Full Press Release Details
Zenas BioPharma Reports Third Quarter 2025 Financial
Results and Provides Corporate Update
- Obexelimab Phase 3 INDIGO trial topline results
in Immunoglobulin G4-Related Disease (IgG4-RD) expected around year-end 2025 -
- Reported highly positive 12-week primary endpoint
results from Phase 2 MoonStone trial of obexelimab in Relapsing MS (RMS) -
- Secured development and commercialization
rights for three autoimmune product candidates, including orelabrutinib, a BTK Inhibitor in Phase 3 development for progressive forms
of Multiple Sclerosis (MS) -
- Entered into obexelimab funding agreement
with Royalty Pharma for up to $300.0 million, including $75M upfront, to support clinical development and potential commercial launch
WALTHAM, Mass, November 12, 2025 (GLOBE NEWSWIRE)
- Zenas BioPharma, Inc. ("Zenas" or the "Company") (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical
company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune
diseases, today reported financial results for the third quarter ended September 30, 2025, and provided recent corporate updates.
"Our recent achievements mark a significant step toward our vision
of becoming a fully integrated, global development and commercial-stage biopharmaceutical company that brings impactful treatments to
patients living with autoimmune diseases," said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. "The outstanding
results from our Phase 2 MoonStone trial in relapsing multiple sclerosis validates the rapid, deep and sustained inhibitory mechanism
of obexelimab and provide strong evidence of its potential to broadly address the pathogenic role of B cells in autoimmune conditions.
In addition, we significantly expanded our pipeline with the in-licensing of three potentially best-in-class product candidates, including
orelabrutinib which we are advancing in a Phase 3 progressive multiple sclerosis program, and recently completed two financing transactions.
We look forward to sharing topline results from the obexelimab Phase 3 INDIGO trial in IgG4-RD around year-end."
Recent corporate highlights
Other pipeline updates
Obexelimab, a CD19 and Fc RIIb inhibitor of B cell function
ZB021, a novel oral, IL-17AA/AF inhibitor that blocks IL-17 AA homodimer
and IL-17AF heterodimer signaling with best-in-class potential
ZB022, an oral, brain-penetrant, TYK2 inhibitor with best-in-class
Third quarter 2025 financial results
Obexelimab is a bifunctional monoclonal antibody designed to bind both
CD19 and Fc RIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many
autoimmune diseases without depleting them. This unique mechanism of action and self-administered, subcutaneous injection regimen may
broadly and effectively address the pathogenic role of the B cell lineage in chronic autoimmune disease.
Obexelimab has been evaluated in seven clinical trials, including MoonStone,
in a total of 286 subjects who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well
tolerated and demonstrated clinical activity across these clinical trials. Zenas is conducting a fully enrolled Phase 3 trial in Immunoglobulin
G4-Related Disease and Phase 2 trials for Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus.
Orelabrutinib is a late-stage, potentially best-in-class, highly selective
CNS-penetrant, oral, small molecule Bruton's Tyrosine Kinase (BTK) inhibitor. In Multiple Sclerosis (MS), Zenas is advancing a
Phase 3 trial in Primary Progressive MS (PPMS). A Phase 3 trial in Secondary Progressive MS (SPMS) is expected to initiate in the first
quarter of 2026. Orelabrutinib is approved for B cell malignancies in mainland China and Singapore, marketed by our partner InnoCare.
About Zenas BioPharma, Inc.
Zenas is a clinical-stage global biopharmaceutical
company committed to becoming a leader in the development and commercialization of transformative therapies for patients living with
autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition
approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients
living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab,
Zenas' lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and Fc RIIb, which are broadly
present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them.
We believe that obexelimab's unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively
address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective
CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib's mechanism of action targets pathogenic B cells not only in the
periphery but also within the CNS. Additionally, orelabrutinib directly modulates macrophages and microglial cells in the CNS, with the
potential to address compartmentalized inflammation and disease progression in MS. Zenas' earlier stage programs include a potentially
best-in-class, oral, IL-17AA/AF inhibitor, and a potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor, both in IND enabling
Forward looking statements
This press release contains "forward-looking statements"
which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results,
performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements
of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified
by terms such as "may," "will," "should," "expect," "plan," "anticipate,"
"could," "intend," "target," "project," "contemplate," "believe,"
"estimate," "predict," "potential" or "continue" or the negative of these terms or other
similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not
limited to, statements concerning Zenas' milestones, expectations and intentions, including the potential for obexelimab to become
a meaningful therapy across multiple autoimmune diseases and to address the pathogenic role of B cells in autoimmune diseases, the timing
of the initiation of, results and data from clinical trials, including timing of reporting topline results from the INDIGO trial, the
timing of reporting 24-week topline results from the MoonStone trial, the timing of completing enrollment in and the reporting the topline
results from the SunStone trial, the timing of initiation of the Phase 3 clinical trial of orelabrutinib in SPMS, the timing to submit
an IND and initiate clinical development in ZB021 and ZB022 as well as the timing and proposed therapeutic areas for ZB021 and ZB022;
the potential benefits, development and commercialization of orelabrutinib and obexelimab; the expansion of the Zenas pipeline and cash
guidance, including assuming receipt of the potential $75 million milestone from Royalty Pharma associated with achieving defined success
criteria in the Phase 3 INDIGO trial. The forward-looking statements in this press release speak only as of the date of this press release
and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company's actual results
to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company's limited
operating history, incurrence of substantial losses since the Company's inception and anticipation of incurring substantial and
increasing losses for the foreseeable future; the Company's need for substantial additional financing to achieve the Company's
goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related
to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company's current
product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials;
the impact of any significant adverse events or undesirable side effects caused by the Company's product candidates; potential competition,
including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company's
current indications; the Company's ability to realize the benefits of the Company's current or future collaborations or licensing
arrangements and ability to successfully consummate future partnerships; the Company's ability to obtain regulatory approval to
commercialize any product candidate in the United States or any other jurisdiction, the risk that the data from our clinical trials is
not sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a biologics license
application or other comparable submission or to obtain regulatory approval for our product candidates for which we seek approval in the
U.S. or elsewhere, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company's
dependence on the services of the Company's senior management and other clinical and scientific personnel, and the Company's
ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company's ability
to grow the Company's organization, and manage the Company's growth and expansion of the Company's operations; risks
related to the manufacturing of the Company's product candidates, which is complex, and the risk that the Company's third-party
manufacturers may encounter difficulties in production; the Company's ability to obtain and maintain sufficient intellectual property
protection for the Company's product candidates or any future product candidates the Company may develop; the Company's reliance
on third parties to conduct the Company's preclinical studies and clinical trials; the Company's compliance with the Company's
obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company's product
candidates; significant political, trade, regulatory developments, including changes in relations between the U.S. and China; risks related
to the operations of the Company's suppliers, many of which are located outside of the United States, including the Company's
current single source contract manufacturing organizations for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, and