Summary of Jade Biosciences Conference Call Company Overview - **Company**: Jade Biosciences (NasdaqCM:JBIO) - **Founded**: June 2024 - **Management Team**: Includes experienced members from Chinook Therapeutics, focusing on iGAN (IgA nephropathy) and autoimmune diseases - **Assets**: Three key assets acquired from Paragon, a protein engineering company Industry and Market Insights - **Lead Program**: Anti-APRIL for IgA nephropathy, a significant unmet medical need with a market opportunity exceeding $10 billion in the US alone [2] - **Clinical Development**: Initiated a Phase I study in August 2025, with results expected in the first half of 2026, aiming for rapid transition to patient studies [2][3] Key Programs and Developments - **JADE201**: A eufucosylated antibody targeting BAFF-R, expected to enter clinical trials in the first half of 2026 [2][3] - **Third Program**: Details not disclosed, anticipated to enter trials in the first half of 2027 [3] - **Financial Position**: Strong resources to fund trials through the first half of 2028 [3] Clinical Data and Efficacy - **ASN Conference Insights**: - iGAN is emerging as a large prospective market with promising data from competitors like Vera and Vertex [5][6] - Vertex reported a 64% reduction in proteinuria in Phase II studies, while Vera showed a 42% placebo-adjusted reduction [6] - Sibeprenlimab data indicated a 54% decrease in proteinuria over 12 months, highlighting the importance of APRIL inhibition [7][8] Mechanism of Action and Therapeutic Window - **APRIL vs. BAFF**: - Evidence suggests that APRIL inhibition alone provides significant disease-modifying benefits in iGAN without the need for BAFF [10][11] - Adding BAFF does not enhance clinical outcomes, indicating that iGAN is primarily driven by APRIL-responsive plasma cells [10][11] Regulatory Landscape - **FDA Considerations**: - The FDA is exploring new study designs to support innovation in iGAN, potentially shortening confirmatory study durations from two years to one year [30][31] - This shift is seen as beneficial for anti-APRIL therapies, which show early and significant eGFR improvements [30][31] Future Directions and Lifecycle Management - **Exploration of New Indications**: - Plans to investigate other autoimmune diseases, including IgM-mediated diseases and Sjogren's syndrome, based on the success of current programs [24][34] - JADE201's development will focus on generating safety and tolerability data in RA patients before expanding to other indications [34] Conclusion - Jade Biosciences is positioned to capitalize on significant market opportunities in the autoimmune disease space, particularly with its lead program targeting iGAN. The company is leveraging strong clinical data and a robust financial position to advance its pipeline and explore new therapeutic avenues.

Summary of Jade Biosciences Conference Call Company Overview - **Company**: Jade Biosciences (NasdaqCM:JBIO) - **Founded**: Last year as the fourth spin-out of Paragon Therapeutics - **Lead Asset**: Jade 101, an anti-APRIL monoclonal antibody targeting IgA nephropathy [4][5] Key Points on Jade 101 - **Unmet Need**: High unmet need in IgA nephropathy with no approved disease-modifying therapies [5] - **Market Opportunity**: Significant market potential due to the lack of effective treatments [5] - **Mechanism of Action**: Targets APRIL, a cytokine implicated in IgA nephropathy, with a focus on potency and extended half-life [5][12] - **Half-Life**: Non-human primate (NHP) half-life of 27 days, with expectations for human half-life to be two to four times longer [7][9] - **Dosing Interval**: Targeting a dosing interval of at least every eight weeks, potentially extending beyond that [10][15] Financial Background - **Recent Financing**: Completed a reverse merger in April with a $200 million PIPE and a $95 million convertible note, followed by a $135 million financing [6] Clinical Development - **Phase I Data**: Expected in the first half of 2026, focusing on biomarkers such as APRIL and IgA levels [14][15] - **Biomarker Predictiveness**: Healthy volunteer data is expected to correlate strongly with patient outcomes in IgA nephropathy [20] - **Safety Profile**: Historical data shows a favorable safety profile for APRIL inhibitors, with no increased risk of infections [22][23] Competitive Landscape - **Comparison with Competitors**: Other anti-APRIL therapies have shown varying efficacy and safety profiles, with Jade 101 aiming for superior APRIL suppression [16][17] - **Regulatory Environment**: The FDA is exploring innovative trial designs for IgA nephropathy therapies, which may benefit Jade 101's development path [32][33] Jade 201 Overview - **Mechanism**: Jade 201 is a half-life extended anti-BAFFR monoclonal antibody designed to enhance B cell depletion while avoiding depletion of immature B cells [35][36] - **Indication**: Targeting rheumatoid arthritis (RA) as the first indication, with a focus on safety and biomarker responses [41] - **Market Potential**: The potential market opportunity for Jade 201 is estimated at $80 billion across various indications [45] Conclusion - **Future Outlook**: Jade Biosciences is positioned to capitalize on the growing interest in IgA nephropathy therapies and has a robust pipeline with Jade 101 and Jade 201, aiming for efficient development paths and favorable safety profiles [25][32][45]

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]