On November 14, 2022 Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, reported third quarter 2022 financial results and provided an update on the cytisinicline development program (Press release, OncoGenex Pharmaceuticals, NOV 14, 2022, View Source [SID1234624013]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Highlights
Completion of targeted enrollment in Phase 3 ORCA-3 clinical trial of cytisinicline in 750 adult smokers was announced in September
Early completion of targeted enrollment in the Phase 2 ORCA-V1 clinical trial of cytisinicline in 150 adult nicotine e-cigarette users was announced in November
New active pharmaceutical ingredient (API) suite construction completed by Sopharma, expanding the global commercial manufacturing capacity for cytisinicline
"Completing enrollment in the ORCA-3 trial this quarter and more recently, the ORCA-V1 trial, has moved us closer to potentially bringing a critical treatment option to people who wish to end their nicotine dependence," stated John Bencich, CEO of Achieve Life Sciences. "We are excited to build upon the previously reported cessation benefit, safety, and tolerability of cytisinicline and look forward to releasing top-line data for both trials in the second quarter of next year."
Completed Enrollment in Confirmatory Phase 3 ORCA-3 Trial
In September, Achieve announced the completion of targeted enrollment of 750 adult smokers in its confirmatory Phase 3 ORCA-3 clinical trial of cytisinicline being conducted across 20 clinical trial locations in the United States. The participants in ORCA-3 were randomized to one-of-three study arms to determine the efficacy and safety of cytisinicline administered for either 6 or 12 weeks, compared to placebo. Similar to the previously reported ORCA-2 trial, the primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. Topline ORCA-3 data are currently expected to be reported in Q2 of 2023.
Early Completion of Enrollment in Phase 2 ORCA-V1 Trial
In November, Achieve announced the early completion of targeted enrollment of 150 adult users of nicotine e-cigarettes in the Phase 2 ORCA-V1 clinical trial of cytisinicline being conducted across 5 clinical trial locations in the United States. Participants were randomized in this two-arm trial to receive either cytisinicline, dosed at 3 mg three times daily, or placebo, for a period of 12 weeks. All subjects are also receiving standardized behavioral support throughout the trial. The primary outcome assessment of ORCA-V1 will be continuous vaping abstinence during the final 4 weeks of treatment. ORCA-V1 is supported through grant funding from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH). Topline results are expected to be reported in Q2 of 2023.
Sopharma Expansion of Manufacturing Facility
Achieve’s commercial manufacturing partner, Sopharma, financed and completed the build out of a new dedicated cytisinicline API purification suite at its primary manufacturing plant. At an estimated build out cost of more than €3 million, the newly completed API suite significantly expands the capacity to produce quantities of cytisinicline at a global scale. The new API suite complements Sopharma’s capacity to produce nearly 3 billion tablets annually.
Financial Results
As of September 30, 2022, the company’s cash, cash equivalents, and restricted cash were $18.2 million. Total operating expenses for the three and nine months ended September 30, 2022 were $12.6 million and $29.9 million, respectively. Total net loss for the three and nine months ended September 30, 2022 was $13.1 million and $31.1 million, respectively.
As of November 10, 2022, Achieve had 9,710,747 shares of common stock outstanding.
Conference Call Details
Achieve will host a conference call today at 4:30 PM EST, Monday, November 14, 2022. To access the webcast, please use the following link 3Q22 Earnings Webcast. Alternatively, you may access the live conference call by dialing (877) 269-7756 (Domestic) or (201) 689-7817 (International) and referencing conference ID 13733008. A webcast replay will be available approximately three hours after the call and will be archived on the website for 90 days.