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
4/26/2024 Letter Continued (Full PDF)