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ArriVent BioPharma(AVBP) - 2025 Q2 - Quarterly Report
2025-08-11 12:01
Table of Contents ☐ 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) 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 June 30, 2025 OR (State of Other Jurisdiction of inc ...
ArriVent BioPharma(AVBP) - 2025 Q2 - Quarterly Results
2025-08-11 12:00
Exhibit 99.1 ArriVent BioPharma Reports Second Quarter 2025 Financial Results NEWTOWN SQUARE, PA, August 11, 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 reported financial results for the second quarter ended June 30, 2025, and highlighted recent Company progress. "Firmonertinib continues to advance with strong momentum toward registration, ...
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
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 Transcript
2025-06-23 13:00
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 ...
ArriVent Announces Investor Event on Firmonertinib Path Forward for EGFR PACC Mutant NSCLC
Globenewswire· 2025-06-20 20:05
Company Overview - ArriVent BioPharma, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for cancer patients [2] - The company aims to leverage its team's extensive drug development experience to advance its lead candidate, firmonertinib, and a pipeline of novel therapeutics [2] Product Information - Firmonertinib is an oral, mutation-selective EGFR inhibitor effective against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations [3] - The drug was approved in China in March 2021 for first-line treatment of advanced NSCLC with specific EGFR mutations [3] Regulatory Designations - Firmonertinib received Breakthrough Therapy Designation from the U.S. FDA for treating previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations [4] - The drug also holds Orphan Drug Designation from the U.S. FDA for treating NSCLC with various EGFR mutations [4] Clinical Trials - Firmonertinib is currently undergoing a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations and a Phase 1b study for patients with EGFR PACC mutations [5] - The drug is also part of a clinical combination study targeting advanced or metastatic NSCLC patients with classical EGFR mutations, in collaboration with Beijing InnoCare Pharma Tech Co., Ltd. [5] Market Context - Lung cancer is the leading cause of cancer-related deaths globally, with NSCLC accounting for approximately 85% of all cases [6] - Uncommon EGFR mutations, such as exon 20 insertion and PACC mutations, represent significant unmet medical needs, with exon 20 mutations constituting about 9% and PACC mutations about 12% of all EGFR mutations [6]
ArriVent BioPharma(AVBP) - 2025 Q1 - Quarterly Report
2025-05-12 13:35
PART I — FINANCIAL INFORMATION [Item 1. Condensed Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Financial%20Statements%20(Unaudited)) Unaudited statements show a Q1 net loss of $64.4 million and decreased assets, driven by R&D spending and a major license payment [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to $215.5 million as of March 31, 2025, reflecting a reduction in cash and a higher accumulated deficit Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $49,865 | $74,293 | | Short-term investments | $126,212 | $144,570 | | Total current assets | $185,785 | $226,979 | | **Total assets** | **$215,495** | **$274,942** | | **Liabilities & Equity** | | | | Total liabilities | $12,953 | $17,288 | | Accumulated deficit | $(302,720) | $(238,333) | | **Total stockholders' equity** | **$202,542** | **$257,654** | [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for Q1 2025 widened to $64.4 million, driven by a substantial increase in research and development expenses Statement of Operations Summary (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $61,289 | $16,975 | | General and administrative | $5,483 | $3,699 | | **Total operating expenses** | **$66,772** | **$20,674** | | Operating loss | $(66,772) | $(20,674) | | **Net loss** | **$(64,387)** | **$(17,417)** | | Net loss per share | $(1.90) | $(0.70) | [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash used in operations increased significantly to $68.0 million due to a $40 million upfront collaboration payment Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(68,008) | $(18,628) | | Net cash provided by investing activities | $36,821 | $— | | Net cash provided by financing activities | $6,759 | $185,632 | | **Net (decrease) increase in cash** | **$(24,428)** | **$167,004** | | Cash and cash equivalents at end of period | $49,865 | $317,393 | [Notes to Condensed Interim Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Interim%20Financial%20Statements) Notes detail the company's liquidity, IPO proceeds, a $40 million license payment, and new financing facilities - The company believes its cash, cash equivalents, and marketable securities of **$205.5 million** are sufficient to fund operations for at least the next twelve months[36](index=36&type=chunk) - In January 2025, the company entered an exclusive license agreement with Lepu Biopharma, paying a **$40 million** upfront fee[79](index=79&type=chunk)[80](index=80&type=chunk) - An 'at-the-market' (ATM) offering program for up to **$250.0 million** was established in February 2025, raising **$6.5 million** in net proceeds in Q1[87](index=87&type=chunk)[90](index=90&type=chunk) - Subsequent to the quarter end, the company entered into a Loan and Security Agreement for up to **$75.0 million** in term loans[91](index=91&type=chunk)[155](index=155&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased R&D expenses from a $40 million upfront payment and confirms liquidity for the next 12 months [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Operating expenses rose by $46.1 million year-over-year, primarily due to a $40 million upfront payment for a collaboration Operating Expense Comparison (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $61,289 | $16,975 | $44,314 | | General and administrative | $5,483 | $3,699 | $1,784 | | **Total operating expenses** | **$66,772** | **$20,674** | **$46,098** | - The **$44.3 million increase in R&D expenses** was primarily due to a **$40.0 million** one-time up-front payment to initiate the collaboration with Lepu[114](index=114&type=chunk) - Costs for the lead product candidate, firmonertinib, increased by **$1.5 million**, driven by higher expenses for the FURVENT Phase 3 clinical trial[115](index=115&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $205.5 million in cash and securities, sufficient for the next year, and secured a new $75 million credit facility - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of **$205.5 million**[118](index=118&type=chunk) - The company believes its existing cash will be sufficient to meet anticipated cash requirements through at least twelve months from the financial statement issuance date[123](index=123&type=chunk) - In May 2025, the company entered into a **$75 million** loan and security agreement with Silicon Valley Bank, with an initial tranche of **$35 million** available at the company's option[120](index=120&type=chunk)[155](index=155&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's exposure to interest rate, foreign currency, and inflation risks is considered not significant - The company believes its exposure to interest rate risk, foreign currency risk, and inflation is **not significant** and has not had a material effect on its results of operations[141](index=141&type=chunk)[142](index=142&type=chunk)[143](index=143&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes in internal controls - Based on an evaluation as of March 31, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were **effective**[145](index=145&type=chunk) - **No changes occurred** during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[146](index=146&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to or aware of any proceedings that it believes will have a **material adverse effect** on its business[147](index=147&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor was added concerning potential cost increases from U.S. tariffs, particularly on imports from China - A new risk factor was added regarding changes in United States trade policy, including recently announced tariffs, which could **materially impact the business** by increasing costs for essential materials[149](index=149&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales occurred, and the planned use of IPO proceeds remains materially unchanged - The company received net proceeds of **$183.2 million** from its initial public offering in January 2024[151](index=151&type=chunk) - There has been **no material change** in the planned use of proceeds from the IPO as described in the prospectus[152](index=152&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information) The company secured a new $75 million loan facility in May 2025 and reported no new director Rule 10b5-1 trading plans - On May 8, 2025, the company secured a Loan and Security Agreement with Silicon Valley Bank for a term loan of up to **$75.0 million**, available in tranches[155](index=155&type=chunk) - **No directors or executive officers** adopted, modified, or terminated a Rule 10b5-1 trading plan during the quarter ended March 31, 2025[160](index=160&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including material contracts and required certifications
ArriVent BioPharma(AVBP) - 2025 Q1 - Quarterly Results
2025-05-12 12:00
[Overview and Recent Highlights](index=1&type=section&id=First%20Quarter%202025%20and%20Recent%20Highlights) ArriVent demonstrated strong Q1 2025 execution by completing pivotal study enrollment, expanding its pipeline, and strengthening its leadership team - The company's lead program, **firmonertinib**, continues to show potential for EGFR-mutant non-small cell lung cancer (NSCLC), while the newly acquired ADC, **ARR-217**, is expected to be the first from its ADC pipeline to enter clinical trials[4](index=4&type=chunk) - Completed enrollment in the global pivotal **Phase 3 FURVENT study** for **firmonertinib monotherapy** in first-line NSCLC with EGFR exon 20 insertion mutations, receiving **FDA Breakthrough Therapy Designation** for this population[5](index=5&type=chunk) - Expanded the pipeline by entering a collaboration with Lepu Biopharma for **ARR-217**, a **CDH17-targeted ADC**, securing exclusive development and commercialization rights worldwide outside of greater China[6](index=6&type=chunk) - The first **IND application** for **ARR-217** was submitted in China in March 2025, with an initial focus on colorectal, pancreatic, and other GI cancers[8](index=8&type=chunk) - Appointed **Merdad Parsey**, M.D., Ph.D., former Chief Medical Officer of Gilead Sciences, to the Board of Directors in April 2025[11](index=11&type=chunk) [Upcoming Milestones](index=3&type=section&id=Upcoming%20Milestones) ArriVent anticipates providing a clinical development plan update for firmonertinib in EGFR PACC mutant NSCLC and expects topline data from the pivotal Phase 3 FURVENT study in 2025 - An update on the development plan for **firmonertinib** in NSCLC patients with **EGFR PACC mutations** is expected in **Q2 2025**, based on maturing data from the FURTHER Phase 1b trial[13](index=13&type=chunk) - **Topline data** from the event-driven global pivotal **FURVENT Phase 3 study** of **firmonertinib** is anticipated in **2025**[13](index=13&type=chunk) [First Quarter 2025 Financial Results](index=3&type=section&id=2025%20Financial%20Results) ArriVent ended Q1 2025 with $205.5 million in cash, projecting funding into H2 2026, while reporting a net loss of $64.4 million, primarily due to a one-time payment and increased clinical expenses Q1 2025 Financial Highlights (vs. Q1 2024, in millions) | Metric | Q1 2025 | Q1 2024 | Change Driver | | :--- | :--- | :--- | :--- | | **Cash, Cash Equivalents & Marketable Securities** | $205.5 | - | Expected to fund operations into H2 2026 | | **Research & Development (R&D) Expenses** | $61.3 | $17.0 | One-time upfront payment to Lepu Biopharma and increased firmonertinib clinical expenses | | **General & Administrative (G&A) Expenses** | $5.5 | $3.7 | Increased costs for operating as a public company | | **Net Loss** | $64.4 | $17.4 | Primarily driven by the increase in R&D expenses | Condensed Balance Sheets (Unaudited, in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $49,865 | $74,293 | | Total current assets | $185,785 | $226,979 | | **Total assets** | **$215,495** | **$274,942** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $12,953 | $17,274 | | **Total liabilities** | **$12,953** | **$17,288** | | **Total stockholders' equity** | **$202,542** | **$257,654** | | **Total liabilities and stockholders' equity** | **$215,495** | **$274,942** | Condensed Statements of Operations (Unaudited, in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $61,289 | $16,975 | | General and administrative | $5,483 | $3,699 | | **Total operating expenses** | **$66,772** | **$20,674** | | Operating loss | ($66,772) | ($20,674) | | Interest and investment income | $2,385 | $3,257 | | **Net loss** | **($64,387)** | **($17,417)** | | **Net loss per share, basic and diluted** | **($1.90)** | **($0.70)** | [Company and Pipeline Overview](index=5&type=section&id=About%20ArriVent) ArriVent is a clinical-stage biopharmaceutical company focused on developing and commercializing differentiated cancer medicines, leveraging its team to advance firmonertinib and a pipeline of novel therapeutics - ArriVent's mission is to identify, develop, and commercialize **differentiated medicines** to address **unmet medical needs in cancer**[15](index=15&type=chunk) - The company's strategy focuses on maximizing the potential of its lead candidate, **firmonertinib**, and advancing a pipeline of novel therapeutics like **next-generation antibody drug conjugates (ADCs)**[15](index=15&type=chunk) [About Firmonertinib and Target Indications](index=5&type=section&id=About%20Firmonertinib) Firmonertinib is an oral, brain-penetrant EGFR inhibitor active against various NSCLC mutations, holding FDA Breakthrough Therapy Designation and addressing significant unmet medical needs - **Firmonertinib** is an oral, highly brain-penetrant, and broadly active mutation-selective **EGFR inhibitor**, effective against both classical and uncommon EGFR mutations like **PACC** and **exon 20 insertions**[16](index=16&type=chunk) - The drug has received **U.S. FDA Breakthrough Therapy Designation** for treating previously untreated locally advanced or metastatic non-squamous NSCLC with **EGFR exon 20 insertion mutations**[17](index=17&type=chunk) - Firmonertinib is currently being studied in a global **Phase 3 trial (FURVENT)** for first-line NSCLC with **EGFR exon 20 mutations** and a global **Phase 1b study (FURTHER)** which includes a cohort for **EGFR PACC mutations**[18](index=18&type=chunk) - Patients with **uncommon EGFR mutations**, such as **exon 20 insertions (~9% of EGFR mutations)** and **PACC mutations (~12% of EGFR mutations)**, have limited treatment options and represent a significant area of **unmet medical need**[19](index=19&type=chunk)[20](index=20&type=chunk)
ArriVent BioPharma Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-12 12:00
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].