Achieve Life Sciences Reports Financial Results, Net Loss, and Progress on Cytisinicline Development

Achieve Life Sciences, Inc. reported significant financial developments in its recent 10-Q filing for the quarter ending September 30, 2024. The company, focused on the development of cytisinicline for nicotine dependence, has not yet generated revenue from product sales and continues to face substantial operating losses. For the nine months ended September 30, 2024, Achieve recorded a net loss of $27.5 million, compared to a loss of $24.3 million for the same period in 2023. The net loss per share for the latest quarter was $(0.36), slightly higher than $(0.34) in the prior year.

Total operating expenses for the three months ended September 30, 2024, reached $12.5 million, up from $6.6 million in the same quarter of 2023. This increase was primarily driven by higher research and development (R&D) expenses, which amounted to $7.6 million for the latest quarter, compared to $3.6 million a year earlier. The rise in R&D costs is attributed to the initiation of the ORCA-OL open-label safety trial, offset by reduced costs from completed trials.

As of September 30, 2024, Achieve reported cash and cash equivalents of $9.5 million, a decrease from $15.5 million at the end of 2023. However, total current assets increased significantly to $45.5 million from $17.0 million, while total assets rose to $47.9 million from $19.4 million. The company’s total current liabilities decreased to $6.7 million from $20.8 million, leading to a substantial improvement in stockholders' equity, which reached $31.4 million, recovering from a negative equity position of $(1.4 million) at the end of 2023.

In terms of financing, Achieve raised approximately $56.1 million in net proceeds from a registered direct offering in February 2024. The company also entered into a New Debt Agreement with Silicon Valley Bank, providing term loans of up to $20 million, with the first tranche of $10 million already advanced. This agreement includes a floating interest rate and a conversion feature allowing lenders to convert debt into equity under certain conditions.

Strategically, Achieve is preparing to submit a New Drug Application (NDA) for cytisinicline, with ongoing trials expected to support this submission. The company received Breakthrough Therapy designation from the FDA in Q3 2024, which aims to expedite the development process. However, Achieve faces challenges, including reliance on a single manufacturer for cytisinicline and the need for additional capital to sustain operations and clinical development activities.