UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
MIRA Pharmaceuticals Reports Significant Weight and Fat Reduction With Oral SKNY-1 in Obese Mice, Showing Favorable Lean-Mass and Weight-Regain Outcomes Compared With Semaglutide
On October 28, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) announced initial positive proof-of-concept results from an exploratory pilot study evaluating SKNY-1, its investigational oral drug candidate for obesity and metabolic disorders.
Conducted in an established diet-induced obesity (DIO) mouse model, the study demonstrated statistically significant reductions in body weight and fat mass following oral administration of SKNY-1 compared with vehicle-treated controls. The study also identified three potentially meaningful areas of differentiation from the semaglutide reference group:
| 1. | Food Intake: Weight reduction occurred without a statistically significant decrease in food consumption, raising the possibility that SKNY-1 may influence metabolic pathways beyond appetite suppression. Following treatment discontinuation, oral SKNY-1-treated groups showed no statistically significant increase in food consumption relative to vehicle controls, while semaglutide-treated mice demonstrated a statistically significant increase. |
| 2. | Lean-Mass Outcomes: Oral SKNY-1-treated mice did not demonstrate statistically significant lean-mass loss relative to vehicle controls, while semaglutide-treated mice demonstrated statistically significant lean-mass loss compared with vehicle-treated controls. |
| 3. | Weight Regain Following Treatment Discontinuation: Oral SKNY-1-treated mice demonstrated slow and limited weight regain during the two-week observation period following treatment cessation, contrasting with rapid and substantial weight rebound in semaglutide-treated mice. |
A copy of the Company’s press release, scheduled for distribution on October 29, 2026, is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is 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, 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 Securities Exchange Act of 1934, as amended, except as expressly set forth by specific reference in such filing.
Cautionary Note Regarding Forward-Looking Statements
This report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally may be identified by the use of words such as “anticipate,” “expect,” “plan,” “can,” “could,” “would,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” “guidance,” “potential,” “intend,” “seek,” “target” and other words of similar meaning, although not all forward-looking statements include these words. Forward-looking statements may include, but are not limited to, statements regarding the therapeutic potential, mechanism of action, development plans, regulatory pathway, safety profile, efficacy, anticipated clinical development, commercialization prospects, market opportunity, and future development of MIRA-55, SKNY-1, Ketamir-2, and the Company’s other product candidates.
These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management’s current beliefs and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical and clinical development, the ability to obtain regulatory approvals, the outcome of future studies, reliance on third parties, intellectual property protection, financing needs, market conditions, and the other risks identified under the heading “Risk Factors” contained in the Company’s Annual Report on Form 10-K and the Company’s subsequent filings with the U.S. Securities and Exchange Commission (“SEC”).
Forward-looking statements contained in this report speak only as of the date of this report, and the Company undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.
Investors are cautioned not to place undue reliance on these forward-looking statements. Additional information regarding these and other risks and uncertainties is contained in the Company’s filings with the SEC, including its Annual Report on Form 10-K and subsequent filings, available at www.sec.gov and in the Investors section of the Company’s website at www.mirapharmaceuticals.com. Forward-looking statements should be considered in light of these risks and uncertainties.
Item 9.01 Financial Statements and Other Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release of MIRA Pharmaceuticals, Inc., dated October 29, 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: October 28, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |