Summary of Nanobiotix Conference Call Company Overview - **Company**: Nanobiotix (NasdaqGS:NBTX) - **Industry**: Healthcare, specifically focused on oncology and CNS disorders through nanophysics-based therapeutics [1][2] Core Points and Arguments Nanobiotix's Unique Approach - Nanobiotix is pioneering nanophysics for healthcare, developing small objects that can trigger physical effects at the cellular level, impacting treatments for oncology and CNS disorders [2][3] - The company has three platforms: one for oncology, one for rethinking drug development, and one for CNS disorders [3] NBTXR3 Program - NBTXR3 is the most advanced program, currently in a Phase 3 study for head and neck cancer, with a partnership with Johnson & Johnson (J&J) [4] - The focus is on early-stage cancer treatment, where the majority of patients have local disease, representing a significant market opportunity [5][6] - NBTXR3 aims to enhance radiation therapy by improving the dose delivered to tumors while minimizing damage to surrounding healthy tissue [6][7] Market Opportunity - Approximately 60% of all cancer patients receive radiation therapy, with significant potential for NBTXR3 to impact around 160,000 patients in the EU5 and US for the initial indications [7][8] - The potential market size for NBTXR3 is estimated between $5 billion and $10 billion based on addressing 20% of the patient population [8] Partnership with J&J - The deal with J&J includes $2.6 billion in milestones and royalties ranging from low teens to low twenties percentage [8] - J&J is responsible for running three trials for NBTXR3, with the aim of broad commercialization [7][8] Clinical Data and Efficacy - In a Phase 1 study, NBTXR3 showed an 81% overall response rate and a 63% complete response rate among treated patients, with a median overall survival of 23 months [17][18] - The ongoing Phase 3 trial aims to improve progression-free survival (PFS) from nine months to 13 months, which could serve as registration data for the FDA [25] Future Directions - J&J has initiated a Phase 1 study for cisplatin-eligible head and neck cancer patients, indicating confidence in expanding the use of NBTXR3 [26] - The company is also exploring the use of NBTXR3 in lung cancer, where radiation therapy is widely used [29][30] Additional Important Content Other Platforms - Nanobiotix is developing Curadigm, a technology aimed at improving the delivery of various therapies by preventing their capture by the liver, thus enhancing systemic distribution [39][40] - The company is positioned to leverage its nanophysics-based approach beyond oncology, indicating potential for significant business development opportunities [39][40] Regulatory and Market Readiness - The transfer of the Phase 3 trial to J&J was completed in September 2025, with expected interim data in H1 2027 [24] - The company anticipates significant revenue from the J&J partnership, with plans for commercialization and recurrent revenue from royalties [38] This summary encapsulates the key points discussed during the Nanobiotix conference call, highlighting the company's innovative approach, market potential, partnership dynamics, and future directions in research and development.

Dianthus Therapeutics Conference Call Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Focus**: Development of therapies for autoimmune diseases, specifically targeting myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) Key Developments Claseprubart (C1s Inhibitor) - **Phase 2 Data**: Positive results for myasthenia gravis with a 300 mg dose every two weeks showing rapid efficacy across five measures [2][3] - **Phase 3 Plans**: Transitioning to phase 3 with both every two-week and every four-week dosing paradigms [3][10] - **Efficacy Comparison**: Anticipated better efficacy than traditional complement inhibitors (C5s) due to its upstream inhibition mechanism [5][6] - **Placebo Response**: Noted a high placebo response in phase 2, which may be mitigated by adjusting screening criteria for future studies [16][17] Financial Position - **Funding**: Recently raised $288 million, resulting in a cash balance of approximately $525 million, providing a runway into 2028 [8] DNTH212 (Bifunctional Fusion Protein) - **Mechanism**: Targets both innate and adaptive immune systems, aiming for infrequent subcutaneous self-administration [9] - **Phase 1 Study**: IND cleared in the U.S. and soon in China, with a single-dose study in healthy volunteers starting imminently [10] Upcoming Catalysts - **Phase 3 for Claseprubart**: Expected to start in 2026, with details to be announced post-FDA alignment [10][40] - **CIDP Interim Analysis**: Results anticipated in the second quarter of 2026, moved up from the second half of the year [10][40] - **MMN Phase 2 Results**: Expected in the second half of 2026 [10][40] Market Positioning and Pricing Strategy - **Pricing Considerations**: Pricing for MG will inform CIDP and MMN pricing strategies, with potential flexibility based on market dynamics [31][32] Competitive Landscape - **Comparison with Competitors**: Dianthus aims to differentiate itself from competitors like Sanofi and Argenx by offering improved dosing and administration [22][30][34] Conclusion - **Strategic Focus**: Dianthus is positioned to leverage its innovative therapies in the autoimmune space, with a strong financial foundation and a clear roadmap for upcoming clinical trials and market entry strategies [40]

Rapport Therapeutics Conference Call Summary Company Overview - **Company**: Rapport Therapeutics - **Focus**: Precision neuroscience, specifically through receptor-associated proteins - **Lead Program**: RAP-219, a TARP8 AMPA modulator targeting focal onset seizures and bipolar mania [4][5] Key Points and Arguments Product Development and Milestones - **RAP-219**: Demonstrated a best-in-class profile in focal onset seizures with a robust efficacy and tolerability profile [5][8] - **Phase Two Results**: Showed over 70% reduction in seizures over an eight-week period, with 24% of patients achieving complete seizure freedom [9][11] - **FDA Meeting**: Scheduled for Q4 2025 to discuss end of phase two results and path forward for pivotal studies in 2026 [18][19] - **Bipolar Mania Study**: Ongoing evaluation of RAP-219 with expected data in 2027 [5][6] Market Opportunity - **Focal Onset Seizures**: Approximately 1.8 million patients in the U.S. with 30-40% being treatment-resistant, representing a $10 billion-$15 billion market [11][12] - **Polypharmacy Management**: RAP-219 aims to provide a novel mechanism of action with better tolerability compared to existing treatments [12][13] - **Long-Acting Injectable (LAI)**: Development underway, expected to be transformational for patients, with potential for once-monthly or quarterly dosing [15][33][34] Safety and Efficacy - **Tolerability Profile**: RAP-219 showed no severe adverse events, with most being mild or moderate, even among patients on multiple background anti-seizure medications [9][10] - **Long Half-Life**: RAP-219 has a half-life of over 18 days, which may help prevent breakthrough seizures if doses are missed [13][28] Future Data and Expectations - **Upcoming Data Releases**: Full trial results from phase two and open-label extension study expected in 2026 [6][27] - **Phase Three Design**: Standard design anticipated, focusing on seizure reduction and responder analysis [20][21] - **Bipolar Program Read-Through**: Positive implications for RAP-219's efficacy in treating acute mania due to its mechanism targeting glutamate pathways [37][38] Additional Important Insights - **Market Research**: Indicated that RAP-219 will be utilized by both epileptologists and general neurologists across various treatment lines [14] - **Patient Population**: Phase two study included heavily treated patients, suggesting robust efficacy in difficult-to-treat populations [24] - **Regulatory Strategy**: Ongoing discussions with the FDA to align on NDA submission requirements [19][36] This summary encapsulates the critical aspects of Rapport Therapeutics' conference call, highlighting the company's strategic direction, product development, market potential, and future expectations.

人力资源社会保障部近日印发通知，确定了北京、天津、唐山等39个人力资源服务业与制造业融合发展 试点城市。这些城市有何特点？开展试点的重点任务是什么？记者采访了人力资源社会保障部人力资源 流动管理司负责人。 人力资源服务业作为现代生产性服务业重要门类，发挥着促进高质量充分就业、加强人力资源开发利 用、助力现代化产业体系建设的积极作用。 新华社北京11月14日电 题：推进人力资源服务业与制造业融合发展，39个城市开展试点 新华社记者张晓洁 下一步，人力资源社会保障部将指导有关省级人力资源社会保障部门和试点城市进一步修改完善试点工 作方案。及时梳理工作进展、机制创新、典型案例以及困难问题，形成可复制可推广的有效经验和典型 项目。对融合发展新业态、新模式实施包容审慎监管，依法打击虚假招聘、就业歧视、泄露个人信息等 违法违规行为，维护劳动者和用人单位合法权益。 上述负责人说，试点城市制造业年产值规模体量大、吸纳就业能力强，是所在省份制造业发展较快或代 表性较强的城市，产业领域涉及智能制造等重点领域，招聘用人需求旺盛。同时，人力资源服务骨干企 业集聚，业态模式丰富，服务能力突出。 试点城市将聚焦制造业重点领域，结合当地产 ...

Group 1 - The core viewpoint of the articles highlights the strengthening of economic and technological cooperation between Vietnam and South Korea, particularly following the elevation of their relationship to a comprehensive strategic partnership in 2022 [1][2] - The bilateral trade volume reached $57.7 billion in the first eight months of 2025, marking a 7.3% year-on-year increase, with South Korea being Vietnam's third-largest trade partner [1] - South Korea remains the leading investor in Vietnam with approximately $94.2 billion in registered capital across 10,301 effective projects as of September 2025 [1] Group 2 - Both countries agreed to enhance collaboration in sectors such as semiconductors, AI, and renewable energy, and to establish joint R&D plans and technology transfer initiatives [2] - From 2026 to 2030, priority projects will focus on transportation infrastructure, urban development, and high-tech infrastructure, with an emphasis on sharing experiences and information [2] - Vietnam aims to leverage South Korea's expertise in infrastructure and high-tech manufacturing to support its goal of becoming a high-income developed country by 2045 [2]

人力资源社会保障部近日印发通知，确定了北京、天津、唐山等39个人力资源服务业与制造业融 合发展试点城市。这些城市有何特点？开展试点的重点任务是什么？记者采访了人力资源社会保障部人 力资源流动管理司负责人。 人力资源服务业作为现代生产性服务业重要门类，发挥着促进高质量充分就业、加强人力资源开发 利用、助力现代化产业体系建设的积极作用。 近年来，我国人力资源服务业实现长足发展。截至2024年底，全国各类人力资源服务机构7.4万 家，从业人员109万人。"十四五"时期，全行业年均为3亿人次劳动者提供就业、择业和流动服务，为 5000余万家次用人单位提供专业支持。在服务制造业等实体经济过程中，形成了一批适应制造企业招 聘用工需求的人力资源服务产品、模式和解决方案。 据介绍，试点城市基本覆盖我国经济大市和制造业重点区域，普遍具备较大规模的制造业特别是先 进制造业集群、比较发达的人力资源服务业基础、丰富的教育人才资源、较强的区域示范带动作用等条 件。 上述负责人说，试点城市制造业年产值规模体量大、吸纳就业能力强，是所在省份制造业发展较快 或代表性较强的城市，产业领域涉及智能制造等重点领域，招聘用人需求旺盛。同时，人力资源 ...

近年来，我国人力资源服务业实现长足发展。截至2024年底，全国各类人力资源服务机构7.4万家，从 业人员109万人。"十四五"时期，全行业年均为3亿人次劳动者提供就业、择业和流动服务，为5000余万 家次用人单位提供专业支持。在服务制造业等实体经济过程中，形成了一批适应制造企业招聘用工需求 的人力资源服务产品、模式和解决方案。 "试点城市将聚焦智能制造、电子信息、新材料、新能源、生物技术等制造业重点领域，差异化探索产 业升级与就业促进高效协同的创新路径，助力破解制约制造业发展的人力资源要素供给短板，提升制造 业人力资源开发利用水平。"上述负责人说。 新华财经北京11月14日电（记者张晓洁）人力资源社会保障部近日印发通知，确定了北京、天津、唐山 等39个人力资源服务业与制造业融合发展试点城市。这些城市有何特点？开展试点的重点任务是什么？ 记者采访了人力资源社会保障部人力资源流动管理司负责人。 试点城市将聚焦制造业重点领域，结合当地产业基础、资源禀赋和特色优势，确定1到3个细分行业作为 试点方向，开展差异化探索。充分发挥企业主体作用，重点选择制造业链主企业、制造业单项冠军企 业、专精特新中小企业和人力资源服务骨干 ...

Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash balance of $14.3 million and raised an additional $1.2 million since the quarter end, providing a runway through 2026 [23] - The net loss for Q3 2025 was $2.9 million, or $0.65 per share, compared to a net loss of $1.8 million, or $0.46 per share, for Q3 2024 [23] - For the nine months ended September 30, 2025, the net loss was $9.9 million, or $2.39 per share, compared to $8.3 million, or $2.24 per share for the same period in 2024 [23] Business Line Data and Key Metrics Changes - The ongoing trial of agenT-797, an allo off-the-shelf iNKT cell therapy, showed a median overall survival of approximately 23 months in patients with relapsed or refractory solid tumors when combined with PD-1 therapies [4] - Observations included complete remission in a patient with metastatic testicular cancer and durable partial responses in other difficult-to-treat cancers, demonstrating the potential of agenT-797 to restore immune function [5][6] Market Data and Key Metrics Changes - The company has established a strategic partnership with the University of Wisconsin Carbone Cancer Center to advance the iNKT program in immune reconstitution following stem cell transplantation [10] - The company is preparing for a global phase II trial in acute pulmonary dysfunction with multi-drug resistant infections, targeting a patient demographic that mirrors U.S. demographics [12] Company Strategy and Development Direction - MiNK Therapeutics is focused on advancing its iNKT Cell Therapy platform and has become the most clinically advanced company in developing allogeneic iNKT cells [8] - The company aims to redefine immune recovery in various conditions, including cancer, infection, critical illness, and transplantation, through innovative partnerships and disciplined capital use [9][22] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of building public-private partnerships and emphasized the potential of iNKT cells to transform treatment in critical illness and transplantation [9][22] - The company expects to have multiple clinical programs actively enrolling patients by this time next year, with early readouts emerging from GVHD and pulmonary cohorts [28] Other Important Information - The company executed an at-the-market sales agreement, leveraging a significant increase in equity price to access cash while limiting dilution to shareholders [26] - The leadership team has been strengthened with the onboarding of Dr. John Holcomb and Dr. Therese Hammond, enhancing the company's clinical and operational capabilities [25] Q&A Session Summary Question: Expansion of the combination therapy cohort - Management indicated plans to expand the cohort for the combination therapy with PD-1, with a focus on patients who have failed prior PD-1 therapy, and will announce an expanded cohort moving into a phase two study [33][34] Question: Timing for the severe pulmonary disease trial - The company is in the activation phase and aims to dose the first patient by early next year, with efforts to initiate patient enrollment imminently [38] Question: Details on GVHD and pulmonary inflammation trials - Management provided insights into the GVHD trial, emphasizing endpoints such as GVHD presence or absence and the potential for significant improvements in patient outcomes [44][46] - For the pulmonary disease trial, the primary endpoint will be 28-day mortality, with a focus on patients with severe pneumonia and hypoxemic respiratory failure [51]

智通财经APP获悉，11月14日，中国证监会公布《境外发行上市备案补充材料要求((2025年11月10日— 2025年11月14日)》。中国证监会国际司公示10家企业补充材料要求，其中，公示提到要求英派药业补 充说明历次增资及股权转让定价依据、设立以来是否存在股份代持的情形等事项。据港交所9月26日披 露，南京英派药业股份有限公司向港交所主板递交上市申请，高盛、中金为联席保荐人。 中国证监会请英派药业补充说明以下事项，请律师核查并出具明确的法律意见： 四、关于本次发行上市及"全流通"：（1）请公司对照《监管规则适用指引——境外发行上市类第2号》 要求说明本次发行方案；（2）请说明本次拟参与"全流通"股东所持股份是否存在被质押、冻结或其他 权利瑕疵的情形。 英派药业成立于2009年，是一家处于商业化阶段的生物技术公司，专注于基于合成致死机制的精准抗癌 疗法的全球开发。公司建立了全面且先进的合成致死产品组合，是全球仅有三家同时拥有商业化阶段 PARP1/2抑制剂和临床阶段新一代PARP1选择性抑制剂的公司之一。 公司的核心产品塞纳帕利是一种PARP1/2抑制剂，已于2025年1月在中国获批用于卵巢癌"全人群"一线 ...

四、关于本次发行上市及"全流通"：(1)请公司对照《监管规则适用指引——境外发行上市类第2号》要 求说明本次发行方案；(2)请说明本次拟参与"全流通"股东所持股份是否存在被质押、冻结或其他权利 瑕疵的情形。 一、关于股权变动：(1)请说明公司历次增资及股权转让定价依据，是否实缴出资，是否存在未履行出 资义务、抽逃出资、出资方式存在瑕疵的情形，并就历次股权变动是否合法合规出具明确结论性意见； (2)请说明公司3家境外子公司涉及的境外投资、外汇登记等监管程序具体履行情况，并就合规性出具结 论性意见；(3)请说明公司设立以来是否存在股份代持的情形。 二、请说明公司持股5%以上的股东向上穿透后的境内主体是否存在法律法规规定禁止持股的主体。 三、请公司结合药物研发技术路线等情况说明公司及下属公司经营范围、实际业务经营是否涉及"人体 干细胞、基因诊断与治疗技术开发和应用"或其他外商投资准入限制或禁止领域及相关判断依据，本次 发行上市前后是否持续符合外商投资准入政策要求。 11月14日，中国证监会公布《境外发行上市备案补充材料要求((2025年11月10日—2025年11月14日)》。 中国证监会国际司公示10家企业补充材 ...