Spruce Biosciences Reports Second Quarter 2025 Financial Results and Provides Corporate Updates

Integrated Long-Term Clinical Data of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) Demonstrates Profound and Durable Efficacy and Safety in Patients with Sanfilippo Syndrome Type B (MPS IIIB)

Biologics License Application Submission of TA-ERT for MPS IIIB Anticipated in First Quarter of 2026

First Patient Dosed in Phase 2 TAMARIND Trial of Tildacerfont for Major Depressive Disorder (MDD) with Topline Results Anticipated in 1H 2026

Nasdaq Capital Market Relisting Anticipated Following Compliance with Minimum Bid Price for 20 Consecutive Trading Days

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Spruce Biosciences, Inc. (OTCQB: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today reported financial results for the second quarter ended June 30, 2025 and provided corporate updates.

“We remain steadfast in our efforts to advance TA-ERT as a potential first-to-market treatment for children diagnosed with Sanfilippo Syndrome Type B (MPS IIIB). We have a strong sense of urgency to deliver on our commitment to patients and families suffering with MPS IIIB and remain on track to submit the biologics license application under the accelerated approval pathway in the first quarter of 2026,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences. “The integrated long-term clinical data of TA-ERT reinforces its potentially transformative clinical impact and compelling value proposition. TA-ERT has the potential to be the first disease-modifying therapy to treat MPS IIIB and could provide a novel option for families impacted by this devastating condition.”

Corporate Updates

• Integrated Long-Term Clinical Data of TA-ERT Demonstrates Profound and Durable Efficacy and Safety in Patients with MPS IIIB. Earlier today, Spruce announced integrated group-level efficacy data for cerebral spinal fluid heparan-sulfate non-reducing end (CSF HS-NRE), cortical grey matter volume (CGMV), and Bayley-III Cognitive Raw Score (BSID-C), the cognitive subscale of the Bayley Scales of Infant and Toddler Development - Third Edition, as well as safety data over a five-year period from clinical studies 201, 202, and 401. Data from treated patients (n=22) in the studies 201, 202, and 401 was compared with data from untreated patients with MPS IIIB in natural history studies 901 and 902. Integrated group-level data from clinical studies 201, 202, and 401 demonstrate that TA-ERT therapy significantly reduced to normal or near normal CSF HS-NRE levels over a five-year period. At 240 weeks, CSF HS-NRE decreased 91.5 ng/mL from baseline (95% CI: -102.10, -80.90; p