BRISBANE, Calif. — August 14, 2025 — Leads & Copy — Annexon, Inc. (Nasdaq: ANNX) announced portfolio progress, key milestones, and second quarter 2025 financial results. The company’s cash supports operations into the fourth quarter of 2026 through vonaprument topline Phase 3 data in GA.
Tanruprubart (formerly ANX005) for GBS is advancing through regulatory interactions, with a Marketing Authorization Application (MAA) submission in Europe anticipated in the first quarter of 2026. Discussions with the FDA are ongoing regarding the generalizability package to support a Biologics License Application (BLA).
Enrollment for the global Phase 3 ARCHER II trial of vonaprument (formerly ANX007) for dry AMD with GA has been completed. The company has been selected for the EMA PRIME Product Development Candidate Pilot, and topline ARCHER II data is expected in the second half of 2026.
ANX1502, a first-in-kind oral C1s inhibitor, has exceeded the target concentration in fasted patients. Evaluation in relation to food intake is ongoing in a proof-of-concept CAD study, with an update expected by year-end 2025.
“We are well positioned to achieve our mission of helping millions of people with devastating complement-mediated diseases live their best lives by the consistent validation generated by our innovative C1 platform across multiple potential best-in-class therapeutics,” said Douglas Love, president and chief executive officer of Annexon.
Cash and cash equivalents and short-term investments totaled $227 million as of June 30, 2025. Research and development expenses were $44.2 million for the quarter ended June 30, 2025, compared to $25.0 million for the quarter ended June 30, 2024. Net loss was $49.2 million, or $0.34 per share, for the quarter ended June 30, 2025, compared to $29.6 million, or $0.23 per share, for the quarter ended June 30, 2024.
Contact:
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
Beth Keshishian
917-912-7195
beth@bethkeshishian.com
Source: Annexon, Inc.
