Spruce Biosciences (SPRB) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Key program updates and clinical data

• Upcoming Q4 data releases from CAHmelia 204 and CAHptain studies in CAH, with concurrent unveiling planned.

• CAHmelia 203 study failed to meet its primary endpoint, attributed to low patient compliance and highly dysregulated adrenal glands.

• CAHptain pediatric study showed 70% of participants with elevated A4 achieved reductions, prompting dose escalation in ongoing cohorts.

• POWER study in PCOS demonstrated statistically significant DHEAS reduction, with future studies likely to use higher doses and parallel group design.

• Strategic collaboration with Brain Health for MDD, with phase II trial and first patient enrollment expected by year-end.

Pipeline strategy and partnerships

• Tildacerfont, a second-generation CRF1 antagonist, is the lead asset, licensed from Eli Lilly, with orphan designation for CAH in the US and Europe.

• Intellectual property for tildacerfont extends to 2027 for composition of matter and to 2038 for method of use.

• PCOS indication may be partnered out due to the scale of investment required; discussions with interested parties are ongoing.

• Brain Health partnership includes a companion diagnostic (Cortibon) for MDD, enabling precision patient selection.

• Option to in-license worldwide rights for Cortibon after phase II data readout.

Financial and operational outlook

• Cash runway extends into 2025, with approximately $70 million available as of Q2.

• End of 2024 is a critical inflection point with multiple top-line data readouts expected.

• Ongoing engagement in strategic collaborations to support pipeline advancement.