- Zenas BioPharma has entered into a **collaboration agreement** with InnoCare Pharma for the development and commercialization rights of three autoimmune programs: Orelabrutinib, ZB021, and ZB022.  **[0001953926_2172539:10]** 
- The transaction, which closed on **October 7, 2025**, involved an upfront payment to InnoCare of **$35 million cash** and **5 million shares of Zenas common stock**, with potential for additional stock and up to **$240 million** in development and regulatory milestone payments for Orelabrutinib, alongside commercial sales milestones and tiered royalties for all three programs.  **[0001953926_2172539:10]** 
- **Orelabrutinib**, a BTK inhibitor, has initiated a **Phase 3 PPMS** registration-directed trial in Q3 2025, and a **Phase 3 SPMS** registration-directed trial is expected to initiate in Q1 2026.  **[0001953926_2172539:10]** **[0001953926_2172539:12]** 
- Key pipeline milestones include **Obexelimab** with Phase 2 RMS 12-week data expected early Q4 2025 and Phase 3 IgG4-RD topline data around year-end 2025.  **[0001953926_2172539:12]** 
- The global MS market is projected to exceed **$30 billion**, with progressive forms (SPMS and PPMS) accounting for **>$12 billion+** of this market.  **[0001953926_2172539:21]** **[0001953926_2172539:22]**

Zenas BioPharma Announces Collaboration Agreement with InnoCare Pharma and Pipeline Updates

- **Zanis Biopharma** announced a **strategic global collaboration agreement with Innocare Pharma**, significantly expanding its pipeline.  **[0001953926_2172563_1]** **[0001953926_2172563_1]** 
- The collaboration involves **$35,000,000 in upfront cash** and **5,000,000 Zenith common shares**, with additional payments and tiered royalties tied to clinical, regulatory, and commercial milestones for three programs.  **[0001953926_2172563_1]** **[0001953926_2172563_1]** 
- The expanded pipeline includes **arelabrutinib**, a BTK inhibitor for progressive multiple sclerosis, with a Phase III trial for PPMS already initiated and a Phase III study for SPMS planned for next quarter.  **[0001953926_2172563_1]** **[0001953926_2172563_1]** 
- **Arelabrutinib** demonstrated **greater than 90% reduction in new lesions** in its Phase II relapsing multiple sclerosis trial and targets a progressive MS market with **$12,000,000,000 in potential peak sales in the US alone**.  **[0001953926_2172563_4]** **[0001953926_2172563_6]** 
- Zanis aims to become a global, fully integrated commercial-stage biopharmaceutical company, aspiring to launch **three best in class franchise molecules across five indications in three therapeutic areas by 2031**.  **[0001953926_2172563_1]** **[0001953926_2172563_1]** **[0001953926_2172563_11]**

Zanis Biopharma Announces Global Collaboration with Innocare Pharma and Pipeline Expansion

- **Zenas BioPharma** entered a license agreement with InnoCare Pharma, securing global development and commercialization rights for **orelabrutinib**, a BTK inhibitor in Phase 3 development for Multiple Sclerosis (MS), and two early-development product candidates, **ZB021** and **ZB022**.  **[1953926_0001104659-25-097663_tm2528075d1_ex99-1.htm:0]** **[1953926_0001104659-25-097663_tm2528075d1_ex99-3.htm:0]** **[1953926_0001104659-25-097663_tm2528075d1_8k.htm:1]** 
- The agreement includes an upfront payment of **$35 million** in cash and the issuance of **5,000,000 shares** of Zenas common stock to InnoCare.  **[1953926_0001104659-25-097663_tm2528075d1_8k.htm:1]** 
- A global Phase 3 clinical trial for orelabrutinib in Primary Progressive MS (PPMS) has been initiated, with a second Phase 3 trial for Secondary Progressive MS (SPMS) expected to start in **Q1 2026**.  **[1953926_0001104659-25-097663_tm2528075d1_ex99-1.htm:0]** **[1953926_0001104659-25-097663_tm2528075d1_ex99-2.htm:5]** 
- Zenas also announced a **$120.0 million** private placement financing, anticipated to close around October 9, 2025, which, combined with existing cash of approximately **$302 million** as of September 30, 2025, is expected to fund operations into the **fourth quarter of 2026**.  **[1953926_0001104659-25-097663_tm2528075d1_ex99-1.htm:0]** **[1953926_0001104659-25-097663_tm2528075d1_8k.htm:3]** **[1953926_0001104659-25-097663_tm2528075d1_8k.htm:7]**

Zenas BioPharma Enters License Agreement with InnoCare Pharma and Announces $120 Million Private Placement

- Zenas BioPharma, an autoimmune-focused company, anticipates **top-line results around year-end** for its global Phase 3 trial of **obexelimab** in **IgG4-related disease (IgG4RD)**, with the last patient out on **November 15**.  **[1953926_tx_379730_0]** **[1953926_tx_379730_3]** 
- The company also expects results for its global Phase 2 program in **relapsing multiple sclerosis (MS) early in the fourth quarter**, and for its global Phase 2 program in **systemic lupus erythematosus (SLE) around mid-next year**.  **[1953926_tx_379730_0]** 
- Zenas BioPharma reported a **strong cash position** of approximately **$275 million as of June 30**.  **[1953926_tx_379730_0]** 
- A **$300 million Royalty Pharma deal** was announced, with **$225 million allocated to the obexelimab program and IgG4RD**, extending the company's financial runway for **more than a full year beyond the IgG4RD Phase 3 readout**.  **[1953926_tx_379730_0]** 
- The company is in **pre-commercial mode**, with Medical Affairs teams deployed in Europe and the U.S., and is preparing a Biologics License Application (BLA) for obexelimab in IgG4RD.  **[1953926_tx_379730_0]**

Zenas BioPharma (ZBIO)