CLYM

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., May 07, 2026 (GLOBE NEWSWIRE) -- 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 Budoprutug CD19 R&D Spotlight held May 5, 2026. The Company held a webcast to review the development strategy and program updates for budoprutug, the potential opportunity presented by targeting CD19, and anticipated upcoming data readouts. Presented data from Phase 1 trial of subcutaneous (SC) formulation in healthy volunteers. At the recent R&D Spotlight the Company shared data from the completed Phase 1 trial of budoprutug’s SC formulation. Data demonstrated robust B-cell depletion that was similar between SC and intravenous (IV) administration at matched doses. These results, together with...

Dosing completed in Phase 1 study of budoprutug subcutaneous formulation, with data expected in H1 2026 Budoprutug clinical trials ongoing in pMN, ITP, and SLE, with initial data from all three trials expected in H2 2026 Enrollment ongoing in CLYM116 Phase 1 healthy volunteer study, with initial data expected mid-2026 Strong financial position with cash runway expected into 2028 WELLESLEY HILLS, Mass., March 05, 2026 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business updates. “Throughout 2025, we translated strategy into disciplined execution and meaningfully advanced our pipeline,” said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio. “With three clinical trials underway for budoprutug, our anti-CD19 monoclonal antibody, we are in a strong position to evaluate the program across multiple indications with high unmet need. We recently completed dosing in a fourth trial evaluating a subcutaneous formulation of budoprutug and are on track to share data from this study in the first half of 2026. In parallel, we continue to advance the clinical development of CLYM116, our anti-APRIL monoclonal antibody, which we believe has the potential to deliver a differentiated clinical profile in IgAN, and could represent a substantial therapeutic and commercial opportunity. With a global clinical footprint and multiple expected data readouts in 2026, we enter the year positioned for continued execution and an exciting, data-rich period ahead.” Budoprutug Program Updates and Anticipated Milestones PrisMN Phase 2 primary membranous nephropathy (pMN) trial, enrollment ongoing. PrisMN is a global open-label, dose-ranging Phase 2 study designed to evaluate pharmacodynamics (including B cells, anti-PLA2R, and total immunoglobulin) and preliminary efficacy (including complete and partial remission) in pMN patients with persistent proteinuria despite optimized renin-angiotensin-aldosterone system (RAAS) inhibition, and to identify a dose for Phase 3 clinical development. In November 2025, we published long-term outcome data from the Phase 1b trial of budoprutug in pMN at the 2025 American Society of Nephrology (ASN) Kidney Week th...

PrisMN Phase 2 trial of budoprutug in Primary Membranous Nephropathy (pMN) initiated Phase 1 trial of budoprutug subcutaneous formulation initiated, with initial data expected in H1 2026 Clinical trials of budoprutug in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) ongoing, with initial data from both trials expected in H2 2026 Regulatory clearance obtained to initiate CLYM116 Phase 1 trial; anticipate dosing first subject by year-end, with initial data expected mid-2026 Leadership team strengthened with the appointments of Susan Altschuller, Ph.D., MBA, Chief Financial Officer, Adam Villa SVP, Technical Operations, and Ashley Jones SVP, People & Workforce Strategy Cash runway expected through 2027, anticipated to fund company through multiple upcoming clinical milestones WELLESLEY HILLS, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today reported financial results for the third quarter ended September 30, 2025, and provided business updates. “We are proud to have executed effectively against our 2025 plan, advancing the development of budoprutug and CLYM116 while continuing to build organizational strength and capabilities,” said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio. “Both of our programs, budoprutug, an anti-CD19 antibody in clinical development for multiple B-cell mediated diseases, and CLYM116, an anti-APRIL antibody being advanced for IgA nephropathy, have the potential to deliver differentiated clinical profiles and unlock meaningful therapeutic and commercial opportunities in immune-mediated diseases. Looking ahead, we expect 2026 to be an exciting and data-rich year for Climb Bio, with datasets from both programs that will help guide our ascent and the next phase of development.” Budoprutug Program Updates and Anticipated Milestones Phase 2 primary membranous nephropathy (pMN) trial, known as ‘PrisMN,’ initiated in multiple countries, with dosing expected to initiate in the coming weeks. PrisMN, an open-label, dose-ranging Phase 2 clinical trial, is designed to further evaluate safety, pharmacokinetics, pharmacodynamics (including B cells, anti-PLA2R, total immunoglobulin), and preliminary efficacy, including complete and partial remission, and identify...

Clinical Trials of Budoprutug in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) Underway; Trial of Budoprutug in Primary Membranous Nephropathy (pMN) Expected to Initiate in the Coming Weeks Budoprutug Subcutaneous Formulation Demonstrated High Bioavailability and Favorable Tolerability in Non-clinical Studies; Phase 1 Trial Expected to Initiate in the Coming Weeks, with Initial Data Anticipated in First Half 2026 CLYM116 Focused Webcast Event, Including New Preclinical Data, Planned for September 2025; IND or CTA Submission for IgA Nephropathy (IgAN) Expected in Second Half 2025 Edgar D. Charles, M.D., MSc Appointed Chief Medical Officer Strong Financial Position, with Cash Runway Expected Through 2027 WELLESLEY HILLS, Mass., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today reported financial results for the second quarter ended June 30, 2025 and provided business updates. “I am extremely proud of what the Climb Bio team has accomplished this year – we have executed with focus and discipline, building the team and advancing our pipeline. We have now dosed patients in both the ITP and SLE clinical trials of budoprutug, our anti-CD19 monoclonal antibody, and achieved regulatory clearance to initiate the pMN Phase 2 trial and the Phase 1 trial of subcutaneous budoprutug in healthy volunteers, both of which are expected to begin shortly,” said Aoife Brennan, President and CEO of Climb Bio. “We are also making exciting progress with CLYM116, our differentiated anti-APRIL antibody that we believe could be a best-in-class treatment for IgAN and other indications. This execution momentum sets up a data-rich period ahead, beginning with an investor event planned for September 2025 to showcase our CLYM116 program, share supportive preclinical data, and discuss our IgAN development plans.” Second Quarter 2025 and Recent Highlights Budoprutug Program Updates Phase 1b/2a immune thrombocytopenia (ITP) trial FPI achieved, enrollment ongoing. Climb Bio is enrolling an open-label, dose-escalation Phase 1b/2a clinical trial of budoprutug in patients with ITP to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B cell depletion and platelet counts. Phase 1b systemic lupus er...

Clinical Trials of Budoprutug in Primary Membranous Nephropathy (pMN), Immune Thrombocytopenia (ITP), and Systemic Lupus Erythematosus (SLE) on Track to Initiate in 2025 CLYM116 Progressing Towards Anticipated IND or CTA Submission in Second Half 2025 Appointed Kim Cobleigh Drapkin, CPA, and Bo Cumbo as Independent Directors and Perrin Wilson, Ph.D., as Chief Business Officer Strong Financial Position, with Cash Runway Expected Through 2027 WELLESLEY HILLS, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- 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, 2025, and provided business updates. “2025 is a critical year of execution for Climb Bio and we continue to make excellent progress developing a differentiated pipeline targeting immune-mediated diseases with expansive therapeutic and commercial potential,” said Aoife Brennan, President and CEO of Climb Bio. “Our most advanced program, budoprutug, a potential best-in-class anti-CD19 monoclonal antibody designed to treat B-cell mediated diseases, remains on track to initiate clinical studies in ITP and SLE in the coming weeks and in pMN in the second half of 2025. We plan to provide clarity on the anticipated timing of clinical readouts later this year when enrollment dynamics are clearer. In parallel, we are advancing the subcutaneous formulation of budoprutug and subject to regulatory clearance, anticipate initiating a Phase 1 clinical trial in healthy volunteers in the second half of the year.” Dr. Brennan continued, “We have also made progress with our CLYM116 program, a potential best-in-class anti-APRIL monoclonal antibody with potential to provide therapeutic benefit to patients living with IgA nephropathy and other B-cell mediated diseases. We look forward to sharing detailed preclinical data from the program, including pharmacokinetic and pharmacodynamic markers of biological activity, in the second half of 2025 and we anticipate submitting an investigational new drug (IND) or clinical trial application (CTA) for CLYM116 by year end.” First Quarter 2025 and Recent Highlights FDA clearance for budoprutug Phase 2 pMN clinical trial. In March 2025, the Company announced that it had received clearance from the FDA to initiate a Phase 2 clinical trial of bu...

By Exec Edge Research Climb Bio, Inc. (Nasdaq: CLYM) reported full-year results, highlighting a healthy cash cushion and several milestones for investors to watch closely during the remainder of 2025. As we highlighted in our 66-page initiation report last week (download here), CLYM’s lead asset is Budoprutug, an anti-CD19 monoclonal antibody engineered to target diseases such as membranous nephropathy (MN), systemic lupus erythematosus and lupus nephritis (SLE/LN), and immune thrombocytopenia (ITP). The company now has regulatory clearance from the FDA for clinical trials in all three of those indications and continues to strengthen the budoprutug IP. It has begun initiating clinical trials and expects to dose patients later this year. Importantly, CLYM has cash on its balance sheet totaling $212.5 million, up from $106.8 million as of the end of 2023. Per the management, these funds are expected to be sufficient to fund the company’s planned operations through 2027. Please click the link below to read the detailed quarterly update report. Executives-Edge.com [email protected]

Received Clearance from the U.S. Food and Drug Administration (FDA) for Clinical Trials of Budoprutug in Primary Membranous Nephropathy (pMN), Immune Thrombocytopenia (ITP), and Systemic Lupus Erythematosus (SLE) Completed Studies to Support Process Optimization through Cell Line Switch for Budoprutug and Filed Additional Patent Applications to Further Strengthen Intellectual Property Position Expanded Pipeline to Include CLYM116, an Anti-APRIL (A PRoliferation-Inducing Ligand) Monoclonal Antibody for Treatment of IgA Nephropathy (IgAN) Appointed Perrin Wilson, Ph.D. as Chief Business Officer Ended 2024 in a Strong Financial Position, with Cash Runway Expected Through 2027 WELLESLEY HILLS, Mass., March 25, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today reported financial results for the quarter and year ended December 31, 2024, provided a business update, and reiterated anticipated program milestones. “2024 was a transformational year for Climb Bio, as we rebranded the company and embarked on our mission to bring more inspired medicines to patients living with immune-mediated diseases,” said Aoife Brennan, President and CEO of Climb Bio. “Our momentum continues in 2025, which marks a critical year of execution across our portfolio. Our cornerstone asset, budoprutug, a potentially best-in-class anti-CD19 monoclonal antibody, is being developed for three initial indications: pMN, ITP, and SLE, each of which represents a significant opportunity where we believe budoprutug is differentiated and uniquely positioned to deliver meaningful outcomes for patients. With regulatory clearance from the FDA now in place for clinical trials in all three indications, we have begun initiating clinical trials and expect to begin dosing patients later this year.” Dr. Brennan continued, “Additionally, we recently in-licensed a second asset, CLYM116, a potential best-in-class anti-APRIL monoclonal antibody currently in Investigational New Drug (IND)-enabling studies for the treatment of IgAN and other B-cell mediated diseases. We remain focused on progressing this program towards the clinic and expect to share initial preclinical data in the second half of 2025. With two highly differentiated assets in our pipeline, a strong balance sheet, and a deeply experi...