The Tip Desk

Earnings

Annexon Narrows Loss as Tanruprubart BLA Nears

The biopharmaceutical company posted a $51.2 million net loss, or $0.25 a share, in the third quarter as cash of $213.4 million was said to fund milestones into 2028.

Annexon, Inc. (ANNX), a biopharmaceutical company developing C1q-targeted immunotherapies for neuroinflammatory diseases, reported a net loss attributable to common stockholders of $51.2 million, or $0.25 a share, for the quarter ended September 30, 2026, compared with $54.9 million, or $0.37 a share, a year earlier.

The company said cash, cash equivalents and short-term investments were $213.4 million as of September 30, 2026, expected to fund operations and anticipated milestones into 2028. It also entered a strategic credit facility of up to $200 million with Oxford Finance LLC, drawing an initial $50 million at closing. An additional $100 million is available upon milestones related to the vonaprument and tanruprubart registrational programs, with the remaining $50 million subject to lender approval.

Research and development expenses were $41.4 million, down from $49.7 million a year earlier. Annexon attributed the decline primarily to completed contract manufacturing supporting tanruprubart regulatory filings, offset by continued development of vonaprument in geographic atrophy. General and administrative expenses were $10.9 million, versus $7.3 million a year earlier, which the company said reflected corporate consulting and professional services for registrational programs plus compensation and personnel costs.

In the open-label U.S. and European FORWARD study, 18 patients had been treated with tanruprubart to date, up from the first ten U.S. and European patients highlighted in the prior quarter. The company said functional outcomes, complete target engagement and a generally well-tolerated safety profile were observed, consistent with Phase 3 and real-world evidence studies. The EU Marketing Authorisation Application remains under review with the European Medicines Agency. A U.S. Biologics License Application submission is anticipated in the fourth quarter of 2026, with the company saying FORWARD findings further strengthen the package.

ARCHER II, the global Phase 3 trial of vonaprument in geographic atrophy, had all eligible patients receiving at least 15 months of treatment, versus at least 12 months reported in the prior quarter, with patient retention at 90%. Masked vision-loss events tracked closely with projections, the company said. An independent Data Monitoring Committee will assess the Month 15 primary endpoint in the fourth quarter of 2026. If the DMC recommends the endpoint has been met, it will evaluate two pre-specified sub-studies, with results anticipated in the first quarter of 2027. Otherwise the trial may continue through the Month 24 analysis. Completion, including Month 24 analyses, is expected in the third quarter of 2027.

Annexon completed a proof-of-concept study of an enteric-coated tablet formulation of ANX1502 in nine patients with cold agglutinin disease. The company said no significant safety signals were observed and that reductions in bilirubin and LDH support further development. Formulation optimization is underway before studies in diseases including generalized myasthenia gravis.

The company appointed Mark S. Blumenkranz, M.D., M.M.S., to its Board of Directors and added retinal specialist Eleonora (Nora) Lad, M.D., Ph.D., to its Scientific Advisory Board. Jake Shumacher joined as S.V.P., Ophthalmology Franchise Head, and Dr. Donald Fong as S.V.P., Clinical Development, Ophthalmology, to lead vonaprument commercial and clinical work.

President and Chief Executive Officer Douglas Love said Annexon is well-positioned for a transformative next 12 months, with multiple value-creating milestones expected across the C1q platform, and that the company enters the final months of the year with focus on delivering those milestones.

More on ANNX

Annexon, Inc. — all coverage and financials