Summary of Zenas BioPharma Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Event**: Guggenheim Emerging Outlook Biotech Summit 2026 - **Date**: February 11, 2026 Key Points on IgG4-RD and Obexelimab - **Pipeline Focus**: The primary focus is on obexelimab and its application in IgG4-related disease (IgG4-RD) [2][3] - **INDIGO Phase 3 Study Results**: - Reported a **56% risk reduction** in time to disease flare with a hazard ratio of **0.4** [3] - Approximately **75% of patients** were free from flares, indicating strong efficacy [3] - In the open-label extension, **92% of evaluable patients** remained flare-free at six months [4] - **Safety Profile**: - Serious adverse events were comparable to placebo, with no significant increase in infections [4][5] - The subcutaneous administration showed similar injection site reactions to placebo, enhancing its safety profile [5] Market Research Insights - **Market Research Study**: Conducted with **80 participants**, primarily rheumatologists and gastroenterologists [6] - **Prescribing Likelihood**: - **64%** of physicians indicated they would likely prescribe obexelimab [8] - Expected market share allocation: **47%** for obexelimab, with the remainder split between Uplizna and rituximab [8] - **Patient Population Insights**: - Physicians reported treating an average of **18 patients** per year with IgG4-RD [6] - The drug is seen as suitable for older patients or those with concurrent illnesses [9] Commercialization Strategy - **Market Opportunity**: Estimated market size for IgG4-RD treatment in the U.S. is between **$3-$4 billion**, with expectations for obexelimab to exceed **$1 billion** in sales [41][42] - **Patient Population**: Approximately **20,000 diagnosed patients** in the U.S. currently, with potential for growth through increased education and diagnosis [40] - **Launch Timeline**: - BLA filing expected in **Q2 2026** for the U.S. and in the second half of the year for Europe [56] - Initial launch will feature prefilled syringes, followed by an autoinjector within a year [56] Lupus Program Insights - **Sunstone Study**: - Results expected in **Q4 2026**, focusing on the **BICLA primary endpoint** [62] - Emphasis on strict screening criteria to ensure a pure patient population for accurate results [65] - **Biomarker Program**: A gene pattern identified in **30% of lupus patients** may indicate higher responsiveness to treatment [80] BTK Inhibitor Insights - **Orelibrutinib**: Positioned as a potent option for progressive MS, with ongoing trials to demonstrate its efficacy [90] - **Comparison with Competitors**: Fenebrutinib showed promising results compared to Ocrevus, indicating a competitive landscape for BTK inhibitors [88] Future Developments - **New Molecules**: - TYK2 and IL-17 oral molecules are set to enter clinical trials soon, with promising characteristics noted [95][97] - **Rapid Development**: The IL-17 molecule is expected to move quickly through clinical phases, with outcomes anticipated by the end of the year [97] Conclusion - Zenas BioPharma is positioned to capitalize on its robust pipeline, particularly with obexelimab for IgG4-RD, and is preparing for significant market entry and expansion in the coming years. The company is also actively pursuing additional indications, including lupus and progressive MS, with a focus on safety and efficacy in patient populations.