ProKidney Q3 Class A net loss widens to $35.6M
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
ProKidney Corp. (PROK) reported third-quarter 2026 results and updated timelines for its Phase 3 PROACT 1 trial. The company had $141.9 million in cash, cash equivalents and marketable securities at September 30, 2026, which it expects to support operating plans into mid-2027. ProKidney expects to complete enrollment of over 500 patients in Q1 2027, up from 470, with the efficacy analysis set expected to include approximately 320 patients. Pivotal eGFR slope topline results remain on track for Q2 2027; the confirmatory composite time-to-event readout is expected in 2H 2029.
Third-quarter revenue was $174,000, versus $217,000 a year earlier. Research and development expenses were $40.845 million, compared with $26.821 million; general and administrative expenses were $13.087 million, compared with $11.935 million. Net loss available to Class A common stockholders was $35.592 million, compared with $16.469 million. Nine-month net cash used in operating activities was $120.709 million, versus $87.604 million in 2025.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
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.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- None.
Negative
- Moderate pointNet loss available to Class A common stockholders was $35.592 million, versus $16.469 million.
- Moderate pointNine-month operating cash use was $120.709 million, versus $87.604 million.
- Minor pointQuarterly revenue was $174,000, versus $217,000 a year earlier.
Filing Explained
The quarter-end balance sheet shows a shift in reported share classes: at
8-K Event Classification
Key Figures
Key Terms
eGFR slope medical
sham-controlled medical
composite time-to-event medical
albuminuria medical
autologous cell therapy medical
regenerative medicine advanced therapy designation regulatory
Earnings Snapshot
ProKidney expects current cash, cash equivalents and marketable securities to support operating plans into mid-2027.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When does PROK expect PROACT 1 results?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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): |
(Exact name of Registrant as Specified in Its Charter)
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Registrant’s Telephone Number, Including Area Code: |
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(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:
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Trading |
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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.
Item 2.02 Results of Operations and Financial Condition.
On November 12, 2026, ProKidney Corp. (the "Company") issued a press release to announce its financial results for the quarter ended September 30, 2026. A copy of the press release is furnished as Exhibit 99.1.
The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, and shall not be deemed to be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
Description |
99.1 |
Press Release dated November 12, 2026 |
104 |
Cover Page Interactive Data File (embedded within Inline XBRL document) |
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.
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PROKIDNEY CORP. |
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Date: |
November 12, 2026 |
By: |
/s/ James Coulston |
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Chief Financial Officer |
Exhibit 99.1
ProKidney Reports Third Quarter 2026 Financial Results and Business Highlights
WINSTON-SALEM, N.C., November 12, 2026 – 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
American Society of Nephrology (ASN) Kidney Week 2026
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)
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September 30, 2026 |
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December 31, 2025 |
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(Unaudited) |
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Assets |
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Cash and cash equivalents |
$ |
81,355 |
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$ |
108,537 |
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Marketable securities |
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60,509 |
|
|
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161,480 |
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Interest receivable |
|
626 |
|
|
|
1,127 |
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Prepaid assets |
|
3,977 |
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|
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2,808 |
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Prepaid clinical |
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3,737 |
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|
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3,923 |
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Other current assets |
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1,247 |
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|
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2,804 |
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Total current assets |
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151,451 |
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280,679 |
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Fixed assets, net |
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55,815 |
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51,231 |
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Right of use assets, net |
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3,013 |
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3,664 |
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Total assets |
$ |
210,279 |
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$ |
335,574 |
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Liabilities and Stockholders' Deficit |
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Accounts payable |
$ |
2,521 |
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$ |
940 |
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Lease liabilities |
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1,109 |
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1,071 |
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Accrued expenses and other |
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26,408 |
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28,731 |
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Total current liabilities |
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30,038 |
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30,742 |
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Income tax payable, net of current portion |
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1,122 |
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1,074 |
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Lease liabilities, net of current portion |
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2,144 |
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2,965 |
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Total liabilities |
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33,304 |
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34,781 |
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Commitments and contingencies |
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Redeemable noncontrolling interest |
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1,083,826 |
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1,311,990 |
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Stockholders’ deficit |
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Class A common stock, $0.0001 par value; 700,000,000 |
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21 |
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14 |
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Class B common stock, $0.0001 par value; 500,000,000 shares |
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10 |
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16 |
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Additional paid-in capital |
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447,041 |
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258,552 |
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Accumulated other comprehensive (loss) gain |
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(37 |
) |
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|
56 |
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Accumulated deficit |
|
(1,353,886 |
) |
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(1,269,835 |
) |
Total stockholders' deficit |
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(906,851 |
) |
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(1,011,197 |
) |
Total liabilities and stockholders' deficit |
$ |
210,279 |
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$ |
335,574 |
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ProKidney Corp. and Subsidiaries
Consolidated Statements of Operations - Unaudited
(in thousands, except for share and per share data)
|
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenue |
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$ |
174 |
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$ |
217 |
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$ |
550 |
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$ |
668 |
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Operating expenses |
|
|
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||||
Research and development |
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40,845 |
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26,821 |
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|
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110,782 |
|
|
|
79,966 |
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General and administrative |
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13,087 |
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|
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11,935 |
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|
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36,832 |
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|
|
40,338 |
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Total operating expenses |
|
|
53,932 |
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|
|
38,756 |
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|
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147,614 |
|
|
|
120,304 |
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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 |
|
|
(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 |
) |
|
|
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|
||||
Weighted average shares of Class A common stock outstanding: |
|
|
|
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|
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|
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|
|
|
||||
Basic and diluted |
|
|
207,760,422 |
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|
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134,992,796 |
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178,989,995 |
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131,588,705 |
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Net loss per share attributable to Class A common stock: |
|
|
|
|
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|
|
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|
||||
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, |
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|||||
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|
2026 |
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2025 |
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Cash flows from operating activities |
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Net loss before noncontrolling interest |
|
$ |
(140,850 |
) |
|
$ |
(110,760 |
) |
Adjustments to reconcile net loss before noncontrolling interest to net cash flows used |
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Depreciation and amortization |
|
|
5,009 |
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|
|
4,738 |
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Equity-based compensation |
|
|
16,420 |
|
|
|
19,633 |
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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 |
) |
|
|
|
|
|
|
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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 |
|
$ |
140 |
|
|
$ |
835 |
|