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2026-10-27 22:30 4h ago
2026-10-27 17:00 10h ago
ProKidney představila rilparencel pro pokročilé onemocnění ledvin
PROK ProKidney
FMP Stock News 72
Original source text
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
2026-10-22 13:57 5d ago
2026-10-22 08:00 5d ago
ProKidney představí data o rilparencelu na konferenci Kidney Week
PROK ProKidney
FMP Stock News 82
Original source text
 | Source: ProKidney

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.

ProKidney Contact
Ethan Holdaway
[email protected]

Media Contact
Audra Friis
[email protected]

Investor Relations Contact
Daniel Ferry
[email protected]
2026-08-11 00:21 2mo ago
2026-08-10 18:56 2mo ago
ProKidney hlásí vyšší ztrátu a slabé tržby
PROK ProKidney
FMP Stock News 78
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.