PROK ProKidney Corporation

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 3, 2024

 

 

PROKIDNEY CORP.

(Exact name of Registrant as Specified in Its Charter)

 

 

Cayman Islands			001-40560	98-1586514
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
2000 Frontis Plaza Blvd. Suite 250
Winston-Salem, North Carolina				27103
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 336 999-7019

 

(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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Class A ordinary shares, $0.0001 par value per share		PROK		The Nasdaq Stock Market

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. ☐

 

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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 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 September 3, 2024, the Company issued a press release announcing strategic updates to its Phase 3 program for rilparencel, an investigational treatment to potentially preserve kidney function in patients with type 2 diabetes and advanced chronic kidney disease. 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. The Company'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 beliefs that (i) rilparencel is eligible for initial FDA approval under an expedited approval pathway based upon the successful completion of the Phase 3 REGEN-006 (PROACT 1) trial, (ii) the Phase 3 REGEN-016 (PROACT 2) trial is not required for initial U.S. registration, and (iii) the revised Phase 3 program will accelerate estimated topline data readout and deliver topline results by Q3 2027, expectations with respect to financial results and expected cash runway, including the Company’s expectation that current cash will support operating plans into Q1 2027, 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 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 profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the risk that results of the Company’s clinical trials may not support approval; the risk that the FDA could require additional studies before approving the Company’s drug candidates; 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 fact that interim results from our clinical programs may not be indicative of future results; the impact of geo-political conflict 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

 

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Exhibit No.	Description
99.1	Investor Presentation
99.2	Press Release dated September 3, 2024
104	Cover Page Interactive Data File (embedded within Inline XBRL document)

 

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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 3, 2024	By:	/s/ James Coulston
			Name: James Coulston Title: Chief Financial Officer

 

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Developing Solutions for Dialysis Prevention September 2024 Corporate Presentation Exhibit 99.1

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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. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Forward-looking Statements

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Renal Autologous Cell Therapy:  Rilparencel (REACT®) proprietary autologous cellular therapy being evaluated to preserve kidney function in patients with diabetes and advanced chronic kidney disease Disrupting the CKD Treatment Landscape

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Recent Developments An Introduction to ProKidney CKD = chronic kidney disease RMAT = regenerative medicine advanced therapy Preserve kidney function in advanced CKD patients Preserve kidney function in patients with type 2 diabetes and advanced chronic kidney disease who are faced with limited options for care beyond transplantation or dialysis A proprietary autologous cellular therapy with RMAT designation Currently in pivotal Phase 3 clinical development with REGEN-006 (PROACT 1) Supported by three Phase 2 clinical trials in advanced CKD patient populations Leadership Team with Clinical Development & Regulatory Experience Together the team brings over 150 years cumulative experience in the discovery, development, manufacturing and commercialization of biotechnology, pharmaceutical, and device products Meaningful Recent Developments Refined the focus of the Phase 3 program in Sep 2024 to accelerate PROACT 1 and path to potential U.S. approval Completed an upsized common stock offering of $140 million in June 2024 extending cash runway into Q1 2027 Phase 2 REGEN-007 interim results published in June 2024 Goal Rilparencel Leadership

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Preserve kidney function Reduce or potentially eliminate time spent on dialysis Return autonomy to patients and their families Over 35 million U.S. adults have chronic kidney disease (CKD)1 More than 135,000 of these CKD patients progress to dialysis every year1 Total annual costs to Medicare for patients with CKD (including ESRD) exceed $138B2 What is Rilparencel and Why is it Relevant? CDC Fact Sheet. https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html USRDS 2023 Annual Report Rilparencel is a proprietary cell therapy using the patient’s own kidney cells Early clinical data demonstrate a potential to preserve kidney function May provide greater benefit to higher-risk CKD patients The Phase 3 PROACT 1 clinical study is focused on patients with type 2 diabetes and late Stage 3b/4 CKD Potential label expansion to re-dose rilparencel for long-term dialysis prevention Unmet Needs Our Goals Our Product Our Plan

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Rilparencel Goal: Preservation of Kidney Function ProKidney’s Autologous Cell Therapy  1 Renal cortex cells are harvested using a routine kidney biopsy 2 Cells are expanded and then subject to a selection process 3 The selected cells are frozen for storage and thawed just before injection

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Overview of the Rilparencel Clinical Program As of August 2024 Unilateral injections Bilateral injections Frozen product ESRD = End-Stage Renal Disease Overview of the Rilparencel Clinical Program Pivotal Trial Program Diabetes Type II – Prevent/Delay ESRD in Stage 3b/4 CKD (20-35 ml/min/1.73m2, n=685) Long term follow-up study for patients previously treated with rilparencel Supportive Trials Diabetes Type II – Prevent/Delay ESRD in Stage 3/4 CKD (20-50 ml/min/1.73m2, n=83) Diabetes Type I & II – Prevent/Delay ESRD in Stage 3/4 CKD (20-50 ml/min/1.73m2, n=53) Completed Trials Diabetes Type II – Delay ESRD in Stage 4/5 CKD (14-20 ml/min/1.73m2, n=10) Congenital Anomalies – Prevent/Delay ESRD (14-50 ml/min/1.73m2, n=5) PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 STATUS 006/PROACT 1 008 002 007 003 004 Ongoing Ongoing Final Data Presented Fully Enrolled Trial Completed Trial Completed Frozen product Unilateral injections Bilateral injections ESRD = End-Stage Renal Disease As of August 2024 PROKIDNEY

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Advancing a Comprehensive Clinical Plan RMCL-002 Phase 2 Trial; Results published Q2 2024 Open-label safety & efficacy of rilparencel in patients with type 2 diabetes and Stage 3/4 CKD (eGFR 20-50) Potential to preserve kidney function for up to 30 months in several patient groups REGEN-007 Phase 2 Trial; Enrollment complete; Interim results published Q2 2024 Open-label safety & efficacy of rilparencel in patients with diabetes and Stage 3/4 CKD (eGFR 20-50) Bilateral kidney injections & cryopreserved commercial formulation Phase 3 Randomized Controlled Clinical Trial – type 2 diabetes and Stage 3b/4 CKD PROACT 1 is enrolling patients 2024 REGEN-007 Phase 2 Trial; Full 12 month data from Group 1 expected in 1H 2025 Update on rilparencel Mechanism of Action in 2H 2025 Phase 3 Randomized Controlled Clinical Trial – type 2 diabetes and Stage 3b/4 CKD Topline results for the PROACT 1 study anticipated in Q3 2027 2025 and beyond

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Day - 60 to Day 0 ScreeningVisit SHAM Cohort Sham 1st Rilparencel Injection Sham 2nd Rilparencel Injection Sham Biopsy End of Study (EOS) Rilparencel Cohort 1st Rilparencel Injection 2nd Rilparencel Injection Biopsy End of Study (EOS) PROACT 1 eGFR enrollment criteria range of ≥20 to ≤35 ml/min/1.73m2 aligns with Phase 2 study results and payer / clinical feedback Rilparencel Registrational Program:  1 (REGEN-006) Key Entry Criteria 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 Type 2 diabetes and CKD Male or Female 30-80 years of age eGFR ≥20 and ≤35 mL/min/1.73m2 UACR 300-5,000 mg/g for eGFR 30-35 Not on renal dialysis, HbA1c <10% 3 months 3 months 3 months 3 months 6 months 6 months 6 months 6 months 6 months 6 months 6 months 6 months 6 months 6 months R 1:1 n = ~685

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Unmet Clinical and Payer Need in High-Risk CKD Patients Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 clinical practice guideline for diabetes management in chronic kidney disease. Kidney Int 2020;98:S1–115. Moderately Increased High Very High Rilparencel’s Target Population Risk for ESRD Low Moderately Increased High Very High 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 Antihypertensives ACEi ARB Glucose & Inflammation Reduction SGLT2i DPP-4 GLP-1 Today, clinical priorities for patients with Stage 4 CKD (G4) are largely focused on treating co-morbidities and preparing patients for transplantation or dialysis  Persistent albuminuria categories description and range A1 A2 A3 Normal to mildly increased Moderately increased Severely increased <30 mg/g <3 mg/mmol 30-300 mg/g 3-30mg/mmol >30 mg/g 30mg/mmol G G2 G3a G3b G4 G5 Normal or High Mildly decreased Mildly to moderately decreased moderately to several decreased severely decreased kidney failure >=90 60-89 45-59 30-44 15-29 <15 GFR categories (mL/min/1.73m2)

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Study Active Product Subjects with Stage 4 CKD Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy1 Canagliflozin (SGLT2 inhibitor) 0% Dapagliflozin in Patients with CKD2 Dapagliflozin (SGLT2 inhibitor) 14% Empagliflozin in Patients with CKD3 Empagliflozin (SGLT2 inhibitor) 34% Effect of Finerenone on Cardiovascular and Kidney Outcomes in Patients with Type 2 Diabetes and CKD4 Finerenone (Selective MRA) 7% Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes5 Semaglutide (GLP-1RA) 11% Therapeutic Options that Delay the Need for Dialysis in Patients with Stage 4 Chronic Kidney Disease are Limited  All recent landmark clinical trials in CKD primarily focus on Stage 2 and 3 CKD Perkovic V et al. N Eng J Med 2019 Heerspink H et al. N Engl J Med 2020 Herrington et al. N Engl J Med 2023 Agarwal. R et al. Eur Heart J. 2022; Sarafidis. P et al. Clin J Am Soc Nephrol 2023 Perkovic V et al. N Engl J Medicine 2024

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While New Therapies Are a Step Forward, Patients Still Lose Kidney Function and Experience Clinically Significant Events Standard of care includes ACE inhibitors, angiotensin receptor blockers and SGLT2 inhibitors Heerspink HJL et al. N Eng J Med 2020 Current standard of care1 does not prevent events in ~50-75% of people with diabetic kidney disease2 Standard of Care has Limitations Cumulative Incidence (%) of 50% decrease in eGFR, kidney failure and death Dapagliflozin: 19 patients required treatment to prevent one primary outcome event SGLT2 inhibitors Do Not Prevent Progression of Advanced CKD Patients continue to lose kidney function on SGLT2 inhibitors and progress to Stage 4/5 CKD Change in Estimated GFR (ml/min/1.73m2) While dapagliflozin demonstrated <1.0 ml/min/yr difference in eGFR, it was able to achieve a reduction in clinically important events Approx. Change in eGFR (ml/min/1.73m2) Dapagliflozin Placebo Month 12 -4.5 -4 Month 18 -5.5 -6 Month 24 -6.5 -7.5 DAPA: -2.86 ml/min/1.73m2 per year versus SoC: -3.79 ml/min/1.73m2 per year

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REGEN-007 Interim Analysis Data as of May 7, 2024

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Key Entry Criteria Type 1 or type 2 diabetes and CKD Subjects 30-80 years of age eGFR ≥20 and ≤50 mL/min/1.73m2 UACR 30-5000 mg/g HbA1c <10% Day –60 to Day 30 Screening Visit and Biopsy REGEN-007 Trial Design u = Follow-up Visit After Last Injection = 3 Months Group 2 Re-Dosing Trigger Sustained 30-Day: Decline in eGFR of ≥20% from baseline, and/or Increase of ≥30% and ≥30 mg/g in UACR from baseline 2nd Rilparencel Injection Assess 2nd Injection Trigger (Months 3-15) Group 2 (Exploratory Dosing Regimen) n = 25 R 1:1 1st & 2nd Rilparencel Injections EOS Month 18 Following 2nd Injection Group 1 (Ph3 Dosing Regimen) n = 25 EOS Month 18 Following 1st Injection 1st Rilparencel Injection u u u u u u u u u u u u u u u u u u EOS Month 18 Following 2nd Injection eGFR = estimated glomerular filtration rate; UACR = urine albumin-to-creatinine ratio (a measure of albuminuria) Group 1 Dosing Regimen and Use of Cryopreserved Product Mirrors Phase 3 Program

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REGEN-007 Interim Analysis Objectives and Endpoints in Group 1 Objectives Endpoints In subjects with at least 12 months follow-up after 2 injections, assess the safety and efficacy of cryopreserved rilparencel delivered into the biopsied and non-biopsied contralateral kidney using a percutaneous approach Procedural and investigational product-related adverse events Change in kidney function as measured by eGFR 

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Current Enrollment Status & Completion Expectations 53 Subjects were Randomized in REGEN-007 with 27 Subjects Randomized to Group 1 (1 Subject Withdrew Consent Pre-Biopsy) 26 Subjects in Group 1 Of the 26 Subjects who were Biopsied, 24 Subjects Received at-least 1 Injection (2 Subjects’ Biopsies had Insufficient Cells for Injection) 24 Subjects Of the 24 Subjects, 1 Subject had a Contra-indication (Bleeding Risk) for a 2nd Injection & 1 Subject Died before 12 Months Follow-up 22 Subjects Expected to Receive 2 Injections with 12 Months Follow-up As of May 7, 2024: 13 Subjects Have Received 2 Injections with a Minimum of 12 Months Follow-up post 2nd Injection

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SUBJECTS WITH MINIMUM 12 MONTHS FOLLOW-UP AFTER 2ND INJECTION (n=13) Age, years (mean +/- SD) 62.8 +/- 8.2 Female : Male, % 54% : 46% Hispanic or Latino, % 0% Race, %      Black or African American 0%      White 100%      Other 0% Blood pressure, mm HG 135 / 72 eGFR, ml/min/1.73m2  (mean +/- SD) 29.7 +/- 9.5 UACR mg/g (median, min max) 239 (4, 2392) HbA1c, % (mean +/- SD) 7.3 % +/- 1.6 ACE/ARB Use, % 69% SGLT2 Use, % 31% GLP-1 Use, % 46% Baseline Characteristics in Group 1 Subjects with a Minimum of 12 Months Follow-up after Two Rilparencel Injections HbA1c = hemoglobin A1c; SGLT2 = sodium glucose cotransporter 2 protein inhibitor; ACE = angiotensin converting enzyme; ARB = angiotensin II receptor blockers

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Externally Developed Control Arm to Contextualize REGEN-007 Interim Data Objective Methods Explore how 18 month change in kidney function in subjects enrolled in REGEN-007 might compare against matched contemporaneous controls In partnership with Dr. Navdeep Tangri (University of Manitoba), 13 subjects from REGEN-007 were matched 10:1 with diabetic subjects from recent CKD clinical trials Matching was independently performed based upon 2-year risk of kidney failure using Klinrisk1 software and comparable usage of SGLT2 inhibitors https://www.klinrisk.com/

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Klinrisk Founding Team Navdeep Tangri Co-Founder and CEO Founder and Scientific Director, Chronic Disease Innovation Centre Professor of Medicine, University of Manitoba Global leader in risk prediction who developed the most widely used algorithms in nephrology worldwide Published more than 380 manuscripts Risk equations have been integrated in electronic health records (Epic), laboratory information systems, and national & international clinical practice guidelines Strong track record of leading international clinical trials, developing trial endpoints with FDA and participating FDA discussions on drug approval and labeling Relationships with large pharmaceutical companies – considered a key opinion leader internationally in the CKD space J.D. McCullough Chief Operating Officer Health tech executive specializing in regulated AI commercialization First autonomous AI FDA clearance and SaMD reimbursement including CMS coverage at Digital Diagnostics Closed seven figure deals with health systems, payors, labs, and biopharma companies Led FDA strategy and engagement for 10+ SaMD products, including Breakthrough, PMA, De Novo, and 510(k) Licensed over 50M patient records globally to drive AI & drug development Strategic advisor to Top 20 Biopharma, regulatory & reimbursement firms, and venture-backed startups Previous Commercial & Product Executive positions at Aegis Ventures, Arcturis Data, Digital Diagnostics Roche pD TRICIDA University Manitoba Chronic Disease Innovation Digital Diagnostics AscendMed MCRA Lumanity Logo

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Matched Controls Showed a Continuous Decline in Kidney Function over 18 Months -1.2 -2.2 -4.0 -6.2 Klinrisk Matched Subjects (n=125) Average Change in eGFR from Baseline at 18 Months -6.2 ml/min/1.73m2 (95% CI -7.8, -4.6)

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1.7 1.0 -0.5 -2.7* 0.9 -1.3 N= 13 12 13 13 13 13 12 29.8 30.7 29.2 27.0* 30.6 28.8 Kidney Function Stabilizes for 18 Months After 1st Injection Average Change from Baseline with 18 Months Follow-up Post 1st Injection -1.3 ml/min/1.73m2 (95% CI -5.1, 2.5) Interim analysis; Data points are mean +/- SEM ; Data as of May 7, 2024 Average Change from Baseline eGFR (ml/min/1.73m2) Months 1st Inj 2nd Inj 2nd Inj + 3m 2nd Inj + 6m 2nd Inj + 9m 2nd Inj + 12m 2nd Inj + 15m Average eGFR (ml/min/1.73m2) Average eGFR in Group 1 was 29.7 at Baseline vs 28.8 at 18 Months Post 1st Injection [absolute difference -0.9 ml/min/1.73m2 at 18-months] Months 29.7 Group 1 Subjects (n=13) with Minimum 12 Months Follow-up Data Post 2nd Injection 1st Inj 2nd Inj 2nd Inj + 3m 2nd Inj + 6m 2nd Inj + 9m 2nd Inj + 12m 2nd Inj + 15m N= 13 12 13 13 13 13 12 *eGFR highly influenced by 1 patient that recovered on measurements at month 15 and month 18

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ADVERSE EVENT BIOPSY # of SAEs (n=51) RILPARENCEL INJECTION # of SAEs (n=49) Hematoma 2 1 Thrombosis 1 0 Hematuria 1 0 Hydronephrosis 1 0 Death 0 0 Acute Kidney Injury 2 0 No Rilparencel-related Serious Adverse Events have been Observed Data as of May 7, 2024

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Key Findings REGEN-007 Interim Analysis Summary In Group 1 participants who had at least 12 months follow up after a second rilparencel injection, kidney function was preserved for 18 months Bilateral dosing of cryopreserved product showed safety profile consistent with prior studies and comparable to kidney biopsy Next Steps We look forward to providing full results for REGEN-007 in 1H 2025 We are focused on enrolling patients in our registrational Phase 3 PROACT 1 study and expect topline results in Q3 2027

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*As of Aug 9, 2024 **Cash, cash equivalents and marketable securities as of June 30, 2024 Covering Research Analysts Jason Gerberry Bank of America Global Research Justin Zelin BTIG Yigal Nochomovitz Citigroup Inc. Jonathan Miller Evercore ISI Judah Frommer Morgan Stanley Eliana Merle UBS Kelly Shi Jefferies NASDAQ: PROK 289,675,217 shares outstanding* $432M Cash** on hand expected to fund operations into Q1 2027 Headquarters: Boston, MA Winston-Salem, NC Financial Highlights

ProKidney Announces Strategic Updates to its Phase 3 Program to Accelerate Rilparencel’s Registrational Path to Potential Approval in the U.S.

 

 

WINSTON-SALEM, N.C., September 3, 2024 – ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced strategic updates to its Phase 3 program for rilparencel, an investigational treatment to potentially preserve kidney function in patients with type 2 diabetes and advanced CKD.

 

ProKidney recently completed a comprehensive internal and external review, including engaging with ex-FDA officials and seasoned regulatory experts, to determine the optimal path to bring rilparencel to patients in the U.S. with type 2 diabetes and advanced CKD – a market where there is high unmet clinical and economic need. An important conclusion of this review is that under the provisions of the Regenerative Medicine Advanced Therapy (RMAT) designation, the Company believes rilparencel is eligible for initial FDA approval under an expedited approval pathway based upon successful completion of the ongoing Phase 3 REGEN-006 (PROACT 1) trial. ProKidney believes that the Phase 3 REGEN-016 (PROACT 2) trial is not required for initial U.S. registration. Thus, the Company will discontinue PROACT 2, which was focused on enrollment outside the U.S. With the discontinuation of PROACT 2, ProKidney now expects current cash to support operating plans into Q1 2027. The Company estimates the revised Phase 3 program will deliver topline results by Q3 2027 and reduce expenses by approximately $150 to $175 million.

 

“We decided to prioritize PROACT 1 to accelerate potential U.S. registration and commercial launch. We are confident that this strategic shift in our Phase 3 program is the most expeditious and resource efficient approach to bring rilparencel to market in the U.S., our highest priority market,” said Bruce Culleton, M.D., Chief Executive Officer. “The recent positive REGEN-007 interim data update in June further supports the urgency to bring our innovation to patients with advanced CKD. We look forward to continuing our engagement with the FDA, under the RMAT designation, to bring rilparencel to market.”

 

Today’s update follows a transformational period for ProKidney over the past 10 months. In November 2023, Bruce Culleton, M.D., a nephrologist and seasoned leader of kidney care organizations, was appointed Chief Executive Officer. Under Dr. Culleton’s leadership, ProKidney has made significant progress, including the implementation of improved quality management systems to ensure compliance with global standards for commercial manufacturing and the Phase 3 program, the refinement and restart of the Phase 3 program with a renewed focus on patients with advanced CKD in the U.S., and the appointment of several key executive leaders across clinical operations, manufacturing, human resources, and business operations. The Company also released final data from the Phase 2 RMCL-002 trial and interim data from the Phase 2 REGEN-007 trial. Data from these trials suggest that rilparencel’s

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greatest potential therapeutic impact is in advanced CKD patients at high risk of kidney failure. This patient population aligns with feedback from payors and providers who have emphasized the need for treatment options in this population.

 

Rilparencel was granted RMAT designation by the FDA in October 2021. RMAT designation can be granted to regenerative medicine therapies (including cell therapies) that are intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and have preliminary clinical evidence that indicate the drug candidate has the potential to address unmet medical needs for such disease or condition. This designation is intended to facilitate an accelerated development and review process similar to the breakthrough therapy designation. With an RMAT designation for rilparencel, ProKidney will continue to work with the FDA to receive guidance on its registrational program, including guidance on clinical trial design, manufacturing, and long-term patient follow-up, as appropriate.

 

 

About the Phase 3 REGEN-006 (PROACT 1) Clinical Trial

REGEN-006 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel in subjects with type 2 diabetes and advanced CKD. The study protocol was amended in 1H 2024 to focus on a subset of patients with stage 4 CKD (eGFR 20-30ml min/1.73m2) and late stage 3b CKD (eGFR 30-35ml min/1.73m2) with accompanying albuminuria (urine albumin-to-creatinine ratio, or UACR less than 5,000 mg/g for patients with eGFR 20-30ml min/1.73m2 and 300-5,000 mg/g for patients with eGFR 30-35ml min/1.73m2). The total planned enrollment is approximately 685 subjects. Subjects are randomized (1:1) to the treatment group and the sham control group prior to kidney biopsy or a sham biopsy procedure, respectively. Subjects in the treatment group are to receive the first rilparencel injection within 18 weeks of kidney biopsy. After three months it is intended that a second rilparencel injection be given into the contralateral kidney. Subjects in the control group, who previously underwent the sham biopsy procedure, are to receive two sham injections at similar time points as the treatment group. The primary objective is to assess the efficacy of up to two rilparencel injections using a minimally invasive percutaneous approach. The primary composite endpoint is the time from first injection to the earliest of: at least 40% reduction in eGFR; eGFR <15 mL/min/1.73m², and/or chronic dialysis, and/or renal transplant; or renal or cardiovascular death.

 

About ProKidney Corp.
ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, rilparencel (also known as REACT®), is a first-of-its-kind, patented, proprietary autologous cellular therapy being evaluated for its potential to preserve kidney function in diabetic patients at high risk of kidney failure.

 

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 beliefs that (i) rilparencel is eligible for initial FDA approval under an expedited approval pathway based upon the successful completion of the Phase 3 REGEN-006 (PROACT 1) trial, (ii) the Phase 3 REGEN-016 (PROACT 2) trial is not required for initial U.S.

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registration, and (iii) the revised Phase 3 program will accelerate estimated topline data readout and deliver topline results by Q3 2027, expectations with respect to financial results and expected cash runway, including the Company’s expectation that current cash will support operating plans into Q1 2027, 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 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 profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the risk that results of the Company’s clinical trials may not support approval; the risk that the FDA could require additional studies before approving the Company’s drug candidates; 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 fact that interim results from our clinical programs may not be indicative of future results; the impact of geo-political conflict 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.

 

Investor Contacts:

 

ProKidney

Ethan Holdaway

Ethan.Holdaway@prokidney.com

LifeSci Advisors, LLC
Daniel Ferry
Daniel@lifesciadvisors.com

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v3.24.2.u1

Document And Entity Information	Aug. 22, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 03, 2024
Entity Registrant Name	PROKIDNEY CORP.
Entity Central Index Key	0001850270
Entity Emerging Growth Company	true
Entity File Number	001-40560
Entity Incorporation, State or Country Code	E9
Entity Tax Identification Number	98-1586514
Entity Address, Address Line One	2000 Frontis Plaza Blvd.
Entity Address, Address Line Two	Suite 250
Entity Address, City or Town	Winston-Salem
Entity Address, State or Province	NC
Entity Address, Postal Zip Code	27103
City Area Code	336
Local Phone Number	999-7019
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Ex Transition Period	false
Title of 12(b) Security	Class A ordinary shares, $0.0001 par value per share
Trading Symbol	PROK
Security Exchange Name	NASDAQ

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