Soleno Therapeutics(SLNO) - 2024 Q3 - Quarterly Results

Financial Performance - Soleno reported a net loss of approximately $76.6 million, or$1.83 per basic and diluted share, for Q3 2024, compared to a net loss of $10.9 million, or$0.95 per share, in Q3 2023[10]. - Total operating expenses for the three months ended September 30, 2024, were $80,212,000, compared to$10,382,000 for the same period in 2023, representing a significant increase[17]. - The net loss for the three months ended September 30, 2024, was $76,616,000, compared to a net loss of$10,861,000 for the same period in 2023[17]. - Total comprehensive loss for the three months ended September 30, 2024, was $75,568,000, compared to$10,862,000 for the same period in 2023[17]. - The net loss per common share for the three months ended September 30, 2024, was $(1.83), compared to$(0.95) for the same period in 2023[17]. Expenses - Research and development expenses for Q3 2024 were $30.1 million, a significant increase from$6.0 million in the same period of 2023, primarily due to hiring and NDA submission costs[6]. - General and administrative expenses rose to $49.2 million in Q3 2024, compared to$3.3 million in Q3 2023, largely driven by increased personnel and professional services costs[7]. - Stock-based compensation expense for research and development in the three months ended September 30, 2024, was $18,516,000, compared to$935,000 in the same period in 2023[18]. - Total stock-based compensation expense for the nine months ended September 30, 2024, was $70,203,000, compared to$4,036,000 for the same period in 2023[18]. Cash Flow and Assets - Soleno used $14.9 million of cash in its operating activities during Q3 2024, with cash, cash equivalents, and marketable securities totaling$284.7 million as of September 30, 2024[5]. - Soleno's total assets increased to $296.7 million as of September 30, 2024, up from$180.7 million at the end of 2023[16]. Other Income - Total other income for Q3 2024 was $3.6 million, compared to total other expense of$0.5 million in Q3 2023, primarily due to increased interest income[9]. - Interest income for the three months ended September 30, 2024, was $3,596,000, compared to$174,000 for the same period in 2023[17]. Regulatory and Market Developments - The NDA for DCCR (diazoxide choline) extended-release tablets was accepted by the FDA and granted Priority Review, with a target action date of December 27, 2024[2]. - Soleno is preparing for a potential U.S. market launch of DCCR, contingent on FDA approval, supported by a strong balance sheet[3]. Leadership Changes - The company appointed Dawn Carter Bir to its Board of Directors, enhancing its leadership with over 30 years of biotechnology experience[2]. Contingent Liabilities - The fair value of the contingent liability for the Essentialis purchase price was estimated at $14.5 million as of September 30, 2024, reflecting a$0.9 million increase from June 30, 2024[8].