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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): September 15, 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
Pharmaceuticals Reports Positive PTSD Data Demonstrating Ketamir-2 Restores Normalized Behavior in Stressed Animals
MIRA
Pharmaceuticals, Inc. (NASDAQ: MIRA) today announced results from a proof-of-concept validation study evaluating its oral drug candidate,
Ketamir-2, in an animal model of post-traumatic stress disorder (PTSD). The study was conducted in a small group of rats using the Single
Prolonged Stress (SPS) model, a widely accepted paradigm for inducing PTSD-like symptoms. Animals were exposed twice to a predator stressor
(bobcat urine), which induced avoidance behavior, anxiety-like responses, and depressive-like symptoms that persisted and intensified
over time, modeling chronic PTSD-like states.
Following
the development of these symptoms, animals were dosed orally with Ketamir-2 once daily for five consecutive days. Behavioral assessments
included anxiety-and coping/resilience-related behavior in the forced swim test (FST), which measures immobility versus active coping
strategies. Stressed animals displayed hallmark PTSD-like behaviors, including increased despair, immobility, and avoidance of coping.
Treatment with Ketamir-2 was associated with a reversal of these types of behaviors toward the level observed in non-stressed animals.
This
initial validation supports the study design, and a larger follow-on PTSD study is ongoing. Ketamir-2 is also being evaluated in an ongoing
Phase 1 clinical trial for neuropathic pain, where it has demonstrated a favorable safety profile to date.
Ketamir-2
is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and
has shown no significant off-target activity across a broad receptor panel. It was designed to capture the therapeutic efficacy of ketamine
while minimizing dissociative and other central nervous system side effects that limit ketamine’s clinical use. The U.S. Drug Enforcement
Administration’s scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical
under the Controlled Substances Act and its governing regulations. In prior preclinical studies, Ketamir-2 demonstrated superior efficacy
compared to ketamine, pregabalin, and gabapentin in neuropathic pain models.
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:
September 15, 2025 |
By: |
/s/
Erez Aminov |
| |
Name:
|
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
