ProKidney Reports Third Quarter 2026 Financial Results and Business Highlights

Rhea-AI Summary

ProKidney (Nasdaq: PROK) reported third-quarter financial results and maintained its target for pivotal Phase 3 rilparencel results in Q2 2027.

The PROACT 1 readout will assess the rate of change in estimated kidney filtration, with approximately 320 patients expected in the efficacy analysis. ProKidney anticipates full enrollment for the confirmatory analysis in Q1 2027 with over 500 patients, up from 470; confirmatory results are expected in 2H 2029.

Third-quarter net loss before noncontrolling interest widened to $51.793 million from $35.843 million a year earlier. Research and development expenses rose to $40.845 million from $26.821 million. Cash, cash equivalents and marketable securities totaled $141.9 million, versus $181.6 million at June 30, 2026. The company expects funding to support operations into mid-2027.

6 points · 0 major

NegativeiHow this balance works

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It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

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2 major · 13 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.PROACT 1 kidney-filtration slope results remain targeted for Q2 2027, with approximately 320 patients expected in the efficacy analysis.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Existing liquidity is expected to support operations into mid-2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.PROACT 1 confirmatory enrollment is expected to finish in Q1 2027, exceeding 500 patients versus 470 previously.
• Minor point. Forward-looking: it has not happened yet and may not happen.PROACT 1 confirmatory endpoint results are expected in 2H 2029.
• Minor pointNine-month general and administrative expenses declined to $36.832 million from $40.338 million a year earlier.
• Minor pointThird-quarter income taxes shifted to a $436,000 benefit from a $560,000 expense a year earlier.

Negative

• Major pointThird-quarter net loss before noncontrolling interest widened to $51.793 million from $35.843 million a year earlier.
• Major pointNine-month operating cash use increased to $120.709 million from $87.604 million a year earlier.
• Moderate pointCash, cash equivalents and marketable securities fell to $141.9 million from $181.6 million at June 30, 2026.
• Minor pointThird-quarter Class A loss per share widened to $0.17 from $0.12 a year earlier.
• Minor pointThird-quarter research and development expenses rose to $40.845 million from $26.821 million a year earlier.

8 minor points

• Minor pointThird-quarter general and administrative expenses rose to $13.087 million from $11.935 million a year earlier.
• Minor pointThird-quarter revenue declined to $174,000 from $217,000 a year earlier.
• Minor pointThird-quarter interest income declined to $1.530 million from $3.258 million a year earlier.
• Minor pointNine-month net loss before noncontrolling interest widened to $140.850 million from $110.760 million a year earlier.
• Minor pointNine-month Class A loss per share widened to $0.47 from $0.38 a year earlier.
• Minor pointNine-month research and development expenses rose to $110.782 million from $79.966 million a year earlier.
• Minor pointNine-month revenue declined to $550,000 from $668,000 a year earlier.
• Minor pointNine-month interest income declined to $5.795 million from $10.878 million a year earlier.

Key Figures

Cash and marketable securities: $141.9 million R&D expenses: $40.8 million Net loss before noncontrolling interest: $51.8 million +4 more

Cash and marketable securities

$141.9 million

As of September 30, 2026; compared with $181.6 million at June 30, 2026

R&D expenses

$40.8 million

Third quarter 2026; compared with $26.8 million in the third quarter of 2025

Net loss before noncontrolling interest

$51.8 million

Third quarter 2026; compared with $35.8 million in the third quarter of 2025

Efficacy analysis set

Approximately 320 patients

Phase 3 PROACT 1 surrogate endpoint analysis

Expected total enrollment

Over 500 patients

PROACT 1 confirmatory analysis; full enrollment expected in Q1 2027

Surrogate endpoint topline results

Q2 2027

Phase 3 PROACT 1 eGFR slope

Confirmatory endpoint topline readout

2H 2029

PROACT 1 composite time-to-event endpoint

Previous Earnings Reports

1 past event · Latest: Aug 10

Same Type 1 event

1. Aug 10

   2Q26 earnings

   24h Move

   -4.7%

   Set confirmatory enrollment at approximately 470, with Q2 2027 efficacy data and 2H 2029 confirmation expected.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

egfr slope, uacr, sham-controlled, albuminuria

4 terms

egfr slope medical

"pivotal Phase 3 PROACT 1 surrogate endpoint (eGFR slope) topline results"

The eGFR slope measures how quickly kidney function changes over time, calculated by tracking estimated kidney filtration rates across multiple tests. For investors, it provides insight into the progression of kidney health, which can impact the development and valuation of related healthcare products or treatments. A faster decline may signal worsening health, potentially affecting a company's long-term prospects in medical research or drug development.

uacr medical

"with accompanying albuminuria (UACR less than 5,000 mg/g"

UACR is a lab measure that compares the amount of albumin (a blood protein) found in urine to the amount of creatinine, and it indicates how much protein is leaking from the kidneys. Investors watch UACR because rising or falling values act like a car’s warning light for kidney damage — changes can show whether a therapy is working or a disease is progressing, which influences clinical trial outcomes, regulatory decisions and company value.

sham-controlled medical

"randomized, blinded, sham-controlled safety and efficacy study"

A sham-controlled trial compares a real medical procedure or device to a fake version that looks and feels the same but has no therapeutic effect, much like a sugar pill for surgery or implants. For investors, sham control is a sign of rigorous testing because it helps separate true treatment benefits from placebo effects or patient expectations, making clinical results and regulatory prospects more reliable when assessing commercial potential.

albuminuria medical

"with accompanying albuminuria (UACR less than 5,000 mg/g"

Albuminuria is the presence of the blood protein albumin in a person’s urine, which usually indicates the kidneys are leaking and not filtering blood properly. Investors watch it because changes in albuminuria are a common clinical signal used to judge kidney disease progression and treatment effectiveness—similar to spotting oil in a car’s coolant, it flags a malfunction and can affect the market for drugs, diagnostics, and health-related revenue streams.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• On track to deliver pivotal Phase 3 PROACT 1 surrogate endpoint (eGFR slope) topline results in Q2 2027
• Anticipate completing full enrollment for the PROACT 1 confirmatory analysis in Q1 2027 with over 500 patients, up from 470, driven by accelerated patient recruitment in mid-2026
• Presented eight abstracts at ASN Kidney Week 2026, with new data further strengthening the mechanistic and clinical evidence supporting rilparencel; subsequently hosted a KOL event recapping key ASN findings and rilparencel’s potential role in advanced CKD and type 2 diabetes
• Ended the third quarter with $142 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027

WINSTON-SALEM, N.C., Nov. 12, 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 third quarter ended September 30, 2026 and provided business highlights and upcoming milestones.

“The third quarter marked continued progress for ProKidney, with PROACT 1 advancing toward full enrollment and our pivotal eGFR slope topline readout remaining on track for the second quarter of 2027,” said Bruce Culleton, M.D., CEO of ProKidney. “The data presented at Kidney Week further build the mechanistic and clinical evidence supporting rilparencel and provide a more cohesive picture of how it may stabilize kidney function. Together, these advances reinforce our confidence as we approach this important Phase 3 readout and continue our mission to transform the treatment of advanced CKD.”

Business Highlights

Phase 3 REGEN-006 (PROACT 1) Study

• On track to deliver pivotal Phase 3 PROACT 1 surrogate endpoint (eGFR slope) topline results in Q2 2027; the efficacy analysis set is expected to include approximately 320 patients
• Anticipate completing full enrollment for the PROACT 1 confirmatory analysis in Q1 2027 with over 500 patients, up from 470, driven by an acceleration in patient recruitment in mid-2026; the confirmatory endpoint (composite time-to-event) topline readout is expected in 2H 2029

American Society of Nephrology (ASN) Kidney Week 2026

• Presented eight abstracts with new data further strengthening the mechanistic and clinical evidence supporting rilparencel, including seven abstracts spanning CKD translational models and drug product characterization and one pooled Phase 2 clinical analysis
• Following ASN Kidney Week, hosted a virtual KOL event with nephrology leader and researcher Katherine Tuttle, M.D., to discuss key mechanism of action findings, the remaining unmet need in advanced CKD and type 2 diabetes, and rilparencel’s potential role within the evolving treatment paradigm
• A replay of the virtual KOL event is available in the Events & Presentations section of the Company’s website
  
  

Third Quarter 2026 Financial Highlights

Liquidity: Cash, cash equivalents and marketable securities as of September 30, 2026, totaled $141.9 million, compared to $181.6 million as of June 30, 2026.

R&D Expenses: Research and development expenses were $40.8 million for the three months ended September 30, 2026, compared to $26.8 million for the same period in 2025. The increase of $14.0 million was driven by increases in clinical study and related manufacturing costs of $7.4 million, primarily related to the Company’s ongoing PROACT 1 study. Additionally, professional fees and other operational costs increased $1.3 million and $3.5 million, respectively, due to continued enrollment, ongoing activities and preparation for regulatory filings. Finally, compensation costs increased by approximately $1.8 million related to the hiring of additional personnel.

G&A Expenses: General and administrative expenses were $13.1 million for the three months ended September 30, 2026, compared to $11.9 million for the same period in 2025. The increase of $1.2 million was primarily driven by a $1.7 million increase in compensation costs related to the hiring of additional personnel, partially offset by decreases in professional fees and impairment charges.

Net Loss Before Noncontrolling Interest: Net loss before noncontrolling interest was $51.8 million and $35.8 million for the three months ended September 30, 2026 and 2025, respectively.

Shares outstanding: Class A and Class B common stock outstanding at September 30, 2026, totaled 302,371,200.

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 one 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 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 Company now expects total enrollment of over 500 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/1.73m², 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^®), 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, the Company’s belief that 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, cash equivalents and marketable securities will support operating plans into mid-2027, the Company’s ability to continue as a going concern, future performance, development, manufacturing, 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. These statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with: disruptions to the Company’s business or that may otherwise materially harm its results of operations or financial condition as a result of its 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 Company’s need for additional financing and 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 the 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 the Company’s clinical programs may not be indicative of future results; the impact of geopolitical 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)

	September 30, 2026				December 31, 2025
	(Unaudited)
Assets
Cash and cash equivalents	$	81,355			$	108,537
Marketable securities		60,509				161,480
Interest receivable		626				1,127
Prepaid assets		3,977				2,808
Prepaid clinical		3,737				3,923
Other current assets		1,247				2,804
Total current assets		151,451				280,679
Fixed assets, net		55,815				51,231
Right of use assets, net		3,013				3,664
Total assets	$	210,279			$	335,574
Liabilities and Stockholders' Deficit
Accounts payable	$	2,521			$	940
Lease liabilities		1,109				1,071
Accrued expenses and other		26,408				28,731
Total current liabilities		30,038				30,742
Income tax payable, net of current portion		1,122				1,074
Lease liabilities, net of current portion		2,144				2,965
Total liabilities		33,304				34,781
Commitments and contingencies
Redeemable noncontrolling interest		1,083,826				1,311,990
Stockholders’ deficit
Class A common stock, $0.0001 par value; 700,000,000 shares authorized as of September 30, 2026 and December 31, 2025; 208,975,486 and 141,807,277 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively		21				14
Class B common stock, $0.0001 par value; 500,000,000 shares authorized; 93,395,714 and 159,262,779 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively		10				16
Additional paid-in capital		447,041				258,552
Accumulated other comprehensive (loss) gain		(37	)			56
Accumulated deficit		(1,353,886	)			(1,269,835	)
Total stockholders' deficit		(906,851	)			(1,011,197	)
Total liabilities and stockholders' deficit	$	210,279			$	335,574

ProKidney Corp. and Subsidiaries
Consolidated Statements of Operations - Unaudited
(in thousands, except for share and per share data)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Revenue		$	174			$	217			$	550			$	668
Operating expenses
Research and development			40,845				26,821				110,782				79,966
General and administrative			13,087				11,935				36,832				40,338
Total operating expenses			53,932				38,756				147,614				120,304
Operating loss			(53,758	)			(38,539	)			(147,064	)			(119,636	)
Other income (expense):
Interest income			1,530				3,258				5,795				10,878
Interest expense			(1	)			(2	)			(17	)			(3	)
Net loss before income taxes			(52,229	)			(35,283	)			(141,286	)			(108,761	)
Income tax (benefit) expense			(436	)			560				(436	)			1,999
Net loss before noncontrolling interest			(51,793	)			(35,843	)			(140,850	)			(110,760	)
Net loss attributable to noncontrolling interest			(16,201	)			(19,374	)			(56,799	)			(61,005	)
Net loss available to Class A common stockholders		$	(35,592	)		$	(16,469	)		$	(84,051	)		$	(49,755	)
Weighted average shares of Class A common stock outstanding:
Basic and diluted			207,760,422				134,992,796				178,989,995				131,588,705
Net loss per share attributable to Class A common stock:
Basic and diluted		$	(0.17	)		$	(0.12	)		$	(0.47	)		$	(0.38	)

ProKidney Corp. and Subsidiaries
Consolidated Statements of Cash Flows – Unaudited
(in thousands)

		Nine Months Ended September 30,
		2026				2025
Cash flows from operating activities
Net loss before noncontrolling interest		$	(140,850	)		$	(110,760	)
Adjustments to reconcile net loss before noncontrolling interest to net cash flows used in operating activities:
Depreciation and amortization			5,009				4,738
Equity-based compensation			16,420				19,633
Gain on marketable securities, net			(811	)			(2,674	)
Loss on lease disposition			–				143
Impairment of long-lived assets			–				318
Loss on disposal of equipment			50				474
Changes in operating assets and liabilities
Interest receivable			501				1,210
Prepaid and other assets			575				7,795
Accounts payable and accrued expenses			(1,654	)			(8,075	)
Income taxes payable			51				(406	)
Net cash flows used in operating activities			(120,709	)			(87,604	)
Cash flows from investing activities
Purchases of marketable securities			(76,789	)			(176,676	)
Sales and maturities of marketable securities			178,364				261,992
Purchase of equipment and facility expansion			(8,852	)			(9,444	)
Net cash flows provided by investing activities			92,723				75,872
Cash flows from financing activities
Proceeds from sales of Class A common stock, net of offering costs			7				7,102
Payments on finance leases			(12	)			(21	)
Exercise of stock options			809				854
Net cash flows provided by financing activities			804				7,935
Net change in cash and cash equivalents			(27,182	)			(3,797	)
Cash, beginning of period			108,537				99,120
Cash, end of period		$	81,355			$	95,323
Supplemental disclosure of non-cash investing and financing activities:
Right of use assets obtained in exchange for lease obligations		$	–			$	2,005
Exchange of Class B common stock		$	130,007			$	5,252
Impact of equity transactions and compensation on redeemable noncontrolling interest		$	41,245			$	3,903
Equipment and facility expansion included in accounts payable and accrued expenses		$	140			$	835

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does ProKidney expect PROACT 1 Phase 3 results?

ProKidney expects the PROACT 1 kidney-filtration slope results in Q2 2027 and confirmatory composite time-to-event results in 2H 2029. Approximately 320 patients are expected in the efficacy analysis for the earlier readout.

Why did ProKidney's third-quarter 2026 research and development expenses increase?

Research and development expenses increased primarily because of higher clinical study and related manufacturing costs, principally for PROACT 1. Those costs increased $7.4 million. Professional fees increased $1.3 million, other operational costs increased $3.5 million, and compensation costs increased approximately $1.8 million as additional personnel were hired.

What does ProKidney's PROACT 1 confirmatory endpoint measure?

The confirmatory endpoint measures time from first injection to the earliest qualifying kidney or cardiovascular event: at least 40% reduction in estimated kidney filtration; filtration below 15 mL/min/1.73m², chronic dialysis or renal transplant; or renal or cardiovascular death. Participants are randomized 1:1 to rilparencel treatment or a sham control group.