Prokidney Corp. · NASDAQ:PROK
Prokidney — J.P. Morgan Healthcare Conference 2025
23 slides from Prokidney's conference presentation, January 2025
Slide 1: J.P. Morgan Presentation
Developing Solutions for Dialysis Prevention J.P. Morgan Presentation March 2024 January 2025
Slide 2: Forward-looking Statements
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
Slide 3: Disrupting the CKD Treatment Landscape
Disrupting the CKD Treatment Landscape Renal Autologous Cell Therapy: Rilparencel (REACT®) proprietary autologous cellular therapy being evaluated to preserve kidney function in patients with diabetes and advanced chronic kidney disease 3
Slide 4: An Introduction to ProKidney
An Introduction to ProKidney Preserve kidney function in advanced CKD patients Goal Preserve kidney function in patients with type 2 diabetes and advanced chronic kidney disease who are faced with limited options for care beyond transplantation or dialysis A proprietary autologous cellular therapy w
Slide 5: Rilparencel Tissue Acquisition-to-Injection Process Overview
Rilparencel Tissue Acquisition-to-Injection Process Overview Process Overview Kidney cells Then frozen for x are isolated preservation and and expanded shipping to site 2 3 1 4 Rilparencel Tissue acquired injected by kidney biopsy into kidneys Injection #1: Same kidney as biopsy Injection #2: Contra
Slide 6: Unmet Clinical and Payer Need in High-Risk CKD Patients
Unmet Clinical and Payer Need in High-Risk CKD Patients • CKD is defined as abnormalities of kidney structure or function, present for > 3 months • CKD is classified based on Cause, GFR category (G1-G5), and Albuminuria (A1-A3), abbreviated as CGA Standard of Care Antihypertensives o ACEi o ARB Risk
Slide 7: Therapeutic Options that Delay the Need for Dialysis Are Limited
Therapeutic Options that Delay the Need for Dialysis in Patients with Stage 4 Chronic Kidney Disease are Limited Study Active Product Subjects with Stage 4 CKD Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy1 Canagliflozin (SGLT2 inhibitor) 0% Dapagliflozin in Patients with CKD2
Slide 8: New Therapies Are a Step Forward, Patients Still Lose Kidney Function
While New Therapies Are a Step Forward, Patients Still Lose Kidney Function and Experience Clinically Significant Events SGLT2 inhibitors Do Not Prevent Progression of Advanced CKD Standard of Care has Limitations Patients continue to lose kidney function on SGLT2 inhibitors and Current standard of
Slide 9: Overview of the Rilparencel Clinical Program
Overview of the Rilparencel Clinical Program PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 STATUS Pivotal Trial Program Diabetes Type II – Prevent/Delay ESRD in Stage 3b/4 CKD 006/PROACT 1 Ongoing (20-35 ml/min/1.73m2, n=685) Long term follow-up study for patients previously treated with rilparencel 008 O
Slide 10: Advancing a Comprehensive Clinical Plan
Advancing a Comprehensive Clinical Plan RMCL-002 Phase 2 Trial; Results published Q2 2024 2024 • Open-label safety & efficacy of rilparencel in patients with type 2 diabetes and Stage 3/4 CKD (eGFR 20-50) • Potential to preserve kidney function for up to 30 months in several patient groups REGEN-007
Slide 11: Rilparencel Registrational Program: (REGEN-006)
Rilparencel Registrational Program: 1 (REGEN-006) PROACT 1 eGFR enrollment criteria range of ≥20 to ≤35 ml/min/1.73m2 aligns with Phase 2 study results and payer / clinical feedback 1st 2nd Rilparencel Rilparencel Biopsy Injection Injection Rilparencel Cohort n = ~685 End of Study (EOS) 3 3 6 6 6 6
Slide 12: REGEN-007 Interim Analysis
REGEN-007 Interim Analysis Results presented at the AmericanSociety of Nephrology Annual Meeting,October 2024 12
Slide 13: REGEN-007 Trial Design
REGEN-007 Trial Design Group 1 Dosing Regimen and Use of Cryopreserved Product Mirrors Phase 3 Program Key Entry Criteria Group 1 1st & 2nd EOS Type 1 or type 2 diabetes and CKD (Ph3 Dosing Regimen) Rilparencel Month 18 Following Injections 2nd Injection Subjects 30-80 years of age n = 27 Biopsy eGF
Slide 14: REGEN-007 Interim Analysis Objectives and Endpoints in Group 1
REGEN-007 Interim Analysis Objectives and Endpoints in Group 1 • In subjects with at least 12 months follow-up after 2 injections, assess the Objectives safety and efficacy of cryopreserved rilparencel delivered into the biopsied and non-biopsied contralateral kidney using a percutaneous approach •
Slide 15: Current Enrollment Status & Completion Expectations
Current Enrollment Status & Completion Expectations 53 Subjects were Randomized in REGEN-007 with 27 Subjects Randomized to Group 1 (1 Subject Withdrew Consent Pre-Biopsy) 26 Subjects in Group 1 Of the 26 Subjects who were Biopsied, 24 Subjects Received at-least 1 Injection (2 Subjects’ Biopsies had
Slide 16: Baseline Characteristics in Group 1 Subjects with 12 Months Follow-up
Baseline Characteristics in Group 1 Subjects with a Minimum of 12 Months Follow-up after Two Rilparencel Injections SUBJECTS WITH MINIMUM 12 MONTHS FOLLOW-UP AFTER 2ND INJECTION (n=13) Age, years (mean +/- SD) 62.8 +/- 8.2 Female : Male, % 54% : 46% Hispanic or Latino, % 0% Race, % Black or African
Slide 17: Externally Developed Control Arm to Contextualize REGEN-007 Interim Data
Externally Developed Control Arm to Contextualize REGEN-007 Interim Data • Explore how 18 month change in kidney function in subjects enrolled in Objective REGEN-007 might compare against matched contemporaneous controls • In partnership with Dr. Navdeep Tangri (University of Manitoba), 13 subjects
Slide 18: Klinrisk Founding Team
Klinrisk Founding Team Navdeep Tangri J.D. McCullough ◊ Co-Founder and CEO ◊ Chief Operating Officer ◊ Founder and Scientific Director, Chronic ◊ Health tech executive specializing in regulated Disease Innovation Centre AI commercialization ◊ Professor of Medicine, University of Manitoba • Global le
Slide 19: Matched Controls Showed a Continuous Decline in Kidney Function over 18 Months
Matched Controls Showed a Continuous Decline in Kidney Function over 18 Months Klinrisk Matched Subjects (n=125) Average Change in eGFR from Baseline at 18 Months -1.2 -2.2 -6.2 ml/min/1.73m2 (95% CI -7.8, -4.6) -4.0 -6.2 19
Slide 20: Kidney Function Stabilizes for 18 Months After 1st Injection
Kidney Function Stabilizes for 18 Months After 1st Injection Group 1 Subjects (n=13) with Minimum 12 Months Follow-up Data Post 2nd Injection Average Change from Baseline eGFR (ml/min/1.73m2) 10 1st Inj 2nd Inj 2nd Inj + 3m 2nd Inj + 6m 2nd Inj + 9m 2nd Inj + 12m 2nd Inj + 15m Average Change from Ba
Slide 21: No Rilparencel-related Serious Adverse Events have been Observed
No Rilparencel-related Serious Adverse Events have been Observed BIOPSY RILPARENCEL INJECTION # of SAEs # of SAEs ADVERSE EVENT (n=51) (n=49) Hematoma 2 1 Thrombosis 1 0 Hematuria 1 0 Hydronephrosis 1 0 Death 0 0 Acute Kidney Injury 2 0 21 Data as of May 7, 2024
Slide 22: REGEN-007 Interim Analysis Summary
REGEN-007 Interim Analysis Summary Key Findings Next Steps • We look forward to providing full results for • In Group 1 participants who had at least 12 months REGEN-007 Group 1 in 1H 2025 follow up after a second rilparencel injection, • We are focused on enrolling patients in our kidney function w
Slide 23: Financial Highlights
NASDAQ: PROK Headquarters: 291,661,950 shares Boston, MA outstanding* Winston-Salem, NC $407M Cash** on hand expected to fund operations into 2027 Financial Covering Research Analysts Highlights Jason Gerberry Bank of America Yigal Nochomovitz Citi Jonathan Miller Evercore Vamil Divan Guggenheim Kel