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 key clinical and regulatory milestones achieved.

• NDA submission for smoking cessation indication remains on track for the first half of 2025, supported by ongoing ORCA-OL trial enrollment and long-term safety data collection.

• Cash, cash equivalents, restricted cash, and short-term investments totaled $61.3 million as of June 30, 2024, with positive working capital and funding expected to last into the second half of 2025.

• Recent $20 million debt refinancing extends cash runway and supports ongoing clinical and regulatory activities, with debt maturity extended to December 2027.

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

Financial highlights

• 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 same period of 2023.

• Cash, cash equivalents, and short-term investments totaled $61.3 million as of June 30, 2024.

• 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, and general and administrative expenses rose to $3.3 million for Q2 2024.

• 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, but rapid enrollment may reduce trial costs.

• End-of-Phase 2 FDA meeting for vaping cessation indication planned, with Phase 3 trial for vaping potentially starting mid-2025.