Jade Biosciences (JBIO) TD Cowen 46th Annual Health Care Conference summary

Strategic pipeline overview

• Three antibody programs: JADE101 (anti-APRIL for IgA nephropathy), JADE201 (afucosylated anti-BAFF-R for autoimmune diseases), and JADE301 (target to be disclosed, clinic entry expected 1H 2027).

• JADE101 interim phase I data expected 1H 2024; phase II to start mid-2024 with data in 2027.

• JADE201 phase I in RA patients begins Q2 2024, with interim data in 2027.

• JADE301 target disclosure planned for 2H 2024, clinic entry in 1H 2027.

• Cash runway extends into 1H 2028, ending 2025 with $336 million.

Clinical and scientific insights

• JADE101 designed for best-in-class efficacy and convenience, aiming for six or fewer injections per year.

• Phase I focuses on robust PK/PD biomarker data, with strong translation from healthy volunteers to patients.

• Maximal APRIL suppression and IgA reduction are key efficacy drivers; durability of effect is a focus.

• Safety endpoints include immunogenicity, infection rates, and hypogammaglobulinemia, with close monitoring of ADA formation.

• High correlation between total IgA and pathogenic Gd-IgA1 reduction supports biomarker strategy.

Competitive landscape and regulatory strategy

• IgA nephropathy market estimated at $10B+, with new KDIGO guidelines expanding eligible patient pool.

• JADE101 shows >750-fold higher binding affinity than sibeprylimab and aims for commercial differentiation via dosing convenience.

• Regulatory pathway may be accelerated, with phase II starting mid-2024 and potential for expedited registration following NKF/FDA workshop.

• Active comparator trials unlikely; accelerated approval pathway remains viable with proteinuria and EGFR endpoints.

• Market opportunities span rheumatology and nephrology, with focus on high unmet need indications like ANCA-associated vasculitis.