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H.C. Wainwright Forecasts 2026 Data Readouts for Climb Bio’s (CLYM) Budoprutug Across Clinical Tracks
Yahoo Finance· 2025-12-31 16:13
Core Insights - Climb Bio Inc. (NASDAQ:CLYM) is identified as a promising biotech penny stock, with analysts projecting a price target increase from $9 to $11 while maintaining a Buy rating due to anticipated data readouts in 2026 for its lead asset Budoprutug [1][2] Group 1: Company Overview - Climb Bio is a clinical-stage biotechnology company focused on developing therapies for immune-mediated diseases, primarily through its two main assets: Budoprutug and CLYM116 [2][5] - Budoprutug is an anti-CD19 antibody targeting B-cell mediated diseases, while CLYM116 is an anti-APRIL antibody aimed at treating IgA nephropathy [2] Group 2: Clinical Trials and Data Readouts - The company has initiated the PrisMN Phase 2 trial for Budoprutug in Primary Membranous Nephropathy, with the trial designed to evaluate safety, pharmacokinetics, and preliminary efficacy, aiming for data release in 2026 [3] - A Phase 1 trial for a subcutaneous formulation of Budoprutug is currently ongoing, with initial data expected in the first half of 2026 [3] - Climb Bio is also conducting an open-label Phase 1b/2a trial for Budoprutug in patients with Immune Thrombocytopenia and a Phase 1b trial in Systemic Lupus Erythematosus patients, with preliminary efficacy results anticipated in the second half of 2026 [4]
Data-Rich Year Ahead - Will 2026 Readouts Lift Climb Bio Higher
RTTNews· 2025-12-15 08:43
Core Insights - Climb Bio Inc. (CLYM) is set for a data-rich year in 2026, with study results from its key programs expected to influence its strategic direction and future development phases [1] Drug Candidates - Budoprutug is an anti-CD19 monoclonal antibody designed for potent and durable B cell depletion, with both intravenous (IV) and subcutaneous (SC) administration options. It is being investigated for primary membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus [2] - CLYM116 is a novel anti-APRIL monoclonal antibody aimed at promoting the degradation of APRIL, targeting B-cell-mediated diseases such as systemic lupus erythematosus, myasthenia gravis, and IgA nephropathy [3] Ongoing Trials & Upcoming Catalysts - A phase 2 study named PrisMN is evaluating Budoprutug's safety and efficacy in adult subjects with primary membranous nephropathy, enrolling 45 subjects and expected to complete in 2027 [4] - A phase 1b/2a study is assessing Budoprutug in immune thrombocytopenia, with initial efficacy data anticipated in the second half of 2026 [6] - A phase 1b study is evaluating Budoprutug in systemic lupus erythematosus, with preliminary efficacy data expected in the second half of 2026 [8] - A phase 1 study for the SC formulation of Budoprutug in healthy volunteers is ongoing, with initial data expected in the first half of 2026 [10] - Regulatory clearance for a phase 1 trial of CLYM116 has been obtained, with dosing expected to start by the end of 2025 and initial data anticipated mid-2026 [10] Financial Position - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $175.8 million, which is sufficient to fund operations through 2027 [11] Company Background - Climb Bio, formerly Eliem Therapeutics, went public on August 10, 2021, under the ticker symbol "ELYM" at an IPO price of $12.50 per share. The company rebranded to Climb Bio, Inc. and changed its ticker symbol to "CLYM" on October 3, 2024, reflecting a strategic focus on immune-mediated diseases [12] - CLYM's stock has traded between $1.05 and $3.25 over the past year, closing at $3.00 on December 12, 2025, representing a 30.43% increase [13]
Climb Bio (NasdaqGM:CLYM) Earnings Call Presentation
2025-09-29 12:00
CLYM116 & IgAN Opportunity - Climb Bio's mission is to deliver high impact, disease-modifying medicines for individuals living with immune-mediated diseases[5] - CLYM116 is an anti-APRIL monoclonal antibody being developed for IgA Nephropathy (IgAN)[8, 48] - Climb Bio has worldwide rights to CLYM116 outside Greater China, partnering with Beijing Mabworks Biotech Co, Ltd[9, 11] - Phase 1 initiation of CLYM116 is expected in Q4 2025, with initial data anticipated mid-year 2026[8, 15, 16, 106] IgAN Market & Treatment Landscape - IgAN represents a significant market opportunity estimated at ~$10-20 billion in the US, with most patients requiring lifelong treatment[12, 105] - KDIGO 2025 guidelines recommend treatment initiation for patients with proteinuria >=05 g/day, representing approximately 60-75% of patients[13] - The FDA recognizes the need for surrogate outcomes, such as improvement in proteinuria, in IgAN studies for accelerated approval[29] CLYM116 Differentiated Profile - CLYM116 is the only known "sweeper" anti-APRIL mAb in development, designed for improved activity, less frequent dosing, and a favorable safety profile[10, 57, 103, 106] - Preclinical NHP data demonstrated potential for deep and durable IgA suppression, with >70% maximal reduction after a single 6 mg/kg SC dose, and a ~2-3x longer half-life compared to sibeprenlimab[16, 74, 84, 89, 90, 104] - In NHPs, CLYM116 SC demonstrated high bioavailability of ~85% and favorable tolerability, supporting potential for convenient, at-home dosing[81]