Cytisinicline shows promise for smoking cessation

SEATTLE and VANCOUVER, British Columbia - Achieve Life Sciences, Inc. (NASDAQ:ACHV), a specialty pharmaceutical company with a market capitalization of $69 million, announced today that its Phase 3 clinical trial, ORCA-3, has shown that cytisinicline significantly aids in smoking cessation. According to InvestingPro data, while the company maintains a strong liquidity position with a current ratio of 5.46 and more cash than debt on its balance sheet, it faces challenges with rapid cash burn and negative earnings of -$1.24 per share over the last twelve months. The study, recently published in the Journal of the American Medical Association (JAMA) Internal Medicine, demonstrated the drug’s efficacy in reducing nicotine cravings and increasing the likelihood of quitting smoking compared to a placebo.

The ORCA-3 trial involved 792 adult smokers across the United States and provided cytisinicline in 3mg doses three times daily for 6 or 12 weeks. For investors tracking this development, InvestingPro analysis reveals the stock has experienced significant volatility, with a beta of 1.59 and a 60% decline over the past six months. Get access to 13 additional ProTips and comprehensive analysis with an InvestingPro subscription. Participants were monitored for 24 weeks, and the primary endpoint was continuous abstinence from smoking during the last four weeks of treatment. The trial also assessed continued abstinence rates through 6 months.

Cytisinicline, a plant-based alkaloid, targets nicotine receptors in the brain, which is believed to help reduce cravings and the satisfaction derived from nicotine products. According to the study, the drug was well tolerated with limited side effects, a notable finding given the adverse event profiles of some existing treatments.

Dr. Cindy Jacobs, President and Chief Medical Officer of Achieve Life Sciences, highlighted the drug’s selectivity in targeting nicotine receptors, which may lead to its favorable tolerability. Nancy Rigotti, MD, Professor of Medicine at Harvard Medical School and ORCA Program Investigator, emphasized the potential impact of cytisinicline, if approved by the FDA, in helping smokers quit and reduce health risks associated with smoking.

Achieve Life Sciences plans to submit a New Drug Application for cytisinicline to the U.S. Food and Drug Administration in June 2025. The company has completed two Phase 3 studies for smoking cessation and one Phase 2 study for vaping cessation, with an ongoing open-label safety study. InvestingPro analysis indicates analyst consensus remains optimistic, though three analysts have recently revised their earnings expectations downward. The stock is currently trading near its Fair Value, with the next earnings report expected on May 8, 2025. Discover detailed valuation metrics and comprehensive research reports covering 1,400+ US stocks with an InvestingPro subscription.

The development of cytisinicline comes at a crucial time, as tobacco use remains the leading cause of preventable death, causing nearly half a million deaths annually in the United States alone. There are currently no FDA-approved treatments specifically for nicotine e-cigarette cessation, and cytisinicline has been granted Breakthrough Therapy designation by the FDA to address this need.

This report is based on a press release statement from Achieve Life Sciences.

In other recent news, Achieve Life Sciences reported fourth-quarter earnings that did not meet analyst expectations, with a loss of $0.36 per share, compared to the anticipated $0.34 loss. The company recorded total operating expenses of $12.2 million and a net loss of $12.4 million for the quarter. Achieve Life Sciences concluded 2024 with $34.4 million in cash, cash equivalents, and marketable securities. Despite the earnings miss, the company reaffirmed its plan to submit a new drug application for cytisinicline to the U.S. Food and Drug Administration by the end of the second quarter of 2025. The company has successfully completed enrollment in its ORCA-OL long-term exposure trial, a key step toward the submission. Achieve Life Sciences also reported positive outcomes from two data safety monitoring committee reviews of the ORCA-OL trial, indicating no safety concerns. Furthermore, the company recently appointed two new board members and a new Chief Financial Officer to bolster its strategic initiatives and potential commercialization efforts.

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