false
0001904286
0001904286
2025-07-02
2025-07-02
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 (Date of earliest event reported): July 2, 2025
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 Potent Inflammatory Pain Relief from Non-Psychoactive Marijuana Analog Mira-55 in Animal Model, Matching Morphine Without Opioid
Risks
On
July 2, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”) announced preclinical results
demonstrating that its proprietary drug candidate, Mira-55, a non-psychoactive marijuana analog, delivered morphine-comparable
pain relief in a validated animal model of inflammatory pain, without inducing local inflammation.
Mira-55
is a synthetic analog of marijuana engineered to selectively activate CB2 receptors, which are associated with anti-inflammatory
and analgesic effects. Unlike THC, it exhibits minimal activity at CB1 receptors, thus avoiding psychoactive side effects. In a formalin-based
rodent model, Mira-55 significantly reduced pain sensitivity, restored pain thresholds to near-baseline levels, and showed efficacy
comparable to morphine, the opioid control. No sedative or inflammatory effects were observed.
In
addition, the Company previously received confirmation from the U.S. Drug Enforcement Administration (DEA) that Mira-55 is
not classified as a controlled substance, removing a key regulatory barrier to clinical development.
These
new results strengthen MIRA’s pain-focused pipeline by positioning Mira-55 as a complementary program to Ketamir-2, the
Company’s clinical-stage NMDA receptor antagonist currently progressing through Phase 1 development for neuropathic pain.
“With
Mira-55 and Ketamir-2, we believe we’re building a differentiated, non-opioid pain franchise with the potential to treat two of
the largest and most underserved pain markets,” said Erez Aminov, Chairman and CEO of MIRA.
MIRA
also announced continued progress on its previously disclosed acquisition of SKNY Pharmaceuticals, the developer of SKNY-1, a novel investigational
therapy targeting both obesity and nicotine addiction. In recent studies, SKNY-1 demonstrated a 30% reduction in body weight without
muscle loss, along with a reversal of nicotine cravings—highlighting its potential as a differentiated treatment in two major markets.
The U.S. Securities and Exchange Commission (SEC) has completed its review of the merger proxy with no comments, allowing MIRA to proceed
with shareholder approval and the final steps toward completing the transaction.
MIRA
continues to advance Mira-55 toward an Investigational New Drug (IND) submission, with development efforts supporting future clinical
trials in inflammatory pain indications.
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 2, 2025 |
By: |
/s/
Erez Aminov |
| |
Name:
|
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
