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Zenas BioPharma (ZBIO) investor relations material

Zenas BioPharma Status Update summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Status Update summary8 Oct, 2025

Strategic Collaboration, License Agreement, and Transaction Overview

  • Entered a global collaboration and license agreement with InnoCare Pharma, acquiring rights to relabrutinib/orelabrutinib and two early-stage autoimmune candidates for $35M cash, 5M shares upfront, and potential milestone payments up to $240M, with total potential payments exceeding $2B plus royalties.

  • Collaboration closed on October 7, 2025, and accelerates the goal to become a fully integrated, commercial-stage biopharma by 2031.

  • Zenas gains exclusive global rights for orelabrutinib in MS and non-oncology indications, and for the two new candidates outside Greater China and Southeast Asia; InnoCare retains oncology rights.

  • Secured $120 million in private placement financing, with a cash runway into Q4 2026 or Q1 2027 with potential $75 million milestone from Royalty Pharma.

Pipeline Expansion and Clinical Development

  • Orelabrutinib/relabrutinib, a CNS-penetrant BTK inhibitor, is in Phase III for PPMS (initiated Q3 2025) and SPMS (expected Q1 2026), with strong Phase II RMS data showing >90% reduction in new lesions and sustained activity over 96 weeks.

  • Obexelimab is in Phase III for IgG4-RD (INDIGO trial, topline results year-end 2025), Phase II for RMS (MoonStone trial, data early Q4 2025), and Phase II for SLE (mid-2026 data).

  • Two novel oral candidates, an IL-17AA/AF inhibitor (ZB021) and a brain-penetrant TYK2 inhibitor (ZB022), are set for Phase I trials in 2026.

  • Multiple key data readouts and regulatory milestones are expected in 2025 and 2026, including BLA submission for obexelimab and pivotal trial results.

Market Opportunity and Commercial Outlook

  • Progressive MS (SPMS and PPMS) represents a $12B+ US market, with the global MS market projected to exceed $30B by 2030; orelabrutinib/relabrutinib is positioned as a potential best-in-class therapy.

  • IgG4-RD US market opportunity is estimated at $1B+ with potential for $3B, and $2B in Europe, with obexelimab aiming for meaningful share and differentiation from IV competitors.

  • Both orelabrutinib/relabrutinib and obexelimab represent potential multi-billion-dollar commercial opportunities.

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Q3 202511 Nov, 2025
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Frequently asked questions

Zenas BioPharma Inc is a biopharmaceutical company dedicated to the development and commercialization of immunology-based therapies to treat autoimmune and rare diseases. The company focuses on leveraging its expertise in immunology to create innovative treatments that address significant unmet medical needs. Zenas BioPharma’s portfolio includes a range of product candidates designed to modulate immune system responses, aimed at improving the quality of life for patients with challenging and often underserved conditions. The company is headquartered in Waltham, Massachusetts, and its shares are listed on the Nasdaq.

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