
Financial Performance - Soleno reported a net loss of approximately $(175.9) million, or $(4.38) per basic and diluted share, for the year ended December 31, 2024, compared to a net loss of $(39.0) million, or $(2.36) per share, in 2023[17]. - Net loss for Q4 2024 was $55,982,000, compared to a net loss of $11,296,000 in Q4 2023, indicating a 397% increase in losses[27]. - Total comprehensive loss for the year ended December 31, 2024, was $175,489,000, compared to $38,988,000 in 2023, representing a 350% increase[27]. - Total operating loss for the year ended December 31, 2024, was $187,671,000, compared to $41,384,000 in 2023, indicating a 353% increase[27]. - Net loss per common share for Q4 2024 was $1.27, up from $0.33 in Q4 2023, reflecting a 284% increase[27]. Expenses - Research and development expenses for the full year 2024 were $78.6 million, including $33.7 million of non-cash stock-based compensation, compared to $25.2 million in 2023[9]. - General and administrative expenses for the year ended December 31, 2024, totaled $105.9 million, which includes $66.2 million of non-cash stock-based compensation, compared to $13.5 million in 2023[13]. - Total operating expenses for Q4 2024 were $59,116,000, a significant increase from $13,910,000 in Q4 2023, representing a 324% rise[27]. - General and administrative expenses for Q4 2024 were $37,303,000, a substantial rise from $4,410,000 in Q4 2023, which is an increase of 746%[27]. - Stock-based compensation expense for the year ended December 31, 2024, totaled $99,958,000, compared to $5,945,000 in 2023, reflecting a 1,580% increase[29]. Income and Assets - Total other income for the year was $11.8 million, up from $2.4 million in 2023, primarily due to increased interest income[16]. - Interest income for the year ended December 31, 2024, was $12,052,000, compared to $2,578,000 in 2023, showing a 367% increase[27]. - Soleno had $318.6 million in cash, cash equivalents, and marketable securities as of December 31, 2024[8]. - Soleno's total assets grew to $330.972 million as of December 31, 2024, compared to $180.691 million in 2023[25]. Personnel and Operations - Personnel costs increased by $10.7 million in 2024 as the company hired additional employees for research and commercialization activities[14]. - Research and development expenses for the year ended December 31, 2024, reached $78,568,000, compared to $25,189,000 in 2023, marking a 212% increase[27]. - Weighted-average common shares outstanding for calculating basic and diluted net loss per common share increased to 43,924,831 in Q4 2024 from 34,441,721 in Q4 2023, a growth of 28%[27]. Regulatory and Financial Agreements - The company entered into a loan agreement for up to $200 million, with $50 million available upfront, contingent on FDA approval of DCCR for PWS[11]. - Soleno's NDA for DCCR was accepted by the FDA and granted Priority Review, with a target action date of March 27, 2025[4]. - The fair value of contingent liabilities related to the Essentialis merger increased to $14.8 million as of December 31, 2024, reflecting a $3.2 million increase from the previous year[15].