Achieve Life Sciences Q1 2024 Financial Results and Corporate Update

Achieve Life Sciences, Inc. (NASDAQ: ACHV), a prominent pharmaceutical company focused on the development and commercialization of cytisinicline for smoking cessation and nicotine dependence, recently reported its financial results for the first quarter of 2024. Alongside these results, the company also provided updates on the progress of its cytisinicline development program.

In the first quarter of 2024, Achieve Life Sciences has made significant strides. One of the notable achievements was the publication of the Phase 2 ORCA-V1 clinical trial results in the Journal of the American Medical Association Internal Medicine (JAMA IM). This trial demonstrated that cytisinicline significantly increased the odds of vaping cessation and was well tolerated by participants. Achieve plans to conduct an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in 2024 to discuss potential expanded labeling for e-cigarette cessation.

Another milestone was the presentation of data from various trials at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting. These included the Phase 3 ORCA-2 and ORCA-3 trials and the Phase 2 ORCA-V1 trial. The data highlighted the efficacy of cytisinicline in aiding smoking cessation, with 69% of participants in the Phase 3 trials successfully quitting smoking and 22% significantly reducing their smoking habits. Participants credited their success to cytisinicline's ability to reduce cravings and side effects, with most expressing willingness to recommend the treatment.

A significant development in Achieve’s strategy is the advancement of the long-term cytisinicline exposure trial, ORCA-OL. The company and the FDA have agreed that a single, open-label study evaluating the long-term safety of cytisinicline will suffice for a New Drug Application (NDA) submission, now expected in the first half of 2025. This trial is scheduled to begin in May 2024 and will involve over 1,700 participants from previous trials to generate comprehensive long-term safety data.

Financially, Achieve Life Sciences secured substantial funding through an equity financing endeavor totaling up to $124.2 million. This includes an initial upfront funding of $60.0 million and an additional $64.2 million contingent on the exercise of milestone-driven warrants. The proceeds from this financing will support the ongoing development of cytisinicline, including the ORCA-OL trial, and provide working capital and general corporate funds. With these funds, Achieve anticipates having sufficient resources to continue its development efforts through 2026 and potentially achieve FDA approval.

As of March 31, 2024, Achieve reported cash and cash equivalents totaling $66.4 million, reflecting the proceeds from the recent financing efforts. The total operating expenses for the first quarter amounted to $6.0 million, and the net loss was $6.5 million. Achieve had 34,341,303 shares outstanding as of May 9, 2024.

Achieve Life Sciences continues to focus on addressing the global health crisis caused by smoking and nicotine addiction. In the United States alone, an estimated 28 million adults smoke combustible cigarettes, contributing to numerous preventable deaths. Additionally, over 11 million adults use e-cigarettes, with no FDA-approved treatments currently available for vaping cessation.

Cytisinicline, a plant-based alkaloid with a high affinity for nicotinic acetylcholine receptors, is under investigation as a treatment to aid in smoking and e-cigarette cessation. It works by reducing withdrawal symptoms and the reward associated with nicotine use. Although still investigational and not yet approved by the FDA, cytisinicline has shown promise in clinical trials.

Achieve Life Sciences will host a conference call today at 4:30 PM EDT to discuss these developments further. Participants can access the call via the investor relations page on the Achieve website.

In summary, Achieve Life Sciences has made significant progress in the first quarter of 2024, advancing its cytisinicline development program and securing substantial funding to support its efforts. With continued focus and resource allocation, the company aims to bring cytisinicline to market as a viable solution for smoking and nicotine addiction.