Core Insights - Climb Bio, Inc. has initiated a Phase 2 trial of budoprutug for Primary Membranous Nephropathy (pMN) and expects to advance its clinical programs significantly in 2026 [1][2] - The company has strengthened its leadership team with key appointments to enhance operational capabilities [1][11] - Financial results indicate a cash position that is expected to sustain operations through 2027, allowing for continued development of its clinical pipeline [1][8] Budoprutug Program Updates - The Phase 2 trial, named 'PrisMN,' has been initiated in multiple countries, focusing on safety, pharmacokinetics, and preliminary efficacy [5] - A Phase 1 trial of a subcutaneous formulation of budoprutug is ongoing, with initial data expected in H1 2026 [1][5] - Ongoing trials for budoprutug in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) are expected to yield initial data in H2 2026 [1][5] CLYM116 Program Updates - CLYM116, targeting the APRIL pathway for IgA nephropathy, has received regulatory clearance for a Phase 1 trial, with dosing anticipated by year-end 2025 [1][6] - Initial data from the CLYM116 trial is expected in mid-2026, following a recent R&D Spotlight Webcast that highlighted its differentiation from first-generation therapies [6][2] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $175.8 million, expected to fund operations through 2027 [1][11] - Research and Development (R&D) expenses for Q3 2025 were $9.1 million, an increase from $6.2 million in Q3 2024, while General and Administrative (G&A) expenses were $5.8 million, slightly up from $5.5 million in the prior year [8][11]

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]

Core Insights - Climb Bio, Inc. is advancing its clinical pipeline with ongoing trials for budoprutug in immune thrombocytopenia (ITP) and systemic lupus erythematosus (SLE), and plans to initiate a trial for primary membranous nephropathy (pMN) soon [1][3][4] - The company has a strong financial position, with cash reserves expected to fund operations through 2027 [1][10] Budoprutug Program Updates - Budoprutug, an anti-CD19 monoclonal antibody, is currently in Phase 1b/2a trials for ITP and SLE, with enrollment ongoing [6][12] - The pMN Phase 2 trial is set to begin in the coming weeks, focusing on safety and preliminary efficacy [6][12] - A subcutaneous formulation of budoprutug has shown high bioavailability and favorable tolerability in non-clinical studies, with a Phase 1 trial expected to start shortly [1][6] CLYM116 Program Updates - CLYM116, an anti-APRIL monoclonal antibody, is progressing towards clinical development for IgA nephropathy (IgAN), with an IND or CTA submission anticipated in the second half of 2025 [5][14] - An investor event is planned for September 2025 to present new preclinical data on CLYM116 [1][5] Corporate Updates - Edgar D. Charles, M.D., MSc has been appointed as Chief Medical Officer, bringing over 20 years of experience in immunology-focused pharmaceutical development [8] - The company reported a net loss of $8.7 million for the second quarter of 2025, compared to a loss of $54.9 million in the same period of 2024 [10][19] Financial Highlights - As of June 30, 2025, Climb Bio had cash, cash equivalents, and marketable securities totaling $187.4 million [10][17] - Research and development expenses for the second quarter of 2025 were $6.6 million, significantly higher than $1.0 million in the same period of 2024 [10][19]

Core Insights - Climb Bio, Inc. has appointed Dr. Edgar D. Charles as Chief Medical Officer and Cindy J. Driscoll as Senior Vice President, Finance, enhancing its leadership team at a crucial time for the company [1][2] Leadership Appointments - Dr. Charles brings over 20 years of experience in immunology-focused pharmaceutical development, having previously held significant roles at Bristol Myers Squibb, where he led the development of various therapeutic candidates [2][3] - Cindy Driscoll has over two decades of experience in financial and administrative functions within the biopharma sector, previously serving as Senior Vice President of Finance at HC Bioscience [2][4] Clinical Development Focus - The company is focused on advancing its clinical studies for budoprutug and CLYM116, with Dr. Charles emphasizing the therapeutic potential of budoprutug in treating serious diseases where B cells are central to pathology [4][7] - Budoprutug is an anti-CD19 monoclonal antibody that has shown promise in B cell depletion, while CLYM116 is an anti-APRIL monoclonal antibody currently in IND-enabling studies for IgA nephropathy [7] Inducement Equity Awards - Climb Bio has granted inducement equity awards to Dr. Charles and Ms. Driscoll, including stock options to purchase 600,000 and 200,000 shares of common stock, respectively, with an exercise price of $1.20 per share [5][6]