ProKidney NASDAQ: PROK said it remains on track to report top-line results from the interim analysis of its Phase III PROACT 1 study in the second quarter of 2027, following stronger-than-expected patient recruitment for its investigational autologous cell therapy, rilparencel.
Chief Executive Officer Bruce Culleton said the company closed recruitment in August after increased screening activity across more than 80 study sites. While ProKidney had previously guided to complete enrollment in 2026, it will continue enrolling screened and eligible patients into the first quarter of the following year. The planned study population has increased from 470 patients to more than 500 participants, he said.
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Rilparencel is being developed for patients with advanced chronic kidney disease, or CKD, and type 2 diabetes. The therapy uses cells derived from each patient’s own kidney biopsy. Those cells are expanded at ProKidney’s manufacturing site, cryopreserved and returned to the clinical site for injection into the patient’s kidneys. Culleton said the autologous approach does not require immunosuppression, preconditioning or genetic modification.
Phase III Trial Focuses on Kidney Function Decline PROACT 1 is a blinded, sham-controlled registrational trial in which eligible participants are randomized to receive rilparencel or a sham procedure. The interim analysis is intended to support potential accelerated approval using estimated glomerular filtration rate, or eGFR, slope as a surrogate endpoint.
According to Culleton, the study is powered to detect a 1.5 mL per minute difference in eGFR slope between treatment and control groups. The company assumes an annual eGFR decline of 3 mL per minute in the control arm, making the targeted difference equivalent to a 50% reduction in kidney-function decline.
Dr. Katherine Tuttle, executive director for research at Providence Inland Northwest Health and a professor of medicine at the University of Washington, said an eGFR-slope difference greater than 0.75 mL per minute per 1.73 square meters annually in studies lasting at least two years has been associated with a benefit on the clinical outcome of kidney failure. She said the 1.5 mL-per-minute target in PROACT 1 would be clinically meaningful if achieved.
ProKidney previously reported that rilparencel was associated with a 78% slower annual eGFR decline in a cohort from its Phase II REGEN-007 study. The company said that cohort’s design most closely resembled its Phase III program.
Mechanistic Findings Presented at Kidney Week Anthony Conway, ProKidney’s head of research and development, reviewed preclinical and translational findings presented at the American Society of Nephrology’s Kidney Week meeting. The company’s work examined rilparencel in cell-culture systems, donated human kidney tissue and rodent models of CKD.
Conway said single-cell RNA sequencing of rilparencel batches found that the final product consists of cells originating from proximal and distal kidney tubules. Despite differences in starting biopsies from patients with varying CKD stages, he said the manufactured cell products demonstrated a consistent expression profile across the samples evaluated.
In a kidney-on-a-chip model designed to replicate CKD-related injury, ProKidney reported that rilparencel was associated with improved markers of endothelial-cell junctions and barrier integrity, lower inflammatory signaling and reduced permeability. The company also reported findings suggesting effects on oxidative stress, iron handling, mitochondrial function and lipid peroxidation in injured kidney epithelial cells.
In rodent studies, Conway said injected rilparencel cells were observed in kidney tissue after dosing, with some cells still present 28 days later. Spatial and molecular analyses in the models indicated signatures associated with extracellular-matrix remodeling, vascular development, endothelial cell junctions and tissue repair. He said the company plans additional work, including a human decedent study and analyses of clinical biomarkers, to further evaluate the therapy’s mechanism of action.
Positioning Alongside Existing CKD Treatments Tuttle said CKD remains a major global health concern, driven in large part by diabetes and linked to elevated cardiovascular and kidney-failure risks. She described current treatment pillars for diabetic CKD as renin-angiotensin system inhibition, SGLT2 inhibitors, finerenone and GLP-1 receptor agonists.
While those therapies have improved care, Tuttle said some patients continue to face substantial residual risk despite guideline-directed medical treatment. She characterized rilparencel, if successful in development and approved, as a potential complementary “rescue” treatment for patients with advanced CKD who remain at high risk of dialysis or transplantation.
ProKidney said PROACT 1 participants are generally expected to receive standard therapies, including ACE inhibitors or ARBs and SGLT2 inhibitors, unless sites provide an explanation for their absence. Culleton said the company has observed high use of SGLT2 inhibitors and ACE inhibitors or ARBs in blinded baseline medication data, along with what he described as reasonable use of GLP-1 therapies.
Manufacturing and Safety Comments Culleton said the current time from kidney biopsy to availability of product in the study is about 14 weeks, though manufacturing itself takes roughly three weeks. The company believes it may be able to reduce the overall interval to about eight weeks through greater efficiency.
On manufacturing reliability, Culleton said ProKidney has been able to manufacture product for more than 95% of patients, based on its clinical-program experience. He said insufficient biopsy samples have occurred only rarely.
Regarding safety, Culleton said the Phase III program has not shown findings that differ from the company’s prior Phase II experience. He said adverse events observed have been consistent with those expected from kidney biopsy and needle-based kidney procedures, rather than additional treatment-related events.
About ProKidney (NASDAQ:PROK)ProKidney Corporation is a biotechnology company focused on developing cell-based therapies for chronic kidney disease (CKD). The company's lead investigational product is rilparencel, formerly known as REACT, an autologous cell therapy made from a patient's own kidney cells.
Rilparencel is designed to be injected into the patient's kidneys, where the cells are intended to support kidney function and potentially slow the progression of CKD. ProKidney is studying the therapy primarily in patients with diabetic kidney disease and advanced CKD, with the goal of delaying or reducing the need for dialysis or kidney transplantation.
ProKidney's operations are centered on the development and clinical testing of rilparencel, and the company does not currently have an approved commercial product.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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ProKidney Corp. (PROK) Discusses Rilparencel Mechanism and Role in Advanced Chronic Kidney Disease October 27, 2026 10:30 AM EDT
Company Participants
Ethan Holdaway
Bruce Culleton - CEO & Director
Anthony Conway
Katherine Tuttle
Conference Call Participants
Vamil Divan - Guggenheim Securities, LLC, Research Division
Lin Tsai - Jefferies LLC, Research Division
Joseph Pantginis - H.C. Wainwright & Co, LLC, Research Division
Yigal Nochomovitz - Citigroup Inc., Research Division
Dina Ramadane - BofA Securities, Research Division
Presentation
Operator
Good morning, everyone, and welcome to the ProKidney American Society of Nephrology Kidney Week recap and Corporate Update.
[Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the ProKidney website following the conclusion of the event.
I'd now like to turn the call over to Ethan Holdaway, Vice President of Strategic Finance and Investor Relations at ProKidney. Please go ahead, Ethan.
Ethan Holdaway
Thank you, operator, and good morning, everyone, and welcome to our webcast.
Before we begin, I'd like to remind everyone that we will be making forward-looking statements during the presentation today. I encourage you to refer to our most recent SEC filings regarding risk factors associated with these statements.
On the webcast this morning, are Dr. Bruce Culleton, ProKidney's CEO; Dr. Anthony Conway, ProKidney's Head of R&D; and Dr. Katherine Tuttle, Executive Director for Research at Providence Inland Northwest Health and Professor of Medicine at the University of Washington.
I'd now like to turn the call over to Bruce. Bruce?
Bruce Culleton
CEO & Director
Thanks, Ethan. Good morning, everyone, and thank you for joining us today.
At ProKidney, our mission is to transform the outlook for people with advanced chronic kidney disease by extending life without dialysis. Today's discussion will focus on the science supporting our work and the potential role of rilparencel within the evolving
Seven abstracts spanning CKD translational model studies and drug product characterization provide converging evidence supporting a multifactorial mechanism of action for rilparencelOne clinical abstract presents a new pooled Phase 2 analysis of patients meeting key PROACT 1 inclusion criteria that continues to indicate a strong safety profile and kidney function stabilization in patients with advanced CKD and type 2 diabetes mellitus WINSTON-SALEM, N.C., Oct. 22, 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 that the Company will present eight abstracts, including one oral presentation, at the upcoming American Society of Nephrology’s (ASN) Kidney Week being held from October 21-25, 2026, in Denver, CO.
"The data being presented at Kidney Week 2026 continue to build a more cohesive picture of how rilparencel may lead to stabilization of kidney function," said Bruce Culleton, M.D., CEO of ProKidney. "Across multiple complementary non-clinical models, we are seeing evidence supporting an adaptive, multifactorial mechanism that involves attenuation of oxidative damage, metabolic dysregulation, and pro-inflammatory signaling, while supporting vascular and tubular repair within diseased and injured kidney cells. Importantly, these mechanistic observations coupled with the stabilization of kidney function observed across our recent Phase 2 studies in patients with advanced CKD and type 2 diabetes further strengthen our confidence in the ongoing Phase 3 PROACT 1 study."
The titles for the accepted abstracts are provided below and are accessible online at: https://www.asn-online.org/education/kidneyweek/2026/program-search-abstract.aspx
Oral Presentation Details
Rilparencel Is Associated with a Graft-Adjacent Remodeling Response and Preserved Vascular Integrity in an Immunocompromised Rat CKD Model
Abstract Number: FR-OR044
Session Title: Exciting Developments in CKD Research: From Diagnostics to Management and More
Date, Time: October 23, 2026 from 4:30 PM to 6:00 PM MDT (ProKidney presentation starts at 5:40 PM)
Location: Mile High Ballroom 1D
Poster Presentation Details
A Human Microphysiological System Resolves Epithelial Inflammatory Injury Programs and Characterizes Autologous Cell Therapy Responses in a CKD Injury Model
Session Title: Bioengineering: Emerging Research
Date, Time: October 22, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: TH-PO1128
Long-Duration Air-Liquid Interface Culture of Human CKD Kidney Biopsies Enables Ex Vivo Study of Disease Biology and Tissue-Context-Specific Effects of Kidney-Targeted Therapies
Session Title: Bioengineering: Emerging Research
Date, Time: October 22, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: TH-PO1129
Metabolic Transitioning During Manufacturing of Renal Cell Therapy Candidate Rilparencel
Session Title: CKD: Mechanisms of Injury and Fibrosis - 2
Date, Time: October 23, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: FR-PO0236
Renal Autologous Cell Therapy for CKD with Diabetes: Pooled Safety and Efficacy Results from a Phase 2 Program in a Subset of Participants with Key Phase 3 Eligibility Characteristics
Session Title: CKM: Clinical - Trials, Epidemiology, and Biomarkers
Date, Time: October 23, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: FR-PO0498
GPX4-Associated Cytoprotective Activity of an Autologous Cell Therapy in Human In Vitro and Ex Vivo CKD Models
Session Title: Development, Stem Cells, and Regenerative Medicine
Date, Time: October 24, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: SA-PO0013
Rilparencel Manufacturing Induces Transcriptional Dedifferentiation Leading to Two Distinct Populations with Retained Tubular Lineage Memory
Session Title: Development, Stem Cells, and Regenerative Medicine
Date, Time: October 24, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: SA-PO0014
Longitudinal Secretome Characterization of Renal Cell Therapy Candidate Rilparencel During Manufacturing
Session Title: Development, Stem Cells, and Regenerative Medicine
Date, Time: October 24, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: SA-PO0015
Following the event, a copy of the poster presentations will be available on the Company’s website at: https://prokidney.com/our-technology/publications/
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 investigational 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, 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 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 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 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.
WINSTON-SALEM, N.C., Oct. 22, 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 that it will host a virtual key opinion leader (KOL) event on Tuesday, October 27, 2026, at 10:30 AM ET. To register, click here.
Seven abstracts spanning CKD translational model studies and drug product characterization provide converging evidence supporting a multifactorial mechanism of action for rilparencelOne clinical abstract presents a new pooled Phase 2 analysis of patients meeting key PROACT 1 inclusion criteria that continues to indicate a strong safety profile and kidney function stabilization in patients with advanced CKD and type 2 diabetes mellitus WINSTON-SALEM, N.C., Oct. 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 that the Company will present eight abstracts, including one oral presentation, at the upcoming American Society of Nephrology’s (ASN) Kidney Week being held from October 21-25, 2026, in Denver, CO.
"The data being presented at Kidney Week 2026 continue to build a more cohesive picture of how rilparencel may lead to stabilization of kidney function," said Bruce Culleton, M.D., CEO of ProKidney. "Across multiple complementary non-clinical models, we are seeing evidence supporting an adaptive, multifactorial mechanism that involves attenuation of oxidative damage, metabolic dysregulation, and pro-inflammatory signaling, while supporting vascular and tubular repair within diseased and injured kidney cells. Importantly, these mechanistic observations coupled with the stabilization of kidney function observed across our recent Phase 2 studies in patients with advanced CKD and type 2 diabetes further strengthen our confidence in the ongoing Phase 3 PROACT 1 study."
The titles for the accepted abstracts are provided below and are accessible online at: https://www.asn-online.org/education/kidneyweek/2026/program-search-abstract.aspx
Oral Presentation Details
Rilparencel Is Associated with a Graft-Adjacent Remodeling Response and Preserved Vascular Integrity in an Immunocompromised Rat CKD Model
Abstract Number: FR-OR044
Session Title: Exciting Developments in CKD Research: From Diagnostics to Management and More
Date, Time: October 23, 2026 from 4:30 PM to 6:00 PM MDT (ProKidney presentation starts at 5:40 PM)
Location: Mile High Ballroom 1D
Poster Presentation Details
A Human Microphysiological System Resolves Epithelial Inflammatory Injury Programs and Characterizes Autologous Cell Therapy Responses in a CKD Injury Model
Session Title: Bioengineering: Emerging Research
Date, Time: October 22, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: TH-PO1128
Long-Duration Air-Liquid Interface Culture of Human CKD Kidney Biopsies Enables Ex Vivo Study of Disease Biology and Tissue-Context-Specific Effects of Kidney-Targeted Therapies
Session Title: Bioengineering: Emerging Research
Date, Time: October 22, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: TH-PO1129
Metabolic Transitioning During Manufacturing of Renal Cell Therapy Candidate Rilparencel
Session Title: CKD: Mechanisms of Injury and Fibrosis - 2
Date, Time: October 23, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: FR-PO0236
Renal Autologous Cell Therapy for CKD with Diabetes: Pooled Safety and Efficacy Results from a Phase 2 Program in a Subset of Participants with Key Phase 3 Eligibility Characteristics
Session Title: CKM: Clinical - Trials, Epidemiology, and Biomarkers
Date, Time: October 23, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: FR-PO0498
GPX4-Associated Cytoprotective Activity of an Autologous Cell Therapy in Human In Vitro and Ex Vivo CKD Models
Session Title: Development, Stem Cells, and Regenerative Medicine
Date, Time: October 24, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: SA-PO0013
Rilparencel Manufacturing Induces Transcriptional Dedifferentiation Leading to Two Distinct Populations with Retained Tubular Lineage Memory
Session Title: Development, Stem Cells, and Regenerative Medicine
Date, Time: October 24, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: SA-PO0014
Longitudinal Secretome Characterization of Renal Cell Therapy Candidate Rilparencel During Manufacturing
Session Title: Development, Stem Cells, and Regenerative Medicine
Date, Time: October 24, 2026 from 10:00 AM to 12:00 PM MDT
Poster Board Number: SA-PO0015
Following the event, a copy of the poster presentations will be available on the Company’s website at: https://prokidney.com/our-technology/publications/
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 investigational 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, 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 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 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 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 (NASDAQ:PROK – Get Free Report) and Pyxis Oncology (NASDAQ:PYXS – Get Free Report) are both small-cap healthcare companies, but which is the better stock? We will compare the two businesses based on the strength of their dividends, analyst recommendations, valuation, earnings, risk, institutional ownership and profitability.
Analyst Recommendations This is a breakdown of recent ratings and recommmendations for ProKidney and Pyxis Oncology, as reported by MarketBeat.com.
Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score ProKidney 1 0 1 1 2.67 Pyxis Oncology 1 1 8 0 2.70 ProKidney currently has a consensus target price of $12.00, indicating a potential upside of 528.27%. Pyxis Oncology has a consensus target price of $8.75, indicating a potential upside of 162.76%. Given ProKidney’s higher possible upside, analysts clearly believe ProKidney is more favorable than Pyxis Oncology.
Insider and Institutional Ownership 51.6% of ProKidney shares are owned by institutional investors. Comparatively, 39.1% of Pyxis Oncology shares are owned by institutional investors. 39.8% of ProKidney shares are owned by company insiders. Comparatively, 5.7% of Pyxis Oncology shares are owned by company insiders. Strong institutional ownership is an indication that hedge funds, large money managers and endowments believe a company is poised for long-term growth. Earnings and Valuation This table compares ProKidney and Pyxis Oncology”s revenue, earnings per share and valuation.
Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio ProKidney $890,000.00 648.80 -$68.99 million ($0.55) -3.47 Pyxis Oncology $13.86 million 20.04 -$79.62 million ($1.41) -2.36 ProKidney has higher earnings, but lower revenue than Pyxis Oncology. ProKidney is trading at a lower price-to-earnings ratio than Pyxis Oncology, indicating that it is currently the more affordable of the two stocks.
Risk and Volatility ProKidney has a beta of 1.7, suggesting that its share price is 70% more volatile than the S&P 500. Comparatively, Pyxis Oncology has a beta of 1.34, suggesting that its share price is 34% more volatile than the S&P 500.
Profitability This table compares ProKidney and Pyxis Oncology’s net margins, return on equity and return on assets.
Net Margins Return on Equity Return on Assets ProKidney -10,288.39% N/A -27.39% Pyxis Oncology N/A -215.23% -112.19% Summary ProKidney beats Pyxis Oncology on 10 of the 15 factors compared between the two stocks.
About ProKidney (Get Free Report)
ProKidney Corp., a clinical-stage biotechnology company, provides transformative proprietary cell therapy platform for treating various chronic kidney diseases in the United States. The company's lead product is Renal Autologous Cell Therapy (REACT), an autologous homologous cell admixture, which has completed Phase I clinical trial for REACT in patients with congenital anomalies of the Kidney and Urinary Tract (CAKUT), as well as in Phase III and Phase II clinical trials for the treatment of moderate to severe diabetic kidney disease. ProKidney Corp. founded in 2015 and is headquartered in Winston-Salem, North Carolina.
About Pyxis Oncology (Get Free Report)
Pyxis Oncology, Inc., a clinical stage company, engages in the development of therapeutics to treat cancers. Its lead antibody-drug conjugates (ADC) product candidate is PYX-201, an investigational novel ADC consisting of human immunoglobulin G1 (IgG1), which is in Phase 1 clinical trial to treat patients with relapsed or refractory solid tumors; and lead immuno-oncology (IO) product candidate is PYX-106, an investigational fully human IgG1 Siglec-15-targeting antibody that is in Phase 1 clinical trial to treat patients with advanced solid tumors. The company is also developing PYX-107, a CD40 agonist with demonstrated anti-cancer activity in patients who previously progressed on PD-(L)1 inhibitors, which is in Phase 2 clinical trial for the treatment of solid tumors, such as soft tissue sarcomas, esophageal and gastroesophageal junction, cancers, and melanoma in combination with chemotherapy, radiation therapy, and immunotherapy. It has in-license agreement with Pfizer Inc. to develop and commercialize ADC product candidates directed to certain licensed targets, including PYX-201 and PYX-203, and products containing the ADC product candidates; and Biosion USA, Inc. for development, manufacture, and commercialization of PYX-106, an IO product candidate. Pyxis Oncology, Inc. was incorporated in 2018 and is headquartered in Boston, Massachusetts.
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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.
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.
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
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.
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
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 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
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.
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.
