Soleno Therapeutics(US:SLNO) Globenewswire·2025-05-07 20:01Core Insights - Soleno Therapeutics achieved FDA approval for VYKAT XR, a treatment for hyperphagia in patients with Prader-Willi syndrome, marking a significant milestone for the company [3][7] - The company reported a net loss of approximately $43.8 million for Q1 2025, compared to a net loss of $21.4 million in the same period of 2024 [11][27] - Soleno is focused on a robust commercial launch of VYKAT XR, with initial interest indicated by 268 patient start forms and 131 unique prescribers [3][7] Financial Results - For the first quarter ended March 31, 2025, Soleno used $32.8 million in cash for operating activities and had $290.0 million in cash, cash equivalents, and marketable securities [5] - Research and development expenses were $13.5 million, a decrease from $14.6 million in Q1 2024, while selling, general, and administrative expenses rose to $29.3 million from $8.5 million in the same period last year [6][8] - The company incurred a contingent liability of $17.8 million related to potential cash payments to former Essentialis stockholders upon achieving certain sales milestones for VYKAT XR [9] Product Launch and Market Engagement - VYKAT XR was launched on April 14, 2025, following FDA approval on March 26, 2025, and the company is actively engaging with payers to establish broad access for patients [4][7] - The Marketing Authorization Application (MAA) for VYKAT XR is on track for submission to the European Medicines Agency (EMA) in Q2 2025 [7] Stock-Based Compensation - The company recognized $14.7 million in stock-based compensation expenses for Q1 2025, compared to $6.4 million in Q1 2024, with a significant portion attributed to performance-based RSU grants [6][29]