UNITED STATES
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WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
Chief Executive Officer Transition
On November 10, 2023, the board of directors (the “Board”) of ProKidney Corp. (the “Company”) approved the termination, without cause, of Tim Bertram, Ph.D., Chief Executive Officer of the Company, effective November 15, 2023 (the “Effective Date”), following which Dr. Bertram is expected to continue to serve as a consultant of the Company and as a member of the Company’s Scientific Advisory Board. On the Effective Date, and pursuant to the terms of Dr. Bertram’s employment agreement, Dr. Bertram will resign from the Board of Directors (the “Board”) of the Company. The Company expects to enter into a separation agreement and release and consulting agreement with Dr. Bertram, the terms of which will be disclosed once available.
In addition, on November 10, 2023, upon the recommendation of the Nominating and Corporate Governance Committee of the Board, the Board approved the appointment of Bruce Culleton, MD, as Chief Executive Officer and as a Class III director of the Company, effective as of the Effective Date. Dr. Culleton will serve as a director until his term expires at the 2025 annual meeting of stockholders. The Company expects to enter into an employment agreement with Dr. Culleton in connection with his appointment as Chief Executive Officer, the terms of which will be disclosed once available.
Dr. Culleton, age 56, has served as the Company’s Executive Vice President, Clinical Development & Commercialization since July 2023. He has more than two decades of experience in industry and academia with a primary focus on kidney health. Prior to joining the Company, Dr. Culleton served as the Vice President and General Manager of CVS Kidney Care, LLC, a subsidiary of CVS Health Corporation (NYSE: CVS), a health solutions company, from June 2022 to July 2023. Previously, he served as Vice President and Chief Medical Officer at CVS Kidney Care from October 2017 to June 2022. Before joining CVS Health Corporation, he was Vice President, Global Clinical Development and World Wide Vice President, Medical Affairs, Medication and Procedural Solutions at Becton, Dickinson and Company (NYSE: BDX), a global medical technology company, from 2016 to 2017; and previously Vice President, Renal Therapeutic Area at Baxter International Inc. (NYSE: BAX), a healthcare company, from 2007 to 2016. Prior to beginning his industry career in 2007, Dr. Culleton was a Clinical Associate Professor, Department of Medicine at the University of Calgary. Dr. Culleton holds a Bachelor’s degree in Medical Science and a Doctor of Medicine degree from Memorial University of Newfoundland, and a Master’s degree in Business Administration from Northwestern University, Kellogg School of Management. He completed a specialization in Internal Medicine and Nephrology through the Royal College of Physicians and Surgeons of Canada, as well as a fellowship in Clinical Epidemiology at Boston University, Framingham Heart Study.
There are no arrangements or understandings between Dr. Culleton and any other person pursuant to which Dr. Culleton was appointed as Chief Executive Officer and as a director. There are no family relationships between Dr. Culleton and any director or executive officer of the Company, and there are no transactions between Dr. Culleton and the Company that would be reportable under Item 404(a) of Regulation S-K.
Dr. Culleton entered into an indemnification agreement in the form the Company has entered into with its other executive officers, which form is filed as Exhibit 10.13 to the Company’s Current Report on Form 8-K, filed by the Company on July 15, 2022 and is incorporated herein by reference.
| Item 7.01 | Regulation FD Disclosure. |
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 Item 7.01, including Exhibit 99.1 attached hereto, is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in this Item 7.01 and Exhibit 99.1 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 Item 7.01 and Exhibit 99.1 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 8.01 | Other Events. |
On November 13, 2023, the Company issued a press release announcing updated Phase 2 data and the leadership transition described in Item 5.02 above. The Company also announced that the Company will host an investor conference call, with slides presented, on Tuesday, November 14, 2023, at 8:00 a.m. Eastern Time. A copy of the press release is filed as Exhibit 99.2 hereto and incorporated herein by reference.
The disclosure in this report and the incorporated exhibits contains 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 and expected cash runway, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company’s products, if approved, potential regulatory approvals, the size and potential growth of current or future markets for the Company’s products, if approved, the advancement of the Company’s development programs into and through the clinic and the expected timing for reporting data, the making of regulatory filings, updating clinical trial protocols, or achieving other milestones related to the Company’s product candidates, and the advancement and funding of the Company’s developmental programs generally. 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 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 clearances or approvals 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 fact that interim results from our clinical programs may not be indicative of future results; 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 included under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other 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.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description of Exhibit | |
| 99.1 | Investor Presentation | |
| 99.2 | Press Release dated November 13, 2023. | |
| 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: November 13, 2023 | By: | /s/ Todd Girolamo | ||||
| Name: | Todd Girolamo | |||||
| Title: | Chief Legal Officer | |||||
Exhibit 99.1 RMCL-002 Interim Results & Updates November 14, 2023 Developing Solutions for 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. 2
Agenda Opening Remarks 01 REACT Phase 2 RMCL-002 Data 02 Plans for Phase 3 Program (Studies REGEN-006 and REGEN-016) 03 04 Advancing a Comprehensive Clinical Plan 3
Disrupting the CKD Treatment Landscape Renal Autologous Cell Therapy: ® REACT (rilparencel) proprietary autologous cellular therapy being evaluated to preserve kidney function in diabetic patients at high risk of kidney failure 4
® What is REACT and Why is it Relevant? Our Product Unmet Needs Our Goals Our Plan Over 35 million U.S. adults Preserve kidney function REACT® is a proprietary Phase 3 clinical program have chronic kidney cell therapy using the proact 1 and proact 2 are Reduce or potentially 1 disease (CKD) patient’s own kidney cells underway in patients with eliminate time spent on Stage 3b / 4 diabetic kidney More than 135,000 of dialysis Early clinical data disease these CKD patients demonstrate a potential to Return autonomy to progress to dialysis every preserve kidney function Potential label expansion to patients and their families 2 year re-dose REACT for long- May provide greater benefit term dialysis prevention Total annual costs to to higher-risk CKD patients Medicare for patients with CKD (including ESRD) 1 exceed $138B 1. CDC Fact Sheet. https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html 2. USRDS 2023 Annual Report 5
® REACT Goal: Preservation of Kidney Function ProKidney’s REACT® Autologous Cell Therapy 6
® Overview of the REACT Clinical Program PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 STATUS Lead Platform Programs* Pivotal Trial Program Diabetes Type II – Prevent/Delay CKD 3/4 006/proact 1 Ongoing 2 (20-50 ml/min/1.73m , N = 600) Enrollment Diabetes Type II – Prevent/Delay CKD 3/4 stratified for SGLT2i 016/proact 2 2 (20-44 ml/min/1.73m , N = 600) Mid-2024 Enrollment Long term follow-up study for patients previously treated with REACT 008 4Q 2023 Supportive Trials Diabetes Type II – Delay CKD 4/5 Trial 003 2 (14-20 ml/min/1.73m , N = 10) Completed Fully Diabetes Type II – Prevent/Delay CKD 3/4 002 2 (20-50 ml/min/1.73m , N = 81) Enrolled Fully Diabetes Repeat Dose Prevent/Delay CKD 3/4 007 2 (20-50 ml/min/1.73m , N= 50) Enrolled Fully Multi / extended-dosing for previously REACT-treated patients 015 Enrolled Trial Congenital Anomalies – Prevent/Delay 004 2 Completed (14-50 ml/min/1.73m , N= 5) Frozen bilateral Unilateral *As of October 2023 product injections injections 7
Unmet Clinical and Payer Need in High-Risk CKD Patients REACT® May Delay Need for Dialysis in Highest-Risk Progressors • CKD is defined as abnormalities of kidney structure or function, present for > 3 months • CKD is classified based on Cause, GFR category (G1-G5), and Albuminuria (A1- A3), abbreviated as CGA Standard of Care o Antihypertensives Risk for ESRD o ACEi o ARB o Glucose & Inflammation Low Reduction o SGLT2i Moderately o DPP-4 Moderately Increased Increased o GLP-1 REACT’s Hi Hig gh h Target Population Ve Ver ry y H Hi ig gh h Today, clinical priorities for patients with Stage 4 CKD (G4) are largely focused on treating co-morbidities and preparing patients for transplantation or dialysis Janet B McGill et al. BMJ Open Diab Res Care 2022; 10:e002806 8
Therapeutic Options to Delay the Need for Dialysis in Patients with Stage 4 Chronic Kidney Disease are Limited Study Active Product Subjects with Stage 4 CKD (%) 1 Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy Canagliflozin (SGLT2 inhibitor) 0% 2 Dapaglifozin in Patients with CKD Dapaglifozin (SGLT2 inhibitor) 14% 3 Empaglifozin in Patients with CKD Empaglifozin (SGLT2 inhibitor) 34% 4 Effect of Finerenone on CKD Outcomes in Type 2 Diabetes Finerenone (Selective MRA) < 10% Rationale, Design, and Baseline Data of FLOW – a Kidney Outcomes Trial with Once Semaglutide (GLP-1RA) 10% 5 Weekly Semaglutide in People with Type 2 Diabetes and CKD All recent landmark clinical trials in CKD focus on Stage 2/3 CKD 1. Perkovic V et al. N Eng J Med 2019 4. Bakris G et al. N Engl J Med 2020 2. Heerspink H et al. N Engl J Med 2020 5. Rossing P et al. Nephrol Dial Transplant 2023 9 3. Herrington et al. N Engl J Med 2023
While New Therapies Are a Step Forward, Patients Still Lose Kidney Function and Experience Clinically Significant Events Standard of Care has Limitations Current SGLT2 Inhibitors are Blockbusters 1 Patients continue to lose kidney function on SGLT2 inhibitors Current standard of care does not prevent events in ~ 50- 2 and progress to Stage 4/5 CKD 75% of people with diabetic kidney disease 2 DAPA: -2.86 ml/min/1.73 m per year versus 2 SoC: -3.79 ml/min/1.73 m per year While dapagliflozin demonstrated <1.0 ml/min/yr difference in eGFR, Dapagliflozin: 19 patients required treatment to prevent one primary it was able to achieve a reduction in clinically important events outcome event 1. Standard of care includes ACE inhibitors, angiotensin receptor blockers and SGLT2 inhibitors 10 2. Heerspink HJL et al. N Eng J Med 2020 Cumulative Incidence (%) of 50% decrease in eGFR, kidney failure and death Change in Estimated GFR (ml/min/1.73 m2)
RMCL-002 Interim Analysis August 2023 Data Cut 11
® In this Phase 2 Study, REACT Demonstrates the Potential for Preservation of Kidney Function in Patients with Diabetes and Advanced Kidney Disease • REACT showed potential to preserve kidney function for up to 30 months in Key Findings several patient groups • REACT’s benefit on kidney function was most notable in patients who had the 1 highest risk of kidney failure (CKD 4 with high UACR ) • REACT injections were well tolerated with a consistent safety profile comparable to kidney biopsy • We are enriching our Phase 3 Proact 1 Study to include more patients with Next Steps the highest risk of kidney failure 12 1. UACR = urine albumin-to-creatinine ratio (a measure of albuminuria)
RMCL-002: Trial Design Active n = 41* st nd 1 2 EOS REACT® REACT® Month 24 follow-up nd Injection Injection after 2 injection = 6 months u u u u u u u u Screening R st nd 1 2 Visit and EOS u = follow-up visit 1:1 nd REACT® REACT® Biopsy Month 12 follow-up after 2 injection nd Injection Injection after 2 injection Day –60 to Day 0 u u u u Deferred n= 42 Key Entry Criteria Study Endpoints Study Timeframe • Type 2 Diabetes Mellitus (DKD) • REACT and Procedure Related • RMAT granted for Phase 3 program in January Adverse Events 2022 • Male or female 30-80 years of age • Change in kidney function • 13 subjects remaining on study (n= 9 in Deferred 2 • eGFR ≥20 and ≤50 mL/min/1.73m (assessed by eGFR) arm) and will complete by YE 2023 • Not on kidney dialysis, HbA1c <10% 13 RMAT = Regenerative Therapy Advanced Medicine
Study Objectives and Endpoints • To assess the safety and efficacy of up to two REACT injections given 6 Study Objectives months apart and delivered into the biopsied kidney using a percutaneous approach • Procedural- and investigational product-related adverse events Study Endpoints • Change in kidney function as measured by serial measurements of estimated glomerular filtration rate (eGFR) 14
Study Demographics are Balanced and Represent a High-Risk CKD Population ACTIVE DEFERRED (n=41) (n=42) Age, years (mean +/- SD) 66.1 +/- 9.9 64.6 +/- 8.9 Female : Male, % 29% : 71% 36% : 64% Hispanic or Latino, % 17% 10% Race, % Black or African American 2% 14% White 93% 71% Other 5% 14% Blood pressure, mm HG 133 / 72 135 / 73 2 eGFR, ml/min/1.73m (mean +/- SD) 33.9 +/- 8.6 31.8 +/- 7.4 Stage 3A CKD, n (%) 4 (10%) 3 (7%) Stage 3B CKD, n (%) 21 (51%) 19 (45%) Stage 4 CKD, n (%) 16 (39%) 20 (48%) UACR mg/g (median +/- interquartile range) 740 (68, 1597) 598 (58, 1985) Geometric Mean / Median of UACR mg/g 251 / 250 308 / 567 HbA1c, % (mean +/- SD) 7.2 +/- 1.0 7.1 +/- 1.0 15
Current Enrollment Status & Completion Expectations st nd ACTIVE COHORT 1 2 REACT® REACT® Active n = 41 st Before 1 Injection: 2 subjects withdrew Injection Injection 39 EOS nd Before 2 Injection: 4 subjects EOS** as per protocol, 33 1 subject expired, 1 started dialysis 33 29 nd 39 21 (+ 4)* Before 12-month follow-up after 2 injection: 2 R 29 subjects expired, 2 subjects withdrew st nd 1 2 1:1 nd REACT® REACT® Before 24-month follow-up after 2 injection: 3 21 EOS subjects EOS as per protocol, 1 subject started Injection Injection dialysis, 4 subjects remain enrolled but have not reached 24-month follow-up 34 26 11 (+ 9)* Deferred n= 42 DEFERRED COHORT Before cross-over: 7 subjects EOS as per protocol, 1 34 subject started dialysis • Rates of drop-out due to death or dialysis are typical for advanced CKD nd Before 2 injection: 4 subjects EOS as per protocol, 26 1 subject expired, 3 started dialysis • 13 patients remain on study (4 in Active cohort, 9 in Deferred cohort) nd Before 12-month follow-up after 2 injection: 2 • All patients expected to complete the study by end of 2023 11 subjects EOS as per protocol, 2 subjects expired, 2 subjects started dialysis, 9 subjects remain enrolled • Final study results anticipated in 1H 2024 but have not reached 24-month follow-up * Subjects pending last eGFR measurement. EOS = End of Study 16
No REACT-related SAE’s Identified in RMCL-002 BIOPSY REACT INJECTION # of patients (%) # of patients (%) ADVERSE EVENT (N=83)* (N=132)* Hematoma 1(1.2) 1(0.8) Pain 0 3(2.3) Hematuria 0 0 Transfusion 0 1 (0.8) Surgical Intervention 0 0 Death 0 0 Acute Kidney Injury 0 1(0.8) CKD progression 0 1(0.8) Renal vascular disorder 0 1(0.8) Kidney fibrosis 0 1(0.8) *All events are based on sponsor assessment of causality No REACT-related serious adverse events were observed Procedure-related serious adverse events were observed in 6/83 subjects including 1 participant who experienced a hematoma, transfusion, and acute kidney injury. A needle design change was implemented after this event 17
Active Cohort Patients Showed No Clinically Meaningful Active Patients (N = 39) Effect After 1st Injection vs Deferred Patients on SOC (N = 40) Average Change in eGFR eGFR Decline Over 30 Months Screening 1st Inj 1st Inj + 3m 2nd Inj 2nd Inj + 3m 2nd Inj + 6m 2nd Inj + 9m 2nd Inj + 12m 2nd Inj + 15m 2nd Inj + 18m Follow-up Follow-up Follow-up Follow-up Follow-up Follow-up Follow-up ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Screening Biopsy Obs 3m Obs 6m Obs 9m Obs 12m 40 Change in Average eGFR in Active Cohort vs Deferred Cohort on SOC 37.4 st st nd nd nd nd nd nd nd nd nd The Active Cohort showed a 1 Inj 1 Inj 2 Inj 2 Inj 2 Inj 2 Inj 2 Inj 2 Inj 2 Inj 2 Inj 2 Inj 35 + 3m + 3m + 6m + 9m + 12m + 15m + 18m + 21m + 24m 33.9 32.8 cumulative change in average Obs 3m Obs 6m Biopsy Obs 9m Obs 12m 31.7 2 32.0 eGFR of -3.2 ml/min/1.73m Active Cohort 30 after 30-months; 28.4 Deferred Cohort 32.8 25 The Deferred Cohort, receiving 30.9 31.8 32.8 N = 39 39 31 33 29 26 21 15 12 12 standard of care, showed a 29.6 N = 40 40 38 35 39 39 31.8 28.4 cumulative change in average 29.6 20 27.9 2 -6.0 -3.0 0.0 3.0 6.0 9.0 12.0 15.0 18.0 21.0 24.0 eGFR of -3.4 ml/min/1.73m Months Standard of Care after 12-months. Data points are mean +/- SEM ; Data as of August 1, 2023 18 2 eGFR (ml/min/1.73m ) 2 eGFR (ml/min/1.73m )
Deferred to Cross-Over Patients Showed Preservation of eGFR after REACT Injection ® Average eGFR in Deferred Cohort: SOC followed by REACT Treatment Average eGFR of the Deferred cohort was st nd nd nd nd 1 Inj 2 Inj 2 Inj 2 Inj 2 Inj st nd 31.8 at baseline 1 Inj 2 Inj + 3m + 3m + 6m + 9m + 12m Obs 3m Obs 6m vs Biopsy Obs 9m Obs 12m 28.4 at 12 months Standard of Care REACT® Injections & Follow-Up [absolute difference of -3.4 2 ml/min/1.73m over 12 months ] 28.8 st Average eGFR at 1 injection after 28.4 eGFR ACR eGFR ACR cross-over was 28.8 Deferred SOC Patients 31.8 330 -- -- vs Deferred Cross-Over Patients -- -- 28.8 250 28.6 at 18 months [absolute difference of -0.2 2 ml/min/1.73m over 18 months] Data as of August 1, 2023 19 2 eGFR (ml/min/1.73m )
Post-Hoc Analysis of All Subjects who Received at Least One Injection 37% of subjects (27 / 73) had preservation of eGFR during 30 months of follow-up All Subjects who Received at Least One Injection with REACT Grouped into Subjects with an 18-month individual slope in eGFR ≥ 0 (n=27) versus REACT treated subjects with 18- Subjects with an 18-month individual slope in eGFR < 0 (n=46) month individual eGFR Slope ≥ 0 ® Average eGFR in REACT Treated Subjects had a change in average eGFR of 2 -0.5 ml/min/1.73m Baseline CKD Stage CKD Stage, % 3A 3B 4 [56% of these subjects had eGFR slope ≥ 0 7% 37% 56% Stage 4 CKD] eGFR slope < 0 4% 55% 41% 31.1 REACT treated subjects with 18- 30.6 month individual eGFR Slope < 0 30.8 eGFR ACR had change in average eGFR of ≥ eGFR slope 0 31.1 164 25.3 eGFR slope < 0 30.8 440 2 -5.5 ml/min/1.73m [41% of these subjects had Stage 4 CKD] Months Data as of August 1, 2023 20 2 eGFR (ml/min/1.73m )
Post-Hoc Analysis of All Subjects who Received at Least One Injection 37% of subjects (27 / 73) had preservation of eGFR during 30 months of follow-up All Subjects who Received at Least One Injection with REACT Grouped into Subjects with an 18-month individual slope in eGFR ≥ 0 (n=27) versus Subjects with an 18-month individual slope in eGFR < 0 (n=46) REACT treated subjects with 18- month individual eGFR Slope ≥ 0 ® Average Change from Baseline in eGFR in REACT Treated Subjects had an average change from baseline in eGFR of Baseline CKD Stage 2 CKD Stage, % 3A 3B 4 -2.8 ml/min/1.73m eGFR slope ≥ 0 7% 37% 56% at 30 months eGFR slope < 0 4% 54% 41% REACT treated subjects with 18- month individual eGFR Slope < 0 -2.8 eGFR ACR had an average change from eGFR slope ≥ 0 31.1 164 baseline in eGFR of eGFR slope < 0 30.8 440 -7.6 2 -7.6 ml/min/1.73m at 30 months Months Data as of August 1, 2023 21 2 eGFR (ml/min/1.73m )
Subgroup Analysis of Diabetic Patients with CKD Stage 4 and Class A3 Albuminuria* Stabilization of Kidney Function in Active (n=13) and Deferred (n=10) Patients at 12 months vs SOC Avg Change in eGFR from Baseline In Active vs Deferred Patients on SOC Avg Change in eGFR from Baseline in Cross-Over vs Deferred Patients on SOC st st nd nd nd st st nd nd nd 1 Inj 1 Inj + 3m 2 Inj 2 Inj + 3m 2 Inj + 6m 1 Inj 1 Inj + 3mo 2 Inj 2 Inj + 3mo 2 Inj + 6mo Biopsy Obs 3m Obs 6m Obs 9m Obs 12m Biopsy Obs 3mo Obs 6mo Obs 9mo Obs 12mo 0.4 -1.6 -6.0 -6.0 eGFR ACR eGFR ACR eGFR ACR eGFR ACR - -n- - Deferred Cohort SOC 25.7 1750 -- -- Deferred Cohort SOC 25.7 1750 -- -- Active Cohort -- -- 24.6 1979 Deferred Cohort post injection -- -- 20.8 1353 1 *Patients with Stage 4 CKD & Class A3 (Severe Albuminuria, >300 mg/g) are one of the fastest progressing patient populations Data as of August 1, 2023 1. Oshima M, Shimizu M, Yamanouchi M, et al. Trajectories of kidney function in diabetes: a clinicopathological update. Nat Rev Nephrol. 22 2021;17(11):740-750. doi:10.1038/s41581-021-00462-y 2 eGFR (ml/min/1.73m ) 2 eGFR (ml/min/1.73m )
® In this Phase 2 Study, REACT Demonstrates the Potential for Preservation of Kidney Function in Patients with Diabetes and Advanced Kidney Disease • REACT showed potential to preserve kidney function for up to 30 months in Key Findings several patient groups • REACT’s benefit on kidney function was most notable in patients who had the 1 highest risk of kidney failure (CKD 4 with high UACR ) • REACT injections were well tolerated with a consistent safety profile comparable to kidney biopsy • We are enriching our Phase 3 Proact 1 Study to include more patients with Next Steps the highest risk of kidney failure 23 1. UACR = urine albumin-to-creatinine ratio (a measure of albuminuria)
REACT® Registrational Program: 1 (REGEN-006) 2 Modifying proact 1 eGFR enrollment criteria from current range of ≥20 to ≤ 50ml/min/1.73m to new range of 2 ≥20 to ≤ 35 ml/min/1.73m to better align with RMCL-002 results and Payer / Clinical Feedback = 3 months st Sham 1 Sham SHAM Cohort n=300 ® REACT 2nd = 6 months ® Injection Sham REACT Biopsy Injection End of Study (EOS) R st nd Screening 1 2 ® ® Visit REACT 1:1 REACT Injection Biopsy Injection Day - 60 to Day 0 End of Study (EOS) REACT Cohort n=300 Time-to-Event Primary Composite Endpoint New Protocol Modifications Existing Key Entry Criteria (Unchanged) 2 ≥ ≤ • CKD caused by Type II Diabetes • eGFR 20 and 35 ml/min/1.73m • At least 40% reduction in eGFR; • Male or Female 30-80 years of age • UACR 300 - 5,000 mg/g for eGFR 30-35 • eGFR<15mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or renal transplant; or 2 • Updating standard of care expectations • eGFR ≥20 and ≤50 mL/min/1.73m • Death from renal or cardiovascular causes • Not on renal dialysis, HbA1c <10% • 600 patients in addition to ~50 currently enrolled patients who meet new eGFR criteria • UACR 300 - 5,000 mg/g 24
® REACT Registrational Program: 2 (REGEN-016) NO MODIFICATIONS PLANNED = 3 months st Sham 1 Sham = 6 months SHAM Cohort n=300 ® nd REACT 2 ® Injection Sham REACT Biopsy Injection End of Study (EOS) R st nd Screening 1 2 ® ® Visit REACT 1:1 REACT Injection Biopsy Injection Day - 60 to Day 0 End of Study (EOS) REACT Cohort n=300 Key Entry Criteria Protocol Time-to-Event Primary Composite Endpoint • CKD caused by Type II Diabetes • No protocol modifications planned • At least 40% reduction in eGFR; • Male or Female 30-80 years of age • eGFR<15mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or renal transplant; or 2 • eGFR ≥ 20 and ≤ 44 mL/min/1.73m • Death from renal or cardiovascular causes • Not on renal dialysis, HbA1c <10% • UACR 300 - 5,000 mg/g 25
Advancing a Comprehensive Clinical Plan 1H 2023 2H 2023 2024 and beyond REGEN-003 Phase 2 RMCL-002 Phase 2 REGEN-007 Phase 2 REACT® Phase 3 Diabetic CKD Trials Trial; Results Enrollment complete Enrollment complete proact 1 – Enrollment focused on U.S. published 1Q23 Interim results 2H23 proact 2 – Enrollment focused ex-U.S. • Open-label trial • Safety & efficacy of • Last patient last visit ® Diabetic CKD • Enriching proact 1 with high-risk patients to align with 002 data and meet REACT December 2023 Stage 3/4 (eGFR 20-50) clinical and payer needs • Stage 4/5 Diabetic • Stage 3b/4 Diabetic • Bi-lateral kidney • Manufacturing temporarily paused while company amends proact 1 CKD (eGFR 14-20) CKD (eGFR 20-50) injections protocol and concurrently, in response to QP audit, optimizes capabilities • Assess impact on • 2 injections into to meet EU and Global manufacturing and quality management system • Cryopreserved progression and biopsied kidney standards for Phase 3 studies, and prepares for transition to commercial commercial formulation time to dialysis in • Open label safety & manufacturing. NO SAFETY EVENTS are responsible for this pause patients with • Interim Results mid- efficacy of REACT • Expect proact 1 will resume, and proact 2 will commence, enrollment in imminent risk of 2024 • Full results in 1H mid-2024 dialysis • Full results in 1H 2025 2024 • Completion of both studies anticipated in 2027 Cash Position Regulatory • FDA / EMA agreement on pivotal study design $396M cash provides runway (9/30/2023) into 4Q 2025 • RMAT designation in U.S. 26
RMCL-002 Interim Results & Updates November 14, 2023 Developing Solutions for Dialysis Prevention REACT® [REnal Autologous Cell Therapy]
Appendix 28
Annualized eGFR Slopes using Linear Mixed Effects Modeling Subject Group Number of Duration of Follow-up Annualized eGFR Slope 2 Subjects (ml/min/1.73m ) Active Cohort 39 12-months after 1st injection -3.6 Deferred Cohort during standard of care (SOC) 42 12-months after biopsy -3.4 nd Deferred Cohort after Cross-over and injection with REACT 34 12-months after 2 injection -0.8 st Active Cohort, Stage 4 and UACR > 300 mg/g 13 12-months after 1 injection -2.4 Deferred Cohort during SOC, Stage 4 and UACR > 300 mg/g 13 12-months after biopsy -5.8 st Deferred Cohort after Cross-over, Stage 4 and UACR > 300mg/g 10 12 months after 1 injection -0.4 29
Exhibit 99.2
ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT®) for Diabetic CKD and Provides Corporate Updates
Updated positive interim Phase 2 data demonstrate potential efficacy of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients
Focusing Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure and need for renal replacement therapy
Dr. Bruce Culleton appointed ProKidney CEO following Dr. Tim Bertram’s transition to advisory role
Sufficient capital to fund operations into fourth quarter 2025
ProKidney to host conference call and webcast tomorrow at 8:00 a.m. ET
WINSTON-SALEM, N.C., November 13, 2023 — ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced updated positive interim diabetic CKD data from its RMCL-002 Phase 2 study that support the Company’s evolution into late-stage development and position the Company to change the treatment paradigm in high-risk diabetic CKD patients with its REACT® (rilparencel) renal autologous cell therapy.
Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients. Updated interim REACT RMCL-002 study data support continued investigation of REACT’s potential to benefit patients with moderate and high-risk diabetic CKD. The updated data include information from 83 patients enrolled in the RMCL-002 study. All patients had Stage 3 or 4 CKD caused by type 2 diabetes. The ongoing Phase 2 clinical study assessed adverse events and changes in kidney function as measured by estimated glomerular filtration rate (eGFR), as primary study endpoints. The dataset revealed a safety profile in line with previous Phase 1 & 2 REACT trials, with REACT showing a safety profile similar to that of a kidney biopsy. Overall, the updated Phase 2 trial data showed preservation of kidney function in several patient groups with advanced CKD caused by type 2 diabetes, with the most notable potential benefit shown in patients who had the highest risk of kidney failure (CKD Stage 4 with severe albuminuria), where there remains a significant unmet clinical need.
Pablo Legorreta, Chairman of ProKidney’s Board of Directors, said “We are excited to report more mature interim data for ProKidney’s RMCL-002 Phase 2 study which suggests that REACT® was able to preserve kidney function for up to 30 months in a meaningful proportion of the patients treated in the study. When I got involved with ProKidney, I hoped that if REACT could slow the decline of kidney function in a meaningful proportion of patients, it could become an important and differentiated therapy. It is exciting to see that REACT appears to have exceeded my expectations of preservation of kidney function in this population that faces significant unmet medical needs.”
Focusing ongoing Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure and need for renal replacement therapy. Based on these emerging results, the Company plans to update its ongoing proact 1 Phase 3 clinical study (REGEN-006) protocol to focus on patients with higher risk of kidney failure. In the proact 1 Phase 3 clinical study we will modify the eGFR enrollment range from the current range of ≥20 to ≤ 50 ml/min/1.73m2 to a new range of ≥20 to ≤ 35 ml/min/1.73m2, to focus on the most severe patients, to better align with RMCL-002 results and clinical feedback. The Company does not intend to modify the eGFR enrollment range for its second Phase 3 trial, proact 2 (REGEN-016), which is currently ≥20 to ≤ 44 ml/min/1.73m2. Maintaining the eGFR enrollment range of proact 2, which includes the CKD Stage 3B population, will enable the Company to seek a broader
commercial label. The modification to the eGFR enrollment range to our proact 1 Phase 3 clinical study will cause a delay in enrollment of this study, and we expect to resume enrollment during the first half of 2024.
ProKidney to temporarily pause manufacturing to address Qualified Person Audit - No safety events are responsible for this pause. A recent audit performed by the Company’s contracted qualified person (QP) to evaluate its readiness for release and distribution of REACT to the EU, while still in process, identified certain deficiencies in the documentation of the quality management systems to be addressed prior to release and distribution of product for EU clinical sites. Many of these improvements to GMP systems and control activities were ongoing but had not yet been completed at the time of the audit.
The Company is temporarily pausing manufacturing until the first half of 2024, while the Company optimizes its capabilities to meet EU and global standards for its Phase 3 program and future commercial manufacturing. The Company will work to implement these manufacturing and documentation improvements concurrently with the 006 pause for protocol changes such that it expects proact 1 will resume, and proact 2 will commence enrollment in the first half of 2024.
Dr. Bruce Culleton, EVP Clinical Development and Commercialization, to be appointed ProKidney CEO upon Dr. Tim Bertram’s transition to an advisory role. As the Company progresses into pivotal development and commercialization, ProKidney is pleased to announce the appointment of Dr. Bruce Culleton as the Company’s CEO, effective November 15, 2023. Dr. Culleton will also join the ProKidney board of directors. Dr. Tim Bertram will transition from his current role as director and CEO to a scientific advisory role.
“We’re leveraging a novel renal autologous cell therapy to improve care in a population of CKD patients with little to no options other than dialysis, and Dr. Culleton is uniquely qualified as a physician and business leader to guide ProKidney through the pivotal trials of REACT®, said Dr. Bertram. “I look forward to supporting the Company and helping ensure a smooth transition for the organization.”
Commenting on his new role, Dr. Culleton stated, “I am honored to accept the role of CEO at ProKidney and to build upon the foundation laid by Dr. Bertram. I am excited by the opportunity to bring a life-changing solution to patients who are on a path to dialysis. ProKidney is well positioned to execute on a successful Phase 3 program, and I look forward to working with the team on this next phase while staying true to putting patients first in everything we do.”
Mr. Legorreta added “We are thrilled to welcome Dr. Culleton into his new role as CEO, as he builds upon Dr. Betram’s successes at ProKidney. Bruce’s clinical, regulatory and commercial expertise will be invaluable as ProKidney navigates its Phase 3 studies towards completion, prepares for regulatory submission both in the U.S. and abroad, and prepares REACT for commercialization. We are thankful for Dr. Bertram’s development of REACT and his decades-long perseverance and dedication to bringing the therapy forward to patients with kidney disease. Dr. Bertram’s significant contribution has been instrumental in advancing ProKidney from its inception and into clinical development.”
Dr. Culleton joined ProKidney in July 2023 as Executive Vice President of Clinical Development and Commercialization. Dr. Culleton has dedicated his 25-year professional career to improving the health and quality of life of patients with kidney disease. Over this time his responsibilities have included direct patient care, clinical research, product development, and executive leadership positions at Baxter Healthcare and CVS Kidney Care, a wholly owned subsidiary of CVS Health.
Dr. Culleton earned a Doctor of Medicine degree from Memorial University of Newfoundland, and a Master’s Degree in Business Administration from Northwestern University, Kellogg School of Management. He completed specialization in Internal Medicine and Nephrology through the Royal College of Physicians and Surgeons of Canada, as well as a fellowship in Clinical Epidemiology at Boston University, Framingham Heart Study.
Sufficient capital to fund operations into fourth quarter 2025. ProKidney reported it has $396 million in cash, cash equivalents and marketable securities as of September 30, 2023. With the changes the Company announced today, including protocol modifications and manufacturing improvements, the Company expects to be able to fund operations into the fourth quarter of 2025.
The Company expects to provide full data of its RMCL-002 Phase 2 study in the first half of 2024 and interim results on its ongoing RMCL-007 Phase 2 study in mid- 2024 and full results in the first half of 2025. The Company will provide additional guidance regarding the timing of its Phase 3 programs during the conference call on November 14, 2023.
Investor Conference Call
ProKidney management will be hosting a webcast and investor conference call tomorrow, November 14, 2023, at 8:00 a.m. ET. The live webcast presentation may be accessed here. Further, you may listen to the presentation by dialing 1-877-407-0784 (US) or 1-201-689-8560 (International) and entering the Conference ID: 13742672. Following the completion of the presentation, a replay of the webcast will also be accessible on the investor relations section of ProKidney website here.
About ProKidney
ProKidney, a pioneer in the treatment of CKD through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, REACT® (Renal Autologous Cell Therapy), is a first-of-its-kind, patented, proprietary autologous cellular therapy being evaluated to potentially preserve kidney function in diabetic patients at high risk of kidney failure. REACT® has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting its ongoing Phase 3 clinical program that launched in January 2022. For more information, please visit www.prokidney.com.
Forward-Looking Statements
This press release 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 and expected cash runway, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company’s products, if approved, potential regulatory approvals, the size and potential growth of current or future markets for the Company’s products, if approved, the advancement of the Company’s development programs into and through the clinic and the expected timing for reporting data, the making of regulatory
filings, updating clinical trial protocols, or achieving other milestones related to the Company’s product candidates, and the advancement and funding of the Company’s developmental programs generally. 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 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 clearances or approvals 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 fact that interim results from our clinical programs may not be indicative of future results; 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 included under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other 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.
Contacts
Corporate:
Glenn Schulman, PharmD, MPH
SVP, Investor Relations
Glenn.Schulman@prokidney.com
Investors:
LifeSci Advisors, LLC
Daniel Ferry
Daniel@lifesciadvisors.com