Annexon, Inc. (NASDAQ:ANNX) shares declined 6.37% in premarket trading on Wednesday after the biopharmaceutical company reported a wider-than-expected second-quarter loss as spending increased across its late-stage clinical programmes.
For the quarter ended June 30, Annexon recorded a loss of $0.28 per share, compared with the Wall Street consensus estimate for a loss of $0.24 per share.
Net loss attributable to common stockholders widened to $55.3 million from $51.0 million in the corresponding quarter last year, reflecting increased investment in the company’s advanced clinical development programmes.
Clinical development spending increases
Research and development expenses rose to $46.6 million from $44.2 million a year earlier.
The increase was primarily linked to spending on the Phase 3 ARCHER II study evaluating vonaprument for geographic atrophy, together with higher contract manufacturing costs.
General and administrative expenses also increased, reaching $10.6 million compared with $7.6 million in the prior-year period, as Annexon incurred additional costs related to advancing its registrational programmes.
“2026 is a defining year for our company, with meaningful progress across both our Guillain-Barré syndrome and geographic atrophy programs that position us to potentially deliver two transformative therapies for millions of patients in need,” said Douglas Love, president and chief executive officer of Annexon.
Tanruprubart moves towards regulatory submission
Annexon highlighted continued clinical progress across its development pipeline, including positive early results from the ongoing FORWARD study of tanruprubart in Guillain-Barré syndrome.
The company expects to submit a Biologics License Application for tanruprubart during the fourth quarter of 2026, representing an important potential regulatory milestone for the programme.
The planned submission forms part of Annexon’s efforts to advance its complement-targeted therapies towards potential commercialisation.
Vonaprument Phase 3 trial advances
Annexon is also progressing the development of vonaprument for geographic atrophy through its Phase 3 ARCHER II trial.
The company added a Month 24 dual primary endpoint to the study while retaining the Month 15 primary endpoint.
The Month 15 endpoint remains on schedule for the fourth quarter of 2026, providing another significant upcoming clinical milestone for the company.
Credit facility extends cash runway into 2028
Annexon reported $209.2 million in cash, cash equivalents and short-term investments as of June 30.
The company also entered into a $200 million credit facility with Oxford Finance LLC and drew an initial $50 million when the agreement closed.
The additional financing is expected to extend Annexon’s anticipated cash runway into 2028, providing funding as it advances tanruprubart and vonaprument through their respective late-stage development and regulatory programmes.