ArriVent BioPharma(AVBP) - 2025 Q3 - Quarterly Report

Drug Development and Trials - Firmonertinib received Breakthrough Therapy Designation from the FDA in October 2023 for treatment of EGFRm NSCLC, with Orphan Drug Designation granted in February 2024[94]. - In the interim data from the FAVOUR trial, 79% of patients (22 out of 28) experienced a reduction in tumor size of at least 30%, with a median duration of response of 15.2 months[97]. - The final data from the FURTHER trial showed 68.2% of patients treated with 240 mg of firmonertinib experienced a reduction in tumor size of at least 30%, with a median progression-free survival of 16.0 months[100]. - The company plans to initiate the ALPACCA trial in Q4 2025, which will be the first randomized global Phase 3 study in first-line NSCLC patients with PACC mutations[99]. Financial Performance - The company has incurred net losses of $130.8 million and $59.9 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $369.1 million as of September 30, 2025[105]. - The net loss for the three months ended September 30, 2025, was $34.98 million, compared to a net loss of $20.56 million in 2024, reflecting an increase of $14.41 million[117]. - For the nine months ended September 30, 2025, research and development expenses totaled $121.2 million, up from $58.9 million in 2024, a $62.3 million increase[123]. - The total operating expenses for the nine months ended September 30, 2025, were $138.7 million, up from $70.6 million in 2024, an increase of $68.1 million[122]. Research and Development Expenses - Research and development expenses are expected to increase significantly as the company continues the development of firmonertinib and identifies new product candidates[112]. - Research and development expenses increased to $32.2 million for the three months ended September 30, 2025, up from $20.1 million in 2024, representing a $12.1 million increase[119]. - The company has not yet tracked external costs by program prior to 2022, with a significant majority of direct research and development costs related to firmonertinib since then[111]. Revenue and Financing - The company has not generated any revenue from product sales and expects to finance its cash needs through public or private equity offerings and collaborations[107]. - The company raised gross proceeds of $305.0 million from the issuance of convertible preferred stock and $183.2 million from its initial public offering in 2024[126]. - The company plans to fund future operating expenses through additional public or private equity offerings, debt financings, and collaborations[131]. Cash Flow and Operating Activities - The company reported a net cash used in operating activities of $129.93 million for the nine months ended September 30, 2025, compared to $54.06 million in 2024[135]. - Net cash used in operating activities was $129.9 million for the nine months ended September 30, 2025, reflecting a net loss of $130.8 million[136]. - Net cash provided by financing activities was $168.3 million for the nine months ended September 30, 2025, primarily due to $87.3 million from sales under the ATM Program and $80.6 million from the July 2025 Offering[140]. Agreements and Commitments - The Allist License Agreement obligates the company to pay milestone payments up to $765 million upon achieving certain development and regulatory milestones[101]. - The Lepu Biopharma Agreement includes milestone payments up to approximately $1.17 billion for the development and commercialization of ARR-217[103]. - The company has commitments for milestone payments under agreements with various partners, contingent on successful completion of certain milestones[142]. - The company has not recorded contingent milestone payments in financial statements as they are not probable as of September 30, 2025[142]. Market and Economic Factors - The company believes its exposure to interest rate risk is not significant, with a hypothetical 1.0% change in market interest rates not materially impacting the total value of its portfolio[149]. - The company does not regularly incur material expenses in foreign currencies, and exchange rate fluctuations have not materially affected its results of operations[150]. - Inflation has not had a material effect on the company's results of operations during the periods presented and is not anticipated to have a material impact going forward[151].