UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
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.
|
(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.
Exhibit No. |
|
Description of Exhibit |
99.1 |
|
104 |
|
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 hereunto duly authorized.
|
|
|
PROKIDNEY CORP. |
|
|
|
|
Date: |
September 11, 2023 |
By: |
/s/ Todd Girolamo |
|
|
|
Name: Todd Girolamo |
Corporate Presentation September 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
Unmet Needs Our Goals Our Product Our Plan REACT® is a proprietary cell therapy using the patient’s own kidney cells Preclinical activity and mechanism of action translated to clinical activity REACT® includes three cell subtypes with the potential to help preserve kidney function Phase 3 clinical program received FDA and EMA guidance and RMAT designation; proact 1 underway Potential label expansion to re-dose REACT for long-term dialysis prevention Target commercial launch YE 2026 More than 37 million U.S. adults have CKD1. Greater than 120,000 progress to need dialysis every year.2 Total annual costs to Medicare for patients with CKD / ESRD exceed $130B1 Average per person per year cost for ESRD for commercially insured members $180K3 Preserve kidney function Reduce or eliminate time spent on dialysis Return autonomy to patients and their families What is REACT®? REACT is a cell therapy solution for patients with Chronic Kidney Disease (CKD), worldwide CDC Fact Sheet. https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html USRDS 2020 Annual Report JAMA Int Medicine 2019 PROKIDNEY 3
CKD is Serious Public Health Problem Today $80B+ Private insurance may pay up to 4x Medicare costs2 Medicare spend on Chronic Kidney Disease $50B+ Medicare spend on End Stage Renal Disease $93K+ Medicare annual cost per patient on dialysis1 One of the largest healthcare expenditure categories in the U.S. CKD Population Highly prevalent in the U.S. and EU 14% CAGR EU US 82M 61M 74M 91M Kidney failure costs represent one of the largest line items of Medicare Budget 1. Medicare spend and per patient dialysis cost as of 2018. United States Renal Data System - USRDS 2020 Annual Report 2. JAMA Int Medicine 2019 $80B+ $50B+ $93K+ 44M 39M 36M 29M 39M 43M 47M US 32M 2010 2030 2040 PROKIDNY 4
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 Estimated global market sales of Canagliflozin, Dapagliflozin and Empagliflozin are ~$10B in 2026 +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 for DKD Stage 2/3a (eGFR above 40) 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 nearly $10 billion WW sales annually 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 Least Squares Mean Chang (ml/min/1.73 m2) -16 0 8 12 10 20 24 28 32 36 40 Months Since Randomization Racebo Esimated GFR (ml/min/1.73 m2) -13 -14 Dapagliflozin: +1.1 ml/min/1.73 m2 Improvement Baseline mean eGFR of 43 ml/min/1.73 m2 Empagliflozin: +1 ml/min/1.73 m2 4 8 12 10 Months Since Randomization Dapaglifton Placebo 30 66 10 30 40 44 Months Since Randomization -Empagl10n 10mg Empaglio n 25mg Placebo PROKIDNEY 5
Total 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 initially targets a defined subset of advanced T2D CKD Potential for multiple label expansions 2020 U.S. CKD Prevalence (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) 2.5 U.S. CKD Stage 3b&4 Moderate/Severe CKD with 20-44 eGFR
REACT® Goal: Preservation 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 Renal cortex cells are harvested using a routine kidney biopsy The expanded, target cell 3 therapy is frozen for storage and injection • • 4 Cell therapy is injected into the patient's kidneys PROKIDNY 7
REACT® Goal: Preservation of Kidney Function 1 2 5 10 Biopsy Processing Cell Expansion Cell Selection Dose Preparation Cell Delivery 12 weeks from biopsy to cell delivery Biopsy Implantation PROKIDNEY 8
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 suggests REACT® treatment may improve kidney function via multiple mechanisms CONTROLS INFLAMMATION Restores renal VEGF promotes angiogenesis to form new capillaries. function REACT insinuates with mesangial cells Nephron INTEGRATES REACT replaces podocytes REACT REPLACES Damaged Nephron Cells REACT RESTORES Glomerular Cells REVERSES FIBROSIS Fibroblasts become inactivate, and basement membrane remodeling takes place Cell-cycle restarts and replaces tubular epithelial cells REACT REPLACES Tubular Cells PROKIDNY 9
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 of Nephrons REACT® targets preservation of kidney function for dialysis-free living >50 3 Types of Cells in Adult Kidney Lineages 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 shown to 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 10
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/Normal DKD + REACT® DKD Sources: Gene ontology reveals potentially unique mechanism of action underlying selected renal cells bioactivity. Narayan, et al. Poster at ASN 2022 Annual Meeting: November 4, 2022. Selected renal cells self-organize to form neo-nephrons and attenuate kidney disease. Narayan, et al. Poster at ASN 2022 Annual Meeting: November 4, 2022 PROKIDNEY 11
REACT® Trials Designed to Address Multiple Types of CKD Lead Platform Programs (Clinical Development) PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 STATUS REACT® Diabetic Kidney Disease (DKD) Pivotal Trial Progam Diabetes Type II – Prevent/Delay CKD 3/4 (20-50 ml/min/1.73m2, N = 600) Diabetes Type II – Prevent/Delay CKD ¾ stratified for SGLT2i use (20-44 ml/min/1.73m2, N = 600) Long term follow-up study for patients previously treated with REACT Supportive Trials Diabetes Type II – Delay CKD 4/5 (14-20 ml/min/1.73m2, N = 10) Diabetes Type II – Prevent/Delay CKD 3/4 (20-50 ml/min/1.73m2, N = 81) 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® (CAKUT) Congenital Anomalies – Prevent/Delay (14-50 ml/min/1.73m2, N= 5) Fully Enrolled Trial Completed Fully Enrolled US/OUS 2H2023 Enrolling 007 006/proact 1 015 004 003 002 Trial Completed 008 Enrollment 3Q2023 016/proact 2 Enrolling Unilateral injections bilateral injections Frozen product PROKIDNEY 12
Building a Comprehensive Data Package Clinical program designed to expand potential patient population and support premium pricing Assess potential benefit of repeat REACT® doses (REGEN-015) Determine durability of REACT® injection (REGEN-008) 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-016 & REGEN-008) 006 1st Registrational 016 2nd Registrational 015 Repeat dosing & Product Lifecycle 003 Label Expansion 007 re-dose triggers REACT® Potential approval for DKD Goal: Prevent the progression to dialysis 008 Durability Clinical Trial Package Supporting Registration 002 Basis for Phase 3 PROKIDNEY 13
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 12 Active n = 41* Follow-up visits conducted at 3-month intervals after 3 months post 2nd REACT® injection for 24 months for active arm and 12 months post 2nd REACT® injection for Deferred arm * 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 14
REACT® Average eGFR was 4.6 ml/min/1.73m2 higher at 24 months versus the average eGFR for all participants at baseline 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 15 RMCL eGFR (ml/min/1.73mf) 40 Active Patients (N = 39) Effect After 1st Injection vs Deferred Patients on SOC (N = 40) Change in eGFR Screening 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 Followup 2nd Inj + 15m 2nd Inj+ 18m. Followup Follow-up Screening Biopsy Obs 3m Obs 6m Obs 9m Obs 12m 33.9 32.8 31.7 32.0 30 25 28.4 Active Cohort Deferred Cohort N= 39 39 31 33 29 N= 40 40 38 35 39 ng 26 21 15 12 12 39 20 + -6.0 -3.0 0.0 3.0 6.0 9.0 12.0 15.0 18.01 21.0 24.0 Months 37.4 REACTR PROKIDNEY 15
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 n = 10 1st REACT 2nd REACT Biopsy Injection Injection Screening Visit Day-60 to Day 0 EOS Month 24 PROKIDNEY 16
REGEN-003: Pre-Dialysis Patients Benefit from REACT 7/10 patients had 30% increase in dialysis free living (median of ~16 mo.) 2/10 patients had preservation of renal function >2+ years post injection Mean extrapolated REACT Treated Source: 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 eGFR (mU/min/1.73m) 10 17. -5.1 15.5 Follow Up All 003 Patients (N=10): Average Change in eGFR Follow Up Follow Up 2nd 9m 2nd nj 12m 2nd inj+15m 2nd inj 18m 2nd In Follow Up Follow Up 2nd+24m Follow Up Follow Up Follow Up Follow Up 20- -0.7 N= 10 10 10 6 9 8 7 6 3 3 3 2 2 -6 -3 0 3 6 12 15 18 21 24 27 30 Months 17 CKD-EPI Creatinine Equation (2009) 10 20 Months since First REACT Injection PROKIDNEY
Consistently striving to mitigate procedure-related risks while preserving kidney function for late-stage CKD patients Interim Safety Profile: Safety of REACT in Phase 2 Diabetic CKD Stages 3A, 3B, 4, & 5 and CAKUT Serious Adverse Event n Hematoma* 1 Transfusion* 1 Acute Kidney Injury* 1 Macroscopic Hematuria 0 Angiographic Intervention 0 Surgery 0 Death 0 CKD progression 1 Renal vascular event 1 Cortical Scar 1 Renal arteriovenous fistula 0 Events observed in 4/83 participants. *Hematoma, transfusion, & AKI events occurred in one patient pre-needle design-change in Sept. 2017, other SAE events occurred post-needle design change. Data as 2/23. Source: Stavas et al. SIR March 2023. -003 Procedure-related events: Renal Related (N=10 pt biopsies, 19 injections) Serious Adverse Event n Hematoma 2 Transfusion 0 Acute Kidney Injury 2 Macroscopic Hematuria 0 Angiographic Intervention 0 Surgery 0 Death 0 CKD progression 1 Renal vascular event 0 Cortical Scar 0 Renal arteriovenous fistula 1 -002 Interim procedure-related events: Renal Related (N=83 pt biopsies, 132 injections) Events observed in 3/10 participants. No cell product related SAEs were reported. Source: Stavas et al. Blood Purif 2023;52:114–121 DOI: 10.1159/000527582 -004 Procedure-related events: Renal Related (N=5 pt biopsies, 9 injections) Serious Adverse Event n Hematoma 0 Transfusion 0 Acute Kidney Injury 0 Macroscopic Hematuria 0 Angiographic Intervention 0 Surgery 0 Death 0 CKD progression 0 Renal vascular event 0 Cortical Scar 0 Renal arteriovenous fistula 0 Events observed in 4/39 participants. *One hematoma associated with an injection. Two hematomas, two AKI, and one hematuria occurred following biopsy. Data on file and as of 1/23. Serious Adverse Event n Hematoma* 4 Transfusion 1 Acute Kidney Injury 2 Macroscopic Hematuria 1 Angiographic Intervention 0 Surgery 0 Death 0 CKD progression 0 Renal vascular event 0 Cortical Scar 0 Renal arteriovenous fistula 0 -007 Interim procedure-related events: Renal Related (N=39 pt biopsies, 42 injections) Events observed in 0/5 participants. No cell product related SAEs were reported. Data on file and as of 1/23. 202 REACT® injections administered to date in Phase 1 and 2 clinical studies REACT has been tolerated by patients with moderate-severe CKD at high risk for renal failure PROKIDNEY 18
REACT Procedure Continued to Demonstrate a Complication Rate Below a Standard Kidney Biopsy REACT procedure in Phase 2 clinical trials was tolerated with a safety profile similar to a standard biopsy Category Biopsy # of patients (%) (N=133) REACT Injection # of patients (%) (N=202) Hematoma 4 (3.0) 3 (1.5) Pain 0 3 (1.5) Hematuria 1 (0.7) 0 Transfusion 1 (0.7) 1 (0.5) Bleed + intervention 0 0 Death 0 0 REACT Phase 2 Safety Profile Summary Includes data available from ongoing and completed phase 2 trials. Data on file and as of 3/1/2023. 19 What are the complications associated with native kidney biopsy? CJASN Clinical Journal of the American Society of Nephrology Safety Profile Summary Systematic review and meta-analysis of the literature Published from Jan 1983 to Mar 2018 1139 manuscripts in initial PubMed search Complication rates of native kidney ?biopsies performed using automated devices under kidney imaging Native kidney biopsies n = 118,064 events A 11% Hematoma 1.6% Category Bleeding requiring transfusions Hematoma Pre-determined selection criteria 87 manuscripts in final analysis Main biopsy complications 30-79 years Patient age range Complication rates were higher in: 45% Female Hospitalized patients 1 in 1,667 4.3% 0.3% Pain at biopsy site 3.5% Macroscopic hematuria Bleeding requiring Intervention 0.06% or Death in patients who undergo a native kidney biopsy Transfusion Bleed + intervention 1 1 (0.7) 1 Patients with acute kidney injury Conclusions Although the native kidney biopsy is an invasive diagnostic procedure, the rates of bleeding complications are low. Albeit rare, death can occur post biopsy. Complications are more frequently seen after hospitalization and acute kidney injury. Emilio D. Poggio, Robyn L. McClelland, Kristina Blank, Spencer Hansen, et al. Systematic Review and Meta-Analysis of Native Kidney Biopsy Complications. CJASN doi: 10.2215/CJN.04710420. Visual Abstract by Michelle Lim, MBChB, MRCP PROKIDNEY.
Safety Profile Supports Bilateral Dosing of REACT™ to Evaluate Potential for Increased Therapeutic Benefit Phase 2 Study: REGEN-007 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 Re-Dosing Triggers Sustained 30-day - Decline in eGFR using CKD-EPI 2012 by at least 25% from baseline - Increase of ≥30% and at least 30 mg/g in UACR from baseline 20 Screening Visit R 1:1 Day-60 to Day -7 1st 2nd REACT REACT Biopsy Injection Injection 1st REACT Biopsy Injection Cohort 1 n = 25 EOS Month 18 Evaluate ReDose Trigger Month 3-15 2nd REACT Injection 3 months: L Legend 6 months: EOS Month 18 Cohort 2 n= 25 EOS Month 18 PROKIDNEY
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 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 (REGEN-006) 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 Proact proact PROKIDNEY 21
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 SHAM Cohort n=300 REACT Cohort n=300 R 1:1 Sham 1st REACT® Injection Sham 2nd REACT ® Injection Sham Biopsy 1st REACT® Injection 2nd REACT® Injection Biopsy = 6 months = 3 months REACT® Registrational Program: 2 (REGEN-016) Enrolling 2 patients in 2H23 Key Entry Criteria Type 2 Diabetic Mellitus (DKD) Male or Female 30-80 years of age eGFR ≥ 20 and ≤ 44 mL/min/1.73m2 Not on renal dialysis, HbA1c <10% UACR 300 - 5,000 mg/g Protocol modifications to support evolving standard of care, future regulatory, and commercial access Follow-up visits through 60 months (5 years) Stratification at randomization based on CKD stage and SGLT2 or sMRA use EOS 5 Years EOS 5 Years Proact proact 22 PROKIDNEY
* EMA: European Medicines Agency, RMAT: Regenerative Medicine Advanced Therapy, BLA: Biologics License Application, SGLT2i: Sodium-glucose Co-transporter 2 inhibitor, HTA: Health technology assessment 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 align with registration study designs previously used by other FDA approved CKD therapies (i.e., SGLT2i) HTA* Potential Healthcare Savings Validate REACT’s® effect of delaying the time to ESRD (dialysis/transplant) as a potential major healthcare system cost savings PROKIDNEY 23
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% PROKIDNEY 24 Current staging system for CKD and treatment considerations ACR Stages GFR Stages 1 <30 2 30-300 >300 Nephrotic 1 >90 No CKD 2 60-89 3a 45-59 3b 30-44 4 15-29 REACT 5 <15 Moderately CKD stage/Risk No CKD High risk Very high risk high risk Goal for treatment Prevent development Prevent progression and complications Indication for treatment Current area of controversy Agreement that treatments are indicated Patient responses to question asking about the likelihood of taking a new medication to prevent kidney failure: You have a 20% chance of over 20 years developing kidney failure... over 10 years over 5 years 0% 10% 20% 30% 40% 50% very likely likely neutral - somewhat likely not likely • •
Implementing staged construction to expand commercial-scale manufacturing capabilities Addition of Greensboro facility provides scalability beyond Winston-Salem facility to address anticipated post-approval demand In-house manufacturing supports clinical programs and initial commercial launch Cryo-preserved REACT distribution enabled by Covid cold supply chain Potential to add and qualify additional CDMO sites for regional demand / surge capacity Preparing for Commercial Readiness Infrastructure strategy to reduce COGS and address commercial demand Approximately 2.5 million Stage 3b/4 diabetic CKD patients in U.S., >5 million OUS Estimated 128k U.S. patients enter dialysis each year and 2 million worldwide Potential to treat 50,000 patients per year WW Potential Value Proposition: Dialysis cost avoidance for 2-5 years - $200-500k Dialysis cost spend per year in U.S. = $50B by Medicare Maximum processing capacity of Winston-Salem and Greensboro facilities is over 20,000 patients/year Potential financial impact for ProKidney Phase 2 COGS for REACT® ~$100K / patient Aim to decrease COGS by approximately 50% through scale-up for commercialization Manufacturing toward clinical and commercial opportunities
Dr. Joe Stavas SVP, Global Head Clinical Development Ashley Johns SVP, Global Head Clinical Operations Dr. Tim Bertram Chief Executive Officer James Coulston Chief Financial Officer 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 Todd Girolamo Chief Legal Officer & Secretary Dr. Bruce Culleton EVP, Clinical Development & Commercialization Dr. Deepak Jain Chief Operating Officer Dr. Darin Weber Chief Regulatory Officer Mary Weger Chief People Officer 26 NexImmune a REGENMED inRegen Pfizer TARGACEPT EY caladrius LEERINK REGENMEDIX Baxter Merck Jul Medeor Biologics CONSULTING mesoblast FDA Celgene Aegerion Therachon Pharmaceuticals CVS kidney care BD Baxter REGENMEDX tengion Duke UNC SCHOOL OF MEDICINE ROYALTY PHARMA Rockefeller Uninity BROWN UNIVERSITY OPEN MEDICAL INSTITUTE Kidney Health Foundation HSS The New York Academy of Sciences novoure Nuvation Bio CVS Health. 2 Alnylam Visterra PMG Research bridgebio INBURSA Alore PROKIDNEY.
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: 2H23 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 complete Interim results anticipated first half of 2024 Fully-enrolled Open-label trial DKD Stage 3 / 4 (eGFR ≤ 50 – 20) Bi-lateral kidney injections and dose triggers Cryopreserved commercial formulation REGEN-003 Phase 2 Trial completed Results published 1Q23 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 $446M 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 6/30/23) Regulatory REGEN-002 Phase 2 Enrollment complete Interim Results 2H23 Last patient last visit December 2023 DKD Stage 3b / 4 (eGFR 50 – 20) 2 injections into biopsied kidney Open label safety & efficacy of REACT® PROKIDNEY 27
REACT® Initial Clinical Success Maximize dialysis-free living Too many CKD patients require 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) —— Approximately 75 million total CKD patients in U.S. & EU —— 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 —— Registrational Phase 3 trials underway interim data 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 anticipated throughout 2023 and 2024 Value Creation Potential * Approximately $506M as of 9/30/22 Why ProKidney? Returning Autonomy to Patients and their Families PROKIDNEY 28
Corporate Presentation September 2023 PROKIDNEY.A Step Closer to Potential Dialysis Prevention REACT® [REnal Autologous Cell Therapy]