Dosing completed in Phase 1 study of budoprutug subcutaneous formulation, with data expected in H1 2026
Budoprutug clinical trials ongoing in pMN, ITP, and SLE, with initial data from all three trials expected in H2 2026
Enrollment ongoing in CLYM116 Phase 1 healthy volunteer study, with initial data expected mid-2026
Strong financial position with cash runway expected into 2028
WELLESLEY HILLS, Mass., March 05, 2026 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business updates.
"Throughout 2025, we translated strategy into disciplined execution and meaningfully advanced our pipeline," said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio. "With three clinical trials underway for budoprutug, our anti-CD19 monoclonal antibody, we are in a strong position to evaluate the program across multiple indications with high unmet need. We recently completed dosing in a fourth trial evaluating a subcutaneous formulation of budoprutug and are on track to share data from this study in the first half of 2026. In parallel, we continue to advance the clinical development of CLYM116, our anti-APRIL monoclonal antibody, which we believe has the potential to deliver a differentiated clinical profile in IgAN, and could represent a substantial therapeutic and commercial opportunity. With a global clinical footprint and multiple expected data readouts in 2026, we enter the year positioned for continued execution and an exciting, data-rich period ahead."
Budoprutug Program Updates and Anticipated Milestones
-- PrisMN Phase 2 primary membranous nephropathy (pMN) trial, enrollment
ongoing. PrisMN is a global open-label, dose-ranging Phase 2 study
designed to evaluate pharmacodynamics (including B cells, anti-PLA2R, and
total immunoglobulin) and preliminary efficacy (including complete and
partial remission) in pMN patients with persistent proteinuria despite
optimized renin-angiotensin-aldosterone system (RAAS) inhibition, and to
identify a dose for Phase 3 clinical development. In November 2025, we
published long-term outcome data from the Phase 1b trial of budoprutug in
pMN at the 2025 American Society of Nephrology (ASN) Kidney Week that
demonstrated long-term control of proteinuria. Anticipate initial data,
including preliminary B cell and anti-PLA2R data, in H2 2026.
-- Phase 1b/2a immune thrombocytopenia $(ITP)$ trial, enrollment ongoing. This
global open-label, dose-escalation Phase 1b/2a trial of budoprutug in
previously treated patients with ITP is designed to evaluate safety,
tolerability, pharmacokinetics, pharmacodynamics, and preliminary
efficacy, including B-cell depletion and platelet counts. Data from this
trial are expected to provide a deeper understanding of budoprutug
activity and dosing and will help inform future development. At the 2025
American Society of Hematology $(ASH)$ conference, we detailed the Phase
1b/2a trial design. Anticipate initial data, including preliminary
efficacy, in H2 2026.
-- Global Phase 1b systemic lupus erythematosus $(SLE)$ trial, enrollment
ongoing; China Phase 1b/2a SLE trial, in study start-up. The global,
open-label, dose-escalation Phase 1b trial of budoprutug in moderate to
severe SLE is designed to evaluate safety, tolerability, pharmacokinetics,
pharmacodynamics, and preliminary efficacy, including B-cell depletion,
autoantibody levels, and clinical activity. Data from this trial are
expected to provide insights into budoprutug activity and will also help
to inform future development efforts for our program broadly. In December
2025, we received Investigational New Drug $(IND)$ clearance in China to
initiate a separate, parallel Phase 1b trial in SLE, anticipated to
provide complementary data, and will also seek to enroll SLE patients
with lupus nephritis. Anticipate initial data from the Global study,
including preliminary efficacy, in H2 2026 and anticipate first patient
dosed in China SLE study in H1 2026.
-- Phase 1 trial of subcutaneous formulation, dosing completed. Dosing in
the Phase 1 trial in healthy volunteers has been completed. The study is
designed to evaluate bioavailability, pharmacokinetics, and
pharmacodynamics, including B-cell depletion, of the subcutaneous
formulation of budoprutug. Anticipate data in H1 2026.
CLYM116 Program Updates and Anticipated Milestones
-- Phase 1 healthy volunteer study, enrollment ongoing. This Phase 1 trial
in healthy volunteers will evaluate safety, pharmacokinetics, and
pharmacodynamics of CLYM116. Separately, our partner, Beijing Mabworks
Biotech Co., Ltd. (NEEQ Code: 874070, Mabworks), has initiated a Phase
1/2 study consisting of a single ascending dose study in healthy
volunteers, followed by a multiple ascending dose study in IgAN patients.
In November, we presented a poster highlighting additional data on the
favorable CLYM116 preclinical pharmacokinetic and pharmacodynamic profile
at 2025 ASN Kidney Week. Anticipate initial healthy volunteer data in
mid-2026.
Fourth Quarter and Full Year 2025 Financial Results and Guidance
-- Cash Position: Cash, cash equivalents, and marketable securities were
$160.7 million as of December 31, 2025, expected to fund operations into
2028.
-- Research and Development (R&D) expenses: R&D expenses were $13.7 million
for the three months ended December 31, 2025, compared to $6.0 million
for the comparable period in 2024, and were $46.7 million for the full
year 2025, compared to $14.3 million for the full year 2024.
-- General and Administrative (G&A) expenses: G&A expenses were $5.6 million
for the three months ended December 31, 2025, compared to $5.0 million
for the comparable period in 2024, and were $21.2 million for the full
year 2025, compared to $16.0 million for the full year 2024.
-- Other income, net: Other income, net was $1.8 million for the three
months ended December 31, 2025, compared to $2.5 million for the
comparable period in 2024, and was $8.0 million for the full year 2025,
compared to $8.1 million for the full year 2024.
About Climb Bio, Inc.
Climb Bio, Inc. is a clinical-stage biotechnology company with a mission to deliver high impact, disease-modifying medicines for individuals living with immune-mediated diseases, including those affecting kidney health. The Company's pipeline includes, budoprutug, an anti-CD19 monoclonal antibody that has potential to treat a broad range of B-cell mediated diseases, and CLYM116, an anti-APRIL monoclonal antibody being developed for IgA nephropathy. For more information, please visit climbbio.com.
About Budoprutug
Budoprutug is a clinical-stage, anti-CD19 monoclonal antibody with the potential to address a broad range of B-cell mediated, immune-driven diseases. Designed with enhanced effector function and low picomolar affinity, budoprutug targets and depletes CD19-expressing B cells, including plasmablasts and certain plasma cells, key sources of pathogenic autoantibodies. Early clinical data suggest budoprutug may offer durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in primary membranous nephropathy (pMN). Budoprutug is being evaluated in clinical trials for pMN, immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE). A subcutaneous formulation is also in development to enable broader patient access. Budoprutug has been granted orphan drug designation by the FDA for the treatment of pMN.
About CLYM116
CLYM116 is a clinical-stage monoclonal antibody targeting APRIL (A Proliferation-Inducing Ligand), a key driver of pathogenic B-cell activity in autoimmune diseases. CLYM116 employs a novel pH-dependent bind-and-release 'sweeper' mechanism to potently block APRIL signaling, promote lysosomal degradation of APRIL, and recycle the antibody to extend its half-life. This differentiated design offers the potential for rapid, deep, and durable inhibition of APRIL with a favorable safety profile and less frequent dosing. CLYM116 is being advanced for the treatment of IgA nephropathy (IgAN) and may also have broader utility across other B-cell mediated diseases where APRIL plays a critical role.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: future expectations, plans and prospects for Climb Bio; expectations regarding the therapeutic benefits, clinical potential and clinical development of budoprutug and CLYM116; the anticipated timelines for initiating Climb Bio's parallel Phase 1b clinical trial of budoprutug in China; the anticipated timelines for announcing data from Climb Bio's ongoing and planned clinical trials and Beijing Mabworks Biotech Co., Ltd.'s ("Mabworks") Phase 1/2 trial of CLYM116; the anticipated benefits of Climb Bio's technology transfer and exclusive license agreement with Mabworks; the sufficiency of Climb Bio's cash resources for the period anticipated; and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," "will," "working" and similar expressions. Forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or
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