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Achieve Life Sciences(ACHV) - 2024 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company secured financing of up to $124 million, which will support the ORCA-OL trial and provide cash runway through NDA submission and approval [6][16] - As of March 31, 2024, cash, cash equivalents, and restricted cash were $66.4 million, with expectations that initial net proceeds will sustain operations into the second half of 2025 [17] - Total operating expenses decreased to $6 million in Q1 2024 from $8.6 million in Q1 2023, with a net loss of $6.5 million compared to $9 million in the same quarter of the previous year [17] Business Line Data and Key Metrics Changes - The ORCA-V1 trial results showed that cytisinicline more than doubled the odds of quitting e-cigarettes compared to placebo, with 31.8% of treated participants achieving continuous vaping abstinence [8] - The ORCA-OL study is set to begin enrollment soon, focusing on long-term safety data collection for cytisinicline [11][12] Market Data and Key Metrics Changes - The prevalence of vaping is increasing, with an estimated 11 million adults and 2 million middle and high school students using e-cigarettes in the U.S. [8] - More than half of adults who vape have reported interest in quitting, highlighting a significant market opportunity for cytisinicline [8] Company Strategy and Development Direction - The company plans to conduct an end-of-Phase 2 meeting with the FDA later this year to discuss clinical requirements for label expansion for vaping cessation [9] - The focus for 2024 includes the initiation and completion of enrollment for the ORCA-OL study and preparations for NDA submission for smoking cessation [22] Management's Comments on Operating Environment and Future Outlook - Management emphasized the urgent need for effective cessation treatments, noting that there have been no new approved smoking cessation agents in nearly 20 years [21] - The company believes cytisinicline can play a critical role in addressing the public health crisis of nicotine dependence and improving long-term patient outcomes [21] Other Important Information - The company presented survey results indicating that over 80% of participants treated with cytisinicline were willing to recommend it to others, with 69% successfully quitting smoking [10] - The FDA has agreed on the number of subjects required for long-term exposure data necessary for NDA filing, which is critical for the timing of the submission [6][12] Q&A Session Summary Question: Status of the 29 sites for ORCA-OL study - All sites are finishing up their contracts and will be ready to enroll within the next few weeks [25] Question: Clarification on the 1,100 subjects contacted - About 25% of the 1,700 subjects were smoke or vape free, and approximately two-thirds of those contacted are interested in participating [26][28] Question: Expected re-entry of subjects into the study - The screening process will determine how many of the contacted subjects will re-enter the study, but the screening failure rate is not expected to be high [33] Question: Handling of placebo patients in ORCA-OL - There will be no placebo patients in the open-label study; prior placebo subjects will be treated with cytisinicline for the first time [35] Question: Long-term safety data for e-cigarette cessation - The FDA indicated that the current open-label trial will suffice for both smoking and vaping indications, eliminating the need for a separate long-term exposure trial for vaping [57]