Summary of ADC Therapeutics Conference Call Company Overview - **Company**: ADC Therapeutics - **Industry**: Biotechnology, specifically focused on antibody-drug conjugates (ADCs) - **Lead Product**: ZYNLONTA (anti-CD19 ADC) approved for third-line treatment of diffuse large B-cell lymphoma (DLBCL) as a monotherapy [2][3] Core Points and Arguments - **Market Opportunity**: ADC Therapeutics estimates a peak sales opportunity for ZYNLONTA between $600 million to $1 billion, driven by ongoing clinical trials and a favorable competitive landscape [4][3] - **Clinical Trials**: - LOTIS-5: Phase 3 study combining ZYNLONTA with rituximab in second-line DLBCL, with data expected by the end of the year [5][15] - LOTIS-7: Phase 2 study combining ZYNLONTA with Roche's glofitamab, showing promising early results with a 93% overall response rate and 87% complete response rate in initial patients [25][27] - **Competitive Landscape**: The company believes that the DLBCL market is less competitive than perceived, with only 20% of patients receiving CAR-T therapy due to accessibility issues, leaving a significant opportunity for ZYNLONTA [7][9] Important Data Points - **LOTIS-5 Expectations**: Aiming for a progression-free survival (PFS) benefit of approximately 6 months over the current standard of care, with a complete response (CR) rate target of 40-50% [16][19] - **LOTIS-7 Results**: The combination therapy has shown a favorable safety profile with no new safety signals and a lower incidence of neutropenia compared to historical data [28][30] - **Indolent Lymphomas**: Ongoing studies in high-grade follicular and marginal zone lymphoma show promising early results, with a 97% overall response rate and 77% complete response rate in follicular lymphoma [42][43] Financial Position - **Cash Position**: ADC Therapeutics ended Q2 with $265 million in cash, providing a runway into 2028 [54] - **Upcoming Catalysts**: Expected revenue opportunities from potential approvals and guideline inclusions for LOTIS-5 and LOTIS-7 by the first half of 2027 [54] Additional Insights - **Regulatory Engagement**: The company is actively engaging with the FDA and plans to submit data for LOTIS-5, aiming for a swift transition from data readout to submission [24][36] - **Partnership with Roche**: Roche is a key partner in the LOTIS-7 study, providing clinical drug supply and regulatory insights [37][38] - **Market Dynamics**: The company highlights that the DLBCL market is evolving, with a significant portion of patients still lacking effective treatment options, positioning ZYNLONTA as a potential new standard of care [10][12] This summary encapsulates the key points discussed during the conference call, focusing on ADC Therapeutics' strategic direction, clinical trial progress, market opportunities, and financial health.

Core Viewpoint - Heng Rui Medicine has shown strong performance in the stock market, with significant price increases and new clinical trial approvals for innovative drugs [1] Group 1: Stock Performance - Heng Rui Medicine (600276.SH) saw a peak increase of 6.61% to 73.42 CNY, marking a new high since June 16, 2021, with a year-to-date increase of approximately 60% [1] - Heng Rui Medicine (1276.HK) rose by 8.14% to 87.05 HKD, approaching a historical closing high, with a trading volume of 1 billion HKD and a market capitalization of 577.8 billion HKD [1] - Since its listing on the Hong Kong Stock Exchange on May 23, the stock price has increased by 97.62% from the issue price of 44.05 HKD [1] Group 2: Drug Approvals - The company announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for clinical trials of SHR-A2009, an antibody-drug conjugate targeting HER3, which has no similar drugs approved globally [1] - Additionally, the company received approval for clinical trials of HRS-7172 tablets, a new type of small molecule inhibitor for cancer treatment, with no similar drugs approved domestically or internationally [1]

Core Viewpoint - Heng Rui Medicine (600276)(01276) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-A2009, which will commence shortly [1] Group 1: Product Development - SHR-A2009 is an antibody-drug conjugate targeting HER3, specifically binding to HER3 on the surface of tumor cells [1] - The drug is designed to be internalized by the tumor cells and transported to lysosomes, where it releases free toxins to kill the cancer cells [1] - No similar drugs have been approved for market globally, indicating a potential first-mover advantage for the company [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-A2009, a novel antibody-drug conjugate targeting HER3 [1] Company Summary - SHR-A2009 is designed to specifically bind to HER3 on the surface of tumor cells, leading to internalization and subsequent release of cytotoxic agents within lysosomes to kill cancer cells [1] - This drug is notable as there are currently no similar drugs approved for market globally [1]

Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of SHR-A2009, an antibody-drug conjugate targeting HER3, aimed at treating advanced solid tumors [1] Group 1 - The clinical trial will focus on the safety, tolerability, and efficacy of SHR-A2009 in combination with anti-tumor therapy in patients with advanced solid tumors [1] - SHR-A2009 specifically binds to HER3 on the surface of tumor cells, leading to internalization and subsequent release of cytotoxic agents within lysosomes to kill cancer cells [1]

智通财经APP讯，恒瑞医药(600276.SH)公告，公司子公司苏州盛迪亚生物医药有限公司收到国家药品 监督管理局核准签发关于注射用SHR-A2009的《药物临床试验批准通知书》，将于近期开展注射用 SHR-A2009联合抗肿瘤治疗在晚期实体瘤患者中的安全性、耐受性及有效性的开放、多中心ⅠB/Ⅱ期临 床研究。 关于该药物的情况，注射用SHR-A2009是一款以HER3为靶点的抗体药物偶联物，可特异性结合肿瘤细 胞表面上的HER3，进而被内吞至细胞内并转运至溶酶体中，水解释放游离毒素，杀伤肿瘤细胞。 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of two drugs, SHR-A2102 and Adebali monoclonal antibody injection, indicating progress in its oncology pipeline [1] Group 1: Drug Development - The company’s subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has been authorized to conduct clinical trials for SHR-A2102, a targeted antibody-drug conjugate (ADC) that specifically targets Nectin-4, which is associated with tumor progression and poor prognosis [1] - SHR-A2102 contains a topoisomerase I inhibitor as its effective payload, highlighting its potential in cancer treatment [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody developed by the company, has already been approved for use in combination with carboplatin and etoposide for first-line treatment of extensive-stage small cell lung cancer [1] Group 2: Market Position - The approval of Adebali monoclonal antibody injection in March 2023 marks a significant milestone for the company, enhancing its position in the oncology market [1] - The company is actively expanding its oncology portfolio, which may lead to increased market share and revenue growth in the future [1]

Core Insights - NextCure reported significant advancements in its research and development activities, particularly with the licensing deal for SIM0505 and progress in clinical trials for LNCB74, despite a substantial miss in profitability for Q2 2025 [1][5][11] Financial Performance - GAAP net loss per share was $(11.29), significantly higher than the analyst expectation of $(4.62), marking a 70.8% increase year-over-year from $(6.61) [2][7] - GAAP net loss totaled $26.8 million, up from $15.4 million a year earlier, primarily due to a one-time $17.0 million license fee [1][7] - Research and development expenses reached $24.1 million, a 94.4% increase compared to $12.4 million in Q2 2024 [2][7] - General and administrative expenses decreased to $3.2 million from $4.1 million year-over-year, a reduction of 22.0% [2][7] - Cash, cash equivalents, and marketable securities stood at $35.3 million as of June 30, 2025, down 48.5% from $68.6 million at the end of 2024 [2][11] Product Pipeline and Development - LNCB74, the lead program, is a B7-H4 antibody-drug conjugate currently in early-stage clinical trials, with proof-of-concept results expected in the first half of 2026 [3][10] - SIM0505, another ADC targeting cadherin-6, has entered early-stage clinical testing in the U.S., with plans to treat the first patient in the next quarter [4][6] - The company is also developing other oncology candidates, including NC410 and NC525, as well as preclinical assets for Alzheimer's and bone diseases [9][10] Strategic Initiatives - NextCure's strategy focuses on advancing its pipeline through clinical development and forming targeted partnerships, including acquiring global rights to SIM0505 [4][6] - The company aims to align resources with high-impact programs and is seeking collaboration partners for its clinical candidates [4][10] Future Outlook - Management indicated that the available financial resources should sustain operations into mid-2026, with no new formal financial guidance provided for future quarters [11][12] - Investors are expected to monitor clinical enrollment pace, data release timing, and partnership developments to extend NextCure's cash runway [12]

Financial Data and Key Metrics Changes - Research and development (R&D) expenses decreased to $13.7 million for Q2 2025 from $16.2 million in Q2 2024, a reduction of $2.5 million primarily due to workforce reduction and program prioritization [11][12] - General and administrative (G&A) expenses were $5 million for Q2 2025, down from $5.8 million in Q2 2024, reflecting lower stock-based compensation and headcount-related expenses [12] - Net loss for Q2 2025 was $18.7 million compared to a net loss of $21.1 million in Q2 2024, indicating improved financial performance [12] - Cash and cash equivalents as of June 30, 2025, were $18.2 million, down from $49 million as of December 31, 2024, highlighting a significant cash burn [13] Business Line Data and Key Metrics Changes - The dual conditionally binding EpCAM CD3 T cell engager BA-3182 is showing promising results in its Phase 1 dose escalation study, with evidence of objective tumor reductions in patients with various solid tumors [5][6] - The CABWAR2 ADC OSV demonstrated an overall response rate (ORR) of 45% in patients with metastatic HPV-positive head and neck cancer, significantly outperforming the standard of care [8] - The McVe ADC has shown exceptional overall survival rates among heavily pretreated patients with MKRAS non-small cell lung cancer, with one-year and two-year landmark survival rates of 67% and 59%, respectively [9] Market Data and Key Metrics Changes - The company is focusing on indications with high unmet needs, such as colorectal cancer and cholangiocarcinoma, which have shown high expression of EpCAM and limited available therapies [18][19] - The company is progressing with partnering discussions across its CAB portfolio, indicating a strategic focus on collaboration for development and commercialization [10] Company Strategy and Development Direction - The company plans to present its strategy to NASDAQ to regain compliance with listing requirements, indicating a proactive approach to maintain its market position [10] - The company is positioning its OSV asset for a planned Phase III study and is seeking FDA guidance, reflecting a commitment to advancing its clinical pipeline [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in closing one or more partnering transactions this year, which could enhance financial stability and support key clinical activities [14][25] - The company is managing cash resources carefully and expects quarterly cash burn to decrease as it completes Phase II clinical trials [13][14] Other Important Information - The company has completed due diligence for one of its assets and is at the term sheet stage for a potential partnership, indicating progress in its strategic initiatives [10][11] Q&A Session Summary Question: Regarding the expansion cohort study, which indication is being pursued? - Management indicated that colorectal cancer is particularly attractive due to high EpCAM expression and unmet needs, although no formal decision has been made yet [18] Question: What are the tumor reduction levels for patients in the colorectal cancer cohort? - Management confirmed three patients with colorectal cancer have shown tumor reductions of -6%, -8%, and -10%, with additional patients in other cohorts also showing reductions [20] Question: Will there be updates on dosing cohorts? - Management stated that updates will be provided later this year, potentially during the ESMO meeting in October [22]

Core Viewpoint - Huadong Medicine (000963) announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of HDM2012, a novel antibody-drug conjugate targeting Mucin17 (MUC-17) [1] Company Summary - HDM2012 is an innovative antibody-drug conjugate (ADC) developed independently by Huadong Medicine, consisting of an anti-MUC-17 monoclonal antibody linked to a topoisomerase I inhibitor via a cleavable linker, with a drug-antibody ratio (DAR) of 8 [1] - The product is a first-in-class biological product globally, with Huadong Medicine holding worldwide intellectual property rights [1] - HDM2012 specifically targets MUC-17 positive tumor surface antigens, facilitating internalization into tumor cells and releasing cytotoxic agents to exert anti-tumor effects [1] - Preclinical studies indicate that HDM2012 demonstrates good drug-like properties, safety, and efficacy [1]