Summary of Merus Investor Call Company Overview - Merus is an oncology-focused company with a proprietary technology platform for developing bispecific and multispecific antibodies, including pitocentimab and other clinical assets [6][8][35] - The company received its first FDA approval for BIZENGRI, validating its capabilities in oncology drug development [6] Clinical Data Presentation - The call focused on the phase two interim clinical data of pitocentimab in combination with pembrolizumab for first-line recurrent metastatic head and neck squamous cell carcinoma [2][5] - Data will be presented at the ASCO Annual Meeting on June 2, 2025 [2][5] Key Clinical Findings - **Efficacy of Pitocentimab**: - The overall response rate (ORR) for pitocentimab monotherapy was 36% with a median duration of response of 6.2 months [17] - In combination with pembrolizumab, the ORR was 63% (27 out of 43 patients) with a 95% confidence interval indicating a lower bound of 49% [27] - The median progression-free survival (PFS) was 9 months, significantly higher than historical data for pembrolizumab alone [29] - The 12-month overall survival (OS) rate was 79%, compared to 51% for pembrolizumab monotherapy [30] - **Safety Profile**: - The combination therapy was well tolerated with no significant overlapping toxicities observed [32][26] - The incidence of treatment-emerging adverse events was manageable, with 38% of patients reporting infusion-related reactions [26] Market Opportunity - The head and neck cancer market is estimated to be around $4 billion in 2024, with significant unmet medical needs [37][39] - Merus aims to position pitocentimab as a first and best-in-class treatment option, potentially changing clinical practice [38][39] Regulatory and Development Strategy - Merus is confident in the potential for accelerated approval based on strong ORR and survival data [66] - The company plans to substantially enroll both Phase III registration trials by the end of 2025, with top-line readouts expected in 2026 [42][34] Intellectual Property - Merus holds a robust patent estate covering its platform technologies and clinical assets, ensuring protection for its innovations [35] Additional Insights - The company emphasizes the importance of including both HPV positive and negative patients in clinical trials, with a focus on maintaining a consistent patient population across studies [101][102] - There is a strong belief that the combination of pitocentimab and pembrolizumab could provide a transformative treatment option for patients with recurrent metastatic head and neck cancer [41][42] Conclusion - Merus is advancing its clinical development of pitocentimab with promising efficacy and safety data, aiming to address significant unmet needs in the oncology market, particularly in head and neck cancer [41][43]

"癌症与我们每个人都息息相关。和你们许多人一样，我和吉尔也领悟到，正是那些破碎之处让我们变得最为 坚强。感谢你们用爱与支持帮助我们振作。" 责编：汪云鹏 校对：王朝全 百万用户都在看 证监会重拳出手！3人，被罚没7.5亿元！ 美联储，突爆大消息！ 港股，重大调整！即将实施！ 利好来袭！芯片、特朗普，突传重磅！ 违法和不良信息举报电话：0755-83514034 邮箱：bwb@stcn.com 声明称，虽然这是一种更具侵袭性的癌症，但这种癌症似乎对激素敏感，因此可以进行有效治疗，拜登及其家 人正在与他的医生共同探讨治疗方案。 随后，美国现任总统特朗普在其社交媒体平台"真实社交"上发文表示，他和其妻子对于拜登最近的病情诊断深 感悲痛，并向拜登及其家人致以最温暖和最美好的祝愿。特朗普祝愿拜登早日康复。 拜登出生于1942年，2021年1月至2025年1月担任美国总统。 来源：长安街知事 据环球网报道，美国前总统拜登于19日在社交平台X上发表上述内容，这也是他被诊断患有侵袭性前列腺癌后 首次发声。 当地时间5月18日，根据美国前总统拜登办公室发布的一份声明，拜登被确诊患有恶性前列腺癌，癌细胞已扩 散至骨骼。 ...

Jaguar Health (JAGX) Q1 2025 Earnings Call May 15, 2025 04:15 PM ET Company Participants Lisa Conte - Founder, CEO, President & DirectorCarol Lizak - Chief Financial Officer Operator Greetings, and welcome to Jaguar Health's May fifteen, twenty twenty five Investor Webcast. Before I turn the call over to management, I'd like to remind you that management may look forward looking statements relating to such matters as continued growth prospects for the company, uncertainties regarding market acceptance of pr ...

American Shared Hospital Services (AMS) Q1 2025 Earnings Call May 15, 2025 12:00 PM ET Company Participants Kirin Smith - PresidentRaymond Stachowiak - Executive ChairmanGary Delanois - CEOScott Frech - CFO Conference Call Participants M. Marin - Senior Analyst Operator Good day, and welcome to the American Shared Hospital Services First Quarter twenty twenty five Earnings Conference Call. All participants will be in listen only mode. Note this event is being recorded. I would now like to turn the conferenc ...

Financial Data and Key Metrics Changes - For Q1 2025, total revenue increased by 17% to $6.1 million compared to $5.2 million in Q1 2024 [16] - Adjusted EBITDA for Q1 2025 was $949,000, down from $1.75 million in Q1 2024 due to lower procedure volume [7][20] - Net loss for Q1 2025 was $625,000 or $0.10 per diluted share, compared to net income of $119,000 or $0.02 per diluted share in Q1 2024 [20] Business Line Data and Key Metrics Changes - Revenue from the Direct Patient Services segment was $3.1 million for Q1 2025, a 224% increase from $963,000 in Q1 2024, driven by the Rhode Island acquisition and operations in Puebla, Mexico [16][17] - Revenue from the equipment leasing segment decreased to $3 million from $4.3 million in Q1 2024 [17] - Gamma Knife revenue declined by 18% to $2.1 million, with a 24% decrease in procedures [18] - Proton Beam Radiation Therapy revenue decreased by 38% to $1.6 million, with a 35% decrease in treatment fractions [18] Market Data and Key Metrics Changes - The company has established Gamma Knife centers in Peru and Ecuador, with a new center in Puebla, Mexico, enhancing its international presence [12] - The Rhode Island acquisition represents a significant expansion in the U.S. market, with plans for a fourth radiation therapy center and the first proton beam facility in the state [13][14] Company Strategy and Development Direction - The company is transitioning from a cancer treatment equipment leasing focus to a more patient-centric service model, aiming for long-term profitable growth [6][8] - The acquisition of Rhode Island centers and international expansion are key components of the growth strategy [10][12] - Upcoming projects include a new center in Rhode Island and a joint venture for a Gamma Knife center in Guadalajara, Mexico, which is expected to generate revenue by the end of the year [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential despite short-term fluctuations in treatment volumes [15][28] - The company is optimistic about the impact of staffing strategies and upgraded technology on future treatment volumes and profitability [11][15] - Management does not foresee significant risks from potential changes in Medicaid reimbursement rates, as most revenue comes from private insurers and Medicare [23][24] Other Important Information - The company maintains a strong balance sheet with cash and cash equivalents of $11.5 million as of March 31, 2025 [20] - Shareholders' equity was $24.7 million, reflecting a slight decrease from the previous quarter [20] Q&A Session Summary Question: Impact of lower procedure numbers and potential regulatory changes - Management indicated that changes in Medicaid reimbursement are not expected to significantly impact the company, as most revenue is derived from private insurers and Medicare [23][24] Question: Flexibility in managing fixed costs with new center openings - Management confirmed that expanding the Direct Patient Services segment will provide more control over activities and patient growth, enhancing fixed cost absorption [25]

撰文丨王聪 编辑丨王多鱼 排版丨水成文 CAR-T 细胞疗法 是癌症治疗领域的革命性突破，在白血病等血液类肿瘤中显示出了强大的治疗效果，近 年来还成功治疗了系统性红斑狼疮等多种自身免疫疾病。 然而， CAR-T 细胞疗法 却在临床应用中埋藏着一个意想不到的隐患—— 接受 CAR-T 细胞 治疗的部分患 者出现了记忆力减退、注意力不集中等"脑雾"症状。 2025 年 5 月 12 日，斯坦福大学医学院的研究人员在国际顶尖学术期刊 Cell 上发表了题为： Immunotherapy-related cognitive impairment after CAR T cell therapy in mice 的研究论文。 在此基础上， 短暂耗竭小胶质细胞 或 阻断 CCR3 ，可挽救 CAR-T 细胞治疗后小鼠的少突胶质细胞缺 陷，并在注意力和短期记忆功能的行为测试中恢复其认知表现。 癌症治疗相关认知障碍 （ Cancer therapy-related cognitive impairment，CRCI） 影响着众多癌症幸存 者。化疗等传统癌症疗法常常与一种持续性认知障碍综合征相关联，其特征表现为记忆、注意力、信 ...

Relmada Therapeutics (RLMD) Q1 2025 Earnings Call May 12, 2025 04:30 PM ET Company Participants Brian Ritchie - Managing DirectorSergio Traversa - CEO & Member of Board of DirectorsMaged Shenouda - Chief Financial OfficerUy Ear - Vice PresidentYair Lotan - Professor of Urology & Chief of Urologic OncologyMatthew Barcus - Senior Research Associate Operator Good afternoon. Welcome to Ramada Therapeutics First Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. A ...

UroGen Pharma (URGN) Q1 2025 Earnings Call May 12, 2025 10:00 AM ET Company Participants Vincent Perrone - Senior Director of Investor RelationsLiz Barrett - President & CEOMark Schoenberg - Chief Medical OfficerDavid Lin - Chief Commercial OfficerChris Degnan - CFOKelsey Goodwin - Vice PresidentGeorge Farmer - Managing Director Conference Call Participants Tara Bancroft - Director, Senior Analyst, Biotech Equity ResearchLeland Gershell - MD & Senior Biotechnology AnalystRaghuram Selvaraju - Managing Direct ...

【中金医药】百济神州1Q25业绩总结 公司继续维持全年收入指引和费用指引。 1Q25年收入表现： 1Q25产品净销售额11.09亿美元，YoY+48%，其中泽布替尼全球销售7.92亿美元，YoY+62%。 美国泽布替尼销售5.63亿美元，YoY+60%，欧洲1.16亿美元，YoY+73%，主因泽布替尼在CLL新患者治疗中的份 额不断增加，在美国BTK市场销售额已经处于Top1。 替雷利珠单抗销售1.71亿美元，YoY+18%。 1Q25GAAP净利润127万美元，首次实现季度盈利。 部分关键信息： 1）公司将于6月26日举办投资者研发日，介绍乳腺癌和其他实体瘤管线。 2）泽布替尼在11个市场新增纳入或扩大报销范围，包括日本、欧洲和巴西。 3）泽布替尼新增瑞士公司Siegfried作为原料药供应商。 4）BCL2在中国申报上市，用于治疗R/RCLL。 5）BTKCDAC启动治疗R/RCLL的III期临床（vs医生选择治疗方案）。 6）DLL3/CD3双抗（与安进合作）读出2LSCLCIII期积极数据。 7）CDK4将于1H25读出PoC数据。 美国泽布替尼销售5.63亿美元，YoY+60%，欧洲1.16亿美元， ...

撰文丨王聪 编辑丨王多鱼 排版丨水成文 在 细胞 这个精密运转的"微型城市"中，信使RNA （mRNA） 分子如同快递包裹， 承载着生命活动的核心 指令，将来自 DNA 的遗传信息通过核糖体翻译为蛋白质，以执行生命活动。 N 6 -甲基 腺 苷 （ m 6 A ） 是 mRNA 中最常见的化学修饰 ，其在特定的 mRNA 中富集，并发挥着调节 细胞生长、分化和细胞应激反应的重要作用， m 6 A 是由包含 METTL3 和 METTL14 的异二聚体甲基转 移酶在 mRNA 上合成的。 m 6 A 的主要作用是促进 mRNA 的降解，因此，携带 m 6 A 的 mRNA 通常维 持在较低水平，而这些 mRNA 中的许多编码关键细胞过程的重要调控因子，其上调对于激活各种细胞反应 是必需的。 细胞应激反应依赖于由 m 6 A-mRNA 编码的蛋白质。例如，氨基酸耗竭压力会改变基因表达，以增强资源 的保存、恢复营养水平以及提高抗压能力。这些通路通常利用富含 m 6 A 的 mRNA，这些 mRNA 编码代 谢调控因子、DNA 修复通路蛋白和自噬蛋白。尽管已发现某些 mRNA 的水平在应激期间有所上升，但尚 不清楚这 ...