發佈日期：2026年5月15日

8-K
 
 
 
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 
 
 
 

 
 Date of Report (Date of earliest event reported): May 15, 2026

 

  
 
PROKIDNEY CORP.
(Exact name of Registrant as Specified in Its Charter)
 
 

 
 
 
 
 
 
 
 

 
 Delaware

 001-40560

 98-1586514

 

 
 (State or Other Jurisdiction
of Incorporation)

 (Commission File Number)

 (IRS Employer
Identification No.)

 

 
  

  

  

  

  

 

 
 2000 Frontis Plaza Blvd.
Suite 250

  

 

 
 Winston-Salem, North Carolina

  

 27103

 

 
 (Address of Principal Executive Offices)

  

 (Zip Code)

 

  

 
 
 
 

 
 Registrant’s Telephone Number, Including Area Code: 336 999-7019

 

  

 
 
 
 

 
  

 

 (Former Name or Former Address, if Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: 
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:

 
 
 
 
 
 
 
 

 
 
Title of each class

  

 Trading
Symbol(s)

  

 
Name of each exchange on which registered

 

 
 Class A common stock, $0.0001 par value per share

  

 PROK

  

 The Nasdaq Stock Market

 

 Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). 
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 

 

 
 

 Item 2.02 Results of Operations and Financial Condition.
On May 15, 2026, ProKidney Corp. (the "Company") issued a press release to announce its financial results for the quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1.
The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, and shall not be deemed to be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
The Company has updated its investor presentation (the “Presentation”), which its senior management intends to use from time to time when interacting with investors and analysts, among others. The Presentation is available on the Company’s website at https://investors.prokidney.com/news-events/events-and-presentations. The Presentation is also attached hereto as Exhibit 99.2.
The Company is on track to complete enrollment for the Phase 3 PROACT 1 accelerated approval analysis in mid-2026, with pivotal topline results anticipated in Q2 2027. The PROACT 1 study is expected to have 90% power to detect an effect size in annualized eGFR slope of 1.75 mL/min/1.73m2, and 80% power to detect an effect size in annualized eGFR slope of 1.5 mL/min/1.73m2. Under rilparencel’s regenerative medicine advanced therapy (RMAT) designation, the U.S. Food and Drug Administration (FDA) agreed that an effect size in annualized eGFR slope of 1.5 mL/min/1.73m2 would be an acceptable demonstration of efficacy in the setting of patients receiving appropriate standard of care therapies. For context, in Group 1 of the Phase 2 REGEN-007 study, bilateral kidney injections with rilparencel were associated with a 4.6 mL/min/1.73m2 improvement in the annual decline in eGFR slope.
The information in this Item 7.01, including Exhibit 99.2 attached hereto, is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in this Item 7.01 and Exhibit 99.2 of this report will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Item 7.01 and Exhibit 99.2 is not intended to, and does not, constitute a determination or admission by the Company that the information in this report is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company or any of its affiliates.
Item 8.01 Other Events.
The statistical powering assumption for the surrogate endpoint (eGFR slope) analysis in the PROACT 1 study has been updated to 80%, while the statistical powering assumption for the confirmatory endpoint analysis remains at 80%.
Forward-Looking Statements
The disclosure in this Current Report on Form 8-K and the attached exhibits include “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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
 

 
 
 
 
 

 
 

 

 

 
 Exhibit No.

 Description

 

 
 99.1

 Press Release dated May 15, 2026

 

 
 99.2

 Investor Presentation

 

 
 104

 Cover Page Interactive Data File (embedded within Inline XBRL document)

 

  

 

 
 

 SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
 
 
 
 
 
 

 
  

  

  

 PROKIDNEY CORP.

 

 
  

  

  

  

 

 
 Date:

 May 15, 2026

 By:

 /s/ James Coulston

 

 
  

  

  

 James Coulston
Chief Financial Officer