NEWTOWN SQUARE, PA — ArriVent BioPharma Inc. (Nasdaq: AVBP) reported financial results for the year ended December 31, 2025, and said it expects pivotal Phase 3 data for its lung cancer drug candidate firmonertinib in mid-2026.
The clinical-stage biotechnology company said the data will come from the global Phase 3 FURVENT trial evaluating firmonertinib as a first-line treatment for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
The company said enrollment in the FURVENT study was completed in the first quarter of 2025.
ArriVent also reported that the first patient was dosed in December 2025 in the global Phase 3 ALPACCA trial evaluating firmonertinib for first-line treatment of NSCLC with EGFR PACC mutations.
Chief Executive Officer Bing Yao said the company is advancing the drug through two pivotal programs targeting uncommon EGFR mutations.
“We are advancing firmonertinib toward potential registration, supported by two pivotal programs targeting uncommon EGFR mutations in non-small cell lung cancer,” Yao said.
The company previously presented proof-of-concept data from the Phase 1b FURTHER trial in September 2025 at the World Conference on Lung Cancer.
According to the company, the study showed progression-free survival and central nervous system responses in patients with EGFR PACC mutations.
ArriVent also reported progress in its antibody-drug conjugate pipeline, including ARR-217, a CDH17-targeted therapy being evaluated in a Phase 1 clinical trial for gastrointestinal cancers.
The company said it received U.S. Food and Drug Administration investigational new drug clearance for ARR-217 and dosed the first patient in March 2026.
Additional pipeline plans include a U.S. investigational new drug filing in the first half of 2026 for another antibody-drug conjugate candidate, ARR-002.
ArriVent said it expects to complete Phase 1 dose escalation for ARR-217 and move to dose optimization in the second half of 2026.
Separately, the company said its partner Shanghai Allist Pharmaceutical Technology Co. received approval from China’s National Medical Products Administration in February 2026 for firmonertinib as a second-line treatment for adults with advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who have progressed after platinum-based chemotherapy.
ArriVent reported cash and investments of $312.8 million as of December 31, 2025, which it said is expected to fund operations into the third quarter of 2027.
Net cash used in operations totaled $160.6 million in 2025 compared with $70.2 million in 2024.
Research and development expenses were $153.4 million in 2025, up from $79.0 million in 2024, which the company said included a one-time upfront payment to Lepu Biopharma Co. Ltd.
General and administrative expenses rose to $24.2 million from $15.3 million in the prior year.
ArriVent reported a net loss of $166.3 million for 2025, compared with a net loss of $80.5 million in 2024.
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