Data-Rich Year Ahead - Will 2026 Readouts Lift Climb Bio Higher

Eliem Therapeutics

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(RTTNews) - For Climb Bio Inc. (CLYM), 2026 promises to be a data-rich year, with study results from two of its core programs poised to shape the company's strategy and guide subsequent development phases.

The company is focused on delivering disease-modifying medicines for individuals living with immune-mediated diseases. Its drug candidates in focus are Budoprutug and CLYM116.

Budoprutug is an anti-CD19 monoclonal antibody (mAb) designed to result in potent and durable B cell depletion, with a long dosing interval and the potential for both intravenous (IV) and subcutaneous (SC) administration. In IV formulation, Budoprutug is being explored for indications including primary membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus. The subcutaneous (SC) formulation of Budoprutug is designed to offer greater flexibility for patients and providers.

CLYM116 is a novel anti-APRIL mAb with a novel mechanism designed to promote potent degradation of APRIL and extend half-life. APRIL (A PRoliferation Inducing Ligand) plays a key role in B cell regulation, making it an attractive target for multiple B-cell-mediated diseases like systemic lupus erythematosus, myasthenia gravis, or IgA nephropathy.

Ongoing Trials & Upcoming Catalysts

-- A phase 2, open-label, multicenter study evaluating the safety, pharmacodynamics (PD), and preliminary efficacy of three intravenous (IV) dose regimens of Budoprutug in adult subjects with primary membranous nephropathy, dubbed PrisMN. The study, designed to enrol 45 subjects, is expected to be completed in 2027.

Primary Membranous Nephropathy (pMN) is a serious and progressive kidney disease. It occurs when the body's immune system makes autoantibodies that mistakenly attack a protein found in the kidneys. These autoantibodies form immune complexes that build up in the glomeruli - the tiny filters in the kidneys - causing inflammation and kidney damage. Despite being a serious kidney disease, there are currently no approved therapies.

-- A phase 1b/2a, open-label, sequential-cohort, dose escalation and expansion study is evaluating the safety, tolerability, pharmacokinetics (PK), PD, and preliminary clinical effectiveness of Budoprutug as IV infusions in subjects with immune thrombocytopenia (ITP). Initial data from this study, including preliminary efficacy, are anticipated in the second half of 2026.

Immune Thrombocytopenia (ITP) is a chronic autoimmune disorder that affects the blood. It happens when the body's immune system mistakenly targets and destroys its own platelets, which are the small blood particles essential for normal blood clotting. As platelet counts drop, patients become more vulnerable to bruising, bleeding episodes, or, in severe cases, life-threatening hemorrhage. Corticosteroids are the first-line treatment for ITP, but most patients respond poorly to them, and many experience disease progression despite standard second-line therapies.

-- A phase 1b, open-label single-ascending-dose study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and early indications of efficacy of Budoprutug as IV infusion in patients with systemic lupus erythematosus. Initial preliminary efficacy from this trial is expected in the second half of 2026.

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease in which the body's immune system generates autoreactive lymphocytes (white blood cells) and autoantibodies that mistakenly attack healthy tissues. This can lead to swelling, pain, and damage in virtually any part of the body and organ system, including the skin, joints, kidneys, heart, lungs, and brain. While steroids are often used as a first-line treatment, they are not a long-term solution, and many patients relapse even with approved therapies.

A phase 1 study assessing the safety and tolerability of the SC formulation of Budoprutug in healthy volunteers is currently underway. Initial data from this study are expected in the first half of 2026.

-- Regulatory clearance to initiate a phase 1 trial of CLYM116 in healthy volunteers was obtained recently. The company expects to dose the first subject by year-end 2025, with initial data anticipated mid-2026.

Cash Position

The company ended September 30, 2025, with cash, cash equivalents and marketable securities of $175.8 million, sufficient to fund operations through 2027.

Formerly known as Eliem Therapeutics, Inc., the company went public on the Nasdaq Global Market on August 10, 2021, under the ticker symbol "ELYM," at an initial public offering price of $12.50 per share. On October 3, 2024, the company rebranded as Climb Bio, Inc. and changed its ticker symbol to "CLYM," reflecting a strategic shift toward building a pipeline focused on immune-mediated diseases.

CLYM has traded in a range of $1.05 to $3.25 in the last 1 year. The stock closed Friday's (Dec.12, 2025) trading at $3.00, up 30.43%.