Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 187

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 187
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| Valuation                  | Page 7 of 25 |

The Market

Nicotine Dependence

Nicotine dependence is a state of substance dependence on nicotine that occurs when your body gets used to having some level of nicotine in the system. Nicotine is a type of stimulant found in tobacco products. The body constantly depends on chemicals in physical and psychological ways. Tobacco use is one of the leading preventable causes of death worldwide.

It is a chronic, relapsing disease characterized by a compulsive craving to use the drug despite social consequences, loss of control over drug intake, and the emergence of withdrawal symptoms. While cigarettes are the most prevalent form of nicotine delivery, dependence can arise from all tobacco products, including smokeless tobacco and e-cigarettes.

Symptoms include:

| ● | Compulsive                                                   
 drug-seeking behavior – An overwhelming urge to use nicotine |

| ● | Loss                                                 
 of control – Difficulty in limiting nicotine intake. |

| ● | Withdrawal                                                              
 symptoms- Unpleasant physical and psychological effects upon cessation. |

| ● | Tolerance                                                                   
 – The need for increasing doses of nicotine to achieve the desired effects. |

Nicotine dependence is a major public health problem due to its direct link to continued tobacco use, a leading preventable cause of death globally. Tobacco use is responsible for over 8 million deaths annually, with half of long-term users dying prematurely if they do not quit 12. Current smokers face an estimated 10-year reduction in lifespan compared to non-smokers 3.

The World Health Organization (WHO) highlights that greater nicotine dependence is associated with lower quit motivation, increased difficulty in quitting attempts, higher rates of failure, earlier initiation of smoking in the day, and a greater number of cigarettes smoked daily. In 2022, the WHO estimated 1.24 billion tobacco users worldwide, projecting a slight decline to 1.20 billion by 2025 4. In the United States in 2018, of the 34 million smokers, approximately 74.6% were daily smokers, indicating a high potential for nicotine dependence within this population. Furthermore, individuals with psychiatric disorders, such as anxiety and substance use disorders, exhibit a higher incidence of nicotine dependence 5.

1 “Tobacco”. www.who.int. 2024-07-31. Retrieved 2024-10-04.

2 Doll, Richard; Peto, Richard; Boreham, Jillian; Sutherland, Isabelle (2004-06-22). “Mortality