Slide 1: Renal Autologous Cell Therapy: A Step Closer to Potential Dialysis Prevention
Renal Autologous Cell Therapy September 2022 A Step Closer to Potential Dialysis Prevention ProKidney Corp. Nasdaq: PROK
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?
REACT™ utilizes proprietary autologous cell therapy harvested from the patient’s own kidney REACT™ includes three specific cell types with the potential to help restore kidney function Phase 3 clinical program received FDA and EMA guidance; trial underway Target commercial launch in 2026 $130 billio
Slide 4: We are ProKidney
We are ProKidney Novel Investigational Cell Therapy Platform in Late-stage Clinical Trials Aimed at Transforming CKD Treatment REACT™ autologous cell therapy currently conducting Phase 3 trials for diabetic CKD Pre-clinical through Phase 2 programs in additional indication 2019: Acquired technology
Slide 5: ProKidney's REACT Autologous Cell Therapy
The expanded, target cell therapy product is frozen for storage and injection Cells are expanded and then selected renal cells including ureteric bud, cap mesenchyme, and glomerular cells are isolated for preparation Renal cortex cells are harvested using a routine kidney biopsy 1 2 3 Cell therapy p
Slide 6: Preclinical Data Suggest REACT Treatment May Improve Kidney Function
Preclinical Data Suggest REACT™ Treatment May Improve Kidney Function Via Multiple Mechanisms 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 Rest
Slide 7: Chronic Kidney Disease Represents an Exceptionally Large, Worldwide Healthcare Issue
Chronic Kidney Disease Represents an Exceptionally Large, Worldwide Healthcare Issue
Slide 8: CKD is Highly Prevalent in the U.S. & E.U.
82.2 40, 112, 153 93, 213, 191 228,60, 102 165,165,165 69, 195, 255 68, 84, 106 Source: National Health and Nutritional Examination Survey. Data on file. CKD Population (millions) U.S. and E.U Prevalence of CKD 2010 2020 Projected ~50% increase from 2010-2040 in CKD Prevalence CHRONIC KIDNEY DISEASE
Slide 9: CKD Global Market Opportunity
CKD Global Market Opportunity Latin America ~64 Million (~10% of population) China ~100 Million (~11% of population) Korea ~7 Million (~13% of population) Japan ~16 Million (~13% of population) Australia / New Zealand ~4 Million (~12-13% of population) Middle East ~45 Million (~10% of population) So
Slide 10: Treating CKD is Very Costly
PROKIDNEY.!* e ° ef ©@@ Treating CKD is Very Costly
Slide 11: The Rates of CKD & ESKD and Associated Expenditures are Expected to Continue to Rise
Source: Medicare spend and per patient dialysis cost as of 2018. United States Renal Data System - USRDS 2020 Annual Report (https://adr.usrds.org/2020/about-the-new-adr). KDIGO refers to Kidney Disease Improving Global Outcomes Data for the year ended 2020 and any subsequent years are based on cert
Slide 12: CKD has No Known Cure
CKD has No Known Cure While patients continue to lose kidney function despite use of existing therapies, these therapies generate multi-billion dollars in sales SGLT2 WW revenue (FY 2021, $USD) - Dapagliflozin $3,000M - Empagliflozin $4,300M - Canagliflozin $ 563M Total >$ 7,800M Current Standard of
Slide 13: Unrelenting Progression of CKD with No Available Cures
ALBUMINURIA CATEGORIES (mg/g) eGFR CATEGORIES (ml/min/1.73m2) CKD 3a CKD 3b CKD 4 REACT ™ REACT ™ REACT ™ REACT ™ REACT ™ REACT ™ CKD 2 CKD 1 Mild Severe Moderate REACT™ TARGETS At this stage patients have minimal other treatment options and usually progress to ESKD, dialysis or transplantation REAC
Slide 14: Recently Approved CKD Drugs Incrementally Slow eGFR Loss
Recently Approved CKD Drugs Incrementally Slow eGFR Loss, but CKD has No Known Cure Source: The New England Journal of Medicine. EvaluatePharma Note: 2026 sales estimates for therapies reflect all indications and are not limited to CKD WW Sales ~$740mm (2026) WW Sales ~$3.7bn (2026) WW Sales ~$5.1bn
Slide 15: The Potential To be Disease Modifying Could Result In Significant Patient Benefits
The Potential To be Disease Modifying Could Result In Significant Patient Benefits and Reduced Costs to the Healthcare System
Slide 16: Initially Targeting a 4-5 Million Patient Segment
Initially Targeting a 4-5 Million Patient Segment with Multiple Potential Label Expansion Indications REACT’s Addressable U.S. Patient Population Source: Data on file. REACT’s Addressable U.S. Patient Population Initially Targeting a 4-5 Million Patient Segment with Multiple Potential Label Expansio
Slide 17: REACT's Target Market Can Reach >30 Million Patients in the US and EU
REACT’s target market can reach >30 million patients in the US and EU alone Estimated 75 million CKD patients in the U.S. and EU CKD prevalence is growing at 1% per year Potential expansion to ROW with over 230 million additional CKD patients REACT’s Potential Market Expansion in Core US and EU Mark
Slide 18: Targeted Therapies Sharing Characteristics: Pricing and Reimbursement Precedents
Targeted therapies that share 4 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 to
Slide 19: Sizing the U.S. and EU Market Opportunity
Source: Data on file. Estimated 8.5 MM Existing diabetic population in stage 3a, 3b and 4 CKD with 20 – 50 of eGFR Prevalence 1% (85,000 patients) Assumed U.S. and EU Illustrative REACT™ Market Penetration Illustrative price ~$250,000 / patient Based on average of recently launched novel targeted th
Slide 20: Significant Cost Savings Potential
Significant Cost Savings Potential A Disease Modifying Drug in CKD Could Reduce Treatment Cost Incremental Private Insurance Cost ESKD 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-ad
Slide 21: Initial Clinical Data Suggest REACT Could Potentially Stop Progression of CKD
Initial Clinical Data Suggest REACT™ could potentially stop the progression of, or even improve, kidney function for Individuals with Class 3/4 Diabetic Chronic Kidney Disease (CKD)
Slide 22: RMCL-002 Clinical Trial Design
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% Screen Deferred N=42 Active N=39 End of Study (EOS) Part 1 R 1:1 12 months Observation 2nd REACT™ Injection 1st REACT™ Injection 2nd REACT™ Injection 1
Slide 23: RMCL-002 Clinical Trial Design (Part 1)
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% RMCL-002 Clinical Trial Design Preliminary Results From RMCL-002 Trial In Diabetics With CKD Stages 3A, 3B & 4 Day –60 to Day 0 Screening Visit and Bio
Slide 24: Comparing Effect of REACT vs Standard of Care
Comparing Effect of REACT™ vs Standard of Care in Phase 2 Study Preliminary Results From RMCL-002 Phase II Trial In Diabetics With CKD Stages 3A, 3B & 4 REACT ® Stabilizes Kidney Function Baseline eGFR (Cystatin-C): 38.4 active vs 37.3 for deferred patients + 1.1 points higher Baseline eGFR (Creatin
Slide 25: Impact on Albuminuria vs. Control in Phase 2 Study
% Change in Albuminuria P-values calculated using Welch Two Sample T Test for unequal variances, data as of Jul 21, 2021 Significant Reduction in Albuminuria Change p=0.03 N=28 N=42 Impact on Albuminuria vs. Control in Phase 2 Study Preliminary Results from RMCL-002 Trial In Diabetics With CKD Stage
Slide 26: Effect of REACT on Serum Hemoglobin and Phosphorus
Effect of REACT™ on Serum Hemoglobin and Phosphorus of Active Cohort in Phase 2 Study REACT™ Stabilization of CKD Comorbidities: Anemia and Phosphatemia Data on file. Data as of August 3, 2021 Preliminary Results From RMCL-002 Trial In Diabetics With CKD Stages 3A, 3B & 4 All Patients Randomized to
Slide 27: Lead Platform Programs (Clinical Development)
Lead Platform Programs (Clinical Development) Preclinical IND Phase 1 Phase 2 Phase 3 Registration (BLA/MAA) REACTTM Diabetic Kidney Disease (DKD) Diabetes Type II – Prevent/Delay CKD 3/4 (20-50 ml/min/1.73m2, N = 81) Diabetes Type II – Prevent/Delay CKD 3/4 (20-50 ml/min/1.73m2, N = 1,200) Diabetes
Slide 28: 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 Day –60 to Day -7 Screening Visit Cohort 2 n= 25 R 1:1 Biopsy Biopsy 1st REACT Injection EOS Month 24 Evaluate Re-dose Trigger Month 3-18 2nd REACT Injection EOS Month
Slide 29: REACT Registrational Program – REGEN-006 / 016
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 300 - 5,000 mg/g First Patients Enrolled Earlier This Year REACT™ Registrational Program – REGEN-006 / 016 Time-to-Event Primary Composite Endpoin
Slide 30: Regulatory & Reimbursement Engagement Plan
Diabetic Kidney Disease Conducting ‘Gold Standard’ Two Adequate and Well Controlled RCT for BLA* Approval RMAT* Designation provides potential for accelerated approval pathway in U.S. Time to event and composite endpoints aligned with registration study designs followed by other CKD therapies (i.e.,
Slide 31: Manufacturing Strategies: Strategy to Produce Commercial Quantities Efficiently
Reliable, established process in-place Unique industrial process know-how Step-by-step scale up & build out to peak market demand Manufacturing efficiency and supply chain streamlining already underway expected to reduce COGS by up to 50% vs. Phase 2 manufacturing cost Manufacturing Strategies Strat
Slide 32: Infrastructure Development and Strategy to Reduce COGS
Staged construction of commercial scale manufacturing facilities A facility with capacity of 40,000 patients p.a. is estimated to cost $700M–$750M Future facilities will be built to meet market demand Commercial Manufacturing Phase 2 COGS for REACT is ~$100K / patient Anticipate COGS to potentially
Slide 33: Early Clinical Success, Sponsorship & Team
Early Clinical Success Sponsorship & Team Strong healthcare investors, funding runway to commercialization Candidate kidney therapy seeking to delay/prevent dialysis in CKD Strong balance sheet for transformative opportunity Social Capital, Suvretta Capital, existing PROK investors — Healthcare inve
Slide 34: World-class Leadership and Board of Directors
World-class Leadership and Board of Directors Dr. Joe Stavas, SVP Clinical Development Dr. Darin Weber, SVP Regulatory Development Ashley Johns, SVP Clinical Operations Dr. Tim Bertram, CEO Dr. Deepak Jain, COO James Coulston, CFO Dr. Libbie McKenzie, CMO Todd Girolamo, Chief Legal Officer & Secreta
Slide 35: Anticipated Milestones
Anticipated Milestones Aim for Continual Updates on REACT™ Throughout 2022 and Beyond Early / Mid-stage data updates – RMCL-002; REGEN-003 Throughout 2022, 2023 and 2024 015 Booster Protocol – FDA Feedback 4Q 2022 EMA Scientific Advice 3Q 2022 REGEN-007 – Early data 2Q/3Q 2023 Enrollment milestones
Slide 36: PROKIDNEY.!*
PROKIDNEY.!*
Slide 37: Appendix
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