earnings
confidence high
sentiment positive
materiality 0.85
ProKidney Q2 net loss $37M; FDA agrees eGFR slope for accelerated approval; Phase 2 shows 78% eGFR improvement
PROKIDNEY CORP.
- FDA confirmed eGFR slope as surrogate endpoint for accelerated approval of rilparencel; topline data from PROACT 1 expected Q2 2027.
- Phase 2 REGEN-007: eGFR slope improved 78% (from -5.8 to -1.3 mL/min/1.73m²/yr) in Group 1 (n=24), p<0.001; no SAEs related.
- Cash and equivalents $294.7M as of June 30, 2025, down from $328.5M; funds operations into mid-2027.
- Q2 net loss $37.0M vs $38.5M in prior year; R&D expenses $25.9M down from $29.4M.
- More than half of ~350 patients for accelerated approval analysis enrolled in Phase 3 PROACT 1.
item 2.02item 9.01