We are a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology-based therapies for patients in need. With the evolving understanding of the pathogenesis of autoimmune diseases, along with the expansion of promising immunology-based pharmacologic targets, we are building an immunology and inflammation (“I&I”) focused biopharmaceutical company. Our core business strategy combines disciplined product candidate acquisition with strategic deployment of internal expertise and effective use of external resources. We leverage our experienced executive management team and our established networks throughout the biopharmaceutical industry to identify, acquire and develop product candidates that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Our lead I&I product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and Fcγ receptor IIb (“FcγRIIb”), which are broadly present across B cell lineage, in order to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. Based on existing clinical data generated to date, we believe that targeting B cell lineage via CD19 and FcγRIIb can inhibit B cells and has been shown to be well-tolerated. While anti-CD20 or other anti-CD19 targeting agents effectively deplete B cells in systemic circulation, these agents do not fully impact B cells in relevant tissue, and the intermittent dosing regimens of these agents may not provide optimal benefits for all patients. In addition, anti-CD20 and other anti-CD19 targeting agents may cause prolonged depletion of circulating B cells for six months or longer, placing patients at higher risk of opportunistic infections and potentially reducing their ability to respond to, and receive full benefit from, vaccines. We believe obexelimab’s mechanism of action and chronic dosing regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Across five clinical trials, in which 198 subjects were dosed, obexelimab was well-tolerated and demonstrated clinical activity that we believe provides proof-of-concept (“POC”) for obexelimab as a B cell inhibitor for the treatment of patients living with certain autoimmune diseases and, together with its mechanism of action, positions obexelimab to be a potentially differentiated B cell therapy for the treatment of such patients. We are developing obexelimab as a potential I&I franchise for patients in several autoimmune diseases, representing substantial commercial opportunities individually and in the aggregate. The first four indications we are pursuing include immunoglobulin G4-related disease (“IgG4-RD”) through an ongoing registration-directed Phase 3 trial; multiple sclerosis (“MS”) and systemic lupus erythematosus (“SLE”) through Phase 2, double-blind, randomized, placebo-controlled trials each of which we initiated in the third quarter of 2024; and warm autoimmune hemolytic anemia (“wAIHA”) through an ongoing Phase 2/3 trial, currently in the Phase 2 open label portion. IgG4-RD is a chronic fibro-inflammatory condition that can affect virtually all organ systems, including the pancreas, biliary tract, salivary and lacrimal glands, lungs and kidneys. IgG4-RD is a relatively recently described disease that incorporates groups of manifestations that were diagnosed as separate disease entities prior to 2003. We estimate that the currently diagnosed population of IgG4-RD patients in the United States is approximately 20,000, with comparable prevalence rates globally. MS is the most common immune- mediated, chronic inflammatory demyelinating disease of the central nervous system (“CNS”), affecting over two million people worldwide including as many as 1,000,000 in the United States. We estimate a diagnosed prevalence of approximately 650,000 patients in the United States with MS. SLE, the most common form of lupus, is a complex, chronic autoimmune disease characterized most notably by unpredictable flares in joints, skin, kidneys and other vital organs that cause progressive organ damage. According to the Lupus Foundation of America, at least 1.5 million Americans are afflicted by lupus and more than 16,000 new cases are reported annually. It is estimated that five million people throughout the world suffer from some form of lupus, of which 70% suffer from the most common form, SLE. We estimate a diagnosed prevalence of approximately 245,000 patients in the United States having lupus, with approximately 172,000 having SLE. Autoimmune hemolytic anemia (“AIHA”) is an acquired disorder in which autoantibodies directed against a patient’s own red blood cell (“RBC”) membrane antigens lead to their accelerated destruction, and the rate of production of new cells in the bone marrow can no longer compensate for their loss. We estimate that the currently diagnosed population of wAIHA patients in the United States is approximately 40,000, with similar prevalence rates in other countries. We estimate that the commercial opportunity across these four indications is approximately $50 billion in the aggregate in the U.S. alone. To date, we have no product candidates approved for commercial sale in any country and have not generated any revenue from product sales. Zenas BioPharma, Inc. was originally incorporated on November 12, 2019, as Zenas BioPharma (Cayman) Limited as an exempted company organized under the laws of the Cayman Islands. On August 2, 2023, the Company was domesticated as a Delaware corporation and, concurrent therewith, we changed our name from Zenas BioPharma (Cayman) Limited to Zenas BioPharma, Inc. Our principal executive offices are located at 1000 Winter Street, Suite 1200, Waltham, MA 02451.
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Here are 1-3 brief analogies for Zenas BioPharma (ZBIO):
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- OBT002 (NL-101): A humanized monoclonal antibody targeting OX40L, currently in clinical development for various autoimmune diseases.
- ZB003: An investigational CD19-targeting antibody, being developed for autoimmune diseases.
- OBT006: A humanized monoclonal antibody targeting IL-17A, in development for autoimmune diseases.
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Zenas BioPharma (ZBIO) is a clinical-stage biopharmaceutical company focused on developing innovative immunology therapies. As of its latest public filings, Zenas BioPharma has **not generated any revenue from product sales** and therefore does not have major customers in the traditional sense of companies or individuals purchasing its products.
Its operations are primarily financed through:
- Institutional and Private Investors: These entities provide capital through equity financing (e.g., private placements of common and preferred stock) to fund the company's research, development, and operational expenses. While not "customers" in the sales context, they are the primary financial supporters.
In the future, if Zenas BioPharma successfully develops its drug candidates and brings them closer to commercialization, its "customers" or partners would likely fall into the following category:
- Pharmaceutical and Biotechnology Companies: These companies would be potential partners or licensees for Zenas's drug candidates. They would acquire rights to further develop, manufacture, and commercialize the therapies, often involving upfront payments, milestone payments, and royalties. These would be the direct "customers" for its intellectual property and drug candidates.
Currently, Zenas BioPharma is focused on advancing its pipeline and is not selling products directly to other companies or individuals.
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Lonnie Moulder Chief Executive Officer and Chairman of the Board of Directors
Mr. Moulder is the Founder of Zenas BioPharma and has served as its Chief Executive Officer since August 2023, and as Chairman and a board member since 2020. He is also the Managing Member of Tellus BioVentures, LLC, an early-stage life sciences investment fund, a role he has held since March 2019. Previously, he co-founded and served as Chief Executive Officer of TESARO, Inc., a Boston-based oncology-focused biopharmaceutical company, until its acquisition by GlaxoSmithKline. Prior to TESARO, he was President, Chief Executive Officer, and Vice Chairman of the Board of Abraxis BioScience, Inc., before its acquisition by Celgene Corporation. He also served as Vice Chairman of Eisai Corporation of North America following Eisai’s acquisition of MGI PHARMA, where he held various leadership roles including President, Chief Executive Officer, and board member.
Jennifer Fox Chief Business Officer and Chief Financial Officer
Ms. Fox is an experienced finance and corporate development executive with more than 25 years of experience in corporate finance and healthcare investment banking, advising numerous private and public companies on strategy, financings, and mergers and acquisitions. Prior to joining Zenas BioPharma, Ms. Fox served as Chief Financial Officer at Nuvation Bio, a publicly traded biotechnology company. She also held senior positions including Managing Director and Co-Head of North America Healthcare Corporate and Investment Banking Group at CitiGroup, and roles in investment banking at Deutsche Bank, Bear Stearns, Bank of America, and Prudential Securities.
Joe Farmer President and Chief Operating Officer
Mr. Farmer is an accomplished biopharma executive with approximately 25 years of transactional and operational experience, working with emerging biotechnology companies from discovery through commercialization. Prior to joining Zenas, he served as Chief Operating Officer at Xilio Therapeutics. He was also General Counsel and Corporate Secretary at TESARO, where he was a key member of the leadership team through its acquisition by GlaxoSmithKline in 2019. Additionally, he served as Chief Corporate Counsel at Cubist Pharmaceuticals through its acquisition by Merck in 2015.
Tanya Fischer, M.D., PhD. Head of Research and Development and Chief Medical Officer
Dr. Fischer is a physician-scientist with extensive experience in academia and at both pharmaceutical and biotechnology companies, leading early and late-stage research and development programs across multiple therapeutic areas. Before joining Zenas, she served as Chief Development Officer and Head of Translational Medicine at Biohaven, a publicly traded biopharmaceutical company. Her industry career began at Bristol Myers Squibb, and she subsequently held R&D leadership roles of increasing responsibility at EMD-Serono, Sanofi-Genzyme, and Alnylam.
Haley Laken, Ph.D. Chief Scientific Officer
Dr. Laken serves as the Chief Scientific Officer at Zenas BioPharma. The provided search results highlight her role within the company's executive leadership, which Zenas describes as a "veteran team of biopharmaceutical leaders" with a proven track record in scientific innovation and drug development.
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The key risks to Zenas BioPharma's business are:
- Clinical Development and Regulatory Approval Risks: As a clinical-stage biopharmaceutical company, Zenas BioPharma's success is heavily dependent on the successful outcomes of its clinical trials and subsequent regulatory approvals for its product candidates, especially obexelimab and orelabrutinib. There is inherent uncertainty in clinical development, which is often lengthy and expensive, and is characterized by unpredictable outcomes, including the risk of trial failures, delays, or not achieving desired endpoints. For instance, obexelimab previously experienced a Phase 2 failure in lupus nephritis. Any such setbacks could significantly harm the company's prospects.
- Financial Health and Profitability Challenges: Zenas BioPharma has a limited operating history and has consistently incurred substantial losses since its inception, with expectations of continued and increasing losses for the foreseeable future. The company's operating margin is significantly negative, and it has reported no revenue growth over the past three years. Despite some strong financial strength indicators, the company will require substantial additional financing to achieve its goals and fund ongoing clinical development and operations.
- Competition and Pipeline Dependence: Zenas BioPharma operates within the highly competitive biotechnology industry, particularly in the development of treatments for autoimmune diseases. It faces significant competitive pressures from established "Big Pharma" companies, especially in therapeutic areas like Multiple Sclerosis. Furthermore, the company has a limited pipeline depth, meaning its future growth and success are largely reliant on the successful development and commercialization of a few key product candidates.
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- The advanced clinical development of Takeda's TAK-079, an anti-CD38 antibody, in Phase 3 for IgG4-related disease, positioning it ahead of Zenas BioPharma's Phase 2 program for obinutuzumab (ZB001) in the same indication.
- The advanced clinical development of Janssen's nipocalimab, an FcRn inhibitor, in Phase 3 for warm autoimmune hemolytic anemia (wAIHA), significantly preceding Zenas BioPharma's Phase 2 program for obinutuzumab (ZB001) in the same indication.
- The advanced clinical development of argenx's efgartigimod and UCB's rozanolixizumab, both FcRn inhibitors, in Phase 3 for chronic inflammatory demyelinating polyneuropathy (CIDP), placing them substantially ahead of Zenas BioPharma's Phase 2 program for obinutuzumab (ZB001) in the same indication.
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Zenas BioPharma (ZBIO) is a clinical-stage biopharmaceutical company primarily focused on developing therapies for autoimmune diseases. The company's main product candidates and their addressable markets are as follows:
- Obexelimab: Zenas BioPharma's lead product candidate, obexelimab, is a bifunctional monoclonal antibody targeting various immunology and inflammation (I&I) diseases, including immunoglobulin G4-related disease (IgG4-RD), multiple sclerosis (MS), and systemic lupus erythematosus (SLE). The estimated aggregate commercial opportunity for obexelimab across four indications in the U.S. alone is approximately $50 billion.
- Relapsing-Remitting Multiple Sclerosis (RRMS): The global market for relapsing-remitting multiple sclerosis is projected to reach $5.8 billion by 2032.
- Orelabrutinib: This investigational drug is a highly selective, central nervous system (CNS) penetrant, oral small molecule BTK inhibitor. Zenas is advancing orelabrutinib for Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS).
The company also has other pipeline programs, including ZB002 (an anti-TNFa monoclonal antibody), ZB004 (a cytotoxic T-lymphocyte-associated antigen 4-immunoglobulin fusion), ZB001 (an anti-IGF-1R monoclonal antibody for Thyroid Eye Disease), and earlier-stage programs ZB021 and ZB022. Specific addressable market sizes for these earlier-stage pipeline products were not readily available in the provided information.
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Zenas BioPharma (ZBIO) is a clinical-stage biopharmaceutical company focused on developing transformative therapies for autoimmune diseases. Its future revenue growth over the next 2-3 years is expected to be driven by several key factors related to its promising pipeline and strategic partnerships:
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Commercialization of Obexelimab for Immunoglobulin G4-Related Disease (IgG4-RD): Zenas BioPharma anticipates reporting topline data from its pivotal Phase 3 INDIGO trial for obexelimab in patients with active IgG4-RD around the end of 2025. Positive results from this trial and subsequent regulatory approvals would pave the way for the potential launch and commercialization of obexelimab for this indication, serving as a primary source of initial product revenue.
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Advancement and Potential Commercialization of Obexelimab in Multiple Sclerosis and Systemic Lupus Erythematosus (SLE): The company has reported positive Phase 2 data for obexelimab in relapsing multiple sclerosis (RMS), demonstrating a 95% relative reduction in new GdE T1 lesions. Additionally, Zenas is actively enrolling patients in a Phase 2 trial (SunStone) for obexelimab in SLE, with topline results expected in mid-2026. Successful progression through clinical development and eventual market approvals in these broader indications would significantly expand obexelimab's market reach and drive substantial revenue growth.
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Commercialization of Orelabrutinib in Multiple Sclerosis (PPMS and SPMS): Zenas BioPharma recently acquired global rights to orelabrutinib, a CNS-penetrant BTK inhibitor. A global Phase 3 trial for orelabrutinib in Primary Progressive Multiple Sclerosis (PPMS) was initiated in Q3 2025, and another Phase 3 trial for Secondary Progressive Multiple Sclerosis (SPMS) is planned for Q1 2026. The successful development and eventual commercialization of orelabrutinib for these significant neurological indications represent a major potential revenue driver.
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Milestone Payments and Royalties from Strategic Licensing and Funding Agreements: Zenas has secured a funding agreement with Royalty Pharma for up to $300 million related to obexelimab, which includes an upfront payment and additional payments tied to the achievement of specific clinical and regulatory milestones, such as successful outcomes in the INDIGO trial and FDA approvals for IgG4-RD and SLE. Furthermore, the company entered into a substantial licensing deal with InnoCare Pharma, valued at up to $2 billion, granting Zenas global rights to orelabrutinib and other autoimmune product candidates. These agreements provide non-sales revenue through milestone payments and potential future royalties upon product commercialization.
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Progression of Other Pipeline Programs: Beyond its lead candidates, obexelimab and orelabrutinib, Zenas is advancing a pipeline of other clinical programs, including ZB021, ZB022, ZB002, and ZB004, targeting various autoimmune diseases. While these programs are in earlier stages, their successful advancement through clinical trials could lead to future product launches and diversify the company's revenue streams in the longer term.
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Share Issuance
- Zenas BioPharma completed an Initial Public Offering (IPO) on September 13, 2024, offering 13,235,294 shares of common stock at $17.00 per share, resulting in approximately $225 million in proceeds. [cite: 15 of previous search]
- In October 2025, Zenas completed a private placement financing, issuing approximately 6.3 million shares of common stock, which is expected to result in gross proceeds of approximately $120.0 million. [cite: 3, 11 of previous search]
- In November 2020, Zenas issued 5,041,542 shares of Series A Preferred Stock with a fair value of $16.1 million to Xencor as initial consideration for a licensing agreement. [cite: 17 of previous search, 8 of this search]
Inbound Investments
- In September 2025, Zenas entered into a funding agreement with Royalty Pharma for up to $300 million to support the clinical development and potential commercial launch of obexelimab, including an upfront payment of $75 million. [cite: 11 of this search, 12 of this search, 3 of previous search]
- The private placement financing completed in October 2025 brought in approximately $120.0 million from new and existing investors. [cite: 3 of previous search, 11 of this search]
- In September 2023, Zenas received an upfront payment of $50 million from Bristol Myers Squibb (BMS) for exclusive rights to develop and commercialize obexelimab in certain Asian markets (Japan, South Korea, Taiwan, Singapore, Hong Kong, and Australia). BMS also made an equity investment in Zenas as part of the deal. [cite: 9 of this search]
Outbound Investments
- In October 2025, Zenas entered into a license agreement with InnoCare Pharma, securing global development and commercialization rights for orelabrutinib and two other autoimmune product candidates. Under the terms, Zenas will pay InnoCare upfront and near-term milestone payments of up to $100 million in cash, including a $35 million upfront payment. [cite: 1, 2, 3, 4, 5 of this search, 11 of this search]
- The agreement with InnoCare Pharma also includes the potential issuance of up to 7,000,000 shares of Zenas common stock, including shares tied to a milestone expected in early 2026. [cite: 1, 3, 5 of this search]
