Spruce Biosciences is spinning out a preclinical endocrinology program to be led by a newly formed subsidiary called Adrenyx Biosciences, armed with up to $50 million from an unnamed investor.
Spruce's main focus remains gearing up for a planned December regulatory filing for its lead pipeline candidate TA-ERT for Sanfilippo syndrome type B. The spinout means the biotech will retain a focus on neurological disorders, while Adrenyx will prioritize endocrinology, according to a Nov. 9 release.
Adrenyx’s prize is CRHX-101, a monoclonal antibody being investigated for the treatment of congenital adrenal hyperplasia (CAH), a group of inherited disorders affecting the adrenal glands.
The companies are expected to operate as separate, publicly traded companies, with Adrenyx to be led by Spruce's Chief Financial Officer Samir Gharib, who will also continue in his current role.
“Separating CRHX-101 into Adrenyx positions a differentiated, late preclinical-stage program to be advanced by a dedicated team with the resources and time horizon the opportunity deserves,” said Gharib.
CRHX-101, formerly known as SPR-202, has the potential to control CAH in patients who often rely on chronic high-dose steroids that come with side effects including growth impairment, bone loss, metabolic complications and Cushingoid features.
The spinout includes an initial $5 million promissory note agreement from “a leading institutional biotechnology investor,” with another $5 million potentially to follow. The investor is committing up to $50 million in a private equity deal, including the original notes.
The companies intend to split in the first half of next year, given regulatory and listing approval.
“The separation is designed to enable each company to pursue its distinct strategic path with a focused team, a dedicated capital structure and a clearer value proposition for investors,” Spruce CEO Javier Szwarcberg, M.D., said in the release.
Spruce has walked a rocky road to its own FDA filing for TA-ERT, facing manufacturing data delays after taking the baton in 2025 from Allievex, which had faltered in its own regulatory path after licensing the asset from BioMarin in 2019. At the time, Spruce reduced its own workforce by more than half to conserve cash for TA-ERT’s accelerated approval.
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