ProKidney reports REGEN-007 Phase 2 interim: eGFR stable over 18 months; manufacturing resumed

PROKIDNEY CORP.

In Group 1 (n=13), average eGFR change from baseline was -1.3 ml/min/1.73m² at 18 months; subset meeting Phase 3 criteria (n=10) showed -0.6.
No rilparencel-related serious adverse events in any of the 49 patients who received at least one injection.
Manufacturing resumed effective June 1, 2024 for U.S. and non-European clinical sites.
Anticipates QP Declaration of Equivalence to EU GMPs by end of June 2024 to enable European shipments.
PROACT 1 screening resumed under amended protocol enriched for higher risk patients; PROACT 2 activated sites in Spain.

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