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]

Climb Bio Investor Event Summary Company Overview - **Company**: Climb Bio (NasdaqGM:CLYM) - **Focus**: Development of Climb 116 for IgA nephropathy treatment Key Industry Insights - **IgA Nephropathy**: A significant cause of end-stage renal disease with over 170,000 patients in the U.S. alone, expected to grow due to updated diagnostic guidelines [8][9] - **Market Opportunity**: IgA nephropathy represents a large and growing commercial opportunity with established regulatory pathways for drug approval [9][10] Core Points and Arguments - **Climb 116 Development**: - Climb 116 is a next-generation anti-APRIL monoclonal antibody, designed to target APRIL, a key player in IgA nephropathy pathogenesis [28][33] - The drug is expected to enter clinical trials later this year, with initial data anticipated by mid-2026 [48][50] - Climb 116 has shown potential for deeper and more durable IgA reductions compared to first-generation therapies [51][52] - **Clinical Strategy**: - Climb Bio's strategy emphasizes rigorous clinical development with a focus on differentiated monoclonal antibodies against validated B-cell targets [5][6] - The company plans to leverage partnerships, such as with Mabwell, to expedite development and commercialization [7][8] - **Preclinical Results**: - Climb 116 demonstrated superior pharmacokinetics (PK) and pharmacodynamics (PD) in non-human primate studies, showing a longer half-life and deeper IgA suppression compared to sibecrilimumab [42][44][46] - The drug's unique "sweeper" mechanism allows for effective recycling and prolonged APRIL suppression, which may lead to improved clinical outcomes [35][36][40] Important but Overlooked Content - **Regulatory Pathway**: The established regulatory precedent for IgA nephropathy treatments supports a streamlined clinical development process for Climb 116 [51] - **Biomarker Utilization**: The use of biomarkers such as proteinuria and IgA levels will guide dose selection and efficacy predictions in clinical trials [49][50] - **Immunogenicity Concerns**: While anti-drug antibodies (ADAs) were observed in non-human primate models, the company has low suspicion of immunogenicity in humans based on historical data [62] Conclusion - Climb Bio is positioned to potentially lead the market in IgA nephropathy treatments with Climb 116, which shows promise for improved efficacy and patient compliance through less frequent dosing and a favorable safety profile [52]

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 - Climb Bio (NasdaqGM:CLYM) is a newly relaunched company focusing on developing monoclonal antibodies for various indications, particularly in the B cell space [2][3] Core Insights - Climb Bio has two main programs: - BUDO, a B cell depleting CD19 monoclonal antibody - CLIMB-one 116, an April targeted monoclonal antibody [3] - The company sees significant opportunities in addressing unmet needs in B cell mediated diseases, particularly with CD19 as a target [3][5] - Monoclonal antibodies can be manufactured at scale and delivered safely in community healthcare settings, which is a key advantage [5][6] Market Dynamics - There is a growing interest in CD19 as a target for B cell diseases, with a belief that monoclonal antibodies have not been fully exploited in this area [4][5] - The company emphasizes that the market is not a zero-sum game; multiple modalities can coexist and serve different patient needs [11][12] - The historical focus on CD20 over CD19 in oncology has led to a delayed recognition of CD19's potential in immunology [14][19] Development Strategy - Climb Bio is pursuing three strategic buckets for indications: 1. IgG4 mediated diseases (e.g., primary membranous nephropathy) 2. Single organ orphan diseases (e.g., NMOSD, ITP) 3. Complex systemic disorders (e.g., systemic lupus erythematosus) [26][28] - The company is actively enrolling in multiple clinical studies, with data expected in 2026 for subcutaneous formulations and later this year for ITP and SLE studies [30][31] Dosing and Efficacy - The company is focused on understanding B cell biology to optimize dosing strategies, emphasizing the importance of depleting both peripheral and tissue-resident B cells [33][36] - There is a commitment to ensuring that dosing does not prematurely select suboptimal doses, which could impact long-term efficacy [35][36] Pipeline Expansion - Climb Bio is adding CLIMB-one 116 to its pipeline, targeting April, which is seen as a complementary asset to their existing CD19 programs [38][39] - The company believes that differentiation in the April space is crucial, particularly in IgA nephropathy, and is excited about the potential of their unique sweeper technology [42][43] Financial Outlook - Climb Bio's current cash runway extends through 2027, allowing for the advancement of all clinical studies and the CLIMB-one 116 program [45] Additional Insights - The company is focused on delivering value for both patients and shareholders, emphasizing the importance of addressing unmet needs in drug development [12][13] - The upcoming R&D day is anticipated to unveil more data and insights into their programs [41]

Company Performance - Climb Bio, Inc. (CLYM) has gained approximately 32.2% year-to-date, significantly outperforming the average return of -2.3% for Medical companies [4] - The Zacks Consensus Estimate for CLYM's full-year earnings has increased by 12.8% over the past 90 days, indicating improving analyst sentiment [3] - Climb Bio, Inc. is currently ranked 2 (Buy) in the Zacks Rank system, suggesting a positive outlook for the stock [3] Industry Comparison - Climb Bio, Inc. belongs to the Medical - Biomedical and Genetics industry, which includes 485 companies and is currently ranked 94 in the Zacks Industry Rank [5] - The Medical - Biomedical and Genetics industry has seen an average gain of about 4% year-to-date, indicating that CLYM is performing better than its industry peers [5] - In contrast, the Medical - Instruments industry, which includes Idexx Laboratories (IDXX), is ranked 147 and has declined by -10.9% this year [6]

Climb Bio Conference Call Summary Company Overview - Climb Bio is a relatively new biotech company focused on developing monoclonal antibodies targeting well-validated clinical targets with high unmet needs. The company aims to create best-in-class assets with a clear path to approval and significant commercial potential. The lead program is a CD19 B-cell-depleting drug called Budo, with a second therapy targeting IgA nephropathy known as CLYM116 [4][53]. Core Points and Arguments Lead Asset: Budo - Budo targets CD19, which is involved in B-cell development and preserves long-lived plasma cells, making it an ideal target for B-cell-mediated diseases [6]. - The monoclonal antibody approach is favored due to its scalability, well-understood safety profile, and ability to be infused in community settings, which could benefit a large number of patients with over 100 B-cell-mediated diseases [7]. - There is a significant opportunity in the market as Oplinza is the only other CD19-targeted monoclonal antibody in development, focusing on rare neurological indications, leaving a gap for other B-cell-mediated diseases [8]. Comparison with Oplinza - Budo has a higher affinity for CD19 and a low fucosylation compared to Oplinza, which is fully afucosylated. This difference may lead to varying characteristics in efficacy and patient administration options [12]. - Budo can be administered both intravenously and subcutaneously, providing flexibility in treatment options for patients [12]. Development Strategy - Climb Bio has categorized its development strategy into three buckets: 1. **IgG4-mediated diseases**: High probability of success, with PMN (a type of IgG4-mediated disease) showing promising early data. 2. **Single organ IgG1-3 mediated diseases**: Includes conditions like ITP, where Budo could address unmet needs in patients who do not respond to existing therapies. 3. **Complex rheumatological diseases**: Such as rheumatoid arthritis and systemic lupus erythematosus (SLE), which present higher development challenges but also significant commercial opportunities [19][21]. Clinical Data and Trials - In PMN, Budo demonstrated a 60% complete renal response rate at 12 months, the best data set reported for this indication, indicating potential for long-term remission [24][25]. - The ITP study is designed to evaluate B-cell depletion and platelet count changes in patients who have not responded to prior therapies [30][31]. - The SLE study will assess the safety and efficacy of Budo in patients with high disease activity, starting at low doses and escalating based on safety [36][40]. Upcoming Catalysts - Climb Bio plans to share data from the Budo subcutaneous formulation in the first half of the next year and will provide updates on the CLYM116 program later this month. Guidance on data availability for ITP and SLE studies is also expected later this year [53][55]. Other Important Content - Climb Bio has a strong cash runway through 2027, allowing the company to navigate multiple clinical inflection points and gather more data on its programs [55]. - The company is committed to a data-driven approach in its development strategy, ensuring that decisions are based on the outcomes of ongoing studies [43].

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].