On November 6, 2019 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 an update on the cytisinicline clinical development program and announced third quarter 2019 financial results (Press release, OncoGenex Pharmaceuticals, NOV 6, 2019, View Source [SID1234550406]).

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Q3 2019 Highlights

Announced extension of a strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH). As part of the collaboration, the NIH is funding and providing research efforts to conduct additional non-clinical development as requested by the FDA to support cytisinicline’s New Drug Application (NDA).

Presented positive efficacy and compliance results from the Phase 2b ORCA-1 dose-selection trial evaluating cytisinicline in 254 smokers at the Society for Research on Nicotine & Tobacco Europe (SRNT-E) 19th Annual Conference. Cytisinicline demonstrated a statistically significant improvement in quit rates for a simplified 3.0 mg, three times daily dose and was well-tolerated with no serious adverse events reported.

Hosted Company’s first Investor Day, including roundtable discussion with smoking cessation medical experts and presentation of final ORCA-1 data, including plans for Phase 3 development program.

Presented at the H.C. Wainwright 21st Annual Global Investment Conference and the Ladenburg Thalmann 2019 Healthcare Conference.

"It has been a busy and eventful quarter with progressive data analysis further reinforcing the strength of the ORCA-1 Phase 2b trial and the potential for cytisinicline as a new treatment for the millions of people who are battling nicotine addiction," commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. "Our key priority in the fourth quarter is to advance the ongoing, extensive preparations for the Phase 3 clinical trials, including our upcoming meeting with the FDA to finalize the cytisinicline Phase 3 protocols."

Extended Collaboration with NIH

In July, Achieve announced an extension of its strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH). Under the extended collaboration, the NIH is funding and providing research efforts to conduct additional non-clinical studies as requested by the U.S. Food and Drug Administration (FDA) to be included in a cytisinicline New Drug Application (NDA). In discussions with the FDA in 2018, it was determined that a Good Laboratory Practice (GLP) non-clinical reproductive study would be required to support the NDA submission. NCCIH has agreed to sponsor this study which is expected to complete in 2020. In total, the NIH has committed approximately $6 million dollars to the development of cytisinicline.

Presented Final ORCA-1 Data at SRNT-E Conference

Achieve’s Chief Scientific Officer, Dr. Anthony Clarke, facilitated two oral presentations featuring data from the Phase 2b ORCA-1 trial at the SRNT-E Annual Conference in Oslo. The ORCA-1 trial of cytisinicline in 254 U.S. smokers demonstrated a statistically significant improvement in quit rates for the 3.0 mg, three times daily dosing (TID) schedule. In the 3.0 mg TID arm, a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) was observed. Continuous abstinence at weeks 5 through 8 was 30% for cytisinicline compared to 8% for placebo (p= 0.005). Adherence to study treatment was 98% in the 3.0 mg TID arm and cytisinicline was well-tolerated with no serious adverse events reported.

Investor Day and KOL Roundtable Discussion

The Company hosted its first investor day on September 20th, 2019, featuring an updated ORCA-1 data presentation and a roundtable discussion of smoking cessation medical experts, Dr. Mitchell Nides, Dr. Nancy Rigotti, Dr. Judith Prochaska, and Dr. Scott Leischow. The experts highlighted the critical need for the availability of new treatments, like cytisinicline, as an aid to smoking cessation. A replay of the event can be found at View Source

Financial Results

As of September 30, 2019, the company’s cash, cash equivalents, and restricted cash was $7.4 million. Total operating expenses for the three and nine months ended September 30, 2019 were $3.7 million and $13.3 million, respectively. Total net loss for the three and nine months ended September 30, 2019 was $3.7 million and $13.2 million, respectively.

As of November 6, 2019 Achieve had 8,352,764 shares outstanding.

Conference Call Details

Achieve will host a conference call at 8:00 a.m. Eastern time today, Wednesday, November 6, 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 7196429. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.