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Oral Presentation Features Phase 3 Data Showing Rapid Recovery and Durable Benefit of Tanruprubart (formerly ANX005) on Clinically Meaningful Measures across Multiple Stages of GBS Disease Education Campaign for Healthcare Providers called Move GBS Forward™ (MoveGBSForward.com) Highlights Life-altering Impact of GBS BRISBANE, Calif., April 08, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with ...

Oral Plenary Presentation on Tuesday, April 8 Features Phase 3 Data for ANX005, the First Potential Targeted Therapy for GBS, Showing Rapid and Durable Benefit Across Clinical Measures and Time Points Educational Symposium Focuses on Advancing GBS Care and Role of Classical Complement Pathway New Disease Education Campaign “Move GBS Forward” Draws Attention to Life-altering Physical and Mental Impact of GBS BRISBANE, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutic ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 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) (State or other jurisdiction of incorporation or organizat ...

Exhibit 99.1 Annexon Reports Fourth Quarter and Year-End 2024 Financial Results, Portfolio Progress and Key Anticipated Milestones Robust, Consistent Phase 3 Data and Real-World Evidence Outcomes Support ANX005 as Potential First Targeted Therapy for GBS; Pre-BLA Meeting Targeted for 1H 2025 Ahead of Planned Biologics License Application (BLA) Submission Established Groundbreaking Global Registration Path for ANX007 to be Potential First Vision-Preserving Treatment for Dry AMD with GA in Europe and U.S.; To ...

Robust, Consistent Phase 3 Data and Real-World Evidence Outcomes Support ANX005 as Potential First Targeted Therapy for GBS; Pre-BLA Meeting Targeted for 1H 2025 Ahead of Planned Biologics License Application (BLA) Submission Established Groundbreaking Global Registration Path for ANX007 to be Potential First Vision-Preserving Treatment for Dry AMD with GA in Europe and U.S.; Topline Phase 3 ARCHER II Data Expected Second Half 2026 First-in-Kind Oral C1s Inhibitor POC Trial Ongoing with Dosing in Three Pati ...

Core Insights - Annexon, Inc. is advancing its late-stage clinical platform with promising therapies for neuroinflammatory diseases, focusing on three flagship programs: ANX005 for Guillain-Barré Syndrome (GBS), ANX007 for dry age-related macular degeneration (AMD) with geographic atrophy (GA), and ANX1502 for autoimmune conditions [2][3][9] Group 1: Clinical Programs - ANX005 is a first-in-kind monoclonal antibody designed to block C1q, showing early and durable functional improvements in GBS patients, with a pre-BLA meeting targeted for the first half of 2025 [2][3][8] - ANX007 has established a groundbreaking global registration path to potentially be the first approved treatment for dry AMD with GA in Europe and the U.S., with Phase 3 ARCHER II data expected in the second half of 2026 [2][8] - ANX1502 is an oral small molecule currently in a proof-of-concept trial for cold agglutinin disease, with data from an expanded dataset of up to seven patients expected by mid-2025 [2][3][8] Group 2: Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and short-term investments of approximately $312 million, providing a runway into the second half of 2026 [7][11] - Research and development expenses for Q4 2024 were $43.4 million, up from $23.3 million in Q4 2023, reflecting the advancement of priority programs [11][13] - The net loss for the year ended December 31, 2024, was $138.2 million, compared to $134.2 million in 2023, indicating ongoing investment in clinical development [11][13] Group 3: Market Context - GBS affects at least 150,000 people worldwide annually, with no FDA-approved therapies currently available, highlighting a significant unmet medical need [8] - Dry AMD with GA is a leading cause of blindness, affecting over 8 million patients globally, with no approved therapies targeting vision preservation [8]

BRISBANE, Calif., Feb. 26, 2025 (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 announced that Douglas Love, president and chief executive officer, will present at the TD Cowen 45th Annual Health Care Conference on Tuesday, March 4, 2025 at 11:50 a.m. EST. A live webcast of the event can be acc ...

Core Insights - Annexon, Inc. is advancing a late-stage clinical platform for novel therapies targeting classical complement-mediated neuroinflammatory diseases, with a focus on geographic atrophy (GA) [1][7] - The company presented findings on its investigational therapy ANX007 at the Macula Society 48th Annual Meeting, highlighting its potential in vision preservation [1][2] Product Overview - ANX007 is a first-in-kind, non-pegylated antigen-binding fragment designed to block C1q locally in the eye, showing significant vision preservation in GA patients [2][3] - The therapy demonstrated statistically significant protection against vision loss in the Phase 2 ARCHER trial, with a notable treatment effect that increased over time [5] Clinical Trial Details - The Phase 2 ARCHER trial was randomized, multi-center, double-masked, and sham-controlled, showing consistent protection against vision loss across multiple measures [5] - ANX007 provided significant protection from vision loss as measured by best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA), with a treatment effect that was time and dose-dependent [5] Regulatory Designations - ANX007 has received Fast Track designation from the FDA and Priority Medicine (PRIME) designation in the EU, indicating its potential therapeutic advantage [4] Mechanism of Action - ANX007 selectively inhibits C1q, a key driver of neurodegeneration, preventing aberrant activation of the classical complement pathway that leads to vision loss [3][4] - The therapy has shown to protect retinal structures critical for vision, including photoreceptors and retinal pigment epithelial cells [5]

ANX005 First Potential Targeted Therapy for Guillain-Barré Syndrome Advancing Towards 1H 2025 BLA Submission ANX007 First Potential Neuroprotective Therapy for Geographic Atrophy Expected to Complete Enrollment of Phase 3 ARCHER II Trial in 2H 2025 ANX1502 First Oral C1s Inhibitor On Track for Clinical Proof of Concept Data in 1Q 2025 Cash Runway into 2H 2026 to Achieve Key Milestones BRISBANE, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a la ...