Molecular Partners (MOLN) FY 2025 Conference May 20, 2025 03:30 PM ET Speaker0 Good afternoon, and thanks for tuning into the HCW, BioConnect conference. I'm Robert Burns, the managing director and senior biotech analyst at HC Wainwright. And I'm joined by Seth Lewis, head of IR for MyPlay Partners. Seth, thank you for joining us today. Speaker1 Really appreciate the invite. Glad to be here. Awesome. So for Speaker0 those who might be unfamiliar with the company, its pipeline, as well as the Platts thing? S ...

Summary of ALX Oncology Holdings (ALXO) Conference Call Company Overview - **Company**: ALX Oncology Holdings (ALXO) - **Focus**: Development of ALX2004, a differentiated antibody-drug conjugate (ADC) targeting EGFR Key Points and Arguments Industry and Product Development - **ADC Focus**: ALX2004 is designed to maximize therapeutic window and overcome historical toxicity challenges associated with EGFR-targeted ADCs [5][6][10] - **Clinical Pipeline**: The company is advancing its ADC in combination with anti-cancer antibodies, specifically targeting breast and colorectal cancers [4][5] - **IND Clearance**: ALX2004 has received Investigational New Drug (IND) clearance, with plans to launch a Phase I trial in mid-2025 [5][7] Scientific Rationale - **Payload and Linker Design**: ALX2004 utilizes a proprietary topoisomerase one inhibitor payload, designed to minimize off-target toxicity while maximizing tumor cell killing [17][20] - **Immunogenic Cell Death**: The payload triggers immunogenic cell death, potentially enhancing long-term tumor control through adaptive immune response [18][28] - **Optimized Antibody**: The antibody component is designed to block EGFR signaling and bind to a unique epitope, potentially overcoming resistance to existing therapies [30][32] Clinical Development Plans - **Phase I Study**: The study will focus on four tumor types: head and neck squamous cell carcinoma, colorectal cancer, non-small cell lung cancer, and esophageal squamous cell carcinoma, targeting patients with relapsed or refractory disease [40][41] - **Safety and Efficacy Goals**: Initial safety data is expected in the first half of 2026, with an emphasis on establishing a recommended dosing schema [42][43] Competitive Landscape - **Market Positioning**: ALX Oncology aims to be a leader in the ADC space targeting EGFR, which currently lacks an approved drug [43][85] - **Comparison with Competitors**: The company is aware of other ADCs in development, such as MRG003, but believes its optimized design gives it a competitive edge [85] Additional Important Insights - **Preclinical Data**: Robust preclinical data supports the efficacy and safety profile of ALX2004, with encouraging results in various tumor models [14][34] - **Toxicity Management**: The design aims to avoid common toxicities seen in previous EGFR-targeted ADCs, such as skin toxicity and interstitial lung disease [14][72] - **Funding and Capital Allocation**: The company has sufficient cash to fund its ongoing studies into 2024, with plans to explore additional capital options as needed [51][52] This summary encapsulates the critical aspects of ALX Oncology's conference call, highlighting the company's strategic focus on developing ALX2004 and its potential impact on the oncology market.

Core Insights - Merck and Daiichi Sankyo have initiated the phase III IDeate-Esophageal01 study for the B7-H3 directed ADC, ifinatamab deruxtecan (I-DXd), targeting advanced or metastatic esophageal squamous cell carcinoma (ESCC) patients [1][2] - The study aims to compare the safety and efficacy of I-DXd against an investigator's choice of chemotherapy in patients who have progressed after platinum-based therapy and immune checkpoint inhibitors [2] - The primary endpoint is overall survival, with secondary endpoints including progression-free survival and objective response rate [3] Company Developments - Merck's stock has decreased by 22.3% year-to-date, while the industry has seen a decline of 5.2% [6] - Merck acquired global co-development and co-commercialization rights for I-DXd and two other ADCs from Daiichi Sankyo for a potential total of up to $22 billion, retaining exclusive rights for Daiichi in Japan [8] - Merck has expanded its collaboration with Daiichi to co-develop MK-6070, a T-cell engager targeting DLL3, following its acquisition of Harpoon Therapeutics [9] Industry Context - ADCs are viewed as a disruptive innovation in the pharmaceutical industry, enhancing cancer treatment by using antibodies to deliver cytotoxic drugs directly to tumors [11] - Daiichi Sankyo is developing several ADCs across various cancer types, including Enhertu, which is marketed in partnership with AstraZeneca [12] - Pfizer has entered the ADC market by acquiring Seagen for $43 billion, adding three ADCs to its portfolio that have significantly contributed to its revenues in 2024 [13][14]

Core Insights - ALX Oncology is advancing ALX2004, a potential best- and first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, designed to maximize therapeutic efficacy while minimizing toxicity [1][2] - The U.S. FDA has cleared the IND application for ALX2004, with clinical studies set to begin in mid-2025 and initial safety data expected in the first half of 2026 [1][6] - The company plans to initiate trials for its lead therapy, evorpacept, in breast and colorectal cancers around the same time, with significant milestones anticipated in 2026 [1] ALX2004 Development Overview - ALX2004 is developed using a proprietary linker-payload platform, featuring an affinity-tuned EGFR antibody and a stable linker-Top1i payload, aimed at enhancing anti-tumor activity and reducing toxicity [3][4] - Preclinical data indicates that ALX2004 has superior stability and a favorable safety profile compared to other ADCs, showing dose-dependent activity across various tumors and EGFR expression levels [5] Clinical Trial Plans - The Phase 1 clinical trial for ALX2004 will target EGFR-expressing solid tumors, including non-small cell lung cancer and colorectal cancer, focusing on patients with relapsed or refractory cancers [6] - The trial is expected to begin in mid-2025, with initial safety data anticipated in the first half of 2026 [1][6]

拐点已现，积极配置 ——CXO 2024&2025Q1业绩综述 行业评级：看好 2025年05月14日 | 分析师 | 郭双喜 | 王帅 | | --- | --- | --- | | 邮箱 | guoshuangxi@stocke.com.cn | wangshuai@stocke.com.cn | | 电话 | 19801116960 | 13548094491 | | 证书编号 | S1230521110002 | S1230523060003 | 1 1、股价复盘： 2、财务分析： ➢ 本土：业绩、订单&AI是主线。 2024.12.31至2025.04.30，医疗研发外包指数上涨0.82%，跑赢医药生物（申 万）指数0.64pct，其中药明生物（+31.55%） 、药明合联（+23.65%） 、泓博医药（+16.11%） 、凯莱英 （+7.77%）、药明康德（+7.50%）表现较好。 95% ➢ 海外：业绩分化，CDMO更强劲。2024.12.31至2025.04.30，Lonza及LABCORP领涨。从指引看跨国CXO公 司只有Lonza对CDMO业务（胶囊与健康原料CHI以外业务）2025年指引 ...

医药 本周医药板块上涨 1.27%，百济 BTK PROTAC 启动头对头 3 期临 床 证券研究报告 | 行业周报 2025 年 05 月 19 日 | 股票 | 股票 | 投资 | EPS （元） | | PE | | | --- | --- | --- | --- | --- | --- | --- | | 代码 | 名称 | 评级 | 2025E | 2026E | 2025E | 2026E | | 002755.SZ | 奥赛康 | 买入 | 0.2 | 0.28 | 87.7 | 62.64 | | 01952.HK | 云顶新耀 | 买入 | -0.94 | 0.58 | - | - | | 600079.SH | 人福医药 | 增持 | 1.59 | 1.86 | 12.83 | 10.97 | | 688192.SH | 迪哲医药 | 增持 | -1.33 | -0.08 | - | - | | 688315.SH | 诺禾致源 | 买入 | 0.53 | 0.62 | 26.51 | 22.66 | | 688321.SH | 微芯生物 | 增持 | 0.05 | 0.23 | 349. ...

Group 1 - The core point of the article is that CSP301, a novel EGFR antibody-drug conjugate developed by the company, has received its third Fast Track designation from the FDA for treating advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) patients without EGFR mutations or other driver gene alterations who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [1][2] - CPO301 has previously received two Fast Track designations from the FDA, the first in June 2023 for treating EGFR-mutant metastatic NSCLC patients who have relapsed or are refractory after EGFR-targeted therapy, and the second in September 2024 for treating recurrent or metastatic squamous NSCLC patients with EGFR overexpression who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [1][2] - Lung cancer is the most prevalent and deadliest cancer globally, with approximately 2.5 million new cases and 1.8 million deaths annually, driven by activated EGFR gene mutations and overexpression of the EGFR protein [2] Group 2 - CPO301's Fast Track designations are based on encouraging clinical efficacy data, indicating its potential for greater activity compared to existing NSCLC and other cancer treatment options [2] - CPO301 is a humanized monoclonal antibody optimized from cetuximab and conjugated with topoisomerase I inhibitors, currently undergoing clinical studies in both China and the United States [2] - The Fast Track designation from the FDA will facilitate the development and registration process of CPO301 in the U.S. and globally [2]

交银国际研究 | 科伦博泰生物 | | 6990 HK | | --- | --- | --- | | 中国领先的 | ADC 平台，管线价值集中兑现、关键 | 评级: 买入 | | 拐点已至，首予买入 | | | | 收盘价: 港元 321.20 | 目标价: 港元 400.00 | 潜在涨幅: +24.5% | | 丁政宁 | Ethan.Ding@bocomgroup.com | | 中国首屈一指的 ADC 平台和管线：自 2016 年成立后，公司：1）建立了涵 盖 ADC、大分子药物、小分子靶向药的三大技术平台；2）基于三大平台， 打造了一条约 20 个分子的药物管线，包括至少 11 个 ADC 及 I/O + ADC 联用 机会；3）与默沙东就 ADC 资产多次达成合作交易，总交易对价超百亿美元、 目前正合作推进 6 个分子的全球研发。 核心品种芦康沙妥珠差异化优势明显：芦康沙妥珠对比另两款已上市同靶同 机制竞品，在分子设计和临床数据上有明显优势。中国以外，默沙东正快速 推进约 14 项 III 期研究，涵盖多种存在巨大未满足治疗需求的瘤种。我们预 计芦康沙妥珠中国内地和海外销售峰值将分别超过 50 ...

后续产品线迭代加速，进入价值兑现黄金期：除芦康沙妥珠外，2024 年底/2025 年初还获批了PD-L1 和 西妥昔单抗，同时HER2 ADC 已进入上市审评，多年的研发创新努力逐步开花结果。后续管线中，肿 瘤领域正逐步形成I/O + ADC 的综合治疗矩阵，非肿瘤领域布局多个病患群体大、治疗手段有限的适应 症赛道。公司整体正处于从生物科技企业向综合性生物医药平台进化的关键拐点，并可能在两年后迎来 经营层面的盈亏平衡。因此我们认为，当前是投资公司、与公司共享价值成长的黄金时点。 研究员：丁政宁/诸葛乐懿 首次覆盖，给予买入评级：我们预计芦康沙妥珠等产品上市后将推动公司收入快速增长，2025-27 年分 别达到20.4 亿/30.0 亿/43.0 亿元人民币，对应45% CAGR，其中产品销售收入的CAGR 达到82%。基于 DCF 估值模型，我们得到公司目标价400 港元，对应5.0 倍收入达峰时的市销率及25%的潜在升幅，未 来12 个月重点关注产品销售放量、博度曲妥珠审批进展和芦康沙妥珠更多III 期临床数据读出。首次覆 盖，给予买入评级。 机构：交银国际 中国首屈一指的ADC 平台和管线：自2016 年 ...

Core Viewpoint - InnoCare Pharma reported strong financial performance in Q1 2025, with significant revenue growth and a shift to profitability, driven by the sales ramp-up of its key product, orelabrutinib [1][5]. Financial Performance - Q1 2025 revenue reached Rmb381 million, representing a 130% year-over-year increase, while net profit was Rmb18 million, a turnaround from net losses of Rmb142 million in Q1 2024 [1]. - Sales of orelabrutinib amounted to Rmb311 million, reflecting an 89% year-over-year growth [1]. - R&D expenses were Rmb208 million, up 17% year-over-year, and selling expenses reached Rmb114 million, increasing by 27% year-over-year, with the selling expense ratio decreasing by 24.1 percentage points to 30% [1]. - Gross profit margin improved by 5.2 percentage points to 90.5% due to enhanced production efficiency and contributions from business development revenue [1]. - As of March 2025, the company had a cash balance of approximately Rmb7.8 billion [1]. Product Development and Sales Outlook - The sales target for orelabrutinib has been raised from over 30% year-over-year to over 35% year-over-year for 2025, supported by the addition of three indications into the National Reimbursement Drug List (NRDL) and recent NMPA approval for first-line CLL/SLL [1]. - Orelabrutinib is currently undergoing phase III trials for immune thrombocytopenic purpura (ITP) in China, with a new drug application (NDA) expected in the first half of 2026, and phase IIb trials for systemic lupus erythematosus (SLE) with data readouts anticipated in Q4 2025 [1]. Other Product Developments - The Biologics License Application (BLA) for tafasitamab for relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) was accepted by the NMPA, with approval expected in 2025 [2]. - ICP-248 (BCL-2) is in phase III trials in combination with orelabrutinib for first-line CLL/SLL, and has received breakthrough therapy designation (BTD) from the CDE for r/r mantle cell lymphoma (MCL) [2]. - The company is actively developing pipelines for autoimmune diseases, including phase III trials for atopic dermatitis (AD) and psoriasis, and has pre-clinical assets targeting IL-17 [3]. ADC Product Development - The company filed an Investigational New Drug (IND) application for its first antibody-drug conjugate (ADC) product, ICP-B794 (B7-H3 ADC), which has shown promising therapeutic effects and safety in preclinical studies [4]. Investment Outlook - The EPS forecast has been adjusted from -Rmb0.21 to -Rmb0.19 for 2025, from -Rmb0.06 to -Rmb0.05 for 2026, and a forecast of Rmb0.16 for 2027 [5]. - The target price has been raised from HK$10.0 to HK$11.8, indicating a 25% upside potential, and the company maintains a BUY rating [5].