Zenas BioPharma (NasdaqGS:ZBIO) 2025 Conference November 18, 2025 06:00 AM ET Company ParticipantsLonnie Moulder - CEOConference Call ParticipantsRoger Song - Senior AnalystRoger SongAll right. Welcome, everyone, to Jefferies London Healthcare Conference 2025. My name is Roger Song, one of the senior analysts covering mid-cap biotech in the U.S. It is my pleasure to introduce our next presenting company, Zenas BioPharma CEO, Lonnie Moulder. We will have a hybrid mode, and Lonnie is going to do some presenta ...

Core Insights - Zenas BioPharma reported significant advancements in its clinical trials, particularly with obexelimab, which showed promising results in treating autoimmune diseases [1][2][3] - The company has secured substantial funding to support its clinical development and commercialization efforts, including a $300 million agreement with Royalty Pharma [1][6] - Zenas is expanding its product pipeline with the acquisition of three new autoimmune product candidates, including orelabrutinib, which is in Phase 3 development for multiple sclerosis [1][3][10] Clinical Trial Updates - The Phase 3 INDIGO trial for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) is set to report topline results around year-end 2025, marking it as the largest clinical trial for this condition to date [1][3] - The Phase 2 MoonStone trial for obexelimab in Relapsing Multiple Sclerosis (RMS) demonstrated a 95% relative reduction in new gadolinium-enhancing lesions compared to placebo, with a p-value of 0.0009 [3][4] - Zenas expects to report 24-week data from the MoonStone trial in the first quarter of 2026 [3] Financial Highlights - As of September 30, 2025, Zenas had cash, cash equivalents, and investments totaling $301.6 million, which, along with recent financing, is expected to fund operations into the fourth quarter of 2026 [7][18] - The company reported a net loss of $51.5 million for the third quarter of 2025, compared to a net loss of $38.6 million for the same period in 2024 [13][17] - Research and development expenses for the quarter were $34.4 million, while general and administrative expenses increased to $13.2 million from $7.5 million year-over-year [7][17] Pipeline Expansion - Zenas has entered into a license agreement for orelabrutinib, a BTK inhibitor, granting global development and commercialization rights outside Greater China and Southeast Asia [3][10] - The company is also advancing two additional product candidates, ZB021 and ZB022, both of which are expected to enter Phase 1 clinical development in 2026 [4][10] Company Overview - Zenas BioPharma is focused on developing transformative therapies for autoimmune diseases, with a strategy that includes acquiring and developing product candidates that offer superior clinical benefits [11] - The company aims to become a leader in the biopharmaceutical industry, leveraging its experienced leadership and disciplined approach to product development [11]

Q3 2025 Financial Results November 5, 2025 Forward Looking Statements This presentation has been prepared by Royalty Pharma plc (the "Company"), is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities. The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this presentation unless stated otherwise, and neither the deliv ...

Core Insights - Zenas BioPharma announced positive results from the Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis (RMS), achieving a 95% relative reduction in new gadolinium-enhancing T1 lesions compared to placebo [1][2][3] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [12] - The company is advancing two late-stage product candidates: obexelimab and orelabrutinib, with obexelimab being the lead candidate [12] Clinical Trial Results - The MoonStone trial enrolled 116 patients and demonstrated a near-complete suppression of new GdE T1 hyperintense lesions by 8 weeks, sustained through week 12 [3][9] - The adjusted mean number of new GdE T1 lesions per scan in the obexelimab group was 0.01 compared to 0.23 in the placebo group [3] - Obexelimab also significantly reduced the cumulative number of new and/or enlarging T2 weighted hyperintense lesions, indicating a reduction in disease burden [3] Future Developments - Zenas plans to report 24-week data from the MoonStone trial in Q1 2026, which will include additional secondary and exploratory endpoints [4] - The company expects to report topline results from the Phase 3 INDIGO trial in IgG4-RD by the end of 2025 and from the Phase 2 SunStone trial in Systemic Lupus Erythematosus by mid-2026 [4] Mechanism of Action - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell activity without depleting them, targeting both CD19 and FcγRIIb [10][12] - This unique mechanism may effectively address the pathogenic role of B cells in chronic autoimmune diseases [10][12] Disease Context - Multiple Sclerosis (MS) is a chronic autoimmune disorder affecting approximately 2.9 million people globally, with RMS being the most common subtype [5][8] - Early intervention with effective therapies is crucial to manage the disease and prevent disability progression [7][8]

Core Viewpoint - The collaboration between Nocera and Zenas marks a significant milestone in the internationalization process of Nocera, accelerating the global development and commercialization of its products, including Obeticholic Acid [1] Group 1: Internationalization and Partnerships - The partnership with Zenas is highlighted as a crucial step in Nocera's international expansion efforts [1] - The collaboration is expected to expedite the development and commercialization of Obeticholic Acid and other pipeline products globally [1] Group 2: Product Development Timeline - Obeticholic Acid is set to initiate Phase III trials for Primary Progressive Multiple Sclerosis (PPMS) in Q3 2025 and for Secondary Progressive Multiple Sclerosis (SPMS) in Q1 2026 [1] - The Phase III registration clinical trial for Obeticholic Acid in Immune Thrombocytopenic Purpura (ITP) in China has completed patient enrollment, with a market application submission expected in the first half of 2026 [1] - Zenas's core pipeline product, Obexelimab, is anticipated to report 12-week primary endpoint data from its Phase II clinical trial in the RMS field in Q4 2025, with 24-week data expected in Q1 2026 [1] Group 3: Product Pipeline and Market Position - Nocera has a comprehensive pipeline in hematological malignancies, autoimmune diseases, and solid tumors, indicating a broad market presence [1] - The core products are expected to drive performance, with ongoing advancements in the hematological, autoimmune, and solid tumor pipelines [1] - The successful business development (BD) of products like Obeticholic Acid is seen as a continuous coverage strategy for the company [1]

Core Insights - Nuo Cheng Jian Hua has signed a global licensing agreement with Zenas BioPharma worth over $2 billion, which includes an upfront payment of up to $100 million and milestone payments [1][2] - Zenas will gain global rights to Nuo Cheng Jian Hua's core product, Obexelimab, in the field of multiple sclerosis, along with rights to new oral IL-17AA/AF inhibitors and oral TYK2 inhibitors [2] - Obexelimab is a highly selective BTK inhibitor with strong CNS penetration, already commercialized since 2021 and included in the national medical insurance directory in 2022 [3] Financial Performance - Nuo Cheng Jian Hua reported a revenue of 731 million yuan in the first half of 2025, a year-on-year increase of 74.3%, with revenue from Obexelimab reaching 637 million yuan, up 52.8% [4] - The company narrowed its net loss to 30 million yuan in the first half of 2025, compared to a loss of 262 million yuan in the same period last year [4] - As of June 30, 2025, Nuo Cheng Jian Hua had cash and cash equivalents totaling 7.7 billion yuan [4]

Core Viewpoint - Zenas BioSciences has entered into a transformative global licensing agreement worth over $2 billion with InnoCare Pharma, acquiring rights to three autoimmune disease drug candidates, including the previously abandoned BTK inhibitor orelabrutinib, indicating a growing trend of collaboration between multinational pharmaceutical companies and Chinese biotech firms [3][5][6]. Group 1: Financial Details - The agreement includes an initial payment of $100 million in cash, with additional milestone payments expected in the following year. Zenas will also issue up to 7 million shares of common stock to InnoCare, contingent on achieving specific milestones by early 2026 [6]. - InnoCare will receive milestone payments throughout the development, registration, and commercialization phases of the three drugs, with the total value of the agreement potentially exceeding $2 billion. Additionally, InnoCare will earn a tiered royalty rate of "high teens" (approximately 15%-19%) on the annual net sales of these drugs [6]. Group 2: Key Drug Candidates - The core asset of the deal is orelabrutinib, an oral BTK inhibitor capable of penetrating the central nervous system, which is crucial for treating multiple sclerosis (MS). This drug was previously licensed to Biogen, which terminated the agreement in early 2023 [8]. - Orelabrutinib is currently approved in China for treating chronic lymphocytic leukemia and mantle cell lymphoma, and it is in Phase III clinical trials globally for primary progressive MS, with plans for a late-stage global trial to start in Q1 2026 [8]. - In addition to orelabrutinib, Zenas has acquired two other drug candidates: obexelimab, a monoclonal antibody targeting B cells for various autoimmune diseases, and an oral IL-17AA/AF inhibitor, along with a brain-penetrating oral TYK2 inhibitor, both of which are still in early development stages [8][9].

协议主要条款 对公司影响与风险 本次协议签署将加快奥布替尼及其他管线产品全球开发和商业化进程，是国际化战略重要里程碑，预计 对未来业绩产生积极影响，不影响业务独立性，不会形成依赖。但新药研发风险高、周期长，本次交易 付款需满足条件，最终金额存在不确定性，投资者需谨慎决策。 来源：新浪财经-鹰眼工作室 market诺诚健华10月9日发布公告称，其全资子公司InnoCare Pharma Inc.与Zenas BioPharma, Inc.签署授 权许可协议，将奥布替尼及2项临床前资产有偿许可给Zenas，使其可开发、生产、商业化或以其他方式 利用该等产品。 交易详情 交易审议与双方情况 2025年10月7日，诺诚健华董事会审议通过本次交易，无需提交股东大会审议。主要许可产品：奥布替 尼是处于后期临床阶段、具潜在同类最佳优势的高中枢神经系统渗透性、选择性、不可逆口服小分子 BTK抑制剂。在多发性硬化症领域已启动相关III期临床试验；在自身免疫疾病领域，免疫性血小板减少 症三期注册临床完成患者入组，系统性红斑狼疮IIb期临床数据预计于2025年第四季度公布；在血液肿 瘤领域，自中国上市以来已取得显著临床认可及市场覆 ...

Core Insights - Royalty Pharma plc (NASDAQ:RPRX) is recognized as one of the best performing biotech stocks in 2025, focusing on biopharmaceutical royalties by investing in innovative drug products and partnering with various entities to fund clinical trials and product launches [1] Financial Performance - In Q2 2025, Royalty Pharma reported a 20% increase in Portfolio Receipts to $727 million and an 11% rise in Royalty Receipts, driven by products such as Trelegy, Evrysdi, and Tremfya [2] - The company updated its full-year 2025 guidance for Portfolio Receipts to a range of $3.05–$3.15 billion, indicating projected growth of 9%–12% [2] Strategic Moves - A significant milestone was the acquisition of RP Management, LLC in May 2025, which streamlined operations and integrated the royalty portfolio with the company's intellectual property assets, enhancing efficiency and strategic flexibility [3] - The firm expanded its oncology presence by acquiring a royalty interest in Amgen's Imdelltra for an upfront payment of $885 million, with potential royalties of up to $65 million [4] - Royalty Pharma also entered a $2 billion funding arrangement with Revolution Medicines, which included $1.25 billion for a synthetic royalty on daraxonasib and a secured senior loan of $750 million [4] Investment Commitments - In September 2025, Royalty Pharma committed up to $300 million to Zenas Biopharma's obexelimab program in exchange for royalties, highlighting its dedication to supporting innovative pipeline products [5]

Summary of Zenas BioPharma FY Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Focus**: Autoimmune diseases, leveraging a business model for successful drug commercialization [2][4] Key Product: Obexelimab - **Mechanism**: Targets CD19-expressing cells, designed to inhibit B-cell response through co-engagement with Fc gamma R2b (CD32b) [3] - **Clinical Trials**: - Completed five studies prior to licensing, including trials for rheumatoid arthritis and systemic lupus erythematosus [3] - Pivotal Phase III trial for IgG4-related disease (IgG4RD) expected to report top-line results by year-end [3][4] - Ongoing global Phase II trials for systemic lupus erythematosus and relapsing multiple sclerosis (MS) [4] Competitive Advantages - **Administration**: At-home subcutaneous administration offers convenience compared to IV infusions, which require scheduling and monitoring [6][7] - **Cost**: Covered under Medicare Part D with a cap of $2,000 annually, contrasting with the high costs associated with IV infusions [7] - **Efficacy**: Continuous dosing may lead to better long-term outcomes by maintaining target engagement and reducing inflammation [8][9] Market Opportunity - **IgG4RD**: Approximately 20,000 diagnosed patients in the U.S., with potential market size of $3 billion [22][23] - **Differentiation**: Expected to outperform existing therapies based on flare rates and continuous target coverage [24][25] Clinical Development Strategy - **Moonstone Study**: Focused on relapsing MS with MRI endpoints; aims to demonstrate efficacy through cumulative endpoints and novel biomarkers [13][14] - **Regulatory Interaction**: Plans to engage with regulatory agencies post-Phase II data [16] Financial Position - **Capital**: $275 million on the balance sheet as of June 30, supplemented by a $75 million deal with Royalty Pharma, with additional milestones tied to Phase III results [4][21] Lupus Development - **Phase II Study**: Previous study showed a 17% effect size over placebo; current trial aims for a more robust design with optimized dosing [32][33] - **Biomarker Approach**: Evaluating gene expression groupings to identify a subset of patients that may respond better to treatment [36][38] Strategic Considerations - **Global Perspective**: The company has a small team in China for clinical trials and actively seeks licensing opportunities from Chinese firms [41] - **AI Utilization**: Currently assessing how to leverage AI while ensuring data protection [42][43] - **Regulatory Environment**: Monitoring changes at the FDA but not experiencing disruptions in current programs [44] Conclusion Zenas BioPharma is positioned to capitalize on significant market opportunities in autoimmune diseases, particularly with its lead product obexelimab. The company is focused on innovative administration methods, robust clinical trial designs, and strategic partnerships to enhance its market presence and drive shareholder value.