ArriVent BioPharma(AVBP) - 2025 Q2 - Quarterly Results

Company Overview and Recent Progress ArriVent BioPharma reports Q2 2025 financial results and significant clinical program advancements, extending cash runway to mid-2027 Introduction and CEO Commentary ArriVent BioPharma announced Q2 2025 financial results, highlighting strong firmonertinib progress in EGFR-mutated NSCLC and initial patient dosing for ARR-217 ADC, with an extended cash runway to mid-2027 - Firmonertinib shows promise in EGFR-mutated NSCLC patients with positive PACC Phase 1b interim data[3] - Global pivotal Phase 3 PACC study expected to enroll first patient in H2 2025[3] - Topline pivotal data for registration-enabling trial in Exon 20 insertion mutations anticipated in early 2026[3] - ARR-217, a CDH17-targeting ADC, completed first patient dosing in Phase 1 study for gastrointestinal tumors[3] - Strengthened balance sheet extends cash runway to mid-2027[3] Second Quarter 2025 and Recent Highlights ArriVent reported positive firmonertinib Phase 1b interim data in EGFR PACC-mutated NSCLC, initiated the global pivotal Phase 3 ALPACCA study, and completed first patient dosing for ARR-217 ADC, with $254.5 million in cash and investments as of June 30, 2025, extending funding to mid-2027 Firmonertinib Clinical Updates Firmonertinib Phase 1b interim data in EGFR PACC-mutated NSCLC showed clinically meaningful PFS, CNS complete response, and manageable safety, leading to the global pivotal Phase 3 ALPACCA study initiation - Firmonertinib showed positive Phase 1b interim data in EGFR PACC-mutated NSCLC, including clinically meaningful PFS, CNS complete response, and manageable safety[4][6] - Global pivotal Phase 3 ALPACCA study aims to evaluate firmonertinib monotherapy as a first-line treatment for PACC-mutated NSCLC[7] Pipeline Advancement: ARR-217 ADC ARR-217 (MRG007), a CDH17-targeting ADC, completed first patient dosing in its Phase 1 study for gastrointestinal tumors, marking ArriVent's ADC portfolio entry into clinical development - ARR-217 (MRG007), a CDH17-targeting ADC, completed first patient dosing in its Phase 1 study for gastrointestinal tumors[5][8] Financial Position and Outlook As of June 30, 2025, ArriVent held $254.5 million in cash and investments, with an additional $81.1 million raised in July 2025, extending its operational funding into mid-2027 Cash and Investments | Metric | Amount (million USD) | As of Date | | :----- | :-------------------- | :--------- | | Cash and Investments | $254.5 | June 30, 2025 | | Net Proceeds from Public Offering | $81.1 | July 2025 | - Existing cash and recent proceeds are expected to fund operations into mid-2027[5][11] Upcoming Milestones ArriVent anticipates key clinical data readouts and patient enrollment initiations for its firmonertinib programs in 2025 and 2026 Key Upcoming Milestones ArriVent expects to present final EGFR PACC Phase 1b data in September 2025, initiate the global pivotal ALPACCA Phase 3 study in H2 2025, and release topline data for the FURVENT Phase 3 study in early 2026 - Final EGFR PACC Phase 1b data to be presented at the WCLC conference in September 2025[11] - First patient enrollment in the global pivotal ALPACCA Phase 3 study (firmonertinib monotherapy for first-line EGFR PACC-mutated NSCLC) expected in H2 2025[11] - Topline data from the global pivotal FURVENT Phase 3 study (firmonertinib monotherapy for first-line EGFR Exon 20 insertion-mutated NSCLC) anticipated in early 2026[11] Detailed Financial Results ArriVent's financial performance for Q2 and H1 2025 shows increased net loss and operating cash usage, primarily driven by higher R&D expenses Summary of Financial Performance (Q2 & H1 2025) For the six months ended June 30, 2025, ArriVent reported a net loss of $95.8 million, significantly higher than the prior year, mainly due to increased R&D expenses including a $40 million upfront payment to Lepu Biopharma Key Financial Data (Six Months Ended June 30) | Metric | 2025 (million USD) | 2024 (million USD) | Change (YoY) | | :-------------------------- | :------------------ | :------------------ | :----------- | | Net cash used in operating activities | $94.1 | $37.7 | +$56.4 | | Research and development expenses | $89.0 | $38.8 | +$50.2 | | General and administrative expenses | $11.4 | $7.6 | +$3.8 | | Net loss | $95.8 | $39.3 | +$56.5 | - Net cash used in operating activities increased primarily due to a $40 million one-time upfront payment to Lepu Biopharma[11] - Increased R&D expenses were driven by the Lepu Biopharma upfront payment, increased headcount, and firmonertinib clinical costs[11] Balance Sheets As of June 30, 2025, ArriVent's total assets slightly decreased to $269.5 million, with cash and cash equivalents increasing to $112.8 million while short-term investments decreased Balance Sheet Highlights (in thousands of USD) | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $112,765 | $74,293 | +$38,472 | | Short-term investments | $122,922 | $144,570 | -$21,648 | | Total current assets | $250,149 | $226,979 | +$23,170 | | Total assets | $269,506 | $274,942 | -$5,436 | | Total liabilities | $19,636 | $17,288 | +$2,348 | | Total stockholders' equity | $249,870 | $257,654 | -$7,784 | Statements of Operations and Comprehensive Loss Net loss for Q2 2025 was $31.4 million and for H1 2025 was $95.8 million, primarily driven by increased research and development and general and administrative expenses Statements of Operations (in thousands of USD) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :-------------------------- | :------ | :------ | :------ | :------ | | Research and development expenses | $27,720 | $21,778 | $89,009 | $38,753 | | General and administrative expenses | $5,903 | $3,919 | $11,386 | $7,618 | | Total operating expenses | $33,623 | $25,697 | $100,395 | $46,371 | | Loss from operations | $(33,623) | $(25,697) | $(100,395) | $(46,371) | | Interest and investment income | $2,224 | $3,823 | $4,609 | $7,080 | | Net loss | $(31,399) | $(21,874) | $(95,786) | $(39,291) | | Net loss per share (basic and diluted) | $(0.90) | $(0.65) | $(2.78) | $(1.34) | About ArriVent and Therapeutic Programs ArriVent is a clinical-stage biopharmaceutical company focused on developing differentiated oncology drugs, including firmonertinib and novel ADCs About ArriVent BioPharma ArriVent is a clinical-stage biopharmaceutical company dedicated to identifying, developing, and commercializing differentiated oncology drugs, leveraging its expertise to maximize firmonertinib's potential and advance novel therapies - ArriVent is a clinical-stage biopharmaceutical company focused on cancer therapeutics[12] - Aims to maximize firmonertinib's potential and advance a pipeline of novel therapies, including ADCs[12] About Firmonertinib Firmonertinib is an oral, brain-penetrant, broad-spectrum, mutation-selective EGFR inhibitor effective against classic and rare EGFR mutations, with FDA Breakthrough Therapy and Orphan Drug designations - Firmonertinib is an oral, highly brain-penetrant, broad-spectrum, mutation-selective EGFR inhibitor[13] - Effective against both classic and rare EGFR mutations, including PACC and exon 20 insertion mutations[13] - Approved in China for first-line advanced NSCLC with EGFR exon 19 deletion or L858R mutations, and previously treated EGFR T790M-mutated locally advanced or metastatic NSCLC[13] - Received U.S. FDA Breakthrough Therapy Designation for previously untreated EGFR exon 20 insertion-mutated non-squamous NSCLC[14] - Received U.S. FDA Orphan Drug Designation for EGFR, HER2, or HER4-mutated NSCLC[14] - Currently being investigated in global Phase 3 trials for first-line EGFR exon 20 insertion-mutated (FURVENT) and EGFR PACC-mutated (ALPACCA) NSCLC patients[15] About EGFR Mutant NSCLC and PACC Mutations Lung cancer is a leading cause of cancer-related deaths, with NSCLC accounting for 85% of cases; EGFR mutations, including rare PACC and exon 20 insertions, represent significant unmet medical needs due to limited treatment options - Lung cancer is a leading cause of cancer-related deaths globally; NSCLC is the predominant lung cancer subtype, accounting for approximately 85% of cases[16] - EGFR mutations are common in NSCLC, categorized into classic and rare types[16] - EGFR exon 20 insertion mutations account for approximately 9% of all EGFR mutations[16] - PACC mutations account for approximately 12% of all EGFR mutations[16] - Patients with rare EGFR mutations face significantly reduced life expectancy and have unmet medical needs[16] - PACC mutations are approximately 70 activating mutations within the EGFR kinase domain that affect the drug-binding pocket, with no widely adopted first-line standard of care for PACC-mutated patients currently available[17][18] About FURVENT Phase 3 Study FURVENT is a global, pivotal three-arm Phase 3 trial evaluating firmonertinib with platinum-pemetrexed chemotherapy in first-line EGFR exon 20 insertion-mutated NSCLC patients, with PFS as the primary endpoint - FURVENT is a global, pivotal three-arm Phase 3 clinical trial for first-line EGFR exon 20 insertion-mutated NSCLC patients[19] - Compares firmonertinib (160 mg or 240 mg once daily) with platinum chemotherapy plus pemetrexed[19] - Primary endpoint is PFS assessed by BICR (RECIST 1.1); secondary endpoints include brain-specific CNS-ORR and CNS-PFS in patients with brain metastases at baseline[19] - The study enrolled 398 patients globally, including sites in the U.S., Europe, and Asia[19] Forward-Looking Statements This section outlines the inherent uncertainties and risks associated with forward-looking statements regarding ArriVent's future operations and clinical milestones Disclaimer on Forward-Looking Statements This press release contains forward-looking statements regarding ArriVent's future operations, financial condition, business strategy, cash runway, clinical milestones, and data release timelines, subject to inherent uncertainties and risks disclosed in SEC filings - The press release contains forward-looking statements regarding future performance, strategy, cash runway, clinical milestones, and data release timelines[20] - These statements are subject to inherent uncertainties, risks, and assumptions, with details disclosed in SEC filings (e.g., Form 10-K)[20] - ArriVent undertakes no obligation to update forward-looking information, except as required by applicable law[20] Contact Information This section provides contact details for investor relations inquiries Investor Relations Contact Contact information for investor relations inquiries is provided - Investor Relations Contact: Joyce Allaire, LifeSci Advisors, LLC[23]