Achieve Life Sciences (ACHV) Q3 2024 earnings summary

Executive summary

• Management changes and new hires, including a new CEO, Executive Chairman, Chief Commercial Officer, and a nicotine addiction specialist, were made to strengthen commercial and M&A expertise as the company transitions toward NDA submission and commercialization.

• Achieve Life Sciences is focused on developing cytisinicline for nicotine dependence, targeting both smoking and vaping cessation, with no approved products or revenue from sales.

• FDA granted Breakthrough Therapy designation for cytisinicline for vaping cessation, highlighting regulatory progress and potential for first-in-class approval.

• Commercial strategy emphasizes a digital-first, data-driven approach to efficiently reach primary care physicians and motivated patients, with a dedicated U.S. launch team established.

• The company is targeting a large addressable market of over 40 million Americans with nicotine dependence.

Financial highlights

• Cash, cash equivalents, restricted cash, and short-term investments totaled $42.9 million as of September 30, 2024, with positive working capital of $38.8 million.

• Net loss for Q3 2024 was $12.5 million; net loss for the nine months ended September 30, 2024, was $27.5 million; accumulated deficit reached $193.2 million.

• Operating expenses increased in Q3 2024 due to targeted enrollment in the ORCA-OL trial and higher G&A costs from executive restructuring.

• Research and development expenses were $7.6 million for Q3 2024 and $15.5 million for the nine months ended September 30, 2024.

• Interest income increased to $0.7 million for Q3 2024 and $1.9 million for the nine months, while interest expense decreased to $0.4 million for Q3 2024 and $2.0 million for the nine months.

Outlook and guidance

• NDA submission for cytisinicline for smoking cessation remains on track for Q2 2025, with FDA acceptance expected within 74 days and potential approval approximately 12 months post-submission.

• Management expects existing cash and investments to fund operations into the second half of 2025, including through a potential NDA submission.

• Current resources are insufficient to fund planned operations for the next 12 months; additional capital will be required to continue clinical development and commercialization efforts.

• Phase III clinical trial for vaping cessation (ORCA-V2) targeted to commence in Q3 2025.

• Quarterly operating expenses expected to remain elevated as clinical and commercial activities progress.