Acumen Pharmaceuticals (ABOS) investor relations material

Market opportunity and landscape

• Early Alzheimer's disease affects 7.2 million Americans, projected to grow to 13.8 million by 2060, creating a large and expanding market for new therapies.

• Approved anti-amyloid agents have surpassed $1 billion in annual sales, with forecasts of $2–4 billion by 2030, driven by improved diagnostics and treatment infrastructure.

• Adoption of blood-based biomarkers is accelerating, improving diagnostic accuracy, enabling broader patient identification, and streamlining clinical trials.

• Recent FDA clearances for blood-based biomarkers are driving a diagnostics market forecasted to grow from $153M in 2024 to $530M by 2033.

• Market growth is expected to accelerate with new drug formats, combination strategies, and increased physician familiarity.

Pipeline and clinical development

• Sabirnetug, a first-in-class, oligomer-selective IgG2 antibody, is in a pivotal phase II trial (ALTITUDE-AD) with topline results expected in late 2026.

• Phase I data showed robust target engagement, normalization of AD biomarkers, and a favorable safety profile with limited ARIA incidence, supporting advancement to phase II.

• ALTITUDE-AD is a large, well-powered, placebo-controlled study (542 patients) using innovative blood-based screening and multiple clinical and biomarker endpoints.

• The trial uses iADRS as the primary endpoint, with CDR-SB, ADAS-Cog13, and biomarker changes as key secondary endpoints.

• Rapid enrollment and high open-label extension participation reflect strong site and patient engagement.

Scientific differentiation and mechanism

• Sabirnetug targets soluble Aβ oligomers, believed to be the most toxic and early drivers of Alzheimer's pathology, differentiating it from plaque-targeting antibodies.

• The IgG2 backbone may reduce inflammatory side effects and ARIA risk compared to IgG1 antibodies.

• Preclinical and phase I data show rapid, robust effects on amyloid, tau, and synaptic biomarkers, supporting the oligomer hypothesis.

• Comparative studies demonstrate sabirnetug's higher affinity for soluble oligomers and lower affinity for monomers and vascular amyloid, suggesting a differentiated safety and efficacy profile.