Spruce Biosciences (SPRB) Q4 2025 earnings summary

Executive summary

• Achieved key milestones in TA-ERT program for MPS IIIB, including positive FDA meetings and BLA submission on track for Q4 2026.

• Strengthened commercial leadership with new CCO and board appointments to prepare for potential product launch.

• Secured up to $50 million in growth capital to support TA-ERT advancement and commercialization.

Financial highlights

• Cash and cash equivalents at year-end 2025 were $48.9 million, excluding $15 million from a new loan facility.

• R&D expenses decreased to $19.5 million in 2025 from $46.4 million in 2024, mainly due to cessation of tildacerfont development.

• G&A expenses rose to $17.0 million in 2025 from $14.6 million in 2024, driven by higher professional service fees.

• Net loss for 2025 was $39.0 million, an improvement from $53.0 million in 2024.

• Total operating expenses dropped to $36.5 million in 2025 from $61.1 million in 2024.

Outlook and guidance

• Cash runway expected to fund operations into early 2027, beyond anticipated BLA submission.

• BLA submission for TA-ERT planned for Q4 2026, with potential for accelerated approval.