On May 15, 2019 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, reported that first quarter 2019 financial results (Press release, OncoGenex Pharmaceuticals, MAY 15, 2019, View Source [SID1234536324]).

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ORCA-1 Trial Status

Achieve’s 254-subject Phase 2b ORCA-1 trial of cytisinicline in U.S. smokers completed enrollment in February. The Company announced recently that the last study visit for the last subject enrolled in the ORCA-1 trial has occurred. The trial is evaluating cytisinicline in both the 1.5 mg and 3.0 mg doses on a declining titration schedule as well as three times daily dosing, both over 25 days. The primary efficacy endpoint is reduction in the number of cigarettes smoked during treatment with secondary analyses to be conducted on smoking cessation rates, safety, and compliance. ORCA-1 topline efficacy and safety data are expected to be announced by the end of the second quarter.

Maximum Tolerated Dose (MTD) Trial Extension

Achieve recently initiated a trial to assess the MTD for a single administered oral dose of cytisinicline in smokers. The starting dosage of cytisinicline was 6 mg and is increased in separate groups of subjects for each escalated dose level until stopping criteria, based on the occurrence of dose-limiting adverse events, are reached. To date, 21 mg cytisinicline has been evaluated without evidence of dose limiting toxicity. The trial’s Data Safety Monitoring Committee has recommended a protocol amendment to evaluate additional higher doses of cytisinicline.

Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented, "With the results of the ORCA-1 trial expected by the end of the second quarter, we are rapidly approaching another critical milestone for the cytisinicline development program. Importantly, as confirmed by the tolerability of high dose levels in our MTD study, we believe cytisinicline may offer a differentiated and new treatment option for the millions of people who are battling nicotine addiction."

Financial Results

As of March 31, 2019, the company’s cash, cash equivalents, short-term investments and restricted cash were $9.7 million. Each of total operating expenses and net loss for the first quarter of 2019 were $5.9 million.

As of May 15, 2019 Achieve had 6,865,950 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 p.m. Eastern time today, Wednesday, May 15, 2019. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6973659. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.