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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): July 29, 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 New Topical Ketamir-2 shows comparable effects to Injected Morphine in Preclinical Pain Study
Topical
Ketamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, demonstrating rapid onset, durable effect, and
comparable efficacy to injected morphine across both pain phases
On
July 29, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”) announced preclinical data
evaluating the analgesic effects of its new topical Ketamir-2 formulation in a validated rodent model of pain. The study was designed
to assess spontaneous pain-related behaviors in response to formalin injection, a well-established method that induces a biphasic pain
response: an acute phase (0–10 minutes) driven by direct nociceptor activation, and an inflammatory phase (15–60 minutes)
driven by central sensitization.
Topical
Ketamir-2 cream formulation was applied to the injected area at 30 minutes and just prior to formalin administration. Behavioral analysis
was conducted over five-minutes intervals on a 60-minute period using AI-assisted video tracking to quantify two validated endpoints:
| |
● |
Paw
licking, an active response associated with pain severity. |
| |
● |
Paw
lifting, a passive avoidance behavior associated with pain discomfort. |
Study
Results:
| |
● |
In
Phase 1 (0–10 min), Topical Ketamir-2 treatment nearly eliminated paw licking and significantly and markedly reduced
paw lifting compared to formalin-only control and was similar to morphine-treated animals. |
| |
● |
In
Phase 2 (15–60 min), Topical Ketamir-2 continued to show significant reduction in both behaviors, with comparable
overall suppression as morphine. |
| |
● |
Effect
sizes were consistent across all 5-minute intervals throughout the study duration. |
The
formalin test is commonly used to evaluate potential analgesic agents that target both neurogenic and inflammatory pain mechanisms. Phase
2 of the model, in particular, reflects central sensitization, a hallmark of many chronic and neuropathic pain conditions.
The
Company is currently conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers and expects to begin a Phase 2a study
in neuropathic pain later in 2025. MIRA is also continuing preclinical development of the topical formulation, including additional pharmacological
and toxicological assessments.
This
preclinical study supports continued investigation of topical Ketamir-2 as a potential non-opioid treatment for localized pain conditions,
including diabetic neuropathy, postherpetic neuralgia, chemotherapy-induced peripheral neuropathy, osteoarthritis, and other forms of
inflammatory pain.
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 29, 2025 |
By: |
/s/
Erez Aminov |
| |
Name:
|
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
