Core Insights - Annexon, Inc. is advancing its late-stage clinical platform with three flagship programs targeting complement-mediated neuroinflammatory diseases, including ANX005 for Guillain-Barré syndrome, ANX007 for geographic atrophy, and ANX1502 as an oral C1s inhibitor [2][3] Group 1: ANX005 for Guillain-Barré Syndrome (GBS) - ANX005 is positioned to be the first targeted therapy for GBS, with a successful pivotal Phase 3 trial showing rapid improvement in muscle strength and functional recovery compared to placebo [3][6] - The next milestone for ANX005 is a Biologics License Application (BLA) submission targeted for the first half of 2025 [3][6] Group 2: ANX007 for Geographic Atrophy (GA) - ANX007 is the only investigational therapy demonstrating significant vision preservation in GA, with successful Phase 2 ARCHER data showing protection of vision in both standard and low light conditions [3][6] - The ongoing global registrational Phase 3 ARCHER II trial is expected to enroll approximately 630 patients, with completion of enrollment targeted for the second half of 2025 and data expected in the second half of 2026 [6] Group 3: ANX1502 for Autoimmune Conditions - ANX1502 is a first-in-kind oral C1s inhibitor, with a completed bridging study showing a safety and pharmacokinetic profile similar or better than previous studies [6] - The next milestone for ANX1502 is to provide clinical proof of concept data in cold agglutinin disease and updates on future target indications in the first quarter of 2025 [6] Group 4: Company Overview and Strategic Focus - Founded ten years ago, Annexon aims to transform the complement landscape and deliver novel therapies for over 8 million people suffering from complement-mediated neuroinflammatory diseases [2][4] - The company is focused on achieving key milestones with a cash runway extending into the second half of 2026 [1][2]
Annexon Provides 2025 Outlook with Strong Momentum Accelerating into Breakthrough Year