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]

Summary of Jade Biosciences Conference Call Company Overview - **Company**: Jade Biosciences (NasdaqCM: JBIO) - **Focus**: Development of best-in-class therapeutics for autoimmune diseases, particularly through high-affinity monoclonal antibodies sourced from Paragon Therapeutics [2][36] Key Points on IGAN and Therapeutic Landscape - **Lead Program**: Anti-APRIL antibody (Jade 101) targeting Immunoglobulin A Nephropathy (IGAN) with a market potential exceeding $10 billion in the U.S. [3][37] - **Clinical Stage**: Recently transitioned to a clinical stage company with the first cohort dosed, aiming for first-in-human readout in the first half of next year [4][38] - **Current Treatment Landscape**: Most patients currently receive ACE inhibitors or ARBs, with additional therapies like SGLT2s and immunosuppressants added if proteinuria targets are not met [6][40] - **Emerging Therapies**: New KDIGO guidelines propose that all patients should receive agents proven to reduce pathogenic IgA, positioning selective anti-APRIL therapies as frontline treatments [7][41][42] Jade 101 Development Insights - **Dosing Schedule**: Targeting a subcutaneous injection every eight weeks, which is more convenient than existing therapies [3][37] - **Potency and Affinity**: Jade 101 has a femtomolar affinity to APRIL, significantly higher than competitors, allowing for effective suppression at lower doses [13][47] - **Mechanism of Action**: Designed to prevent large immune complex formation, reducing immunogenicity risks and enhancing pharmacokinetics [16][49] Clinical Data and Efficacy - **Phase Two Data**: Previous studies showed that full APRIL suppression led to significant proteinuria reduction and stabilization of eGFR, with a safety profile comparable to placebo [20][54] - **Long-term Goals**: Aiming to achieve proteinuria levels below 0.3 grams per day to minimize long-term kidney failure risks [22][55] Future Development Plans - **Phase One Trial**: Scheduled for the first half of next year in New Zealand, with plans for a targeted open-label phase two study to quickly gather proof of concept data [56][58] - **Regulatory Interactions**: Engaging with regulators to ensure efficient development pathways, particularly in light of new therapies entering the market [59][61] - **Exploration of Other Indications**: Potential expansion into other IGM-driven diseases, pending positive phase one results [63][64] Financial Position - **Funding**: Closed the last quarter with $221 million, sufficient to fund operations through 2027, including the advancement of Jade 101 and other programs [32][66] Conclusion - Jade Biosciences is positioned to capitalize on the growing market for IGAN therapies with its innovative anti-APRIL antibody, Jade 101, and is actively pursuing clinical development while maintaining a strong financial foundation.