MIRA Pharmaceuticals, Inc. filed a Form 8-K on October 28, 2026, disclosing initial proof-of-concept results from a pilot study of its investigational oral drug candidate SKNY-1 in a diet-induced obesity mouse model, with a press release scheduled for distribution on October 29, 2026.

Key Highlights

  • Statistically significant weight and fat reduction: The pilot study demonstrated statistically significant reductions in body weight and fat mass in SKNY-1-treated mice compared with vehicle-treated controls, according to the filing.
  • No significant lean-mass loss: 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, the company disclosed.
  • Food intake pattern: Weight reduction in SKNY-1-treated mice occurred without a statistically significant decrease in food consumption, according to the filing.
  • Post-discontinuation food intake: Following treatment discontinuation, 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, the filing states.
  • Limited weight regain: 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, according to the filing.
  • Emerging growth company status: The registrant indicated it is an emerging growth company as defined under applicable securities regulations.

MIRA Pharmaceuticals Discloses SKNY-1 Pilot Study Results in Diet-Induced Obesity Mouse Model

According to the Form 8-K filed by MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) on October 28, 2026, the company announced what it described as "initial positive proof-of-concept results" from an exploratory pilot study evaluating SKNY-1, its investigational oral drug candidate for obesity and metabolic disorders. The study was conducted in an established diet-induced obesity (DIO) mouse model. The filing notes that these results and the characterizations of differentiation from semaglutide are forward-looking in nature and subject to significant risks and uncertainties.

The filing identifies three areas where SKNY-1-treated mice showed potentially meaningful differences from the semaglutide reference group. First, weight reduction in SKNY-1-treated mice occurred without a statistically significant decrease in food consumption, which the company stated raises "the possibility that SKNY-1 may influence metabolic pathways beyond appetite suppression." Second, SKNY-1-treated mice did not demonstrate statistically significant lean-mass loss, unlike the semaglutide group. Third, weight regain following treatment discontinuation was described as slow and limited for SKNY-1-treated mice over a two-week observation period, compared with what the filing characterizes as rapid and substantial rebound in the semaglutide group.

The information was furnished under Item 7.01 (Regulation FD Disclosure) and, as noted in the filing, "shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934." The associated press release is furnished as Exhibit 99.1 and was scheduled for distribution on October 29, 2026. The filing was signed by Erez Aminov, Chief Executive Officer. The company's registered address is 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 33131.

What Was Disclosed

MIRA Pharmaceuticals furnished a Form 8-K on October 28, 2026, reporting pilot study results for its oral drug candidate SKNY-1 in obese mice, including comparisons to a semaglutide reference group on body weight, fat mass, lean mass, food intake, and post-discontinuation weight regain.