UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On July 6, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive results from preclinical studies evaluating the optimized oral formulation of SKNY-1, the Company’s oral drug candidate being developed for obesity and addiction-related disorders.
The studies demonstrated favorable oral bioavailability together with reproducible systemic exposure and robust brain penetration, and substantial liver exposure following oral administration. Peak plasma concentrations and kinetics supported the potential for convenient once-daily oral dosing.
The Company believes these pharmacokinetic findings further strengthen the development profile of SKNY-1 by demonstrating that the optimized oral formulation delivers meaningful systemic exposure together with distribution into pharmacologically relevant tissues. These findings complement the Company’s previously reported preclinical efficacy and behavioral studies demonstrating significant reductions in body weight, preservation of lean body mass, improvements in metabolic parameters, attenuation of compulsive feeding and nicotine-seeking behaviors, and evidence that SKNY-1 did not produce anxiety-related behavioral effects in a validated preclinical model despite demonstrated cannabinoid receptor activity.
A copy of the Company’s press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information contained in this Item 7.01, including Exhibit 99.1, 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 into 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 July 6, 2026 | |
| 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: July 6, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |