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Climb Bio (Nasdaq: CLYM) ends 2025 with $160.7M cash and key 2026 trial readouts ahead

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(High)
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(Neutral)
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8-K

Rhea-AI Filing Summary

Climb Bio, Inc. reported fourth quarter and full-year 2025 results showing continued investment in its immune-mediated disease pipeline and a stronger balance sheet. Cash, cash equivalents and marketable securities were $160.7 million as of December 31, 2025, which the company expects will fund operations into 2028.

Full-year 2025 research and development expenses rose to $46.7 million from $14.3 million, while general and administrative expenses increased to $21.2 million from $16.0 million, reflecting pipeline and corporate growth. Net loss narrowed to $59.9 million in 2025 from $73.9 million in 2024, with loss per share improving to $0.88 from $1.53.

The company highlighted progress in multiple clinical programs. Budoprutug is in ongoing trials for primary membranous nephropathy, immune thrombocytopenia and systemic lupus erythematosus, plus a completed Phase 1 study of a subcutaneous formulation, with initial data from several studies expected in 2026. CLYM116 is in a Phase 1 healthy volunteer study, supported by a partner-led Phase 1/2 trial in IgA nephropathy.

Positive

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Negative

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Insights

Climb Bio ends 2025 with solid cash, deeper R&D spend, and multiple 2026 data catalysts.

Climb Bio closed 2025 with cash, cash equivalents and marketable securities of $160.7 million, which it expects will fund operations into 2028. This gives room to run several parallel clinical programs without immediate financing pressure, an important factor for a clinical-stage biotech with no product revenue.

R&D expenses rose sharply to $46.7 million in 2025 from $14.3 million in 2024 as the company advanced budoprutug across primary membranous nephropathy, immune thrombocytopenia and systemic lupus erythematosus, and progressed CLYM116 toward IgA nephropathy. Despite this higher ongoing spend, net loss improved to $59.9 million from $73.9 million, helped by the absence of prior-year acquired in-process R&D.

The near-term story centers on execution of clinical milestones. Dosing has completed in a Phase 1 subcutaneous budoprutug trial with data expected in the first half of 2026, and initial readouts from three budoprutug trials plus CLYM116 healthy volunteer data are anticipated in the second half of 2026 and mid-2026. Actual impact will depend on safety and efficacy signals seen in these datasets and on regulatory interactions described in future disclosures.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 05, 2026

 

 

Climb Bio, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40708

83-2273741

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

20 William Street

Suite 145

 

Wellesley Hills, Massachusetts

 

02481

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (866) 857-2596

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

CLYM

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 


Item 2.02 Results of Operations and Financial Condition.

On March 5, 2026, Climb Bio, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

The information in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether filed before or after the date hereof and regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

Description

99.1

Press release of Climb Bio, Inc., dated March 5, 2026

 104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Climb Bio, Inc.

 

 

 

 

Date:

March 5, 2026

By:

/s/ Aoife Brennan

 

 

 

Aoife Brennan, M.B., Ch.B.
President and Chief Executive Officer

 


 

 

Exhibit 99.1

img109660168_0.gif

 

Climb Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates

 

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., (GLOBE NEWSWIRE) – March 5, 2026 – 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 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 acquisition of Tenet Medicines, Inc. and its technology transfer and exclusive license agreement with Mabworks; 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 or 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; managing expenses; changes in applicable laws or regulation; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; 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

 

 


 

Climb Bio, Inc.

 

Condensed Consolidated Balance Sheets

(In thousands)

(unaudited)

 

 

 

December 31,

 

 

 

2025

 

 

2024

 

Assets

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

160,652

 

 

$

212,529

 

Other assets

 

 

7,092

 

 

 

4,658

 

Total assets

 

$

167,744

 

 

$

217,187

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Liabilities

 

$

7,269

 

 

$

5,306

 

Total stockholders’ equity

 

 

160,475

 

 

 

211,881

 

Total liabilities and stockholders’ equity

 

$

167,744

 

 

$

217,187

 

 

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(unaudited)

 

 

 

Three Months Ended
December 31,

 

 

Year Ended
December 31,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

13,738

 

 

$

5,959

 

 

$

46,713

 

 

$

14,336

 

Acquired in-process research and development,
   related party

 

 

 

 

 

 

 

 

 

 

 

51,659

 

General and administrative

 

 

5,558

 

 

 

4,952

 

 

 

21,170

 

 

 

16,025

 

Total operating expenses

 

 

19,296

 

 

 

10,911

 

 

 

67,883

 

 

 

82,020

 

Loss from operations

 

 

(19,296

)

 

 

(10,911

)

 

 

(67,883

)

 

 

(82,020

)

Other income, net

 

 

1,780

 

 

 

2,495

 

 

 

8,032

 

 

 

8,123

 

Net loss

 

$

(17,516

)

 

$

(8,416

)

 

$

(59,851

)

 

$

(73,897

)

Net loss per share, basic and diluted

 

$

(0.26

)

 

$

(0.13

)

 

$

(0.88

)

 

$

(1.53

)

 

 

 


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WELLESLEY HILLS