Summary of Zenas BioPharma Conference Call - October 08, 2025 Company Overview - **Company**: Zenas BioPharma (NasdaqGS: ZBIO) - **Industry**: Biopharmaceuticals, focusing on autoimmune diseases and multiple sclerosis Key Points Collaboration with Innocare Pharma - Zenas BioPharma announced a transformational global collaboration with Innocare Pharma, a fully integrated biopharmaceutical company [6][8] - The collaboration includes an upfront payment of $35 million in cash and 5 million shares of Zenas common stock [6] - Additional payments of $25 million and 2 million shares will be made upon the first patient treated in the Phase III study for secondary progressive multiple sclerosis (SPMS) [7] Pipeline and Product Candidates - Zenas has a differentiated pipeline with potential best-in-class molecules targeting autoimmune diseases, including relabrutinib for multiple sclerosis [6][8] - The company aims to launch three best-in-class franchise molecules across five indications in three therapeutic areas by 2031 [55] - The pipeline includes: - **Arelobrutinib**: A BTK inhibitor in Phase III trials for primary progressive multiple sclerosis (PPMS) and SPMS [10][25] - **Abexolumab**: Focused on IgG4-related disease, with Phase III results expected by year-end [33][55] - **ZB021**: An oral IL-17 targeting small molecule expected to enter clinical trials in 2026 [31] - **ZB022**: A brain-penetrant TYK2 inhibitor also anticipated to enter clinical trials in 2026 [31] Market Opportunity - The market for progressive multiple sclerosis is estimated at approximately $12 billion in potential peak sales in the U.S. alone [27][29] - The global multiple sclerosis market is projected to exceed $30 billion by 2030, with progressive forms representing over 40% of that market [29] Clinical Data and Efficacy - Arelobrutinib has shown promise in addressing disability progression in progressive MS patients, with a unique mechanism of action targeting both peripheral and central nervous system inflammation [12][28] - The Phase II trial for arelobrutinib demonstrated a greater than 90% reduction in new lesions compared to placebo [21] - The safety profile of arelobrutinib is consistent with other BTK inhibitors, with treatment emergent adverse events observed in 53% of the population [23] Regulatory Path and Future Trials - Phase III protocols for both PPMS and SPMS have been cleared by the FDA and EMA, with the first site for the PPMS study initiated in the U.S. [25][29] - The company is focused on regulatory alignment and is prepared to adapt to evolving regulatory endpoints for relapsing MS [90] Financial Position and Strategy - Zenas BioPharma has completed major financings and significantly advanced its pipeline, positioning itself as a fully integrated commercial-stage biopharmaceutical company [55] - The company emphasizes its strong financial position and global development capabilities to execute its vision [55] Conclusion - Zenas BioPharma is poised for significant growth with its strategic collaboration, robust pipeline, and focus on addressing unmet needs in autoimmune diseases, particularly in multiple sclerosis [55]