Earning Date, Transcript Summary & Report

NDA Submission for Cytisinicline: Achieve expects to submit the NDA for cytisinicline as a treatment for nicotine dependence for smoking cessation with the FDA at the end of next quarter, marking a significant milestone as it will be the first new drug for nicotine dependence in nearly 20 years.

Clinical Trial Enrollment Milestone: The company completed enrollment in the ORCA Open Label Long-Term Safety Exposure clinical trial, reaching the requirement of at least 300 participants receiving six months of cumulative cytisinicline treatment, a necessary step for NDA submission.

Breakthrough Therapy Designation: Achieve received Breakthrough Therapy designation for cytisinicline as a treatment for vaping cessation, highlighting the drug's potential impact in addressing a growing public health issue.

FDA Meeting Success: The company successfully completed the end of Phase 2 meeting with the FDA for vaping cessation, receiving agreement on the design of a Phase 3 trial, which is a positive step towards expanding the drug's indications.

Leadership Team Enhancement: Achieve strengthened its leadership team with the appointment of experienced individuals to the Board of Directors, enhancing corporate strategy and commercialization efforts.

Cash and Securities Increase: The company reported a significant increase in cash, cash equivalents, and marketable securities, rising to $34.4 million as of December 31, 2024, providing a solid financial foundation for upcoming initiatives.

Superior Treatment Efficacy: Cytisinicline has demonstrated up to two and a half times better efficacy than the previous market-leading prescription product, with a more benign side effect profile, indicating its potential as a superior treatment option.

Commercial Readiness Strategy: The company is advancing its commercial readiness efforts, focusing on awareness, access, and availability, which are critical for a successful product launch.

Nicotine Dependence Treatment: Cytisinicline is positioned to address the public health crisis of nicotine dependence, with over 29 million Americans battling this issue and a significant number attempting to quit each year, underscoring the urgent need for effective treatment options.

Net Loss Reported: The company reported a net loss of $39.8 million for the year ended December 31, 2024, indicating ongoing financial challenges.

High Operating Expenses: Operating expenses for the fourth quarter were $12.2 million, which reflects high costs associated with the NDA submission and commercial readiness efforts.

Cash Reserves and Funding Concerns: Despite an increase in cash reserves to $34.4 million, the company indicated that this is only sufficient to provide runway into the third quarter of 2025, raising concerns about future funding needs.

Strategic Partnership Challenges: The company has not yet secured a strategic partner, which could impact its ability to effectively launch and market cytisinicline once approved.

Clinical Trial Timeline Delays: The timeline for the Phase 3 ORCA-V2 clinical trial for vaping cessation is dependent on financing, suggesting potential delays in expanding their product offerings.

Urgent Need for Treatments: The company has highlighted the urgency for new nicotine dependence treatments, indicating that existing options are inadequate, which may reflect poorly on their current market position.