Achieve Life Sciences Q4 2024: Discrepancies in Smoking Cessation Trials and Regulatory Timelines

These are the key contradictions discussed in Achieve Life Sciences' latest 2024Q4 earnings call, specifically including: Smoking Cessation Timeline and Access, Vaping Cessation Trial Cost and Timing, NDA Submission Timeline, and Trial Design and Execution:



NDA Submission for Cytisinicline:
- Achieve Life Sciences expects to submit the New Drug Application (NDA) for cytisinicline as a treatment for nicotine dependence in smoking cessation to the FDA at the end of Q2 2025.
- This submission is critical as it will introduce a new drug for nicotine dependence in nearly 20 years, addressing an unmet need for effective treatments.
- The company's focus is on ensuring a successful NDA submission, which is crucial for commercial launch in Q3 2026.

Financial Position and Cash Management:
- As of December 31, 2024, Achieve Life Sciences had $34.4 million in cash, up from $15.6 million in the previous year.
- The company believes its current cash balance will provide runway through the third quarter of 2025.
- Effective cash management is prioritized to efficiently allocate resources towards the NDA submission and commercial readiness.

Clinical Trial Milestones and Safety Data:
- Achieve completed enrollment in the ORCA Open Label Long-Term Safety Exposure clinical trial, meeting the FDA's requirement for six months of cumulative cytisinicline treatment in at least 300 participants.
- By January 2025, the trial reached a milestone of treating 300 subjects with cumulative six months of cytisinicline, satisfying one of the FDA's requirements for NDA submission.
- Two Data Safety Monitoring Committee (DSMC) reviews of the Open Label Safety data reaffirmed the excellent adherence and no safety concerns with cytisinicline.

Commercial Readiness and Launch Strategy:
- Achieve is advancing critical commercial activities and has developed a draft product label highlighting cytisinicline's differentiated efficacy and safety profile.
- The company is working on selecting a third-party logistics (3PL) partner and has finalized details for packaging submission.
- Key commercial priorities include targeting high volume varenicline prescribers and ensuring product availability through a specialty pharmacy approach.

Future indications and Strategic Partnerships:
- Achieve received Breakthrough Therapy designation for cytisinicline as a treatment for vaping cessation and plans to initiate a Phase 3 clinical trial for vaping dependence in the first half of 2026.
- The company is open to strategic partnerships, seeking to leverage an optimized risk/revenue potential in the US and globally, while aiming to maintain independence for the US market.