview and Key Findings
Researchers
tested THC and Mira-55, along with rimonabant’s ability to reverse their effects, in the same study using three standard measures
scientists use to characterize THC-like activity: body temperature, movement, and muscle rigidity (Catalepsy). They also tested for anxiety-like
behavior.
| ● | THC
showed the classic pattern of a THC-like compound. It lowered body temperature, slowed
movement, and catalepsy— and all three effects went away when rimonabant was given
alongside it. That is the textbook signature researchers look for to confirm a compound is
acting through the same CB1 pathway as THC. |
| | | |
| ● | Mira-55
showed a different pattern. It produced only one of those three effects, a modest drop
in body temperature, with no effect on movement or rigidity. |
| | | |
| ● | Mira-55’s
mechanism looks different, too. Rimonabant did not block Mira-55’s effect on body
temperature the way it blocked THC’s, suggesting Mira-55 is not working through the
same mechanism as THC, even in the one area where their effects briefly overlap. |
| | | |
| ● | Mira-55
produced a meaningful effect; THC did not: it reduced anxiety-like behavior. Rimonabant
made animals more anxious in this test; Mira-55 made them less anxious — consistent
with what MIRA reported in March, and a distinguishing feature of Mira-55’s profile
rather than simply an absence of THC-like effects. |
Why
This Matters
Taken
together, these results support a differentiated pharmacological and mechanistic profile for Mira-55 relative to THC. Mira-55 did not
reproduce THC’s full behavioral pattern; the one effect it did show was not driven by the same mechanism as THC’s, and it
produced an anxiety-reducing effect that THC does not. That combination — a distinct mechanism plus a differentiated, favorable
behavioral effect — is the more complete picture MIRA believes this data supports, beyond simply showing what Mira-55 does not
do.
Integrated
Preclinical Profile
This
mechanistic data adds to a growing body of preclinical evidence for Mira-55:
| ● | Delivered
morphine-comparable pain relief in a validated model of inflammatory pain, without opioid-related
risks |
| ● | Did
not produce THC-like CNS side effects across a battery of validated behavioral assays |
| ● | Demonstrated
anxiety-reducing activity, in contrast to rimonabant |
| ● | Now
shown to act through a mechanism distinct from THC, with a meaningful anxiety-reducing effect
THC does not produce |
MIRA
believes this combination of pain-relieving efficacy, a clean CNS safety profile, and a differentiated mechanism supports Mira-55’s
continued advancement toward an IND submission for chronic inflammatory pain.
These
findings are based on preclinical, mechanistic pharmacology studies. Additional studies, including further mammalian and translational
work, will be needed to fully define Mira-55’s receptor activity as MIRA advances its IND-enabling program.
IND
Strategy and Market Opportunity
MIRA
is advancing Mira-55 toward IND-enabling studies for chronic inflammatory pain, a large and growing market with significant unmet medical
need. Current treatment options include opioids, which carry risks of dependence, tolerance, and overdose, and NSAIDs, which may cause
gastrointestinal, renal, and cardiovascular adverse effects.
Leadership
Commentary
“Mira-55
keeps showing the same thing from different angles: a real anxiolytic effect, and a mechanism that doesn’t trace back to THC. That
combination is what differentiates this program. It’s also what we’ll keep building on as we advance Mira-55 toward an IND
in chronic inflammatory pain.”
—
Erez Aminov, Chairman and CEO of MIRA
Dr.
Itzchak Angel, Chief Scientific Advisor, added:
“THC
produced the full pattern you’d expect from a classic THC-like compound, and a CB1 blocker reversed every part of it. Mira-55 only
reproduced one piece of that pattern, and the blocker didn’t reverse it, which tells us Mira-55 is interacting with the receptor
differently than THC does. Mira-55 also did something THC didn’t: it reduced anxiety-like behavior, while the CB1-blocker increased
it. Put together, that’s a distinct mechanism paired with a distinct, favorable effect — a meaningfully different pharmacological
profile, not just an absence of THC’s downsides.”
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 psychoactivity. Following scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not
classified as a controlled substance.
About
MIRA Pharmaceuticals, Inc.
MIRA
Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical company focused on the development of novel therapies for neurologic,
neuropsychiatric, and metabolic disorders. Its pipeline includes Mira-55 for inflammatory pain, Ketamir-2 for neuropathic pain, and SKNY-1
targeting obesity and smoking cessation. The Company is headquartered in Miami, Florida.
Cautionary
Note Regarding 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 development of Ketamir-2;
the planned Phase 2a clinical trial, including its design, objectives, enrollment, timing, initiation and potential outcomes; the potential
efficacy, safety, tolerability and therapeutic benefits of Ketamir-2; the potential advantages of Ketamir-2 compared to existing treatment
options; the potential market opportunity for Ketamir-2; future regulatory interactions; intellectual property protection; strategic
partnership opportunities; and the future development and commercialization of Ketamir-2. 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
