A Achieve Life Sciences, Inc. announced that three oral presentations featuring data from both of the Phase 3 ORCA-2 and ORCA-3 clinical trials of cytisinicline for smoking cessation and from the Phase 2 ORCA-V1 trial for e- vaping cessation will be presented at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting, being held in Edinburgh, Scotland, March 20-23, 2024. Presentation Schedule and Highlights: March 21, 2024, 11:30 AM GMT: Achieve's Director of Clinical Operations, Roxann Becco, will present patient-reported outcomes from the Phase 3 ORCA- 2 and ORCA-3 clinical trial. Data collected include trial participants' experiences, such as cravings and withdrawal symptoms, personal impact on overall health, and opinions on future use.

March 22, 2024, 8:30 AM GMT: Achieve' Chief Medical Officer and President, Dr. Cindy Jacobs, will present data from the second, completed Phase 3 ORCA-3 trial that evaluated the efficacy and safety of cytisinicline in 792 adult smokers in the United States. Findings confirmed results from the previous Phase 3 ORCA-2 trial demonstrating that cytisinicline, when dosed at the 3mg, three times daily schedule for either 6 or 12 weeks, increased smoking abstinence when compared with placebo and was very well-tolerated with no treatment-related serious adverse events reported. March 23, 2024, 9:45 AM GMT: Dr. Nancy Rigotti, ORCA-V1 Principal Investigator and Professor of Medicine at Harvard Medical School and Director of Tobacco Research and Treatment Center, Massachusetts General Hospital, will present data from the Phase 2ORCA-V1 trial.

ORCA-V1 evaluated the effectiveness and safety of cytisinicline in users of nicotine e-cigarettes who wanted to quit vaping. Similar to the efficacy and tolerability findings observed in the combustible cigarette cessation Phase 3 trials, ORCA-V1 participants who received cytisinicline had increased successful vaping cessation rates, compared with placebo, and reported minimal rates of adverse events. ORCA-V1 is supported by the National Institute on Drug Abuse of the National Institutes of Health (NIH) under Award Number 4R44DA054784-02.

The content is the sole responsibility of the authors and does not necessarily represent the official views of the NIH. Achieve?s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are an estimated 28 million adults in the United States alone who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.

More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke. In addition, there are over 11 million adults in the United Stateswho use e-cigarettes, also known as vaping. In 2023, approximately 2.1 million middle and high school students in the United States reported using e-cigarettes.4 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States.