On November 9, 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 third quarter ended September 30, 2026, and highlighted recent Company progress.
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"Enrollment remains on track for our global Phase 3 ALPACCA trial in first line EGFR PACC mutant NSCLC patients. While FURVENT did not meet its primary endpoint, firmonertinib demonstrated clear antitumor activity, with an efficacy and safety profile consistent with prior studies. We are conducting a detailed review of the FURVENT study to better understand the totality of the data.," said Bing Yao, Ph.D., CEO of ArriVent. "Our antibody-drug conjugate (ADC) portfolio is also advancing, with initial ARR-217 data showing promising antitumor activity and a manageable safety profile in colorectal cancer. In addition, we dosed the first patient in a Phase 1 study of ARR-002. We are encouraged by the momentum across our pipeline and excited about the opportunity to advance these programs toward new potential treatment options for patients with significant unmet needs."
Third Quarter 2026 and Recent Highlights
Firmonertinib
· Continued Enrollment in Global Pivotal Phase 3 ALPACCA in PACC-Mutant NSCLC. The ALPACCA study is evaluating firmonertinib 240 mg against investigator’s choice of osimertinib or afatinib in first line patients with EGFR PACC mutant NSCLC. The study builds on encouraging Phase 1b FURTHER findings and includes an interim analysis of objective response rate to support a potential accelerated approval pathway, with PFS assessed for potential full approval.
· Reported Phase 3 FURVENT Results and Evaluating Next Steps. FURVENT did not meet its primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR). At 240 mg, firmonertinib demonstrated median PFS of 11.0 months versus 9.5 months with chemotherapy (HR 0.75; p=0.0654), a confirmed objective response rate by BICR of 60% versus 33%, and a safety profile consistent with prior studies. The Company is reviewing the full dataset, including differences between BICR and investigator-assessed PFS in the chemotherapy arm, to inform potential next steps.
ADC Pipeline
· Presented Phase 1 ARR-217 Data at ESMO (Free ESMO Whitepaper). Preliminary Phase 1 data for ARR-217 (MRG007), a CDH17-targeted ADC being developed in partnership with Lepu Biopharma, was presented in a late breaking rapid oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026. In evaluable patients with colorectal cancer treated at 6 mg/kg, the objective response rate, including confirmed and unconfirmed responses, was 44.8% and the disease control rate was 93.1%. Adverse events were predominantly low-grade gastrointestinal and hematologic toxicities. Phase 1b dose optimization and expansion are ongoing.
· Advanced ARR-002 into Clinical Development. Dosed the first patient in the U.S. Phase 1a/1b first-in-human study of ARR-002, a novel dual-target MUC16/NaPi2b tetravalent ADC. The dose-escalation and expansion study is evaluating safety, dosing and early signals of efficacy in patients with advanced or metastatic ovarian or endometrial cancer.
Corporate
· Strengthened Clinical Leadership. Announced Dr. Priti Patel, M.D., M.S., as Chief Medical Officer. Dr. Patel brings extensive experience, in particular late-stage development experience, in both large pharmaceutical and emerging biotech in global oncology development including AstraZeneca, Acerta and Onyx Pharmaceuticals. Prior to joining ArriVent, Dr. Patel served as Chief Medical Officer at Neoleukin Therapeutics and Vice President, Head of Hematology Clinical Development at AstraZeneca.
· Retirement of Dr. Stuart Lutzker. Stuart Lutzker, M.D., Ph.D., a co-founder of ArriVent, announced his retirement. Over the past five years, Dr. Lutzker served as the President of Research and Development and Board member. During his tenure, Dr. Lutzker led the research and development team and was the architect of our ADC pipeline including advancing ARR-217 and ARR-002 into the clinic. "Dr. Lutzker has been the driving force behind our R&D vision," said Dr. Yao. "We are deeply grateful for his unwavering commitment and passion in advancing new therapies for patients. We thank him for all his contributions."
Upcoming Milestones
· Firmonertinib update. We plan to provide an update on firmonertinib in the first quarter of 2027 around the review of the FURVENT study.
· Phase 1b Data for ARR-217. Phase 1b dose optimization data for ARR-217 in late line colorectal cancer are expected in the first half of 2027, and ARR-217 combination data with bevacizumab as well as combination data with chemotherapy are expected in the second half of 2027.
2026 Financial Results
· As of September 30, 2026, the Company had cash and investments of $393.2 million, which is expected to fund operations to mid-2028.
· Net cash used in operations was $122.2 million and $129.9 million for the nine months ended September 30, 2026 and 2025, respectively.
· Research and development expenses were $118.9 million and $121.2 million for the nine months ended September 30, 2026 and 2025, respectively.
· General and administrative expenses were $28.3 million and $17.5 million for the nine months ended September 30, 2026 and 2025, respectively.
· Net loss was $133.5 million and $130.8 million for the nine months ended September 30, 2026 and 2025, respectively.
(Press release, ArriVent Biopharma, NOV 9, 2026, View Source [SID1234674463])