Core Viewpoint - InnoCare Pharma Inc. has entered into an exclusive licensing and subscription agreement with Zenas BioPharma, granting Zenas rights to develop, manufacture, and commercialize certain products, including the BTK inhibitor Orelabrutinib for multiple sclerosis and other preclinical assets [1][2]. Group 1: Licensing Agreement Details - The agreement allows Zenas exclusive rights to develop and commercialize Orelabrutinib for multiple sclerosis globally, while InnoCare retains rights in oncology and certain regions for non-oncology applications [1]. - Zenas will pay InnoCare up to $100 million in upfront and milestone payments, along with issuing up to 7 million shares of Zenas common stock [2]. - The total potential value of the transaction exceeds $2 billion, including tiered royalties based on annual net sales of the licensed products [2]. Group 2: Product Development and Clinical Trials - Orelabrutinib is a late-stage clinical candidate with potential best-in-class advantages, currently undergoing Phase III trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [3]. - InnoCare has completed patient enrollment for a Phase III trial for immune thrombocytopenia (ITP) and plans to submit a new drug application in mid-2026 [3]. - Zenas aims to lead in the development and commercialization of transformative therapies for autoimmune diseases, leveraging an experienced leadership team and a robust product pipeline [3].

Core Viewpoint - InnoCare Pharma Inc. has entered into an exclusive licensing and subscription agreement with Zenas BioPharma, granting Zenas rights to develop, manufacture, and commercialize certain products, including the BTK inhibitor Orelabrutinib for multiple sclerosis and other indications outside of oncology in specified regions [1][2]. Group 1: Licensing Agreement Details - The agreement includes an upfront payment of up to $100 million and milestone payments, with a potential total value exceeding $2 billion [2]. - Zenas will also issue up to 7 million shares of common stock to InnoCare, contingent upon reaching specific milestones [2]. - InnoCare retains full rights in the oncology field globally and non-oncology rights in Greater China and Southeast Asia [1]. Group 2: Product Development and Clinical Trials - Orelabrutinib is a late-stage, orally administered BTK inhibitor with potential best-in-class advantages, currently in Phase III trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [3]. - The Phase III trial for PPMS is set to start in Q3 2025, with the SPMS trial expected to begin in Q1 2026 [3]. - InnoCare has completed patient enrollment for a Phase III trial targeting immune thrombocytopenia (ITP) in China and plans to submit a new drug application in H1 2026 [3].

Core Viewpoint - InnoCare Pharma Inc., a wholly-owned subsidiary of the company, has entered into an exclusive licensing and subscription agreement with Zenas BioPharma, Inc. for the development, production, and commercialization of certain products, including the BTK inhibitor, Orelabrutinib, in multiple sclerosis and other indications [1][2] Group 1 - The licensing agreement grants Zenas exclusive rights to develop, produce, and commercialize Orelabrutinib in the global multiple sclerosis field and in non-oncology indications outside Greater China and Southeast Asia [1] - The company retains full rights in the global oncology field and rights in non-oncology indications within Greater China and Southeast Asia [1] - The agreement also covers two preclinical assets, with one being an oral IL-17AA/AF inhibitor and the other an oral brain-penetrant TYK2 inhibitor, with specific regional rights outlined [1] Group 2 - Zenas will pay InnoCare up to $100 million in upfront and milestone payments, including expected milestones to be reached by 2026, and will issue up to 7 million shares of Zenas common stock [2] - The total potential value of the transaction exceeds $2 billion, including development, regulatory, and commercial milestone payments [2] - The company is entitled to receive tiered royalties of up to the high teens percentage on the annual net sales of the licensed products [2]

Core Insights - Zenas BioPharma has entered a transformative license agreement with InnoCare Pharma for the global development and commercialization rights to orelabrutinib, a highly selective oral BTK inhibitor for Multiple Sclerosis (MS) [1][4][12] - Orelabrutinib is currently in Phase 3 trials for Primary Progressive MS (PPMS) and is expected to begin trials for Secondary Progressive MS (SPMS) in Q1 2026 [2][21] - Zenas has also secured rights to two additional promising molecules: an oral IL-17AA/AF inhibitor and a TYK2 inhibitor, both expected to enter Phase 1 trials in 2026 [1][4][9] Company Developments - Zenas announced a private placement financing of approximately $120 million to support its operations and clinical development [1][13][16] - The license agreement includes upfront and milestone payments to InnoCare totaling up to $100 million in cash and up to 7 million shares of Zenas common stock, with total potential payments exceeding $2 billion [10][11] - Zenas aims to leverage this collaboration to enhance its position as a fully integrated biopharmaceutical company focused on autoimmune diseases [4][5] Clinical Trials and Pipeline - The Phase 3 trial for PPMS has been initiated, while the SPMS trial is set to start in early 2026 [2][21] - Orelabrutinib has shown significant efficacy in previous Phase 2 trials for Relapsing-Remitting MS (RRMS), demonstrating sustained reductions in inflammatory activity [3][21] - Zenas is also advancing obexelimab, which is concluding Phase 3 development for IgG4-RD, and expects to report key trial results in late 2025 and early 2026 [6][8] Market Potential - Orelabrutinib is positioned as a potential blockbuster treatment for progressive forms of MS, addressing a significant unmet medical need [4][5] - The collaboration with InnoCare is expected to enhance Zenas's capabilities in drug development and commercialization, particularly in the global market for autoimmune therapeutics [5][6] Financial Overview - The private placement is expected to provide sufficient funds to support Zenas's operations into Q4 2026, with additional potential funding from milestone payments [16][14] - Zenas's strategic focus on developing a balanced portfolio of therapies aims to maximize clinical and commercial potential across multiple therapeutic areas [6][10]

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.

Summary of Zenas BioPharma (ZBIO) 2025 Conference Call Company Overview - Zenas BioPharma is a development stage oncology company focused on autoimmune diseases, particularly with its molecule obexelimab, which is completing a global Phase 3 trial for IgG4-related disease (IgG4RD) with top-line results expected by year-end [2][22] - The company is also conducting two global Phase 2 programs: one for relapsing multiple sclerosis, with results expected in early Q4, and another for systemic lupus erythematosus (SLE), with results anticipated mid-next year [2][3] Financial Position - As of June 30, Zenas had approximately $275 million in cash, bolstered by a $300 million deal with Royalty Pharma, which extends the company's financial runway beyond the Phase 3 readout for IgG4RD [4][6] - The deal allocates $225 million specifically for the obexelimab program and IgG4RD, with additional milestones possible after Phase 3 data [4][6] Market Opportunity - The current diagnosed patient population for IgG4RD is about 20,000, with expectations that it could grow to 35,000-40,000 with a new drug on the market [8] - The company believes that the market opportunity for IgG4RD is larger than consensus estimates, which could lead to higher returns for investors [6][8] Product Differentiation - Obexelimab is engineered to target B cells differently than existing therapies, such as anti-CD20 antibodies, by removing certain aspects of the antibody that lead to B cell depletion [9][10] - The drug is designed for chronic administration, allowing for continuous inhibition of B cells, which may prevent disease flares more effectively than current therapies [15][16] - The administration method is subcutaneous and self-contained, which is expected to be more convenient for patients compared to intravenous infusions [31][32] Clinical Data and Efficacy - The Phase 3 INDIGO study for IgG4RD is the largest ever conducted for this indication, with over 190 patients enrolled [26] - The primary endpoint is the disease flare rate, with expectations based on Phase 2 data indicating a flare rate of about 10% for obexelimab compared to over 50% for the control [27][28] - The company aims to demonstrate a significant reduction in corticosteroid use and overall toxicity through its treatment regimen [28] Competitive Landscape - The anti-CD20 antibody market is substantial, accounting for nearly 60% of the market with over $10 billion in sales [37] - Zenas aims to differentiate obexelimab by addressing the ongoing disability progression in multiple sclerosis, which is not adequately managed by current therapies [44] Future Milestones - Upcoming data from the Phase 2 study for relapsing multiple sclerosis is expected soon, which will inform future development strategies [39] - The company is also exploring the potential for obexelimab in SLE, leveraging previous clinical data to support its efficacy [48] Conclusion - Zenas BioPharma is positioned to capitalize on significant market opportunities with its innovative product obexelimab, backed by strong financial support and a clear clinical development strategy aimed at addressing unmet needs in autoimmune diseases [2][4][6]

Summary of Zenas BioPharma (ZBIO) Conference Call Company Overview - **Company**: Zenas BioPharma (Ticker: ZBIO) - **Focus**: Autoimmune diseases, with a lead program on obexelimab, a novel monoclonal antibody targeting CD19 and CD32B [4][5] Key Programs and Developments - **Obexelimab**: - In-licensed from Xencor, designed to inhibit B-cell lineage cells, impacting antibody production and cytokine production [4][5] - Completed five clinical trials prior to Zenas acquiring it, including studies in rheumatoid arthritis and systemic lupus erythematosus [5] - Phase three results for IgG4-related disease expected by the end of 2025 [6][18] - Ongoing phase two global program for relapsing multiple sclerosis (RMS) with results expected early in Q4 2025 [6][42] Financial Position - **Cash Position**: Approximately $275 million as of June 30, 2025 [6] - **Strategic Collaboration**: Announced a $300 million funding deal with Royalty Pharma, with $225 million allocated for the IgG4-related disease program [6][10] Market Opportunity - **IgG4-Related Disease**: - Estimated diagnosed population of 20,000 in the U.S., with a potential market opportunity of around $3 billion [20][21] - Current treatment options are limited to corticosteroids, which are not well tolerated [14][15] - Obexelimab offers a subcutaneous self-administration option, reducing economic burden for patients [20] Clinical Trial Design and Expectations - **IgG4RD Study Design**: - Primary endpoint is time to disease flare, with a focus on reducing flare rates compared to placebo [15][16] - Previous studies showed a 60% flare rate for placebo and a single-digit flare rate for obexelimab [16][17] - **RMS Study Design**: - Phase two trial with MRI readout as the primary endpoint, focusing on cumulative new GAD-enhancing lesions [44][45] - Aims to assess neurodegeneration and disability progression, with a potential for a pivotal registration program [46] Competitive Differentiation - **Mechanism of Action**: - Obexelimab inhibits B cells rather than depleting them, allowing for a more controlled treatment approach [18][31] - Subcutaneous administration is more convenient compared to infusion therapies [19][20] - **Safety Profile**: - Well-tolerated with a potential for pausing treatment to allow for vaccination, addressing concerns raised during the pandemic [31][32] Future Plans - **Lupus Program**: - Phase two data expected mid-2026, with a focus on proper study design and patient selection to ensure robust results [56][60] - Potential to incorporate biomarker analysis into future studies [61][70] - **BLA Process**: - Initiated for IgG4-related disease, with a smaller scale compared to larger registration programs [78][79] Conclusion - Zenas BioPharma is positioned to make significant advancements in the treatment of autoimmune diseases with its lead program, obexelimab, backed by a strong financial position and strategic collaborations. The upcoming clinical trial results will be critical in validating its efficacy and market potential.

Core Insights - Royalty Pharma plc will provide up to $300 million in funding to Zenas BioPharma, in exchange for a royalty on sales of obexelimab, targeting autoimmune diseases such as IgG4-RD [1][2][3] Company Overview - Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation in the biopharmaceutical industry, collaborating with various innovators [8] - Zenas BioPharma is a clinical-stage biopharmaceutical company focused on developing transformative therapies for autoimmune diseases, with obexelimab as its lead product candidate [9] Product Development - Obexelimab is an investigational bifunctional monoclonal antibody designed to inhibit B cell function, currently in Phase 3 development for IgG4-RD and Phase 2 for Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus [2][5][7] - The funding will support the development of obexelimab and a potential commercial launch for IgG4-RD in the first half of 2027, pending FDA approval [2][3][6] Financial Terms - The agreement includes an upfront payment of $75 million, with three additional payments of $75 million each contingent on specific milestones related to clinical trials and FDA approvals [3][6] - Royalty Pharma will receive a 5.5% royalty on worldwide net sales of obexelimab by Zenas and its affiliates [3]

Core Insights - Zenas BioPharma and Royalty Pharma have entered into a partnership where Royalty Pharma will provide up to $300 million in funding for the development and potential commercialization of obexelimab, a treatment for IgG4-Related Disease [1][2][3] Funding and Financial Terms - The agreement includes an initial payment of $75 million, with three additional payments of $75 million each contingent upon specific milestones: success in the Phase 3 INDIGO trial, FDA approval for IgG4-RD, and FDA approval for Systemic Lupus Erythematosus [3] - Royalty Pharma will receive a 5.5% royalty on worldwide net sales of obexelimab by Zenas and its affiliates [3] Product Development and Clinical Trials - Obexelimab is currently in Phase 3 development for IgG4-RD and Phase 2 development for Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus [2][5][7] - The topline results from the pivotal Phase 3 trial for IgG4-RD are expected around the end of 2025, with a potential commercial launch in the first half of 2027, pending FDA approval [2][6] Mechanism of Action - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell function by binding to CD19 and FcγRIIb, which are present across B cell lineage, without depleting them [5][8] Company Background - Zenas BioPharma is a clinical-stage biopharmaceutical company focused on developing therapies for autoimmune diseases, with obexelimab as its lead product candidate [8] - Royalty Pharma is a leading funder of innovation in the biopharmaceutical industry, known for acquiring royalties and co-funding late-stage clinical trials [9]

Company Overview - Zenas BioPharma, Inc. is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [2] - The company's lead product candidate, obexelimab, is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb to inhibit the activity of B cells involved in autoimmune diseases without depleting them [2] - Zenas aims to leverage its experienced leadership and disciplined product acquisition strategy to identify and develop candidates that provide superior clinical benefits for patients [2] Upcoming Events - Zenas will present at the Citi's 2025 Biopharma Back to School Conference on September 2, 2025, at 1:00 p.m. ET [3] - The company will also participate in the Cantor Global Healthcare Conference 2025 on September 3, 2025, at 8:35 a.m. ET [3] - Additionally, Zenas is scheduled to present at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 10, 2025, at 7:45 a.m. ET [3]