Dr. Clark Brings 25 Years of Experience Treating Retina Diseases and Developing Emerging Therapies as a Principal Investigator in Over 70 Clinical Trials and as an Early Pioneer of VEGF Inhibitors ANX007 is the Only Investigational Program Shown to Significantly Preserve Vision and Central Retinal Photoreceptors Critical for Visual Acuity Enrollment of Phase 3 ARCHER II Trial Expected to be Completed in Q3 2025, with Topline Data Expected in Second Half of 2026 BRISBANE, Calif., June 18, 2025 (GLOBE NEWSWIR ...

Core Insights - Annexon, Inc. is advancing a late-stage clinical platform of novel therapies targeting classical complement-mediated neuroinflammatory diseases, with significant progress in its portfolio and financial results for Q1 2025 [1][2][9] Group 1: Clinical Development Updates - The FDA meeting for Tanruprubart (formerly ANX005), a potential treatment for Guillain-Barré Syndrome (GBS), is scheduled for Q2 2025 ahead of a planned Biologics License Application (BLA) submission [1][2] - The open-label Tanruprubart FORWARD study is set to initiate in Q2 2025, aimed at broadening patient and healthcare community experience in North America and Europe [1][8] - The Phase 3 ARCHER II trial for ANX007, targeting dry age-related macular degeneration (AMD) with geographic atrophy (GA), is on track for completion in Q3 2025, with pivotal topline data expected in the second half of 2026 [1][2][8] - Completion of the proof-of-concept trial for ANX1502, an oral C1s inhibitor for cold agglutinin disease, is anticipated by mid-2025 [1][2][8] Group 2: Financial Performance - As of March 31, 2025, the company reported $263.7 million in cash, cash equivalents, and short-term investments, providing a runway into the second half of 2026 [1][7] - Research and development expenses for Q1 2025 were $48.2 million, significantly higher than $21.0 million in Q1 2024, reflecting the advancement of priority programs [7][13] - General and administrative expenses increased to $9.2 million in Q1 2025 from $7.6 million in Q1 2024 [7][13] - The net loss for Q1 2025 was $54.4 million, or $0.37 per share, compared to a net loss of $25.2 million, or $0.21 per share, in Q1 2024 [7][13] Group 3: Market Potential and Strategic Positioning - Tanruprubart is positioned as the first potential therapy for GBS, addressing a significant unmet need with no FDA-approved treatments currently available [2][3] - ANX007 aims to be the first vision-preserving treatment for dry AMD with GA, potentially benefiting over eight million patients globally [2][5] - The company's innovative C1 platform is designed to halt harmful neuroinflammation, with a focus on addressing the unmet needs of nearly 10 million people worldwide [2][9]

医药生物 2025 年 05 月 11 日 投资评级：看好（维持） 行业走势图 TCE 实体瘤赛道更新，关注 Janux 和 Vir 积极进展 数据来源：聚源 -24% -12% 0% 12% 24% 2024-05 2024-09 2025-01 医药生物 沪深300 相关研究报告 《首选创新药，关注消费复苏—医药 行业 2025 年度中期投资策略 》 -2025.5.7 《关注左侧中药板块的结构性机会— 行业周报》-2025.4.27 《Orforglipron 产业链被低估，国内相 关公司有望长周期受益—行业点评报 告》-2025.4.26 TCE 实体瘤赛道更新，关注 Janux 和 Vir 积极进展 ——行业周报 | 余汝意（分析师） | 余克清（分析师） | 石启正（联系人） | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | shiqizheng@kysec.cn | | 证书编号：S0790523070002 | 证书编号：S0790525010002 | 证书编号：S0790125020004 | Janux 和 Vir ...

医药生物 2025 年 05 月 11 日 投资评级：看好（维持） 行业走势图 数据来源：聚源 -24% -12% 0% 12% 24% 2024-05 2024-09 2025-01 医药生物 沪深300 《首选创新药，关注消费复苏—医药 行业 2025 年度中期投资策略 》 -2025.5.7 《关注左侧中药板块的结构性机会— 行业周报》-2025.4.27 《Orforglipron 产业链被低估，国内相 关公司有望长周期受益—行业点评报 告》-2025.4.26 TCE 实体瘤赛道更新，关注 Janux 和 Vir 积极进展 ——行业周报 | 余汝意（分析师） | 余克清（分析师） | 石启正（联系人） | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | shiqizheng@kysec.cn | | 证书编号：S0790523070002 | 证书编号：S0790525010002 | 证书编号：S0790125020004 | TCE 实体瘤赛道更新，关注 Janux 和 Vir 积极进展 Janux 和 Vir 更新了其 T ...

Core Insights - Annexon, Inc. announced positive Phase 2 ARCHER trial results for ANX007, a novel therapy aimed at preserving vision in patients with dry age-related macular degeneration (AMD) and geographic atrophy (GA) [1][2][3] - The company is preparing for a Phase 3 trial, ARCHER II, which will enroll approximately 630 patients globally [1][10] Group 1: ANX007 and Its Mechanism - ANX007 is a first-in-kind, non-pegylated antigen-binding fragment designed to inhibit C1q locally in the eye, addressing neurodegeneration caused by classical complement pathway activation [3][4] - The therapy has shown significant vision preservation in clinical endpoints such as best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) [3][6] - ANX007 has received Fast Track designation from the FDA and Priority Medicine (PRIME) designation in the EU, indicating its potential therapeutic advantage [5] Group 2: Clinical Trial Results - In the Phase 2 ARCHER trial, ANX007 demonstrated statistically significant protection against vision loss, with a time and dose-dependent effect observed [6][8] - The treatment effect was maintained during a six-month off-treatment period, suggesting a durable benefit [8] - ANX007 was well-tolerated, with no increase in choroidal neovascularization rates or retinal vasculitis events reported [8] Group 3: Future Developments - The Phase 3 ARCHER II trial aims to prevent ≥15-letter loss of BCVA, a well-established functional endpoint for ophthalmology drug approvals [10] - Topline data from the ARCHER II trial is expected in the second half of 2026 [10] - The trial will further assess safety and visual function outcomes, including low-luminance visual acuity and photoreceptor integrity [10]