ANX1502 / Annexon Biosci - LARVOL DELTA

Annexon Provides 2025 Outlook with Strong Momentum Accelerating into Breakthrough Year (GlobeNewswire) - "ANX005 for GBS: Next Milestone: BLA Submission targeted for first half of 2025....ANX007 in GA: 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: Next Milestone: Clinical proof of concept data in CAD and update on future target indications in first quarter of 2025."

Clinical data • Enrollment status • FDA filing • P3 data • Immunology • Ophthalmology • Rare Diseases

Dose Study of ANX1502 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=135 | Completed | Sponsor: Annexon, Inc. | Recruiting ➔ Completed

Trial completion

Dose Study of ANX1502 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=141 | Recruiting | Sponsor: Annexon, Inc. | N=84 ➔ 141 | Trial completion date: Jun 2023 ➔ Nov 2024 | Trial primary completion date: Jun 2023 ➔ Nov 2024

Enrollment change • Trial completion date • Trial primary completion date

Annexon Reports First Quarter 2024 Financial Results and Key Anticipated Milestones (GlobeNewswire) - "ANX005 in GBS: Topline data from the pivotal, randomized, placebo-controlled Phase 3 trial expected in the second quarter of 2024. Initial data from RWE comparability protocol with IGOS expected in first half 2025 to support a planned BLA submission. ANX007 in GA: Global pivotal Phase 3 ARCHER II trial vs. sham control expected to initiate in mid-2024. Pivotal Phase 3 head-to-head ARROW trial vs. SYFOVRE (pegcetacoplan injection) planned to initiate in the second half of 2024. Expect to host an R&D Day on GA and therapeutic potential of ANX007 in mid-2024. ANX1502 in CAD: POC trial evaluating the pharmacodynamics and efficacy of an oral tablet formulation in CAD anticipated to provide initial data in the second half of 2024....R&D expenses were $21.0 million for the quarter ended March 31, 2024, reflecting the advancement of the Company’s priority programs, including GBS, GA and ANX1502, compared to $32.3 million for the quarter ended March 31, 2023."

Clinical data • Commercial • New P3 trial • P3 data: top line • Immunology • Ophthalmology • Rare Diseases

Dose Study of ANX1502 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Annexon, Inc.

New P1 trial • ANXA10