On March 10, 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 fourth quarter and year-end 2021 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, MAR 10, 2022, View Source [SID1234609851]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Business Highlights

Initiated ORCA-3, the second Phase 3 trial, in 750 adult smokers at 15 clinical sites in the United States

Announced last subject and last follow-up visit in the Phase 3 ORCA-2 trial of cytisinicline for smoking cessation

Entered into a $25 million loan facility with Silicon Valley Bank

Facilitated Key Opinion Leader virtual roundtable on smoking and e-cigarette cessation

Received U.S. Food and Drug Administration (FDA) acceptance of Investigational New Drug (IND) application for investigation of cytisinicline as a treatment for nicotine e-cigarette/vaping cessation

"We finished 2021 strong achieving multiple milestones and are starting the new year off with continued momentum in the cytisinicline development program," commented John Bencich, Chief Executive Officer of Achieve. "We are eagerly anticipating topline results from the Phase 3 ORCA-2 trial in the coming months, as we enroll smokers in the recently initiated Phase 3 ORCA-3 trial at 15 clinical sites in the United States. Additionally, our cash position remains strong with funding into 2023, allowing us to execute on the final stages of clinical development needed to support an NDA for smoking cessation."

Phase 3 ORCA-3 Trial Initiated

Achieve announced it has initiated enrollment for the Phase 3 ORCA-3 trial at 15 clinical sites in the United States in January 2022. Similar to the ORCA-2 trial, ORCA-3 will evaluate the efficacy and safety of 3 mg cytisinicline dosed three times daily compared to placebo. Approximately 750 smokers will be randomized to one-of-three treatment arms to evaluate cytisinicline administered for either 6 or 12 weeks.

Phase 3 ORCA-2 Trial Completed Last Subject and Last Follow-up Visit

Achieve completed the last study follow-up visit for the last subject enrolled in the Phase 3 ORCA-2 trial in late December 2021. The ORCA-2 trial is the first Phase 3 trial in Achieve’s ORCA (Ongoing Research of Cytisinicline for Addiction) Program, designed to evaluate the smoking cessation effectiveness, safety, and tolerability of 3 mg cytisinicline taken three times daily for either 6 or 12 weeks, compared with placebo. ORCA-2 randomized 810 subjects across 17 clinical trial sites in the United States. Topline data regarding the primary results are expected in the second quarter of 2022.

$25 Million Loan Facility with Silicon Valley Bank

In December 2021, Achieve announced a $25 million debt agreement with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P. (SVB). The proceeds and funds available under the debt agreement are expected to fund the completion of the cytisinicline smoking cessation clinical development program. SVB funded $15 million in the form of contingent convertible indebtedness and Achieve may borrow additional non-convertible term loans in an aggregate original principal amount of up to $10 million.

Virtual Smoking Cessation KOL Roundtable

Achieve hosted a Key Opinion Leader virtual roundtable on smoking and e-cigarette cessation in December 2021. Two esteemed smoking cessation experts discussed the current market for smoking and e-cigarette cessation, challenges with available treatments, and the potential of cytisinicline to be the first new FDA approved smoking cessation therapy in nearly two decades. Click here to view the event.

FDA Acceptance of IND for Cytisinicline in e-Cigarette and Vape Cessation

The FDA completed its review and accepted an IND application to investigate cytisinicline as a cessation treatment for nicotine e-cigarette users in November 2021. The Phase 2 ORCA-V1 study will enroll approximately 150 adult nicotine e-cigarette users in the United States and is expected to initiate in the second quarter of 2022. Grant funding to support the trial has been awarded in two phases from the National Institute on Drug Abuse of the National Institutes of Health. Completion of required milestones for the first phase of grant funding included the submission of the IND and clearance to proceed with the clinical trial by FDA. Achieve has submitted for completion of the first phase milestones and awaits clearance under the grant to proceed with ORCA-V1 study.

Financial Results

As of December 31, 2021, the company’s cash, cash equivalents, and restricted cash was $43.1 million. Total operating expenses for the fourth quarter and year ended December 31, 2021 were $7.1 million and $33.1 million, respectively. Total net loss for the fourth quarter and year ended December 31, 2021 was $7.2 million and $33.2 million, respectively. As of March 10, 2022, Achieve had 9,460,835 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 PM EST today, Thursday, March 10, 2022. 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 8066623. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.