Summary of Zenas BioPharma Conference Call Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Focus**: Development of obexelimab for the treatment of immunoglobulin G4-related disease (IgG4-RD) Key Industry Insights - **Disease Prevalence**: Estimated diagnosed prevalence of IgG4-RD in the U.S. is around 20,000 patients, with total prevalence (including undiagnosed) potentially reaching 40,000. Similar global prevalence is suggested [doc id='9'] - **Market Opportunity**: The market opportunity for IgG4-RD treatment is approximately $3 billion in the U.S. and $2 billion in Europe, with over half of diagnosed patients experiencing frequent flares [doc id='17'] Core Findings from INDIGO Trial - **Trial Results**: The INDIGO trial met its primary endpoint, showing a 56% reduction in the risk of IgG4-RD flare compared to placebo, with a hazard ratio of 0.443 and a p-value of 0.0005 [doc id='12'] - **Secondary Endpoints**: All four key secondary endpoints were met, including time to first flare and the proportion of patients achieving complete remission [doc id='13'] - **Safety Profile**: Obexelimab demonstrated a compelling safety and tolerability profile, with lower incidences of serious adverse events and infections compared to placebo [doc id='15] Treatment Advantages - **Mechanism of Action**: Obexelimab's unique inhibitory mechanism targets B-cells without depleting them, which may provide advantages over existing therapies like Uplizna [doc id='16'] - **Administration**: The drug is administered subcutaneously at home, aligning with patient preferences and reducing the need for infusion center visits [doc id='16'] - **Cost-Effectiveness**: The at-home administration model may lead to lower out-of-pocket costs for patients compared to high-priced infused therapies [doc id='17'] Future Plans - **Regulatory Submissions**: Plans to submit a Biologics License Application (BLA) to the U.S. FDA in Q2 and a marketing authorization application to the European Medicines Agency in the second half of the year [doc id='6'] - **Pipeline Expansion**: Zenas is advancing multiple candidates, including orelabrutinib and ZBO21, into clinical trials, aiming to establish a strong portfolio in autoimmune diseases [doc id='19'] Market Dynamics - **Underdiagnosis**: IgG4-RD is currently underdiagnosed, and the approval of obexelimab could enhance disease recognition and treatment [doc id='18'] - **Competitive Landscape**: The efficacy and safety profile of obexelimab positions it as a potential first-line therapy, especially for older patients who may not tolerate B-cell depletion [doc id='24'] Additional Insights - **KOL Feedback**: Key opinion leaders expressed enthusiasm for obexelimab's efficacy and safety, viewing it as a strong candidate for first-line treatment [doc id='23'] - **Payer Discussions**: Preliminary conversations with payers indicate a favorable view of obexelimab's risk-benefit profile, especially in comparison to existing therapies [doc id='49'] Conclusion - **Transformational Year**: 2025 was highlighted as a transformational year for Zenas, with the INDIGO results expected to drive momentum into 2026 and beyond [doc id='18']