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2026-08-14 19:50 27d ago
2026-08-14 15:36 28d ago
ProKidney: Do-Or-Die Phase 3 Meets A Dwindling Balance Sheet (Rating Downgrade)
PROK ProKidney
FMP Stock News
Original source text
ProKidney Corp. is a single-asset biotech with a dwindling cash position and an unproven lead therapy, rilparencel. Phase 2 data for rilparencel is weak, with confounding factors and no robust evidence of efficacy; Phase 3 PROACT data in 2027 is pivotal. PROK's cash runway extends only into mid-2027, with just $181.6M remaining and ongoing high cash burn, raising 'going concern' doubts.
2026-08-11 00:21 1mo ago
2026-08-10 18:56 1mo ago
ProKidney Corp. (PROK) Reports Q2 Loss, Misses Revenue Estimates
PROK ProKidney
FMP Stock News
Original source text
ProKidney Corp. (PROK - Free Report) came out with a quarterly loss of $0.15 per share versus the Zacks Consensus Estimate of a loss of $0.13. This compares to a loss of $0.13 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of -15.39%. A quarter ago, it was expected that this company would post a loss of $0.13 per share when it actually produced a loss of $0.14, delivering a surprise of -7.69%.

Over the last four quarters, the company has surpassed consensus EPS estimates just once.

PROKIDNEY CP, which belongs to the Zacks Medical - Drugs industry, posted revenues of $0.15 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 31.82%. This compares to year-ago revenues of $0.22 million. The company has topped consensus revenue estimates just once over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

PROKIDNEY CP shares have lost about 26.8% since the beginning of the year versus the S&P 500's gain of 13.3%.

What's Next for PROKIDNEY CP?While PROKIDNEY CP has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for PROKIDNEY CP was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.13 on $0.23 million in revenues for the coming quarter and -$0.49 on $0.45 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the top 41% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

MediWound (MDWD - Free Report) , another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 13.

This developer of treatments for burns and hard-to-heal wounds is expected to post quarterly loss of $0.76 per share in its upcoming report, which represents a year-over-year change of +38.2%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

MediWound's revenues are expected to be $2.59 million, down 54.7% from the year-ago quarter.
2026-06-12 15:47 2mo ago
2026-03-22 02:14 5mo ago
ProKidney Corp. (NASDAQ:PROK) Given Consensus Recommendation of “Moderate Buy” by Brokerages
PROK ProKidney
FMP Stock News
Original source text
Shares of ProKidney Corp. (NASDAQ: PROK - Get Free Report) have earned a consensus rating of "Moderate Buy" from the eight ratings firms that are presently covering the firm, MarketBeat reports. Two investment analysts have rated the stock with a sell rating, one has given a hold rating, four have given a buy rating and one
2026-06-12 15:47 2mo ago
2026-03-25 16:01 5mo ago
ProKidney Expands Senior Leadership Team with Appointment of Greg Madison as Chief Commercial Officer
PROK ProKidney
FMP Stock News
Original source text
Veteran commercial executive brings deep nephrology and specialty biopharma leadership experience as ProKidney advances rilparencel toward potential commercialization March 25, 2026 16:01 ET  | Source: ProKidney

WINSTON-SALEM, N.C., March 25, 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 announced the appointment of Greg Madison as Chief Commercial Officer. In this role, Mr. Madison will drive ProKidney’s commercial strategy as the Company advances towards the potential commercialization of rilparencel.

“Greg is a seasoned commercial biopharma executive with a proven track record of building high-performing organizations, shaping strategy, and preparing innovative therapies for market,” said Bruce Culleton, M.D., CEO of ProKidney. “He brings valuable operational and leadership skills needed to help guide ProKidney through its next phase of growth, including strong depth in nephrology and other specialty markets. As we advance our clinical and regulatory objectives for rilparencel, Greg will play a key role in strengthening our leadership team and positioning rilparencel for potential commercialization.”

Mr. Madison brings more than two decades of executive leadership experience across commercial strategy, general management, launch planning, business development, and company building in both clinical and commercial-stage biopharmaceutical companies. Most recently, he served as Chief Executive Officer of Shield Therapeutics plc, where he redesigned the commercial strategy, identified and led a transformative business development transaction, and raised capital to position the company on a path to profitability. Previously, he was Chief Executive Officer of Melt Pharmaceuticals, creating the company and advancing a novel sublingual combination drug from preclinical to Phase 2. Prior to that, he served as President and CEO of Keryx Biopharmaceuticals, leading its evolution from a clinical to commercial-stage organization, launching a novel iron-based phosphate binder for dialysis patients, and advancing a second indication for iron deficiency anemia. Earlier in his career, Mr. Madison was Executive Vice President and Chief Commercial Officer of AMAG Pharmaceuticals, and Vice President/General Manager of the Global Renal Business at Genzyme, where he helped drive Renagel/Renvela to blockbuster status with over $1 billion in annual revenue.

“ProKidney is developing a truly novel cell therapy with the potential to address a profound unmet need for patients with advanced CKD and diabetes,” said Greg Madison. “As a potential first cell therapy for CKD patients and nephrologists, I am excited to join the Company at such an important time. I look forward to working alongside Bruce and the broader team to shape the commercial strategy, organization, and execute the plans needed to support the potential launch of rilparencel.”

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 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 advancement of our clinical and regulatory objectives for rilparencel and, if approved, potential commercialization of rilparencel. 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.

Media Contact
Audra Friis
[email protected]
2026-06-12 15:47 2mo ago
2026-03-27 02:19 5mo ago
Head-To-Head Contrast: ProKidney (NASDAQ:PROK) & Phio Pharmaceuticals (NASDAQ:PHIO)
PROK ProKidney
FMP Stock News
Original source text
Phio Pharmaceuticals (NASDAQ: PHIO - Get Free Report) and ProKidney (NASDAQ: PROK - Get Free Report) are both small-cap medical companies, but which is the superior business? We will compare the two businesses based on the strength of their profitability, analyst recommendations, dividends, risk, earnings, valuation and institutional ownership. Insider and Institutional Ownership 57.3% of Phio Pharmaceuticals
2026-06-12 15:47 2mo ago
2026-05-15 11:45 3mo ago
ProKidney Reports First Quarter 2026 Financial Results and Business Highlights
PROK ProKidney
FMP Stock News
Original source text
May 15, 2026 11:45 ET  | Source: ProKidney

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 2027Peer-reviewed results from the Phase 2 REGEN-007 study were published in the Clinical Journal of the American Society of Nephrology (CJASN) in January 2026Ended Q1 2026 with $224.9 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027 WINSTON-SALEM, N.C., May 15, 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 first quarter ended March 31, 2026, and provided business highlights.

“As we progress through 2026, we continue to build on the momentum established last year through positive Phase 2 REGEN-007 results, alignment with the FDA on the accelerated approval pathway, and meaningful progress on Phase 3 PROACT 1 study enrollment,” said Bruce Culleton, M.D., CEO of ProKidney. “We expect to complete enrollment in PROACT 1 this year, positioning us to deliver pivotal eGFR slope topline results in the second quarter of 2027. Our mission remains highly focused on advancing a potential new treatment option for patients with advanced CKD and diabetes at high risk of kidney failure, an area of significant unmet medical need.”

Business Highlights

Phase 3 REGEN-006 (PROACT 1) — Pivotal Study

Enrollment: On track to complete enrollment for the surrogate (eGFR slope) endpoint in mid-2026Topline readout: Pivotal results expected in Q2 2027Study Power 90% power to detect an effect size of 1.75 mL/min/1.73m² in annualized eGFR slope80% power to detect an effect size of 1.5 mL/min/1.73m² in annualized eGFR slope FDA Alignment: Under rilparencel’s regenerative medicine advanced therapy (RMAT) designation, the U.S. Food and Drug Administration (FDA) confirmed in a prior Type B meeting that a rilparencel effect size of 1.5 mL/min/1.73m² per year would be an acceptable demonstration of efficacy in patients receiving appropriate standard of carePhase 2 REGEN-007 Data: In Group 1, bilateral kidney injections with rilparencel were associated with a 4.6 mL/min/1.73m² improvement in the annual decline in eGFR slope in the pre-injection period versus the period after the last rilparencel injection
Regulatory Position

July 2025 Type B meeting: FDA confirmed that eGFR slope in patients from the ongoing PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Application (BLA) submission under the accelerated approval pathwayFDA also confirmed that PROACT 1 may be used to support both accelerated and confirmatory approval of rilparencelProKidney continues to maintain its ongoing dialogue with the FDA under rilparencel’s RMAT designation
Publications & Presentations

January 2026: Phase 2 REGEN-007 results published in the Clinical Journal of the American Society of Nephrology (CJASN)November 2025: Phase 2 REGEN-007 results presented as a late-breaking clinical trial at ASN Kidney Week Key Clinical Takeaway
The Company has achieved FDA alignment on the accelerated and confirmatory approval pathways for rilparencel. Completion of PROACT 1 enrollment this year is a key 2026 milestone. The positive Phase 2 REGEN-007 results provide confidence heading into the expected pivotal topline results (eGFR slope) in the second quarter of 2027.

First Quarter 2026 Financial Highlights

Liquidity: Cash, cash equivalents and marketable securities as of March 31, 2026, totaled $224.9 million, compared to $270.0 million as of December 31, 2025. We expect that our existing cash, cash equivalents and marketable securities held at March 31, 2026, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027.

R&D Expenses: Research and development expenses were $33.8 million for the three months ended March 31, 2026, compared to $27.3 million for the same period in 2025. The increase of $6.6 million was driven primarily by increases in clinical study and related manufacturing costs of $6.5 million related to our ongoing PROACT 1 study. Additionally, compensation costs increased $1.2 million related to the hiring of additional personnel to support our operations. These increases have been offset by decreases in costs of $1.6 million related to clinical study costs for trials that have been completed or terminated.

G&A Expenses: General and administrative expenses were $11.3 million for the three months ended March 31, 2026 compared to $14.4 million for the same period in 2025. The decrease of $3.1 million was driven primarily by decreases in compensation costs of approximately $1.7 million due to vesting of awards issued prior to the business combination coupled with forfeitures of equity-based awards and reductions in severance costs. Additionally, professional fees and other operating costs have decreased $1.4 million driven by ongoing initiatives, including the domestication and restructuring transactions in 2025.

Net Loss Before Noncontrolling Interest: Net loss before noncontrolling interest was $42.6 million and $38.0 million for the three months ended March 31, 2026, and 2025, respectively.

Shares Outstanding: Class A and Class B common stock outstanding at March 31, 2026, totaled 301,953,977.

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 ≥ 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/1.73m2) 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 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, 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
[email protected]

ProKidney Corp. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except for share data)
       March 31, 2026  December 31, 2025  (Unaudited)    Assets     Cash and cash equivalents$101,895  $108,537 Marketable securities 123,049   161,480 Interest receivable 1,032   1,127 Prepaid assets 3,083   2,808 Prepaid clinical 4,049   3,923 Other current assets 1,794   2,804 Total current assets 234,902   280,679       Fixed assets, net 54,441   51,231 Right of use assets, net 3,441   3,664 Total assets$292,784  $335,574       Liabilities and Stockholders' Deficit     Accounts payable$2,592  $940 Lease liabilities 1,108   1,071 Accrued expenses and other 22,231   28,731 Income taxes payable –   – Total current liabilities 25,931   30,742       Income tax payable, net of current portion 1,074   1,074 Lease liabilities, net of current portion 2,675   2,965 Total liabilities 29,680   34,781 Commitments and contingencies     Redeemable noncontrolling interest 1,286,887   1,311,990       Stockholders’ deficit     Class A common stock, $0.0001 par value; 700,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 141,980,643 and 141,807,277 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively 14   14 Class B common stock, $0.0001 par value; 500,000,000 shares authorized; 159,973,334 and 159,262,779 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively 16   16 Additional paid-in capital 266,112   258,552 Accumulated other comprehensive (loss) gain (53)  56 Accumulated deficit (1,289,872)  (1,269,835)Total stockholders' deficit (1,023,783)  (1,011,197)Total liabilities and stockholders' deficit$292,784  $335,574  ProKidney Corp. and Subsidiaries
Consolidated Statements of Operations - Unaudited
(in thousands, except for share and per share data)
    Three Months Ended March 31,  2026  2025 Revenue$226  $230       Operating expenses     Research and development 33,842   27,263 General and administrative 11,317   14,355 Total operating expenses 45,159   41,618 Operating loss (44,933)  (41,388)      Other income (expense):     Interest income 2,327   4,027 Interest expense (15)  – Net loss before income taxes (42,621)  (37,361)Income tax expense —   591 Net loss before noncontrolling interest (42,621)  (37,952)Net loss attributable to noncontrolling interest (22,584)  (21,218)Net loss available to Class A common stockholders$(20,037) $(16,734)      Weighted average shares of Class A common stock outstanding:     Basic and diluted 141,925,099   126,976,366 Net loss per share attributable to Class A common stock:     Basic and diluted$(0.14) $(0.13) ProKidney Corp. and Subsidiaries
Consolidated Statements of Cash Flows – Unaudited
(in thousands)
    Three Months Ended March 31,  2026  2025 Cash flows from operating activities     Net loss before noncontrolling interest$(42,621) $(37,952)Adjustments to reconcile net loss before noncontrolling interest to net cash flows used
in operating activities:     Depreciation and amortization 1,658   1,600 Equity-based compensation 4,945   6,416 Gain on marketable securities, net (413)  (1,069)Loss on disposal of equipment –   300 Changes in operating assets and liabilities     Interest receivable 95   695 Prepaid and other assets 609   5,729 Accounts payable and accrued expenses (5,957)  (5,902)Income taxes payable –   591 Net cash flows used in operating activities (41,684)  (29,592)      Cash flows from investing activities     Purchases of marketable securities (44,754)  (55,449)Sales and maturities of marketable securities 83,366   84,873 Purchase of equipment and facility expansion (3,785)  (1,135)Net cash flows provided by investing activities 34,827   28,289       Cash flows from financing activities     Proceeds from sales of Class A common stock, net of offering costs 7   – Payments on finance leases (3)  (12)Exercise of stock options 211   – Net cash flows provided by (used in) financing activities 215   (12)      Net change in cash and cash equivalents (6,642)  (1,315)Cash, beginning of period 108,537   99,120 Cash, end of period$101,895  $97,805       Supplemental disclosure of non-cash investing and financing activities:     Right of use assets obtained in exchange for lease obligations$–  $322 Exchange of Class B common stock$26  $2,418 Impact of equity transactions and compensation on redeemable noncontrolling interest$2,366  $4,426 Equipment and facility expansion included in accounts payable and
accrued expenses$859  $1,653 
2026-06-12 15:47 2mo ago
2026-05-15 13:55 3mo ago
ProKidney Corp. (PROK) Reports Q1 Loss, Tops Revenue Estimates
PROK ProKidney
FMP Stock News
Original source text
ProKidney Corp. (PROK - Free Report) came out with a quarterly loss of $0.14 per share versus the Zacks Consensus Estimate of a loss of $0.13. This compares to a loss of $0.13 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of -7.69%. A quarter ago, it was expected that this company would post a loss of $0.16 per share when it actually produced a loss of $0.14, delivering a surprise of +12.5%.

Over the last four quarters, the company has surpassed consensus EPS estimates two times.

PROKIDNEY CP, which belongs to the Zacks Medical - Drugs industry, posted revenues of $0.23 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 222.86%. This compares to year-ago revenues of $0.23 million. The company has topped consensus revenue estimates just once over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

PROKIDNEY CP shares have lost about 23.7% since the beginning of the year versus the S&P 500's gain of 9.6%.

What's Next for PROKIDNEY CP?While PROKIDNEY CP has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for PROKIDNEY CP was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.12 on $0.11 million in revenues for the coming quarter and -$0.72 on $0.5 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

One other stock from the same industry, MARKER THERAPEUTICS, INC. (MRKR - Free Report) , is yet to report results for the quarter ended March 2026.

This company is expected to post quarterly loss of $0.18 per share in its upcoming report, which represents a year-over-year change of +55%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

MARKER THERAPEUTICS, INC.'s revenues are expected to be $0.6 million, up 71.4% from the year-ago quarter.
2026-06-12 15:47 2mo ago
2026-06-02 08:00 3mo ago
ProKidney Appoints Kenneth Locke as Chief Technical Officer
PROK ProKidney
FMP Stock News
Original source text
Kenneth Locke joins as Chief Technical Officer, bringing more than 25 years of experience across Chemistry, Manufacturing and Controls (CMC) and Supply Chain as ProKidney progresses toward the potential commercialization of rilparencel June 02, 2026 08:00 ET  | Source: ProKidney

WINSTON-SALEM, N.C., June 02, 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 announced the appointment of Kenneth Locke as Chief Technical Officer.

“Ken is an accomplished leader with a proven ability to scale advanced therapy platforms and execute complex manufacturing strategies,” said Bruce Culleton, M.D., CEO of ProKidney. “As we approach our pivotal topline readout in Q2 2027 and advance toward commercialization, his leadership will be critical in strengthening our technical foundation and ensuring we are well-positioned for long-term success.”

Mr. Locke joins ProKidney from Carisma Therapeutics, where he oversaw CMC, Quality and Regulatory functions and led technical strategy for first-in-human CAR Myeloid programs. He built and scaled teams to support clinical development and contributed to strategic asset transitions through licensing and technology transfer of cell and viral vector manufacturing processes.

Previously, he held leadership roles at Celgene (now Bristol Myers Squibb), where he led external manufacturing and strategic sourcing for cell therapy programs, and at Novartis, where he helped advance early-stage cell therapy programs and established global capabilities across manufacturing and supply chain.

“The opportunity to help advance a first-in-class autologous cell therapy for patients with severe chronic kidney disease is incredibly compelling,” said Mr. Locke. “ProKidney has built a strong foundation with its in-house manufacturing capabilities and expertise in kidney disease, and I’m energized to work with this talented team as we execute on our Phase 3 study and prepare for the next stage of growth.”

Mr. Locke began his career in research and procurement roles of increasing responsibility at Bristol Myers Squibb and other biopharmaceutical organizations. He holds a Master of Science in Molecular Biology from Lehigh University and a Bachelor of Science in Biology Education from Millersville University of Pennsylvania.

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
[email protected]