Spruce Biosciences FY23 Loss Widens, CAHmelia-203 Study Fails; Stock Down In Pre-market

(RTTNews) - Shares of Spruce Biosciences Inc. (SPRB) were plunging more than 77 percent in pre-market trading on Nasdaq after the late-stage biopharmaceutical company reported a wider net loss in fiscal 2023, and said its CAHmelia-203 study failed to meet targets.

The company noted that CAHmelia-203 Study of Tildacerfont in adult classic congenital adrenal hyperplasia or CAH with severe hyperandrogenemia did not meet primary efficacy endpoint.

Javier Szwarcberg, Chief Executive Officer, Spruce Biosciences, said, "CAHmelia-203 is the first study of its kind to address a difficult-to-treat CAH patient population with severe and more refractory hyperandrogenemia, which is often attributed to challenging real-life compliance with daily Glucocorticoid or GCs. We garnered important data from this study which will inform ongoing development of tildacerfont in adult classic CAH."

Further, the company noted that positive data from CAHptain-205 study of tildacerfont in pediatric classic CAH supports further dose-ranging across additional dosing cohorts.

Spruce expects to report topline results from CAHmelia-204, which is focused on assessing GC reduction, in the third quarter of 2024.

In fiscal 2023, net loss was $47.9 million, compared to $46.2 million in 2022. Total operating expenses were $62.1 million, compared to $47.3 million last year.

Research and Development expenses for the year were $49.4 million, compared to last year's $35.2 million.

Collaboration revenue was $10.1 million compared to nil in 2022, reflecting the partial recognition of the $15.0 million upfront payment received from Kaken Pharmaceutical.

Cash and cash equivalents as of December 31, 2023 were $96.3 million. The company currently has over $81 million in cash and cash equivalents.

In pre-market activity on Nasdaq, Spruce Biosciences shares were trading at $1.17, down 77.5 percent.

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