Achieve Life Sciences (ACHV) Q2 2024 earnings summary

Executive summary

• Significant progress in cytisinicline development for nicotine dependence, with FDA Breakthrough Therapy designation for vaping cessation and initiation of the ORCA-OL trial to support an NDA submission in the first half of 2025.

• No products are yet approved or revenue generated from sales; all activities are focused on cytisinicline for smoking and e-cigarette cessation.

• Achieve joined the Russell 3000 and Microcap Indexes, increasing investor visibility.

Financial highlights

• Cash, cash equivalents, restricted cash, and short-term investments totaled $61.3 million as of June 30, 2024, with positive working capital of $48.8 million.

• Net loss for Q2 2024 was $8.5 million, and for the first six months of 2024 was $15.0 million, down from $17.2 million in the prior year.

• Operating expenses were $8.4 million for Q2 2024 and $14.4 million for the first six months of 2024.

• R&D expenses were $5.1 million for Q2 2024, $7.9 million for the six months; general and administrative expenses were $3.3 million for Q2 2024, $6.5 million for the six months.

• Net cash used in operating activities was $10.2 million for the six months ended June 30, 2024.

Outlook and guidance

• NDA submission for cytisinicline in smoking cessation is targeted for the first half of 2025, pending completion of the ORCA-OL trial.

• Existing cash and investments are expected to fund operations into the second half of 2025.

• Quarterly operating expenses are expected to increase as the ORCA-OL trial progresses.

• End-of-Phase 2 FDA meeting for vaping cessation indication is planned, with potential for accelerated development.