UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39402 ANNEXON, INC. (Exact name of Registrant as specified in its Charter) Delaware 27-5414423 (State or other jurisdiction of in ...

Exhibit 99.1 Annexon Reports Second Quarter 2025 Financial Results, Portfolio Progress and Key Anticipated Milestones Tanruprubart (formerly ANX005) for GBS Advancing Through Regulatory Interactions; MAA Submission in Europe Anticipated in First Quarter of 2026; Ongoing Discussions with FDA Regarding Generalizability Package to Support a BLA Accelerated Completion of Enrollment for Global Phase 3 ARCHER II Trial of Vonaprument (formerly ANX007) for Dry AMD with GA; Selected for EMA PRIME Product Development ...

Tanruprubart (formerly ANX005) for GBS Advancing Through Regulatory Interactions; MAA Submission in Europe Anticipated in First Quarter of 2026; Ongoing Discussions with FDA Regarding Generalizability Package to Support a BLA Accelerated Completion of Enrollment for Global Phase 3 ARCHER II Trial of Vonaprument (formerly ANX007) for Dry AMD with GA; Selected for EMA PRIME Product Development Candidate Pilot; Topline ARCHER II Data Expected in Second Half of 2026 ANX1502 First-in-Kind Oral C1s Inhibitor Expo ...

Summary of Annexon (ANNX) FY Conference - August 13, 2025 Company Overview - **Company**: Annexon Biosciences - **Industry**: Ophthalmology and Neuroinflammatory Diseases - **Key Focus**: Development of therapies targeting complement-mediated diseases, particularly in ophthalmology Core Points and Arguments 1. **Leadership and Experience**: Lloyd Clark, a retina specialist with 25 years of experience, has joined Annexon to advance their lead candidate for dry Age-related Macular Degeneration (AMD) through Phase 3 trials, aiming for a potential blockbuster treatment option [5][6][34] 2. **Product Pipeline**: - **Lead Candidate**: Vonapruvment (formerly known as ANX007) for geographic atrophy associated with dry AMD, which has shown vision preservation in clinical trials [12][13][29] - **Other Candidates**: - Tanrupebar, a systemic C1Q inhibitor for Guillain-Barré syndrome, has completed Phase 3 trials with positive results [7][11] - An oral complement inhibitor in earlier phases targeting multiple indications [8] 3. **Scientific Approach**: The company utilizes a pioneering scientific approach to inhibit the classical complement pathway, specifically targeting C1Q to mitigate neuroinflammation across various diseases [9][10][30] 4. **Clinical Data**: - Positive Phase 2 results for vonapruvment indicate significant visual acuity preservation and anatomical benefits, with a 73% risk reduction in 15-letter loss compared to sham treatment [23][31] - The ARCHER II Phase 3 trial has completed enrollment with over 630 patients, focusing on those with potential for vision preservation [26][33] 5. **Regulatory Progress**: - Vonapruvment has received PRIME designation in the EU, marking it as the first dry AMD drug to achieve this status [16][28] - The company is in discussions with global regulators to bring therapies to market [8][11] Important but Overlooked Content 1. **Market Need**: There are currently no approved therapies for geographic atrophy outside the US, highlighting a significant unmet medical need for patients suffering from severe blinding eye diseases [14][16] 2. **Safety Profile**: The ARCHER study indicated a favorable safety profile for vonapruvment, with minimal adverse events reported, including only one case of endophthalmitis [25][32] 3. **Future Outlook**: The company anticipates reporting top-line data from the ARCHER II trial in 2026, with a strong cash runway to support ongoing development [34] This summary encapsulates the key insights from the conference, focusing on Annexon's strategic direction, product pipeline, and the significant clinical advancements in treating neuroinflammatory diseases and ophthalmological conditions.

Vonaprument (ANX007) in Geographic Atrophy (GA) - Vonaprument is the only GA program to demonstrate significant vision preservation, representing a potential blockbuster market opportunity[9, 15] - Phase 2 trial (ARCHER) showed significant time and dose-dependent vision preservation in GA patients, with a 73% risk reduction in BCVA ≥15-letter loss at two consecutive visits in the monthly (EM) dosing group (p = 0.0207) compared to sham[29] - In the ARCHER trial, 21.3% of patients in the sham group experienced persistent BCVA ≥15-letter loss through month 12+, compared to 5.6% in the Vonaprument EM group and 9.8% in the Vonaprument EOM group[25] - Photoreceptor protection was numerically greater in the central macula with Vonaprument, showing a 59% decrease in total Ellipsoid Zone (EZ) loss in the central 1.5 mm area compared to sham[34] - ARCHER II Phase 3 program is now fully enrolled with approximately 630 patients randomized in a 2:1 ratio (Vonaprument to Sham), with topline data expected in 2H'26[39] Safety and Clinical Development - ARCHER trial safety data showed Choroidal Neovascularization events in 3.4% of the sham group, 4.5% of the Vonaprument EM group, and 4.3% of the Vonaprument EOM group[36] - Global registration path established supporting potential first approval in both EU and US for dry AMD with GA; PRIME designation in EU[17] Pipeline and Platform - Annexon has a clinically validated scientific platform with broad potential across multiple therapeutic areas[9] - The company is pioneering a scientific approach to stop complement-driven neuroinflammation by blocking C1q[11, 12] - Annexon has a diverse late-stage clinical platform for classical complement-mediated neuroinflammatory diseases of the body, brain, and eye[14]

New Pilot Appoints Designated Product Development Coordinator to Navigate Regulatory Interactions, Respond to Ad-hoc Queries, and Support Evidence Planning Vonaprument Selected by EMA as One of ~20 PRIME Development Programs in the Pilot Vonaprument Has the Potential to Be the First Treatment Approved in Europe and the U.S. for Dry AMD with Geographic Atrophy Based on Protection of Visual Acuity and Visual Structures BRISBANE, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) --  Annexon, Inc. (Nasdaq: ANNX), a biopha ...

Expedited Enrollment Surpassing 630 Targeted Participants Underscores the Strong Demand for a Therapy Focused on Vision Preservation Phase 3 ARCHER II Trial Design and Rationale to Be Presented at ASRS, a Leading Meeting for Retina Science and Innovation Topline Pivotal Phase 3 Data Expected in the Second Half of 2026 Potential for Vonaprument to Be the First Treatment Approved in Europe and the U.S. for Dry AMD with Geographic Atrophy Based on Protection of Visual Acuity and Structural Measures BRISBANE, C ...

Expedited Enrollment Surpassing 630 Targeted Participants Underscores the Strong Demand for a Therapy Focused on Vision Preservation Phase 3 ARCHER II Trial Design and Rationale to Be Presented at ASRS, a Leading Meeting for Retina Science and Innovation Topline Pivotal Phase 3 Data Expected in the Second Half of 2026 Potential for Vonaprument to Be the First Treatment Approved in Europe and the U.S. for Dry AMD with Geographic Atrophy Based on Protection of Visual Acuity and Structural Measures BRISBANE, C ...

Group 1: Company Overview - Belite Bio (BLTE) is focused on developing novel therapeutics for untreatable eye diseases and metabolic diseases [1] - 3D Systems (DDD) provides 3D content-to-print solutions including printers, materials, and custom parts services [2] - Annexon (ANNX) is developing therapies for classical complement-mediated disorders affecting the body, brain, and eye [3] Group 2: Earnings Estimates - Belite Bio's current year earnings estimate has been revised downward by 59.1% over the last 60 days [1] - 3D Systems' current year earnings estimate has been revised downward by 17% over the last 60 days [2] - Annexon's current year earnings estimate has been revised downward by almost 5.8% over the last 60 days [3]

Core Insights - The article discusses the performance and outlook of Annexon (NASDAQ: ANNX), particularly in relation to its challenges with the FDA and the market's reaction to its stock [1]. Group 1 - The author has previously written about Annexon, indicating ongoing concerns regarding FDA hurdles that may impact the company's stock performance [1]. - The market has not responded positively to Annexon's situation, maintaining a "Hold" rating from earlier analyses [1]. - The author emphasizes the importance of learning from both investment successes and failures, particularly in the healthcare sector [1].