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.
2023 Annual Report
Dear Shareholders,
As we prepare for our 2024 Annual General Mee  ng of Shareholders, I am honored to address you for the
  rst   me as ProKidney   s Chief Execu  ve O  cer. I would like to thank ProKidney   s Board of Directors for
entrus  ng me with this opportunity. Over the last six months, we have navigated considerable challenges
with courage and determina  on, posi  oning our Company for future success.
Re  ec  ng on the events of the past year, it is evident that we faced substan  al hurdles. We temporarily
paused the manufacturing of rilparancel (also known as REACT  ), our proprietary autologous cell therapy,
to optimize our capabilities to meet EU and global standards for our Phase 3 registrational program
(PROACT1 and PROACT2 studies) and enable future commercial manufacturing. In doing so, we also
paused enrollment in our Phase 3 registra  onal program and completed an amendment to PROACT1 to
be  er align the study   s design with our interim Phase 2 RMCL-002 clinical study results. The amendment
also aligned with payor and provider research that found rilparancel to be most a  rac  ve in a subset of
pa  ents with advanced kidney disease. These measures were not taken lightly, but they were necessary
steps in our commitment to bring a safe and e  ec  ve autologous cell therapy to pa  ents with advanced
kidney disease. We remain con  dent that we will re-start manufacturing and begin enrollment of new
pa  ents in PROACT1 and PROACT2 in the very near future.
At the   me of the 2024 Annual General Mee  ng, we expect to have presented the   nal results of RMCL002 as a late-breaking clinical trial at the 61st Annual ERA Mee  ng in Stockholm. Analysis of this data
suggests that rilparancel preserves kidney func  on in several pa  ent groups with advanced kidney disease
caused by Type 2 diabetes, with the most notable poten  al bene  t observed in pa  ents who were at the
highest risk of kidney failure. Today, there are limited therapeu  c op  ons to delay progression to kidney
failure and dialysis in this high-risk pa  ent group. We are also excited to share interim results from the
Phase 2 REGEN-007 clinical study shortly a  er the Annual General Mee  ng. Results from this study will
provide a window into the poten  al outcomes of our Phase 3 studies.
As we navigate through this transforma  ve period and look to the future, I am op  mis  c and con  dent in
our ability to relaunch our Phase 3 studies and deliver value to our shareholders. More importantly,
ProKidney   s team is mo  vated to help pa  ents and their families who seek treatment op  ons that are
be  er than dialysis. As a company, we share this sense of urgency because every day counts when endstage kidney disease is on the horizon.
In closing, I would like to thank you, our shareholders, for your commitment and unwavering support of
ProKidney. I am also grateful for our employees and their dedica  on to our mission. Together, we will
drive meaningful impact and transform the lives of CKD pa  ents around the world.
Best regards,
Dr. Bruce Culleton
Chief Execu  ve O  cer and Director
 • shareholder letter icon 4/26/2024 Letter Continued (Full PDF)
 • stockholder letter icon 5/26/2023 PROK Stockholder Letter
 • stockholder letter icon More "Biotechnology" Category Stockholder Letters
 • Benford's Law Stocks icon PROK Benford's Law Stock Score = 71


PROK Shareholder/Stockholder Letter Transcript:

ProKidney Corp.
2023 Annual Report


Dear Shareholders,
As we prepare for our 2024 Annual General Mee  ng of Shareholders, I am honored to address you for the
  rst   me as ProKidney   s Chief Execu  ve O  cer. I would like to thank ProKidney   s Board of Directors for
entrus  ng me with this opportunity. Over the last six months, we have navigated considerable challenges
with courage and determina  on, posi  oning our Company for future success.
Re  ec  ng on the events of the past year, it is evident that we faced substan  al hurdles. We temporarily
paused the manufacturing of rilparancel (also known as REACT  ), our proprietary autologous cell therapy,
to optimize our capabilities to meet EU and global standards for our Phase 3 registrational program
(PROACT1 and PROACT2 studies) and enable future commercial manufacturing. In doing so, we also
paused enrollment in our Phase 3 registra  onal program and completed an amendment to PROACT1 to
be  er align the study   s design with our interim Phase 2 RMCL-002 clinical study results. The amendment
also aligned with payor and provider research that found rilparancel to be most a  rac  ve in a subset of
pa  ents with advanced kidney disease. These measures were not taken lightly, but they were necessary
steps in our commitment to bring a safe and e  ec  ve autologous cell therapy to pa  ents with advanced
kidney disease. We remain con  dent that we will re-start manufacturing and begin enrollment of new
pa  ents in PROACT1 and PROACT2 in the very near future.
At the   me of the 2024 Annual General Mee  ng, we expect to have presented the   nal results of RMCL002 as a late-breaking clinical trial at the 61st Annual ERA Mee  ng in Stockholm. Analysis of this data
suggests that rilparancel preserves kidney func  on in several pa  ent groups with advanced kidney disease
caused by Type 2 diabetes, with the most notable poten  al bene  t observed in pa  ents who were at the
highest risk of kidney failure. Today, there are limited therapeu  c op  ons to delay progression to kidney
failure and dialysis in this high-risk pa  ent group. We are also excited to share interim results from the
Phase 2 REGEN-007 clinical study shortly a  er the Annual General Mee  ng. Results from this study will
provide a window into the poten  al outcomes of our Phase 3 studies.
As we navigate through this transforma  ve period and look to the future, I am op  mis  c and con  dent in
our ability to relaunch our Phase 3 studies and deliver value to our shareholders. More importantly,
ProKidney   s team is mo  vated to help pa  ents and their families who seek treatment op  ons that are
be  er than dialysis. As a company, we share this sense of urgency because every day counts when endstage kidney disease is on the horizon.
In closing, I would like to thank you, our shareholders, for your commitment and unwavering support of
ProKidney. I am also grateful for our employees and their dedica  on to our mission. Together, we will
drive meaningful impact and transform the lives of CKD pa  ents around the world.
Best regards,
Dr. Bruce Culleton
Chief Execu  ve O  cer and Director




shareholder letter icon 4/26/2024 Letter Continued (Full PDF)
 

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