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Climb Bio Inc. (CLYM+2.34%) has submitted its Annual Report on Form 10-K filing for the fiscal year ended December 31, 2024.
The company, a clinical-stage biotechnology firm, focuses on developing therapeutics for immune-mediated diseases. Climb Bio has acquired or in-licensed product candidates that target significant unmet medical needs.
Climb Bio's lead product candidate, budoprutug, is a clinical-stage anti-CD19 monoclonal antibody designed to treat B-cell mediated diseases. The company is initially targeting primary membranous nephropathy (pMN), immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE) with budoprutug.
In March 2025, Climb Bio received clearance from the FDA for a Phase 2 clinical trial of budoprutug in pMN. The company plans to dose the first patient in the second half of 2025. Budoprutug has shown potential in a Phase 1b trial, with 60% of patients achieving complete remission of proteinuria.
Climb Bio also received FDA clearance for a Phase 1b/2a trial of budoprutug in ITP and a Phase 1b trial in SLE. The company anticipates dosing the first patients in these trials in the first half of 2025.
In addition to budoprutug, Climb Bio is developing CLYM116, an anti-APRIL monoclonal antibody for IgA nephropathy (IgAN) and other B-cell mediated diseases. CLYM116 is currently in IND-enabling studies, with preclinical data expected in the second half of 2025.
Climb Bio has identified material weaknesses in its internal control over financial reporting. The company is working to remediate these weaknesses and improve its financial reporting processes.
The company reported net losses of $73.9 million for the year ended December 31, 2024, with an accumulated deficit of $229.9 million. Climb Bio expects to continue incurring significant expenses as it advances its clinical programs.
Climb Bio's strategy includes advancing budoprutug into late-stage development, expanding its indications, optimizing manufacturing processes, and accelerating the development of CLYM116.
The company acknowledges its dependence on third-party manufacturers and CROs for the development and commercialization of its product candidates.
Climb Bio is subject to various risks, including regulatory, competitive, and financial risks, as outlined in the risk factors section of the filing.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Climb Bio Inc. annual 10-K report dated March 25, 2025. To report an error, please email earnings@qz.com.