Preclinical data for CLYM116, anti-APRIL monoclonal antibody, highlight favorable pharmacokinetic and pharmacodynamic profile, supporting development for IgA nephropathy (IgAN) Long-term follow-up clinical data for budoprutug, anti-CD19 monoclonal antibody, support potential for therapeutic benefit in primary membranous nephropathy (pMN) WELLESLEY HILLS, Mass., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with ...

Core Viewpoint - Climb Bio, Inc. has appointed Susan Altschuller, Ph.D., MBA, as Chief Financial Officer, enhancing its leadership team to support the advancement of its therapeutic pipeline for immune-mediated diseases [1][2][3] Company Leadership - Susan Altschuller brings over 20 years of strategic and financial leadership experience in the biopharmaceutical sector, having previously served as CFO at Cerevel Therapeutics and ImmunoGen [2][3] - Her expertise includes financial strategy, capital allocation, and operational execution, which will be valuable as Climb Bio progresses with its clinical programs [2][3] Clinical Pipeline - Climb Bio is advancing two key programs: budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody for IgA nephropathy [4] - The company anticipates generating significant clinical data from both programs in the upcoming year, which will inform future strategies [2][3] Inducement Equity Award - In connection with her appointment, Climb Bio granted Dr. Altschuller an inducement equity award consisting of a non-statutory stock option to purchase up to 600,000 shares of common stock, with a ten-year term and a four-year vesting schedule [3]

R&D Spotlight: CLYM116 and the IgAN Opportunity SEPTEMBER 29, 2025 © 2025 Climb Bio 1 Forward Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: future expectations, plans and prospects for Climb Bio, Inc. ("Climb Bio"); expectations regarding the therapeutic benefits, clinical potential and clinical development of budoprutug and CLYM116; the trial design for ...

New preclinical data demonstrate deeper IgA reduction and a longer half-life compared to first-generation anti-APRIL monoclonal antibody CLYM116 Phase 1 trial initiation expected in Q4 2025, with initial biomarker and dosing interval data anticipated mid-year 2026 Company to host R&D Spotlight Webcast today, September 29, 2025 WELLESLEY HILLS, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company developing therapeutics for immune-mediated diseases, ...

Climb Bio Conference Call Summary Company Overview - **Company Name**: Climb Bio - **Focus**: RNI (Receptor-Negative Immunology) with a focus on developing therapies for B-cell mediated diseases - **Key Programs**: - CD19 B-cell depleting therapy (Budo) - CLYM116, an anti-APRIL antibody - **Company Age**: Approximately 12 months since rebranding from Ellium Therapeutics [4][6] Key Points and Arguments Company Strategy and Differentiation - Climb Bio aims to leverage recent advancements in understanding B-cell mediated diseases to develop therapies that allow for drug-free remission [7] - The company is focused on scalable therapies using monoclonal antibodies rather than complex and costly cell therapies like CAR-T [9] - The strategy includes prioritizing indications with high unmet needs and substantial commercial potential [11] Product Pipeline - **Lead Asset**: Budo (anti-CD19 monoclonal antibody) - Targeting CD19 is seen as optimal due to its expression across various B-cell stages and its ability to deplete auto-reactive B-cells [13][14] - Budo is differentiated from existing CD19 therapies by its high affinity and potential for subcutaneous administration [15][16] - **Second Asset**: CLYM116 (anti-APRIL antibody) - Unique mechanism of action that degrades APRIL, potentially leading to increased efficacy and reduced treatment burden [46] Clinical Development Insights - Budo is currently under investigation for primary membranous nephropathy (PMN) and immune thrombocytopenia (ITP) [29][42] - Early data from PMN trials showed promising results with complete B-cell depletion and significant proteinuria reduction [34] - The company plans to initiate a phase 2 study for Budo in the second half of 2025, guided by insights from the phase 1b study [36][40] Market Opportunity - There is a significant unmet need in PMN, with no approved therapies currently available, presenting a substantial market opportunity [31] - Climb Bio is also exploring indications in IgE-mediated diseases, single organ autoimmunity, and complex systemic diseases, with a focus on lupus [24][27] Biomarker Strategy - Biomarkers are central to Climb Bio's development strategy, particularly B-cell depletion and autoantibody reductions, which are expected to correlate with clinical outcomes [22][23] Future Outlook - Key value-creating accomplishments anticipated over the next year include successful execution of clinical studies, differentiation of their products, and strategic indication selection [48] Additional Important Content - The company was formed through a shell company acquisition, which has implications for its market positioning and investor awareness [5] - The leadership team has extensive experience in both large pharma and biotech, enhancing the company's strategic capabilities [2][3] This summary encapsulates the critical insights and strategic direction of Climb Bio as discussed during the conference call, highlighting its innovative approach to addressing unmet medical needs in the field of immunology.

Core Viewpoint - Climb Bio, Inc. is advancing its CLYM116 program, a preclinical-stage monoclonal antibody targeting APRIL for the treatment of IgA nephropathy, with a webcast event scheduled to discuss its potential and development strategy [1][2]. Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for immune-mediated diseases, with a pipeline that includes CLYM116 and budoprutug, an anti-CD19 monoclonal antibody [4]. CLYM116 Program Details - CLYM116 targets APRIL, a key driver of pathogenic B cell activity in autoimmune diseases, and employs a unique 'sweeper' mechanism to recycle the antibody and eliminate APRIL, potentially leading to best-in-class efficacy with less frequent dosing [2][5]. - The company plans to file an IND or CTA for CLYM116 in the second half of 2025, with a Phase 1 clinical trial to follow upon regulatory clearance [2][5]. Upcoming Webcast Event - The CLYM116 webcast event is scheduled for September 29, 2025, featuring Climb Bio's management and nephrologist Craig E. Gordon, and will be accessible via the company's website [1][3]. Research and Development Strategy - The event will cover an overview of IgA nephropathy, preclinical data comparing CLYM116 to a first-generation anti-APRIL monoclonal antibody, and the company's development strategy for CLYM116 [7].

Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for immune-mediated diseases [4] - The company's pipeline includes budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody currently in IND-enabling studies for IgA nephropathy [4] Upcoming Investor Conferences - Climb Bio's executive team will participate in several investor conferences in September 2025, including: - Cantor Global Healthcare Conference on September 5, 2025, at 10:55 a.m. ET in New York, NY [2] - Baird Global Healthcare Conference on September 9, 2025, at 4:20 p.m. ET in New York, NY [2] - Morgan Stanley Annual Global Healthcare Conference on September 10, 2025, with one-on-one meetings only [2] - Stifel Virtual Immunology and Inflammation Forum on September 16, 2025, at 10:30 a.m. ET, conducted virtually [3] Webcast Information - Live webcasts of the conferences will be accessible via the "Investors and News" section of the Climb Bio website, with replays available approximately two hours after each event and archived for at least 30 days [3]

Core Viewpoint - Climb Bio, Inc. is actively engaging with investors through participation in multiple upcoming healthcare conferences, showcasing its commitment to transparency and investor relations [1][2][3]. Group 1: Upcoming Conferences - Climb Bio will participate in the Cantor Global Healthcare Conference on September 5, 2025, featuring a fireside chat and one-on-one investor meetings [2]. - The company will also attend the Baird Global Healthcare Conference on September 9, 2025, with a similar format of fireside chat and one-on-one meetings [2]. - Additionally, Climb Bio is scheduled for the Morgan Stanley Annual Global Healthcare Conference on September 10, 2025, which will consist of one-on-one meetings only [2]. Group 2: Virtual Forum - Climb Bio will take part in the Stifel Virtual Immunology and Inflammation Forum on September 10, 2025, offering a presentation and one-on-one investor meetings [3]. - Live webcasts of these events will be accessible on the Climb Bio website, with replays available approximately two hours after each event and archived for at least 30 days [3]. Group 3: Company Overview - Climb Bio, Inc. is a clinical-stage biotechnology company focused on developing therapeutics for immune-mediated diseases [4]. - The company's pipeline includes budoprutug, an anti-CD19 monoclonal antibody aimed at treating a range of B-cell mediated diseases, and CLYM116, an anti-APRIL monoclonal antibody currently in IND-enabling studies for IgA nephropathy [4].

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]