SOLENO THERAPEUTICS Business Summary

Soleno Therapeutics Inc. (SLNO) is a commercial-stage biopharmaceutical company that generates revenue primarily through the sale of VYKAT XR (diazoxide choline extended-release tablets), the first and only FDA-approved therapy for hyperphagia in Prader-Willi Syndrome (PWS). Following its U.S. commercial launch in April 2025, the company transitioned to profitability in late 2025, reporting preliminary full-year net revenues of approximately $189–$191 million. The business operates within a single segment focused on rare disease therapeutics, leveraging a specialized commercial infrastructure to target an addressable U.S. market of approximately 10,000 patients. Soleno maintains a dominant market position as the current standard of care, significantly distancing itself from direct competitors such as Rhythm Pharmaceuticals, Aardvark Therapeutics, and Harmony Biosciences. While rivals like Rhythm and Aardvark are still in clinical phases for PWS-related indications, Soleno’s first-mover advantage and orphan drug exclusivity provide a substantial competitive moat that is expected to remain unchallenged by new Phase 3 data until at least late 2026. The company is led by Chairman and CEO Anish Bhatnagar, M.D., who has steered the organization since its 2017 formation via the merger of Capnia and Essentialis; his background includes executive roles at Titan Pharmaceuticals and Coulter Pharmaceuticals. The leadership team was significantly bolstered for commercialization with the appointments of Meredith Manning as Chief Commercial Officer, previously of PharmaEssentia, and Dr. Joshi as Chief Development Officer, who joined in late 2025 from Neurona Therapeutics. Financial operations are overseen by CFO Jim Mackaness, while the Board of Directors features seasoned industry veterans including Lead Independent Director Matthew Pauls (CEO of Savara) and Mark W. Hahn, a former Verona Pharma executive who joined the board in October 2025. Notable institutional backing and a recent $100 million share repurchase program underscore the company's strong capitalization and the board's confidence in the long-term commercial trajectory of its PWS franchise.