Spruce Biosciences (SPRB) Guggenheim Inaugural Global Healthcare Innovation Conference summary

Focus areas and asset overview

• Dedicated to advanced science in disease states with real patient need, including CAH, PCOS, and major depressive disorders, all using tildacerfont.

• Tildacerfont was licensed from Eli Lilly in 2014, company formed in 2016, IPO in 2020.

• CAH remains a large unmet need due to chronic high-dose steroid use and associated side effects.

Clinical development and study updates

• 203 study did not achieve its primary endpoint, but valuable learnings were gained.

• December data readouts planned for 204 (adult) and 205 (pediatric/adolescent) studies, which differ in design, population, and dosing.

• 204 study aims to show steroid reduction while maintaining androgenic control over 24 weeks, with most patients on extension.

• 205 study tests higher doses in children and adolescents, targeting a larger effect size and informing future dosing.

Comparative analysis and endpoints

• 204 study's primary endpoint is absolute steroid reduction from baseline to week 24, aiming to match or exceed Neurocrine's 5 mg/day reduction while maintaining androgenic control.

• Differences in patient baseline A4 levels and steroid titration algorithms make direct comparison with Neurocrine challenging.

• Extension data from 204 will assess benefits for patients switching from placebo to active treatment.

• 205 study is open-label, focuses on A4 change, and targets a 50% reduction, referencing Neurocrine's results.