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Annexon (ANNX) investor relations material

Annexon Jefferies London Healthcare Conference 2025 summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Jefferies London Healthcare Conference 2025 summary19 Nov, 2025

Platform and pipeline overview

  • Developing a next-generation complement platform targeting the neuroinflammatory cascade at the source, aiming for differentiated outcomes in vision, muscle strength, and cognition across multiple diseases.

  • Leading programs include late-stage assets in Guillain-Barré syndrome (GBS) and geographic atrophy (GA), with a first-in-class oral small molecule (ANX1502) in early-stage development for autoimmune conditions.

  • GA program is the only one to show significant vision preservation and photoreceptor protection on all endpoints, setting it apart from downstream approaches.

  • Multiple regulatory and clinical milestones are expected in 2026, including filings and pivotal data readouts.

Guillain-Barré syndrome (GBS) program

  • GBS affects 22,000–25,000 patients annually in the U.S. and Europe, with over 90% receiving treatment, representing a significant commercial opportunity.

  • Pricing is estimated at $100,000–$150,000 per therapy course, with low cost of goods (<3%) and a concentrated sales model targeting fewer than 200 hospitals.

  • Phase III data showed a safety profile similar to placebo and superior efficacy to standard care, with rapid functional recovery and reduced hospital stays.

  • Regulatory filing in Europe is planned for January 2026, with U.S. filing contingent on additional FDA discussions and provision of U.S. patient data.

  • An open-label study is proactively enrolling U.S. and European patients to address regulatory expectations, with initial data to be shared in cohorts.

Geographic atrophy (GA) program

  • Phase III enrollment completed ahead of schedule with 650 patients across 30+ sites in the U.S. and Europe.

  • The program targets the neurodegenerative root of GA, aiming to preserve photoreceptors and functional vision, unlike competitors focused on RPE cells.

  • Regulatory strategy shifted from a head-to-head to a single protocol with two sub-analyses, increasing statistical power and efficiency.

  • Approval in Europe requires one positive study, while the U.S. considers the totality of evidence from both sub-analyses.

  • Primary endpoint is 15-letter best corrected visual acuity change, a clinically meaningful and regulatory-accepted measure.

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Frequently asked questions

Annexon, Inc. is a clinical-stage biopharmaceutical company engaged in discovering and developing therapeutics for autoimmune, neurodegenerative, and ophthalmic disorders. The company focuses on targeting C1q, an initiating molecule of the classical complement pathway, which plays a critical role in various disease processes, including antibody-mediated autoimmune diseases and complement-mediated neurodegeneration. Annexon's pipeline includes several product candidates such as ANX005, which is in clinical trials for Guillain-Barré syndrome, and other trials for warm autoimmune hemolytic anemia, Huntington's disease, and amyotrophic lateral sclerosis. Annexon is headquartered in Brisbane, California, and its shares are listed on the Nasdaq.

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