On March 5, 2026 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the year ended December 31, 2025, and highlighted recent Company progress.

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"We are advancing firmonertinib toward potential registration, supported by two pivotal programs targeting uncommon EGFR mutations in non-small cell lung cancer (NSCLC), a high unmet need with limited treatment options," said Bing Yao, CEO of ArriVent. "Our robust clinical data, including CNS activity, underscores the potential of firmonertinib to become a chemotherapy-free standard of care. We look forward to topline pivotal data for firmonertinib monotherapy in frontline EGFR exon 20 insertion mutant NSCLC expected in mid-2026. This is an event driven study, so we plan to continue sharpening our timeline as we look forward to sharing our data."

Dr. Yao continued, "Our antibody-drug conjugate (ADC) portfolio is also gaining momentum, led by ARR-217, a CDH17-targeted ADC currently in an ongoing Phase 1 trial, with best-in-class potential in gastrointestinal cancers. We expect additional ADC candidates to advance toward the clinic, broadening our pipeline beyond lung cancer into multiple additional solid tumor indications. Backed by a strong balance sheet and a projected cash runway into 3Q 2027, we are well positioned to deliver on our near-term catalysts."

Recent and Full Year 2025 Highlights

Firmonertinib

● Dosed first in patient pivotal ALPACCA study. In December 2025, ArriVent announced dosing of the first patient in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of epidermal growth factor receptor (EGFR) PACC mutant non-small cell lung cancer (NSCLC) (NCT07185997).
● Positive final data in EGFR PACC mutant NSCLC. In September 2025, ArriVent presented positive final proof-of-concept data from the randomized global Phase 1b FURTHER trial cohort of first-line firmonertinib monotherapy in patients with NSCLC harboring EGFR PACC mutations at the 2025 World Conference on Lung Cancer (WCLC) (NCT05364073). Firmonertinib demonstrated clinically meaningful progression free survival, central nervous system (CNS) complete responses, and a
manageable safety profile consistent with previous trials. We believe this to be the first clinical dataset testing an EGFR inhibitor in a prospectively defined population of EGFR PACC mutant NSCLC.
● Completed enrollment for pivotal FURVENT trial. During the first quarter of 2025, we completed enrollment in the global pivotal Phase 3 FURVENT study of firmonertinib monotherapy in first-line NSCLC EGFR exon 20 insertion mutations (NCT05607550). Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective EGFR inhibitor, received Food and Drug Administration (FDA) Breakthrough Therapy Designation in this patient population.
● Received National Medical Products Administration (NMPA) approval in China in second-line EGFR exon 20 insertion mutations. In February 2026, our partner Shanghai Allist Pharmaceutical Technology Co., Ltd., received NMPA approval for firmonertinib for adults with locally advanced or metastatic NSCLC who have progressed on or after prior platinum-based chemotherapy or who are intolerant to platinum-based chemotherapy and who have been tested for the presence of EGFR exon 20 insertion mutations.

Pipeline

● Clinical advancement of ADC lead ARR-217 (MRG007). Ongoing Phase 1 dose escalation for ARR-217, a CDH17 targeted ADC, in gastrointestinal malignancies in partnership with Lepu Biopharma Co., Ltd. ArriVent also received FDA IND clearance for ARR-217 and dosed its first patient in March 2026.
Upcoming Milestones

● Firmonertinib pivotal EGFR exon 20 insertions data. Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertions mutant NSCLC is projected to be in mid-2026.
● IND filing for ARR-002. U.S. IND filing for first-in-class ADC program planned for first half 2026. Plan to present preclinical data at an upcoming conference.
● Complete Phase 1 dose escalation for ARR-217. Plan to complete Phase 1 dose escalation and enter into dose optimization for ARR-217, a CDH17 targeting ADC program, in the second half of 2026.
2025 Financial Results

● As of December 31, 2025, the Company had cash and investments of $312.8 million, which is expected to fund operations into 3Q 2027.
● Net cash used in operations was $160.6 million and $70.2 million for the years ended December 31, 2025 and 2024, respectively.
● Research and development expenses were $153.4 million and $79.0 million for the years ended December 31, 2025 and 2024, respectively. The research and development expenses in 2025 include a one-time upfront payment to Lepu Biopharma Co., Ltd.
● General and administrative expenses were $24.2 million and $15.3 million for the years ended December 31, 2025 and 2024, respectively.
● Net loss was $166.3 million and $80.5 million for the years ended December 31, 2025 and 2024, respectively.

(Press release, ArriVent Biopharma, MAR 5, 2026, View Source [SID1234663293])