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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