Jade Biosciences (JBIO) ERA 2025 Conference summary

Strategic Overview and Market Opportunity

• IgA nephropathy (IgAN) is a large, underserved market with a projected U.S. branded market exceeding $10 billion and significant global potential.

• Current treatments for IgAN are limited, with no reliably disease-modifying options; selective anti-APRIL therapies are positioned to become foundational, frontline treatments.

• Recent and proposed KDIGO guideline updates recommend earlier diagnosis and more ambitious proteinuria targets, increasing the need for effective, targeted therapies and expanding the at-risk patient population.

• The company is well-capitalized following a reverse merger and $300 million in private financing, with funding expected to last through 2027.

• Patent protection for JADE101 extends into the mid-2040s, supporting long-term commercial potential.

JADE101: Mechanism, Differentiation, and Preclinical Data

• JADE101 is a fully human, selective anti-APRIL monoclonal antibody with femtomolar affinity, engineered for extended half-life and subcutaneous dosing every eight weeks or less (≤6 injections/year).

• Preclinical data show JADE101 achieves deeper and more sustained IgA reductions than sibeprenlimab, the current class benchmark, due to higher affinity and mitigation of TMDD.

• JADE101 demonstrates potent inhibition of APRIL-mediated signaling, reducing plasma cell proliferation and IgA production, with deep, sustained IgA reductions in non-human primates.

• JADE101 avoids high molecular weight immune complex formation, reducing immunogenicity and supporting predictable pharmacokinetics.

• The antibody targets plasma cells while sparing broader B-cell function, aiming to maximize efficacy and minimize unnecessary immunosuppression.

Clinical Development Plans and Regulatory Outlook

• Phase one healthy volunteer study for JADE101 is set to begin in the second half of 2025, with interim PK/PD data expected in the first half of 2026.

• Biomarker-rich data from healthy volunteers will inform dose and interval selection for patient trials, leveraging strong translational consistency in IgAN.

• Interim healthy volunteer data in 1H26 is anticipated to be predictive of clinical efficacy and may accelerate development timelines.

• JADE201, the second pipeline candidate, is on track to enter the clinic in the first half of 2026, with further details to be disclosed later in the year.

• Jade holds an exclusive license for JADE101 from Paragon Therapeutics and options for JADE201 and JADE-003, targeting multiple autoimmune indications.