Zenas BioPharma (ZBIO) Conference Transcript

Summary of Zenas BioPharma (ZBIO) Conference Call Company Overview - Company: Zenas BioPharma (Ticker: ZBIO) - Focus: Autoimmune diseases, with a lead program on obexelimab, a novel monoclonal antibody targeting CD19 and CD32B [4][5] Key Programs and Developments - Obexelimab: - In-licensed from Xencor, designed to inhibit B-cell lineage cells, impacting antibody production and cytokine production [4][5] - Completed five clinical trials prior to Zenas acquiring it, including studies in rheumatoid arthritis and systemic lupus erythematosus [5] - Phase three results for IgG4-related disease expected by the end of 2025 [6][18] - Ongoing phase two global program for relapsing multiple sclerosis (RMS) with results expected early in Q4 2025 [6][42] Financial Position - Cash Position: Approximately $275 million as of June 30, 2025 [6] - Strategic Collaboration: Announced a $300 million funding deal with Royalty Pharma, with $225 million allocated for the IgG4-related disease program [6][10] Market Opportunity - IgG4-Related Disease: - Estimated diagnosed population of 20,000 in the U.S., with a potential market opportunity of around $3 billion [20][21] - Current treatment options are limited to corticosteroids, which are not well tolerated [14][15] - Obexelimab offers a subcutaneous self-administration option, reducing economic burden for patients [20] Clinical Trial Design and Expectations - IgG4RD Study Design: - Primary endpoint is time to disease flare, with a focus on reducing flare rates compared to placebo [15][16] - Previous studies showed a 60% flare rate for placebo and a single-digit flare rate for obexelimab [16][17] - RMS Study Design: - Phase two trial with MRI readout as the primary endpoint, focusing on cumulative new GAD-enhancing lesions [44][45] - Aims to assess neurodegeneration and disability progression, with a potential for a pivotal registration program [46] Competitive Differentiation - Mechanism of Action: - Obexelimab inhibits B cells rather than depleting them, allowing for a more controlled treatment approach [18][31] - Subcutaneous administration is more convenient compared to infusion therapies [19][20] - Safety Profile: - Well-tolerated with a potential for pausing treatment to allow for vaccination, addressing concerns raised during the pandemic [31][32] Future Plans - Lupus Program: - Phase two data expected mid-2026, with a focus on proper study design and patient selection to ensure robust results [56][60] - Potential to incorporate biomarker analysis into future studies [61][70] - BLA Process: - Initiated for IgG4-related disease, with a smaller scale compared to larger registration programs [78][79] Conclusion - Zenas BioPharma is positioned to make significant advancements in the treatment of autoimmune diseases with its lead program, obexelimab, backed by a strong financial position and strategic collaborations. The upcoming clinical trial results will be critical in validating its efficacy and market potential.