Company: MIRA
Filing Date: 2025-06-24
Form Type: 8-K
Source: 0001641172-25-016285
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-24
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA Pharmaceuticals, Inc. (the “ Company” or “ MIRA”)
is providing an update on newly generated preclinical data for SKNY-1, a next-generation oral drug candidate being developed for weight
loss and smoking cessation by SKNY Pharmaceuticals, Inc. (“ SKNY”). MIRA has signed a definitive agreement to acquire SKNY,
and the proposed transaction remains subject to regulatory review and shareholder approval.

The Company is reporting newin vitro pharmacology datagenerated
by Eurofins laboratories in the United States and France. These studies evaluated SKNY-1’s receptor binding, signaling specificity,
and some off-target activity. The results highlight a unique and differentiated profile that may enable SKNY-1 to achieve therapeutic
effects in metabolic syndrome, weight loss and addiction without triggering the central nervous system (CNS) side effects associated with
prior CB1-targeting drugs.

Key Findings from the Eurofins Data:

  Biased CB1 receptor modulation: SKNY-1 demonstrated selective inhibition of the β-arrestin signaling pathway at                                                                                       

This“biased antagonist” profileis designed
to preserve beneficial CB1 activity while silencing the craving-related pathways. This differentiates SKNY-1 from earlier central CB1
blockers like rimonabant, which shut down both pathways and were linked to psychiatric side effects such as anxiety, depression, and suicidal
ideation - ultimately leading to rimonabant’s withdrawal from the European market.

By sparing the G-protein pathway, SKNY-1 may allow for craving
suppressionwithout disrupting dopamine balance, emotional tone, or motivation, thereby aiming to avoid the emotional dulling and
mood instability that previously limited this drug class.

  CB2 receptor activity: In addition to CB1 modulation, SKNY-1 demonstrated higher affinity partial agonist activity at the                 

  Selective MAO-B inhibition: SKNY-1 also showed low-affinity inhibition of the MAO-B enzyme, which plays a key role in                        

These findings were derived fromnon-clinical in vitro studiesand provide early validation of SKNY-1’s unique multi-pathway mechanism. The combination of targeted CB1 signaling, CB2 partial
activation, and selective MAO-B modulation is intended to reduce cravings and support weight loss and nicotine cessation without the
emotional or psychiatric side effectsthat have historically constrained CB1-targeting therapies.

In addition to these findings, the Company is finalizingin vivo
animal studiesevaluating