Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Achieve Life Sciences Inc (ACHV, Financial) received FDA breakthrough therapy designation for Cytisinicline for vaping cessation, enhancing regulatory support.
- The company completed enrollment for the ORCA-OL safety trial ahead of schedule, demonstrating efficient trial management.
- Cytisinicline is positioned to be the first new prescription smoking cessation drug in nearly 20 years, with promising efficacy and tolerability.
- Achieve Life Sciences Inc (ACHV) has a strategic plan for a digital-first commercial launch, leveraging data-driven approaches to target primary care physicians and patients effectively.
- The company successfully refinanced its SVB loan, securing up to $20 million in availability, which supports financial stability and future operations.
Negative Points
- Achieve Life Sciences Inc (ACHV) reported a net loss of $12.5 million for the third quarter, an increase from the previous year, indicating rising operational costs.
- The company faces challenges in transitioning from a clinical development focus to a commercial entity, requiring significant strategic and operational shifts.
- There is uncertainty regarding the timeline and cost of the upcoming phase three clinical trial for vaping cessation, which could impact financial planning.
- The synthetic Cytisinicline development process is ongoing with no definitive timeline for completion, potentially delaying product diversification.
- Achieve Life Sciences Inc (ACHV) must navigate complex regulatory requirements for potential adolescent trials and new nicotine products like tobacco pouches, which could complicate future development plans.
Q & A Highlights
Q: There was a spike in G&A expenses in the third quarter. Were there any one-time or non-recurring amounts in that $4.9 million?
A: Yes, there were one-time charges this quarter related to the executive restructure and associated severance costs. - Jerry Wan, Principle Accounting Officer
Q: Can you share how many patients in the ORCA-OL trial had prior exposure to cytisinicline and how many completed a full 12-week course?
A: The ratios are similar to our phase three trials, with about a third of participants in the 12-week arm, a third in the six-week arm, and a third in the placebo group. - Cindy Jacobs, Chief Medical Officer
Q: Will the ORCA-OL trial data be disclosed before the NDA submission?
A: No, we will not present results before the NDA submission. We are focusing on the Data Safety Monitoring Committee reviews, which have shown no safety concerns. - Cindy Jacobs, Chief Medical Officer
Q: What are the plans for commercial preparations for vaping cessation?
A: The focus is currently on smoking cessation. Once the commercial structure for smoking cessation is in place, we will expand it to include vaping cessation. - Richard Stewart, CEO
Q: What are the next steps after completing the ORCA-OL data analysis before the NDA submission?
A: After completing the six-month data for 300 patients, we will monitor the data, integrate it into the NDA, and conduct a full quality control before submission. - Richard Stewart, CEO
Q: What has Dr. Mark Rubinstein contributed to the strategy discussions since joining?
A: Dr. Rubinstein has provided insights from his experience in treating nicotine dependence, helping refine our messaging and medical education strategy. - Jamie Xinos, Chief Commercial Officer
Q: What considerations are there for a potential adolescent vaping cessation trial?
A: We will focus on completing the phase three trial in adults first. Discussions with the FDA will determine the pediatric study plan for adolescents. - Cindy Jacobs, Chief Medical Officer
Q: Is there any update on the synthetic cytisinicline development process?
A: Progress is ongoing, and we will provide updates when there is more to share. - Richard Stewart, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
