Prokidney Corp. · NASDAQ:PROK
Prokidney — Investor Presentation (September 2024)
24 slides from Prokidney's investor presentation, Sep 3, 2024
Slide 1: Developing Solutions for Dialysis Prevention
Developing Solutions for Dialysis Prevention September 2024 Corporate Presentation Exhibit 99.1
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: Renal Autologous Cell Therapy: Rilparencel (REACT)
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 Disrupting the CKD Treatment Landscape
Slide 4: An Introduction to ProKidney
Recent Developments An Introduction to ProKidney CKD = chronic kidney disease RMAT = regenerative medicine advanced therapy Preserve kidney function in advanced CKD patients Preserve kidney function in patients with type 2 diabetes and advanced chronic kidney disease who are faced with limited optio
Slide 5: What is Rilparencel and Why is it Relevant?
Preserve kidney function Reduce or potentially eliminate time spent on dialysis Return autonomy to patients and their families Over 35 million U.S. adults have chronic kidney disease (CKD)1 More than 135,000 of these CKD patients progress to dialysis every year1 Total annual costs to Medicare for pa
Slide 6: Rilparencel Goal: Preservation of Kidney Function
Rilparencel Goal: Preservation of Kidney Function ProKidney’s Autologous Cell Therapy 1 Renal cortex cells are harvested using a routine kidney biopsy 2 Cells are expanded and then subject to a selection process 3 The selected cells are frozen for storage and thawed just before injection
Slide 7: Overview of the Rilparencel Clinical Program
Overview of the Rilparencel Clinical Program As of August 2024 Unilateral injections Bilateral injections Frozen product ESRD = End-Stage Renal Disease Overview of the Rilparencel Clinical Program Pivotal Trial Program Diabetes Type II – Prevent/Delay ESRD in Stage 3b/4 CKD (20-35 ml/min/1.73m2, n=6
Slide 8: Advancing a Comprehensive Clinical Plan
Advancing a Comprehensive Clinical Plan RMCL-002 Phase 2 Trial; Results published Q2 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 Phase 2
Slide 9: Rilparencel Registrational Program: PROACT 1 (REGEN-006)
Day - 60 to Day 0 Screening Visit SHAM Cohort Sham 1st Rilparencel Injection Sham 2nd Rilparencel Injection Sham Biopsy End of Study (EOS) Rilparencel Cohort 1st Rilparencel Injection 2nd Rilparencel Injection Biopsy End of Study (EOS) PROACT 1 eGFR enrollment criteria range of ≥20 to ≤35 ml/min/1.7
Slide 10: Unmet Clinical and Payer Need in High-Risk CKD Patients
Unmet Clinical and Payer Need in High-Risk CKD Patients Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 clinical practice guideline for diabetes management in chronic kidney disease. Kidney Int 2020;98:S1–115. Moderately Increased High Very High Rilparencel’s Target
Slide 11: Therapeutic Options that Delay the Need for Dialysis in Stage 4 CKD 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 Dapagliflozin (SGLT2 inhibitor) 14% Empagliflozin in Patients with CKD3 Empagliflozin (SGLT2 inhibitor) 34% Effec
Slide 12: While 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 Standard of care includes ACE inhibitors, angiotensin receptor blockers and SGLT2 inhibitors Heerspink HJL et al. N Eng J Med 2020 Current standard of care1 does not prevent event
Slide 13: REGEN-007 Interim Analysis Data as of May 7, 2024
REGEN-007 Interim Analysis Data as of May 7, 2024
Slide 14: REGEN-007 Trial Design and Key Entry Criteria
Key Entry Criteria Type 1 or type 2 diabetes and CKD Subjects 30-80 years of age eGFR ≥20 and ≤50 mL/min/1.73m2 UACR 30-5000 mg/g HbA1c <10% Day –60 to Day 30 Screening Visit and Biopsy REGEN-007 Trial Design u = Follow-up Visit After Last Injection = 3 Months Group 2 Re-Dosing Trigger Sustained 30-
Slide 15: REGEN-007 Interim Analysis Objectives and Endpoints in Group 1
REGEN-007 Interim Analysis Objectives and Endpoints in Group 1 Objectives Endpoints In subjects with at least 12 months follow-up after 2 injections, assess the safety and efficacy of cryopreserved rilparencel delivered into the biopsied and non-biopsied contralateral kidney using a percutaneous app
Slide 16: 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 17: Baseline Characteristics in Group 1 Subjects
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 American 0% White 100% Other 0% Blood pressure, mm HG 135 / 72 eGFR, ml/min/1.73m2 (mean +/- SD) 29.7 +/- 9.5 UACR m
Slide 18: Externally Developed Control Arm to Contextualize REGEN-007 Interim Data
Externally Developed Control Arm to Contextualize REGEN-007 Interim Data Objective Methods Explore how 18 month change in kidney function in subjects enrolled in REGEN-007 might compare against matched contemporaneous controls In partnership with Dr. Navdeep Tangri (University of Manitoba), 13 subje
Slide 19: Klinrisk Founding Team
Klinrisk Founding Team Navdeep Tangri Co-Founder and CEO Founder and Scientific Director, Chronic Disease Innovation Centre Professor of Medicine, University of Manitoba Global leader in risk prediction who developed the most widely used algorithms in nephrology worldwide Published more than 380 man
Slide 20: Matched Controls Showed a Continuous Decline in Kidney Function over 18 Months
Matched Controls Showed a Continuous Decline in Kidney Function over 18 Months -1.2 -2.2 -4.0 -6.2 Klinrisk Matched Subjects (n=125) Average Change in eGFR from Baseline at 18 Months -6.2 ml/min/1.73m2 (95% CI -7.8, -4.6)
Slide 21: Kidney Function Stabilizes for 18 Months After 1st Injection
1.7 1.0 -0.5 -2.7* 0.9 -1.3 N= 13 12 13 13 13 13 12 29.8 30.7 29.2 27.0* 30.6 28.8 Kidney Function Stabilizes for 18 Months After 1st Injection Average Change from Baseline with 18 Months Follow-up Post 1st Injection -1.3 ml/min/1.73m2 (95% CI -5.1, 2.5) Interim analysis; Data points are mean +/- SE
Slide 22: Adverse Events: Biopsy and Rilparencel Injection
ADVERSE EVENT BIOPSY # of SAEs (n=51) RILPARENCEL INJECTION # of SAEs (n=49) Hematoma 2 1 Thrombosis 1 0 Hematuria 1 0 Hydronephrosis 1 0 Death 0 0 Acute Kidney Injury 2 0 No Rilparencel-related Serious Adverse Events have been Observed Data as of May 7, 2024
Slide 23: Key Findings: REGEN-007 Interim Analysis Summary
Key Findings REGEN-007 Interim Analysis Summary In Group 1 participants who had at least 12 months follow up after a second rilparencel injection, kidney function was preserved for 18 months Bilateral dosing of cryopreserved product showed safety profile consistent with prior studies and comparable
Slide 24: Financial Highlights and Covering Research Analysts
*As of Aug 9, 2024 **Cash, cash equivalents and marketable securities as of June 30, 2024 Covering Research Analysts Jason Gerberry Bank of America Global Research Justin Zelin BTIG Yigal Nochomovitz Citigroup Inc. Jonathan Miller Evercore ISI Judah Frommer Morgan Stanley Eliana Merle UBS Kelly Shi