NEWTOWN SQUARE, PA — ArriVent BioPharma (Nasdaq: AVBP) reported first-quarter results as the company advanced late-stage testing of its lung cancer therapy firmonertinib and moved two antibody-drug conjugate programs closer to clinical development milestones.
The clinical-stage biotechnology company expects topline Phase 3 data in mid-2026 for firmonertinib in first-line treatment of non-small cell lung cancer patients with EGFR exon 20 insertion mutations, a difficult-to-treat subset of lung cancer.
ArriVent also disclosed that the U.S. Food and Drug Administration cleared its investigational new drug application for ARR-002, a dual-targeting antibody-drug conjugate being developed initially for ovarian and endometrial cancers. The company expects to dose the first patient in the second half of 2026.
Chief Executive Officer Bing Yao pointed to the company’s ongoing pivotal studies and recent preclinical findings presented at the American Association for Cancer Research meeting.
“We presented preclinical data highlighting the unique structural features of firmonertinib that improve binding and enhance activity against EGFR mutant proteins,” Yao said, adding that the data reinforced confidence in the drug’s activity across EGFR-mutant non-small cell lung cancer.
The company also presented preclinical data for ARR-002 showing stronger anti-tumor activity and tolerability in ovarian cancer models compared with single-target and bivalent antibody-drug conjugate approaches.
ArriVent’s pipeline progress comes as competition intensifies in targeted oncology therapies and antibody-drug conjugates, an area that has attracted significant pharmaceutical investment and licensing activity in recent years.
In February, ArriVent’s partner Shanghai Allist Pharmaceutical Technology received accelerated approval in China for firmonertinib in second-line treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer patients who progressed after platinum chemotherapy.
The company is also advancing ARR-217, a CDH17-targeted antibody-drug conjugate for gastrointestinal cancers developed with Lepu Biopharma. ArriVent dosed the first patient in a Phase 1 study in March and expects to begin dose optimization in the second half of 2026.
ArriVent reported cash and investments of $326.4 million as of March 31 and projected that existing capital would fund operations into the fourth quarter of 2027.
Net loss for the quarter narrowed to $43.3 million from $64.4 million a year earlier. Research and development expenses fell to $37.6 million from $61.3 million in the prior-year quarter, while general and administrative expenses increased to $8.5 million from $5.5 million.
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