Achieve Life Sciences, Inc. Q3 FY2024 earnings call

• The third quarter was eventful with management changes, new hires, FDA breakthrough therapy designation for vaping cessation, and SVB loan refinancing. The company is transitioning to a more commercially focused entity.
• Cindy Jacobs noted the ORCA-OL open-label safety study completed enrollment with 479 participants from prior studies, with no safety concerns reported. NDA submission for cytisinicline is targeted for Q2 2025.
• Jaime Xinos discussed commercial planning, including customer research, launch strategy preparation, and hiring key personnel. A digital-first commercial strategy is being developed.
• Jerry Wan provided financial updates, including $42.9M cash balance as of 9/30/2024, net loss of $12.5M for Q3 2024, and debt refinancing with SVB.
• Rick Stewart emphasized the importance of treating nicotine dependence as a disease, focus on NDA submission, ORCA-V2 Phase 3 trial, and commercial planning for cytisinicline.

No detailed product segment financial performance with revenue contribution % provided in the transcript.

• NDA submission for cytisinicline is targeted for Q2 2025, subject to data collection, safety analysis, and product stability. NDA acceptance is expected within 74 days of submission, with product approval around 12 months after acceptance.
• Target to commence Phase 3 clinical trial for vaping cessation in Q3 2025.
• Debt refinancing with SVB: $10M received at closing, $5M upon FDA NDA acceptance, $5M subject to SVB's discretion.

• Uncertainty in clinical trial timelines and outcomes.
• Regulatory challenges in NDA submission and approval.
• Dependence on successful execution of innovative digital commercial strategy and market access.

Q: There was a spike in G&A in the third quarter. Were there one-time or nonrecurring amounts in that $4.9 million?

A: Yes, there were one-time charges this quarter relating to the executive restructure and associated severance costs.

Q: Cindy, you mentioned that all the patients that were enrolled in ORCA-OL had come from prior studies. Would you be willing to share how many of those patients were -- had prior exposure to cytisinicline?

A: Actually, it's pretty much similar to what the ratios were in the Phase 3 trials. We basically have about one-third that have -- were on the 12-week arm and one-third on the 6-week arm and one-third in placebo.

Q: What are your expectations with respect to disclosing data from the ORCA-OL trial? Do you expect that we'll get to see a complete presentation of the results before the NDA submission moves forward?

A: Not at this time, actually, because it's an ongoing. We are not going to be presenting results at a meeting before submitting to the NDA. Focus on the Data Safety Monitoring Committee reviews that all the safety looks good and there are no safety concerns.

Q: Obviously, smoking cessation is the near-term focus in terms of commercial preparations. But I'm curious if any efforts have been made towards laying the groundwork for a potential vaping cessation label expansion down the line?

A: Keep focused on the smoking cessation opportunity, and once we've got the commercial structure in place for smoking cessation, we'll expand it into vaping cessation.

Q: With regards to the ORCA-OL, once the data analysis is completed, are there any additional steps needed before submission? Do you need any more pre-submission meetings?

A: Once the ORCA-OL 6-month data with 300 patients is complete, we're going to have to monitor the data, put it into the ISS and insert that into the NDA and then do a full quality control on the actual NDA itself. Late January, early February for the completion of the 300 patients at six months and then step process through that to the NDA submission.

Q: You mentioned vaping potentially setting that down to the adolescent population. What might a trial look like there? What kinds of special considerations are you going to have to take into account to get that adolescent teen population?

A: We'll be focusing on getting the Phase 3 completed in adults 18 years and older. We will need to agree on a pediatric study plan, which will involve discussions with FDA on a possible adolescent trial, timing, and design.

Q: You mentioned nicotine pouches as well. That's another use case that's growing. What would that look like? And could that be combined with vaping?

A: Focus is on near-term priorities like NDA submission for smoking cessation and ORCA-V2 Phase 3 trial. Tobacco pouches are on the radar but will come after smoking cessation and vaping Phase 3.

Q: Do you have any updates you could share on the potential synthetic cytisinicline development process, where that timeline is?

A: That's an ongoing process. We continue to make progress, but we'll keep you updated when we've got more to say about it.

Q: Initially, you plan to include 650 patients, but actual enrollment was completed with 20% fewer participants. Could you give some clarification regarding the decision to decrease that number?

A: We had put in 650 as the maximum, but early discontinuation rate was low, so we capped enrollment under 500. Early discontinuation rate remains very low, so no concerns about achieving required subjects.

Q: You mentioned leveraging some non-dilutive financing from the NIH to fund the vaping study. Is that still on the cards?

A: That's definitely still on the cards. Once we've scoped out the size and protocol related to the vaping study, we'll be able to engage more fully.