Annexon — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and short-term investments totaled $213.4 million as of September 30, 2026, providing an anticipated operational runway into 2028.
• Research and development (R&D) expenses were $41.4 million for the quarter ended September 30, 2026, a decrease from $49.7 million in the same period in 2025, driven by completed contract manufacturing expenses for tanruprubart regulatory filings offset by continued vonaprument development.
• General and administrative (G&A) expenses were $10.9 million for the quarter ended September 30, 2026, an increase from $7.3 million in the same period in 2025, reflecting ongoing corporate consulting, professional services, and personnel-related expenses.
• Net loss attributable to common stockholders was $51.2 million, or $0.25 per share, for the quarter ended September 30, 2026, compared to a net loss of $54.9 million, or $0.37 per share, in the quarter ended September 30, 2025.
• Total operating expenses for the quarter were $52.2 million, down from $57.0 million in the prior year quarter.
• Interest expense for the quarter was $0.8 million, compared to zero in the prior year quarter.
• Interest and other income, net, was $1.9 million for the quarter ended September 30, 2026, compared to $2.1 million in the prior year quarter.
• Total assets were $250.4 million as of September 30, 2026, compared to $277.6 million as of December 31, 2025.
• Total liabilities were $107.6 million as of September 30, 2026, compared to $65.9 million as of December 31, 2025, primarily due to the inclusion of a term loan.
• Stockholders' equity was $142.8 million as of September 30, 2026, compared to $211.6 million as of December 31, 2025.

Guidance and Future Outlook:

• A U.S. Biologics License Application (BLA) submission for tanruprubart is anticipated in the fourth quarter of 2026, strengthened by U.S./EU FORWARD data.
• The European Medicines Agency (EMA) is currently reviewing the Marketing Authorisation Application (MAA) for tanruprubart.
• An independent Data Monitoring Committee (DMC) will assess the ARCHER II Phase 3 trial Month 15 primary endpoint in the fourth quarter of 2026.
• If the Month 15 endpoint is met, results for two pre-specified sub-studies for U.S. filing are anticipated in the first quarter of 2027; otherwise, the trial may continue to the Month 24 endpoint.
• ARCHER II completion, including Month 24 analyses, is expected in the third quarter of 2027.
• Formulation optimization for the oral C1s inhibitor ANX1502 is underway to improve absorption prior to studies in diseases such as generalized myasthenia gravis (gMG).

Business Segments and Product Lines:

• Tanruprubart (GBS): The open-label U.S./EU FORWARD study has treated 18 patients to date, showing functional outcomes, complete target engagement, and a well-tolerated safety profile consistent with Phase 3 expectations. Patient-level data for the first six patients is available.
• Vonaprument (GA): The ARCHER II Phase 3 trial is a global, double-masked study designed to demonstrate clinically meaningful vision protection at Months 15 and 24. The trial has 90% patient retention, and all eligible patients have received at least 15 months of treatment.
• ANX1502: A proof-of-concept study in nine patients with cold agglutinin disease (CAD) showed no significant safety signals and reductions in disease biomarkers (bilirubin and LDH).
• Leadership Appointments: Mark S. Blumenkranz, M.D., M.M.S., was appointed to the Board of Directors. Eleonora (Nora) Lad, M.D., Ph.D., joined the Scientific Advisory Board. Jake Shumacher joined as S.V.P., Ophthalmology Franchise Head, and Dr. Donald Fong serves as S.V.P., Clinical Development, Ophthalmology.

Market and Competitive Landscape:

• Tanruprubart targets Guillain-Barré syndrome (GBS), a life-threatening neuromuscular emergency affecting 150,000 people annually worldwide with an estimated U.S. healthcare burden of approximately $20 billion.
• Vonaprument targets geographic atrophy (GA), a leading cause of blindness affecting more than 8 million people worldwide.
• ANX1502 is positioned as a potential first-in-kind oral small molecule inhibitor for autoimmune diseases, including gMG.
• The company's platform targets C1q, the initiating molecule of a potent inflammatory pathway, aiming to stop classical complement-driven neuroinflammation.

Risks and Challenges:

• Forward-looking statements highlight risks including the final results of the Phase 3 ARCHER II trial and the formulation optimization for ANX1502.
• Risks include the ability to develop ANX1502 for gMG, the company's history of net operating losses, and the ability to obtain necessary capital.
• Potential delays in clinical trials due to regulatory acceptance of data outside the United States or public health crises are noted.
• Risks also include the ability to obtain regulatory approval, successfully commercialize product candidates, and maintain intellectual property rights.
• The company relies on third-party suppliers and manufacturers.

Management Commentary and Tone:

• Douglas Love, President and CEO, stated the company is "well-positioned for a transformative next 12 months" with multiple value-creating milestones expected.
• Management highlighted that tanruprubart and vonaprument have demonstrated "first-in-kind benefits" in clinical trials to date.
• The tone emphasizes significant focus and momentum to deliver on the mission to help millions live their best lives, noting the advancement of both registrational programs and the strengthening of the balance sheet.

Other Key Points:

• Entered into a strategic credit facility of up to $200 million with Oxford Finance LLC, drawing an initial $50 million at closing.
• An additional $100 million is available under the credit facility upon achievement of milestones related to the vonaprument and tanruprubart registrational programs.
• The remaining $50 million of the credit facility is available subject to lender approval.
• The company operates in the biopharmaceutical sector focusing on targeted immunotherapies for neuroinflammatory diseases.