Spruce Biosciences (NASDAQ:SPRB) has separated its CRHX-101 drug development programme into a newly formed, wholly owned subsidiary, Adrenyx Biosciences, Inc., with plans to distribute shares in the new company to Spruce stockholders during the first half of 2027.
The separation, formalised on November 6, 2026, is intended to establish two independent publicly traded biotechnology companies, each focused on a separate drug development programme.
The proposed share distribution remains subject to regulatory and corporate approvals, including authorisation from Spruce’s board of directors.
Adrenyx will concentrate on developing CRHX-101, previously known as SPR-202, an investigational monoclonal antibody targeting classic congenital adrenal hyperplasia (CAH).
The treatment is designed to neutralise corticotropin-releasing hormone, which contributes to excessive adrenal androgen production in patients with the condition.
CRHX-101 is currently in late preclinical development. Adrenyx plans to complete the studies and other activities required to support an Investigational New Drug (IND) application with the US Food and Drug Administration.
The programme has not yet entered clinical testing.
Adrenyx has entered into a secured convertible note purchase agreement allowing it to issue up to $10 million in notes to support its operations.
An initial $5 million was issued at closing.
The company also plans a private placement of Adrenyx equity securities in connection with the proposed share distribution.
Under the contemplated financing arrangements, the same investor may provide up to $50 million in total funding, including amounts invested through the convertible notes.
Spruce stated that proceeds from the Adrenyx notes cannot be used to finance Spruce’s own operations.
Samir Gharib, currently President and Chief Financial Officer of Spruce Biosciences, will serve as President and Chief Executive Officer of Adrenyx while retaining his existing responsibilities at Spruce.
Spruce will continue under Chief Executive Officer Javier Szwarcberg and remain focused on TA-ERT, its lead investigational therapy for mucopolysaccharidosis type IIIB (MPS IIIB).
The company plans to submit a Biologics License Application (BLA) for TA-ERT to the FDA in December 2026.
The separation is intended to allow the two businesses to pursue their respective development programmes independently.
Spruce expects to distribute Adrenyx shares to its stockholders during the first half of 2027, although its board has not yet approved the distribution or established a record date.
Completion will require several conditions to be satisfied, including effectiveness of the relevant Securities and Exchange Commission registration statement and Nasdaq approval for Adrenyx’s listing.
The company expects the distribution to be taxable for US federal income tax purposes.
If completed, the transaction would establish Adrenyx as a separately traded company focused on CRHX-101, while Spruce continues development of TA-ERT.
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