Climb Bio Announces Pipeline Progress and Strategic Priorities for 2026

Rhea-AI Summary

Climb Bio (NASDAQ: CLYM) reported clinical and corporate progress and refreshed guidance on Jan 8, 2026. Key program updates include first patient dosed in the PrisMN Phase 2 trial for primary membranous nephropathy and ongoing dosing in budoprutug Phase 1b/2a ITP and Phase 1b SLE trials, plus IND clearance for a China SLE trial. First cohorts were dosed in a subcutaneous budoprutug Phase 1 healthy volunteer study. CLYM116 advanced into a Phase 1 healthy volunteer study after an in-license and FPI; partner Mabworks cleared a China IND. The company reported 20 regulatory clearances, activation of 45 trial sites, and cash runway expected into 2028. Multiple initial data readouts are anticipated across budoprutug and CLYM116 in 2026.

Positive

• First patient in PrisMN Phase 2 (budoprutug) — FPI Nov 2025
• Budoprutug: dosing ongoing in ITP and global SLE Phase 1b trials
• CLYM116: first cohort dosed in Phase 1 healthy volunteer study (Dec 2025 FPI)
• Achieved 20 regulatory clearances and activated 45 trial sites globally
• Cash runway expected into 2028

Negative

• No pivotal efficacy readouts; initial efficacy data primarily expected H2 2026
• Programs remain early clinical stage (Phase 1/Phase 2) with inherent clinical risk
• Commercial and regulatory success in China depends on partner Mabworks and separate INDs

Key Figures

Regulatory clearances 20 clearances Total regulatory clearances to conduct clinical trials across portfolio

Active trial sites 45 sites Trial sites activated globally for budoprutug and CLYM116 programs

Clinical trials initiated 4 trials Four clinical trials initiated for budoprutug across multiple indications

Budoprutug Phase 2 pMN Phase 2 PrisMN trial in primary membranous nephropathy initiated November 2025

ITP trial design Phase 1b/2a Open-label dose-escalation study in relapsed/refractory ITP

SLE global trial Phase 1b Dose-escalation trial in moderate to severe systemic lupus erythematosus

Cash runway Into 2028 Company states cash, equivalents and securities fund operations into 2028

CLYM116 Phase 1 First cohort dosed Healthy volunteer Phase 1 with first cohort completed December 2025

Market Reality Check

$5.03 Last Close

Volume Volume 631,008 is well below 20-day average of 2,733,420 (relative volume 0.23) low

Technical Price $4.20 is trading above the 200-day MA of $1.86 and 16.8% below 52-week high

Peers on Argus

CLYM gained 10.24% on pipeline and 2026 milestones while peers were mixed: GLSI +21.26%, KYTX +9.02%, CABA +3.88%, AARD +3.09%, and VTYX -10.38%. Scanner data shows no coordinated sector momentum, pointing to a stock-specific reaction.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 25	Inducement option grant	Neutral	+2.3%	Reported stock option grant to a new employee under inducement plan.
Nov 06	Earnings and update	Positive	+1.6%	Q3 2025 results and confirmation of cash runway and trial progress.
Nov 03	Investor conferences	Neutral	-2.4%	Announcement of participation in multiple upcoming investor conferences.
Oct 21	Senior hires	Neutral	-2.6%	Appointment of new senior leaders and related inducement option grants.
Oct 17	Clinical data update	Positive	-1.0%	ASN Kidney Week data showing long-term proteinuria control with budoprutug.

Pattern Detected

Recent news has seen modest moves, with one positive data event sold off and an earnings/progress update bid higher, suggesting mixed alignment between news tone and short-term price action.

Recent Company History

Over the last few months, Climb Bio has focused on clinical progress, corporate build-out, and investor outreach. An Oct 17, 2025 ASN Kidney Week data update for budoprutug highlighted long-term proteinuria control but saw a small negative price reaction. Subsequent corporate hiring and conference participation in Oct–Nov 2025 produced minor moves. The Nov 6, 2025 Q3 report, emphasizing cash of $175.8M and advancing trials, coincided with a modest gain. Today’s broader 2026 pipeline and runway update extends that trajectory of execution-focused news.

Market Pulse Summary

The stock moved +9.1% in the session following this news. A strong positive reaction aligns with the company’s update highlighting broad clinical execution and an extended cash runway into 2028. The stock traded about 16.8% below its 52-week high and well above its $1.86 200-day average, so optimism had already been building. Past data-related news saw mixed follow-through, with at least one positive update sold off, so investors may watch for whether interest persists as 2026 readouts approach.

Key Terms

phase 2 medical

"First patients dosed in budoprutug PrisMN Phase 2 trial in pMN"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 1b/2a medical

"Dosing ongoing in budoprutug Phase 1b/2a trial in ITP"

Phase 1b/2a is a combined early-stage clinical study that first tests safety and optimal dosing in a small group and then expands to look for initial signs that the drug works in the target patients. Think of it as a prototype test followed by a small pilot run: it helps companies decide whether to invest in larger, more expensive trials. Investors watch these results because they reduce scientific uncertainty and can sharply affect a drug’s value and development timeline.

phase 1b medical

"Phase 1b trial in SLE; achieved regulatory clearance for SLE IND in China"

"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.

monoclonal antibody medical

"budoprutug, our anti-CD19 monoclonal antibody, with the initiation of four clinical trials"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

anti-cd19 medical

"budoprutug, our anti-CD19 monoclonal antibody"

Anti‑CD19 describes a therapy—often an antibody or an engineered immune cell—that specifically seeks out and binds to the CD19 protein found on the surface of certain B cells, marking them for removal. For investors, anti‑CD19 treatments matter because they target cancers and immune disorders with precision, so clinical trial results, approval decisions, manufacturing scale and safety data can drive a drug maker’s value much like a new, highly effective product can reshape a company’s future.

igan medical

"With CLYM116 for IgAN, budoprutug in pMN, ITP, and SLE"

IgAN, short for IgA nephropathy, is a chronic kidney disease in which an immune protein called IgA builds up in the kidneys, slowly damaging the filters that remove waste from the blood. Think of it as rust accumulating in a water filter: over time the filter clogs and performance declines. It matters to investors because it is a leading cause of kidney failure with large unmet treatment needs, driving clinical development, regulatory milestones, and potential market opportunity for new therapies.

AI-generated analysis. Not financial advice.

First patients dosed in budoprutug PrisMN Phase 2 trial in pMN, with initial data expected second half 2026 

Dosing ongoing in budoprutug Phase 1b/2a trial in ITP and Phase 1b trial in SLE; achieved regulatory clearance for SLE IND in China

First patients dosed in CLYM116 Phase 1 healthy volunteer study

Anticipating a data-rich 2026, with initial readouts from all ongoing budoprutug and CLYM116 studies

Strong financial position with cash runway expected into 2028

WELLESLEY HILLS, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today announced progress updates for its budoprutug and CLYM116 programs. The Company also highlighted its strategic priorities and key anticipated milestones for 2026 and refreshed its financial guidance.

“Reflecting on 2025, we set out with ambitious goals, and I am proud of the substantial progress made across our clinical development and corporate objectives,” said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio. “We are now primed for a fulsome evaluation of budoprutug, our anti-CD19 monoclonal antibody, with the initiation of four clinical trials and the clearance of our China IND. We also rapidly advanced CLYM116, our anti-APRIL monoclonal antibody, into the clinic and dosed our first subjects in less than one year after announcing the in-licensing transaction. Across the portfolio we achieved 20 regulatory clearances to conduct clinical trials and activated 45 trial sites globally, a testament to our robust clinical execution.”

“Looking ahead, 2026 is poised to be a transformative and data-rich year for Climb, with initial readouts expected from all our ongoing trials,” continued Dr. Brennan. “With CLYM116 for IgAN, budoprutug in pMN, ITP, and SLE, and the potential to evaluate lupus nephritis in a separate, parallel China SLE trial, our pipeline has the potential to address the high unmet need which exists across renal and other B-cell mediated diseases. Together, the anticipated datasets from our ongoing studies will inform the next steps in our mission to deliver differentiated treatments for immune-mediated diseases with substantial therapeutic and commercial potential.”

2025 Major Accomplishments and Pipeline Status        

Budoprutug anti-CD19 monoclonal antibody

• Initiated Phase 2 Trial in Primary Membranous Nephropathy (pMN): In November 2025, FPI was achieved in the PrisMN Phase 2 trial. The study is 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 RAAS inhibition, and to identify a dose to carry forward into Phase 3 clinical development. In November 2025, the Company also published budoprutug pMN Phase 1b long-term outcome data at the 2025 American Society of Nephrology (ASN) Kidney Week that demonstrated long-term control of proteinuria.
• Initiated Phase 1b/2a Trial in Immune Thrombocytopenia (ITP): Dosing is ongoing in the open-label, dose-escalation Phase 1b/2a clinical trial of budoprutug in relapsed/refractory ITP designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B cell depletion and platelet counts. At the 2025 American Society of Hematology (ASH) conference in December, the Company presented a poster detailing the Phase 1b/2a trial design.
• Initiated Global Phase 1b Trial in Systemic Lupus Erythematosus (SLE) and Received Regulatory Clearance of SLE IND in China: Dosing is ongoing in the global, open-label, dose-escalation Phase 1b trial of a single dose of budoprutug in moderate to severe SLE to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B-cell depletion, autoantibody levels, and clinical activity. In December 2025, the Company received clearance of its investigational new drug application (IND) in China to initiate a separate, parallel China Phase 1b trial in SLE, which will complement our ongoing study and also seek to enroll SLE patients who have lupus nephritis.
• Initiated Subcutaneous (SC) formulation Phase 1 Trial: First cohorts were dosed in the Phase 1 trial in healthy volunteers, which is designed to evaluate bioavailability, pharmacokinetics, and pharmacodynamics, including B cell depletion, of the subcutaneous formulation of budoprutug.

CLYM116 anti-APRIL monoclonal antibody

• Obtained Exclusive License to Develop and Commercialize CLYM116: Entered into a technology transfer and exclusive license agreement with Beijing Mabworks Biotech Co., Ltd. (NEEQ Code: 874070, Mabworks) in January 2025 for the rights to develop and commercialize CLYM116 in the territory outside of Greater China. 
• Presented Preclinical Data: Completed IND enabling studies and shared preclinical data highlighting the unique ‘sweeper’ mechanism and product profile at the 2025 ASN Kidney Week in November and reviewed the opportunity in IgAN at a CLYM116-focused R&D Spotlight Webcast in September 2025.
• Initiated Phase 1 Clinical Trial: In December 2025, the Company achieved FPI and completed dosing of the first cohort in the ongoing Phase 1 clinical trial in healthy volunteers to evaluate safety, pharmacokinetics, and pharmacodynamics.
• Regulatory Clearance of Mabworks IND in China: In December 2025, our partner, Mabworks, received clearance of its IND in China to initiate a Phase 1 trial.

Corporate Milestones and Cash Guidance

• Expanded senior leadership team with appointments of Edgar D. Charles, M.D., MSc as Chief Medical Officer, Perrin Wilson, Ph.D., as Chief Business Officer, Susan Altschuller, Ph.D., MBA as Chief Financial Officer, Adam Villa, MS, MBA as SVP, Technical Operations, and Ashley Jones as SVP, People & Workforce Strategy.
• Strengthened Board of Directors with the addition of industry veterans Kim Cobleigh Drapkin, CPA and Bo Cumbo.
• Refreshed financial guidance, with cash, cash equivalents, and marketable securities expected to fund operations into 2028.
  

2026 Anticipated Milestones

Budoprutug:

• SC formulation Phase 1: initial data from healthy volunteer study (H1 2026)
• China SLE Phase 1b: first patient dosed (H1 2026)
• PrisMN (pMN) Phase 2: initial data (H2 2026)
• ITP Phase 1b/2a: initial data, including preliminary efficacy (H2 2026)
• SLE Phase 1b: initial data, including preliminary efficacy (H2 2026)
  

CLYM116

• Phase 1: initial data from healthy volunteer study (mid-2026)
  

About Climb Bio, Inc.
Climb Bio, Inc. is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. The Company’s pipeline includes, budoprutug, an anti-CD19 monoclonal antibody that has demonstrated B-cell depletion and 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 being developed by Climb Bio 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 plasma blasts that are key sources of pathogenic autoantibodies. Budoprutug clinical development is underway for three lead indications - primary membranous nephropathy (pMN), immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE). Early clinical data suggest budoprutug may offer durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in pMN. A subcutaneous formulation is also in clinical development to enable broader patient access and potential home-based dosing. 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 reporting initial data from Climb Bio’s ongoing and planned clinical trials of budoprutug and CLYM116; the anticipated timeline for initiating Climb Bio’s parallel Phase 1b clinical trial of budoprutug in patients with systemic lupus erythematosus in China and the projected enrollment of patients with systemic lupus erythematosus that have lupus nephritis; the anticipated benefits of Climb Bio’s technology transfer and exclusive license agreement with Beijing Mabworks Biotech Co., Ltd. (“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 implied by, such forward-looking statements. Climb Bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: the ability of Climb Bio to timely and successfully achieve or recognize the anticipated benefits of its technology transfer and exclusive license agreement with Mabworks; changes in applicable laws or regulation; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; Climb Bio’s ability to advance budoprutug and CLYM116 on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring boards; replicating in clinical trials positive results found in early-stage clinical trials and nonclinical studies; competing successfully with other companies that are seeking to develop treatments for primary membranous nephropathy, immune thrombocytopenia, systemic lupus erythematosus, IgA nephropathy and other immune-mediated diseases; maintaining or protecting intellectual property rights related to budoprutug, CLYM116 and/or its other product candidates; the outcome of any legal proceedings or other disputes; managing expenses; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug, CLYM116 and any other product candidates Climb Bio may develop. For a discussion of other risks and uncertainties and other important factors, any of which could cause Climb Bio’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Climb Bio’s most recent filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Climb Bio’s views as of the date hereof and should not be relied upon as representing Climb Bio’s views as of any date subsequent to the date hereof. Climb Bio anticipates that subsequent events and developments will cause Climb Bio’s views to change. However, while Climb Bio may elect to update these forward-looking statements at some point in the future, Climb Bio specifically disclaims any obligation to do so, except as required by law. 

Investors and Media
Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com

FAQ

What milestones did Climb Bio (CLYM) announce for budoprutug in 2026?

Climb expects initial SC formulation data in H1 2026 and initial PrisMN Phase 2 efficacy/pharmacodynamic readouts in H2 2026.

When will Climb Bio (CLYM) report initial data from CLYM116 Phase 1?

Initial Phase 1 healthy volunteer data for CLYM116 is anticipated mid-2026.

What is Climb Bio's (CLYM) cash runway guidance announced Jan 8, 2026?

The company indicated cash, cash equivalents, and marketable securities are expected to fund operations into 2028.

Has Climb Bio (CLYM) received regulatory clearance to study budoprutug in China SLE patients?

Yes; the company received clearance of an SLE IND in China in December 2025 to initiate a parallel China Phase 1b trial.

What clinical programs will provide readouts for Climb Bio (CLYM) in 2026?

Expected readouts in 2026 include budoprutug studies in pMN, ITP, and SLE plus initial CLYM116 Phase 1 data.