On this page of StockholderLetter.com we present the latest annual shareholder letter from PROKIDNEY CORP. — ticker symbol PROK. Reading current and past PROK letters to shareholders can bring important insights into the investment thesis.
ProKidney Corp. 2024 Annual Report
Dear Shareholders, As we come together for the 2025 Annual General Mee ng, I m proud to re ect on the meaningful progress ProKidney has made over the past year. When I addressed you in 2024, we were naviga ng a pivotal phase of transi on and strategic realignment. Today, I m pleased to report that the steps we took are driving momentum across several cri cal areas of our business. While we remain grounded by the challenges that lie ahead, our team is steadily advancing toward our goal of delivering a novel treatment op on for pa ents with advanced chronic kidney disease (CKD) and Type 2 diabetes (T2D). In the rst half of 2024, we completed a comprehensive manufacturing update that included the implementa on of improved quality management systems to ensure compliance with global standards and lay the founda on for future commercial produc on. During this period, we also completed a protocol amendment for our Phase 3 REGEN-006 (PROACT 1) study to focus on pa ents at highest risk of kidney failure with advanced CKD and T2D. This re nement was driven by data insights from our Phase 2 RMCL-002 study presented in May 2024 as a late-breaking clinical trial at the 61st Annual ERA Congress in Stockholm. Importantly, the amendment also re ected feedback from payors and providers emphasizing the urgent need for solu ons in this high-risk CKD popula on. In June 2024, we shared interim data from our ongoing Phase 2 REGEN-007 study. Among pa ents with at least 12 months of follow-up a er a second injec on of rilparencel (n=13), kidney func on stabilized for 18 months, with an average eGFR change from baseline of -1.3 ml/min/1.73m2. REGEN-007 marked our rst use of bilateral dosing and cryopreserved rilparencel an approach that aligns with our Phase 3 protocol. Notably, no serious adverse events related to rilparencel were observed among the 49 treated pa ents. Upon sharing the REGEN-007 interim update, we strengthened our nancial posi on with , extending cash runway into mid-2027. This capital raise supports the con nued execu on of our Phase 3 PROACT 1 study and re ects growing con dence in our science, team, and long-term vision. In the second half of the year, we conducted a thorough review of our Phase 3 program and made the strategic decision to discon nue the Phase 3 REGEN-016 (PROACT 2) study designed to enroll pa ents outside of the U.S. This adjustment re ects our ini al focus to accelerate rilparencel s path to market in the U.S. We also made important regulatory progress. In Q4, we held a produc ve Type B mee ng with the FDA under our Regenera ve Medicine Advanced Therapy (RMAT) designa on. The FDA con rmed that PROACT 1 may be su cient to support a Biologics License Applica on (BLA) and poten al full approval of rilparencel. Notably, the FDA also con rmed that eGFR slope may be an acceptable surrogate endpoint to support an accelerated approval. We look forward to our next Type B mee ng with the FDA in mid-2025 where we aim to align with FDA on an accelerated study design. We have clear priori es in 2025: Con nue advancing pa ent enrollment in the Phase 3 PROACT 1 study Present nal data from the Phase 2 REGEN-007 study Align with the FDA on an accelerated approval pathway Share new insights from our ongoing mechanism of ac on research
To our employees: thank you for your steadfast commitment to our mission. To our inves gators and clinical study par cipants: your partnership is essen al to our progress, thank you. And to our shareholders: thank you for your con nued trust and commitment as we work to transform the therapeu c landscape for pa ents with advanced CKD and T2D. Best regards, Bruce Culleton, M.D. Chief Execu ve O cer and Director
 • shareholder letter icon 4/28/2025 Letter Continued (Full PDF)
 • stockholder letter icon 5/26/2023 PROK Stockholder Letter
 • stockholder letter icon 4/26/2024 PROK Stockholder Letter
 • stockholder letter icon More "Biotechnology" Category Stockholder Letters
 • Benford's Law Stocks icon PROK Benford's Law Stock Score = 95


PROK Shareholder/Stockholder Letter Transcript:

ProKidney Corp.
2024 Annual Report


Dear Shareholders,
As we come together for the 2025 Annual General Mee  ng, I   m proud to re  ect on the meaningful
progress ProKidney has made over the past year. When I addressed you in 2024, we were naviga  ng a
pivotal phase of transi  on and strategic realignment. Today, I   m pleased to report that the steps we took
are driving momentum across several cri  cal areas of our business. While we remain grounded by the
challenges that lie ahead, our team is steadily advancing toward our goal of delivering a novel treatment
op  on for pa  ents with advanced chronic kidney disease (CKD) and Type 2 diabetes (T2D).
In the   rst half of 2024, we completed a comprehensive manufacturing update that included the
implementa  on of improved quality management systems to ensure compliance with global standards
and lay the founda  on for future commercial produc  on. During this period, we also completed a
protocol amendment for our Phase 3 REGEN-006 (PROACT 1) study to focus on pa  ents at highest risk of
kidney failure with advanced CKD and T2D. This re  nement was driven by data insights from our Phase 2
RMCL-002 study presented in May 2024 as a late-breaking clinical trial at the 61st Annual ERA Congress in
Stockholm. Importantly, the amendment also re  ected feedback from payors and providers emphasizing
the urgent need for solu  ons in this high-risk CKD popula  on.
In June 2024, we shared interim data from our ongoing Phase 2 REGEN-007 study. Among pa  ents with at
least 12 months of follow-up a  er a second injec  on of rilparencel (n=13), kidney func  on stabilized for
18 months, with an average eGFR change from baseline of -1.3 ml/min/1.73m2. REGEN-007 marked our
  rst use of bilateral dosing and cryopreserved rilparencel   an approach that aligns with our Phase 3
protocol. Notably, no serious adverse events related to rilparencel were observed among the 49 treated
pa  ents.
Upon sharing the REGEN-007 interim update, we strengthened our   nancial posi  on with                     
                                                                                                        , extending cash runway into mid-2027. This capital
raise supports the con  nued execu  on of our Phase 3 PROACT 1 study and re  ects growing con  dence in
our science, team, and long-term vision.
In the second half of the year, we conducted a thorough review of our Phase 3 program and made the
strategic decision to discon  nue the Phase 3 REGEN-016 (PROACT 2) study designed to enroll pa  ents
outside of the U.S. This adjustment re  ects our ini  al focus to accelerate rilparencel   s path to market in
the U.S.
We also made important regulatory progress. In Q4, we held a produc  ve Type B mee  ng with the FDA
under our Regenera  ve Medicine Advanced Therapy (RMAT) designa  on. The FDA con  rmed that
PROACT 1 may be su  cient to support a Biologics License Applica  on (BLA) and poten  al full approval of
rilparencel. Notably, the FDA also con  rmed that eGFR slope may be an acceptable surrogate endpoint to
support an accelerated approval. We look forward to our next Type B mee  ng with the FDA in mid-2025
where we aim to align with FDA on an accelerated study design.
We have clear priori  es in 2025:


Con  nue advancing pa  ent enrollment in the Phase 3 PROACT 1 study
Present   nal data from the Phase 2 REGEN-007 study
Align with the FDA on an accelerated approval pathway
Share new insights from our ongoing mechanism of ac  on research

To our employees: thank you for your steadfast commitment to our mission. To our inves  gators and
clinical study par  cipants: your partnership is essen  al to our progress, thank you. And to our
shareholders: thank you for your con  nued trust and commitment as we work to transform the
therapeu  c landscape for pa  ents with advanced CKD and T2D.
Best regards,
Bruce Culleton, M.D.
Chief Execu  ve O  cer and Director



shareholder letter icon 4/28/2025 Letter Continued (Full PDF)
 

PROK Stockholder/Shareholder Letter (PROKIDNEY CORP.) | www.StockholderLetter.com
Copyright © 2023 - 2026, All Rights Reserved

Nothing in StockholderLetter.com is intended to be investment advice, nor does it represent the opinion of, counsel from, or recommendations by BNK Invest Inc. or any of its affiliates, subsidiaries or partners. None of the information contained herein constitutes a recommendation that any particular security, portfolio, transaction, or investment strategy is suitable for any specific person. All viewers agree that under no circumstances will BNK Invest, Inc,. its subsidiaries, partners, officers, employees, affiliates, or agents be held liable for any loss or damage caused by your reliance on information obtained. By visiting, using or viewing this site, you agree to the following Full Disclaimer & Terms of Use and Privacy Policy.