UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events
MIRA Pharmaceuticals Unveils Additional Preclinical Success
MIRA Pharmaceuticals, Inc. (the “Company”) unveiled promising preclinical data on Ketamir-2’s principal metabolite, Nor-Ketamir – a longer acting, brain penetrating and selective compound acting on the NMDA Complex’s PCP Receptor.
The Company recently received the results of new preclinical testing on its innovative drug candidate Ketamir-2 and its primary metabolite Nor-Ketamir-2. The new data reveals that Nor-Ketamir-2 selectively interacts with the NMDA PCP site while avoiding activity on the glutamate NMDA site. Additionally, a new salt formulation, Ketamir-2 Pamoate, has been developed to enhance pharmacokinetics, achieving nearly 100% oral bioavailability and improved brain penetration.
The Company is actively progressing with its IND-enabling regulatory work and Good Manufacturing Practice (GMP) drug scale-up. The Company’s plan is to submit an Investigational New Drug (IND) application by the end of the year, aiming to initiate clinical trials. These advancements highlight the commitment to developing safer and more effective treatments, moving closer to bringing Ketamir-2 to market.
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: August 9, 2024 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |
Cover |
Aug. 09, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Aug. 09, 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 | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Stock, $0.0001 par value per share |
| Trading Symbol | MIRA |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | true |
| Elected Not To Use the Extended Transition Period | false |