UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
ProKidney Corp. (the “Company”) has updated its investor presentation (the “Presentation”), which its senior management intends to use from time to time when interacting with investors and analysts, among others. The Presentation is available on the Company’s website at https://investors.prokidney.com/news-events/events-and-presentations. The Presentation is also attached hereto as Exhibit 99.1.
The information in this report is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in Items 7.01 and 9.01 of this report will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this report is not intended to, and does not, constitute a determination or admission by the Company that the information in this report is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company or any of its affiliates.
Item 9.01 |
Financial Statements and Exhibits. |
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(d) |
Exhibits. |
The exhibits filed as part of this Current Report on Form 8-K are listed in the index to exhibits immediately preceding the signature page to this Current Report on Form 8-K, which index to exhibits is incorporated herein by reference.
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Description of Exhibit |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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PROKIDNEY CORP. |
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Date: |
September 8, 2022 |
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/s/ James Coulston |
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Name: James Coulston |
Renal Autologous Cell Therapy September 2022 A Step Closer to Potential Dialysis Prevention ProKidney Corp. Nasdaq: PROK
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 should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to financial results, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company’s products, if approved, potential regulatory approvals, and the size and potential growth of current or future markets for the Company’s products, if approved. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the inability to maintain the listing of the Company’s Class A ordinary shares on the Nasdaq; the inability to implement business plans, forecasts, and other expectations or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the Company’s products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s financial performance; the Company’s intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the impact of COVID-19 or geo-political conflict such as the war in Ukraine on the Company’s business; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission. The Company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
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 billion Medicare cost to care for the 40 million CKD/ESKD patients in U.S. 75 million CKD patients in the U.S. and EU Meaningfully reduce the number of people on dialysis or requiring transplantation each year Target population includes millions of diabetic CKD patients Potential indications expand up to 33 million patients in the U.S. and EU alone Stabilize, or reverse the decline of kidney function to delay or prevent dialysis / renal transplantation Reduce the lifetime cost of care for CKD afflicted patients What is ProKidney? REACT™ Aims to be the Disruptive World Leader in Treating Chronic Kidney Disease (CKD) The Problem The Goal The Product The Plan The Mission
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 in development since 2004 80+ employees $597M received from July 2022 business combination with Social Capital Suvretta Holdings III and concurrent PIPE Nasdaq-listed: PROK Top shareholder: Pablo Legorreta (~40% of shares outstanding); 4-year lockup on 50% of shares Existing therapies slow the progression of CKD; REACT’s objective is to reverse it Study Objective Status Projected Data Readout RMCL-002 (Ph2) Safety & efficacy in Stage 3b/4 CKD Fully enrolled 4Q 2023 REGEN-003 (Ph2) Safety & efficacy in Stage 4/5 CKD Fully enrolled 1H 2023 REGEN-007 (Ph2) Bilateral injections Frozen product Enrolling 2Q/3Q 2023 REGEN-006 / 016 (Ph3) US Registration (006) OUS Registration (016) Enrolling in U.S. 4Q 2024 (006) Summary of Active Clinical Studies
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 product is injected into the patient’s kidneys 4 ProKidney’s REACT™ Autologous Cell Therapy REACT™ Goal: Restoration of 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 Restores Renal function Controls Inflammation Integrates Reveses Fibrosis VEGF promotes angiogenesis to form new capillaries REACT insinuates with mesangial cells REACT replaces podocytes REACT restores Glomerular Cells REACT replaces Damaged nephron cells Fibroblasts inactive and basement membrane remodeling takes place Cell-cycle restarts and replaces tubular epithelial cells react replaces tubular cells
Chronic Kidney Disease Represents an Exceptionally Large, Worldwide Healthcare Issue
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 MARKET IS BIG CKD is Highly Prevalent in the U.S. & E.U. 31.5 29.3 60.8 38.5 35.8 74.4 42.6 38.6 47.1 43.8 90.9 2030 2040 1. 1. 1. U.S. E.U.
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) Source: International Society of Nephrology Global Kidney Health Atlas; Saudi Center for Organ Transplantation; Imai et al, Prevalence of chronic kidney disease in the Japanese general population. Clin Exp Nephrol. 2009; Oh, KH., Park, S.K., Park, H.C. et al. KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease): design and methods. BMC Nephrol 15, 80 (2014); White et al, Comparison of the prevalence and mortality risk of CKD in Australia using the CKD Epidemiology Collaboration (CKD-EPI) and Modification of Diet in Renal Disease (MDRD) Study GFR estimating equations: the AusDiab (Australian Diabetes, Obesity and Lifestyle) Study. Am J Kidney Dis. 2010 Apr; USRDS 2020 Annual Data Report; National Health and Nutrition Examination Survey (NHANES) CKD Presents Attractive Core US And EU Market Opportunity of ~75 Million Individuals with an Additional 230+ Million Individuals in ROW Initial Target Markets USA ~39 Million (~15% of population) EU + UK ~36 Million (~13% of population)
Treating CKD is Very Costly
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 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 the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties The Rates of CKD & ESKD and Associated Expenditures are Expected to Continue to Rise 1 ~$80 Billion Private insurance may pay up to 4x Medicare costs Annual Medicare spend on Chronic Kidney Disease ~$50 Billion Annual Medicare spend on End Stage Renal Disease ~$93 Thousand Medicare annual cost per patient for dialysis CKD Burden to the Healthcare System CKD/Dialysis is One of the Largest Healthcare Expenditure Categories in the U.S. and ROW US Adult population with CKD - by KDIGO stage of Disease (renal function) % of US Adult population with CKD 13.4% 15.0% 15.2% 15.4% 31.5 1.2 3.9 9.7 7.3 9.2 38.5 1.0 4.8 11.8 8.5 12.2 42.6 1.1 5.3 13.0 9.4 13.5 47.1 1.2 5.9 14.4 10.4 14.9 2010 2020 2030 2040 Stage 1 Stage 2 Stage 3a Stage 3b Stage 4 Stage 5
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 Care merely slows the expected eventual loss of kidney function Preliminary Phase 2 data suggest REACT™ has the potential to stabilize or even improve kidney function Standard of Care has Limitations Current Therapies are Blockbusters
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 REACT™ May Rescue Highest-Risk Progressors before ESKD Unrelenting Progression of CKD with No Available Cures Antihypertension ACEi ARB Glucose and Inflammation Reduction SGLT2i DPP4 GLP-1 MRA Standard of Care
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 (2026) Estimated Global Market Sales of Canagliflozin, Dapagliflozin and Empagliflozin are ~$10bn in 2026 Treatment Effect at 24 Months While New Therapies are a Step Forward, Patients Still Lose Kidney Function Dapagliflozin: +1.1 ml/min/1.73 m2 Improvement Baseline mean eGFR of 43.1 ml/min/1.73 m2 +1.1 ml/min/1.73 m2 +2.2 ml/min/1.73 m2 Canagliflozin: +2.2 ml/min/1.73 m2 Improvement Baseline mean eGFR of 56.2 ml/min/1.73 m2 +1 ml/min/1.73 m2 Empagliflozin: +1 ml/min/1.73 m2 Improvement Baseline adjusted mean eGFR of ~76 ml/min/1.73 m2 REACT™ evaluating more severe CKD (30-50 eGFR; mean 32.5 in Ph 2) and data suggests potential to stabilize or even improve kidney function relative to SGLT2s
The Potential To be Disease Modifying Could Result In Significant Patient Benefits and Reduced Costs to the Healthcare System
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 Expansion Indications 15% of U.S. Adult Population 2020 U.S. Patients (mm)1 REACT™ Eligible Patients Today 38.5 17.6 8.3 4.4 U.S. Prevalence of CKDTotal CKD CKD Stage 3&4 CKD Stage 3&4 Caused by Diabetes U.S. CKD Stage 3&4 Caused by Diabetes with 20-50 eGFR
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 Markets 20–50 eGFR 20-50 eGFR 51-60 eGFR 20-50 eGFR Source: Company estimates based upon USRDS Annual Report, and NHANES source data. EU prevalence estimated to be 93% of US prevalence based upon ERA-EDTA registry 2018 Annual Report. Data on file. 8.5 13.7 18.1 Patients (mm) 33.3 3.7mm diabetes 2.3mm hypertension 1.9mm other 3.5mm diabetes 2.1mm hypertension 1.8mm other US: EU: 8.5mm 5.2mm 4.4mm 15.2mm 30 20 10 0 REACT™ market potential could reach 33 million CKD patients in the U.S. and EU 4.4 18.1 4.1 2.7 2.3 7.9 2.5 2.1 7.3 Diabetic CKD Hypertensive CKD Other CKD Causes CKD with Higher eGFR
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 up to $2m (mean $680k) and many billions to healthcare budgets While expensive and benefitting small numbers of patients, payors have agreed to reimburse them Clinical benefit ranges from strong to marginal, yet drugs expected to reach market penetration rates of between 13% to 30% (mean 20%; >90% for CF). These penetration rates are well over REACT’s assumed rates Price / Patient ($) Cumulative Projected Cost (2020- 2030) $, billions (2) (1) 19% (2030) Source: Evaluate Pharma, company press release and Wall Street Research for U.S. and WW sales (2020 to 2030); Price per patient from company press releases, trade journals, online pharmacies, etc.; Estimated penetration in U.S. from Wall Street Research or calculated based on forecasted U.S. sales, U.S. price and prevalent population. U.S. Median: ~$360k Drug Pricing for Disease Modification Recently Launched Novel Targeted Therapies Command High Prices Drug Marketer Launch Year Indication Modality 2020E WW sales ($, m) 2030E PEAK WW sales ($,m) 2020E-2030E WW Cumulative sales 2020E-2030E u.s. cumulative sales 2019 2020 2019 2017 2020 2019 2016 filed cystic fibrosis graves disease PNH, HUS, MG, NMO, Haemophilia A SMA SMA SMA hATTR & wtATTR amyliodosis small molecule antibody antibody antibody small molecule gene therapy oligo RNA $6203 $936 $5141 $2002 $59 $920 $2052 -- $10732 $4589 $6621 $4976 $2723 $1896 $1139 $2941 $87449 $35332 $69551 $44031 $20538 $18335 $16176 $14117 $61982 $33320 $32666 $28912 $10477 $7902 $5879 $9176
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 therapies in U.S. and EU Illustrative REACT™ Price per Treatment Illustrative Unadjusted Sales ~$21BN Per 1% market penetration of REACT™ Sizing the U.S. and EU Market Opportunity Meaningful Potential Payoff For REACT™ For Every 1% (85,000 Patients) Market Penetration
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-adr), National Kidney Foundation (https://www.kidney.org/atoz/content/dialysisinfo#how-long-can-you-live-dialysis), company estimates X 5 Years Potential Impact of a Disease Modifying Product Improve Patients’ Quality of Life Enable Patients to be Productive Reduce Burden to Families Reduce Healthcare System Costs
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)
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 1st REACT™ Injection Biopsy & Randomization End of Study (EOS) Part 2 Visits will occur at 3-month intervals for 3 years Open Label Extension (OLE) Part 2 N=81 RMCL-002 Clinical Trial Design Preliminary Results From RMCL-002 Trial 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% 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 Biopsy Deferred n= 42 R 1:1 1st REACT Injection 2nd REACT Injection EOS Month 24 1st REACT Injection 2nd REACT Injection EOS Month 24 Active n = 41 Follow-up visits conducted at 3-month intervals after 3 months post 2nd REACT injection for 24 months until End of Study part 1
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 (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 over 18 months of + 5.7 ml/min/1.73m2 Standard of Care Progressive decline in renal function of ‒4.0 ml/min/1.73m2/yr A characteristic of SOC for CKD 3a, 3b, and 4 Note: As of August 3, 2021, 31 of 42 patients randomized to Deferred Cohort had reached 12 months of follow-up while maintained on best Standard of Care (SOC). The other 11 patients were enrolled in H2’20 and expected to reach 12 months of follow-up later in 2021 Reached Active Patients (N=39) vs Deferred Patients that have reach 12 months of SOC observation (N=31) Average Change in eGFR and UACR Screening biopsy 1st inj 1st inj + 3m Follow up 2nd inj 2nd inj +3m follow up 2nd inj +6m follow up 2nd inj +9m follow up 2nd inj +12m follow up screening biopsy Obs 3m Obs 6m Obs 9m Obs 12m -3.3 +4.1 38.5 32.8 33.9 31.6 28.2 -4.0 391 357 404 430 372 316 316 264 262 301 206 296 193 270 N = 39 39 39 34 32 29 21 18 14 N = 31 31 30 29 29
% 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 Stages 3A, 3B & 4
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 Active (N=39) Average change in Hemoglobin and Phosphorus Screening biopsy 1st inj 1st inj + 3m Follow up 2nd inj 2nd inj +3m follow up 2nd inj +6m follow up 2nd inj +9m follow up 2nd inj +12m 13.2 +0.7 -1.0 12.2 12.6 3.9 +0.1 3.9 -0.6 3.5 N = 38 39 39 30 29 22 16 14 10 Hemoglobin (g/dl) Phosphorus (mg/dl) months
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 Type II – Delay CKD 4/5 (14-20 ml/min/1.73m2, N = 10) Diabetes Repeat Dose Prevent/Delay CKD 3/4 (20-50 ml/min/1.73m2, N= 50*) REACTTM Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) Congenital Anomalies – Prevent/Delay (14-50 ml/min/1.73m2, N= 15) Potential Therapeutic Targets for Treatment of CKD REACT™ Designed to Address Multiple Areas of High Unmet Need 002 002 OLE 003 004 007 006/016 008 Fully Enrolled Trial Completed Enrolling Enrolling Enrolling in U.S. Phase 2 (injecting both kidneys w/ re-dose trigger) Phase 2 Phase 3 Phase 2 Phase 1 * Increased from 30 as indicated in Proxy Amendment No. 1, page 289
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 24 Cohort 1 n = 25 2nd REACT Injection 1st REACT Injection EOS Month 24 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/g Endpoints: Reflective of Phase 3
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 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 and Biopsy SHAM Cohort n=300 REACT Cohort n=300 R 1:1 Sham 1st REACT Injection Sham 2nd REACT Injection Sham Biopsy End of Study (EOS) Global Trial End Date (GTED) 1st REACT Injection 2nd REACT Injection Biopsy End of Study (EOS) Global Trial End Date (GTED)
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., SGLT2i) HTA* Potential Healthcare Savings Validate REACT delay in time to ESKD (dialysis/transplant) as major healthcare system cost savings with HTAs MHRA/NICE* parallel advice for UK U.S., France, Germany HTAs FDA / EMA* HTA Regulatory & Reimbursement Engagement Plan REACT™ Registrational Program * 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 Institute for Health and Care Excellence in the United Kingdom
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 Strategy to Produce Commercial Quantities Efficiently
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 decrease by approximately 50% as scale-up for commercialization Supply Chain Automation Bioprocess developments Formulation Cost of Goods Sold (COGS) Manufacturing Strategies Infrastructure Development and Strategy to Reduce COGS to Serve Addressable Market
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 investor expertise already in PROK — $597 million received through SCS business combination and concurrent PIPE — Experienced management team and Board Potential benefits to afflicted patients, society, and investors Phase 2 data show potential to improving multiple kidney function — Open-label 007 Phase 2 will provide insight 2Q/3Q 2023 — Phase 3 program underway — RMAT designation from FDA Capital raised supports Phase 3; Cash runway to interim Phase 3 data — Manufacturing in place for Phase 3, phased scale up planned contingent on approval — $130 billion Medicare spend on ESKD/CKD — Strong IP & know-how Investment opportunity Why ProKidney? Financial Strength 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 certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties
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 & Secretary Pablo Legorreta, Chairman of the Board José Ignacio Jiménez Santos William Doyle Jennifer Fox Dr. Tim Bertram Dr. Alan Lotvin Dr. John Maraganore Dr. Brian Pereira Dr. Uma Sinha
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 – REGEN-006; REGEN-007; RMCL-002; REGEN-003 Throughout 2022, 2023 and 2024 Multiple peer-reviewed publications – Study designs; Clinical data; Mechanism of Action Throughout 2022, 2023 and 2024
Q&A
Appendix