Prokidney Corp. · NASDAQ:PROK
Prokidney — Corporate Update (June 2024)
27 slides from Prokidney's corporate update, Jun 10, 2024
Slide 1: Developing Solutions for Dialysis Prevention: REGEN-007 Interim Results and Updates
Developing Solutions for Dialysis Prevention REGEN-007 Interim Results March 2024 & Updates June 2024
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: An Introduction to ProKidney
An Introduction to ProKidney Preserve kidney function in advanced CKD patients Goal Preserve kidney function in patients with moderate to severe chronic kidney disease caused by diabetes who are faced with limited options for care beyond transplantation or dialysis A proprietary autologous cellular
Slide 4: What is Rilparencel and Why is it Relevant?
What is Rilparencel and Why is it Relevant? Unmet Needs Our Goals Our Product Our Plan Over 35 million U.S. adults Preserve kidney function Rilparencel is a proprietary Phase 3 clinical program have chronic kidney disease cell therapy using the PROACT 1 and PROACT 2 (CKD)1 Reduce or potentially pati
Slide 5: 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) Diabetes Type II – Prevent/Delay ESRD in Stage 3b/4 CKD 2 016/PROACT 2 Ongoing (
Slide 6: Relaunch of Manufacturing and Phase 3 Studies
With Relaunch of Manufacturing and Phase 3 Studies, We Look Forward to Advancing our Clinical Program Manufacturing Relaunch Resumption of Phase 3 Program • In our PROACT 1 study, we filed a protocol • Effective June 1st, we restarted manufacturing amendment with the FDA in March, 2024; Central for
Slide 7: Advancing a Comprehensive Clinical Plan
Advancing a Comprehensive Clinical Plan REGEN-003 Phase 2 Trial; Results published 1Q 2023 2023 • Safety & efficacy of rilparencel in Stage 4/5 CKD caused by type 2 diabetes (eGFR 14-20) • Assessed impact on progression and time to dialysis in patients with imminent risk of dialysis 2024 RMCL-002 Ph
Slide 8: 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 Risk for E
Slide 9: Therapeutic Options that Delay Dialysis in Stage 4 CKD 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 10: New Therapies Are a Step Forward, but 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 11: REGEN-007 Interim Analysis May 7, 2024
REGEN-007 Interim Analysis May 7, 2024
Slide 12: 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 CKD with type 1 or type 2 diabetes (Ph3 Dosing Regimen) Rilparencel Month 18 Following Injections 2nd Injection Subjects 30-80 years of age n = 25 2 eGFR ≥2
Slide 13: 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 14: 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 Subject’s Biopsies had
Slide 15: Baseline Characteristics in Group 1 Subjects
Baseline Characteristics in Group 1 Subjects with a Minimum of 12 Months Follow-up after Two Rilparencel Injections SUBJECTS WITH MINIMUM 12 MONTHS SUBJECTS WITH MINIMUM 12 MONTHS FOLLOW-FOLLOW-UP AFTER 2ND INJECTION UP AFTER 2ND INJECTION AND COMPARABLE TO (n=13) PHASE 3 INCLUSION CRITERIA (n=10) A
Slide 16: 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 17: 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 leader in ri
Slide 18: 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 18
Slide 19: Kidney Function Stabilizes for 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 5 1.7 1.0 0.9 -0.5 -1.
Slide 20: Kidney Function Stabilizes in Subjects Meeting Phase 3 Criteria
Kidney Function Stabilizes for 18 Months After 1st Injection in Subjects Meeting Phase 3 Criteria Group 1 Subjects Ph 3 Eligible Subgroup (n=10) 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
Slide 21: Kidney Function After 1st Injection Across All Subjects
Kidney Function After 1st Injection Across All Subjects All Subjects (n=24) and All Phase 3 Eligible Subjects (n=20) Treated in Group 1 Kidney Function After 1st Injection Across All Subjects (n=24): Avg Change from Baseline eGFR (ml/min/1.73m2) 10 1st Inj 2nd Inj 2nd Inj + 3m 2nd Inj + 6m 2nd Inj +
Slide 22: No Rilparencel-related Serious Adverse Events have been Observed
No Rilparencel-related Serious Adverse Events have been Observed BIOPSY RILPARENCEL INJECTION ADVERSE EVENT # of SAEs # of SAEs (n=51) (n=49) Hematoma 2 1 Thrombosis 1 0 Hematuria 1 0 Hydronephrosis 1 0 Death 0 0 Acute Kidney Injury 2 0 22 Data as of May 7, 2024
Slide 23: REGEN-007 Interim Analysis Summary and Next Steps
REGEN-007 Interim Analysis Summary Next Steps • We look forward to providing full results in 1H • In Group 1 participants who had at least 12 months 2025 follow up after a second rilparencel injection, kidney function was preserved for 18 months. Similar results were observed in participants who • W
Slide 24: Headquarters and Financial Highlights
Headquarters: Boston, MA Winston-Salem, NC Financial Highlights Justin Zelin BTIG Yigal Nochomovitz Citigroup Inc. Jonathan Miller Evercore ISI Judah Frommer Morgan Stanley Eliana Merle UBS Kelly Shi Jefferies *As of May 10, 2024 **Cash, cash equivalents and marketable securities as of March 31, 202
Slide 25: Appendix
Appendix 25 PROKIDNEY:~:~· .....
Slide 26: Group 2 Patients After Receiving At Least One Injection
Group 2 Patients After Receiving At Least One Injection (n=25) 12 patients received a 2nd rilparencel injection based on eGFR criteria (n=3) or UACR criteria (n=9) Group 2 Patients After Receiving At Least One Injection (n=25): Average Change from Baseline eGFR (ml/min/1.73m2) Group 2 Re-Dosing Trig
Slide 27: Approximate Change in eGFR in Canagliflozin and Empagliflozin Trials
Approximate Change in eGFR in Canagliflozin and Empagliflozin Clinical Trials SGLT2 Inhibitors Do Not Prevent Progression of Advanced CKD and Patients Lose ~4 to 7 eGFR in the First 18 Months Canagliflozin (CREDENCE) Empagliflozin (EMPA-KIDNEY) Approx. Change in Approx. Change in 2 Canagliflozin Pla