NEWTOWN SQUARE, PA — ArriVent BioPharma, Inc. (Nasdaq: AVBP) reported third-quarter financial results and outlined major clinical milestones that position the company for a pivotal two-year stretch focused on advancing its late-stage lung cancer candidate firmonertinib and expanding its antibody-drug conjugate pipeline.
CEO Bing Yao said the company’s flagship firmonertinib program continues to show strong momentum across multiple EGFR-mutant non-small cell lung cancer (NSCLC) populations. Two global Phase 3 trials are underway or nearing enrollment, targeting patient groups with limited treatment options. ArriVent highlighted new Phase 1b data demonstrating clinically meaningful progression-free survival, central nervous system responses, and a well-tolerated safety profile in patients with uncommon EGFR PACC mutations.
“Firmonertinib consistently shows the potential to address significant unmet needs in these underserved patient populations,” Yao said. The company expects to enroll the first patient in its global ALPACCA Phase 3 study for EGFR PACC mutant NSCLC in the fourth quarter of 2025 and anticipates topline data from the pivotal exon 20 insertion trial in early 2026. Firmonertinib previously received FDA Breakthrough Therapy Designation for this indication.
ADC Pipeline Expands With FDA IND Clearance
ArriVent’s broader oncology strategy also advanced with the FDA clearing an Investigational New Drug application for ARR-217, a CDH17-targeted antibody-drug conjugate being developed with partner Lepu Biopharma. A Phase 1 dose-escalation study is ongoing in China in gastrointestinal cancers, and the company expects additional ADC programs to advance toward the clinic.
Yao said ARR-217’s emerging profile positions it as a potential best-in-class option for multiple solid tumors, with additional ADC candidates expected to follow.
Strengthened Commercial Team Ahead of Pivotal Readouts
In September, ArriVent appointed veteran industry leader Brent S. Rice as Chief Commercial Officer, adding more than 25 years of U.S. and global commercial experience. Rice previously led commercialization efforts at Autolus Therapeutics, including early and late-stage oncology assets.
Financials Support Multi-Year Development Horizon
ArriVent ended the quarter with $305.4 million in cash and investments, providing operational runway into mid-2027. Research and development expenses climbed to $121.2 million for the first nine months of 2025, reflecting a $40 million upfront payment for the in-licensing of ARR-217 and growing investment in the firmonertinib program. Net loss for the period totaled $130.8 million.
The company said its balance sheet positions it to execute on near-term catalysts, including pivotal trial enrollment, expanding global development, and advancing its ADC portfolio.
As ArriVent moves into 2026 with multiple late-stage trials approaching major readouts, the company is positioning firmonertinib — alongside a growing suite of ADC candidates — to play a differentiated role in the evolving landscape of targeted oncology therapies.
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