-- On track to complete enrollment for the Phase 3 PROACT 1 accelerated
approval analysis of rilparencel in mid-2026; anticipate pivotal topline
results in Q2 2027
-- In a July 2025 Type B meeting, aligned with FDA on the accelerated
approval pathway for rilparencel using eGFR slope as the surrogate
endpoint
-- Presented positive results from the Phase 2 REGEN-007 study of
rilparencel as a late-breaking clinical trial at ASN Kidney Week 2025
followed by a peer-reviewed publication in CJASN
-- Ended 2025 with $270.0 million in cash and cash equivalents and
marketable securities, supporting operations into mid-2027
WINSTON-SALEM, N.C., March 18, 2026 (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 full year ended December 31, 2025, and provided business highlights.
"2025 was a pivotal year for ProKidney, highlighted by positive Phase 2 REGEN-007 study results, alignment with the FDA on the accelerated approval pathway for rilparencel, and significant enrollment momentum in the Phase 3 PROACT 1 study," said Bruce Culleton, M.D., CEO of ProKidney. "Looking ahead, we are well positioned to deliver on key upcoming milestones, including completion of enrollment for the Phase 3 PROACT 1 study this year followed by pivotal eGFR slope data in the second quarter of 2027. Our mission remains highly focused on bringing a potential new treatment option to patients with advanced CKD and diabetes at high risk of kidney failure -- an area of high unmet medical need."
Key Accomplishments in 2025
-- Generated significant enrollment momentum in the Phase 3 PROACT 1 study,
positioning the Company for a pivotal topline readout in Q2 2027 using
eGFR slope.
-- Confirmed with the U.S. Food and Drug Administration (FDA) in a July 2025
Type B meeting 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. 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.
-- Presented positive results from the Phase 2 REGEN-007 study of
rilparencel in patients with advanced CKD and diabetes as a late-breaking
clinical trial at the American Society of Nephrology (ASN) Kidney Week in
November 2025, followed by a peer-reviewed publication in the Clinical
Journal of the American Society of Nephrology (CJASN).
-- Initiated expansion of in-house manufacturing footprint in two adjacent,
company-owned facilities totaling 180,000 square feet in Winston-Salem,
NC.
Anticipated Upcoming Milestones
-- Mid-2026: Complete enrollment of patients to be included in the Phase 3
PROACT 1 accelerated approval efficacy analysis (n=360)
-- 2H 2026: Complete full enrollment for Phase 3 PROACT 1 confirmatory
composite time-to-event analysis (n=470)
-- Throughout FY 2026: Present results from ongoing mechanism of action
studies of rilparencel at medical and scientific conferences
-- Q2 2027: Phase 3 PROACT 1 readout of surrogate endpoint (eGFR slope) for
accelerated approval
-- Q4 2027: BLA submission of rilparencel
-- 2H 2028: BLA approval and commercial launch of rilparencel
-- 2H 2029: Phase 3 PROACT 1 topline readout of confirmatory endpoint
(composite time-to-event) for full approval
Full Year 2025 Financial Highlights
Liquidity: Cash, cash equivalents and marketable securities as of December 31, 2025, totaled $270.0 million, compared to $358.3 million as of December 31, 2024. We expect that our existing cash, cash equivalents and marketable securities held at December 31, 2025, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027.
R&D Expenses: Research and development expenses were $114.1 million for the year ended December 31, 2025, compared to $127.7 million for the year ended December 31, 2024. The decrease of $13.5 million was driven primarily by decreases in clinical study costs of $18.1 million from our clinical trials that have been completed or terminated. Additionally, operating costs have decreased $3.3 million related to the recognition of costs related to the remediation of quality management systems and processes in the 2024 period. These decreases have been offset by increases in cash and equity based compensation costs of approximately $5.5 million as we continue to hire additional personnel in the areas of clinical development, quality, manufacturing, and biostatistics to support our ongoing clinical trials. Also, clinical trial costs have increased approximately $2.4 million related to our ongoing PROACT 1 study.
G&A Expenses: General and administrative expenses were $51.8 million for the year ended December 31, 2025 compared to $56.1 million for the year ended December 31, 2024. The decrease of $4.3 million was driven primarily by decreases in impairment charges of $5.0 million related to our former facility in Greensboro, North Carolina and decreases in equity based compensation of approximately $3.4 million due to forfeitures of awards and lower fair value of recent awards. These decreases have been partially offset by increases in professional fees and other operating expenses of approximately $3.8 million driven by the domestication of our foreign subsidiaries to the U.S. in 2025 and other business initiatives.
Net Loss Before Noncontrolling Interest: Net loss before noncontrolling interest was $151.6 million and $163.3 million for the years ended December 31, 2025, and 2024, respectively.
Shares outstanding: Class A and Class B common stock outstanding at December 31, 2025, totaled 301,070,056.
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 over 1 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 470 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 achievement and timing of the topline data readout of the Company's PROACT 1 trial and other milestones provided, 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)
December 31, 2025 December 31, 2024
Assets
Cash and cash
equivalents $ 108,537 $ 99,120
Marketable securities 161,480 259,172
Interest receivable 1,127 2,447
Prepaid assets 2,808 4,192
Prepaid clinical 3,923 11,505
Assets held for sale -- 19,368
Other current assets 2,804 80
--------------- ---------------
Total current assets 280,679 395,884
Fixed assets, net 51,231 42,222
Right of use assets, net 3,664 2,967
Total assets $ 335,574 $ 441,073
=============== ===============
Liabilities and
Stockholders' Deficit
Accounts payable $ 940 $ 3,633
Lease liabilities 1,071 765
Accrued expenses and
other 28,731 31,137
Income taxes payable -- 682
--------------- ---------------
Total current
liabilities 30,742 36,217
Income tax payable, net of
current portion 1,074 748
Lease liabilities, net of
current portion 2,965 2,471
--------------- ---------------
Total liabilities 34,781 39,436
Commitments and
contingencies
Redeemable noncontrolling
interest 1,311,990 1,396,591
Stockholders' deficit
Class A common stock,
$0.0001 par value;
700,000,000 and
500,000,000 shares
authorized as of
December 31, 2025 and
December 31, 2024,
respectively;
141,807,277 and
128,054,417 shares
issued and outstanding
as of December 31, 2025
and December 31, 2024,
respectively 14 13
Class B common stock,
$0.0001 par value;
500,000,000 shares
authorized; 159,262,779
and 163,693,707 shares
issued and outstanding
as of December 31, 2025
and December 31, 2024,
respectively 16 16
Additional paid-in
capital 258,552 205,736
Accumulated other
comprehensive gain 56 130
Accumulated deficit (1,269,835) (1,200,849)
--------------- ---------------
Total stockholders'
deficit (1,011,197) (994,954)
--------------- ---------------
Total liabilities and
stockholders'
deficit $ 335,574 $ 441,073
=============== ===============
ProKidney Corp. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except for share and per share data)
2025 2024 2023
------------ ----------- -----------
Revenue $ 893 $ 76 $ --
Operating expenses
Research and
development 114,123 127,668 106,707
General and
administrative 51,777 56,084 44,815
----------- ---------- ----------
Total operating
expenses 165,900 183,752 151,522
Operating loss (165,007) (183,676) (151,522)
Other income
(expense):
Interest income 13,813 19,752 22,083
Interest expense (4) (9) (12)
----------- ---------- ----------
Net loss
before income
taxes (151,198) (163,933) (129,451)
Income tax expense
(benefit) 414 (598) 5,996
----------- ---------- ----------
Net loss before
noncontrolling
interest (151,612) (163,335) (135,447)
Net loss
attributable to
noncontrolling
interest (82,626) (102,149) (99,979)
----------- ---------- ----------
Net loss
available to
Class A common
stockholders $ (68,986) $ (61,186) $ (35,468)
=========== ========== ==========
Weighted average
shares of Class A
common stock
outstanding:
Basic and
diluted 133,942,736 97,916,193 61,714,225
Net loss per share
attributable to
Class A common
stock:
Basic and
diluted $ (0.52) $ (0.62) $ (0.57)
=========== ========== ==========
ProKidney Corp. and Subsidiaries
Consolidated Statements of Cash Flows
(in thousands)
Years Ended December 31,
2025 2024 2023
--------- --------- ---------
Cash flows from
operating activities
Net loss before
noncontrolling
interest $(151,612) $(163,335) $(135,447)
Adjustments to
reconcile net loss
before noncontrolling
interest to net cash
flows used in operating
activities:
Depreciation and
amortization 6,575 5,432 3,853
Equity-based
compensation 25,336 29,372 30,846
Gain on marketable
securities, net (3,417) (6,995) (6,018)
Loss (gain) on lease
disposition (29) (161) --
Impairment of
long-lived assets 318 5,324 --
Loss on disposal of
equipment 1,431 56 23
Changes in
operating assets
and liabilities
Interest
receivable 1,320 (1,072) (1,375)
Prepaid and other
assets 6,236 (5,955) 4,648
Accounts payable
and accrued
expenses (5,919) 11,592 11,639
Income taxes
payable (356) (609) 1,762
-------- -------- --------
Net cash flows used in
operating activities (120,117) (126,351) (90,069)
Cash flows from
investing activities
Proceeds from sale of
facility 18,215 -- --
Purchases of
marketable
securities (217,076) (324,023) (471,604)
Sales and maturities
of marketable
securities 318,022 373,946 175,818
Purchase of equipment
and facility
expansion (15,196) (29,509) (34,197)
-------- -------- --------
Net cash flows provided
by (used in) investing
activities 103,965 20,414 (329,983)
Cash flows from
financing activities
Proceeds from sales of
Class A common stock,
net of offering
costs 24,247 144,322 --
Payments on finance
leases (26) (54) (52)
Exercise of stock
options 1,348 140 --
Repurchase of Class A
common stock -- -- (9,499)
--------
Net cash flows provided
by (used in) financing
activities 25,569 144,408 (9,551)
Net change in cash and
cash equivalents 9,417 38,471 (429,603)
Cash, beginning of
period 99,120 60,649 490,252
-------- -------- --------
Cash, end of period $ 108,537 $ 99,120 $ 60,649
======== ======== ========
Supplemental disclosure
of non-cash investing
and financing
activities:
Right of use assets
obtained in exchange
for lease
obligations $ 2,005 $ 2,621 $ 2,594
======== ======== ========
Exchange of Class B
common stock $ 5,311 $ 15,442 $ 9,500
======== ======== ========
Impact of equity
transactions and
compensation on
redeemable
noncontrolling
interest $ 3,426 $ 19,448 $ 2,577
======== ======== ========
Change in redemption
value of
noncontrolling
interest $ -- $ -- $ 79
======== ======== ========
Equipment and facility
expansion included in
accounts payable and
accrued expenses $ 131 $ 347 $ 218
======== ======== ========
(END) Dow Jones Newswires
March 18, 2026 16:00 ET (20:00 GMT)
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