Business
Annexon Reports Third Quarter 2024 Portfolio and Financial Results, and Key Anticipated Milestones
Topline Real-World Evidence (RWE) Comparability and Outcomes Data for ANX005 in Guillain-Barré Syndrome (GBS) Expected by Year-End 2024; Biologics License
About this update from Annexon, Inc.
[{"type":"text","content":"Topline Real-World Evidence (RWE) Comparability and Outcomes Data for ANX005 in Guillain-Barré Syndrome (GBS) Expected by Year-End 2024; Biologics License Application (BLA) Submission Targeted for First Half 2025 Ongoing Enrollment in Phase 3 ARCHER II Trial for ANX007 in Geographic Atrophy (GA); Topline Data Expected Second Half 2026 Proof-of-Concept Study with First-in-Kind Oral C1s Inhibitor ANX1502 Transitioned to an Enhanced Tablet Formulation; Data in Cold Agglutinin Disease (CAD) Expected in First Quarter 2025 Bolstered Commercial, Medical Affairs and Health Economics Senior Leadership in Preparation for Potential ANX005 Commercialization Robust Balance Sheet with Cash, Cash Equivalents, and Short-term Investments of Approximately $340 Million as of September 30, 2024, and Anticipated Runway into Second Half 2026 BRISBANE, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- 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 highlighted portfolio progress and reported third quarter 2024 financial results. “We are executing toward a strong finish for the year to propel us into the start of an impactful 2025. The RWE data for our ANX005 GBS program expected by year end 2024 will be an important part of our first BLA submission as a company and a significant step toward providing GBS patients with a targeted and approved therapy. ARCHER II, our Phase 3 trial in GA, is actively enrolling and designed to provide the first significant data for protection of vision in a pivotal GA trial. Finally, we’re anticipating data from our first-in-kind oral C1s program, ANX1502, with an improved tablet formulation in patients with CAD in the first quarter of 2025,” said Douglas Love, president and chief executive officer of Annexon. Mr. Love continued, “Our portfolio of programs has provided consistent support for our approach to target C1q, a key upstream driver of neuroinflammatory diseases of the body, brain and eye, and we’re encouraged by the outlook for our programs. With a strong balance sheet and runway into the second half of 2026, we are laser-focused to deliver on our near-term goals and achieve our mission of helping millions of patients live thei...