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: |
January 10, 2023 |
By: |
/s/ Todd Girolamo |
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Name: Todd Girolamo |
J.P. Morgan Investor Conference January 2023 Exhibit 99.1 PROKIDNEY A Step Closer to Potential Dialysis Prevention REACT® [REnal Autologous Cell Therapy]
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. PROKIDNEY 2
The Problem The Goal The Product The Plan Contribution to Society REACT® is a proprietary cell therapy using the patient’s own kidney cells Mechanism of action has been observed to result in clinical activity REACT® includes three specific cell types with the potential to help restore kidney function Phase 3 clinical program received FDA and EMA guidance and RMAT designation; proact 1 underway Ongoing Phase 2 trials to expand clinical insights Target commercial launch YE 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 Currently, no treatment options (other than transplant) exist to stop decline of kidney function Afflicted population includes millions of moderate-severe diabetic CKD patients Potential label expansion could expand TAM to nearly all chronic kidney diseases Reduce overall cost to the healthcare system Stop kidney failure Reduce the lifetime cost of care for CKD patients and payers What is ProKidney? REACT® aims to be the world leader in treating Chronic Kidney Disease (CKD) PROKIDNEY 3
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: 1H23 ROW enrollment; Interim anticipated by YE25 Global Phase 3 blinded, sham-controlled trials to establish safety & efficacy of REACT® Stage 3b / 4 DKD (eGFR ≤ 50 – 20) FDA-defined time-to-event endpoints REGEN-007 Phase 2 Enrollment ongoing Interim results anticipated 2H23 Safety & efficacy Open-label trial DKD Stage 3 / 4 (eGFR ≤ 50 – 20) Bi-lateral kidney and dose triggers Cryopreserved commercial formulation Ph3 “preview” REGEN-003 Phase 2 Trial fully enrolled Interim results anticipated 2Q23 Safety & efficacy of REACT® DKD Stage 4 / 5 (eGFR < 20 – 14) Identify potential re-dosing triggers Assess impact on progression and time to dialysis in patients with imminent risk of renal failure/dialysis 2024 and beyond 2H 2023 1H 2023 $506M cash sufficient to fund these key milestones, and to interim Phase 3 data FDA / EMA agreement on pivotal study design RMAT designation in U.S. Potency Assay Matrix alignment Cash Position (as of 9/30/22) Regulatory REGEN-015 Multi-dose trial Safety & efficacy of repeat dosing Previously treated DKD Dosing triggers, re-dosing, and durability PROKIDNEY 4
Building a Comprehensive Data Package Clinical designed to expand potential patient population and support premium pricing Assess potential benefit of multiple REACT® doses (REGEN-015) Determine durability of REACT® injection (REGEN-008 and RMCL-002) Identify re-dosing triggers (REGEN-007) Assess potential benefit of bilateral REACT® injections (REGEN-007) Support potential label expansion (REGEN-003) Support durability, reimbursement and value-based pricing (REGEN-008) 006 1st Registrational 016 2nd Registrational 015 Multi-dosing & Product Lifecycle 003 Label Expansion 007 re-dose triggers & preview of Phase 3 REACT® Potential approval for DKD, >8M eligible patients U.S. and EU Goal: Prevent the progression to dialysis 008 Durability & Value-based Pricing Clinical Trial Package Supporting Registration 002 Basis for Phase 3 PROKIDNEY 5 Proact Proact
REACT® Initial Clinical Success Maximize dialysis-free living Too many CKD patients end up requiring 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) —— Of ~75 million total CKD patients in U.S. & EU, we estimate ~8.5 million are REACT® eligible —— Currently, no treatment options (other than transplant) exist to stop decline of kidney function Ongoing Phase 2 program providing insight on durability, multi-dosing, and re-dosing triggers —— 1 Phase 3 trial underway. interim estimated YE 24 —— RMAT designation granted by FDA Cash runway to deliver interim Phase 3 data* —— In-house manufacturing supports Phase 3 and initial commercialization —— Experienced employees, strong product and cell therapy IP & development know-how —— Identified milestones and results throughout 2023 + Value Creation Potential 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. * Approximately $506M as of 9/30/22 Why ProKidney? Contribution to Society: Stop Kidney Failure PROKIDNEY 6 Proact
CKD is Serious Public Health Problem Today $80B+ Private insurance may pay up to 4x Medicare costs Medicare spend on Chronic Kidney Disease $50B+ Medicare spend on End Stage Renal Disease $93K+ Medicare annual cost per patient for dialysis One of the largest healthcare expenditure categories in the U.S. CKD Population Highly prevalent in the U.S. and EU 50% CAGR EU US 82M 61M 74M 91M Kidney Failure costs represent one of the largest line items of Medicare Budget 29M 32M 2010 36M 39M 2020 39M 43M 2030 44M 47M 2040 PROKIDNEY 7
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 Recently approved CKD drugs incrementally slow eGFR loss, but CKD has no known cure Estimated global market sales of Canagliflozin, Dapagliflozin and Empagliflozin are ~$10B in 2026 REACT® evaluating more severe CKD (15-50 eGFR; mean <30 ml/min/1.73m2 in Ph 2) and data suggests potential to preserve kidney function in patients with very high risk of kidney failure +2.2 ml/min/1.73 m2 WW Sales ~$740mm (2026) +1.1 ml/min/1.73 m2 WW Sales ~$3.7bn (2026) +1 ml/min/1.73 m2 WW Sales ~$5.1bn (2026) Current standard of care merely slows the eventual loss of kidney function Standard of Care has Limitations Current Therapies are Blockbusters While patients continue to lose kidney function on existing therapies, those therapies still generate multi-billion $ sales Dapagliflozin: +1.1 ml/min/1.73 m2 Improvement Baseline mean eGFR of 43 ml/min/1.73 m2 Canagliflozin: +2.2 ml/min/1.73 m2 Improvement Baseline mean eGFR of 56 ml/min/1.73 m2 Empagliflozin: +1 ml/min/1.73 m2 Improvement Baseline adjusted mean eGFR of 76 ml/min/1.73 m2 PROKIDNEY 8
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 REACT’s Addressable U.S. Patient Population Initially targeting a 4-5 million patient segment with multiple potential label expansion indications 2020 U.S. Patients (mm)1 Total CKD CKD Stage 3&4 U.S. Prevalence of CKD 38.5 17.6 CKD Stage 3&4 Caused by Diabetes U.S. CKD Stage 3&4 Caused by Diabetes with 20-50 eGFR 8.3 4.4 (15% of U.S. Adult Population) REACT® Eligible Patients Today PROKIDNEY 9
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 I’m sure I would be much more open to trying some things.” Panelist with CKD stage 3b stated: “Anything to help … slow [the] progress of the kidney disease — I’m all for it.” REACT ~75% Current staging system for treatment considerations ACR Stages 1 2 3 GFR Stages <30 30-300 >300 Nephrotic 1 >90 No CKD 2 60-89 3a45-59 3b 30-44 4 15-29 5 <15 REACT CKD Stage/Risk No CKD Moderately high risk High risk Very high risk Goal for treatment Prevent development Prevent progression and complications Indication for treatment Current area of controversy Agreement that treatments are indicted patient responses to question asking about the likelihood of taking a new medication to prevent kidney failure: You have a 20%chance of developing kidney failure… over 20 years over 10 years overs 5 years 0% 10% 20% 30% 40% 50% very likely likely neutral somewhat likely not likely 75% PROKIDNEY 10
Targeted therapies that share four 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 per Patient Cumulative Projected Cost (2020- 2030, in 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 Cystic Fibrosis Small Molecule 2020 Graves’ Disease Antibody 2019 PNH, HUS, MG, NMO Antibody 2017 Haemophilia A Antibody 2020 SMA Small Molecule 2019 SMA Gene Therapy 2016 SMA Oligo Filed hATTR & wtATTR amyloidosis RNA $6,203 $10,732 $936 $4,589 $5,141 $6,621 $2,002 $4,976 $59 $2,713 $920 $1,896 $2,052 $1,139 -- $2,941 $87,449 $61,982 $35,332 $33,320 $69,551 $32,666 $44,031 $28,912 $20,538 $10,477 $18,335 $7,902 $16,176 $5,879 $14,117 $9,176 Treatable Prevalence (U.S) 27k 70k 5-6 (PNH) 30-33k 10-25k 10-25k 10-25k 290k Est. 2030 / Peak U.S. Penetration (Year) >90% (2030) 13% (2030) 20% (2026) 26% (2030) 13% (2030) 16% (2019) 19% (2030) PROKIDNEY 11
Potential REACT® Market Opportunity in US and EU Stage 3b CKD Stage 4 CKD Diabetes primary cause of CKD Diabetes primary cause of CKD (Estimates after 5-year ramp) 950,000 to 1 million CKD 4 patients (includes estimated 300-350k eGFR 15-19) Penetration ~20% prevalent patients (mean of recently launched disease modifying therapies) ~200,000 potential patients Estimated incidence 150,000 (Estimates after 5-year ramp) 4.8 to 5.0 million CKD 3b patients Penetration ~5% prevalent patients ~250,000 potential patients Estimated incidence 750,000 eGFR 15-29 eGFR 30-44 Repeat-dosing (REGEN-015) will provide terminal growth for REACT ~450,000 Potential patients per year 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 Anticipate significant penetration in sicker CKD patients PROKIDNEY 12
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-new-adr), National Kidney Foundation (https://www.kidney.org/atoz/content/dialysisinfo#how-long-can-you-live-dialysis), company estimates Significant Cost Savings Potential 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 A disease-modifying drug in CKD could reduce cost of kidney failure Estimated ESRD Cost Per Patient (Illustratively Based on 5 Years on Dialysis) Incremental Private Insurance Cost X 5 Years ~$100k Up to ~$400k ~$500k Up to ~$2M Medicare Cost / Year Private Insurance Cost / Year Cumulative 5-Year Cost / Patient PROKIDNEY 13
REACT® Goal: Restoration 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. 3 The expanded, target cell therapy is frozen for storage and injection 4 cell therapy is injected into the patient’s kidneys PROKIDNEY 14
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 and Renovation of Nephrons REACT® aims to preserve kidney function for dialysis-free living 26 3 Types of Cells in Adult Kidney Types of Progenitors in REACT® REACT®: Autologous Homologous Triple Cell admixture Renal cells Cap Mesenchyme, Podocytes, and Ureteric Bud: Six-2/OSR1/PAX-2 (Cap Mesenchyme) RET (Ureteric Bud) Podocin / Nephrin Intra-tubular and Glomerular (REACT® – Blue) Interstitial (REACT® – Blue) Cells rapidly distribute throughout kidney and integrate into nephrons and interstitium 150 x 106 REACT® @1.5mL 50 x 106 REACT® @ 0.5mLs 25 X106REACT® @ 0.25mLs PROKIDNEY 15
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 culture SRC/REACT® preserves kidney microarchitecture REACT® treated kidney shows reduced glomerular and interstitial fibrosis and inflammation, protein leakage and tubular ectasia Control DKD + REACT® DKD PROKIDNEY 16
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 suggest REACT® treatment may improve kidney function via multiple mechanisms Controls information restores renal function VEGF promotes angiogenesis to form new capillaries REACT insinuates with mesangial cells REACT replaces podocytes REACT RESTORES Glomerular Cells INTEGRATES REACT REPLACES Damaged Nephron Cells REVERSES FIBROSIS Fibroblasts become inactivate, and basement membrane remodeling takes place Cell-cycle restarts and replaces tubular epithelial cells REACT REPLACE Tubular Cells PROKIDNEY 17
REACT® Designed to Address Multiple Areas of CKD Potential therapeutic indications Lead Platform Programs (Clinical Development) PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 STATUS REACT® 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*) Multi / extended-dosing for previously REACT-treated patients REACT® Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) Congenital Anomalies – Prevent/Delay (14-50 ml/min/1.73m2, N= 15) Fully Enrolled Trial Completed Enrolling Ongoing US/ exUS Enrollment 2Q2023 007 Phase 2 (injecting both kidneys and re-dose trigger) (006/016) 008 Phase 3 015 Phase 1/2 (additional injections 3 mos apart) Phase 2 (expand application) 004 003 Phase 2 (late-stage, high risk for kidney failure) 002 002 OLE Phase 2 (basis for Phase 3) Trial Completed PROKIDNEY 18
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® 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 * 2 ‘Active’ patients dropped out of the study resulting in n=39 in subsequent slides. RMCL-002: Study in Diabetics with CKD Stages 3A, 3B & 4 Clinical trial design = 6 months PROKIDNEY 19
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 an absolute improvement over 24 months of + 4.6 ml/min/1.73m2 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: Preliminary Results from Study in Diabetics with CKD Stages 3A, 3B & 4 Comparing effect of REACT® vs. standard of care (SoC) in Phase 2 study Active patients (N=39) Effect After 1st Injection vs Deferred Patients on SOC (N=40) Average Change in eGFR Screening 1st Inj 1st Inj + 3m Follow-up 2nd Inj 2nd Inj +6m Follow-up 2nd inj+9m Follow-up 2nd Inj+12m Follow-up 2nd Inj+15m Follow-up 2nd Inj+18m Follow-up Screening Biopsy Obs 3m Obs 6m Obs 9m Obs 12m 40 35 30 25 20 eGFR (ml/min/1.73m2) 33.9 31.7 N=39 N=40 32.8 32.0 39 40 31 38 33 35 29 39 26 39 28.4 21 15 12 12 Active Cohort Deferred Cohort -6.0 -3.0 0.0 3.0 6.0 9.0 12.0 15.0 18.0 21.0 24.0 Months Note: As of March 1, 2022 37.4 PROKIDNEY 20
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 months Key Entry Criteria Type 2 Diabetic Mellitus (DKD) Male or female 30-65 years of age eGFR ≥14 - ≤20 mL/min/1.73m2 Not on renal dialysis, HbA1c <10% Follow-up visits conducted at 3-month intervals after 3 months post 2nd REACT® injection for 24 months until End of Study part 1 n=10 screening visit Day-60 to Day 0 1st REACT Biopsy Injection 2nd REACT Injection EOS Month 24 PROKIDNEY 21
REGEN-003: Pre-Dialysis Patients Benefit from REACT 7/10 patients had 30% increase in dialysis free living (median of ~16 mo.) eGFR improvement of 38% (>2.5 ml/min/1.73 m2) 2/10 patients have preservation of renal function >2+ years post injection Mean extrapolated REACT Treated LABEL EXTENSION Stavas, et al. Renal Autologous Cell Therapy in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis. J Blood Purification. Published Online Jan 2023 All 003 Patients (N=10): Average Change in eGFR eGFR(ml/min/1.73m2) 10 15 20 25 -6 -3 0 3 6 9 12 15 18 21 24 27 30 Months N= 10 10 10 6 9 8 7 6 3 3 3 2 2 17 -0.7 15.5 -5.1 17.5 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 2nd Inj+15m Follow Up 2nd Inj+18m Follow Up 2nd Inj+21m Follow Up 2nd Inj+24m Follow Up CKD-EPI Creatinine Equation (2009) eGFR 0 5 10 15 20 -10 0 10 20 30 Months since First REACT Injection REACT Treated Mean extrapolated PROKIDNEY 22
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) = 6 months = 3 months REACT® Registrational Program: 1 & 2 (REGEN-006 / 016) First 1 patients enrolled in 2022 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 PROKIDNEY 23
* 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 REACT® Registrational Program Regulatory & reimbursement engagement plan: Diabetic Kidney Disease FDA / EMA* HTA 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 ESRD (dialysis/transplant) as major healthcare system cost savings with HTAs MHRA/NICE* parallel advice for UK U.S., France, Germany HTAs PROKIDNEY 24
Staged construction of commercial scale manufacturing facilities In-house manufacturing supports clinical trials and scalable and meet future commercial needs Future facilities will be built to meet market demand Manufacturing toward clinical and commercial opportunities Phase 2 COGS ~$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 strategy to reduce COGS and expand addressable market Anticipate~50% Reduction in COGS Labor Materials Other Phase 2 COGS $100k/pt COGS at commercial scale PROKIDNEY 25
Dr. Joe Stavas SVP, Global Head Clinical Development Dr. Darin Weber Chief Regulatory Officer Ashley Johns SVP, Global Head Clinical Operations Dr. Tim Bertram Chief Executive Officer Dr. Deepak Jain Chief Operating Officer James Coulston Chief Financial Officer Dr. Libbie McKenzie Chief Medical Officer 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 World-class Leadership and Board of Directors PROKIDNEY 26 regnmedTX Nexlmmune inregen Pfizer regenmedtx baxter Merck Targacept ey Naphcare duke university UNC school of medicine Medeor therapeutics Biologics consulting mesoblast the adult stem cell company FDA Regenmedtx tengion regenerative medicine brought to life pmg research tomorrow’s medicine today caladrius biosciences Leerink ROYALTY PHARMA SCIENTIA PRO BONO HUMANI GENERIS The Rockefeller University 1901 BROWN UNIVERSITY The New York Academy of Sciences OPEN MEDICAL INSTITUTE Medical Education Beyond Borders Kidney Health Foundation Hss Lazard Freres Gestion novocure Nuvation Bio CVS Health Alnylam PHARMACEUTICALS Visterra bridgebio INBURSA Afore
REACT® Initial Clinical Success Maximize dialysis-free living Too many CKD patients end up requiring 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) —— Of ~75 million total CKD patients in U.S. & EU, we estimate ~8.5 million are REACT® eligible —— Currently, no treatment options (other than transplant) exist to stop decline of kidney function Ongoing Phase 2 program providing insight on durability, multi-dosing, and re-dosing triggers —— 1 & 2 dual Phase 3 trials underway. proact 1 interim estimated YE 24 —— RMAT designation granted by FDA Cash runway to deliver interim Phase 3 data* —— In-house manufacturing supports Phase 3 and initial commercialization —— Experienced employees, strong product and cell therapy IP & development know-how —— Identified milestones and results throughout 2023 + Value Creation Potential 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. * Approximately $506M as of 9/30/22 Why ProKidney? Contribution to Society: Stop Kidney Failure PROKIDNEY 27 Proact
J.P. Morgan Investor Conference January 2023 PROKIDNEY A Step Closer to Potential Dialysis Prevention REACT® [REnal Autologous Cell Therapy]