Company: MIRA
Filing Date: 2025-07-10
Form Type: 8-K
Source: 0001641172-25-018595
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-10
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Reports Clear Reversal of Anxiety-Related Behavior in Animal Model Using SKNY-1, an Oral Drug Candidate for Obesity and Nicotine Addiction
Under Definitive Agreement for Acquisition

SKNY-1
was previously shown to achieve up to 30% weight loss, reverse nicotine craving, and preserve muscle mass in animal models - and
is designed to avoid the CNS side effects that halted earlier CB1-targeting drugs

On
July 10, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) announced new preclinical results from SKNY-1, an oral drug candidate
for obesity and nicotine addiction currently under definitive agreement for acquisition. In a validated behavioral model used to measure
Cannabinoid 1 receptor (CB1)-related anxiety-like effects, SKNY-1 demonstrated clear reversal of anxiety-related behavior induced by
a CB1 activator, setting it apart from earlier CB1-targeting drugs that were discontinued due to serious central nervous system (CNS)
effects.

The
study was conducted using the light-dark preference test in zebrafish - a behavioral model used to assess anxiety-related responses.
Zebrafish naturally prefer darker environments, but when anxiety levels are elevated, they avoid light even more strongly. Reduced dark
preference (i. e., more time spent in the light) is interpreted as a calming effect.

Four
groups were evaluated:

  Control                                                                                            
  CP55,940                                                                                           
  Rimonabant                                                                                         
  SKNY-1                                                                                             

SKNY-1
is under investigation for its differentiated pharmacological profile, which includes biased CB1 antagonism (blocking β-arrestin
signaling while preserving G-protein signaling), partial CB2 receptor activation, mild MAO-B inhibition, and no inhibition of MAO-A as
confirmed through in vitro screening. This profile is intended to avoid the psychiatric side effects historically observed with first-generation
CB1 antagonists such as rimonabant.

MIRA
Pharmaceuticals, Inc. is currently preparing for shareholder approval in connection with the proposed acquisition of SKNY Pharmaceuticals,
Inc. Pending approval, the Company expects to initiate Investigational New Drug (IND)-enabling studies for SKNY-1.

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.