Full Press Release Details
Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
marketing applications for the treatment of IgG4 RD expected to be submitted to the FDA in Q2 2026 and the EMA in H2 2026 based on
the Phase 3 INDIGO trial results -
of the global Phase 2 SunStone trial of obexelimab in SLE expected in Q4 2026 -
extended anti-CD-19 and FcgRIIb mAb (ZB014) progressing toward clinical development -
- Global orelabrutinib
Phase 3 trial for primary progressive multiple sclerosis (MS) ongoing; global Phase 3 trial for non-active secondary progressive MS expected
to be initiated in Q1 2026 -
inhibitor (ZB021) Phase 1 trial expected to be initiated in 2Q 2026 with initial clinical data by year-end -
million non-dilutive, multi-tranche debt financing secured from Pharmakon -
WALTHAM, Mass, Mar. 16, 2026 (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 quarter and year ended December 31, 2025, and provided recent corporate updates.
"Following the highly positive Phase 3 INDIGO results reported
earlier this year, we enter 2026 with strong momentum as we prepare for the potential commercialization of obexelimab for the treatment
of IgG4-RD. We are on track to submit obexelimab marketing applications for the treatment of IgG4-RD to the FDA in the second quarter
and to the EMA in the second half of the year, both major milestones for the program and patients living with this disease,"
said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. "We look forward to progressing multiple Zenas pipeline programs
this year, including the orelabrutinib progressive MS Phase 3 studies, clinical development of our oral IL-17 inhibitor, ZB021, and the
advancement of an exciting new molecule, ZB014, a half-life extended anti-CD-19 and FcgRIIb antibody.
In addition, we expect to report topline overall and biomarker population results of the Phase 2 SunStone trial of obexelimab in SLE.
Collectively, these programs represent the foundation for compelling franchises across numerous areas of unmet need for patients living
with immune mediated diseases. We are also very pleased to announce today a non-dilutive financing arrangement with Pharmakon, a respected
leader in strategic life sciences funding. This partnership strengthens our balance sheet and provides us with the financial flexibility
to commercialize obexelimab while investing in our broader pipeline."
Corporate highlights
Obexelimab, a CD-19 and FcgRIIb
inhibitor of B cell function
Orelabrutinib, a highly selective CNS-penetrant
Bruton's Tyrosine Kinase (BTK) inhibitor
Other corporate highlights
Other pipeline updates
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 potential
Fourth quarter and year end 2025 financial
Obexelimab is a bifunctional monoclonal
antibody designed to bind both CD19 and FcgRIIb, 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 inhibitory 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 eight
clinical trials in a total of 383 subjects, including INDIGO. Obexelimab was well tolerated and demonstrated clinical activity across
these clinical trials. The registrational Phase 3 INDIGO trial for Immunoglobulin G4-Related Disease met its primary endpoint and all
four key secondary endpoints with high statistical significance. The trial continues to evaluate patients in the 3-year open label extension
period which will further build upon the largest body of clinical data reported for IgG4-RD patients to date. A randomized Phase 2 trial
for Systemic Lupus Erythematosus is ongoing and Zenas expects to report topline results, including biomarker data from this trial in
the fourth quarter of 2026.
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 PriMroSe, a Phase 3 trial in Primary Progressive MS (PPMS). Monarch,
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 meaningful 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 FcgRIIb,
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 inhibitory 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 central nervous system (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, it directly modulates macrophages
and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis
(MS). Zenas' earlier stage programs include ZB021, a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and ZB022,
a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor. For more information about Zenas BioPharma, please visit
Zenas BioPharma 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's milestones, expectations and intentions, including the potential for
obexelimab to become a meaningful therapy across multiple autoimmune diseases, the timing of the initiation of, results and data
from clinical trials, including the timing of reporting the topline results from the SunStone trial and the timing of initiation of
the Phase 3 clinical trial of orelabrutinib in patients with naSPMS; the timing of regulatory submissions, including timing of our
submission of a BLA to FDA for obexelimab in IgG4-RD, our plans to submit a marketing application to the EMA for obexelimab in
IgG4-RD; subject to IND clearance, the initiation of Phase 1 clinical studies and indications selections of ZB021 and ZB022; the
potential of ZB014; our ability to draw down on the Pharmakon debt facility; receipt of additional funding under our Royalty Pharma
and Pharmakon agreements contingent upon FDA approval of obexelimab; and our cash guidance. 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