Slide 1: Corporate Presentation September 2023
Corporate Presentation September 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 REACT?
Unmet Needs Our Goals Our Product Our Plan 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 cell subtypes with the potential to help preserve kidney function Phase 3 clinical p
Slide 4: CKD is Serious Public Health Problem Today
CKD is Serious Public Health Problem Today $80B+ Private insurance may pay up to 4x Medicare costs2 Medicare spend on Chronic Kidney Disease $50B+ Medicare spend on End Stage Renal Disease $93K+ Medicare annual cost per patient on dialysis1 One of the largest healthcare expenditure categories in the
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 Estimated global market sales of Canagliflozin, Dapagliflozin and Empagl
Slide 6: REACT initially targets a defined subset of advanced T2D CKD
Total 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 certainty due to th
Slide 7: REACT Goal: Preservation of Kidney Function
REACT® Goal: Preservation 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 Renal cortex cells are harvested using a routine kidney biopsy The expanded, ta
Slide 8: REACT Goal: Preservation of Kidney Function
REACT® Goal: Preservation of Kidney Function 1 2 5 10 Biopsy Processing Cell Expansion Cell Selection Dose Preparation Cell Delivery 12 weeks from biopsy to cell delivery Biopsy Implantation PROKIDNEY 8
Slide 9: 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 suggests REACT® treatment may improve kidney function via multiple mechanisms CON
Slide 10: Remodeling 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 of Nephrons REACT® targets preservation of kidney function for dialysis-free living >50 3 Types of Cells in Adult Kidney
Slide 11: 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 12: REACT Trials Designed to Address Multiple Types of CKD
REACT® Trials Designed to Address Multiple Types of CKD Lead Platform Programs (Clinical Development) PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 STATUS REACT® Diabetic Kidney Disease (DKD) Pivotal Trial Progam Diabetes Type II – Prevent/Delay CKD 3/4 (20-50 ml/min/1.73m2, N = 600) Diabetes Type II – Pr
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 repeat REACT® doses (REGEN-015) Determine durability of REACT® injection (REGEN-008) Identify re-dosing triggers (REGEN-007) Assess potential
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: RMCL-002: Preliminary Results from Study in Diabetics with CKD
REACT® Average eGFR was 4.6 ml/min/1.73m2 higher at 24 months versus the average eGFR for all participants at baseline Standard of Care Progressive decline in kidney function over 12 months of ‒3.6 ml/min/1.73m2 A characteristic of SOC for CKD 3a, 3b, and 4 Note: As of March 1, 2022 RMCL-002: Prelim
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.) 2/10 patients had preservation of renal function >2+ years post injection Mean extrapolated REACT Treated Source: Stavas, et al. Renal Autologous Cell Therapy in Type 2 Diab
Slide 18: Interim Safety Profile of REACT
Consistently striving 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
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: Safety Profile Supports Bilateral Dosing of REACT
Safety Profile Supports Bilateral Dosing of REACT™ to Evaluate Potential for Increased Therapeutic Benefit Phase 2 Study: REGEN-007 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% UACR 30 - 5,000 mg/
Slide 21: REACT Registrational Program: proact 1 (REGEN-006)
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 22: REACT Registrational Program: proact 2 (REGEN-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 23: REACT Registrational Program Regulatory & Reimbursement 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 REACT® Registrational Program Regulatory & reimbursement engagement plan: Diabetic Kidney Disease F
Slide 24: 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 25: Preparing for Commercial Readiness
Implementing staged construction to expand commercial-scale manufacturing capabilities Addition of Greensboro facility provides scalability beyond Winston-Salem facility to address anticipated post-approval demand In-house manufacturing supports clinical programs and initial commercial launch Cryo-p
Slide 26: World-class Leadership and Board of Directors
Dr. Joe Stavas SVP, Global Head Clinical Development Ashley Johns SVP, Global Head Clinical Operations Dr. Tim Bertram Chief Executive Officer James Coulston Chief Financial Officer Pablo Legorreta Chairman of the Board José Ignacio Jiménez Santos William Doyle Jennifer Fox Dr. Tim Bertram Dr. Alan
Slide 27: 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: 2H23 ROW enrollment; Interim anticipated by YE25 Global Phase 3
Slide 28: 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 29: ProKidney. A Step Closer to Potential Dialysis Prevention
Corporate Presentation September 2023 PROKIDNEY.A Step Closer to Potential Dialysis Prevention REACT® [REnal Autologous Cell Therapy]