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].