Prokidney Corp. · NASDAQ:PROK
Prokidney — Social Capital Suvretta Holdings Corp. III — SPAC Merger (January 2022)
70 slides from Prokidney's SPAC merger presentation, Jan 18, 2022
Slide 1: Renal Autologous Cell Therapy
Renal Autologous Cell Therapy January 2022 A Potential Step Closer to Preventing Dialysis Exhibit 99.2
Slide 2: General Disclaimer and Confidentiality
General Disclaimer and Confidentiality This confidential 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 for its intended audience and for information
Slide 3: Participants in the Solicitation
Participants in the Solicitation The SPAC and its directors and executive officers may be deemed participants in the solicitation of proxies from the SPAC's shareholders with respect to the proposed Business Combination. A list of the names of those directors and executive officers and a description
Slide 4: Chronic Kidney Disease Market Is BIG
Chronic Kidney Disease Market Is BIG 4
Slide 5: Chronic Kidney Disease is Highly Prevalent in the U.S. and E.U.
Chronic Kidney Disease is Highly Prevalent in the U.S. and E.U. 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 1.Total addressable market data for the year ended 2020 and any subsequent years are based on certain
Slide 6: Large Amount Of Money Is Spent Treating CKD Globally
Large Amount Of Money Is Spent Treating CKD Globally 6
Slide 7: CKD/Dialysis is One of the Largest Healthcare Expenditure Categories
CKD/Dialysis is One of the Largest Healthcare Expenditure Categories in the U.S. and ROW 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 Improvin
Slide 8: Current Standard of Care Merely Slows Loss of Kidney Function
Current Standard of Care Merely Slows Down The Expected Eventual Loss of Kidney Function While Patients Continue to Lose Kidney Function on Existing Therapies, Those Therapies Still Exhibit Multi-Billion $ Sales Currently, CKD Has No Known Cure 8
Slide 9: While This is a Step Forward, Patients Still Lose Kidney Function
Source:EvaluatePharma. The New England Journal of Medicine 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 (2026) Empagliflozin: +1 ml/min/1.73 m2 Improvement +2.2 ml/min/1.73 m2 +1.1 ml/min/1
Slide 10: The Ability To Modify Diseases Can Result In Big Payoffs
The Ability To Modify Diseases Can Result In Big Payoffs 10
Slide 11: Novel Targeted Therapies Can Command High Prices for Disease Modification
$1,125,000 These are “game changing” (disease modifying medicines) for the affected patients These medicines can command high prices for their medical impact – total cost per patient of $200k to >$1mm (median ~$360k) Recently Launched Novel Targeted Therapies Can Command High Prices for Disease Modi
Slide 12: Early Clinical Data Shows REACT Driving Improvement in Kidney Function
Early Clinical Data Shows REACT is Not Just Stopping The Progression of CKD, But Also Driving Meaningful IMPROVEMENT in Kidney Function – A First of Its Kind 12
Slide 13: 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 + 4.1 ml/min/1.73m2/yr An absolute improvement ove
Slide 14: REACT Renal function improved: eGFR slope for all injected patients
REACT® Renal function improved + 2.7 ml/min/1.73m2 eGFR slope now + 1.7 ml/min/1.73m2 /yr Effect of REACT on All Injected Patients: eGFR for All Injected Patients (N = 59), Active Cohort (N = 39) and Deferred Cohort Patients that Have Been Crossed Over After 12 Months to Receive REACT Injection (N =
Slide 15: REACT's Addressable Patient Population
8.3 million CKD stage 3&4 caused by diabetes 15% of US Adult Population 38.5 17.6 13.4 Total CKD CKD Stage 3&4 CKD Stage 3&4 Caused by Diabetes or Hypertension ProKidney is Initially Targeting a 4-5 Million Patient Segment with Multiple Potential Label Expansion Indications. EU and ROW Populations R
Slide 16: Sizing the US Market Opportunity Alone
Sizing the US Market Opportunity Alone MEANINGFUL POTENTIAL PAYOFF FOR REACT FOR EVERY 1% (44,000 PATIENTS) MARKET PENETRATION Illustrative REACT Market Penetration 1% (44,000 patients) Assumed in the US alone Illustrative REACT Price per Treatment ~$360,000 / patient2 Based on median of recently la
Slide 17: Disease Modifying Drug in CKD Would Delay or Prevent ESRD
A Disease Modifying Drug in CKD Would Stabilize or Improve Kidney Function and Delay or Prevent ESRD SIGNIFICANT COST SAVINGS POTENTIAL 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-
Slide 18: Global CKD Prevalence by Region
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) Source: Seeking Alpha; Internati
Slide 19: Investment Thesis
Targeting a high acuity, large global unmet medical need Novel platform with broad potential in kidney disease Strong scientific underpinnings Compelling, controlled proof of concept Phase 2 data RMAT Designation received from FDA Comprehensive manufacturing plan to achieve supply goals Seasoned man
Slide 20: ProKidney and Social Capital Suvretta Leadership Teams
Deepak Jain, COO Gail Ward, Head of Quality James Coulston, SVP Finance Dr. Joe Stavas, SVP Clinical Development Darin Weber, SVP Regulatory Development Ashley Johns, VP Clinical Operations PROKIDNEY AND SOCIAL CAPITAL SUVRETTA HOLDINGS CORP III LEADERSHIP TEAMS Pablo Legorreta, Chairman of the Boar
Slide 21: REACT – A New Generation of CKD Cell Therapy
REACT – A New Generation of CKD Cell Therapy 21
Slide 22: How REACT Works
PROKIDNEY How REACT Works
Slide 23: ProKidney's REACT Autologous Cell Therapy
ProKidney’s REACT® Autologous Cell Therapy The expanded, target cell therapy is frozen for storage and injection Cells are expanded and then selected for the 3 KEY CELL TYPES Renal cortex cells are harvested using a routine kidney biopsy 1 2 3 Cell therapy is injected into the patient’s kidneys 4 23
Slide 24: Remodeling and Renovation of Renal Nephrons
Remodeling and Renovation of Renal Nephrons REACT® COMPOSITION OF PROGENITOR CELLS CREATED FOR RESTORATION OF KIDNEY FUNCTION 26 3 Types of Cells in Adult Kidney Types of Progenitors in REACT® REACT®: Autologous Homologous Triple Cell admixture Active Biological Ingredient: Cap Mesenchyme, Podocytes
Slide 25: Structural and Functional Effects of REACT in Animal Models
4 Animal Models with established CKD: ZSF1 Diabetic Rat 5/6th Nephrecomtized Rat Ischemia/Gentimycin Rat 70% Nephrectomized Canine Improved nephron function and structure Glomerular Filtration Tubular Transport Ability to Concentrate Urine Reduced glomerulotubular fibrosis Restoration of normal bloo
Slide 26: Clinical Development Program & Regulatory Progress
Clinical Development Program & Regulatory Progress 26
Slide 27: Potential Therapeutic Targets for Treatment of CKD
Potential Therapeutic Targets for Treatment of CKD REACT® DESIGNED TO ADDRESS MULTIPLE INDICATIONS WITH UNMET MEDICAL NEEDS Lead Platform Programs (Clinical Development) Optimize Preclinical IND Phase 1 Phase 2 Phase 3 Registration (BLA/MAA) Expected Milestones REACT®/DKD Diabetic CKD 3/4 (20-50 ml/
Slide 28: Clinical Data Multi-Center Randomized Phase II Trial
Clinical Data Multi-Center Randomized Phase II Trial 28
Slide 29: Clinical Trial Design Overview
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% Pre-Screen eGFR UACR Screen & Biopsy Deferred (N = 42) End of Study (EOS) R 1 x 1 Stable Max Tolerated Meds ACEI/ARB, SGLT2, etc. 12 months Observation
Slide 30: Treatment Effects of REACT on Diabetic Kidney Disease
Treatment Effects of REACT® on Diabetic Kidney Disease (DKD) in Trials to Date Robust Safety Profile in REACT®: Repeated injections of REACT® into kidneys have shown to be well tolerated in trials to date No product related SAEs and minimal with procedure Incidence of renal bleeds lower than standar
Slide 31: REACT vs Standard of Care: Annual eGFR Slope
REACT® Annual slope of eGFR +4.1 ml/min/1.73m2/yr SOC Annual average change in eGFR -3.9 ml/min/1.73m2/yr Comparing Effect of REACT® vs. Standard of Care: eGFR for Active Cohort (N = 39) from 1st Injection to 12-Months Follow-up after 2nd Injection vs eGFR for SOC (Deferred Cohort, N= 31) Before Cro
Slide 32: REACT Renal function improved by +4.1 ml/min/1.73m2/yr
REACT® Renal function improved + 4.1 ml/min/1.73m2 /yr An absolute improvement of + 5.7 ml/min/1.73m2 After a full course of REACT treatment eGFR decline is reversed Effect of REACT® on eGFR and UACR of Active Cohort (N=39) Of the 39 patients randomized to Active cohort, 17 patients have early data:
Slide 33: Stabilization of CKD Comorbidities: Anemia and Phosphatemia
REACT® Stabilization of CKD Comorbidities: Anemia and Phosphatemia Effect of REACT® on Serum Hemoglobin and Phosphorus of Active Cohort (N=39) PRELIMINARY RESULTS FROM A MULTI-CENTER RANDOMIZED (1 X 1) PHASE II TRIAL IN DIABETICS WITH CKD STAGES 3A, 3B & 4 33
Slide 34: REACT Slowed Decline in High-Risk CKD Populations
REACT® Slowed decline from -5.1 ml/min/1.73m2/yr to -2.4 ml/min/1.73m2/yr REACT® demonstrated impact on very high-risk CKD populations for ESRD PRELIMINARY RESULTS FROM A PHASE II TRIAL IN HIGH-RISK PATIENTS RECEIVING 2 INJECTIONS OF REACT IN THE SAME KIDNEY. LOW EGFR (15 – 20 ML/MIN/1.73M2) AND SEV
Slide 35: REACT Safety Summary
No product related SAEs Rate and type of adverse events in-line with expectations typical of a type 2 diabetic population <1.5% Procedurally related hematomas of the kidney capsule Standard biopsy <2% 1 2 3 >150 3 & 4 7 7 REACT® Injections CKD Stage Patients Clinical Trials Years in Human Clinical T
Slide 36: REACT Phase 3 Development Plan
Diabetic Kidney Disease Phase 3 – 1:1 RCT trial with bi-lateral kidney dosing study of REACT® including a sham control arm and composite primary endpoint Patient Population: Type 2 Diabetes Mellitus, 30-80yrs of age; moderate to severe CKD with eGFR 20 - 50 mL/min/1.73m2 (a subset of Stages 3a, 3b a
Slide 37: Clinical Development Timeline
* Time to Event analysis ** Performed After Interim Analysis *** REGEN-008 Long Term Follow-up will continue to 2030 REGEN-006 Interim Analysis Anticipated in mid-2024, Conditional Approval Expected 2025 CLINICAL DEVELOPMENT TIMELINE 2027 2026 2025 2024 2023 2022 2021 REGEN-006 Patient Recruiting RE
Slide 38: Ad-hoc Analysis of Phase 2 Trial Using Phase 3 Endpoint
Phase 3 Primary Composite Endpoint Time to the earliest of: ≥ 40% Reduction in eGFR <15mL/min eGFR or Chronic Dialysis Increase in UACR 30% and >30 mg/g Renal or Cardiovascular mortality Necessary sample size is 1,000 vs. > 5,000 w/SGLT2s because of strong hazard ratio Hazard Ratio REACT ® = 0.4 (p=
Slide 39: Manufacturing Process
Manufacturing Process 39
Slide 40: Manufacturing Strategy and Implications
High Level Manufacturing and Regulatory Expertise To Date, Manufacturing Process Produced REACT® for 100% Patients (At least 5 doses for most patients) Compares favorably to most cell therapies average of ~85% Facilities and Processes Reviewed by EMA: Phase 3 / Commercial Ready Projected COGS at Sca
Slide 41: REACT Manufacturing Process Overview
Biopsy using standard diagnostic procedure Biopsy processed at ProKidney’s manufacturing facility - commercial-ready facility HCTP/ MPA inspected QP approved Meets GMP requirement for phase 2/3 manufacturing Over 200 cell therapies produced Product injected in patient’s kidney Biopsy Processing (<1
Slide 42: REACT Commercial Manufacturing Strategy
REACT® launch facility - built after Phase 3 patients enrolled and dosing Scale out to up to 20,000 patients per year – Estimated Cost of ~$300M Bioprocess improvements Process automation Supply chain management Commercial manufacturing facilities – built post-launch, funded from commercial cash flo
Slide 43: Use of Proceeds
Use of Proceeds 43
Slide 44: Current Funding Requirements
~$450 Million Required to Fund Through REGEN-006 Interim Analysis in Mid-2024 Up to ~$775 Million to Allow for Additional Clinical Development and Launch Preparation Activities CURRENT FUNDING REQUIREMENTS Spend ($ mm) Uses Estimated Allocation of Proceeds R&D Clinical program costs through YE2024 $
Slide 45: Summary
Summary 45
Slide 46: ProKidney Summary
The Problem The Goal The Goal REACT® utilizes proprietary autologous cell therapy harvested from the patient’s own kidney REACT ® contains three specific cell types to help promote regrowth of all functional kidney segments Phase 3 clinical program received FDA and EMA guidance for immediate start C
Slide 47: Transaction Overview
Overview1 Pre-money equity value of $1.75 billion Pro forma equity value of ~$2.64 billion PIPE Financing $575 million common equity PIPE at $10.00 per share Affiliates of DNAC’s sponsor to commit $125 million Existing ProKidney investors to commit up to $50 million3 Ownership2 Existing shareholders
Slide 48: Detailed Transaction Overview
Detailed Transaction Overview Assumes no redemptions by DNAC public shareholders Pro forma basis. At $10.00 per share, assumes a $575mm common equity PIPE, no redemptions, and excludes impact of unvested stock-based compensation and reserved and unvested shares pursuant to the new, to-be-established
Slide 49: Appendix
Appendix 49
Slide 50: Additional Mechanism of Action Detail
Additional Mechanism of Action Detail 50
Slide 51: Multiple Mechanisms of Repair, Regeneration and Restoration
Expected Clinical Outcome Biological Activity Anti-fibrosis Anti-inflammation Integration Chemotaxis-induction Repair +++ +++ +++ + Regeneration + + ++ +++ Restoration +++ +++ +++ +++ GO resource: Annotation and Ontology 150 x 106 REACT® @1.5mL 50 x 106 REACT® @ 0.5mLs 25 X106REACT® @ 0.25mLs Cells
Slide 52: Long-Term CKD Canine Study Supports Durability
Improved filtration Protein balance (UPC) improves with renal cell treatment Renal cell treatment promotes body weight gain Significant decrease in deleterious histological changes Increase in eGFR and Stabilization of UPC LONG-TERM CKD CANINE STUDY SUPPORTED DURABILITY OF REDUCTION IN UPC (9 MONTHS
Slide 53: Additional Clinical Data
PROKIDNEY Additional Clinical Data
Slide 54: REACT Clinical Trials Overview
CKD Underlying Condition Study Design Dosing Regimen Study Population FVFP Enrollment Status Expected Milestones RMCL-002 Phase 2 US & Cayman Islands Type 2 Diabetes Prospective, randomized, double arm deferred treatment, open label, repeat dose, multi-center Two doses 3 x 106 cells/gKWest 6 months
Slide 55: REACT Development Pipeline Study Design
REACT DEVELOPMENT PIPELINE 006 Study Design Schematic 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% Screening Visit Cohort 2 (2 REACT Injections) End of Study R Randomization Time between 1st and 2
Slide 56: Baseline eGFR and Responder Definitions
Baseline eGFR: In 002, baseline eGFR decline was defined as the annual eGFR slope observed in deferred patients who were maintained on SOC for 12 months before crossed over to receive REACT®. This cohort had an eGFR decline slope of ‒4.0 ml/min/1.73m2/yr A REACT® eGFR-Responder: Patient with a post
Slide 57: Randomization Scheme Balanced High Risk Patient Population
Randomization Scheme Balanced High Risk Patient Population for eGFR and UACR Active (n=39*) Mean ± SD SOC (n=42) Mean ± SD Age 66.3 ± 10.1 64.5 ± 8.9 Gender 28.2% Female 71.8% Male 35.7% Female 64.3% Male eGFR All Patients 33.9 ± 8.59 31.5 ± 8.46 3A 43 ± 9 (n=3) 50 ± 2.65 (n=3) 3B 38.1 ± 6.55 (n=20)
Slide 58: Full REACT Course vs Standard of Care eGFR slope
REACT® Annual slope of eGFR +5.0 ml/min/1.73m2/yr SOC Annual average change in eGFR -3.9 ml/min/1.73m2/yr Note: P-values calculated using Two Sided Welch Two Sample T Test PRELIMINARY RESULTS FROM A MULTI-CENTER RANDOMIZED (1 X 1) PHASE II TRIAL IN DIABETICS WITH CKD STAGES 3A, 3B & 4 Comparing Effe
Slide 59: eGFR-Responders vs eGFR-Progressors in All Injected Patients
REACT® Renal function improved by + 6.5 ml/min/1.73m2 eGFR slope now + 4.3 ml/min/1.73m2/yr REACT® eGFR slope -2.5 ml/min/1.73m2/yr With stabilization of kidney function 6 months after 2nd injection Level of UACR appears to correlate with eGFR improvement Note: P-values calculated using Two Sided We
Slide 60: Larger eGFR Effect with Earlier Injection of REACT
REACT ® Larger eGFR effect size with earlier injection of REACT® slope improved + 4.1 ml/min/1.73m2/yr Delayed REACT ® injection still provides eGFR benefit by attenuating decline of eGFR slope Deferred patients’ initial baseline eGFR of 35 declines to 28.7 at time of injection. These patients lost
Slide 61: eGFR and UACR of Active Cohort: Responders vs Progressors
REACT® Renal function improved by + 8.6 ml/min/1.73m2 eGFR slope now + 6.5 ml/min/1.73m2/yr REACT® eGFR slope -0.3 ml/min/1.73m2/yr With stabilization of kidney function. Potential increase 6 months after 2nd injection Level of UACR appears to correlate with eGFR improvement Note: P-values calculate
Slide 62: Full Course 12-Month Follow-up: Responders vs Progressors
REACT® Renal function improved by +5.4 ml/min/1.73m2 eGFR slope now + 4.6 ml/min/1.73m2 /yr Progressors REACT® slowed Renal function slope decline by 12.3 ml/min/1.73m2/yr Level of UACR appears to correlate with eGFR improvement PRELIMINARY RESULTS FROM A MULTI-CENTER RANDOMIZED (1 X 1) PHASE II TRI
Slide 63: Effect of REACT on Deferred Cohort
REACT® eGFR-Responders improved eGFR by 2.4 ml/min/1.73m2 over 18 months eGFR slope stabilized SOC Patients with eGFR of around 25 ml/min/1.73m2 do not sustain renal function over 12-month observation period and now on dialysis Progessors had an irregular response after REACT® injection losing on av
Slide 64: Active Cohort Patients Receiving One Injection
REACT® Renal function improved to + 4.4 ml/min/1.73m2/yr After only a single injection eGFR-Responders Renal function improvement eGFR-Progressors REACT® slowed decline by 8.3 ml/min/1.73m2/yr PRELIMINARY RESULTS FROM A MULTI-CENTER RANDOMIZED (1 X 1) PHASE II TRIAL IN DIABETICS WITH CKD STAGES 3A,
Slide 65: eGFR Slope Improvement Predictive of Clinical Benefit
0.5 – 1.0 ml/min/1.73 m2/yr improvement in eGFR Slope over 3-months predictive of clinical benefit.1 While This is a Step forward, Patients Still Lose Kidney Function MOST RECENTLY APPROVED CKD DRUG CLASS INCREMENTALLY SLOWS EGFR LOSS Source:The New England Journal of Medicine 1.Inker et al, METAANA
Slide 66: Additional Manufacturing Detail
Additional Manufacturing Detail 66
Slide 67: Enhancing Manufacturing Capabilities
Enhancing Manufacturing Capabilities MANUFACTURING STRATAGIES Biopsy Processing Cell Expansion Cell Selection Dose Preparation 1 2 5 10 40 Available Commercially Automations Project Available Commercially 67
Slide 68: Risk Factors
Risk Factors 68
Slide 69: Risk Factors Overview
Certain factors may have a material adverse effect on the business, financial condition and results of operations of Social Capital Suvretta Holdings Corp. III (“SCS”) and ProKidney, LP (“ProKidney”). The risks and uncertainties described below are not the only ones SCS and ProKidney face. Additiona
Slide 70: Risks Related to Legal and Regulatory Compliance Matters
Risks Related to Legal and Regulatory Compliance Matters ProKidney’s relationships with customers, health care providers, physicians, prescribers, purchasers, third-party payors, charitable organizations and patients will be subject to applicable anti-kickback, fraud and abuse and other health care
Social Capital Suvretta Holdings Corp. III — SPAC Merger (January 2022) on 6ix