A Late-Stage Company With a Global Oncology Pipeline PACC Update June 23, 2025 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements include, but are not limited to, implied and express statements about our strategy, business plans and objectives for our programs; plans and timelines for the preclinical and clinical development of our product candidates, i ...

ArriVent BioPharma (AVBP) Update / Briefing June 23, 2025 08:00 AM ET Speaker0 Good morning and welcome to the Forte Biosciences Investor Webcast. At this time, all attendees are in a listen only mode. A Q and A session will follow the formal presentations. As a reminder, this call is being recorded and a replay will be made available on the Forte Biosciences Biosciences website following the conclusion of the event. I'd now like to turn the call over to Doctor. Paul Wagner, Chief Executive Officer of Forte ...

Virtual webinar on June 23, 2025 at 8:00 am ETNEWTOWN SQUARE, Pa., June 20, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced the Company will host a virtual investor event to discuss the firmonertinib clinical program for the treatment of EGFR PACC mutant non-small cell lung cancer (NSCLC) on June 23, 2025 at 8:00 am ET. To register fo ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission file number: 001-41929 ARRIVENT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) (State of Other Jurisdiction of in ...

Exhibit 99.1 ArriVent BioPharma Reports First Quarter 2025 Financial Results Dr. Yao continued, "In the year ahead, we plan to present updated data for firmonertinib in first line EGFR PACC mutant NSCLC, including Progression Free Survival (PFS) and duration of response, and provide our clinical development plan on the PACC program in the second quarter of 2025. We expect topline data in 2025 in our event-driven global pivotal Phase 3 study for firmonertinib monotherapy in first-line NSCLC harboring EGFR ex ...

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].

Core Insights - ArriVent BioPharma, Inc. has appointed Dr. Merdad Parsey to its Board of Directors, bringing extensive experience in global clinical development from his previous role at Gilead Sciences, Inc. [1][2] - Dr. Parsey expressed enthusiasm about ArriVent's potential to transform cancer treatment with its lead candidate firmonertinib and its pipeline of next-generation antibody drug conjugates (ADCs) [2][3] - ArriVent is focused on developing differentiated medicines to meet unmet medical needs in cancer treatment, leveraging its team's drug development expertise [3] Company Overview - ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of innovative therapeutics for cancer patients [3] - The company aims to maximize the potential of its lead candidate firmonertinib and advance its ADC pipeline through approval and commercialization [3] Leadership Experience - Dr. Parsey has held significant roles in the biopharmaceutical industry, including Senior Vice President at Genentech and CEO of 3-V Biosciences, Inc. [2] - His academic background includes an M.D. and Ph.D. in immunology, with training at prestigious institutions such as Stanford University and the University of Colorado [2]

Financial Performance - The net loss for the year ended December 31, 2024, was $80.5 million, compared to a net loss of $69.3 million in 2023[16]. - Net loss for 2024 was $80,488,000, compared to a net loss of $69,333,000 in 2023, indicating a 16.1% increase in losses[24]. - Total comprehensive loss for 2024 was $80,699,000, compared to $69,333,000 in 2023, an increase of 16.5%[24]. Cash and Cash Equivalents - ArriVent reported cash and cash equivalents of $266.5 million as of December 31, 2024, expected to fund operations into 2026[16]. - Cash and cash equivalents decreased to $74,293,000 in 2024 from $150,389,000 in 2023, a decline of 50.6%[23]. Research and Development - Research and development expenses increased to $79.0 million for the year ended December 31, 2024, compared to $64.9 million in 2023, primarily due to increased headcount and clinical expenses related to firmonertinib[16]. - Research and development expenses increased to $79,004,000 in 2024, up 21.8% from $64,884,000 in 2023[24]. - Firmonertinib demonstrated robust systemic and CNS anti-tumor activity in first-line NSCLC patients with EGFR PACC mutations, as presented at the 2024 World Conference on Lung Cancer[9]. - The company plans to provide an update on firmonertinib's development for EGFR PACC mutant NSCLC in the first half of 2025[11]. Operating Expenses - General and administrative expenses rose to $15.3 million in 2024 from $9.7 million in 2023, attributed to costs associated with operating as a public company[16]. - Operating expenses rose to $94,308,000 in 2024, up 26.4% from $74,590,000 in 2023, driven by higher research and development costs[24]. Equity and Assets - Total assets increased to $274,942,000 in 2024 from $163,098,000 in 2023, representing a growth of 68.5%[23]. - Total stockholders' equity improved to $257,654,000 in 2024 from a deficit of $153,193,000 in 2023, marking a significant turnaround[23]. Shareholder Information - The number of common shares outstanding increased to 33,706,765 in 2024 from 2,745,480 in 2023, a growth of 1,130.5%[23]. - The weighted-average shares of common stock outstanding increased to 31,469,328 in 2024 from 2,140,951 in 2023, a rise of 1,372.5%[24]. Income and Proceeds - Interest and investment income rose to $13,820,000 in 2024, compared to $5,257,000 in 2023, reflecting a 162.5% increase[24]. - ArriVent completed an IPO in 2024, raising net proceeds of $183.2 million after deducting underwriting discounts and other expenses[16]. Clinical Trials - ArriVent achieved target enrollment of 375 patients in its global pivotal Phase 3 study of firmonertinib for first-line NSCLC patients with EGFR exon 20 insertion mutations[4]. - The company selected ARR-002 as its next-generation ADC candidate for IND-enabling studies[6]. - ArriVent entered into a collaboration agreement with Alphamab to discover and develop novel ADCs for cancer treatment[12].

Financial Performance - The company has incurred significant operating losses of $80.5 million and $69.3 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $238.3 million as of December 31, 2024[286]. - The company has not generated any revenue since its inception and may never achieve significant revenue if firmonertinib is not successfully developed, approved, and commercialized[286]. - The company expects to incur substantial additional capital expenses as it continues the development of firmonertinib and other product candidates[291]. - The company may need to seek additional funding sooner than planned due to uncertainties in its operating plans and cash resource demands[292]. - Future capital requirements will depend on various factors, including the costs and timing of clinical trials, manufacturing, and regulatory approvals for firmonertinib[295]. - The company may face challenges in raising additional capital due to potential adverse global economic conditions, which could impact its ability to finance operations[294]. - If the company raises additional funds through equity or convertible debt, it may cause dilution to stockholders and impose restrictions on operations[299]. - The company is currently not generating any committed external source of funds, which increases its reliance on market conditions for financing[298]. Product Development and Regulatory Approval - Firmonertinib has received Breakthrough Therapy Designation and Fast Track Designation from the FDA, which may not guarantee a faster development or approval process[284]. - The company has a limited operating history, having commenced operations in April 2021, and has not completed any pivotal clinical trials or obtained regulatory approvals[290]. - The company must demonstrate the safety and efficacy of firmonertinib to regulatory authorities, which is critical for obtaining marketing approvals[304]. - The regulatory approval process for product candidates is lengthy and unpredictable, with a small percentage of drugs successfully completing the FDA approval process[350]. - The company may need to conduct additional clinical trials or post-marketing studies based on findings from ongoing trials or competitors' trials[331][348]. - The FDA may require additional clinical trials or studies before granting marketing approval, impacting the commercialization timeline[363]. - The company may seek to utilize the FDA's accelerated approval pathway for certain firmonertinib indications, but there is no assurance of timely approval[363]. - The acceptance of clinical trial data from foreign trials by the FDA is subject to strict conditions, which may necessitate additional trials and increase costs[340]. Clinical Trials and Patient Safety - Firmonertinib is in Phase 3 clinical development, and the company relies on additional financing to achieve its business objectives, as it does not expect to generate substantial product revenue for many years[302][297]. - Adverse side effects associated with firmonertinib have been observed, with 10 out of 178 patients in the FURLONG trial experiencing treatment-related serious adverse events (TRSAEs)[329]. - In the FAVOUR trial, as of June 15, 2023, 6 out of 86 treated patients reported TRSAEs, with common issues including diarrhea and liver enzyme elevation[329]. - The discontinuation rate due to TRAEs across the FURLONG, FAVOUR, and FURTHER trials was 3.7%, affecting 14 out of 318 patients[329]. - The company may encounter difficulties in patient enrollment due to limited patient pools and competition from other clinical trials[320]. - The integrity of clinical trial data may be compromised if patients drop out or fail to follow protocols, which could hinder regulatory approval[324]. - The company relies on contract research organizations (CROs) for clinical trial management, and any failures in their performance could adversely affect trial outcomes[324]. Manufacturing and Supply Chain Risks - The company relies on a Chinese third party for the manufacture of firmonertinib and other product candidates, increasing the risk of supply issues[284]. - The company does not own or operate manufacturing facilities and has no plans to develop its own manufacturing capabilities, relying entirely on third-party manufacturers[385]. - The company relies on two third-party contract manufacturers in China, Raybow and WuXi STA, for the supply of drug substance for firmonertinib and ARR-217, which poses risks of supply disruption due to potential political unrest or regulatory changes[391]. - The company’s clinical trials and regulatory approvals may be delayed if third-party manufacturers fail to comply with cGMP requirements[386]. - The company has no long-term commitments or supply agreements with third-party manufacturers, increasing the risk of failing to obtain sufficient quantities of firmonertinib[387]. Competition and Market Dynamics - The company faces significant competition in the biopharmaceutical industry, which could adversely affect its ability to commercialize products[287]. - The company faces significant competition from larger pharmaceutical companies and emerging therapies targeting EGFRm-positive NSCLC, which could impact market share[439]. - The approval of firmonertinib does not guarantee commercial success, as market acceptance among healthcare providers and patients is uncertain[418]. - The total addressable market for firmonertinib is uncertain and may be smaller than anticipated, affecting revenue projections[444]. Compliance and Regulatory Challenges - The company is subject to various healthcare laws and regulations, which could increase compliance costs and expose it to penalties[287]. - Regulatory approvals for firmonertinib will require ongoing compliance and could lead to significant additional expenses, including post-marketing studies and risk management requirements[401]. - Failure to comply with regulatory requirements could result in penalties, including product recalls or withdrawal from the market, adversely affecting the company's financial condition[402]. - The FDA strictly regulates the marketing and promotional claims for prescription drugs, limiting the company's ability to promote off-label uses[409]. - The company could face significant liability for improper promotion of off-label uses, which would materially adversely affect its business and financial condition[410]. Strategic Partnerships and Collaborations - The company is collaborating with Allist on firmonertinib and Lepu Biopharma on ARR-217, but faces risks in establishing and maintaining these collaborations, which could affect product development and commercialization[395]. - The company is evaluating firmonertinib in combination with ICP-189, a SHP2 inhibitor, in collaboration with InnoCare[334]. Human Resources and Organizational Challenges - The company had 52 full-time employees as of December 31, 2024, and relies heavily on retaining qualified personnel for its growth strategy[456]. - The company competes with various organizations for resources and talent, which could affect its ability to execute its business plan effectively[438]. - Significant investment will be required to establish a marketing and sales organization or to collaborate with third parties for commercialization[443]. Pricing and Reimbursement Issues - The company must establish adequate reimbursement strategies to ensure that patients can afford firmonertinib, as coverage by third-party payors is critical[423]. - Pricing pressures are expected due to managed healthcare trends and governmental price controls, which may affect revenue generation[434]. - The company may face challenges in obtaining and maintaining reimbursement status, which is often a time-consuming and costly process[430]. - The Medicare and Medicaid programs influence private payors' coverage and reimbursement policies, adding complexity to the reimbursement landscape[429].

Core Viewpoint - ArriVent BioPharma, Inc. has reported significant progress in its clinical programs, particularly with firmonertinib, and has expanded its antibody-drug conjugate (ADC) portfolio, indicating a strong commitment to developing innovative cancer therapies [2][5][11]. Recent and Full Year 2024 Highlights - Firmonertinib demonstrated robust anti-tumor activity in NSCLC patients with EGFR PACC mutations, with clinical data presented at major conferences [5][6]. - The global pivotal Phase 3 study for firmonertinib in first-line NSCLC with EGFR exon 20 insertion mutations achieved its target enrollment of 375 patients [5][6]. - The company has selected ARR-002 as its next-generation ADC candidate for IND-enabling studies [5][6]. - As of December 31, 2024, ArriVent had cash and cash equivalents of $266.5 million, expected to fund operations into 2026 [5][8]. Financial Results - For the year ended December 31, 2024, research and development expenses increased to $79.0 million from $64.9 million in 2023, primarily due to increased headcount and clinical expenses related to firmonertinib [8][21]. - General and administrative expenses rose to $15.3 million from $9.7 million in 2023, reflecting the costs associated with operating as a public company [8][21]. - The net loss for 2024 was $80.5 million, compared to a net loss of $69.3 million in 2023 [8][21]. Pipeline Developments - Firmonertinib is being studied in multiple clinical trials, including 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 [14][15]. - The company has entered into collaborations to enhance its ADC portfolio, including a partnership with Lepu Biopharma for ARR-217 and a collaboration with Alphamab for novel ADCs [11][12]. Upcoming Milestones - ArriVent plans to provide updates on its investigations of firmonertinib in first-line NSCLC patients with EGFR PACC mutations in the first half of 2025 [7][11]. - The company anticipates top-line data from the pivotal Phase 3 study of firmonertinib in 2025 and plans to file the first IND for ARR-217 in the first half of 2025 [7][11].