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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):
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)
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
8.01 Other Events
MIRA
Reports Clear Reversal of Anxiety-Related Behavior in Animal Model Using SKNY-1, an Oral Drug Candidate for Obesity and Nicotine Addiction
Under Definitive Agreement for Acquisition
SKNY-1
was previously shown to achieve up to 30% weight loss, reverse nicotine craving, and preserve muscle mass in animal models—and
is designed to avoid the CNS side effects that halted earlier CB1-targeting drugs
On
July 10, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) announced new preclinical results from SKNY-1, an oral drug candidate
for obesity and nicotine addiction currently under definitive agreement for acquisition. In a validated behavioral model used to measure
Cannabinoid 1 receptor (CB1)-related anxiety-like effects, SKNY-1 demonstrated clear reversal of anxiety-related behavior induced by
a CB1 activator, setting it apart from earlier CB1-targeting drugs that were discontinued due to serious central nervous system (CNS)
effects.
The
study was conducted using the light-dark preference test in zebrafish—a behavioral model used to assess anxiety-related responses.
Zebrafish naturally prefer darker environments, but when anxiety levels are elevated, they avoid light even more strongly. Reduced dark
preference (i.e., more time spent in the light) is interpreted as a calming effect.
Four
groups were evaluated:
| ● | Control
Group (No Drug): Fish displayed balanced light-dark behavior. |
| ● | CP55,940
Group (CB1 Agonist): At high doses, CP55,940 increased time spent in the dark, indicating
anxiety-related behavior. At low doses, it produced a calming effect. |
| ● | Rimonabant
Group (CB1 Inverse Agonist): Increased anxiety-like behavior was observed at both high
and low doses of CP55,940. The response was greater than that of the CP55,940 group alone,
consistent with previously documented psychiatric effects. |
| ● | SKNY-1
Groups: In animals co-treated with CP55,940, SKNY-1 reversed the anxiety-inducing effects
of high-dose CP55,940 and enhanced the calming effects at low doses. In all treatment conditions,
SKNY-1 normalized behavior to control or better-than-control levels. |
SKNY-1
is under investigation for its differentiated pharmacological profile, which includes biased CB1 antagonism (blocking β-arrestin
signaling while preserving G-protein signaling), partial CB2 receptor activation, mild MAO-B inhibition, and no inhibition of MAO-A as
confirmed through in vitro screening. This profile is intended to avoid the psychiatric side effects historically observed with first-generation
CB1 antagonists such as rimonabant.
MIRA
Pharmaceuticals, Inc. is currently preparing for shareholder approval in connection with the proposed acquisition of SKNY Pharmaceuticals,
Inc. Pending approval, the Company expects to initiate Investigational New Drug (IND)-enabling studies for SKNY-1.
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:
July 10, 2025 |
By: |
/s/
Erez Aminov |
| |
Name:
|
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
