PresentationGood morning, everyone. Welcome to the Zenas Biopharma Conference Call. [Operator Instructions] Be advised that this call is being recorded at the company's request, and a replay will be available in the Investors section of the company's website following the call.Jennifer FoxChief Business Officer & CFO Thank you, operator, and thank you all for joining us to discuss the top line results of our registrational Phase III INDIGO trial for obexelimab for the treatment of immunoglobulin G4-related ...

Summary of Zenas BioPharma Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Event**: Jefferies London Healthcare Conference 2025 - **Date**: November 18, 2025 Key Points Industry and Pipeline Developments - Zenas BioPharma has expanded its pipeline significantly with new molecules, including obexelimab and rilzabrutinib [2][3] - Obexelimab is concluding a phase three trial in IgG4-related disease, with top-line results expected by the end of the year [3][7] - The company is also advancing a lupus program with 70% enrollment and plans to report a 24-week top-line endpoint in 2026 [3][4] Obexelimab Details - Obexelimab is a novel B cell inhibitor that co-engages CD19 and Fc gamma R2b (CD32b), leading to profound B cell inhibition [4][5] - The phase three trial for IgG4-related disease has shown a dramatic improvement in the IgG4-RI responder index, with a low flare rate of approximately 10% expected compared to a placebo flare rate of 60% [5][7][31] - The trial design is validated by the successful launch of Amgen's OPLISNA, which had a strong market performance [6][7] Market Opportunity - The U.S. market opportunity for IgG4-related disease is estimated at over $3 billion, targeting approximately 30,000-40,000 patients [9][10] - A recent market study indicated a 45% share for obexelimab compared to competitors OPLISNA and rituximab, suggesting strong market potential [10] Rilzabrutinib Insights - Rilzabrutinib is positioned as a best-in-class BTK inhibitor, with a focus on progressive multiple sclerosis (PPMS and SPMS) [11][12] - The drug has shown a 90% reduction in lesions in early studies, with a phase three program already initiated for PPMS [15][24] - The pharmacological profile of rilzabrutinib is highlighted as superior, with a CNS concentration IC90 ratio significantly higher than competitors [14][36] Clinical Trial Design and Strategy - The phase two study for obexelimab in relapsing multiple sclerosis (RMS) demonstrated a 95% risk reduction, setting a new benchmark for B cell targeting [11][19] - The company is optimistic about the transition from RMS to IgG4-related disease, leveraging insights from previous trials to optimize dosing regimens [18][19] - The phase three trial for IgG4-RD is considered overpowered with 194 patients enrolled, compared to 135 in the successful MITIGATE trial [26][31] Future Outlook - Zenas BioPharma anticipates significant milestones in 2026, including results from the IgG4-RD trial and further developments in the lupus program [16][38] - The company is confident in its ability to execute trial designs agreed upon with regulatory agencies, enhancing its position in the competitive landscape of MS treatments [37][36] Additional Considerations - The company is focused on patient preferences for at-home subcutaneous administration, which may lead to better patient compliance and lower costs compared to IV infusions [9][10] - The competitive landscape for BTK inhibitors is evolving, with several companies advancing their products in the MS space, indicating a growing market [35][36] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting Zenas BioPharma's strategic direction and market positioning.