Why did ACHV's operating expenses surge in Q4 2024?

Achieve Life Sciences Inc (ACHV) experienced a significant increase in operating expenses in Q4 2024, with the quarterly figure standing at $12.2 million. This surge in operating expenses can be attributed to several factors:

1. **Clinical Trial Costs**: The company has been actively involved in clinical trials, particularly the ORCA Open label long-term safety exposure clinical trial. Completing enrollment and meeting FDA requirements for NDA submission would have incurred substantial costs.
2. **Regulatory Activities**: Achieve Life Sciences has been engaging in activities to define the development of cytisinicline as a treatment for vaping cessation, which includes interactions with the FDA. These regulatory activities can be expensive.
3. **Strategic Enhancements**: The company has strengthened its leadership team by appointing new members, such as Dr. Kristen Slaoui and Nancy Phelan, to enhance corporate strategy and commercialization efforts. Leadership changes often come with transition costs and new initiatives that can elevate operational expenses.
4. **Commercialization Preparations**: Achieve Life Sciences has been preparing for market entry with a robust commercialization plan, focusing on awareness, access, and availability. These preparations, including marketing and sales force buildup, would have contributed to the increase in operating expenses.

In summary, the surge in operating expenses in Q4 2024 is likely a result of the company's ongoing clinical trials, regulatory activities, strategic enhancements, and commercialization preparations. These factors combined have driven the increase in operating expenses to support the company's goals of NDA submission and market entry for Cytisinicline.