Achieve Life Sciences announces latest cytisinicline developments

Achieve Life Sciences, Inc., a pharmaceutical company dedicated to helping smokers quit and overcoming nicotine addiction, has announced its financial report for the third quarter of 2022. The company also unveiled the latest progress in the development plan of cytisinicline (a plant-based compound used to treat nicotine addiction).

Focus" or "Focus on

In September, it was announced that the targeted recruitment of 750 adult smokers for the phase three ORCA-3 clinical trial of cytisinicline (a.k.a. varenicline) had been completed.

In November, it was announced that the targeted recruitment for the second phase of the ORCA-V1 clinical trial for cytisinicline (a nicotine replacement therapy) was completed ahead of schedule. The trial focused on 150 adult e-cigarette users.

Sopharma has completed the construction of a new suite of active pharmaceutical ingredient (API) facilities, thereby expanding its global commercial manufacturing capacity for cytisinicline (also known as varenicline).

John Bencich, CEO of Achieve Life Sciences, announced that the completion of the ORCA-3 trial this quarter and the recent recruitment for the ORCA-V1 trial bring the company one step closer to offering a critical treatment option for those seeking to end their nicotine dependence. "We are pleased to build upon the previously reported benefits, safety, and tolerability of cytisinicline (also known as varenicline) and look forward to releasing the latest data from these two trials in the second quarter of next year.

The targeted recruitment for the completion of Phase 3 ORCA-3 testing has been achieved.

In September, Achieve announced the completion of targeted recruitment of 750 adult smokers for the Phase 3 clinical trial of cytisinicline (also known as varenicline) at 20 trial sites in the United States (ORCA-3). Participants in ORCA-3 were randomized to one of three study groups to determine the efficacy and safety of cytisinicline after 6 or 12 weeks of treatment compared to placebo. This trial is similar to ORCA-2, which aimed to assess the continuous abstinence rate during the final 4 weeks of treatment using biochemical verification in smokers who received cytisinicline for 6 or 12 weeks compared to placebo. Each treatment group will be compared independently to the placebo group, and if one or both cytisinicline treatment groups demonstrate statistically significant benefits compared to placebo, the trial will be considered successful. The latest data from ORCA-3 is expected to be reported in the second quarter of 2023.

The ORCA-V1 trial has completed its recruitment ahead of schedule.

In November, Achieve announced the successful recruitment of 150 adult users of nicotine electronic cigarettes for the second phase clinical trial of cytisinicline (also known as "golden bird's eye" alkaloid) at 5 different trial sites in the United States, known as ORCA-V1. Participants will be randomly assigned to receive either a daily dose of 3 milligrams of cytisinicline or a placebo for a period of 12 weeks. Throughout the trial, standardized behavioral support will be provided to all participants. The main outcome measure of ORCA-V1 will be smoking cessation achieved during the final 4 weeks of treatment. The trial is supported by funding from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH), with preliminary results expected to be reported in the second quarter of 2023.

Expansion of production facilities.

Achieve's business partner Sopharma has invested over 3 million euros in building a new purification plant for cytisinicline API, a raw material for the production of goldenrods alkaloids, at its main manufacturing facility. This greatly expands the global production capacity of cytisinicline, with the new API plant enhancing Sopharma's ability to produce nearly 3 billion tablets of medicine annually.

Financial performance.

As of September 30th, 2022, the company had $18.2 million in cash, cash equivalents, and restricted cash. Total operating expenses for the past three months and nine months were $12.6 million and $29.9 million, respectively, with net losses of $13.1 million and $31.1 million. As of November 10th, 2022, Achieve had 9,710,747 shares of common stock outstanding.

Regarding Achieve and Cytisinicline

Achieve's focus is on developing cytisinicline (also known as varenicline) as a solution to the global problem of smoking and nicotine addiction. Smoking cessation is currently the leading preventable cause of death, with over 8 million deaths worldwide and nearly 500,000 deaths annually in the United States alone. More than 87% of lung cancer deaths, 61% of deaths from lung disease, and 32% of deaths from coronary heart disease are attributable to smoking or exposure to secondhand smoke.

In addition, almost 11 million adults in the United States use e-cigarettes. Despite nicotine e-cigarettes being considered less harmful than traditional cigarettes, they can still create addictive behavior and potentially distribute harmful chemicals that can lead to lung damage or cardiovascular disease. In 2021, e-cigarettes were the most commonly used tobacco product in a survey of 1.72 million high school students. Research shows that adolescents who have used e-cigarettes are seven times more likely to start smoking compared to those who have never used them. Currently, there are no FDA-approved treatments specifically designed to aid in quitting e-cigarette use.

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