Annexon Reports Third Quarter 2026 Financial Results, Business Updates and Key Anticipated Milestones

(NASDAQ:ANNX) Annexon, Inc. reported third quarter 2026 financial results and highlighted progress across its portfolio of targeted immunotherapies for neuroinflammatory diseases. The company is advancing tanruprubart as a potential first targeted, fast-acting therapy for Guillain-Barré syndrome (GBS), which affects 150,000 people annually worldwide and has an estimated annual U.S. healthcare burden of approximately $20 billion. In the ongoing FORWARD study, 18 patients have been treated with tanruprubart, showing functional outcomes, complete target engagement, and a generally well-tolerated safety profile. The EU Marketing Authorisation Application (MAA) for tanruprubart is under review with the European Medicines Agency (EMA), and a U.S. Biologics License Application (BLA) submission is anticipated in the fourth quarter of 2026. Vonaprument is being developed as a potential first targeted vision-preserving therapy for geographic atrophy (GA), which affects more than 8 million people worldwide. The ARCHER II Phase 3 trial is designed to demonstrate vision protection at Months 15 and 24, with all eligible patients having received at least 15 months of treatment and patient retention at 90%. The ARCHER II Month 15 primary endpoint assessment is expected in the fourth quarter of 2026, with completion including Month 24 analyses expected in the third quarter of 2027. ANX1502, an oral small molecule inhibiting activated C1s, completed a proof-of-concept study in nine patients with cold agglutinin disease (CAD), showing no significant safety signals and observed reductions in disease biomarkers. Annexon entered into a strategic credit facility of up to $200 million with Oxford Finance LLC, drawing an initial $50 million at closing, with an additional $100 million available upon achievement of milestones related to vonaprument and tanruprubart, and the remaining $50 million subject to lender approval. The company appointed Mark S. Blumenkranz, M.D., M.M.S., to its Board of Directors, added Eleonora (Nora) Lad, M.D., Ph.D., to its Scientific Advisory Board, and hired Jake Shumacher as S.V.P., Ophthalmology Franchise Head, and Dr. Donald Fong as S.V.P., Clinical Development, Ophthalmology. As of September 30, 2026, cash, cash equivalents, and short-term investments were $213.4 million, expected to fund operations and milestones into 2028. Research and development expenses were $41.4 million for the quarter ended September 30, 2026, compared to $49.7 million for the same period in 2025. General and administrative expenses were $10.9 million for the quarter, compared to $7.3 million in the prior year. Net loss attributable to common stockholders was $51.2 million or $0.25 per share for the quarter, compared to $54.9 million or $0.37 per share for the same period in 2025. For the nine months ended September 30, 2026, research and development expenses were $123,744,000 and general and administrative expenses were $31,774,000. Cash and cash equivalents as of December 31, 2025, were $162,051,000, and short-term investments were $76,294,000. Total assets as of September 30, 2026, were $250,408,000, compared to $277,571,000 as of December 31, 2025. Stock-based compensation expense for research and development was $2,630,000 for the quarter and $7,661,000 for the nine months ended September 30, 2026. Stock-based compensation expense for general and administrative was $2,480,000 for the quarter and $6,418,000 for the nine months ended September 30, 2026.