Prokidney Corp. · NASDAQ:PROK
Prokidney — Investor Presentation (January 2024)
31 slides from Prokidney's investor presentation, Jan 26, 2024
Slide 1: Developing Solutions for Dialysis Prevention
Exhibit 99.1 Corporate Presentation January 2024 Developing Solutions for Dialysis Prevention REACT® [REnal Autologous Cell Therapy]
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: Agenda
Agenda Opening Remarks 01 REACT Phase 2 RMCL-002 Data 02 Plans for Phase 3 Program (Studies REGEN-006 and REGEN-016) 03 04 Advancing a Comprehensive Clinical Plan 3
Slide 4: Disrupting the CKD Treatment Landscape
Disrupting the CKD Treatment Landscape Renal Autologous Cell Therapy: ® REACT (rilparencel) proprietary autologous cellular therapy being evaluated to preserve kidney function in diabetic patients at high risk of kidney failure 4
Slide 5: What is REACT and Why is it Relevant?
® What is REACT and Why is it Relevant? Our Product Unmet Needs Our Goals Our Plan Over 35 million U.S. adults Preserve kidney function REACT® is a proprietary Phase 3 clinical program have chronic kidney cell therapy using the proact 1 and proact 2 are Reduce or potentially 1 disease (CKD) patient’
Slide 6: REACT Goal: Preservation of Kidney Function
® REACT Goal: Preservation of Kidney Function ProKidney’s REACT® Autologous Cell Therapy 6
Slide 7: Overview of the REACT Clinical Program
® Overview of the REACT Clinical Program Lead Platform Programs* PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 STATUS Pivotal Trial Program Diabetes Type II – Prevent/Delay CKD 3/4 006/proact 1 Ongoing 2 (20-50 ml/min/1.73m , N = 600) Diabetes Type II – Prevent/Delay CKD 3/4 stratified for SGLT2i Enrollme
Slide 8: Unmet Clinical and Payer Need in High-Risk CKD Patients
Unmet Clinical and Payer Need in High-Risk CKD Patients REACT® May Delay Need for Dialysis in Highest-Risk Progressors • 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), abbrevi
Slide 9: Therapeutic Options to Delay Dialysis in Stage 4 CKD are Limited
Therapeutic Options to Delay the Need for Dialysis in Patients with Stage 4 Chronic Kidney Disease are Limited Study Active Product Subjects with Stage 4 CKD (%) 1 Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy Canagliflozin (SGLT2 inhibitor) 0% 2 Dapaglifozin in Patients with C
Slide 10: Patients Still Lose Kidney Function Despite New Therapies
While New Therapies Are a Step Forward, Patients Still Lose Kidney Function and Experience Clinically Significant Events Standard of Care has Limitations Current SGLT2 Inhibitors are Blockbusters 1 Patients continue to lose kidney function on SGLT2 inhibitors Current standard of care does not preven
Slide 11: RMCL-002 Interim Analysis August 2023 Data Cut
RMCL-002 Interim Analysis August 2023 Data Cut 11
Slide 12: REACT Demonstrates Potential for Preservation of Kidney Function in Phase 2
® In this Phase 2 Study, REACT Demonstrates the Potential for Preservation of Kidney Function in Patients with Diabetes and Advanced Kidney Disease • REACT showed potential to preserve kidney function for up to 30 months in Key Findings several patient groups • REACT’s benefit on kidney function was
Slide 13: RMCL-002: Trial Design
RMCL-002: Trial Design Active n = 41* st nd 1 2 EOS REACT® REACT® Month 24 follow-up nd Injection Injection after 2 injection = 6 months uu uuuuuu Screening R st nd 1 2 EOS Visit and u = follow-up visit 1:1 nd REACT® REACT® Biopsy Month 12 follow-up after 2 injection nd Injection Injection after 2 i
Slide 14: Study Objectives and Endpoints
Study Objectives and Endpoints • To assess the safety and efficacy of up to two REACT injections given 6 Study Objectives months apart and delivered into the biopsied kidney using a percutaneous approach • Procedural- and investigational product-related adverse events Study Endpoints • Change in kid
Slide 15: Study Demographics are Balanced and Represent a High-Risk CKD Population
Study Demographics are Balanced and Represent a High-Risk CKD Population ACTIVE DEFERRED (n=41) (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% 14% White 93% 71% Other 5% 14% Blood press
Slide 16: Current Enrollment Status & Completion Expectations
Current Enrollment Status & Completion Expectations st nd ACTIVE COHORT 1 2 REACT® REACT® Active n = 41 st Before 1 Injection: 2 subjects withdrew Injection Injection 39 EOS nd Before 2 Injection: 4 subjects EOS** as per protocol, 33 1 subject expired, 1 started dialysis 39 33 29 21 (+ 4)* nd Before
Slide 17: No REACT-related SAEs Identified in RMCL-002
No REACT-related SAE’s Identified in RMCL-002 BIOPSY REACT INJECTION # of patients (%) # of patients (%) ADVERSE EVENT (N=83)* (N=132)* Hematoma 1(1.2) 1(0.8) Pain 0 3(2.3) Hematuria 0 0 Transfusion 0 1 (0.8) Surgical Intervention 0 0 Death 0 0 Acute Kidney Injury 0 1(0.8) CKD progression 0 1(0.8) R
Slide 18: Active Cohort Showed No Clinically Meaningful Effect After 1st Injection
Active Cohort Patients Showed No Clinically Meaningful Active Patients (N = 39) Effect After 1st Injection vs Deferred Patients on SOC (N = 40) Average Change in eGFR eGFR Decline Over 30 Months Screening 1st Inj 1st Inj + 3m 2nd Inj 2nd Inj + 3m 2nd Inj + 6m 2nd Inj + 9m 2nd Inj + 12m 2nd Inj + 15m
Slide 19: Deferred to Cross-Over Patients Showed Preservation of eGFR after REACT
Deferred to Cross-Over Patients Showed Preservation of eGFR after REACT Injection ® Average eGFR in Deferred Cohort: SOC followed by REACT Treatment Average eGFR of the Deferred cohort was nd st nd nd nd 1 Inj 2 Inj 2 Inj 2 Inj 2 Inj st nd 1 Inj 2 Inj 31.8 at baseline + 3m + 3m + 6m + 9m + 12m Biops
Slide 20: Post-Hoc Analysis of All Subjects who Received at Least One Injection
Post-Hoc Analysis of All Subjects who Received at Least One Injection 37% of subjects (27 / 73) had preservation of eGFR during 30 months of follow-up All Subjects who Received at Least One Injection with REACT Grouped into Subjects with an 18-month individual slope in eGFR ≥ 0 (n=27) versus REACT t
Slide 21: Post-Hoc Analysis of All Subjects who Received at Least One Injection
Post-Hoc Analysis of All Subjects who Received at Least One Injection 37% of subjects (27 / 73) had preservation of eGFR during 30 months of follow-up All Subjects who Received at Least One Injection with REACT Grouped into Subjects with an 18-month individual slope in eGFR ≥ 0 (n=27) versus Subject
Slide 22: Subgroup Analysis of Diabetic Patients with CKD Stage 4 and A3 Albuminuria
Subgroup Analysis of Diabetic Patients with CKD Stage 4 and Class A3 Albuminuria* Stabilization of Kidney Function in Active (n=13) and Deferred (n=10) Patients at 12 months vs SOC Avg Change in eGFR from Baseline In Active vs Deferred Patients on SOC Avg Change in eGFR from Baseline in Cross-Over v
Slide 23: REACT Demonstrates Potential for Preservation of Kidney Function in Phase 2
® In this Phase 2 Study, REACT Demonstrates the Potential for Preservation of Kidney Function in Patients with Diabetes and Advanced Kidney Disease • REACT showed potential to preserve kidney function for up to 30 months in Key Findings several patient groups • REACT’s benefit on kidney function was
Slide 24: REACT Registrational Program: REGEN-006 (proact 1)
REACT® Registrational Program: 1 (REGEN-006) 2 Modifying proact 1 eGFR enrollment criteria from current range of ≥20 to ≤ 50ml/min/1.73m to new range of 2 ≥20 to ≤ 35 ml/min/1.73m to better align with RMCL-002 results and Payer / Clinical Feedback = 3 months st Sham 1 Sham SHAM Cohort n=300 ® REACT
Slide 25: REACT Registrational Program: REGEN-016 (proact 2)
® REACT Registrational Program: 2 (REGEN-016) NO MODIFICATIONS PLANNED = 3 months st Sham 1 Sham = 6 months SHAM Cohort n=300 ® nd REACT 2 ® Sham Injection REACT Biopsy Injection End of Study (EOS) st nd Screening R 1 2 ® ® Visit REACT 1:1 REACT Biopsy Injection Injection Day - 60 to Day 0 End of St
Slide 26: Advancing a Comprehensive Clinical Plan
Advancing a Comprehensive Clinical Plan 1H 2023 2H 2023 2024 and beyond REGEN-003 Phase 2 RMCL-002 Phase 2 REGEN-007 Phase 2 REACT® Phase 3 Diabetic CKD Trials Trial; Results Enrollment complete Enrollment complete proact 1 – Enrollment focused on U.S. published 1Q23 Interim results 2H23 proact 2 –
Slide 27: World-class Leadership and Board of Directors
World-class Leadership and Board of Directors Pablo Legorreta Dr. Bruce Culleton Chairman of the Board Chief Executive Officer & Director James Coulston Nikhil Pereira-Kamath Chief Financial Officer Chief Business Officer Jennifer Fox William Doyle Dr. Bruce Culleton Todd Girolamo Mary Weger Chief L
Slide 28: Developing Solutions for Dialysis Prevention
Corporate Presentation January 2024 Developing Solutions for Dialysis Prevention REACT® [REnal Autologous Cell Therapy]
Slide 29: Appendix
Appendix 29
Slide 30: Annualized eGFR Slopes using Linear Mixed Effects Modeling
Annualized eGFR Slopes using Linear Mixed Effects Modeling Subject Group Number of Duration of Follow-up Annualized eGFR Slope 2 Subjects (ml/min/1.73m ) Active Cohort 39 12-months after 1st injection -3.6 Deferred Cohort during standard of care (SOC) 42 12-months after biopsy -3.4 nd Deferred Cohor
Slide 31: Subgroup Analysis of Diabetic Patients with CKD Stage 4 and A3 Albuminuria
Subgroup Analysis of Diabetic Patients with CKD Stage 4 and Class A3 Albuminuria* Stabilization of Kidney Function in Deferred (n=10) Patients at 12 months vs SOC Avg Change in eGFR from Baseline in Cross-Over vs Deferred Patients on SOC st st nd nd nd 1 Inj 1 Inj + 3mo 2 Inj 2 Inj + 3mo 2 Inj + 6mo