Jade Biosciences (NasdaqCM:JBIO) 2025 Conference Transcript

Summary of Jade Biosciences Conference Call Company Overview - Company: Jade Biosciences (NasdaqCM:JBIO) - Focus: Development of therapies for autoimmune diseases, recently formed in June 2024 - Key Assets: Acquired three assets from Paragon Therapeutics, specializing in high affinity antibodies with half-life extension technology [1][2] Core Programs - Lead Program: JADE101, an anti-APRIL therapy targeting IgA nephropathy - Market Potential: Estimated at over $10 billion in the US [2] - Mechanism: Disease-modifying potential without unnecessary immunosuppression - Dosing Schedule: Aiming for one injection every eight weeks [2][4] - Phase I Study: Initiated with first cohort dosed, expected readout in the first half of next year [2][4] - Second Program: JADE201, a BAFF receptor targeting antibody - Indication: Initially targeting rheumatoid arthritis [3] - Development Timeline: First trial expected in the first half of next year [3] - Third Program: JADE03, details not extensively discussed, expected to enter the clinic in the first half of 2027 [4] Financial Position - Funding: - Initial reverse merger raised $300 million - Additional PIPE financing brought in $135 million [4] - Cash Runway: Pro forma cash position of approximately $356 million, expected to last into the first half of 2028 [42] Treatment Landscape for IgA Nephropathy - Current Treatments: Historically involved ACE inhibitors and steroids, evolving towards new therapies [6][7] - KDIGO Guidelines: New guidelines recommend treating all patients with agents that deplete pathogenic IgA and achieving ambitious proteinuria targets [8][9] - Future Expectations: Selective anti-APRIL therapies expected to become frontline treatments [8][9] Clinical Insights - Biomarker Richness: IgA nephropathy is biomarker-rich, aiding in the prediction of clinical efficacy [3][24] - Phase III Trials: Initial data from phase III trials of other therapies show promising results, with selective anti-APRIL showing a 51% reduction in proteinuria [12][20] JADE101 Design and Mechanism - Potency: JADE101 designed to have ultra-high binding affinity to APRIL, significantly higher than existing therapies [14][16] - Half-Life Extension: Incorporates YTE mutation for extended plasma exposure, aiming for convenient dosing [15][16] - Clinical Activity: Expected to provide significant clinical activity with minimal dosing frequency [23] JADE201 Development - Mechanism: Designed to deplete B-cells while blocking compensatory BAFF upregulation, enhancing therapeutic efficacy [35][36] - Phase I Study: Planned for rheumatoid arthritis patients, focusing on safety and pharmacokinetics [38] Regulatory Environment - FDA Engagement: Ongoing discussions with the FDA regarding the potential for accelerated approval based on proteinuria as a surrogate endpoint [31][32] Conclusion - Jade Biosciences is positioned to capitalize on significant market opportunities in autoimmune therapies, with a strong financial foundation and promising clinical programs aimed at addressing unmet medical needs in IgA nephropathy and other autoimmune conditions [4][42]