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. announced promising preclinical data for CLYM116, an anti-APRIL monoclonal antibody, showing deeper IgA reduction and a longer half-life compared to the first-generation antibody sibeprenlimab [1][3][4] Company Developments - CLYM116 is set to enter a Phase 1 trial in healthy volunteers, expected to begin in Q4 2025, with initial biomarker and dosing interval data anticipated by mid-2026 [1][5][7] - The company is hosting a virtual investor event on September 29, 2025, featuring nephrologist Craig E. Gordon, who has extensive experience in treating IgA nephropathy [2][3] Product Profile - CLYM116 is characterized as a "sweeper" anti-APRIL monoclonal antibody, demonstrating a subcutaneous formulation with high bioavailability (~85%) and a favorable tolerability profile [7][10] - The antibody exhibits a 2-3 times longer half-life compared to sibeprenlimab and achieves over 70% maximal reduction in IgA after a single administration at equivalent doses [7][10] Market Opportunity - IgA nephropathy (IgAN) represents a significant market opportunity, estimated at $10-20 billion in the U.S. alone, with a high unmet need for effective treatments [6][12] - The updated KDIGO 2025 guidelines emphasize the need for more active management of IgAN, potentially expanding the market opportunity for CLYM116 [3][12] Clinical Context - IgAN is the most common primary glomerular disease worldwide, affecting approximately 170,000 patients in the U.S. and typically requiring lifelong management [12] - The KDIGO guidelines recommend stricter proteinuria control and highlight the importance of reducing pathogenic IgA, positioning anti-APRIL therapy as a core treatment approach for IgAN [12]

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].

Core Viewpoint - Climb Bio, Inc. (CLYM) shows potential as a stock pick due to a recent "golden cross" event, indicating a bullish trend reversal [1][4]. Technical Analysis - A "golden cross" occurs when a stock's short-term moving average (50-day) crosses above its long-term moving average (200-day), suggesting a bullish breakout is likely [2]. - The successful golden cross event consists of three stages: a price decline bottoming out, the shorter moving average crossing above the longer one, and maintaining upward momentum [3]. Performance Metrics - Over the past four weeks, CLYM has gained 28.2%, indicating strong performance [4]. - CLYM currently holds a 2 (Buy) rating on the Zacks Rank, suggesting further breakout potential [4]. Earnings Outlook - Positive earnings outlook for the current quarter strengthens the bullish case for CLYM, with no earnings estimates decreasing in the past two months and two revisions higher [4]. - The Zacks Consensus Estimate for CLYM has also increased, further supporting the positive sentiment [4][5].

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].