InnoCare Collaboration - Zenas BioPharma has a collaboration agreement with InnoCare Pharma, a biopharmaceutical company with a market cap exceeding $4.5 billion USD, two marketed products, and over 10 candidates in clinical development[9] - InnoCare will receive global rights to Orelabrutinib and ZB022, and global rights to ZB021 excluding China and Southeast Asia, while retaining global rights to Orelabrutinib in oncology indications[11] - Zenas will receive $35 million USD in cash and 5 million shares of Zenas common stock upfront from InnoCare[11] - Zenas is eligible for up to an additional 2 million shares of Zenas stock and up to $240 million USD in development and regulatory milestone payments for Orelabrutinib, as well as commercial sales milestone payments and tiered royalties on net sales[11] Orelabrutinib (BTKi) Program - A Phase 3 PPMS registration-directed trial has been initiated in the U S for Orelabrutinib, with a Phase 3 SPMS registration-directed trial expected to initiate in Q1 2026[11] - Orelabrutinib treatment in a Phase 2 RRMS trial resulted in a significant reduction in new GdE+ T1 lesions, with a >90% reduction observed at the 80mg QD dose at week 12 (P=0 0018)[48] - The global MS market is expected to exceed $30 billion USD, with SPMS and PPMS representing >$12 billion USD[61] Pipeline Programs - IND clearance and enrollment of the first patient for ZB021, an oral IL-17AA/AF inhibitor, and ZB022, a brain penetrant TYK2 inhibitor, are expected in 2026[11] - The anti-IL-17 biologics market is currently a $10 billion USD global market with ~50% average annual growth since first approval[74] Obexelimab Program - Phase 3 INDIGO trial for IgG4-RD is fully enrolled with topline results expected around year-end 2025[83] - Phase 2 MoonStone trial for RMS is fully enrolled with (12-week) data expected early Q4 2025[83] - Phase 2 SunStone trial for SLE is enrolling with (24-week) data expected mid-2026[83] - Obexelimab represents a compelling $1 billion+ USD commercial revenue opportunity in the U S alone for IgG4-RD[120]

Core Viewpoint - InnoCare Pharma Inc. has entered into an exclusive licensing and subscription agreement with Zenas BioPharma, granting Zenas rights to develop, manufacture, and commercialize certain products, including the BTK inhibitor Orelabrutinib for multiple sclerosis and other preclinical assets [1][2]. Group 1: Licensing Agreement Details - The agreement allows Zenas exclusive rights to develop and commercialize Orelabrutinib for multiple sclerosis globally, while InnoCare retains rights in oncology and certain regions for non-oncology applications [1]. - Zenas will pay InnoCare up to $100 million in upfront and milestone payments, along with issuing up to 7 million shares of Zenas common stock [2]. - The total potential value of the transaction exceeds $2 billion, including tiered royalties based on annual net sales of the licensed products [2]. Group 2: Product Development and Clinical Trials - Orelabrutinib is a late-stage clinical candidate with potential best-in-class advantages, currently undergoing Phase III trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [3]. - InnoCare has completed patient enrollment for a Phase III trial for immune thrombocytopenia (ITP) and plans to submit a new drug application in mid-2026 [3]. - Zenas aims to lead in the development and commercialization of transformative therapies for autoimmune diseases, leveraging an experienced leadership team and a robust product pipeline [3].