[8-K] Climb Bio, Inc. Reports Material Event
Rhea-AI Filing Summary
Climb Bio, Inc. reported first quarter 2026 results, continued progress across its two lead programs, and strengthened its balance sheet. The company recorded a net loss of $13.7 million for the three months ended March 31, 2026, compared with $20.8 million a year earlier, as research and development spending declined.
Cash, cash equivalents and marketable securities totaled $146.3 million as of March 31, 2026, and management expects this to fund operations into 2028, excluding proceeds from a recently completed private placement. On April 29, 2026, Climb Bio closed a $110 million private financing led by healthcare investors.
Clinically, the anti‑CD19 antibody budoprutug showed robust B‑cell depletion with its subcutaneous formulation in healthy volunteers, supporting further development in autoimmune diseases. Multiple Phase 1b/2a and Phase 2 trials in primary membranous nephropathy, immune thrombocytopenia and systemic lupus erythematosus are enrolling, with several data readouts anticipated in 2026.
Positive
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Insights
Q1 loss narrowed, pipeline advanced, and a $110M raise bolstered cash.
Climb Bio reported a Q1 2026 net loss of $13.7 million, improving from $20.8 million a year earlier, mainly as prior-period R&D included a $9 million upfront license payment. Operating expenses fell to $15.2 million, reflecting a more focused development spend.
Cash, cash equivalents and marketable securities were $146.3 million as of March 31, 2026, with management expecting this to fund operations into 2028, before factoring in the additional $110 million private placement. That financing, completed on April 29, 2026, meaningfully extends financial flexibility during an intensive clinical data period.
On the pipeline, robust B‑cell depletion with subcutaneous budoprutug and ongoing trials in pMN, ITP and SLE, plus Phase 1 work on APRIL‑targeting antibody CLYM116, set up multiple efficacy and PK/PD data readouts through 2026. Actual impact will depend on the quality of upcoming data and regulatory interactions.
8-K Event Classification
Key Figures
Key Terms
Fast Track Designation regulatory
primary membranous nephropathy medical
immune thrombocytopenia medical
systemic lupus erythematosus medical
IgA nephropathy medical
Phase 1b/2a technical
Earnings Snapshot
Based on its current operating plan, the company expects its March 31, 2026 cash, cash equivalents and marketable securities balance to fund operations into 2028, excluding proceeds from the April 2026 private placement.
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
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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 May 7, 2026, Climb Bio, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026. 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.
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Description |
99.1 |
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Press release of Climb Bio, Inc., dated May 7, 2026 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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.
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Climb Bio, Inc. |
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May 7, 2026 |
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/s/ Aoife Brennan |
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Aoife Brennan, M.B., Ch.B. |
Exhibit 99.1
Climb Bio Reports First Quarter 2026 Financial Results and Provides Business Updates
Robust B-cell depletion observed with budoprutug subcutaneous formulation in healthy volunteers, supporting continued development
CLYM116 modeling and initial Phase 1 safety data to be presented at ERA 2026 with initial Phase 1 PK/PD data expected mid-2026
Budoprutug pMN, ITP, and SLE clinical trials enrolling to plan; anticipate data from all ongoing trials in 2026
Secured $110 million private placement led by top-tier healthcare investors
WELLESLEY HILLS, MASS., (GLOBE NEWSWIRE) – May 7, 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 first quarter ended March 31, 2026, and provided business updates.
“During the first quarter, we continued to execute on a focused development strategy aimed at generating clear clinical and translational data across our two programs,” said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio. “For budoprutug, our anti‑CD19 monoclonal antibody, we recently hosted an R&D Spotlight highlighting our clinical progress, including topline data from the subcutaneous formulation and the broader potential opportunity for CD19 targeting in autoimmune disease. With multiple studies underway, we believe we are well positioned to assess the potential of budoprutug across several indications with significant unmet need. In parallel, we continue to advance CLYM116, our anti‑APRIL monoclonal antibody, and look forward to sharing additional data on this program in the coming months. As we move through 2026, we remain focused on disciplined execution and building a robust data foundation to inform the long‑term potential of both programs.”
Budoprutug Program Updates and Anticipated Milestones
CLYM116 Program Updates and Anticipated Milestones
Corporate Updates
Fourth Quarter and Full Year 2025 Financial Results and Guidance
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 and Fast Track 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 Phase 1b/2a clinical trial of budoprutug in systemic lupus erythematosus 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; the impact of the proceeds from the April 2026 private placement on Climb Bio’s balance sheet; 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; the outcome of any legal proceedings or other disputes; 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)
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March 31, 2026 |
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December 31, 2025 |
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Assets |
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Cash, cash equivalents and marketable securities |
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$ |
146,305 |
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$ |
160,652 |
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Other assets |
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6,067 |
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7,092 |
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Total assets |
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$ |
152,372 |
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$ |
167,744 |
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Liabilities and stockholders’ equity |
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Liabilities |
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$ |
4,287 |
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$ |
7,269 |
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Total stockholders’ equity |
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148,085 |
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160,475 |
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Total liabilities and stockholders’ equity |
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$ |
152,372 |
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$ |
167,744 |
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Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(unaudited)
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Three Months Ended |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
9,373 |
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$ |
17,327 |
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General and administrative |
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5,838 |
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5,691 |
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Total operating expenses |
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15,211 |
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23,018 |
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Loss from operations |
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(15,211 |
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(23,018 |
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Other income, net |
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1,489 |
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2,237 |
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Net loss |
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$ |
(13,722 |
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$ |
(20,781 |
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Net loss per share, basic and diluted |
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$ |
(0.20 |
) |
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$ |
(0.31 |
) |