Slide 1: RMCL-002 Final Analysis: Developing Solutions for Dialysis Prevention
RMCL-002 Final Analysis Developing Solutions for Dialysis Prevention May 2024
Slide 2: Forward-Looking Statements
This presentation includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. ProKidney’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these fo
Slide 3: RMCL-002: Trial Design
Key Entry Criteria Study Endpoints Study Timeframe Type 2 Diabetes Mellitus (DKD) Male or female 30-80 years of age eGFR ≥20 and ≤50 mL/min/1.73m2 Not on kidney dialysis, HbA1c <10% RMAT = Regenerative Therapy Advanced Medicine; SOC = Standard of Care = 6 Months u = Follow-up Visit After 2nd Injecti
Slide 4: RMCL-002: Study Objectives and Endpoints
RMCL-002: Study Objectives and Endpoints Study Objectives Study Endpoints To assess the safety and efficacy of up to two rilparencel injections given 6 months apart and delivered into the biopsied kidney using a percutaneous approach Procedural and investigational product-related adverse events Chan
Slide 5: RMCL-002 Baseline Subject Characteristics are Balanced and Represent a High-Risk CKD Population
ACTIVE ARM (n=41) DEFERRED ARM (n=42) Age, years (mean +/- SD) 66.1 +/- 9.9 64.6 +/- 8.9 Female : Male, % 29% : 71% 36% : 64% Hispanic or Latino, % 17% 10% Race, % Black or African American 2.5% 14% White 95% 74% Other 2.5% 12% Blood pressure, mm HG 133 / 72 135 / 73 eGFR, ml/min/1.73m2 (mean +/- SD
Slide 6: No Rilparencel-related SAEs Identified in RMCL-002
Other events with possible-relatedness include kidney fibrosis and indeterminate renal vessel occlusion or vasospasm ADVERSE EVENT BIOPSY # of events (n=83)* RILPARENCEL INJECTION # of events (n=132)* Hematoma (including Page Kidney during biopsy) 2 2 Pain 0 2 Acute Kidney Injury 1 1 CKD progression
Slide 7: Active Cohort Subjects Showed No Clinically Meaningful eGFR Decline Over 30 Months
Active Cohort Subjects Showed No Clinically Meaningful eGFR Decline Over 30 Months The Active Cohort showed a cumulative change in average eGFR of -5.1 ml/min/1.73m2 after 30 months; The Deferred Cohort, receiving standard of care, showed a cumulative change in average eGFR of -3.3 ml/min/1.73m2 aft
Slide 8: Deferred to Cross-Over Subjects Showed Preservation of eGFR after Rilparencel Injection
Data points are mean +/- SEM ; Data as of April 26, 2024 Deferred to Cross-Over Subjects Showed Preservation of eGFR after Rilparencel Injection Average eGFR of the Deferred cohort was 31.7 at baseline vs 28.4 at 12 months [absolute difference of -3.3 ml/min/1.73m2 over 12 months] Average eGFR at 1s
Slide 9: Stabilization of Kidney Function in Active and Deferred Arm Subjects at 12 Months vs SOC
Stabilization of Kidney Function in Active and Deferred Arm Subjects at 12 Months vs SOC Subgroup Analysis of Diabetic Subjects with CKD Stage 4 and Class A3 Albuminuria* Data points are mean +/- SEM ; Data as of April 26, 2024; 1. Oshima M, et al. Trajectories of kidney function in diabetes: a clin
Slide 10: RMCL-002 Summary: Key Findings
Key Findings RMCL-002 Summary Showed potential to preserve kidney function for up to 30 months in several patient groups Benefit to kidney function was most notable in subjects who had the highest risk of kidney failure (Stage 4 CKD with high UACR1) Injections were well tolerated with a consistent s