Earnings summaries and quarterly performance for Zenas BioPharma.
Executive leadership at Zenas BioPharma.
Leon O. Moulder, Jr.
Detailed
Chief Executive Officer
CEO
Haley Laken
Chief Scientific Officer
Jennifer Fox
Chief Business Officer and Chief Financial Officer
Joseph Farmer
President and Chief Operating Officer
Lisa von Moltke
Head of Research and Development and Chief Medical Officer
Orlando Oliveira
Chief Commercial Officer
Board of directors at Zenas BioPharma.
Research analysts covering Zenas BioPharma.
Recent press releases and 8-K filings for ZBIO.
Zenas BioPharma Highlights 2025 Accomplishments and Upcoming Milestones
ZBIO
New Projects/Investments
- Zenas BioPharma completed the Phase III IgG4-related disease trial of obexelimab in November 2025, with data expected by the end of 2025.
- The company reported strong Phase II results for obexelimab in relapsing multiple sclerosis (RMS) from the MoonStone study, demonstrating a 95% reduction in new T1 GAD-enhancing lesions versus placebo.
- Zenas expanded its pipeline through business development, adding orelabrutinib (now in Phase III for progressive MS) and two other molecules (an oral IL-17 inhibitor and a brain penetrant TYK2 inhibitor) expected in the clinic in 2026.
- A $300 million potential financing deal with Royalty Pharma was secured, primarily supporting obexelimab.
- The company expects Phase II SunStone results for obexelimab in lupus in Q3 2026, aiming for a significant difference from placebo.
1 day ago
Zenas BioPharma Wraps Up 2025 with Key Clinical Milestones and Pipeline Expansion
ZBIO
New Projects/Investments
M&A
Product Launch
- Zenas BioPharma completed enrollment for the Phase III IgG4-related disease trial of obexelimab in November 2025, with data expected around year-end 2025, and is preparing for BLA activities.
- The company reported strong results from the MOONSTONE Global Phase II study in relapsing multiple sclerosis (RMS) for obexelimab, showing a 95% reduction in new T1 GAD-enhancing lesions versus placebo.
- Zenas significantly expanded its pipeline by acquiring orelabrutinib, a BTK inhibitor currently in a Phase III trial for progressive MS, and secured a $300 million potential financing deal with Royalty Pharma.
- The company anticipates a substantial market opportunity for obexelimab in IgG4-related disease, estimating 30,000 to 40,000 patients in the U.S. and Europe, with competitive drug pricing exceeding $250,000 annually.
1 day ago
Zenas BioPharma provides update on obexelimab Phase III IgG4-RD results and pipeline expansion
ZBIO
New Projects/Investments
M&A
- Zenas BioPharma expects top-line Phase III results for obexelimab in IgG4-related disease around the end of 2025, following the last patient out. The trial, with 194 patients, is considered overpowered, anticipating a 60% flare rate in the control arm.
- The company reported outstanding Phase II data for obexelimab in relapsing multiple sclerosis (RMS), showing a 95% risk reduction in new enhancing GAD lesions.
- Zenas has expanded its pipeline through a transaction, including rilzabrutinib, a BTK inhibitor for progressive multiple sclerosis (PPMS and SPMS), with a PPMS trial underway and an SPMS trial set to begin in Q1 2026.
- The estimated market opportunity for obexelimab in IgG4-RD in the U.S. is over $3 billion for patients requiring continuous therapy, with market research suggesting a potential 45% share.
Nov 18, 2025, 11:00 AM
Zenas BioPharma Highlights Key Clinical Milestones and Pipeline Expansion
ZBIO
Product Launch
New Projects/Investments
- Zenas BioPharma is expecting top-line Phase 3 results for obexelimab in IgG4-related disease around the end of 2025, following the last patient out. The trial is considered overpowered and is designed similarly to a recently successful competitor.
- The company recently reported outstanding Phase 2 data for obexelimab in Relapsing Multiple Sclerosis (RMS), demonstrating a 95% risk reduction in new enhancing GAD lesions.
- Zenas BioPharma has expanded its pipeline with rilzabrutinib, a BTK inhibitor for Progressive Multiple Sclerosis (PPMS and SPMS), with a PPMS trial already started and an SPMS trial beginning in Q1 2026.
- An IL-17 oral small molecule program is also advancing, with Phase 1 trials expected to start in 2026 and patient data in 2027.
Nov 18, 2025, 11:00 AM
Zenas BioPharma Reports Q3 2025 Financial Results and Provides Corporate Update
ZBIO
Earnings
Guidance Update
New Projects/Investments
- Zenas BioPharma reported a net loss of $51.5 million for the third quarter ended September 30, 2025, compared to a net loss of $38.6 million for the same period in 2024. Research and development expenses for Q3 2025 were $34.4 million, and general and administrative expenses were $13.2 million.
- As of September 30, 2025, the company's cash, cash equivalents, and investments totaled $301.6 million. This is expected to fund operating expenses and capital expenditure requirements into the fourth quarter of 2026, or into the first quarter of 2027 if a potential $75 million milestone from Royalty Pharma is received.
- The company expects to report topline results from the obexelimab Phase 3 INDIGO trial around year-end 2025 and announced highly positive 12-week primary endpoint results from the Phase 2 MoonStone trial in Relapsing MS.
- Zenas secured development and commercialization rights for three autoimmune product candidates, including orelabrutinib, and entered into an obexelimab funding agreement with Royalty Pharma for up to $300.0 million, which includes an upfront payment of $75 million.
Nov 12, 2025, 12:12 PM
Zenas BioPharma Announces Positive Phase 2 MoonStone Trial Results for Obexelimab in Relapsing Multiple Sclerosis
ZBIO
Product Launch
New Projects/Investments
- Zenas BioPharma announced positive results from its Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis (RMS).
- Obexelimab met the primary endpoint, showing a 95% relative reduction in new gadolinium (Gd)-enhancing T1 lesions compared with placebo (p=0.0009).
- The adjusted mean number of new GdE T1 hyperintense lesions per scan in the obexelimab group was 0.01 (95% CI: 0.00, 0.06) compared to 0.23 (95% CI: 0.11, 0.51) with placebo.
- The safety profile of obexelimab was consistent with that observed in prior completed trials.
- The company expects to report 24-week data from the MoonStone trial in Q1 2026, topline results from the Phase 3 INDIGO trial around year-end 2025, and topline results from the Phase 2 SunStone trial in mid-2026.
Oct 27, 2025, 11:19 AM
Zenas BioPharma Announces Collaboration Agreement with InnoCare Pharma and Pipeline Updates
ZBIO
M&A
New Projects/Investments
Product Launch
- 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.
- 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.
- 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.
- 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.
- The global MS market is projected to exceed $30 billion, with progressive forms (SPMS and PPMS) accounting for >$12 billion+ of this market.
Oct 8, 2025, 12:00 PM
Zanis Biopharma Announces Global Collaboration with Innocare Pharma and Pipeline Expansion
ZBIO
M&A
New Projects/Investments
Guidance Update
- Zanis Biopharma announced a strategic global collaboration agreement with Innocare Pharma, significantly expanding its pipeline.
- 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.
- 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.
- 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.
- 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.
Oct 8, 2025, 12:00 PM
Zenas BioPharma Enters License Agreement with InnoCare Pharma and Announces $120 Million Private Placement
ZBIO
M&A
New Projects/Investments
- 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.
- 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.
- 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.
- 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.
Oct 8, 2025, 10:01 AM
Zenas BioPharma Provides Updates on Clinical Pipeline and Financial Position
ZBIO
New Projects/Investments
Product Launch
Guidance Update
- 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.
- 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.
- Zenas BioPharma reported a strong cash position of approximately $275 million as of June 30.
- 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.
- 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.
Sep 3, 2025, 1:42 PM
Quarterly earnings call transcripts for Zenas BioPharma.
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