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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): August 19, 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 Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple
Ascending Dose Stage
Following
FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025
On
August 19, 2025, MIRA Pharmaceuticals, Inc. (the “Company”) announced the completion of the Single Ascending Dose (“SAD”)
portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2 in healthy adult volunteers.
The
trial is being conducted at the Hadassah Clinical Research Center in Israel under the direction of Principal Investigator Prof. Yoseph
Caraco.
The
SAD portion of the trial enrolled 32 participants across four single dose cohorts ranging from 50 mg to 600 mg of Ketamir-2.
Dosing
decisions were overseen by an independent Safety Steering Committee, which reviewed blinded emerging safety and tolerability data before
advancing to next higher dose levels.
Safety
monitoring also included the Columbia-Suicide Severity Rating Scale (C-SSRS), Bowdle Visual Analogue Scale (VAS), and Ketamine Side Effect
Tool (KSET) questionnaires.
Based
on blinded safety data available to date in the SAD portion, no severe or clinically significant adverse effects have been observed at
any dose level.
The
Company is proceeding to the Multiple Ascending Dose (“MAD”) portion of the trial, the final stage of Phase 1, which will
evaluate three cohorts receiving daily oral doses of 150 mg, 300 mg, or 600 mg for five consecutive days in up to 24 participants.
The
trial is designed to evaluate the safety, tolerability, and pharmacokinetics of repeated administration of Ketamir-2 in healthy adult
volunteers.
The
Company has previously received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application
for Ketamir-2 in neuropathic pain and expects to initiate a U.S. Phase 2a clinical trial in Q4 2025, subject to ongoing results and regulatory
review.
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:
August 19, 2025 |
By: |
/s/
Erez Aminov |
| |
Name:
|
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
