Spruce Biosciences Faces Financial Uncertainty Despite Clinical Progress
Spruce Biosciences, a biopharmaceutical company focused on neurological disorders, reported a net loss of $39 million for the year ended December 31, 2025, compared to a net loss of $53 million in the previous year. The company's operations consumed $33.3 million in cash during 2025, a decrease from the $56 million used in 2024. As of December 31, 2025, Spruce Biosciences held $48.9 million in cash and cash equivalents and had an accumulated deficit of $289.2 million. The company has cautioned that substantial doubt exists regarding its ability to continue as a going concern, citing insufficient working capital to fund planned operations for the next twelve months.
The company's financial performance reflects a strategic shift towards the development of tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB). Research and development expenses decreased to $19.5 million in 2025 from $46.4 million in 2024, primarily due to the discontinuation of the tildacerfont CAH development program and lower expenses associated with the TA-ERT development program. These decreases were partially offset by the acquisition of SPR202 for the treatment of congenital adrenal hyperplasia (CAH) from HBM Alpha Therapeutics, Inc. General and administrative expenses increased to $17 million from $14.6 million, mainly due to higher professional fees related to patent litigation and other legal costs.
Spruce Biosciences is pursuing regulatory approval for TA-ERT, which has received Breakthrough Therapy Designation from the FDA. The company anticipates submitting a biologics license application (BLA) for TA-ERT in the fourth quarter of 2026. To support its financial position, Spruce Biosciences entered into a Loan Agreement with Avenue Capital in January 2026, providing access to term loans up to $50 million, contingent on achieving certain regulatory milestones. The company also completed a private placement in October 2025, generating net proceeds of $46.6 million.
The company's future success hinges on securing additional financing and achieving key milestones in the development and commercialization of TA-ERT. Spruce Biosciences acknowledges the risks associated with clinical trials, regulatory approvals, and market acceptance, as well as the competitive landscape of the biopharmaceutical industry. The company's ability to maintain compliance with Nasdaq listing requirements and manage its intellectual property portfolio will also be critical to its long-term viability.
About SPRUCE BIOSCIENCES, INC.
Spruce Biosciences is a biopharmaceutical company developing therapies for neurological and rare diseases, including enzyme replacement and small molecule drugs. Its pipeline features treatments for MPS IIIB, depression, and congenital adrenal hyperplasia. The company focuses on targeted, biologic and small molecule therapeutics, leveraging strategic licensing, collaborations, and proprietary IP to address high unmet medical needs in niche markets worldwide.
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