Annexon (ANNX) Provides 2025 Outlook with Strong Momentum Accelerating into Breakthrough Year

Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced its 2025 outlook and key catalysts for its flagship programs: ANX005 in Guillain-Barré syndrome (GBS), ANX007 in geographic atrophy (GA), and oral small molecule ANX1502 for a host of diseases.

“Founded ten years ago, Annexon has pursued an intentional path to transform the complement landscape and thereby drive immense value by effectively translating our pioneering science into potential treatments for millions of patients suffering from complement-mediated neuroinflammatory diseases. With significant progress and achievements across our diverse and wholly-owned complement portfolio, we’re more encouraged than ever by the opportunity for each of our potentially best-in-class flagship programs, and we remain laser focused on our mission to help scores of patients live their best lives,” said Douglas Love, president and chief executive officer of Annexon.”

Mr. Love continued, “Specifically regarding the flagship programs, our ANX005 program is most advanced and positioned to displace current standard of care in GBS as the first potential targeted treatment to rapidly improve muscle strength and restore normal function in this devastating neurological condition, and we are preparing our BLA submission for the first half of 2025. Additionally, our ANX007 registrational Phase 3 ARCHER II trial in GA is designed to replicate the significant vision preservation observed in the ARCHER proof-of-concept trial, and enrollment is on pace for completion in the second half of 2025. Finally, ANX1502, our first-in-kind oral C1s inhibitor, is advancing toward clinical proof-of-concept data in the first quarter of 2025 with the potential to disrupt the landscape treating a range of autoimmune and other diseases currently managed with infused biologics. With significant catalysts approaching, we’re excited to take advantage of our strong momentum and are well-positioned for a breakthrough year ahead.”

2025 Strategic Priorities and Key Catalysts

• ANX005 for GBS: Potential to be the first targeted therapy for GBS
  • Successful pivotal Phase 3 trial showed ANX005 helped patients get better sooner with rapid improvement in muscle strength and more complete functional recovery than placebo through 6 months, and provided an important benefit in the burden of care by enabling patients to walk or be off ventilation earlier
  • Real World Evidence (RWE) study matched ANX005-treated patients from the pivotal Phase 3 study with a Western world patient population predominantly from Europe and North America treated with current standards of care (intravenous immunoglobulin (IVIg) or plasma exchange (PE)). Consistent with Phase 3, ANX005 showed rapid increase in muscle strength with more complete recovery over IVIg or PE.
  • Next Milestone: BLA Submission targeted for first half of 2025
• ANX007 in GA: Only investigational therapy to show significant vision preservation on the endpoints of best corrected visual acuity (BCVA) and low light visual acuity (LLVA) in GA
  • Successful Phase 2 ARCHER data showed significant protection of vision in both standard and low light conditions, as well as enhanced visual protection in patients with healthier eyes, and structural protection of photoreceptors in the central fovea that are associated with visual acuity
  • Ongoing global registrational Phase 3 ARCHER II trial, a well-powered, sham-controlled study with a robust safety database, expected to enroll ~630 patients and use BCVA protection against ≥15-letter loss as primary outcome measure
  • Next Milestone: Phase 3 ARCHER II trial enrollment to be completed in second half of 2025; data expected in second half of 2026
• ANX1502 for Autoimmune Conditions: First-in-kind oral C1s inhibitor with convenient and flexible dosing
  • Completed bridging study in healthy volunteers from a liquid suspension formulation to a twice-daily tablet with safety and pharmacokinetic profile similar or better than previous studies
  • Ongoing open label single arm study in cold agglutinin disease (CAD) evaluating enteric-coated tablet formulation with improved tolerability will inform next steps for later-stage clinical development
  • Next Milestone: Clinical proof of concept data in CAD and update on future target indications in first quarter of 2025

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