Vonaprument (ANX007) in Geographic Atrophy (GA) - Vonaprument is the only GA program to demonstrate significant vision preservation, representing a potential blockbuster market opportunity[9, 15] - Phase 2 trial (ARCHER) showed significant time and dose-dependent vision preservation in GA patients, with a 73% risk reduction in BCVA ≥15-letter loss at two consecutive visits in the monthly (EM) dosing group (p = 0.0207) compared to sham[29] - In the ARCHER trial, 21.3% of patients in the sham group experienced persistent BCVA ≥15-letter loss through month 12+, compared to 5.6% in the Vonaprument EM group and 9.8% in the Vonaprument EOM group[25] - Photoreceptor protection was numerically greater in the central macula with Vonaprument, showing a 59% decrease in total Ellipsoid Zone (EZ) loss in the central 1.5 mm area compared to sham[34] - ARCHER II Phase 3 program is now fully enrolled with approximately 630 patients randomized in a 2:1 ratio (Vonaprument to Sham), with topline data expected in 2H'26[39] Safety and Clinical Development - ARCHER trial safety data showed Choroidal Neovascularization events in 3.4% of the sham group, 4.5% of the Vonaprument EM group, and 4.3% of the Vonaprument EOM group[36] - Global registration path established supporting potential first approval in both EU and US for dry AMD with GA; PRIME designation in EU[17] Pipeline and Platform - Annexon has a clinically validated scientific platform with broad potential across multiple therapeutic areas[9] - The company is pioneering a scientific approach to stop complement-driven neuroinflammation by blocking C1q[11, 12] - Annexon has a diverse late-stage clinical platform for classical complement-mediated neuroinflammatory diseases of the body, brain, and eye[14]

Core Insights - The International Guillain-Barré Syndrome Outcomes Study (IGOS) presented real-world evidence showing improved outcomes with tanruprubart compared to current standards of care in matched patient populations [1][2] - Tanruprubart, a first-in-kind monoclonal antibody, is designed to block C1q to halt neuroinflammation and nerve damage in Guillain-Barré Syndrome (GBS) [2][3] - The drug has received Fast Track and Orphan Drug designations from the U.S. FDA and the European Medicines Agency for GBS treatment [5] Company Overview - Annexon, Inc. is focused on developing novel therapies for classical complement-mediated neuroinflammatory diseases affecting the body, brain, and eye [1][7] - The company aims to deliver innovative treatments targeting C1q to prevent tissue damage and loss in various neuroinflammatory conditions [7] - Annexon's pipeline includes investigational drug candidates addressing unmet needs in autoimmune, neurodegenerative, and ophthalmic diseases, potentially benefiting over 8 million people globally [7] Industry Context - GBS is a rare autoimmune disease with no FDA-approved therapies, characterized by rapid progression and severe weakness, often leading to paralysis [2][6] - The disease results in over 22,000 hospitalizations annually in the U.S. and Europe, contributing to significant morbidity and economic costs to the healthcare system [6] - The long-term burden of GBS has led to a multi-billion-dollar annual economic impact on the U.S. healthcare system [6]