MIRA Pharmaceuticals Inc. filed SEC Form 8-K: Other Events
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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 | |