Prokidney Corp. · NASDAQ:PROK
Prokidney — Investor Presentation (March 2023)
27 slides from Prokidney's investor presentation, Mar 6, 2023
Slide 1: ProKidney Corporate Overview March 2023
ProKidney Corporate Overview March 2023 Exhibit 99.1 A step closer to potential Dialysis Prevention React®[Renal Autologous Cell Therapy] Corporate Overview March 2023 Exhibit 99.1
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 Preclinical activity and mechanism of action translated to clinical activity REACT® includes three specific cell types with the potential to help restore kidney
Slide 4: What is the Problem? CKD is Serious Public Health Problem Today
What is the Problem? 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 expenditu
Slide 5: 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 6: 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 7: 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 8: REACT Goal: Restoration of Kidney Function
REACT® Goal: Restoration of Kidney Function ProKidney’s REACT® Autologous Cell Therapy REACT® Goal: Restoration of Kidney Function ProKidney’s REACT® Autologous Cell Therapy 1 Rental cotex cells are harvested using a routine kidney biopsy 2 Cells are expanded and then selected for the three key cell
Slide 9: 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 10: 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 11: 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 REAC
Slide 12: REACT Trials Designed to Address Multiple Areas of CKD
REACT® Trials 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
Slide 13: Building a Comprehensive Data Package
Building a Comprehensive Data Package Clinical program 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) A
Slide 14: 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 15: 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 16: 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 17: 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.) 6/10 patients observed to have improved eGFR or stabilization 2/10 patients have preservation of renal function >2+ years post injection Mean extrapolated REACT Treated LABE
Slide 18: Interim Safety Profile of REACT in Phase 2
Consistently aiming to mitigate procedure-related risks while preserving kidney function for late-stage CKD patients Interim Safety Profile: Safety of REACT in Phase 2 Diabetic CKD Stages 3A, 3B, 4, & 5 and CAKUT Serious Adverse Event n Hematoma* 1 Transfusion* 1 Acute Kidney Injury* 1 Macroscopic H
Slide 19: REACT Procedure Complication Rate Below a Standard Kidney Biopsy
REACT Procedure Continued to Demonstrate a Complication Rate Below a Standard Kidney Biopsy REACT procedure in Phase 2 clinical trials was tolerated with a safety profile similar to a standard biopsy Category Biopsy # of patients (%) (N=133) REACT Injection # of patients (%) (N=202) Hematoma 4 (3.0)
Slide 20: REACT Registrational Program: REGEN-006 / 016
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 SHAM Cohort n=300 REACT Cohort n=300 R 1:1 Sham 1st RE
Slide 21: 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 22: 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 23: 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 24: Manufacturing Strategies
Staged construction of commercial scale manufacturing facilities In-house manufacturing supports clinical program Scalable to meet initial commercial demand upon regulatory approval Future facilities will be built to meet market demand Manufacturing toward clinical and commercial opportunities Phase
Slide 25: World-class Leadership and Board of Directors
Dr. Joe Stavas SVP, Global Head Clinical Development Ashley Johns SVP, Global Head Clinical Operations Dr. Darin Weber Chief Regulatory Officer Dr. Tim Bertram Chief Executive Officer Dr. Deepak Jain Chief Operating Officer James Coulston Chief Financial Officer Pablo Legorreta Chairman of the Board
Slide 26: REACT Initial Clinical Success
REACT® Initial Clinical Success Maximize dialysis-free living Too many CKD patients require 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 insurance) —
Slide 27: Corporate Overview March 2023
Corporate Overview March 2023 ProKidney Corporate Overview March 2023 A step closer to potential Dialysis Prevention React®[Renal Autologous Cell Therapy]