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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.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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