Spruce raises $84M, resolves going concern, targets Q4 2026 BLA for lead rare disease therapy

Filed May 13, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 6, 2025 · ~2 min read

Key Changes

• high

  Company eliminated going concern warning after securing $69M equity raise (April 2026) and $15M debt facility (January 2026), extending cash runway beyond 12 months versus prior period's insufficient liquidity disclosure.

  MD&A: Liquidity verify on EDGAR →
• high

  TA-ERT received FDA breakthrough therapy designation (October 2025) and company now targets Q4 2026 BLA submission with potential mid-2027 commercial launch for Sanfilippo Syndrome Type B treatment.

  MD&A: Clinical Milestones verify on EDGAR →
• high

  Discontinued Phase 2 tildacerfont study in major depressive disorder (Q1 2026) following serious adverse event with elevated liver enzymes, narrowing pipeline focus to TA-ERT.

  Risk Factors: Clinical Development verify on EDGAR →