Prokidney Corp. · NASDAQ:PROK
Prokidney — J.P. Morgan Investor Conference January 2023
28 slides from Prokidney's conference presentation, Jan 10, 2023
Slide 1: A Step Closer to Potential Dialysis Prevention
J.P. Morgan Investor Conference January 2023 Exhibit 99.1 PROKIDNEY A Step Closer to Potential 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: What is ProKidney?
The Problem The Goal The Product The Plan Contribution to Society REACT® is a proprietary cell therapy using the patient’s own kidney cells Mechanism of action has been observed to result in clinical activity REACT® includes three specific cell types with the potential to help restore kidney functio
Slide 4: REACT: REnal Autologous Cell Therapy for CKD
REACT®: REnal Autologous Cell Therapy for CKD Advancing a comprehensive clinical plan to demonstrate commercial potential REACT® Phase 3 DKD Trials proact 1: Ongoing enrollment in U.S., Canada, and EU; Interim anticipated YE24 proact 2: 1H23 ROW enrollment; Interim anticipated by YE25 Global Phase 3
Slide 5: Building a Comprehensive Data Package
Building a Comprehensive Data Package Clinical designed to expand potential patient population and support premium pricing Assess potential benefit of multiple REACT® doses (REGEN-015) Determine durability of REACT® injection (REGEN-008 and RMCL-002) Identify re-dosing triggers (REGEN-007) Assess po
Slide 6: REACT Initial Clinical Success
REACT® Initial Clinical Success Maximize dialysis-free living Too many CKD patients end up requiring dialysis Preservation of kidney function intended to delay/prevent kidney failure/dialysis Experienced board and management team $130B U.S. Medicare spend annually on ESRD / CKD (excludes private ins
Slide 7: CKD is Serious Public Health Problem Today
CKD is Serious Public Health Problem Today $80B+ Private insurance may pay up to 4x Medicare costs Medicare spend on Chronic Kidney Disease $50B+ Medicare spend on End Stage Renal Disease $93K+ Medicare annual cost per patient for dialysis One of the largest healthcare expenditure categories in the
Slide 8: While New Therapies Are a Step Forward, Patients Still Lose Kidney Function
Source: The New England Journal of Medicine. EvaluatePharma Note: 2026 sales estimates for therapies reflect all indications and are not limited to CKD While New Therapies Are a Step Forward, Patients Still Lose Kidney Function Recently approved CKD drugs incrementally slow eGFR loss, but CKD has no
Slide 9: REACT's Addressable U.S. Patient Population
Total addressable market data for the year ended 2020 is based on certain estimates of management. This information may prove to be inaccurate because of the method by which the underlying data for the estimates was obtained or because this information cannot always be verified with complete certain
Slide 10: High Patient Acceptance for New Medications
High Patient Acceptance for New Medications Survey participants were overwhelmingly willing to take a medication - even if side effects occurred (93.6%) Inker et al Am J Kidney Dis. 80(4):513-526 Panelist with the CKD stage 3a stated: “….if I did see an appreciable decrease in my kidney health then
Slide 11: Targeted therapies precedents: pricing and penetration
Targeted therapies that share four characteristics: These are “game changing” (disease modifying medicines) for the afflicted patients These targeted therapies treat only between 5k to 70k patients (potentially 290k with Vutrisiran) These medicines are extremely expensive – cost per patient of $200k
Slide 12: Potential REACT Market Opportunity in US and EU
Potential REACT® Market Opportunity in US and EU Stage 3b CKD Stage 4 CKD Diabetes primary cause of CKD Diabetes primary cause of CKD (Estimates after 5-year ramp) 950,000 to 1 million CKD 4 patients (includes estimated 300-350k eGFR 15-19) Penetration ~20% prevalent patients (mean of recently launc
Slide 13: ESRD Patients Remain on Dialysis for 5-10 Years on Average
ESRD Patients Remain on Dialysis for 5-10 Years on Average Source: United States Renal Data System - USRDS 2020 Annual Report (https://adr.usrds.org/2020/about-the-new-adr), National Kidney Foundation (https://www.kidney.org/atoz/content/dialysisinfo#how-long-can-you-live-dialysis), company estimate
Slide 14: REACT Goal: Restoration of Kidney Function
REACT® Goal: Restoration of Kidney Function ProKidney’s REACT® Autologous Cell Therapy 1 Renal cortex cells are harvested using a routine kidney biopsy 2 cells are expanded and then selected for the three key cell types. 3 The expanded, target cell therapy is frozen for storage and injection 4 cell
Slide 15: Remodeling and Renovation of Nephrons
Kelly et al, Am J Physiol Renal Physiol 299: F1026-F1039, 2010. Bruce et al, Regenerative Medicine 10(7), 2015 Preclinical studies in rodents and canines, data on file. Remodeling and Renovation of Nephrons REACT® aims to preserve kidney function for dialysis-free living 26 3 Types of Cells in Adult
Slide 16: REACT MoA in CKD – ASN November 2022
REACT® MoA in CKD – ASN November 2022 Nephrogenic potential of SRCs may underlie renal restorative and reparative activity observed to-date SRCs participate in processes associated with kidney development SRCs forms organoids, which self-assemble into tubules in vitro SRC/REACT® in human cell cultur
Slide 17: REACT Impact on Kidney Function
Kelly et al, Am J Physiol Renal Physiol 299: F1026-F1039, 2010. Bruce et al, Regenerative Medicine 10(7), 2015 Preclinical studies in rodents and canines, data on file. REACT® Impact on Kidney Function Preclinical data suggest REACT® treatment may improve kidney function via multiple mechanisms Cont
Slide 18: REACT Designed to Address Multiple Areas of CKD
REACT® Designed to Address Multiple Areas of CKD Potential therapeutic indications Lead Platform Programs (Clinical Development) PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 STATUS REACT® Diabetic Kidney Disease (DKD) Diabetes Type II – Prevent/Delay CKD 3/4 (20-50 ml/min/1.73m2, N = 81) Diabetes Type II
Slide 19: RMCL-002: Study in Diabetics with CKD Stages 3A, 3B & 4
Key Entry Criteria Type 2 Diabetic Mellitus (DKD) Male or female 30-80 years of age eGFR ≥20 and ≤50 mL/min/1.73m2 Not on renal dialysis, HbA1c <10% Day –60 to Day 0 Screening Visit and Biopsy Deferred n= 42 R 1:1 1st REACT® Injection 2nd REACT® Injection EOS Month 24 1st REACT® Injection 2nd REACT®
Slide 20: REACT Stabilizes Kidney Function
REACT ® Stabilizes Kidney Function Baseline eGFR (Cystatin-C): 38.4 active vs 37.3 for deferred patients + 1.1 points higher Baseline eGFR (Creatinine): 34.5 active vs 32.2 for deferred patients + 2.3 points higher REACT® Renal function improved by an absolute improvement over 24 months of + 4.6 ml/
Slide 21: REGEN-003: Phase 2 Study in Stage 4/5 Diabetic CKD Patients
REGEN-003: Phase 2 Study in Stage 4/5 Diabetic CKD Patients Clinical trial design: Participants' baseline rate of eGFR decline served as comparator UACR mean 3190 mg/gr; mean eGFR 15.5 mL/min/1.73m2; >90% probability of dialysis initiation No other marketed drug is indicated for these patients = 6 m
Slide 22: REGEN-003: Pre-Dialysis Patients Benefit from REACT
REGEN-003: Pre-Dialysis Patients Benefit from REACT 7/10 patients had 30% increase in dialysis free living (median of ~16 mo.) eGFR improvement of 38% (>2.5 ml/min/1.73 m2) 2/10 patients have preservation of renal function >2+ years post injection Mean extrapolated REACT Treated LABEL EXTENSION Stav
Slide 23: REACT Registrational Program: proact 1 & 2
Time-to-Event Primary Composite Endpoint: At least 40% reduction in eGFR; eGFR<15mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or renal transplant; or Death from renal or cardiovascular causes Day - 60 to Day 0 Screening Visit and Biopsy SHAM Cohort n=300 REACT Cohort n=300 R 1:1
Slide 24: REACT Registrational Program Regulatory & Reimbursement Engagement Plan
* EMA: European Medicines Agency, RMAT: Regenerative Medicine Advanced Therapy, BLA: Biologics License Application, SGLT2i: Sodium-glucose Co-transporter 2 inhibitor, HTA: Health technology assessment, MHRA: Medicines & Healthcare products Regulatory Agency of the United Kingdom, NICE: National Inst
Slide 25: Manufacturing toward clinical and commercial opportunities
Staged construction of commercial scale manufacturing facilities In-house manufacturing supports clinical trials and scalable and meet future commercial needs Future facilities will be built to meet market demand Manufacturing toward clinical and commercial opportunities Phase 2 COGS ~$100K / patien
Slide 26: World-class Leadership and Board of Directors
Dr. Joe Stavas SVP, Global Head Clinical Development Dr. Darin Weber Chief Regulatory Officer Ashley Johns SVP, Global Head Clinical Operations Dr. Tim Bertram Chief Executive Officer Dr. Deepak Jain Chief Operating Officer James Coulston Chief Financial Officer Dr. Libbie McKenzie Chief Medical Off
Slide 27: REACT Initial Clinical Success
REACT® Initial Clinical Success Maximize dialysis-free living Too many CKD patients end up requiring dialysis Preservation of kidney function intended to delay/prevent kidney failure/dialysis Experienced board and management team $130B U.S. Medicare spend annually on ESRD / CKD (excludes private ins
Slide 28: A Step Closer to Potential Dialysis Prevention
J.P. Morgan Investor Conference January 2023 PROKIDNEY A Step Closer to Potential Dialysis Prevention REACT® [REnal Autologous Cell Therapy]
ProKidney — J.P. Morgan Investor Conference January 2023 on 6ix