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Spruce Biosciences (SPRB) investor relations material

Spruce Biosciences Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary10 Nov, 2025

Executive summary

  • Focused on developing therapies for neurological disorders, shifting primary focus to tralesinidase alfa (TA-ERT) for MPS IIIB after discontinuing tildacerfont CAH program; TA-ERT received FDA Breakthrough Therapy Designation, expediting development and review.

  • Biologics License Application for TA-ERT is on track for submission in Q1 2026, with potential commercial launch in late 2026.

  • No products approved or product revenue to date; continues to incur significant R&D and operating losses.

  • Completed $50 million private placement financing in October 2025, strengthening capital position.

  • Relisted on Nasdaq Capital Market after a one-for-75 reverse stock split in August 2025.

Financial highlights

  • Net loss of $8.2M for Q3 2025, improved from $8.7M in Q3 2024; net loss of $24.3M for nine months ended September 30, 2025, down from $29.5M in prior year.

  • Cash and cash equivalents of $10.7M as of September 30, 2025, excluding $50M from October financing; down from $38.8M at year-end 2024.

  • Collaboration revenue was $0.6M for Q3 2025, down from $4.2M in Q3 2024; no collaboration revenue recognized in 2025.

  • Total operating expenses for Q3 2025 were $8.2M, down from $10.0M in Q3 2024; R&D expenses for Q3 2025 were $5.0M, down from $6.6M in Q3 2024.

  • Stockholders' equity was $5.4M as of September 30, 2025, down from $28.8M at year-end 2024; accumulated deficit reached $274.6M as of September 30, 2025.

Outlook and guidance

  • Expects expenses to increase as TA-ERT advances toward regulatory approval and commercialization; BLA submission for TA-ERT anticipated in Q1 2026.

  • Research and development spending anticipated to rise with planned BLA submission and confirmatory studies for TA-ERT.

  • Cash position, including October financing, expected to fund operations into Q4 2026.

  • Substantial doubt exists about ability to continue as a going concern without additional financing; recent $50M private placement in October 2025 extends runway but may be insufficient for 12 months of operations.

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Frequently asked questions

Spruce Biosciences Inc. is a biopharmaceutical company developing and commercializing therapies for rare endocrine disorders. The company's leading product candidate, tildacerfont, is a non-steroidal therapy designed to improve disease control and reduce steroid dependency in patients suffering from congenital adrenal hyperplasia (CAH). Tildacerfont is under clinical trial for both adult and pediatric classic CAH, as well as for females with polycystic ovary syndrome in a separateclinical trial. Spruce Biosciences has entered into strategic partnerships, including a license agreement with Eli Lilly and Company for research, development, and commercialization of compounds, and a collaboration and license agreement with Kaken Pharmaceutical for the treatment of CAH in Japan. The company is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ under the ticker symbol SPRB.

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