-- Full results from the Phase 2 REGEN-007 study of rilparencel were
recently presented as a late-breaking clinical trial at the American
Society of Nephrology (ASN) Kidney Week 2025
-- More than half of the patients required for the Phase 3 REGEN-006 (PROACT
1) accelerated approval analysis using estimated glomerular filtration
rate (eGFR) slope have been enrolled; topline results anticipated in Q2
2027
-- Ended the third quarter with $272 million in cash and cash equivalents
and marketable securities, supporting operations into mid-2027
WINSTON-SALEM, N.C., Nov. 10, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) ("ProKidney" or the "Company"), a leading late clinical-stage cell therapy company focused on chronic kidney disease (CKD), today reported financial results for the third quarter ended September 30, 2025, and provided regulatory and clinical updates.
"The Phase 2 REGEN-007 full results recently presented at ASN Kidney Week further strengthen the body of evidence supporting our ongoing Phase 3 PROACT 1 study and underscore the potential of rilparencel to become a novel treatment option for patients with advanced CKD and diabetes," said Bruce Culleton, M.D., Chief Executive Officer of ProKidney. "In Group 1, which mirrored the dosing regimen being evaluated in the ongoing Phase 3 PROACT 1 study, treatment with rilparencel led to statistically significant and clinically meaningful stabilization of kidney function. Notably, 63% of Group 1 patients met the key PROACT 1 inclusion criteria, and similar efficacy was observed in this subgroup compared to the overall Group 1 results. We remain focused on the continued execution of PROACT 1 to bring a potential new treatment option to patients with advanced CKD and diabetes at high risk of kidney failure, an area of significant unmet need."
Phase 2 REGEN-007 Full Results Recently Presented at ASN Kidney Week 2025
On November 6, 2025, ProKidney presented full results from the Phase 2 REGEN-007 study evaluating rilparencel in patients with advanced CKD and diabetes. The data, featured in a late-breaking clinical trials presentation, further demonstrate the potential of rilparencel to preserve kidney function in patients with advanced CKD and diabetes who are at high risk of kidney failure. Highlights include:
-- In Group 1 (n=24), bilateral kidney injection with rilparencel resulted
in a 4.6 mL/min/1.73m2 improvement in the annual decline in eGFR slope;
this 78% improvement was statistically significant and clinically
meaningful (p<0.001)
-- Among Group 1 patients, 15 of 24 (63%) met key Phase 3 PROACT 1 inclusion
criteria; in this subgroup, bilateral kidney injection resulted in a 5.5
mL/min/1.73m2 improvement in the annual decline in eGFR slope; this 85%
improvement was statistically significant and clinically meaningful
(p=0.005)
-- Post-hoc analysis of patient subgroups on standard-of-care $(SOC)$
medications, including sodium-glucose cotransporter-2 inhibitors (SGLT2i)
and glucagon-like peptide-1 receptor agonists (GLP-1 RA), suggest
rilparencel had a treatment effect incremental to that observed with SOC
-- Rilparencel was well tolerated and had an acceptable safety profile
Phase 3 PROACT 1 Registrational Program Update: Alignment Achieved with FDA on Accelerated Path
In a July 2025 Type B meeting, the U.S. Food and Drug Administration (FDA) confirmed that eGFR slope in patients from the ongoing Phase 3 PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Application (BLA) submission of rilparencel under the accelerated approval pathway. The FDA also confirmed that PROACT 1 may be used to support both accelerated and confirmatory approval of rilparencel. ProKidney continues to maintain its ongoing dialogue with the FDA under rilparencel's regenerative medicine advanced therapy (RMAT) designation. More than half of the approximately 360 patients required for the accelerated approval analysis using eGFR slope had been enrolled as of August 2025. Topline data readout to support an application for accelerated approval is anticipated in Q2 2027. Rilparencel is the only cell therapy in a Phase 3 clinical study for the treatment of CKD and type 2 diabetes.
Third Quarter 2025 Financial Highlights
Liquidity: Cash, cash equivalents and marketable securities as of September 30, 2025, totaled $271.7 million, compared to $358.3 million on December 31, 2024. ProKidney expects that its existing cash, cash equivalents and marketable securities held on September 30, 2025, will enable the Company to fund its operating expenses and capital expenditure requirements into mid-2027.
R&D Expenses: Research and development expenses were $26.8 million for the three months ended September 30, 2025, compared to $31.3 million for the same period in 2024. The decrease of $4.4 million was driven primarily by decreases in costs for clinical operations of approximately $4.2 million driven by the wind down of activities related to REGEN-016 and our other clinical trials that have been completed or terminated. Additionally, the Company has seen decreases in spending on manufacturing process development and professional fees of approximately $1.5 million and $0.9 million, respectively. These decreases have been partially offset by increases in equity and cash compensation costs of approximately $1.4 million as the Company continues to hire additional personnel to support our operations and increases in materials costs of $1.2 million to support the Phase 3 clinical program.
G&A Expenses: General and administrative expenses were $11.9 million for the three months ended September 30, 2025, compared to $17.7 million for the same period in 2024. The decrease of $5.8 million has been primarily driven by the decrease in the amount of non-cash impairment charges of $5.0 million related to the Greensboro facility and decreases in cash and equity compensation of approximately $1.9 million. These increases have been partially offset by increases in professional fees of approximately $0.8 million.
Net Loss Before Noncontrolling Interest: Net loss before noncontrolling interest was $35.8 million and $41.1 million for the three months ended September 30, 2025 and 2024, respectively.
Shares outstanding: Class A and Class B common stock outstanding as of September 30, 2025 totaled 295,266,876.
About Chronic Kidney Disease
CKD is a progressive condition characterized by the gradual decline of kidney function, which can ultimately lead to end-stage kidney disease (ESKD) requiring dialysis or transplantation. An estimated 37 million adults in the U.S. have CKD, though many remain undiagnosed in the early stages. Diabetes is the leading cause of CKD, and individuals with both conditions face significantly elevated risks of cardiovascular events, hospitalization, and mortality. ProKidney is developing rilparencel for patients with Stage 3b/4 CKD and diabetes, a population that includes 1 to 2 million people in the U.S. While current treatment options aim to slow disease progression, there remains a substantial unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in patients with advanced CKD.
About the Phase 2 REGEN-007 Clinical Trial
REGEN-007 was a multi-center Phase 2 open-label 1:1 randomized two-armed trial in patients with diabetes and CKD who have an eGFR of 20-50 mL/min/1.73m(2). At randomization, patients were assigned to one of two treatment groups using different dosing regimens. Group 1 replicated the dosing schedule of the ongoing Phase 3 PROACT 1 study in which patients received two scheduled rilparencel injections (one in each kidney), approximately three months apart. Group 2 tested an exploratory dosing regimen to investigate whether disease progression triggers, rather than a time-based trigger, could optimize multiple administrations of rilparencel. In Group 2, patients received a single rilparencel injection in one kidney and a second injection in the contralateral kidney only if triggered by a sustained eGFR decline from baseline of >= 20%, and/or an increase of >= 30% and >= 30 mg/g in the urine albumin to creatinine ratio (UACR) from baseline. The purpose of this study was to assess the safety, efficacy, and durability of up to two rilparencel injections on renal function progression.
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 advanced CKD and type 2 diabetes. The study protocol was amended in 1H 2024 to focus on a subset of patients with Stage 4 CKD (eGFR 20-30 mL/min/1.73m(2) ) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m(2) ) with accompanying albuminuria (UACR less than 5,000 mg/g for patients with eGFR 20-30 mL/min/1.73m(2) and 300-5,000 mg/g for patients with eGFR 30-35 mL/min/1.73m(2) ). 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. The primary objective is to assess the efficacy of up to two rilparencel injections (one in each kidney) using a minimally invasive percutaneous approach. The surrogate endpoint for accelerated approval is eGFR slope, and the primary composite endpoint is the time from first injection to the earliest of: at least 40% reduction in eGFR; eGFR <15 mL/min/1.73m(2), and/or chronic dialysis, and/or renal transplant; or renal or cardiovascular death.
About ProKidney Corp.
ProKidney, a pioneer in the treatment of CKD through innovations in cell therapy, was founded in 2015 after a decade of research. ProKidney's lead product candidate, rilparencel (also known as REACT(R)), is a first-in-class, patented, proprietary autologous cell therapy with regenerative medicine advanced therapy designation that is being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) study for its potential to preserve kidney function in patients with advanced CKD and type 2 diabetes. 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 beliefs that its Phase 3 REGEN-006 (PROACT 1) trial could be sufficient to support a potential BLA submission and full regulatory approval, eGFR slope can be used as a surrogate endpoint on an accelerated approval pathway for rilparencel, expectations with respect to financial results and expected cash runway, including the Company's expectation that current cash will support operating plans into mid-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: disruptions to our business or that may otherwise materially harm our results of operations or financial condition as a result of our recent domestication to the United States; the inability to maintain the listing of the Company's Class A common stock on Nasdaq; the inability of the Company's Class A common stock to remain included in various indices and the potential negative impact on the trading price of the Class A common stock if excluded from such indices; 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.
ProKidney Contact
Ethan Holdaway
Ethan.Holdaway@prokidney.com
Media Contact
Audra Friis
audrafriis@sambrown.com
Investor Relations Contact
Daniel Ferry
Daniel@lifesciadvisors.com
ProKidney Corp. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except for share data)(1)
September 30, 2025 December 31, 2024
(Unaudited)
-------------------- -------------------
Assets
Cash and cash
equivalents $ 95,323 $ 99,120
Marketable securities 176,402 259,172
Interest receivable 1,237 2,447
Prepaid assets 3,516 4,192
Prepaid clinical 4,351 11,505
Assets held for sale 19,050 19,368
Other current assets 110 80
---------------- ---------------
Total current assets 299,989 395,884
Fixed assets, net 47,754 42,222
Right of use assets, net 3,865 2,967
Total assets $ 351,608 $ 441,073
================ ===============
Liabilities and
Stockholders' Deficit
Accounts payable $ 1,942 $ 3,633
Lease liabilities 991 765
Accrued expenses and
other 26,068 31,137
Income taxes payable 62 682
---------------- ---------------
Total current
liabilities 29,063 36,217
Income tax payable, net of
current portion 962 748
Lease liabilities, net of
current portion 3,245 2,471
---------------- ---------------
Total liabilities 33,270 39,436
Commitments and
contingencies
Redeemable noncontrolling
interest 1,326,358 1,396,591
Stockholders' deficit
Class A common stock,
$0.0001 par value;
700,000,000 and
500,000,000 shares
authorized as of September
30, 2025 and December 31,
2024, respectively;
135,977,945 and
128,054,417 shares issued
and outstanding as of
September 30, 2025 and
December 31, 2024,
respectively 14 13
Class B common stock,
$0.0001 par value;
500,000,000 shares
authorized; 159,288,931
and 163,693,707 shares
issued and outstanding as
of September 30, 2025 and
December 31, 2024,
respectively 16 16
Additional paid-in capital 242,480 205,736
Accumulated other
comprehensive gain 74 130
Accumulated deficit (1,250,604) (1,200,849)
---------------- ---------------
Total stockholders' deficit (1,008,020) (994,954)
---------------- ---------------
Total liabilities and
stockholders' deficit $ 351,608 $ 441,073
================ ===============
________________________
(1 For presentation purposes, unless otherwise noted, "ordinary shares" before the domestication and "common stock" subsequent to the domestication are referred to herein as common stock)
ProKidney Corp. and Subsidiaries
Consolidated Statements of Operations - Unaudited
(in thousands, except for share and per share data)(2)
Three Months Ended Nine Months Ended
September 30, September 30,
2025 2024 2025 2024
------------ ------------ ------------ -----------
Revenue $ 217 $ -- $ 668 $ --
Operating expenses
Research and
development 26,821 31,250 79,966 87,887
General and
administrative 11,935 17,723 40,338 44,218
----------- ----------- ----------- ----------
Total operating
expenses 38,756 48,973 120,304 132,105
----------- ----------- ----------- ----------
Operating loss (38,539) (48,973) (119,636) (132,105)
Other income
(expense):
Interest income 3,258 5,580 10,878 14,960
Interest expense (2) (2) (3) (7)
----------- ----------- ----------- ----------
Net loss
before income
taxes (35,283) (43,395) (108,761) (117,152)
Income tax expense
(benefit) 560 (2,342) 1,999 (2,300)
----------- ----------- ----------- ----------
Net loss before
noncontrolling
interest (35,843) (41,053) (110,760) (114,852)
----------- ----------- ----------- ----------
Net loss
attributable to
noncontrolling
interest (19,374) (23,143) (61,005) (74,944)
----------- ----------- ----------- ----------
Net loss available
to Class A common
stockholders $ (16,469) $ (17,910) $ (49,755) $ (39,908)
=========== =========== =========== ==========
Weighted average
shares of Class A
common stock
outstanding:
Basic and
diluted 134,992,796 126,173,463 131,588,705 87,818,229
Net loss per share
attributable to
Class A common
stock:
Basic and
diluted $ (0.12) $ (0.14) $ (0.38) $ (0.45)
=========== =========== =========== ==========
________________________
(2 For presentation purposes, unless otherwise noted, "ordinary shares" before the domestication and "common stock" subsequent to the domestication are referred to herein as common stock.)
ProKidney Corp. and Subsidiaries
Consolidated Statements of Cash Flows - Unaudited
(in thousands)(3)
Nine Months Ended
September 30,
2025 2024
--------- ---------
Cash flows from operating activities
Net loss before noncontrolling interest $(110,760) $(114,852)
Adjustments to reconcile net loss before
noncontrolling interest to net cash flows
used in operating activities:
Depreciation and amortization 4,738 3,858
Equity-based compensation 19,633 22,424
Gain on marketable securities, net (2,674) (5,521)
Loss on lease disposition 143 --
Impairment of long-lived assets 318 5,324
Loss on disposal of equipment 474 186
Changes in operating assets and
liabilities
Interest receivable 1,210 (3,728)
Prepaid and other assets 7,795 (8,489)
Accounts payable and accrued
expenses (8,075) (114)
Income taxes payable (406) (1,268)
-------- --------
Net cash flows used in operating
activities (87,604) (102,180)
Cash flows from investing activities
Purchases of marketable securities (176,676) (277,291)
Sales and maturities of marketable
securities 261,992 286,625
Purchase of equipment and facility
expansion (9,444) (4,000)
-------- --------
Net cash flows provided by investing
activities 75,872 5,334
Cash flows from financing activities
Proceeds from sales of Class A common
stock, net of offering costs 7,102 144,325
Payments on finance leases (21) (40)
Exercise of stock options 854 --
Net cash flows provided by financing
activities 7,935 144,285
Net change in cash and cash equivalents (3,797) 47,439
Cash, beginning of period 99,120 60,649
-------- --------
Cash, end of period $ 95,323 $ 108,088
======== ========
Supplemental disclosure of non-cash
investing and financing activities:
Right of use assets obtained in exchange
for lease obligations $ 2,005 $ 2,621
======== ========
Exchange of Class B common stock $ 5,252 $ 15,357
======== ========
Impact of equity transactions and
compensation on redeemable
noncontrolling interest $ 3,903 $ 18,748
======== ========
Equipment and facility expansion
included in accounts payable and
accrued expenses $ 835 $ 910
======== ========
________________________
(3 For presentation purposes, unless otherwise noted, "ordinary shares" before the domestication and "common stock" subsequent to the domestication are referred to herein as common stock.)
(END) Dow Jones Newswires
November 10, 2025 16:15 ET (21:15 GMT)