Company: MIRA
Filing Date: 2025-06-30
Form Type: 8-K
Source: 0001641172-25-017046
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-30
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Reports Up to 30% Weight Loss and Reversal of High-Calorie and Nicotine Cravings in an Animal Model of Obesity and Craving Using SKNY-1,
a Drug Candidate Under Definitive Agreement for Acquisition

On
June 30, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (the “ Company”) announced new animal study results from SKNY-1,
a next-generation oral therapeutic the Company is under definitive agreement to acquire from SKNY Pharmaceuticals, Inc.

In
a zebrafish model that mimics human obesity and craving behaviors, SKNY-1 demonstrated weight loss, suppression of appetite and craving
for high-calorie diets, and reversal of nicotine-seeking behavior - all achieved within six days of oral treatment.

Key
Results

Weight
Loss and Muscle Preservation:

SKNY-1
reduced body weight by approximately 30% after just six days of oral treatment. Treated animals ended up weighing about 10% less than
healthy controls. Importantly, this weight loss was not accompanied by muscle density changes - suggesting SKNY-1 helps burn fat
while preserving lean body mass.

Metabolic
Activity and Ventilation Rate:

Treated
animals showed an increase in breathing rate, which is a reliable signal that their metabolism was speeding up. This aligns with the
observed weight loss and suggests that SKNY-1 helps the body burn more energy.

Liver
and Lipid Profile Improvements:

In
untreated obese animals, fat buildup in the liver was about 50% higher than normal. SKNY-1 reversed this buildup, bringing liver fat
back to healthy levels. At the same time, cholesterol levels - including LDL (‘bad’ cholesterol) and HDL (‘good’
cholesterol) - also returned to normal, without affecting fat levels in the blood. This points to improved fat processing without
disrupting the body’s overall metabolic balance.

Appetite,
Craving, and Compulsive Eating:

Obese
animals were eating 2 - 3 times more high-calorie food than normal. SKNY-1 dose-dependently reduced this behavior - high-dose
animals ate less than healthy controls. The drug also made the animals less likely to pursue food in stressful environments and reduced
obsessive food-seeking in tests designed to measure craving.

Nicotine
Craving and Compulsivity:

SKNY-1
significantly reduced the