SPRUCE BIOSCIENCES, INC. 8-K

What Happened

• On February 5, 2026, Spruce Biosciences, Inc. (SPRB) filed an 8‑K disclosing a presentation at the 22nd Annual WORLDSymposium™ reporting long‑term results for tralesinidase alfa enzyme replacement therapy (TA‑ERT) in Sanfilippo Syndrome Type B (MPS IIIB). The company said the data demonstrate a rapid and durable reduction in heparan sulfate and preservation of cognitive and non‑cognitive outcomes versus natural history patients. The company also presented a case study of two siblings at the conference.
• The presentation included new analyses of existing study data (Observational Study 902 and Interventional Studies 250‑201, 250‑202, 250‑401) using the validated Vineland Adaptive Behavior Scales, Second Edition (VABS‑II). These analyses showed TA‑ERT was associated with stabilization of receptive and expressive communication and both fine and gross motor skills, compared with declines seen in untreated natural history cohorts. Excerpts and a press release were furnished as Exhibits 99.1 and 99.2 to the 8‑K.

Key Details

• Date of disclosure: February 5, 2026; event: 22nd Annual WORLDSymposium™ presentation.
• Studies referenced: Observational Study 902 and Interventional Studies 250‑201, 250‑202, 250‑401; outcomes measured with VABS‑II.
• Clinical findings: reported rapid/durable reduction in heparan sulfate and stabilization (vs decline in natural history) of communication and motor domains.
• Regulatory context: Spruce noted potential to seek accelerated approval and advance a biologics license application (BLA) for TA‑ERT; these are forward‑looking statements subject to risk and uncertainty.

Why It Matters

• For investors, the disclosed data represent important clinical signals for TA‑ERT in a rare, progressive pediatric disease: biochemical improvement (heparan sulfate reduction) plus preserved functional outcomes can support regulatory discussions and value inflection points if confirmed.
• The company explicitly mentions pursuing regulatory pathways (including potential accelerated approval and a BLA), but also included standard forward‑looking disclaimers that outcomes, timing, and approvals are uncertain. This filing is informational about clinical progress—not a guarantee of regulatory success or commercial returns.