The following is a summary of the Achieve Life Sciences, Inc. (ACHV) Q4 2023 Earnings Call Transcript:

Financial Performance:

• Achieve Life Sciences reported a decrease in cash, cash equivalents, and restricted cash from $24.8 million in 2022 to $15.6 million at the end of 2023.

• The company secured $124.2 million in equity financing, raising their pro forma cash and equivalents to approximately $71.8 million.

• Achieve Life Sciences reported a net loss of $29.8 million for the year ended December 31, 2023, including the expenses of several clinical trials that took place.

• Operating expenses were lowered in Q4 2023, resulting in savings.

• The anticipated cost of ORCA-OL trial to be around $20 million, spread over 2024 and 2025.

Business Progress:

• The development of the cytisinicline program for nicotine dependence has marked significant clinical, regulatory, and financial milestones in the year 2023.

• Results from Phase 3 ORCA-3 and Phase 2 ORCA-V1 trials demonstrated cytisinicline's potential in treating nicotine dependence and smoking cessation.

• Achieve Life Sciences reached an agreement with the FDA about their New Drug Application (NDA) submission requirements and timeline.

• A new open-label study, the ORCA-OL trial, is planned for long-term cytisinicline exposure data, to be initiated in Q2 2024 at 30 U.S. locations.

• Their financial position has strengthened due to clarity on NDA requirements from FDA, set to fund operations into H2 2025.

• The company is contemplating expanding cytisinicline as a treatment for e-cigarette cessation.

• Completion of the ORCA-V1 trial and plans to initiate end of Phase 2 meeting with FDA regarding expansion into nicotine e-cigarette cessation.

• ORCA-OL trial tablets have been manufactured and will be clinic-ready soon.

• The company plans to clarify the pathway for vaping program and nicotine e-cigarette cessation trial in H2 2024.

More details: Achieve Life IR

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