Prokidney Corp. · NASDAQ:PROK
Prokidney — Social Capital Suvretta Holdings Corp. III — SPAC Merger (April 2022)
56 slides from Prokidney's SPAC merger presentation, Apr 28, 2022
Slide 1: Renal Autologous Cell Therapy: A Step Closer to Potential Dialysis Prevention
Exhibit 99.1 Renal Autologous Cell Therapy A Step Closer to Potential Dialysis Prevention April 28, 2022 1
Slide 2: Disclaimer
Disclaimer General Disclaimer This investor presentation (this “Presentation”) was prepared by Social Capital Suvretta Holdings Corp. III (the “SPAC” or “DNAC”) and ProKidney, LLC (the “Company” or “ProKidney”). This Presentation is intended for research analysts and institutional investors in conne
Slide 3: Disclaimer: Additional Information and Where to Find It
Disclaimer Additional Information and Where to Find It In connection with the Business Combination between the SPAC and ProKidney, the SPAC has filed a preliminary proxy statement with the U.S. Securities and Exchange Commission (the “SEC”) and intends to file a definitive proxy statement with the S
Slide 4: Today's Participants
Today’s Participants Pablo Legorreta, Chairman of the Board Chamath Palihapitiya, CEO Dr. Joe Stavas, Tim Bertram, CEO SVP Clinical Development Darin Weber, Deepak Jain, COO SVP Regulatory Development Kishen Mehta, Ashley Johns, James Coulston, CFO Portfolio Manager SVP Clinical Operations Todd Giro
Slide 5: Chronic Kidney Disease Market Is BIG
Chronic Kidney Disease Market Is BIG 5
Slide 6: CKD is Highly Prevalent in the U.S. & E.U.
CHRONIC KIDNEY DISEASE MARKET IS BIG CKD is Highly Prevalent in the U.S. & E.U. U.S. and E.U Prevalence of CKD Projected ~50% increase 1. 90.9 from 2010 -2040 in CKD 1. 82.2 Prevalence 1. 74.4 43.8 60.8 38.6 35.8 29.3 47.1 42.6 38.5 31.5 2010 2020 2030 2040 U.S. E.U. Source: National Health and Nutr
Slide 7: Large Amount Of Money Is Spent Treating CKD Globally
Large Amount Of Money Is Spent Treating CKD Globally 7
Slide 8: CKD Is an Enormous Burden on the Healthcare System
CKD IS AN ENORMOUS BURDEN ON THE HEALTHCARE SYSTEM CKD/Dialysis is One of the Largest Healthcare 1 Expenditure Categories in the U.S. and ROW The Rates of CKD & ESRD and Associated Expenditures are Expected to Continue to Rise ~$80 Billion U.S. Adult Population with CKD - by KDIGO Stage of Disease (
Slide 9: Currently, CKD Has No Known Cure
LARGE AMOUNT OF MONEY ISSPENT TREATING CKD GLOBALLY Currently, CKD Has No Known Cure Standard of Current Care has Therapies are Limitations Blockbusters • While Patients Continue to Lose • Current Standard of Care Kidney Function on Existing Merely Slows Down The Therapies, Those Therapies Still Exp
Slide 10: REACT May Rescue Highest-Risk Progressors before ESRD
® REACT May Rescue Highest-Risk Progressors before ESRD Unrelenting Progression of CKD with no Available Cures ALBUMINURIA CATEGORIES (mg/g) Severe Mild Moderate Standard of Care CKD 1 o Antihypertension o ACEi o ARB o Glucose and CKD 2 Inflammation Reduction o SGLT2i ® REACT CKD 3a ® ® REACT REACT
Slide 11: Recently Approved CKD Drugs Incrementally Slow eGFR Loss
Recently Approved CKD Drugs Incrementally Slow eGFR Loss, But CKD Has No Known Cure While New Therapies are a Step Forward, Treatment Effect at 24 Months Patients Still Lose Kidney Function 2 2 2 Empagliflozin: +1 ml/min/1.73 m Improvement Canagliflozin: +2.2 ml/min/1.73 m Improvement Dapagliflozin:
Slide 12: The Ability To Modify Diseases Can Result In Big Payoffs
The Ability To Modify Diseases Can Result In Big Payoffs 12
Slide 13: REACT's Addressable Patient Population
® REACT ’s Addressable Patient Population We Initially Target a 4-5 Million Patient Segment with Multiple Potential Label Expansion Indications 1 2020 US Patients (mm) US Prevalence of CKD Total CKD 38.5 CKD Stage 3&4 17.6 CKD Stage 3&4 Caused by Diabetes or Hypertension 13.4 8.3 million 5.1 million
Slide 14: Drug Pricing for Disease Modification
Drug Pricing for Disease Modification Recently Launched Novel Targeted Therapies Command High Prices * 1 $1,125,000 Median: ~$360k Price / Patient ($) 1. These are “game changing” (disease modifying medicines) for the affected patients 2. These medicines can command high prices for their medical imp
Slide 15: Meaningful Potential Payoff For REACT
® Meaningful Potential Payoff For REACT For Every 1% (44,000 Patients) Market Penetration Sizing the US Market Opportunity Illustrative Illustrative Illustrative ® ® Prevalence REACT Market REACT Price Unadjusted Penetration per Treatment Sales 1 ~$360,000 / ~$16BN 4.4 MM 1% 2 (44,000 patients) Per
Slide 16: Significant Cost Savings Potential
Significant Cost Savings Potential A Disease Modifying Drug in CKD Would Reduce Treatment Cost ESRD Patients Remain on Dialysis for 5-10 Years on Average Estimated ESRD Cost Per Patient (Illustratively Potential Effects of Disease Based on 5 Years on Dialysis) Modifying Product Up to ~$2mm • Improve
Slide 17: Rest of World Opportunity Presents Attractive Potential Upside
Rest of World Opportunity Presents Attractive Potential Upside ® REACT ’s Market Opportunity ex-US/EU is ~230 Million Individuals China ~100 Million (~11% of population) Latin America ~64 Million (~10% of population) Middle East ~45 Million (~10% of population) Japan ~16 Million (~13% of population)
Slide 18: Early Clinical Data Suggest REACT Improves Kidney Function
® Early Clinical Data Suggest REACT is Not Just Stopping The Progression of CKD, But Also Driving Meaningful IMPROVEMENT in Kidney Function – A First of Its Kind 18
Slide 19: Preliminary Results From RMCL-002 Phase II Trial
Preliminary Results From RMCL-002 Phase II Trial In Diabetics With CKD Stages 3A, 3B & 4 ® Comparing Effect of REACT vs Standard of Care ® REACT ® REACT Stabilizes Kidney Function Renal function improved by Baseline eGFR (Cystatin -C): Reached 2 38.4 active vs 37.3 for + 4.1 ml/min/1.73m /yr deferre
Slide 20: Effect of REACT on All Injected Patients
Preliminary Results From RMCL-002 Phase II Trial In Diabetics With CKD Stages 3A, 3B & 4 ® Effect of REACT on All Injected Patients ® REACT Renal function improved 2 + 2.7 ml/min/1.73m eGFR slope now 2 + 1.7 ml/min/1.73m /yr Note: As of August 3, 2021, 31 of 42 patients randomized to Deferred Cohort
Slide 21: ProKidney Investment Thesis
ProKidney opportunity Social Capital Suvretta Holdings Corp. III (Nasdaq:DNAC) Investment Thesis Attractive Investment World Class Opportunity Leadership with Team Significant Potential • Seasoned management team with deep • Targeting a high acuity, large global unmet medical need experience and exp
Slide 22: Merger with DNAC Presents Potential to Create Leading CKD Company
ProKidney opportunity Merger with DNAC Presents Potential to Create Leading Chronic Kidney Disease Company 1 Overview Earn-out • Pre-money equity value of $1.75 billion • 17.5 million shares issuable to ProKidney’s existing • Pro forma equity value of ~$2.64 billion shareholders in ~5.8 million shar
Slide 23: Why ProKidney?
Investment opportunity Why ProKidney? Financial Sponsorship Early Clinical Strength & Team Success Strong healthcare investors, Candidate kidney therapy to Strong balance sheet for funding runway to commercialization delay/prevent dialysis in CKD transformative opportunity Capital raised supports Ph
Slide 24: ProKidney and our Renal Autologous Cell Therapy (REACT)
ProKidney and our Renal ® Autologous Cell Therapy (REACT ) 24
Slide 25: ProKidney and REACT aim to disrupt the CKD treatment landscape
® ProKidney and REACT aim to disrupt the CKD treatment landscape 25
Slide 26: REACT Designed to Address Multiple Areas of High Unmet Need
® REACT Designed to Address Multiple Areas of High Unmet Need Potential Therapeutic Targets for Treatment of CKD Lead Platform Programs Registration (Clinical Development) Preclinical IND Phase 1 Phase 2 Phase 3 (BLA/MAA) Diabetes Type II – Prevent/Delay CKD 3/4 Fully Enrolled 002 à 002 OLE Phase 2
Slide 27: Identifying a Potential Cell-based Therapeutic
Identifying a Potential Cell-based Therapeutic Selecting the Active Biological Ingredients ® REACT : Autologous Homologous Triple Cell admixture 26 3 Types of Cells Types of Progenitors ® in Adult Kidney in REACT Active Biological Ingredient: • Six-2/OSR1/PAX-2 (Cap Mesenchyme) • RET (Ureteric Bud)
Slide 28: REACT Progenitor Composition: Restoration of Kidney Function
® REACT Progenitor Composition: Restoration of Kidney Function Remodeling and Renovating Renal Nephrons Canine cells rapidly migrate throughout kidney and integrate into nephrons and interstitium Intra-tubular and Glomerular Interstitial Injection Injection + 4 hours Injection + 24 hours ® ® (REACT
Slide 29: Correlation of Structural and Functional Effects
Correlation of Structural and Functional Effects Impact on Multiple Kidney Functions with Survival Advantage IMPROVED NEPHRON FUNCTION AND STRUCTURE • Glomerular Filtration Pre- • Tubular Transport treated • Ability to Concentrate Urine • Reduced glomerulotubular fibrosis RESTORATION OF NORMAL BLOOD
Slide 30: REACT Impact on Kidney Function
® REACT Impact on Kidney Function ® Data Suggest that REACT Treatment May Improve Kidney Function 30 Source: Am J Physiol Renal Physiol 299: F1026-F1039, 2010
Slide 31: Clinical Data from RMCL-002 Phase II Trial
Clinical Data from RMCL-002 Phase II Trial 31
Slide 32: REACT: Restoration of Kidney Function
® REACT : Restoration of Kidney Function ® ProKidney’s REACT Autologous Cell Therapy The expanded, target cell therapy is frozen for 3 storage and injection 2 Cells are expanded and then selected for the 3 KEY CELL TYPES 4 Cell therapy is injected into the patient’s kidneys Renal cortex cells are ha
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Slide 34: Early Clinical Data Suggest REACT Improves Kidney Function
® Early Clinical Data Suggest REACT is Not Just Stopping The Progression of CKD, But Also Driving IMPROVEMENT in Kidney Function – A First of Its Kind 34
Slide 35: RMCL-002 Clinical Trial Design
Preliminary Results From RMCL-002 Trial In Diabetics With CKD Stages 3A, 3B & 4 RMCL-002 Clinical Trial Design Active N=39 Open Label st nd 1 2 Extension (OLE) ® ® REACT REACT N=81 R Injection Part 2 Injection 1:1 Screen Deferred N=42 Biopsy & Randomization Visits will occur at nd 12 months 2 3-mont
Slide 36: REACT vs. Standard of Care, Alignment by Enrollment
Preliminary Results From RMCL-002 Trial In Diabetics With CKD Stages 3A, 3B & 4 ® Comparing Effect of REACT vs. Standard of Care, alignment by enrollment ® REACT Annual slope of eGFR +4.1 2 ml/min/1.73m /yr SOC Annual average change in eGFR -3.9 2 ml/min/1.73m /yr 36 Note: P-values calculated using
Slide 37: Impact on Albuminuria vs. Control
Preliminary Results from RMCL-002 Trial In Diabetics With CKD Stages 3A, 3B & 4 Impact on Albuminuria vs. Control 200 180 160 140 120 % Change in 100 Albuminuria 80 Significant 60 Reduction in 40 Albuminuria p=0.03 Change 20 0 Standard of Care REACT® treated N=28 N=42 P-values calculated using Welch
Slide 38: Effect of REACT on eGFR in Subjects with UACR Stages
Preliminary Results from RMCL-002 Trial ® Effect of REACT on eGFR in Subjects with UACR Stages A1/A2 and A3 ® REACT Renal function improved or stabilized After REACT treatment in Subjects with average eGFR 2 of 33.8 ml/min/1.73m and at high risk of ESRD Data on file, data as of March 1, 2022 38
Slide 39: REACT vs. Standard of Care, Longer Term Follow-up
Preliminary Results From RMCL-002 Trial In Diabetics With CKD Stages 3A, 3B & 4 ® Comparing Effect of REACT vs. Standard of Care, Alignment by Enrollment Longer term Active Patients (N = 39) Effect After 1st Injection vs Deferred Patients on SOC (N = 40) Average Change in eGFR follow -up: REACT Scre
Slide 40: Data Suggest REACT May Have Multiple Clinical Benefits
Preliminary Results From RMCL-002 Trial In Diabetics With CKD Stages 3A, 3B & 4 ® Data suggest that REACT treatment may have multiple clinical benefits IMPROVE ® Data suggest that REACT cells integrate and release cytokines and may improve kidney function 40 Source: Data on file
Slide 41: Effect of REACT on Serum Hemoglobin and Phosphorus
Phosphorus (mg/dl) Preliminary Results From RMCL-002 Trial In Diabetics With CKD Stages 3A, 3B & 4 ® Effect of REACT on Serum Hemoglobin and Phosphorus of Active Cohort All Patients Randomized to Active (N = 39) Average Change in Hemoglobin and Phosphorus 15 6.0 Screening Biopsy 1st Inj 1st Inj + 3m
Slide 42: REACT Clinical Studies Summary
® REACT clinical studies Summary Phase 2 In Diabetics With CKD Stages 3A, 3B & 4 Treatment Effects of ® REACT on Diabetic Kidney Disease (DKD) in Trials to Date VS *Based on Subjects Randomized to the Active and SOC Arms Standard of Care Patients: >2/3 projected to progress to ESRD and dialysis* ® ®
Slide 43: REACT Registrational Program Phase in Diabetic CKD
® REACT Registrational Program Phase 3 in Diabetic CKD Diabetic Kidney Disease REGEN-016 REGEN-006 REGEN-008 Phase 3 1:1 blinded RCT* with bi- Phase 3 1:1 blinded RCT Phase 4 Long Term Follow-Up – ® ® lateral dosing study of REACT with bi-lateral dosing study of safety and durability of REACT ® incl
Slide 44: Regulatory & Reimbursement Engagement Plan
® REACT Registrational Program Regulatory & Reimbursement Engagement Plan Diabetic Kidney Disease Conducting ‘Gold Standard’ Two Adequate and Well Controlled RCT for BLA* Approval FDA / o RMAT* Designation provides potential for accelerated approval pathway in U.S. EMA* o Time to event and composite
Slide 45: REACT Registrational Program Trial Design
® REACT Registrational Program First patients enrolled earlier this year Sham Control / SoC N~300 nd st 2 Sham 1 Sham Sham ® REGEN-008 Long ® REACT REACT Biopsy N~600 Injection Injection R Term Follow Up 1:1 ® Screen Randomization REACT N~300 Visits will occur at 3-month intervals st Biopsy nd 1 2 f
Slide 46: REACT Registrational Program Global Reach
® REACT Registrational Program Global reach REGEN -006, 7 countries REGEN -016, 17 countries 46
Slide 47: Clinical Development Timeline
Clinical Development Timeline Key data sets Phase III REGEN-006/REGEN-016 Patient Recruiting & all Events Reached Registrational Program REGEN-008 Long Term Follow-Up (1,200 Pts) ® Interim REACT Analysis Launch* 2022 2023 2024 2025 2026 2027 All deferred All deferred All active patients CSR Last Pat
Slide 48: Manufacturing Process
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Slide 49: Manufacturing Strategies: Current Process
Manufacturing Strategies Current Process Biopsy Processing Cell Expansion Cell Selection Dose Preparation Cell Delivery (Module 1) (Module 2) (Module 3) (Module 4) (Module 5) 10 5 2 1 12 weeks from biopsy to cell delivery 18 49
Slide 50: Step-by-step Production Capacity Increases
Manufacturing Strategies Step-by-step Production Capacity Increases Based on 1% Penetration Scenario U.S. + ex-U.S. U.S. + ex-U.S. U.S. 20K per year 40-45K per year 60-65K per year Launch Launch Launch +2 years +4 years Staged investment to align with market uptake and business continuity 50
Slide 51: Major Opportunities for COGS Reduction
Manufacturing Strategies Major Opportunities for COGS Reduction Reduction of Labor and Materials through: o Automation COGS o Bioprocess o Formulation o Supply chain 51
Slide 52: Strategy to Produce Commercial Quantities
Manufacturing Strategies Strategy to Produce Commercial Quantities Reliable, established process in-place Unique industrial process know-how Step-by-step scale up & build out to 65K+ annual capacity 52
Slide 53: Evergreen potential of IP
Evergreen potential of IP Strong and long exclusivity Patent estate extends into 2042, with potential to extend • Composition of Matter, Potency Valuation, & Dose/Dosing Regimen: 282 Patents & Applications, 14 Families • Manufacturing Know-how, Assays, & Trade secrets • Market Exclusivity from BCPIA
Slide 54: Why ProKidney?
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Slide 55: Opportunity to create disruptive world leader in CKD therapy
Opportunity to create disruptive world leader in CKD therapy Why ProKidney The Problem The Goal The Product The Plan The Mission ® • $130 billion • Stabilize, or • REACT utilizes • Phase 3 clinical • Meaningfully reduce the Medicare cost REVERSE the proprietary program received to care for the decli
Slide 56: Q&A
Q&A 56
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