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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 22, 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 Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine
Analog
Study
demonstrated that Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no
severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption and a favorable duration
of action supporting once-daily dosing.
On
September 22, 2025, MIRA Pharmaceuticals, Inc. (the “Company”) announced topline results from the single ascending dose (SAD)
portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2 in healthy volunteers.
The
randomized, placebo-controlled study enrolled 32 healthy adult participants across four escalating oral dose cohorts (50 mg to 600 mg).
The primary endpoints were safety, tolerability, and pharmacokinetic (PK) characterization.
Pharmacokinetic
Results
| |
● |
Dose-proportional
increases in exposure (Cmax and AUC) were observed across all dose levels tested. |
| |
● |
Median
time to maximum plasma concentration (Tmax) was reached within 1–2 hours, consistent across cohorts. |
| |
● |
Terminal
half-life (t½) of Ketamir-2 ranged from 2 to 5 hours. |
| |
● |
The
primary active metabolite, nor-Ketamir, demonstrated a half-life of 6.5 to 8.5 hours. |
Safety
and Tolerability Results
| |
● |
Ketamir-2
was generally safe and well tolerated across all four cohorts. |
| |
● |
No
dose-limiting toxicities or serious adverse events were observed. |
| |
● |
Reported
treatment-emergent adverse events were transient and resolved without intervention. |
| |
● |
Central
nervous system (CNS) safety was monitored using validated tools (C-SSRS, Bowdle VAS, KSET). Across all SAD cohorts, no clinically
significant adverse effects of Ketamir-2 observed. |
Next
Steps
Based
on the data, the Company is initiating the multiple ascending dose (MAD) portion of the Phase 1 study in healthy volunteers, to be followed
by a Phase 2a trial in patients with neuropathic pain.
Additional
Information
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.
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 22, 2025 |
By: |
/s/
Erez Aminov |
| |
Name:
|
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
