Spruce Biosciences (SPRB) Jefferies Global Healthcare Conference summary

Strategic focus and market opportunities

• Advancing tildacerfont for CAH, PCOS, and major depressive disorder, targeting markets estimated at $3 billion for CAH and significant potential in PCOS and depression.

• Recent partnership with a German company to develop a companion diagnostic for major depressive disorder.

• Orphan drug designation for CAH in the U.S. and Europe, with method of use patent exclusivity through 2038.

• Actively seeking partnerships for PCOS due to the large investment required.

• Cash position of $81 million, expected to fund operations through the end of 2025.

Clinical development and milestones

• Upcoming data readouts from phase II/III (204) and pediatric (205) CAH studies expected in Q3; major depressive disorder study to start in Q4.

• POWER study in PCOS showed significant DHEAS reduction, with potential for greater effects at higher doses.

• Phase IIa CAH study showed up to 84% ACTH reduction and 60% of patients achieving normal ACTH levels.

• Pediatric CAH program demonstrated safety, target engagement, and A4 control, with higher dose cohorts underway.

• Collaboration with HMNC Brain Health to use a companion diagnostic for patient selection in major depressive disorder trials.

Study results and analysis

• Phase II/III CAH study did not meet its primary endpoint, attributed to poor patient compliance; post-hoc analysis showed ACTH reduction and better outcomes with higher compliance.

• PCOS study indicated improvements in DHEAS and sex hormone-binding globulin, suggesting potential symptom control in future studies.

• Major depressive disorder program leverages genetic companion diagnostic to identify likely responders, with phase II study planned.