regulatory
confidence high
sentiment positive
materiality 0.85
FDA confirms PROACT 1 Phase 3 may support full approval; Q3 cash $406.8M
PROKIDNEY CORP.
- FDA Type B meeting confirms PROACT 1 Phase 3 could be sufficient for BLA; accelerated approval pathway available using eGFR slope as surrogate endpoint.
- Cash, equivalents and marketable securities $406.8M at Sept 30, 2024, expected to fund operations into 2027.
- Q3 2024 net loss before noncontrolling interest $41.1M vs $42.0M in Q3 2023; R&D $31.3M, G&A $17.7M including $5.3M impairment.
- Presented five posters at ASN Kidney Week including Phase 2 REGEN-007 late-breaking data.
- Shares outstanding: 291,661,950 Class A and B ordinary shares.