Soleno Therapeutics Provides Update on U.S. Launch of VYKAT(TM) XR and Reports Second Quarter 2025 Financial Results

Core Insights - Soleno Therapeutics has successfully launched VYKAT XR, the first FDA-approved therapy for treating hyperphagia in patients with Prader-Willi syndrome (PWS), marking a significant milestone for the company and the PWS community [3][4]. Financial Performance - For the second quarter ended June 30, 2025, Soleno reported product revenue of $32.7 million, with VYKAT XR generating revenue for the first time since its launch [6]. - The company incurred an operating loss of $6.5 million for the quarter, a significant improvement compared to a loss of $24.9 million in the same period of 2024 [26]. - Cash used in operating activities was $12.6 million, with total cash, cash equivalents, and marketable securities amounting to $293.8 million at the end of the quarter [5]. Operational Highlights - Since the FDA approval on March 26, 2025, and the commercial launch on April 14, 2025, Soleno has received 646 patient start forms and engaged 295 unique prescribers for VYKAT XR [8]. - The company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for VYKAT XR, aiming for approval in the European market [8]. Research and Development - Research and development expenses for the quarter were $9.1 million, down from $12.3 million in the same period of 2024, reflecting a decrease in costs associated with clinical activities and NDA submissions [9]. - The company also incurred $0.6 million in expenses related to the MAA submission in Europe during the second quarter [9]. Selling, General and Administrative Expenses - Selling, general, and administrative expenses rose to $28.2 million, up from $10.9 million in the same quarter of 2024, driven by increased personnel costs and marketing efforts for the commercial launch of VYKAT XR [10]. Contingent Liabilities - Soleno has a contingent liability of up to $21.2 million to former Essentialis stockholders based on future sales milestones of VYKAT XR, with the fair value of this liability estimated at $18.9 million as of June 30, 2025 [11].