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]

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]

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].

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].

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]

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.

Core Insights - ArriVent BioPharma announced promising data from the Phase 1b FURTHER trial for firmonertinib in treating non-small cell lung cancer (NSCLC) with EGFR PACC mutations, highlighting a median progression-free survival (mPFS) of 16.0 months [2][3][6] - The company plans to initiate a pivotal Phase 3 study (ALPACCA) for first-line PACC patients in the second half of 2025 [3][13] Clinical Data Highlights - Firmonertinib demonstrated a median progression-free survival of 16.0 months with a 12.5-month follow-up, and a median duration of response of 14.6 months [6] - The overall response rate (ORR) was 68.2% at the 240 mg dose and 43.5% at the 160 mg dose, with confirmed responses observed in the majority of patients at the first tumor assessment [6] - In patients with CNS evaluable disease, there was a 41% confirmed complete response (CR) and a 53% confirmed overall response rate (ORR) [6] Safety Profile - Firmonertinib maintained a generally well-tolerated safety profile over a longer treatment duration, with the most frequent treatment-related adverse events being diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin [6][5] - The safety profile is consistent with the EGFR-TKI class and previous firmonertinib data [6][5] Development Plans - The company is advancing firmonertinib towards a registration study for EGFR PACC mutant NSCLC, with potential for accelerated approval [3] - The first patient enrollment in the ALPACCA Phase 3 trial is expected in the second half of 2025 [3][13] Company Overview - ArriVent BioPharma is focused on developing innovative biopharmaceutical therapeutics to address unmet medical needs in cancer treatment [7] - Firmonertinib is an oral, highly brain-penetrant EGFR inhibitor effective against both classical and uncommon EGFR mutations, including PACC mutations [8]

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]

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

[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)