On August 11, 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 addiction, reported second quarter 2022 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, AUG 11, 2022, View Source [SID1234618218]).
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Recent Events & Highlights
Reported statistically significant results from the Phase 3 ORCA-2 clinical trial of cytisinicline in 810 adult smokers
Awarded $2.5 million grant from the National Institutes of Health (NIH) to conduct ORCA-V1 Phase 2 trial of cytisinicline in nicotine e-cigarette users
Initiated the Phase 2 ORCA-V1 clinical trial to evaluate cytisinicline in adult e-cigarette users
"We continue to build upon the progress of cytisinicline with the announcement of the initiation of the ORCA-V1 trial and the continued enrolment in ORCA-3, our final NDA-enabling smoking cessation clinical trial," stated John Bencich, CEO of Achieve Life Sciences. "We remain focused on executing on our milestones and potentially expanding cytisinicline to e-cigarette and vaping users who currently have no FDA-approved cessation treatments."
Reported Phase 3 ORCA-2 Results
In April, Achieve announced positive, statistically significant results in its Phase 3 ORCA-2 clinical trial of cytisinicline in 810 adult smokers across 17 clinical trial locations in the United States. ORCA-2 evaluated the efficacy and safety of 3mg of cytisinicline dosed 3 times daily for either 6 or 12-weeks compared to placebo in adult smokers. Both the primary and secondary endpoints demonstrated increased quit rates, showing 6-8 times increased odds of smoking abstinence when compared to placebo. Cytisinicline was well tolerated with single-digit rates of adverse events observed and no treatment-related serious adverse events reported.
Awarded $2.5 Million from NIH for Phase 2 ORCA-V1 Trial
In June, Achieve was awarded $2.5 million in grant funding from the NIH to evaluate the use of cytisinicline as a treatment for cessation of nicotine e-cigarette use. In total, $2.8 million has been awarded and is expected to cover approximately half of the ORCA-V1 trial costs.
Initiated Phase 2 ORCA-V1 Trial
Also in June, following the NIH grant award, Achieve initiated the ORCA-V1 clinical trial across five trial locations in the United States. Approximately 150 participants are planned to be randomized to receive 3mg of cytisinicline 3 times daily or placebo for 12 weeks in combination with standard behavioral support.
Financial Results
As of June 30, 2022, the company’s cash, cash equivalents, and restricted cash were $29.4 million. Total operating expenses for the three and six months ended June 30, 2022 were $10.1 million and $17.3 million, respectively. Total net loss for the three and six months ended June 30, 2022 was $10.5 million and $18.0 million, respectively.
As of August 11, 2022, Achieve had 9,681,855 shares outstanding.
Conference Call Details
Achieve will host a conference call at 4:30 PM EDT, Thursday, August 11, 2022. To access the webcast, please use the following link 2Q22 Earnings Webcast. Alternatively, you may access the live conference call by dialing (888) 645-4404 (Domestic) or (404) 267-0371 (International) and referencing conference ID 13731865. A webcast replay will be available approximately three hours after the call and will be archived on the website for 90 days.