On May 12, 2022 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported first quarter 2022 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, MAY 12, 2022, View Source [SID1234614475]).
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Recent Events & Highlights
Reported clinically robust and statistically significant Phase 3 topline results from the ORCA-2 clinical trial of cytisinicline in adult smokers
Following positive ORCA-2 results, Achieve updated its agreements with Silicon Valley Bank, providing access to an additional $10.0 million of capital
Cytisinicline development program overview presented at Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting
Appointed Dr. Vaughn Himes to Achieve’s Board of Directors
"Cytisinicline exceeded our expectations in the ORCA-2 trial by delivering impressive efficacy and tolerability in a difficult-to-treat population of smokers, who had lengthy and intense smoking histories, but who courageously attempted to quit smoking in the height of the COVID-19 pandemic," said John Bencich, Chief Executive Officer of Achieve. "We are delighted for those who were successful in ORCA-2 and inspired to continue our efforts to bring this important cytisinicline treatment to the FDA for review and potential approval as a new cessation option for the millions of people battling nicotine addiction."
Positive Phase 3 ORCA-2 Topline Results
The Phase 3 ORCA-2 trial of cytisinicline achieved statistically significant results in primary and secondary endpoints for both 6- and 12-week cytisinicline treatment compared to placebo, and was very well tolerated with single-digit rates of adverse events observed.
Subjects who received 12 weeks of cytisinicline treatment had 6.3 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 9-12 was 32.6% for cytisinicline compared to 7.0% for placebo.
Subjects who received 6 weeks of cytisinicline treatment had 8 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 3-6 was 25.3% for cytisinicline compared to 4.4% for placebo.
Updated Debt Facility Agreement with SVB
In connection with the positive ORCA-2 trial results, Achieve received approval from Silicon Valley Bank to access the remaining capital available under its $25.0 million debt facility put in place in December 2021. Per the terms of the agreement, the remaining $10.0 million of commitments are being made available to the Company through April 30, 2023. Amounts drawn under the remaining commitments will incur interest at the greater of 3.50% and the WSJ prime rate, and will be subject to interest only payments through April 30, 2024, and then amortize fully over the following 24 months. No amounts have been drawn to date and the Company will have the discretion to make draws under the facility through April 30, 2023.
Cytisinicline Development Program Presented at SRNT Annual Meeting
An overview of the cytisinicline development program was included in the "Promising New Smoking Cessation Pharmacotherapies" Symposium during the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting on March 16, 2022.
Dr. Vaughn Himes Appointed to the Board of Directors
In March, Achieve announced the appointment of Vaughn B. Himes, PhD, to Achieve’s Board of Directors. Dr. Himes currently serves as the Chief Technology Officer at Seagen, where he leads the manufacturing, supply chain, process sciences, and quality functions. He has more than 30 years of experience in product development and commercialization in the pharmaceutical and biotech industry, including previous roles as Senior Vice President of Technical Operations at ZymoGenetics, and Vice President of Worldwide Manufacturing Operations at Corixa Corporation.
Financial Results
As of March 31, 2022, the company’s cash, cash equivalents, and restricted cash was $36.4 million. Total operating expenses for the three months ended March 31, 2022 was $7.2 million. Total net loss for the three months ended March 31, 2022 was $7.6 million. As of May 12, 2022, Achieve had 9,681,855 shares outstanding.
Conference Call Details
Achieve will host a conference call at 4:30 PM EDT, Thursday, May 12, 2022. To access the webcast, please use the following link 1Q22 Earnings Webcast. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 3887417. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.