Company: MIRA
Filing Date: 2025-08-08
Form Type: DEFM14A
Source: 0001641172-25-022816
Chunk: 76

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-08
Form: DEFM14A
Chunk 76
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 trial will be initiated in treatment-seeking adult smokers. The primary endpoint will be continuous smoking abstinence, typically measured over weeks 9–12 post-quit date in line with FDA guidance. Secondary endpoints will include:

| ● | 7-day                                            
 point prevalence abstinence                      |
| ● | Time                                             
 to relapse                                       |
| ● | Changes                                          
 in body weight from baseline to the end of study |
| ● | Patient-reported                                 
 craving and withdrawal scores                    |

Subjects will be monitored using standardized tools such as the Fagerström Test for Nicotine Dependence (FTND) and exhaled carbon monoxide (CO) levels to confirm abstinence. Weight will be tracked using digital scales and analyzed for statistical differences between groups.

The trial will be designed to demonstrate that SKNY-1 not only helps subjects achieve smoking cessation but also avoids the common side effect of post-cessation weight gain, a leading cause of relapse among smokers.

Strategic Rationale

This dual-pathway strategy allows SKNY to target a well-established FDA approval path for smoking cessation (e.g., similar to Chantix or Nicorette), while also differentiating SKNY-1 with a unique weight-stabilizing mechanism. If successful, SKNY-1 may represent a first-in-class therapeutic that addresses both physiological and behavioral drivers of relapse.

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Our Market Opportunity and Market Advantage

The two leading causes of preventable death in the United States are smoking and obesity. Obesity is a significant health concern, affecting over 70 million people in the United States and accounting for about 40.3% of the adult population, according to data from the Centers for Disease Control and Prevention (“CDC”) for the years 2021–2023. This widespread health issue not only undermines the quality of life and daily functioning of individuals but also imposes a substantial economic burden, with costs in the United States. amounting to over $100 billion annually. Additionally, the productivity loss related to obesity is estimated at an annual cost of $6.4 billion. If approved by the FDA, SKNY-1 may potentially provide weight-loss benefits for patients.

Smoking is a significant U.S. health concern, with approximately 28.8 million smokers in the United States, accounting for about 11.6% of the adult population, according to data from the (CDC) as of 2022. This widespread health issue imposes a substantial economic burden, with costs in the U.S. amounting to over $240 billion