Zenas BioPharma (NasdaqGS:ZBIO) FY Conference Transcript

Summary of Zenas BioPharma FY Conference Call Company Overview - Company: Zenas BioPharma (NasdaqGS: ZBIO) - Date of Conference: December 03, 2025 Key Accomplishments in 2025 - Completion of patient enrollment in the Phase III trial for obexelimab targeting IgG4-related disease, with last patient out in November [2][5] - Successful enrollment in a lupus study, with results expected in Q3 of the following year [3][5] - Significant results from the MOONSTONE Global Phase II study in relapsing multiple sclerosis (RMS), showing a 95% reduction in new T1 GAD-enhancing lesions compared to placebo [4][5] - Expansion of the pipeline with the acquisition of orelabrutinib, now in Phase III trials for progressive MS [4][5] - Partnership with Royalty Pharma for a potential $300 million financing related to obexelimab [5] Clinical Trials and Data Insights - The MOONSTONE study involved 116 patients and demonstrated a new benchmark for B-cell targeting agents in RMS [3][4] - Upcoming 24-week data from the MOONSTONE study will provide insights into various parameters, including T1 GAD-enhancing lesions and biomarkers [10][11] - Discussion on regulatory pathways for RMS trials, emphasizing the need for evolving endpoints beyond annualized relapse rates [14] Market Opportunities - Estimated 20,000 to 40,000 diagnosed patients in the U.S. for IgG4-related disease, with a potential market size based on competitive drug pricing exceeding $250,000 annually [23][24] - Observations on the competitive landscape, noting the successful launch of a competing drug with sales growth from mid-$20 million to over $40 million in the first two quarters [25] Future Expectations - Anticipation of Phase II SUNSTONE results for lupus, aiming for a significant difference from placebo [26][27] - Plans to integrate findings from the lupus study into the broader rheumatology franchise [27] Differentiation of Products - Obexelimab is positioned as a more flexible treatment option compared to continuous B-cell depleting therapies, with at-home auto-injector capabilities [20][21] - Orelabrutinib is highlighted as a best-in-class BTK inhibitor, with superior brain penetration and potency compared to competitors [28][29] Conclusion - Zenas BioPharma has made significant strides in 2025, with promising clinical trial results and strategic partnerships that position the company for future growth in the biopharmaceutical market. The focus on innovative treatment options and market opportunities in IgG4-related disease and lupus reflects a strong potential for success in upcoming years.