false
0001904286
0001904286
2026-02-02
2026-02-02
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: February 02, 2026
MIRA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in its Charter)
| Florida |
|
001-41765 |
|
85-3354547 |
| (State or Other Jurisdiction |
|
(Commission |
|
(IRS Employer |
| of Incorporation) |
|
File Number) |
|
Identification No.) |
1200
Brickell Avenue, Suite 1950 #1183
Miami,
Florida 33131
(Address
of Principal Executive Offices)
(786)
432-9792
(Registrant’s
telephone
number,
including area code)
(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
On
February 2, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) announced that it has initiated dosing in the final
cohort of its Phase 1 multiple ascending dose (MAD) clinical trial evaluating Ketamir-2, the Company’s lead oral NMDA
receptor antagonist.
To
date, 50 healthy volunteers have already been dosed, while dosing in the final cohort is underway, with 6 subjects remaining.
The Company expects to complete the Phase 1 clinical program by the end of the first quarter of 2026.
The
Phase 1 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and pharmacokinetics
of single and multiple oral doses of Ketamir-2 in healthy volunteers.
The
Company is currently finalizing its Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy (CIPN), including clinical
site selection, and plans to submit the Phase 2a protocol to the U.S. Food and Drug Administration following completion of Phase 1. Subject
to regulatory feedback, the Company anticipates initiating the Phase 2a study in the second quarter of 2026. Given the oncology-related
nature of CIPN and the lack of FDA-approved therapies, the Company intends to pursue FDA Fast Track designation for Ketamir-2 as the
program advances.
The
Company also announced that it plans to engage in partnering discussions at the BIO Partnering Investment & Growth Summit
in March 2026 and to present Phase 1 data on Ketamir-2 at the American Association for Cancer Research (AACR) Annual Meeting
in April 2026.
In
addition, the Company provided an update on its preclinical pipeline programs. SKNY-1 is an orally administered small-molecule
program under development for weight loss and nicotine addiction and is designed to avoid central nervous system–related adverse
effects historically associated with prior CB1 receptor antagonists and muscle loss reported with certain injectable GLP-1–based
therapies. MIRA-55 is a preclinical program under development for inflammatory pain, which has demonstrated analgesic and anti-inflammatory
activity in preclinical models. Both programs are currently undergoing CMC optimization, with the objective of advancing each into IND-enabling
status by year-end 2026.
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
PHARMACUTICALS, INC. |
| |
|
| Dated:
February 02, 2026 |
By: |
/s/
Erez Aminov |
| |
Name: |
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
