ArriVent BioPharma(AVBP)

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ArriVent Appoints Brent S. Rice as Chief Commercial Officer
Globenewswire· 2025-09-22 20:05
Core Insights - ArriVent BioPharma, Inc. has appointed Brent S. Rice as Chief Commercial Officer, bringing over 25 years of experience in the biotechnology and pharmaceutical industry [1][2] - The company is focused on the commercialization of firmonertinib for EGFR mutant non-small cell lung cancer (NSCLC) and advancing its antibody drug conjugate (ADC) portfolio [2][4] Company Overview - ArriVent is a clinical-stage biopharmaceutical company dedicated to developing and commercializing differentiated medicines for cancer patients [4] - The company aims to leverage its team's drug development expertise to maximize the potential of its lead candidate, firmonertinib, and advance its pipeline of novel therapeutics [4] Leadership Experience - Brent S. Rice previously served as Senior Vice President and global Chief Commercial Officer at Autolus Therapeutics, where he led the transition from clinical stage to commercial organization [2][3] - He has extensive experience in marketing, operations, and reimbursement, and has a strong track record in launching novel therapies and building high-performing organizations [3]
Arrivent Presents the Final Analysis of Firmonertinib Monotherapy Data from Global Phase 1b Study in EGFR PACC Mutant Non-Small Cell Lung Cancer at the 2025 World Conference on Lung Cancer
Globenewswire· 2025-09-09 12:00
Core Insights - ArriVent BioPharma, Inc. presented positive final proof-of-concept data for firmonertinib in treating non-small cell lung cancer (NSCLC) with EGFR PACC mutations at the IASCLC 2025 conference [1][2] Summary by Category Clinical Data - Firmonertinib demonstrated a median progression-free survival (mPFS) of 16.0 months in first-line patients, with a confirmed overall response rate (cORR) of 68.2% and a duration of response (DOR) of 14.6 months [5][6] - CNS responses included a confirmed overall response rate of 42.9% and complete responses of 35.7% in CNS evaluable patients [6] - Rapid clearance of PACC circulating tumor DNA (ctDNA) was observed, with 82% clearance in patients treated with 240 mg and 79% clearance in those treated with 160 mg [6] Safety Profile - The safety profile of firmonertinib remained consistent with no new safety signals reported, and the most common treatment-related adverse events included diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin [4][6] Future Developments - The company plans to enroll the first patient in the global pivotal Phase 3 ALPACCA study for first-line EGFR PACC mutant NSCLC patients in the second half of 2025 [5][6] - Firmonertinib is also being studied in a global Phase 3 trial for patients with EGFR exon 20 insertion mutations [10]
ArriVent BioPharma(AVBP) - 2025 Q2 - Quarterly Report
2025-08-11 12:01
[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q%20Filing%20Information) This section provides key administrative details of the Form 10-Q filing, including the reporting period, registrant information, and outstanding shares - This is a Quarterly Report on Form 10-Q for the period ended June 30, 2025[2](index=2&type=chunk) - The registrant, ARRIVENT BIOPHARMA, INC., is incorporated in Delaware with Commission file number 001-41929[2](index=2&type=chunk) Registrant Status | Status | Checkmark | | :---------------------- | :-------- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ⊠ | | Smaller reporting company | ☒ | | Emerging growth company | ☒ | - The number of outstanding shares of common stock as of August 8, 2025, was **40,568,944**[4](index=4&type=chunk) [Special Note Regarding Forward-Looking Statements](index=2&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions readers that the report contains forward-looking statements subject to risks and uncertainties, and the company undertakes no obligation to update them - The report contains forward-looking statements regarding future operations, financial position, business strategy, product candidates, clinical trials, regulatory approvals, and financial performance[5](index=5&type=chunk)[6](index=6&type=chunk) - These statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results to differ materially from those expressed or implied[5](index=5&type=chunk)[7](index=7&type=chunk) - Readers are cautioned not to rely on forward-looking statements as predictions of future events and the company undertakes no obligation to update them, except as required by law[8](index=8&type=chunk) [PART I — FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) This part presents the company's unaudited condensed financial statements and management's analysis of its financial condition and operations [Item 1. Condensed Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements, including balance sheets, statements of operations and comprehensive loss, statements of convertible preferred stock and stockholders' equity (deficit), and statements of cash flows, along with detailed notes explaining the company's financial position, performance, and significant accounting policies [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and equity at specific reporting dates Condensed Balance Sheet Highlights (in thousands) | Item | 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 current liabilities | $19,636 | $17,274 | +$2,362 | | Total liabilities | $19,636 | $17,288 | +$2,348 | | Accumulated deficit | $(334,119) | $(238,333) | -$95,786 | | Total stockholders' equity | $249,870 | $257,654 | -$7,784 | [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's financial performance over specific periods, including revenues, expenses, and net loss Condensed Statements of Operations Highlights (in thousands, except per share data) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $27,720 | $21,778 | $89,009 | $38,753 | | General and administrative | $5,903 | $3,919 | $11,386 | $7,618 | | Total operating expenses | $33,623 | $25,697 | $100,395 | $46,371 | | Operating loss | $(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) | [Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=7&type=section&id=Condensed%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) This section details changes in the company's equity structure, including common stock, additional paid-in capital, and accumulated deficit Stockholders' Equity Changes (in thousands, except share data) | Item | Balance Dec 31, 2024 | Balance June 30, 2025 | Change | | :------------------------------------ | :------------------- | :-------------------- | :----- | | Common stock shares outstanding | 33,706,765 | 37,490,439 | +3,783,674 | | Common stock amount | $3 | $4 | +$1 | | Additional paid-in capital | $496,195 | $584,003 | +$87,808 | | Accumulated deficit | $(238,333) | $(334,119) | -$95,786 | | Total stockholders' equity | $257,654 | $249,870 | -$7,784 | - Issuance of common stock, net of issuance costs, contributed **$6.5 million** and **$75.3 million** to equity during the six months ended June 30, 2025[23](index=23&type=chunk) - Stock-based compensation expense added **$2.3 million** and **$3.3 million** to additional paid-in capital during the six months ended June 30, 2025[23](index=23&type=chunk) [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(94,132) | $(37,715) | | Net cash provided by investing activities | $50,731 | $0 | | Net cash provided by financing activities | $81,873 | $185,995 | | Net (decrease) increase in cash and cash equivalents | $38,472 | $148,280 | | Cash and cash equivalents at end of year | $112,765 | $298,669 | - The increase in cash used in operating activities in H1 2025 was primarily due to a higher net loss, including a **$40.0 million** upfront payment for the Lepu collaboration[30](index=30&type=chunk)[138](index=138&type=chunk) - Investing activities provided **$50.7 million** in H1 2025, mainly from maturities of marketable securities, compared to no cash provided in H1 2024[30](index=30&type=chunk)[141](index=141&type=chunk) - Financing activities provided **$81.9 million** in H1 2025, primarily from 'at-the-market' (ATM) program sales, while H1 2024 saw **$186.0 million** from the initial public offering[30](index=30&type=chunk)[143](index=143&type=chunk) [Notes to Condensed Interim Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Interim%20Financial%20Statements) These notes provide detailed explanations and disclosures supporting the unaudited condensed financial statements, covering company background, liquidity, significant accounting policies, fair value measurements, specific balance sheet accounts, commitments, stock-based compensation, license agreements, segment information, common stock activities, debt, and subsequent events [Note 1 Background](index=10&type=section&id=Note%201%20Background) This note provides an overview of the company's founding, its lead product candidate firmonertinib, and its initial public offering - ArriVent BioPharma, Inc. was founded on April 14, 2021, as a clinical-stage biopharmaceutical company[32](index=32&type=chunk) - The company's lead candidate, firmonertinib, a third-generation tyrosine kinase inhibitor, is being evaluated in multiple clinical trials for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor mutations (EGFRm)[32](index=32&type=chunk) - The company completed its initial public offering (IPO) on January 30, 2024, raising net proceeds of **$183.2 million**[33](index=33&type=chunk) [Note 2 Development Stage Risks and Liquidity](index=10&type=section&id=Note%202%20Development%20Stage%20Risks%20and%20Liquidity) This note discusses the company's accumulated deficit, expected increase in expenses, and its capital resources to fund future operations - The company has incurred losses since inception, with an accumulated deficit of **$334.1 million** as of June 30, 2025[34](index=34&type=chunk) - It expects research and development and general and administrative expenses to increase, necessitating additional capital[35](index=35&type=chunk) - The aggregate balance of cash, cash equivalents, and marketable securities (**$254.5 million** as of June 30, 2025), along with **$81.1 million** from a July 2025 public offering, is believed to be sufficient for planned operations through at least twelve months[36](index=36&type=chunk) [Note 3 Summary of Significant Accounting Policies](index=11&type=section&id=Note%203%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements, including estimates and new pronouncements [Interim Financial Statements](index=11&type=section&id=Note%203(a)%20Interim%20Financial%20Statements) This sub-note confirms the preparation of unaudited interim financial statements in accordance with U.S. GAAP - The unaudited interim financial statements are prepared in accordance with U.S. GAAP and include all necessary normal recurring adjustments[40](index=40&type=chunk)[41](index=41&type=chunk) [Use of Estimates](index=11&type=section&id=Note%203(b)%20Use%20of%20Estimates) This sub-note explains that financial statement preparation requires management estimates and assumptions - Preparation of financial statements requires estimates and assumptions, particularly for the fair value of common stock (prior to IPO) and accrued research and development expenses[42](index=42&type=chunk)[43](index=43&type=chunk) [Fair Value Measurements](index=11&type=section&id=Note%203(c)%20Fair%20Value%20Measurements) This sub-note describes the company's approach to fair value measurements, categorizing inputs into a hierarchy - The company uses valuation techniques that maximize observable inputs, categorizing them into Level 1, Level 2, and Level 3 of the fair value hierarchy[44](index=44&type=chunk) - Carrying amounts of cash equivalents and accounts payable approximate fair value due to their short-term nature[45](index=45&type=chunk) [Net Loss per Share](index=12&type=section&id=Note%203(d)%20Net%20Loss%20per%20Share) This sub-note details the calculation of basic and diluted net loss per share and the treatment of potentially dilutive securities - Basic and diluted net loss per share are computed by dividing net loss by the weighted-average common shares outstanding[46](index=46&type=chunk) - Potentially dilutive securities, such as stock options, are excluded from diluted net loss per share calculation when a net loss exists, as their impact would be anti-dilutive[46](index=46&type=chunk)[47](index=47&type=chunk) [Accounting Pronouncements Not Yet Adopted](index=12&type=section&id=Note%203(e)%20Accounting%20Pronouncements%20Not%20Yet%20Adopted) This sub-note identifies new accounting pronouncements issued but not yet adopted by the company - FASB issued ASU 2024-03 (Expense Disaggregation Disclosures) in November 2024, effective for annual periods after December 15, 2026, which the company is evaluating for impact[48](index=48&type=chunk) [Accounting Pronouncements Becoming Effective in 2025](index=13&type=section&id=Note%203(f)%20Accounting%20Pronouncements%20Becoming%20Effective%20in%202025) This sub-note highlights new accounting pronouncements that become effective in 2025 - FASB issued ASU 2023-09 (Income Tax Disclosures) in December 2023, effective for annual periods after December 15, 2024, which the company is evaluating for impact[49](index=49&type=chunk) [Reverse Stock Split](index=13&type=section&id=Note%203(g)%20Reverse%20Stock%20Split) This sub-note describes a reverse stock split that occurred and its retroactive adjustment to share and per-share amounts - A 15.21-for-1 reverse stock split of common stock was effected on January 23, 2024, with all share and per-share amounts retroactively adjusted[50](index=50&type=chunk) [License and Collaboration Agreements](index=13&type=section&id=Note%203(h)%20License%20and%20Collaboration%20Agreements) This sub-note explains the accounting treatment for license and collaboration agreements, particularly regarding expense recognition - License and collaborative agreements are assessed under ASC 808; costs are recognized as research and development expense when incurred[51](index=51&type=chunk)[52](index=52&type=chunk) - Clinical, regulatory, and development milestones are recognized as R&D expense only when deemed probable of achievement[52](index=52&type=chunk) [Comprehensive Loss](index=13&type=section&id=Note%203(i)%20Comprehensive%20Loss) This sub-note defines comprehensive loss as including net loss and certain changes in stockholders' deficit - Comprehensive loss includes net loss and certain changes in stockholders' deficit, primarily unrealized gains or losses on marketable securities[53](index=53&type=chunk) [Note 4 Fair Value Measurements](index=14&type=section&id=Note%204%20Fair%20Value%20Measurements) This note details the valuation techniques and categorization of financial assets measured at fair value, primarily marketable securities Financial Assets Measured at Fair Value (in thousands) | Item | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :-------------------------- | :----------------------- | :--------------------------- | | Money market funds | $99,808 | $49,031 | | Corporate securities | $85,524 | $114,439 | | Government securities | $64,185 | $98,077 | | Total assets measured at fair value | $249,517 | $261,547 | - Money market funds are classified as Level 1, while corporate and government securities are primarily Level 2[55](index=55&type=chunk) - As of June 30, 2025, **$131.0 million** of fixed income securities have maturity dates within the next twelve months[57](index=57&type=chunk) [Note 5 Prepaid Expenses and Other Current Assets](index=15&type=section&id=Note%205%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note provides a breakdown of prepaid expenses and other current assets, highlighting changes in research and development prepayments Prepaid Expenses and Other Current Assets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Research and development | $13,170 | $7,209 | | Professional fees | $130 | $233 | | Insurance | $657 | $174 | | Tax credit receivable | $505 | $500 | | Total prepaid expenses and other current assets | $14,462 | $8,116 | - Prepaid research and development expenses significantly increased from **$7.2 million** to **$13.2 million**[59](index=59&type=chunk) [Note 6 Accrued Expenses](index=15&type=section&id=Note%206%20Accrued%20Expenses) This note details the composition of accrued expenses, including research and development, professional fees, and compensation Accrued Expenses (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Research and development | $11,814 | $8,626 | | Professional fees | $716 | $474 | | Compensation and related expenses | $2,792 | $4,163 | | Other accrued expenses | $156 | $67 | | Total accrued expenses | $15,478 | $13,330 | - Accrued research and development expenses increased by **$3.2 million**, while compensation and related expenses decreased by **$1.4 million**[60](index=60&type=chunk) [Note 7 Commitments and Contingencies](index=15&type=section&id=Note%207%20Commitments%20and%20Contingencies) This note refers to the company's obligations under license and collaboration agreements, which involve potential contingent payments - The company is obligated to make contingent payments under various license and collaboration agreements, as described in Note 9[61](index=61&type=chunk) [Note 8 Stock-based Compensation](index=15&type=section&id=Note%208%20Stock-based%20Compensation) This note details the stock-based compensation expense recognized and the outstanding stock options, along with unrecognized compensation costs Stock-based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $1,495 | $418 | $2,480 | $652 | | General and administrative | $1,816 | $348 | $3,102 | $738 | | Total | $3,311 | $766 | $5,582 | $1,390 | - Total stock-based compensation expense increased significantly to **$5.6 million** for the six months ended June 30, 2025, from **$1.4 million** in the prior year[62](index=62&type=chunk) - As of June 30, 2025, **4,325,617** stock options were outstanding with a weighted-average exercise price of **$15.46**[63](index=63&type=chunk) - Unrecognized compensation cost for unvested awards was **$44.1 million**, to be expensed over a weighted-average period of **2.93 years**[64](index=64&type=chunk) [Note 9 License and Collaboration Agreements](index=16&type=section&id=Note%209%20License%20and%20Collaboration%20Agreements) This note details the company's key license and collaboration agreements with Allist, Alphamab, Aarvik, and Lepu, outlining exclusive rights, upfront payments, potential milestone payments (clinical, regulatory, commercial), and tiered royalty obligations for various product candidates and technologies [Allist Agreement](index=16&type=section&id=Note%209%20Allist) This sub-note outlines the exclusive licensing agreement with Allist for firmonertinib outside Greater China, including milestone and royalty obligations - In June 2021, the company licensed exclusive rights to develop and commercialize firmonertinib outside Greater China from Allist[65](index=65&type=chunk) - The agreement includes potential future milestone payments of up to **$105.0 million** for clinical/regulatory achievements and **$655.0 million** for commercial milestones, plus tiered royalties on net sales[66](index=66&type=chunk) - Cost reimbursements to Allist under the Clinical Collaboration were **$0.6 million** for the six months ended June 30, 2025, and **$0.3 million** for the same period in 2024[67](index=67&type=chunk) [Alphamab Agreement](index=17&type=section&id=Note%209%20Alphamab) This sub-note describes the collaboration with Alphamab for novel antibody drug conjugates, detailing global rights, milestone payments, and royalties - In June 2024, the company entered a collaboration with Alphamab to discover, develop, and commercialize novel antibody drug conjugates (ADCs) for cancer, with exclusive global rights except Greater China[68](index=68&type=chunk)[69](index=69&type=chunk) - The agreement includes potential milestone payments of up to **$201.5 million** for regulatory/development and **$414.0 million** for commercial achievements, plus tiered sales royalties[70](index=70&type=chunk) - During the six months ended June 30, 2025, the company paid **$1.2 million** upon approval of a target pair selection, recorded as R&D expense[71](index=71&type=chunk) [Aarvik Collaboration Agreement](index=17&type=section&id=Note%209%20Aarvik) This sub-note outlines the research collaboration with Aarvik, including an option exercise payment and future milestone and royalty obligations - In December 2021, the company entered a research collaboration with Aarvik, amended in June 2023[72](index=72&type=chunk) - In August 2024, the company paid **$1.0 million** to exercise an exclusive option to license Aarvik intellectual property[72](index=72&type=chunk) - Future obligations include up to **$18.0 million** per product for clinical/regulatory milestones and **$80.0 million** per product for commercial milestones, plus mid-single digit royalties[73](index=73&type=chunk) - R&D expenses related to Aarvik SOWs were **$0.3 million** for the six months ended June 30, 2025, compared to **$1.0 million** in 2024[75](index=75&type=chunk) [Lepu Biopharma Agreement](index=18&type=section&id=Note%209%20Lepu) This sub-note details the licensing agreement with Lepu Biopharma for ARR-217, including upfront and milestone payments, and royalty obligations - On January 21, 2025, the company licensed exclusive rights to develop and commercialize ARR-217 (an ADC for GI cancers) outside Greater China from Lepu[76](index=76&type=chunk)[77](index=77&type=chunk) - The agreement included a one-time upfront payment of **$40.0 million** (recorded as R&D expense) and a **$1.0 million** payment for the first developmental milestone in Q2 2025[77](index=77&type=chunk) - Lepu is eligible for up to **$0.3 billion** in development/regulatory milestones, **$0.89 billion** in commercial milestones, and tiered royalties[77](index=77&type=chunk) [Note 10 Segment Information](index=19&type=section&id=Note%2010%20Segment%20Information) This note clarifies the company's single operating segment and details significant research and development expense categories - The company operates as a single reportable and operating segment: life science, focused on identifying, licensing, and globalizing biopharma innovations[79](index=79&type=chunk) - The Chief Operating Decision Maker (CODM) assesses performance based on net loss and uses cash forecast models to allocate resources[79](index=79&type=chunk)[82](index=82&type=chunk) Significant R&D Expense Categories (in thousands) for Six Months Ended June 30, | Category | 2025 | 2024 | | :---------------------------------------------------------------- | :----- | :----- | | Firmonertinib (excluding personnel-related and other internal costs) | $30,786 | $24,233 | | Research and development: Discovery-stage programs | $44,606 | $6,614 | | Research and development: Personnel-related and other internal costs | $13,617 | $7,906 | | Total Research and Development | $89,009 | $38,753 | - Discovery-stage programs R&D expenses increased significantly in 2025, largely due to the **$40.0 million** upfront payment for the Lepu collaboration[83](index=83&type=chunk) [Note 11 Common Stock](index=20&type=section&id=Note%2011%20Common%20Stock) This note describes the company's 'at-the-market' equity program, including shares sold and remaining availability for future issuances - On February 3, 2025, the company filed an automatic shelf registration statement (Form S-3ASR) for up to **$250.0 million** of common stock through an 'at-the-market' (ATM) equity program[85](index=85&type=chunk) - During the six months ended June 30, 2025, **3,693,224** shares of common stock were sold via the ATM program, generating **$81.9 million** in net proceeds[87](index=87&type=chunk) - As of June 30, 2025, approximately **$164.9 million** remained available for future issuances under the ATM program[87](index=87&type=chunk) [Note 12 Debt](index=20&type=section&id=Note%2012%20Debt) This note details the company's loan and security agreement with Silicon Valley Bank, including the term loan amount and interest rate - On May 8, 2025, the company entered a Loan and Security Agreement with Silicon Valley Bank for a Term Loan of up to **$75.0 million**[88](index=88&type=chunk) - No amounts have been drawn on this Term Loan as of June 30, 2025[88](index=88&type=chunk) - The Term Loan matures on March 1, 2030 (or March 1, 2029, if certain conditions are not met) and bears interest at a variable annual rate, generally the greater of **6.00%** or (Prime Rate - **0.75%**)[89](index=89&type=chunk) [Note 13 Subsequent Events](index=20&type=section&id=Note%2013%20Subsequent%20Events) This note discloses significant events occurring after the reporting period, including a public offering and new tax legislation - On July 3, 2025, the company closed an underwritten public offering, issuing common stock and pre-funded warrants, generating **$81.1 million** in net proceeds[91](index=91&type=chunk)[92](index=92&type=chunk) - On July 4, 2025, the 'One Big Beautiful Bill Act' was enacted, allowing accelerated tax deductions for qualified R&D expenditures, the impact of which is being evaluated[94](index=94&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, results of operations, and liquidity, highlighting key developments in its clinical programs, financial performance for the three and six months ended June 30, 2025 and 2024, and future funding strategies [Overview](index=22&type=section&id=Overview) This section provides a high-level summary of the company's business, lead product candidate, clinical trial progress, and financial position - ArriVent BioPharma is a clinical-stage biopharmaceutical company focused on developing differentiated medicines for cancer, with an initial focus on solid tumors[96](index=96&type=chunk) - Its lead candidate, firmonertinib, is being evaluated in multiple clinical trials for EGFRm NSCLC, including a pivotal Phase 3 trial (FURVENT) for exon 20 insertion mutations[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - Firmonertinib received FDA Breakthrough Therapy Designation in October 2023 and Orphan Drug Designation in February 2024 for NSCLC with EGFRm[96](index=96&type=chunk) - Interim data from the FAVOUR trial showed a **79%** overall response rate (ORR) and **15.2-month** median duration of response (DOR) in first-line EGFR exon 20 insertion mutations[99](index=99&type=chunk) - Interim data from the FURTHER trial (PACC mutations) showed a **64%** ORR (Sept 2024) and, with **240 mg** dose, **16.0 months** median progression-free survival (PFS) and **14.6 months** median DOR (June 2025)[100](index=100&type=chunk)[101](index=101&type=chunk) - The company plans to initiate ALPACCA (FURMO-006), a randomized global Phase 3 study for PACC mutations, in the second half of 2025[102](index=102&type=chunk) - The company has incurred significant operating losses since inception, with an accumulated deficit of **$334.1 million** as of June 30, 2025, and expects losses to increase as it advances product candidates[107](index=107&type=chunk)[110](index=110&type=chunk) [Key Components of Our Results of Operations](index=25&type=section&id=Key%20Components%20of%20Our%20Results%20of%20Operations) This section explains the primary drivers of the company's financial performance, including research and development, general and administrative expenses, and interest income - Research and development expenses are expensed as incurred, primarily related to firmonertinib development, preclinical studies, and manufacturing[111](index=111&type=chunk)[112](index=112&type=chunk) - General and administrative expenses include salaries, legal fees, accounting, and insurance, expected to increase with continued R&D and potential commercialization[116](index=116&type=chunk) - Interest and investment income is derived from interest earned on cash, cash equivalents, and marketable securities[117](index=117&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance for the three and six months ended June 30, 2025 and 2024, detailing changes in expenses and net loss [Comparison of the Three Months Ended June 30, 2025 and 2024](index=26&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This sub-section compares the company's financial results for the three-month periods, highlighting changes in operating expenses and net loss Financial Performance (Three Months Ended June 30, in thousands) | Item | 2025 | 2024 | Change | | :-------------------------- | :----- | :----- | :----- | | Research and development | $27,720 | $21,778 | +$5,942 | | General and administrative | $5,903 | $3,919 | +$1,984 | | Total operating expenses | $33,623 | $25,697 | +$7,926 | | Operating loss | $(33,623) | $(25,697) | -$7,926 | | Interest and investment income | $2,224 | $3,823 | -$1,599 | | Net loss | $(31,399) | $(21,874) | -$9,525 | - Research and development expenses increased by **$5.9 million**, primarily due to increased costs for the FURVENT Phase 3 clinical trial (**$2.8 million**) and general firmonertinib costs (**$3.3 million**), partially offset by a decrease in discovery-stage programs (**$2.6 million**)[121](index=121&type=chunk) - General and administrative expenses rose by **$2.0 million**, mainly due to higher personnel-related costs and accounting/legal services[122](index=122&type=chunk) - Interest and investment income decreased by **$1.6 million** due to decreased invested balances[123](index=123&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=27&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This sub-section compares the company's financial results for the six-month periods, emphasizing significant increases in research and development expenses Financial Performance (Six Months Ended June 30, in thousands) | Item | 2025 | 2024 | Change | | :-------------------------- | :----- | :----- | :----- | | Research and development | $89,009 | $38,753 | +$50,256 | | General and administrative | $11,386 | $7,618 | +$3,768 | | Total operating expenses | $100,395 | $46,371 | +$54,024 | | Operating loss | $(100,395) | $(46,371) | -$54,024 | | Interest and investment income | $4,609 | $7,080 | -$2,471 | | Net loss | $(95,786) | $(39,291) | -$56,495 | - Research and development expenses surged by **$50.3 million**, primarily driven by a **$38.0 million** increase in discovery-stage programs (including a **$40.0 million** upfront payment for the Lepu collaboration) and a **$6.6 million** increase in firmonertinib costs[125](index=125&type=chunk) - General and administrative expenses increased by **$3.8 million**, mainly due to higher personnel-related costs and accounting/legal/software services[126](index=126&type=chunk) - Interest and investment income decreased by **$2.5 million** due to decreased invested balances[127](index=127&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's funding sources, future capital requirements, and cash flow activities, including recent financing events [Sources of Liquidity](index=28&type=section&id=Sources%20of%20Liquidity) This sub-section identifies the company's primary funding mechanisms, including equity offerings and a new loan agreement - Operations have been funded through convertible preferred stock (**$305.0 million** gross proceeds), an initial public offering (**$183.2 million** net proceeds in Q1 2024), and 'at-the-market' (ATM) offerings[128](index=128&type=chunk) - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled **$254.5 million**[128](index=128&type=chunk) - The company sold **3,693,224** common shares through its ATM program for **$81.9 million** net proceeds during the six months ended June 30, 2025, with **$164.9 million** remaining for future issuances[130](index=130&type=chunk) - A **$75 million** loan and security agreement was entered with Silicon Valley Bank in May 2025, with no amounts drawn as of the report date[131](index=131&type=chunk) - A public offering closed on July 3, 2025, raising **$81.1 million** in net proceeds from common stock and pre-funded warrants[132](index=132&type=chunk) [Future Funding Requirements](index=29&type=section&id=Future%20Funding%20Requirements) This sub-section outlines the company's anticipated capital needs and strategies for securing additional financing to support its operations - Existing cash, cash equivalents, marketable securities, and July 2025 offering proceeds are expected to be sufficient for at least twelve months from the financial statements' issuance date[134](index=134&type=chunk) - Future capital requirements are dependent on the progress and costs of drug discovery, preclinical studies, clinical trials, regulatory approvals, manufacturing, and commercialization[135](index=135&type=chunk) - The company expects to finance future cash needs through public/private equity offerings, debt financings, collaborations, and licensing arrangements[136](index=136&type=chunk) [Cash Flows](index=30&type=section&id=Cash%20Flows) This sub-section provides a detailed analysis of cash movements from operating, investing, and financing activities Summary of Cash Flows (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Operating activities | $(94,132) | $(37,715) | | Investing activities | $50,731 | $0 | | Financing activities | $81,873 | $185,995 | | Net (decrease) increase in cash and cash equivalents | $38,472 | $148,280 | - Net cash used in operating activities increased to **$94.1 million** in H1 2025, reflecting a higher net loss, including a **$40.0 million** upfront payment for the Lepu collaboration[138](index=138&type=chunk) - Net cash provided by investing activities was **$50.7 million** in H1 2025, primarily from maturities of marketable securities[141](index=141&type=chunk) - Net cash provided by financing activities was **$81.9 million** in H1 2025, mainly from ATM program sales, compared to **$185.9 million** in H1 2024 from the IPO[143](index=143&type=chunk) [Contractual Obligations and Commitments](index=31&type=section&id=Contractual%20Obligations%20and%20Commitments) This sub-section clarifies the company's long-term financial obligations, noting the absence of certain commitments and the nature of contingent payments - As of June 30, 2025, the company had no long-term obligations, capital lease obligations, or purchase obligations, except for operating leases[144](index=144&type=chunk) - Contingent milestone payments under license and collaboration agreements are not recorded as contractual obligations because their achievement is not probable as of June 30, 2025[145](index=145&type=chunk) [Critical Accounting Policies, Significant Judgments and Use of Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%2C%20Significant%20Judgments%20and%20Use%20of%20Estimates) This sub-section confirms no changes to the company's critical accounting policies from its previous annual report - There have been no changes to the company's critical accounting policies from those described in its Annual Report[147](index=147&type=chunk) [JOBS Act and Emerging Growth Company Status](index=32&type=section&id=JOBS%20Act%20and%20Emerging%20Growth%20Company%20Status) This section explains the company's status as an emerging growth company and the implications for accounting standards and future compliance costs - The company is an emerging growth company (EGC) and a smaller reporting company, electing to use the extended transition period for new accounting standards[148](index=148&type=chunk) - It will transition out of EGC status by December 31, 2025, which is expected to result in significant additional legal, accounting, and compliance expenses[149](index=149&type=chunk) [Recent Accounting Pronouncements](index=32&type=section&id=Recent%20Accounting%20Pronouncements) This section refers to disclosures regarding new accounting pronouncements and their potential impact on the company's financial statements - A description of recent accounting pronouncements that may impact financial position, results of operations, or cash flows is disclosed in Note 3 to the financial statements[150](index=150&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section assesses the company's exposure to market risks, including interest rate risk, foreign currency risk, and the effects of inflation, concluding that these risks have not had a material impact on operations to date - The company's exposure to interest rate risk is not significant, with a hypothetical **1.0%** change in market interest rates not materially impacting its portfolio value[151](index=151&type=chunk) - Foreign currency exchange rate fluctuations have not had a material effect on results of operations to date, as the company does not regularly incur material expenses in foreign currencies[152](index=152&type=chunk) - Inflation has not had a material effect on the company's results of operations during the periods presented, and no material impact is anticipated going forward[153](index=153&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, and confirms no material changes in internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[154](index=154&type=chunk)[155](index=155&type=chunk) - There were no changes in internal control over financial reporting during the three months ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[156](index=156&type=chunk) [PART II — OTHER INFORMATION](index=33&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This part provides additional information including legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the company is not currently a party to any legal proceedings expected to have a material adverse effect on its business, financial condition, or results of operations - The company is not currently a party to or aware of any legal proceedings that are believed to have a material adverse effect on its business, financial condition, or results of operations[157](index=157&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the risk factors detailed in the company's Annual Report on Form 10-K for December 31, 2024, and the Quarterly Report on Form 10-Q for March 31, 2025, indicating no additional material changes - There have been no additional material changes to the company's risk factors as set forth in its Annual Report on Form 10-K for December 31, 2024, and Quarterly Report on Form 10-Q for March 31, 2025[158](index=158&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports no unregistered sales of equity securities and confirms that the use of proceeds from the January 2024 initial public offering remains consistent with previously disclosed plans - There were no unregistered sales of equity securities during the period[159](index=159&type=chunk) - The company received net proceeds of **$183.2 million** from its initial public offering in January 2024[160](index=160&type=chunk) - There has been no material change in the planned use of proceeds from the initial public offering[161](index=161&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there have been no defaults upon senior securities - There have been no defaults upon senior securities[162](index=162&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section reports no mine safety disclosures - There are no mine safety disclosures to report[163](index=163&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) This section discloses that no directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading plans during the fiscal quarter ended June 30, 2025 - None of the company's directors or executive officers adopted, modified, or terminated any Rule 10b5-1 trading plans during the fiscal quarter ended June 30, 2025[164](index=164&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents, agreements, certifications, and XBRL interactive data files - Exhibits include the Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, Amended and Restated Non-Employee Director Compensation Policy, and the Loan and Security Agreement[168](index=168&type=chunk) - Certifications from the Chief Executive Officer and Chief Financial Officer are included, both pursuant to Rule 13a-15(e) or Rule 15d-15(e) and 18 U.S.C. Section 1350[168](index=168&type=chunk) - Interactive Data Files in Inline XBRL format are also provided as exhibits[168](index=168&type=chunk) [Signatures](index=35&type=section&id=Signatures) This section contains the required signatures from the company's Chairman, President, and Chief Executive Officer, and Chief Financial Officer and Treasurer, certifying the filing of the report - The report was signed on August 11, 2025, by Zhengbin (Bing) Yao, Ph.D., Chairman, President and Chief Executive Officer, and Winston Kung, Chief Financial Officer and Treasurer[172](index=172&type=chunk)
ArriVent BioPharma(AVBP) - 2025 Q2 - Quarterly Results
2025-08-11 12:00
[Company Overview and Recent Progress](index=1&type=section&id=Company%20Overview%20and%20Recent%20Progress) ArriVent BioPharma reports Q2 2025 financial results and significant clinical program advancements, extending cash runway to mid-2027 [Introduction and CEO Commentary](index=1&type=section&id=Introduction%20and%20CEO%20Commentary) 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](index=3&type=chunk) - Global pivotal Phase 3 PACC study expected to enroll first patient in **H2 2025**[3](index=3&type=chunk) - Topline pivotal data for registration-enabling trial in Exon 20 insertion mutations anticipated in **early 2026**[3](index=3&type=chunk) - ARR-217, a CDH17-targeting ADC, completed first patient dosing in Phase 1 study for gastrointestinal tumors[3](index=3&type=chunk) - Strengthened balance sheet extends cash runway to **mid-2027**[3](index=3&type=chunk) [Second Quarter 2025 and Recent Highlights](index=1&type=section&id=Second%20Quarter%202025%20and%20Recent%20Highlights) 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](index=1&type=section&id=Firmonertinib%20Clinical%20Updates) 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](index=4&type=chunk)[6](index=6&type=chunk) - Global pivotal Phase 3 ALPACCA study aims to evaluate firmonertinib monotherapy as a first-line treatment for PACC-mutated NSCLC[7](index=7&type=chunk) [Pipeline Advancement: ARR-217 ADC](index=3&type=section&id=Pipeline%20Advancement%3A%20ARR-217%20ADC) 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](index=5&type=chunk)[8](index=8&type=chunk) [Financial Position and Outlook](index=1&type=section&id=Financial%20Position%20and%20Outlook) 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](index=5&type=chunk)[11](index=11&type=chunk) [Upcoming Milestones](index=3&type=section&id=Upcoming%20Milestones) ArriVent anticipates key clinical data readouts and patient enrollment initiations for its firmonertinib programs in 2025 and 2026 [Key Upcoming Milestones](index=3&type=section&id=Key%20Upcoming%20Milestones) 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](index=11&type=chunk) - 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](index=11&type=chunk) - 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](index=11&type=chunk) [Detailed Financial Results](index=3&type=section&id=Detailed%20Financial%20Results) 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)](index=3&type=section&id=Summary%20of%20Financial%20Performance%20%28Q2%20%26%20H1%202025%29) 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](index=11&type=chunk) - Increased R&D expenses were driven by the Lepu Biopharma upfront payment, increased headcount, and firmonertinib clinical costs[11](index=11&type=chunk) [Balance Sheets](index=7&type=section&id=Balance%20Sheets) 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](index=8&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=4&type=section&id=About%20ArriVent%20and%20Therapeutic%20Programs) ArriVent is a clinical-stage biopharmaceutical company focused on developing differentiated oncology drugs, including firmonertinib and novel ADCs [About ArriVent BioPharma](index=4&type=section&id=About%20ArriVent%20BioPharma) 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](index=12&type=chunk) - Aims to maximize firmonertinib's potential and advance a pipeline of novel therapies, including ADCs[12](index=12&type=chunk) [About Firmonertinib](index=4&type=section&id=About%20Firmonertinib) 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](index=13&type=chunk) - Effective against both classic and rare EGFR mutations, including PACC and exon 20 insertion mutations[13](index=13&type=chunk) - 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](index=13&type=chunk) - Received U.S. FDA Breakthrough Therapy Designation for previously untreated EGFR exon 20 insertion-mutated non-squamous NSCLC[14](index=14&type=chunk) - Received U.S. FDA Orphan Drug Designation for EGFR, HER2, or HER4-mutated NSCLC[14](index=14&type=chunk) - 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](index=15&type=chunk) [About EGFR Mutant NSCLC and PACC Mutations](index=4&type=section&id=About%20EGFR%20Mutant%20NSCLC%20and%20PACC%20Mutations) 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](index=16&type=chunk) - EGFR mutations are common in NSCLC, categorized into classic and rare types[16](index=16&type=chunk) - EGFR exon 20 insertion mutations account for approximately **9%** of all EGFR mutations[16](index=16&type=chunk) - PACC mutations account for approximately **12%** of all EGFR mutations[16](index=16&type=chunk) - Patients with rare EGFR mutations face significantly reduced life expectancy and have unmet medical needs[16](index=16&type=chunk) - 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](index=17&type=chunk)[18](index=18&type=chunk) [About FURVENT Phase 3 Study](index=6&type=section&id=About%20FURVENT%20Phase%203%20Study) 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](index=19&type=chunk) - Compares firmonertinib (160 mg or 240 mg once daily) with platinum chemotherapy plus pemetrexed[19](index=19&type=chunk) - 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](index=19&type=chunk) - The study enrolled **398** patients globally, including sites in the U.S., Europe, and Asia[19](index=19&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) 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](index=6&type=section&id=Disclaimer%20on%20Forward-Looking%20Statements) 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](index=20&type=chunk) - These statements are subject to inherent uncertainties, risks, and assumptions, with details disclosed in SEC filings (e.g., Form 10-K)[20](index=20&type=chunk) - ArriVent undertakes no obligation to update forward-looking information, except as required by applicable law[20](index=20&type=chunk) [Contact Information](index=8&type=section&id=Contact%20Information) This section provides contact details for investor relations inquiries [Investor Relations Contact](index=8&type=section&id=Investor%20Relations%20Contact) Contact information for investor relations inquiries is provided - Investor Relations Contact: Joyce Allaire, LifeSci Advisors, LLC[23](index=23&type=chunk)
ArriVent BioPharma Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-11 12:00
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]
ArriVent’s Topline Pivotal Phase 3 FURVENT Data for Firmonertinib in First-Line NSCLC EGFR Exon20 Insertion Mutations is Projected to be Early 2026
GlobeNewswire· 2025-07-21 12:00
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]
ArriVent Announces Pricing of $75 Million Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-07-02 03:15
Core Viewpoint - ArriVent BioPharma, Inc. has announced a public offering of common stock and pre-funded warrants, aiming to raise approximately $75 million to support its drug development programs and general corporate purposes [1][3]. Group 1: Offering Details - The public offering consists of 2,482,692 shares priced at $19.50 each and pre-funded warrants for 1,363,469 shares priced at $19.4999 each, with gross proceeds expected to be around $75 million before expenses [1]. - Underwriters have a 30-day option to purchase an additional 576,923 shares under the same terms [1]. - The offering is expected to close on or about July 3, 2025, pending customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to support the development of firmonertinib and other pipeline programs, as well as for working capital and general corporate purposes [3]. Group 3: Company Background - ArriVent is a clinical-stage biopharmaceutical company focused on developing innovative therapies to meet unmet medical needs in cancer treatment [6]. - The company aims to leverage its team's extensive drug development experience to advance its lead candidate, firmonertinib, and a pipeline of novel therapeutics [6].
ArriVent Announces Proposed $75 Million Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-07-01 20:05
Core Viewpoint - ArriVent BioPharma, Inc. plans to offer and sell $75 million of its common stock and pre-funded warrants, with a potential additional 15% option for underwriters, to support its drug development and general corporate purposes [1][2]. Group 1: Offering Details - The public offering includes $75 million in common stock and pre-funded warrants, with a 30-day option for underwriters to purchase an additional 15% [1]. - Goldman Sachs, Citigroup, and Guggenheim Securities are the joint book-running managers for the offering [2]. - An automatic shelf registration statement was filed with the SEC on February 3, 2025, which became effective upon filing [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to support activities related to firmonertinib and other pipeline programs, as well as for working capital and general corporate purposes [2]. Group 3: Company Overview - ArriVent is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer treatment, with a strong emphasis on its lead candidate, firmonertinib [5].
ArriVent BioPharma (AVBP) Earnings Call Presentation
2025-06-23 13:43
Firmonertinib Clinical Development - Firmonertinib has Breakthrough Therapy Designation in 1L EGFR Exon 20 insertion mutant NSCLC[6] - Topline results in registrational 1L EGFR Exon 20 insertion mutant NSCLC study are expected in 2025[6] - A pivotal trial for 1L EGFR PACC mutant NSCLC is reinforced by positive clinical data[6] - The company is initiating a global pivotal Phase 3 study in 1L NSCLC PACC mutations[12] - In the FURTHER study, the confirmed Overall Response Rate (ORR) for 1L PACC patients was 68.2% at 240 mg QD and 56% at 160 mg QD[38] - Median Progression-Free Survival (mPFS) was 16 months with 240 mg QD and 11.1 months with 160 mg QD in 1L EGFR PACC mutant NSCLC[43] - The CNS Overall Response Rate (ORR) was 53% and the CNS Complete Response (CR) rate was 41% in CNS evaluable patients from the PACC cohort[46] Pipeline Expansion - The company is advancing a next-generation ADC portfolio, with an IND filed this year and others expected starting in 2026[6] - An IND for ARR-002 (tetravalent dual-target ADC) is planned for 2026[68] - A Phase 1 study for ARR-217 (MRG007) in GI Tumors is expected to enroll its first patient in 2H 2025[69] Market Opportunity - Estimated global patients (excluding China) with metastatic uncommon EGFR mutations is approximately 51,000[63]
ArriVent BioPharma (AVBP) Update / Briefing Transcript
2025-06-23 13:00
Summary of the Conference Call for Forte Biosciences Company Overview - **Company**: Forte Biosciences - **Focus**: Development of FV102, an antibody targeting celiac disease and other autoimmune conditions Key Points and Arguments FV102 and Celiac Disease - FV102 is an antibody targeting CD122, involved in the immune response related to celiac disease [4][5] - The Phase 1b trial for celiac disease has shown positive histological and symptom data, with plans for a Phase 2 study to begin soon [5][28] - The trial demonstrated a **42% reduction in gluten-induced symptoms** in the treatment group compared to placebo [24] Mechanism of Action - FV102 blocks the interaction of pro-inflammatory cytokines IL-2 and IL-15, preventing the activation of autoreactive T cells and NK cells [6][7] - The treatment aims to modulate the immune response without significantly affecting regulatory T cells [7] Trial Design and Results - The Phase 1b trial involved **32 subjects** across nine sites in Australia and New Zealand, with a **3:1 randomization** of FV102 to placebo [16] - The trial included a **16-day gluten challenge**, with increasing gluten doses to assess the treatment's efficacy [17] - Histological measurements showed a significant difference in intraepithelial lymphocyte (IEL) density, with a **decrease of 1.5 IELs per 100 enterocytes** in the treatment group compared to an increase of **13.3 IELs in the placebo group** [22] Future Developments - A Phase 2 trial is set to enroll **100 patients**, with a focus on longer gluten exposure and more robust symptom assessment [28] - The Phase 2 study will utilize a **composite analysis** of histological and symptom data, aiming for statistically significant results [41] Safety Profile - The safety profile of FV102 is consistent with previous studies, with only one grade three adverse event reported in the placebo group [26] - Most adverse events were mild, indicating a favorable safety profile for the treatment [26] Additional Insights - The unmet need in celiac disease is significant, with an estimated **2.5 million people affected** in the U.S. alone, many of whom are underdiagnosed [10] - The treatment's ability to reduce gluten-induced symptoms is particularly noteworthy, as many patients reported being able to consume gluten without adverse effects during the trial [25] - The combination of IL-2 and IL-15 blockade is believed to enhance the therapeutic effects of FV102 compared to other treatments currently in development [60] Conclusion - Forte Biosciences is advancing its clinical trials for FV102, showing promising results in treating celiac disease with a focus on both symptom relief and histological improvement. The upcoming Phase 2 trial aims to further validate these findings and explore the treatment's potential in other autoimmune diseases.