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].

Core Insights - ArriVent BioPharma, Inc. reported strong progress in its clinical pipeline, particularly with firmonertinib, which is advancing towards registration for treating EGFR-mutant NSCLC [2][6][12] - The company has a robust financial position with cash and investments totaling $254.5 million as of June 30, 2025, and an additional $81.1 million raised in a public offering [6][16] Financial Results - For the six months ended June 30, 2025, net cash used in operations was $94.1 million, an increase from $37.7 million in the same period of 2024, primarily due to a one-time payment of $40 million to Lepu Biopharma [16] - Research and development expenses rose to $89.0 million from $38.8 million year-over-year, driven by the collaboration with Lepu Biopharma and increased clinical expenses related to firmonertinib [16] - The net loss for the six months ended June 30, 2025, was $95.8 million, compared to $39.3 million for the same period in 2024 [16][23] Clinical Pipeline Progress - Firmonertinib has shown promising interim Phase 1b data for EGFR PACC mutant NSCLC, with plans to present final data at the World Conference on Lung Cancer in September 2025 [2][7][8] - The first patient has been dosed in the Phase 1 study for ARR-217, a CDH17-targeted ADC for gastrointestinal cancers, marking a significant milestone in the ADC pipeline [4][6] - The global pivotal Phase 3 ALPACCA study for firmonertinib is expected to enroll its first patient in the second half of 2025, with top-line data from the FURVENT Phase 3 study projected for early 2026 [6][9][14] Market Context - Lung cancer remains the leading cause of cancer-related deaths globally, with NSCLC accounting for approximately 85% of cases [15] - Uncommon EGFR mutations, including exon 20 insertions and PACC mutations, represent significant unmet medical needs, as patients with these mutations have limited treatment options [15][17]

Core Insights - ArriVent BioPharma, Inc. announced that enrollment in the FURVENT Phase 3 study of firmonertinib was completed in Q1 2025, with topline data expected in early 2026 [1] - Firmonertinib has received FDA Breakthrough Therapy Designation for treating patients with untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations [4] Group 1: FURVENT Study - FURVENT is a global Phase 3 trial assessing firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations, comparing it to platinum-based chemotherapy [2] - The study enrolled 398 patients globally, including sites in the United States, Europe, Japan, and China [2] - The primary endpoint is progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST 1.1 [2] Group 2: Firmonertinib Overview - Firmonertinib is an oral, mutation-selective EGFR inhibitor effective against both classical and uncommon EGFR mutations, including exon 20 insertion mutations [3] - It was approved in China in March 2021 for first-line advanced NSCLC with specific EGFR mutations [3] - The drug is also being studied in other global Phase 3 trials targeting different EGFR mutations [5] Group 3: Industry Context - Lung cancer is the leading cause of cancer-related deaths globally, with NSCLC accounting for approximately 85% of all cases [6] - Uncommon EGFR mutations, such as exon 20 insertions, represent about 9% of all EGFR mutations and indicate a significant unmet medical need [6] - Patients with NSCLC harboring uncommon EGFR mutations have a notably lower life expectancy with current therapies [6] Group 4: Company Profile - ArriVent is a clinical-stage biopharmaceutical company focused on developing differentiated medicines for cancer treatment [7] - The company aims to leverage its drug development expertise to advance firmonertinib and other novel therapeutics [8]

Company Overview - ArriVent BioPharma, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for cancer patients [2] - The company aims to leverage its team's extensive drug development experience to advance its lead candidate, firmonertinib, and a pipeline of novel therapeutics [2] Product Information - Firmonertinib is an oral, mutation-selective EGFR inhibitor effective against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations [3] - The drug was approved in China in March 2021 for first-line treatment of advanced NSCLC with specific EGFR mutations [3] Regulatory Designations - Firmonertinib received Breakthrough Therapy Designation from the U.S. FDA for treating previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations [4] - The drug also holds Orphan Drug Designation from the U.S. FDA for treating NSCLC with various EGFR mutations [4] Clinical Trials - Firmonertinib is currently undergoing a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations and a Phase 1b study for patients with EGFR PACC mutations [5] - The drug is also part of a clinical combination study targeting advanced or metastatic NSCLC patients with classical EGFR mutations, in collaboration with Beijing InnoCare Pharma Tech Co., Ltd. [5] Market Context - Lung cancer is the leading cause of cancer-related deaths globally, with NSCLC accounting for approximately 85% of all cases [6] - Uncommon EGFR mutations, such as exon 20 insertion and PACC mutations, represent significant unmet medical needs, with exon 20 mutations constituting about 9% and PACC mutations about 12% of all EGFR mutations [6]

Core Insights - ArriVent BioPharma, Inc. reported financial results for Q1 2025, highlighting progress in its oncology pipeline and upcoming milestones [1][10]. Pipeline Developments - The firmonertinib program is advancing, with completed enrollment in the global pivotal Phase 3 FURVENT study for first-line NSCLC patients with EGFR exon 20 insertion mutations [3][7]. - ARR-217 (MRG007), a newly acquired antibody drug conjugate targeting CDH17, is expected to be the first ADC from ArriVent's pipeline to enter clinical trials [2][4]. Financial Performance - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $205.5 million, sufficient to fund operations into the second half of 2026 [7][16]. - Research and development expenses increased to $61.3 million in Q1 2025 from $17.0 million in Q1 2024, primarily due to a one-time upfront payment of $40 million to Lepu Biopharma [16][24]. - The net loss for Q1 2025 was $64.4 million, compared to a net loss of $17.4 million in Q1 2024 [16][24]. Upcoming Milestones - The company plans to present updated data for firmonertinib in first-line EGFR PACC mutant NSCLC in Q2 2025, including Progression Free Survival (PFS) and duration of response [2][8]. - Topline data from the pivotal Phase 3 study for firmonertinib is anticipated in 2025, with updates on timing expected in Q2 2025 [8][10]. Corporate Updates - Merdad Parsey, M.D., Ph.D., was appointed to the Board of Directors in April 2025, bringing extensive experience in global clinical development [9].