Why did Soleno's expenses surge in Q3 2024?

The surge in Soleno's expenses in Q3 2024 can be attributed to several factors: 1. **Clinical Trial Costs**: The company is in the final stages of clinical trials for its lead candidate, DCCR, which involves significant expenses for trial operations, patient enrollment, and data analysis. These costs are typically highest in the final phases of development, as the focus shifts from research to regulatory submissions and potential commercialization. 2. **Regulatory Activities**: Soleno has been actively preparing for regulatory submissions, including the submission of a New Drug Application (NDA) to the FDA. These activities, such as preparing for FDA reviews and addressing regulatory queries, can be resource-intensive and may include hiring additional personnel or consultants. 3. **Commercialization Readiness**: The company is preparing for the potential launch of DCCR, which involves developing market access strategies, sizing sales forces, and identifying medical education needs. These activities are crucial for ensuring a smooth transition from clinical to commercial stages but require significant investment. 4. **Public Offering and Financing**: Soleno recently closed an underwritten public offering of common stock, which could have been used to fund operations, including covering increased expenses. Public offerings often come with additional costs associated with legal, accounting, and marketing efforts. In summary, the surge in Soleno's expenses in Q3 2024 is likely a result of the company's significant investments in clinical trials, regulatory preparations, commercialization readiness, and financing activities. These expenses are critical for the company's advancement towards potential approval and commercialization of its lead therapeutic candidate.