Acumen Pharmaceuticals, Inc. Q1 FY2025 earnings call

• Completed enrollment of the 542-participant Phase 2 study ALTITUDE-AD in roughly 10 months, faster than expected, to evaluate Sabirnetug in early AD; topline results expected in late 2026. • Presented at ADPD and AAN conferences, highlighting innovative use of plasma phospho-tau 217 screening in ALTITUDE-AD to improve enrollment efficiency, reduce patient burden, and lower costs. • Completed Phase 1 study on subcutaneous administration of Sabirnetug, showing good tolerance; ongoing formulation and drug delivery assessments. • As of March 31, 2025, had $197.9 million in cash and marketable securities; R&D expenses in Q1 were $25.3 million, G&A expenses $5.1 million, resulting in a net loss of $28.8 million.

• Topline results for ALTITUDE-AD are expected in late 2026. • Cash and marketable securities are expected to support current clinical and operational activities into early 2027.

• Risks associated with forward-looking statements, including factors that could cause actual results to differ materially from those in forward-looking statements, as detailed in SEC filings.

Q: Once the formulation and drug delivery assessments for subcutaneous administration are complete, how will it be incorporated into future development?

A: Jim Doherty mentioned options include adding a subcu arm to an ongoing Phase 3 study for IV Sabirnetug or a standalone study; the team is evaluating the most efficient pathway.

Q: What are the powering assumptions and interim analysis for ALTITUDE-AD?

A: Eric Siemers stated there is no interim analysis in the study, and the powering is appropriate for a Phase 2 study.

Q: How do commercial antibodies impact the ALTITUDE study?

A: Eric Siemers said no risk seen to date, enrollment was higher than projected, and discontinuation rates are good.

Q: Thoughts on plasma p-tau 217 and synaptic biomarkers?

A: Jim Doherty and Eric Siemers discussed the evolving nature of biomarkers, with plasma-based biomarkers continuing to develop, and synaptic biomarkers being a focus.

Q: Thoughts on Roche data on synaptic biomarkers and Sabirnetug's competitive position?

A: Dan O'Connell and Eric Siemers noted positive results in INTERCEPT and the positioning of ALTITUDE-AD to read out next year with potential impactful results.