ProKidney Reports Full Year 2025 Financial Results and Business Highlights
Rhea-AI Summary
ProKidney (Nasdaq: PROK) reported full-year 2025 results and business highlights on March 18, 2026. Key points: $270.0M cash and marketable securities at year-end; positive Phase 2 REGEN-007 data; FDA alignment on an accelerated approval pathway using eGFR slope; Phase 3 PROACT 1 enrollment accelerating with pivotal readout expected Q2 2027.
Management expects existing cash to fund operations into mid-2027 and plans BLA submission in Q4 2027 with potential approval and commercial launch in 2H 2028.
Positive
- $270.0M cash and marketable securities at December 31, 2025
- FDA alignment on eGFR slope as surrogate for accelerated approval
- Positive Phase 2 REGEN-007 results presented and peer-reviewed in CJASN
- Phase 3 PROACT 1 enrollment momentum toward pivotal readout in Q2 2027
- Expanded in-house manufacturing footprint: 180,000 sq ft in Winston-Salem
Negative
- Cash decreased 24.7% from $358.3M to $270.0M year-over-year
- Cash runway explicitly extends only into mid-2027, financing risk thereafter
- Accelerated approval relies on surrogate endpoint, requiring confirmatory data by 2029
News Market Reaction – PROK
In the Mar 19 session, PROK declined 6.25%, reflecting a notable negative market reaction. Argus tracked a trough of -6.0% from its starting point during tracking. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Nov 10 | Q3 2025 earnings | Positive | +3.7% | Q3 2025 results, strong REGEN-007 data and FDA surrogate endpoint agreement. |
| Aug 12 | Q2 2025 earnings | Positive | +5.8% | Q2 2025 results, FDA confirmation of eGFR slope and solid cash balance. |
| May 12 | Q1 2025 earnings | Positive | +15.8% | Q1 2025 results with clear runway and upcoming Phase 2 data milestones. |
| Mar 17 | FY 2024 results | Positive | +5.7% | Full-year 2024 results, higher R&D to advance rilparencel and FDA pathway clarity. |
| Aug 09 | Q2 2024 earnings | Positive | +4.3% | Q2 2024 results, interim REGEN-007 data and resumed Phase 3 programs. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings and financial update releases have consistently been followed by positive price reactions, suggesting investors have historically rewarded this news type.
Over the past two years, ProKidney’s earnings and financial updates have combined pipeline progress on rilparencel with detailed cash runway disclosures. Prior reports highlighted FDA acceptance of eGFR slope for accelerated approval, steady Phase 3 PROACT 1 enrollment, and cash balances projected to fund operations into mid-2027. These updates typically coincided with narrower losses or disciplined R&D and G&A spending. Today’s full-year 2025 results continue that pattern of pairing clinical momentum with a reinforced liquidity outlook.
Key Terms
phase 3 medical
egfr slope medical
surrogate endpoint regulatory
biologics license application (bla) regulatory
accelerated approval regulatory
regenerative medicine advanced therapy (rmat) designation regulatory
composite time-to-event medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss Before Noncontrolling Interest: Net loss before noncontrolling interest was
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/1.73m². 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 ≥
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/1.73m2) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m2) with accompanying albuminuria (UACR less than 5,000 mg/g for patients with eGFR 20-30 mL/min/1.73m2 and 300-5,000 mg/g for patients with eGFR 30-35 mL/min/1.73m2). 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
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®), 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, | 14 | 13 | ||||||
| Class B common stock, | 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 | ||||||
