Annexon to Present Patient Baseline Characteristics from Vonaprument Phase 3 ARCHER II Pivotal Trial for Geographic Atrophy at The Retina Society 59th Annual Scientific Meeting

Oral Presentations Highlight Phase 2 Vision Protection and Enrollment of a Consistent Phase 3 Patient Population Well-Positioned to Replicate Phase 2 Vision Outcomes

ARCHER II is the First Pivotal Trial Designed to Demonstrate Protection of Vision in Geographic Atrophy, with Month 15 Results Expected in the Fourth Quarter of 2026

BRISBANE, Calif., Sept. 24, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced two oral presentations on vonaprument at The Retina Society 59th Annual Scientific Meeting being held September 23-26, 2026 in Los Angeles, California.

​Geographic atrophy (GA) is a neurodegenerative eye disease and leading cause of blindness affecting more than 8 million people worldwide. GA gradually destroys the central vision patients need to read, drive, recognize faces, and maintain independence.

Upcoming oral presentations highlight vision protection findings in diverse GA patient populations in the Phase 2 ARCHER study that informed the design and execution of the ongoing Phase 3 ARCHER II trial. Presentations highlight the replication of key baseline clinical characteristics between the Phase 2 and Phase 3 patient populations, an important strategy to position the Phase 3 trial to confirm the potential of vonaprument to protect vision across a broad population of patients with GA.

Oral Presentation Details

“Baseline Characteristics of Participants in the Phase 3 ARCHER II Trial in Dry AMD With GA”

• Presenter: Ashkan Abbey, M.D., Texas Retina Associates
• Date/Time: Friday, September 25, 2026 at 9:10 a.m. PT

“Vision Outcomes in Eyes with Subfoveal RPE Lesions in Geographic Atrophy: A Post Hoc Analysis of the Phase 2 ARCHER Trial”

• Presenter: Mark Barakat, M.D. FASRS, Retina Macula Institute of Arizona
• Date/Time: Friday, September 25, 2026 at 9:13 a.m. PT

Presentations can be found on the publications page of Annexon’s website following the meetings.

About Vonaprument (formerly ANX007)
Vonaprument is a clinical-stage investigational antigen-binding fragment (Fab) designed as a first-in-kind therapeutic to selectively inhibit C1q, the initiating molecule of the classical complement pathway and a key driver of neurodegeneration. It is formulated for intravitreal (IVT) administration, with the potential to be the first targeted vision-protecting therapy for GA. Vonaprument involves a differentiated neuroprotective approach designed to protect photoreceptor cells and retinal function by blocking C1q and the entire classical pathway, while allowing for normal immune activity of the lectin and alternative complement pathways. Vonaprument has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) and is the first therapeutic candidate for the treatment of GA to receive Priority Medicine (PRIME) designation from the European Medicines Agency (EMA) for the treatment of GA.

About the ARCHER Clinical Program
ARCHER (NCT04656561) is a completed Phase 2 trial that evaluated vonaprument in a broad population of patients with GA. Vonaprument consistently protected visual function and ellipsoid zone retinal structure across multiple measures, providing significant, time- and dose-dependent protection from vision loss as measured by confirmed best corrected visual acuity (BCVA) ≥15-letter loss. It was generally well-tolerated through month 12, with no increase in choroidal neovascularization (CNV) rates versus sham and no events of retinal vasculitis. ARCHER II (NCT06510816) is an ongoing global Phase 3 trial in 659 patients that was designed to replicate the findings of ARCHER, with confirmed BCVA ≥15-letter loss as the primary endpoint measured through months 15 and 24. A global registration path has been established with U.S. and European regulators. ARCHER II is a single protocol that will also be analyzed as two sub-studies after meeting the primary endpoint. Results from the month 15 primary analysis are expected in the fourth quarter of 2026.

About Annexon
Annexon Biosciences (Nasdaq: ANNX) is advancing the next generation platform of targeted immunotherapies for nearly 10 million people worldwide living with serious neuroinflammatory diseases. Our founding scientific approach focuses on C1q, the initiating molecule of a potent inflammatory pathway that when misdirected can lead to tissue damage and loss of function in a host of diseases. Our targeted therapies are designed to stop classical complement-driven neuroinflammation at its source to provide meaningful functional benefit and alter the course of disease. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit annexonbio.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “suggest,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, the potential therapeutic benefit of vonaprument and the timing of results of ongoing clinical trials of vonaprument. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the ongoing off-treatment follow-up portion of the ARCHER trial and final results from the ARCHER trial; the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

Media Contact:
Christian Vaughn
annexonpr@syneoshealth.com