Zenas BioPharma (NasdaqGS:ZBIO) 2026 Conference Transcript

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.