Neumora Therapeutics (NMRA) Guggenheim Securities Inaugural Healthcare Innovation Conference summary

Strategic vision and pipeline development

• Raised over $850 million to build a leading neuroscience pipeline with seven programs in clinical and preclinical stages.

• Most advanced asset, navacaprant, is in phase 3 for MDD monotherapy, with additional studies in bipolar depression and Alzheimer's agitation.

• Strong financial position with $342 million in cash, providing runway into mid-2026.

Clinical trial design and execution

• Coastal program includes three phase 3 studies (Coastal 1, 2, 3) for navacaprant, with top-line data expected from late 2024 through first half 2025.

• Studies focus on moderate to severe MDD, using a MADRS score ≥25 to enrich for anhedonia.

• Multiple measures implemented to mitigate placebo response, including high-quality site selection, central raters, compliance apps, and expectation bias controls.

• Studies powered at 90% to detect a 3.2-point placebo-adjusted change on the moderate scale, with flexibility to increase sample size by up to 25%.

Rationale and differentiation of kappa opioid receptor antagonists

• Preclinical and clinical data support kappa antagonists' efficacy in depression and anhedonia.

• Navacaprant is highly selective and dosed for optimal receptor occupancy, targeting monotherapy as the largest commercial opportunity.

• Monotherapy approval could enable off-label adjunctive use, expanding market potential.