Core Viewpoint - ArriVent BioPharma, Inc. is making significant progress in its clinical programs, particularly with firmonertinib for treating EGFR-mutant non-small cell lung cancer (NSCLC), and has a strong financial position to support ongoing and future developments [1][2][6]. Company Progress - The firmonertinib program is advancing with two global Phase 3 pivotal studies targeting uncommon EGFR mutant NSCLC populations, with the first patient enrollment in the pivotal Phase 3 trial for PACC mutant NSCLC expected in Q4 2025 [2][7]. - Final Phase 1b data for firmonertinib in EGFR PACC mutant NSCLC was presented at the 2025 World Conference on Lung Cancer, demonstrating clinically meaningful progression-free survival and a manageable safety profile [3][6]. - The antibody-drug conjugate (ADC) portfolio is also progressing, with ARR-217, a CDH17-targeted ADC, currently in a Phase 1 trial and having received FDA IND clearance [4][6]. Financial Highlights - As of September 30, 2025, the company reported cash and investments totaling $305.4 million, expected to fund operations into mid-2027 [6][14]. - For the nine months ended September 30, 2025, net cash used in operations was $129.9 million, with research and development expenses amounting to $121.2 million, which includes a $40 million upfront payment for ARR-217 [14][21]. - The net loss for the nine months ended September 30, 2025, was $130.8 million, compared to a net loss of $59.9 million for the same period in 2024 [14][21]. Upcoming Milestones - The company anticipates topline pivotal data from the global Phase 3 trial in exon 20 insertion mutant NSCLC in early 2026 [2][8]. - The enrollment of the first patient in the randomized global pivotal ALPACCA Phase 3 study for first-line firmonertinib monotherapy in EGFR PACC mutant NSCLC is expected in Q4 2025 [7][8]. Corporate Developments - Brent S. Rice has been appointed as Chief Commercial Officer, bringing over 25 years of experience in the biotechnology and pharmaceutical industry [9].
ArriVent BioPharma Reports Third Quarter 2025 Financial Results