Annexon (ANNX -8.46%), a clinical-stage biopharmaceutical company developing therapies for serious autoimmune and neurodegenerative diseases, released its second quarter 2025 financial results on August 14, 2025. The company’s net loss per share (GAAP) was $0.34, beating analyst expectations of $(0.37) GAAP EPS. This smaller-than-expected GAAP loss came amid higher spending on research and development, with no revenue reported during the period, which aligns with its pre-commercial status. Annexon’s cash, cash equivalents, and short-term investments were $227.0 million as of June 30, 2025, supporting its clinical programs and late-stage development into the fourth quarter of 2026. Overall, the quarter reflected significant progress in the company’s clinical pipeline, but also a continued burn of cash as it invests in late-stage trials and regulatory submissions.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.34) | $(0.37) | $(0.23) | (47.8%) |
| Revenue (GAAP) | N/A | $0.0 | N/A | N/A |
| Research & Development Expenses | $44.2 million | $25.0 million | 76.8% | |
| General & Administrative Expenses | $7.6 million | $8.6 million | (11.6%) |
Source: Analyst estimates for the quarter provided by FactSet.
Annexon’s Business: Focus and Key Drivers
Annexon develops therapeutic antibodies and oral inhibitors targeting the complement pathway, a part of the immune system linked to autoimmune and neurodegenerative conditions. Its business revolves around advancing new therapies for diseases with limited or no current treatment options, focusing on disorders like Guillain-Barré Syndrome (GBS), geographic atrophy (GA) in age-related macular degeneration, and chronic autoimmune diseases.
The company’s recent business has concentrated on moving its lead drug programs through late-stage clinical development and preparing regulatory submissions. Success depends on delivering positive clinical trial results, securing regulatory approvals, and managing cash to support these milestones. Partnerships and intellectual property protection are also critical to maximizing the value of its therapies and ensuring commercialization readiness.
Quarterly Highlights: Clinical and Financial Performance
During the quarter, Annexon accelerated progress on its three main programs. Its lead drug, tanruprubart (formerly ANX005), is a monoclonal antibody targeting a protein called C1q for treating Guillain-Barré Syndrome. Roughly 90% of patients treated with tanruprubart in Phase 3 trials showed improvement by week 1. These results helped support regulatory efforts. The company plans to submit a Marketing Authorization Application to the European Medicines Agency in Q1 2026 and is working with the U.S. Food and Drug Administration to clarify requirements for a Biologics License Application.
The company also reported completion of a large “generalizability package,” including a Real-World Evidence study matching Phase 3 patients to immunoglobulin (IVIg) or plasma exchange-treated Western patients from a 2,000-patient GBS prospective observational study, bolstering its case for regulatory approval. Annexon is in discussions with pharmaceutical partners about tanruprubart commercialization but has not yet secured a formal deal.
Vonaprument (formerly ANX007), an antibody treatment for geographic atrophy in dry age-related macular degeneration, also progressed. The company completed enrollment of 659 patients in the pivotal ARCHER II Phase 3 trial. Vonaprument was selected for the European Medicines Agency PRIME program, which can help speed development for therapy candidates with the potential to address unmet medical needs. Topline results from ARCHER II are expected in the second half of 2026. Positive Phase 2 data showing preservation of vision and retinal structure were presented at medical conferences during the period.
An early-stage oral drug, ANX1502, is being tested for chronic autoimmune indications including cold agglutinin disease. The therapy exceeded target drug concentrations in fasted patients in a Phase 1 trial of ANX1502. An update from the ongoing proof-of-concept study is expected at year-end 2025.
Business Outlook and Key Watch Points
Management projects that $227.0 million in cash and investments as of June 30, 2025 will fund the company through late-stage milestones for its lead programs into Q4 2026. The company did not provide quantitative financial guidance for upcoming quarters or fiscal 2025 beyond this cash runway statement.
For the quarters ahead, investors should monitor progress in regulatory submissions for tanruprubart in GBS, the ARCHER II Phase 3 data for vonaprument, and results from the ANX1502 study. Progress on pharmaceutical partnerships will also be crucial for future commercialization planning and funding needs.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
