Spruce Biosciences, Inc. (Nasdaq: SPRB) reported financial results for the third quarter ended September 30, 2026, and provided updates on its lead therapeutic candidate, TA-ERT. The company announced that its Biologics License Application (BLA) for tralesinidase alfa (TA-ERT) to treat mucopolysaccharidosis type IIIB (MPS IIIB) remains on track for submission in December 2026.
The BLA seeks accelerated approval based on the reduction of cerebrospinal fluid heparan sulfate non-reducing end (CSF HS-NRE) as a surrogate endpoint. The company noted that the FDA requested the initiation of a confirmatory study, the TrAnsform trial, while the BLA is under review. Spruce initiated this randomized, single-blind study in December 2026, expecting to enroll approximately 14 children aged 1 to 5 years with severe MPS IIIB to evaluate the effect of TA-ERT on cognition. Additionally, the company initiated a U.S. Expanded Access Program (EAP) in November 2026, partially funded by a $5.5 million investment from the Cure Sanfilippo Foundation and the National MPS Society, to provide TA-ERT to patients not eligible for the confirmatory study.
On the financial front, Spruce reported cash and cash equivalents of $87.7 million as of September 30, 2026, compared to $48.9 million at the end of 2025. The company stated this balance is sufficient to fund operations and debt obligations into the second half of 2027. Third-quarter research and development expenses were $18.1 million, while general and administrative expenses totaled $5.8 million. The company recorded a net loss of $24.0 million for the quarter.
On November 6, 2026, Spruce amended its Avenue Loan Agreement with Avenue Capital Management II, L.P. and Avenue Venture Opportunities Fund II, L.P. The amendment increased the amount available under Tranche 2 to up to $15.0 million, which may be drawn between January 1, 2027, and March 31, 2027. The agreement also extended the interest-only period through March 31, 2027, with potential further extensions through October 2028.
Separately, Spruce separated its CRHX-101 (formerly SPR-202) program into Adrenyx Biosciences, a newly formed wholly-owned subsidiary. The company intends to distribute all outstanding shares of Adrenyx common stock to Spruce stockholders on a pro rata basis in the first half of 2027. Adrenyx entered into a secured convertible note purchase agreement with an institutional investor, issuing $5.0 million in principal amount at the initial closing, with up to $10.0 million available in total.
