Form 8-K - Current report
2024年7月20日 - 6:12AM
Edgar (US Regulatory)
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0001904286
0001904286
2024-07-19
2024-07-19
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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 19, 2024
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) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (737) 289-0835
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(s) |
|
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.
MIRA
Pharmaceuticals Unveils Additional Preclinical Success
MIRA
Pharmaceuticals, Inc. (the “Company”) recently received the results of new preclinical testing data for its novel oral ketamine
analog, Ketamir-2. Ketamir-2 is under investigation for its potential in treating neurological and neuropsychiatric disorders, including
depression, treatment-resistant depression (TRD), and post-traumatic stress disorder (PTSD).
The
Company plan to use this data as it works towards its goal of submitting an Investigational New Drug application to the U.S. Food and
Drug Administration by the end of this year which, if granted, would allow for human testing of Ketamir-2.
The
data highlights Ketamir-2’s potential for superior brain penetration and reduced drug resistance compared to traditional ketamine.
Ketamir-2 demonstrated in in vitro studies that it is not a substrate for interaction with P-glycoprotein (P-gp), a membrane protein
that typically pumps many drugs out of cells, including cells located in the brain. This characteristic might allow Ketamir-2 to have
a better oral absorption and to penetrate the blood-brain barrier more effectively than traditional ketamine, which is a substrate of
P-gp.
The
Company previously announced that Ketamir-2’s oral bioavailability is predicted to be around 80%, significantly higher than traditional
ketamine’s less than 30%. Additionally, preclinical studies have shown that while oral Ketamir-2 has been shown to be safe at high
doses and is effective in several anti-depressant and anxiolytic models, and it does not appear to induce hyper-locomotor activity, a
common side effect of traditional ketamine. Moreover, Ketamir-2 has shown no interaction with the mu-opioid receptor, unlike traditional
ketamine. This could potentially mean a reduced risk of opioid-related side effects and dependency.
Building
on these promising preclinical results, the Company has additional ongoing preclinical studies to demonstrate Ketamir-2’s potential
efficacy in treating chemotherapy-induced depression and cancer-related neuropathic pain. Due to its novel chemical profile, the Company
is exploring options for orphan drug indications such as multiple sclerosis-induced depression and Huntington’s disease-induced
depression. Models are being developed to validate these designations and ongoing studies have been designed to help support these efforts.
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. Readers are cautioned that actual future results related to Ketamir-2
may deviate materially and adversely from the forward-looking statements regarding 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.
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. |
|
|
|
Date:
July 19, 2024 |
By: |
/s/
Erez Aminov |
|
|
Erez
Aminov |
|
|
Chief
Executive Officer |
v3.24.2
Cover
|
Jul. 19, 2024 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Jul. 19, 2024
|
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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|
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Pre-commencement Tender Offer |
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Pre-commencement Issuer Tender Offer |
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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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MIRA Pharmaceuticals (NASDAQ:MIRA)
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