Soleno Therapeutics ( (SLNO) ) has released its Q3 earnings. Here is a breakdown of the information Soleno Therapeutics presented to its investors.
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Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for the treatment of rare diseases. The company is currently advancing its lead product candidate, DCCR (diazoxide choline) extended-release tablets, designed to treat Prader-Willi syndrome (PWS).
In its third-quarter 2024 financial report, Soleno Therapeutics delivered significant corporate updates, notably the FDA’s acceptance of their New Drug Application for DCCR, which was granted Priority Review, with a target action date set for December 27, 2024. This milestone highlights the company’s progress toward potential approval and market launch in the U.S.
Financially, Soleno reported a substantial increase in research and development expenses, rising to $30.1 million from $6.0 million in the previous year, primarily due to stock-based compensation and preparation for commercial launch. General and administrative expenses also saw a notable increase to $49.2 million, driven by preparations for the product’s market entry. The company’s net loss for the quarter was approximately $76.6 million, reflecting the heightened expenditure as it moves towards commercialization.
Despite these losses, Soleno maintains a robust financial position with $284.7 million in cash, cash equivalents, and marketable securities, supporting its continued advancement in development and commercialization efforts. The company is poised for a U.S. market launch of DCCR, contingent upon FDA approval, and is actively preparing for this potential transition.
Looking ahead, Soleno’s management remains optimistic about the future, with plans to continue their collaboration with the FDA and readiness for a successful launch of their transformative therapy, DCCR, assuming regulatory approval is granted.
