Form 8-K MIRA PHARMACEUTICALS, For: Jun 17
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
(Exact Name of Registrant as Specified in its Charter)
| (State or Other Jurisdiction | (Commission | (IRS Employer | ||
| of Incorporation) | File Number) | Identification No.) |
(Address of Principal Executive Offices)
Registrant’s
telephone number, including area code:
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 | Name of each exchange on which registered | ||
| The
|
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 7.01 Regulation FD Disclosure.
On June 17, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) for Ketamir-2, the Company’s proprietary oral NMDA receptor modulator, in chemotherapy-induced peripheral neuropathy (CIPN). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
In connection with the submission, the Company received an acknowledgment of receipt from the FDA confirming acceptance of the Phase 2a clinical trial protocol submission for Protocol Mira-002. A copy of the FDA submission receipt is attached hereto as Exhibit 99.2 and incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Other Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release of MIRA Pharmaceuticals, Inc., dated June 17, 2026 | |
| 99.2 | FDA Acknowledgment of Receipt — Phase 2a Clinical Trial Protocol Submission, Protocol Mira-002 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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. | ||
| Dated: June 17, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |
ATTACHMENTS / EXHIBITS