Form 8-K - Current report
September 10 2024 - 4:01PM
Edgar (US Regulatory)
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0001904286
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2024-09-10
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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: September 10, 2024
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)
(737)
289-0835
(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
Mira
Pharmaceuticals Announces Selection of Neuropathic Pain as Indication for Ketamir-2 and Submits Pre-IND Meeting Request to FDA
Mira
Pharmaceuticals, Inc. (Nasdaq: MIRA) today announced that it has selected neuropathic pain as the primary indication for its novel oral
ketamine analog, Ketamir-2. The Company has submitted a pre-Investigational New Drug (pre-IND) meeting request to the U.S. Food and Drug
Administration (FDA) and anticipates the meeting to occur in October 2024. This selection marks a significant milestone as Mira Pharmaceuticals
advances toward its IND submission, with plans to begin human trials in the first quarter of 2025.
Cautionary
Note Regarding Forward Looking Statements
This
Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Such forward-looking statements are characterized by future or conditional verbs such as
“may,” “will,” “expect,” “intend,” “plans,” “anticipate,” “believe,”
“estimate,” “continue” and similar words. Such statements are only predictions and actual events or results may
differ materially from those anticipated in these forward-looking statements. You should not place undue reliance on any forward-looking
statements. In this report, such forward-looking statements relate to the anticipated benefits of the Company’s preclinical testing
results for, and the time for regulatory filings related to, Ketamir-2 or Nor-Ketamir-2. Readers are cautioned that actual future results
related to Ketamir-2 or Nor-Ketamir-2 may deviate materially and adversely from the forward-looking statements regarding Ketamir-2 and
Nor-Ketamir-2 contained herein. The Company does not assume any obligation to update forward-looking statements as circumstances change,
except as required by securities laws. These and other risks concerning the Company’s programs and operations are described in
additional detail in Annual Report on Form 10-K for the year ended December 31, 2023 and other SEC filings, which are on file with the
SEC at www.sec.gov and the Company’s website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly
disclaims any obligation to update any forward-looking statements except to the extent required by law.
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:
September 10, 2024 |
By: |
/s/
Erez Aminov |
|
Name:
|
Erez
Aminov |
|
Title: |
Chief
Executive Officer |
v3.24.2.u1
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Sep. 10, 2024 |
Cover [Abstract] |
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Document Period End Date |
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|
Entity File Number |
001-41765
|
Entity Registrant Name |
MIRA
PHARMACEUTICALS, INC.
|
Entity Central Index Key |
0001904286
|
Entity Tax Identification Number |
85-3354547
|
Entity Incorporation, State or Country Code |
FL
|
Entity Address, Address Line One |
1200
Brickell Avenue
|
Entity Address, Address Line Two |
Suite 1950 #1183
|
Entity Address, City or Town |
Miami
|
Entity Address, State or Province |
FL
|
Entity Address, Postal Zip Code |
33131
|
City Area Code |
(737)
|
Local Phone Number |
289-0835
|
Written Communications |
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Title of 12(b) Security |
Common
Stock, $0.0001 par value per share
|
Trading Symbol |
MIRA
|
Security Exchange Name |
NASDAQ
|
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