Spruce Biosciences Reports Increased Net Loss and Decreased Collaboration Revenue for 2024

Spruce Biosciences, Inc. reported a net loss of $53.0 million for the year ended December 31, 2024, compared to a net loss of $47.9 million in 2023. Collaboration revenue decreased significantly from $10.1 million in 2023 to $4.9 million in 2024. Research and development expenses decreased by $3.0 million, primarily due to the termination of the CAHmelia-203 study and completion of other studies, partially offset by costs related to the Allievex asset purchase. General and administrative expenses increased by $2.0 million, mainly due to higher legal and professional service fees. The company's cash and cash equivalents decreased from $96.3 million to $38.8 million during the same period.

Significant changes compared to the previous fiscal year include a substantial decrease in collaboration revenue and a net loss increase of $5.1 million. The company's cash position decreased considerably, raising substantial doubt about its ability to continue as a going concern for at least the next twelve months. The company's accumulated deficit as of December 31, 2024, was $250.3 million. The decrease in cash was primarily due to net cash used in operating activities of $55.9 million, compared to $33.3 million in 2023.

During the year, Spruce Biosciences entered into several significant agreements. In October 2024, the company acquired assets from Allievex Corporation, including intellectual property and inventory, for a total net acquisition cost of $15.1 million. This acquisition included the assumption of certain liabilities. In January 2025, a collaboration and license agreement was signed with HBM Alpha Therapeutics, Inc., granting Spruce an exclusive license to a specified product candidate. The company also entered into an antibody license agreement with Twist Bioscience Corporation in December 2024.

As of December 31, 2024, Spruce Biosciences employed 21 people, with 15 in research and development and 6 in general and administrative functions. The company's common stock is traded on the Nasdaq Capital Market under the symbol "SPRB." The aggregate market value of the company's common stock held by non-affiliates as of June 28, 2024, was approximately $18.8 million. The number of outstanding shares of common stock as of April 11, 2025, was 42,231,285.

The company intends to submit a biologics license application (BLA) for TA-ERT for the treatment of MPS IIIB in the first half of 2026. Further, topline results from the TAMARIND clinical trial for tildacerfont are anticipated in the first half of 2026. The company acknowledges significant risks associated with its business, including its limited operating history, substantial net losses, dependence on additional financing, and the uncertainties inherent in clinical trials and regulatory approvals. The company's future financial performance is highly dependent on the successful development and commercialization of its product candidates.