Soleno Therapeutics Reports $175.9 Million Net Loss and Expands Workforce in Annual Filing

Soleno Therapeutics, Inc. reported significant financial developments in its annual Form 10-K filing for the year ended December 31, 2024. The company, which focuses on developing therapeutics for rare diseases, particularly its lead product candidate, diazoxide choline extended-release tablets (DCCR) for Prader-Willi syndrome (PWS), recorded a net loss of $175.9 million, a substantial increase from a loss of $38.99 million in the previous year. This increase in losses is attributed to heightened research and development expenses, which surged to $78.6 million from $25.2 million in 2023, largely due to costs associated with clinical trials and preparations for a potential commercial launch.

In terms of revenue, Soleno has yet to generate any income from the commercialization of DCCR, which is currently under review by the U.S. Food and Drug Administration (FDA). The FDA accepted the New Drug Application (NDA) for DCCR in August 2024 and initially set a target action date of December 27, 2024, which was later extended to March 27, 2025. The company has received Breakthrough Therapy and Fast-Track designations for DCCR, indicating its potential significance in treating PWS.

Operationally, Soleno has expanded its workforce significantly, increasing its employee count from 33 to 92 over the past year, reflecting its commitment to advancing its clinical programs and preparing for commercialization. The company has also made strides in its financial position, with cash and cash equivalents totaling $87.9 million and marketable securities of $230.7 million as of December 31, 2024. This financial cushion is expected to support the company through its ongoing operational needs and potential commercialization efforts.

Looking ahead, Soleno anticipates continued losses as it navigates the complexities of drug development and regulatory approval processes. The company has indicated that it may require additional capital to support its operations and commercialization plans, particularly if DCCR receives FDA approval. The ability to secure funding will be crucial for Soleno as it aims to establish a market presence for DCCR and address the unmet medical needs of patients with PWS. The company remains focused on executing its strategic plans while managing the inherent risks associated with the biopharmaceutical industry.