Spruce Biosciences(US:SPRB)2025-11-10 21:10Financial Performance - For the nine months ended September 30, 2025, the company incurred a net loss of $24.3 million, compared to a net loss of $29.5 million for the same period in 2024, reflecting a decrease of $5.2 million [94]. - The total operating expenses for the nine months ended September 30, 2025, were $25.4 million, down from $36.3 million in 2024, indicating a reduction of $10.9 million [114]. - The company incurred interest expense of $84,000 for the nine months ended September 30, 2025, compared to $251,000 in 2024, reflecting a decrease of $167,000 [114]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $26.9 million, an improvement of $8.4 million compared to $35.3 million in 2024 [140]. - Net cash used in operating activities decreased by $8.4 million during the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to lower payments from decreased clinical development activities [141]. - Net cash used in financing activities for the nine months ended September 30, 2025, was $1.2 million, compared to $1.0 million for the same period in 2024, with principal payments on the Term Loan being the main component [142]. Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $15.4 million, a decrease of $9.5 million from $25.0 million in 2024 [114]. - Research and development expenses decreased by $1.5 million to $5.0 million for the three months ended September 30, 2025, compared to $6.6 million for the same period in 2024 [116]. - For the nine months ended September 30, 2025, research and development expenses decreased by $9.5 million to $15.4 million, down from $24.9 million in 2024 [117]. - The decrease in clinical development expenses for the nine months was $6.4 million, primarily due to the discontinuation of the tildacerfont CAH development program, which accounted for $11.0 million [117]. - The company anticipates an increase in research and development expenses as it advances TA-ERT through an anticipated biologics license application in Q1 2026 [118]. Cash and Liquidity - As of September 30, 2025, the company had cash and cash equivalents of $10.7 million, which is expected to be insufficient to fund operations for at least the next 12 months [96]. - As of September 30, 2025, the company had cash and cash equivalents of $10.7 million, down from $38.8 million as of December 31, 2024 [124]. - The company raised approximately $50.0 million through a private placement transaction on October 7, 2025, selling 502,181 shares of common stock [125]. - As of September 30, 2025, cash and cash equivalents totaled $10.7 million, consisting of bank deposits and money market funds, with no excessive risk anticipated in future investments [149]. Company Status and Future Outlook - The company has no products approved for commercial sale and has not generated any product revenue to date [93]. - The company anticipates submitting a biologics license application for TA-ERT in the first quarter of 2026, targeting the treatment of Sanfilippo Syndrome Type B [92]. - The company expects to continue incurring net losses and will need to finance future cash needs through various means, including equity offerings and collaborations [126]. - The accumulated deficit increased to $274.6 million as of September 30, 2025, compared to $250.3 million at the end of 2024 [124]. - The company is classified as an "emerging growth company" under the JOBS Act and may retain this status until December 31, 2025, unless certain revenue or debt thresholds are met [146]. Accounting and Risk Management - There were no changes to critical accounting estimates during the nine months ended September 30, 2025, compared to those discussed in the Annual Report [145]. - The company has not engaged in hedging transactions to manage exposure to interest rate risk [150]. - Operating results are exposed to changes in foreign currency exchange rates, but there was no material impact on results for the periods presented [151]. - A hypothetical 1% change in interest rates as of September 30, 2025, would not have a material effect on the financial statements [150]. - The company does not expect anticipated changes in inflation to have a material effect on its business, financial condition, or results of operations for future reporting periods [152]. Stock and Shareholder Information - The company executed a one-for-seventy-five reverse stock split on August 4, 2025, retroactively adjusting share numbers and prices in financial statements [99]. - Payments made for asset acquisitions amounted to $7.1 million during the nine months ended September 30, 2025 [141]. - Collaboration revenue recognized in the nine months ended September 30, 2024, was $4.2 million, while no collaboration revenue was recognized in 2025 [115].