Business
Achieve Life Sciences Reports Financial Results for Second Quarter 2023 and Provides Corporate Update
Company to host conference call tomorrow, Tuesday, August 15, 2023, at 8:30 AM EDT SEATTLE and VANCOUVER, British Columbia, Aug. 14, 2023 (GLOBE NEWSWIRE) --
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"Company to host conference call tomorrow, Tuesday, August 15, 2023, at 8:30 AM EDT SEATTLE and VANCOUVER, British Columbia, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced second quarter 2023 financial results and provided an update on the cytisinicline development program. Recent Highlights Publication of Phase 3 ORCA-2 trial results in the Journal of the American Medical Association (JAMA)Reported statistically significant smoking cessation benefit for cytisinicline in the confirmatory Phase 3 ORCA-3 trialAnnounced Phase 2 ORCA-V1 trial results showing statistically significant vaping cessation benefit with cytisinicline treatmentClosed equity financing with gross proceeds of approximately $16.5 million, prior to deducting placement agent commissions and estimated offering expensesRefinanced outstanding loan with Silicon Valley Bank (SVB) \"We’ve had a very exciting and eventful first half of 2023, with two additional clinical trials reading out with positive results for cytisinicline in both smoking and vaping cessation, and the recent publication of the completed Phase 3 ORCA-2 trial in the highly prestigious Journal of the American Medical Association,” commented John Bencich, CEO of Achieve. “In the upcoming months, our primary emphasis remains on fulfilling essential prerequisites and completion of multiple documents that will enable the submission of a New Drug Application for cytisinicline in the first half of 2024. Concurrently, we are dedicated to advancing commercialization strategies and engaging in crucial discussions that hold the potential of making cytisinicline the first FDA-approved therapy for smoking cessation in nearly two decades.\" JAMA PublicationThe positive Phase 3 ORCA-2 trial results for cytisinicline as a treatment for smoking cessation were published in JAMA. Authors concluded that both 6- and 12-week treatment durations of cytisinicline, with behavioral support, demonstrated “smoking cessation efficacy and excellent tolerability” in adult smokers. In addition to the previously reported cessation rates, the publication provided additional data demonstrating that cytisinicline participants had a rap...