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ProKidney Corp. 2025 Annual Report
Dear Stockholders, As we gather for the 2026 Annual Mee ng, I am pleased to re ect on a transforma ve year for ProKidney. In 2025, we achieved pivotal milestones that strengthened rilparencel s clinical founda on, advanced our regulatory strategy, and posi oned the company for meaningful progress in the years ahead. Last year, we delivered posi ve Phase 2 REGEN-007 results, secured alignment with the U.S. Food and Drug Administra on (FDA) on the accelerated approval pathway for rilparencel, and generated strong enrollment momentum in the Phase 3 PROACT 1 study. These accomplishments re ect the dedica on of our team and the growing recogni on of rilparencel s poten al to address the urgent unmet need in pa ents with advanced chronic kidney disease (CKD) and diabetes who are at high risk of kidney failure. In November 2025, we presented full Phase 2 REGEN-007 data as a late-breaking clinical trial at the American Society of Nephrology (ASN) Kidney Week, followed by publica on in the Clinical Journal of the American Society of Nephrology in January 2026. These results reinforced rilparencel s therapeu c poten al and validated key elements of our Phase 3 design, including bilateral dosing and the use of cryopreserved product. Our regulatory progress was equally signi cant. In a July 2025 Type B mee ng, the FDA con rmed that eGFR slope from the ongoing Phase 3 PROACT 1 study may serve as the surrogate endpoint and primary basis for a Biologics License Applica on (BLA) under the accelerated approval pathway. Importantly, the FDA also con rmed that PROACT 1 may support both accelerated and con rmatory approval of rilparencel. We con nue to engage with the FDA under our Regenera ve Medicine Advanced Therapy (RMAT) designa on as we work to bring this novel therapy to pa ents as e ciently as possible. Enrollment in the Phase 3 PROACT 1 study accelerated throughout 2025, posi oning us to complete full enrollment in the second half of 2026 and to expect a pivotal eGFR slope topline readout in the second quarter of 2027. These milestones represent important steps toward the poten al commercializa on of rilparencel. I remain deeply grateful to our employees for their unwavering commitment, to our inves gators and clinical study par cipants for their essen al partnership, and to our shareholders for their con nued support. Together, we are advancing toward a poten al new treatment op on for pa ents with signi cant unmet need, and we look forward to sharing our progress as this important work con nues. Best regards, Bruce Culleton, M.D. Chief Execu ve O cer and Director
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 • shareholder letter icon 4/17/2026 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 4/28/2025 PROK Stockholder Letter
 • stockholder letter icon More "Biotechnology" Category Stockholder Letters
 • Benford's Law Stocks icon PROK Benford's Law Stock Score = 76


PROK Shareholder/Stockholder Letter Transcript:

ProKidney Corp.
2025 Annual Report


Dear Stockholders,
As we gather for the 2026 Annual Mee  ng, I am pleased to re  ect on a transforma  ve year for
ProKidney. In 2025, we achieved pivotal milestones that strengthened rilparencel   s clinical founda  on,
advanced our regulatory strategy, and posi  oned the company for meaningful progress in the years
ahead.
Last year, we delivered posi  ve Phase 2 REGEN-007 results, secured alignment with the U.S. Food and
Drug Administra  on (FDA) on the accelerated approval pathway for rilparencel, and generated strong
enrollment momentum in the Phase 3 PROACT 1 study. These accomplishments re  ect the dedica  on of
our team and the growing recogni  on of rilparencel   s poten  al to address the urgent unmet need in
pa  ents with advanced chronic kidney disease (CKD) and diabetes who are at high risk of kidney failure.
In November 2025, we presented full Phase 2 REGEN-007 data as a late-breaking clinical trial at the
American Society of Nephrology (ASN) Kidney Week, followed by publica  on in the Clinical Journal of the
American Society of Nephrology in January 2026. These results reinforced rilparencel   s therapeu  c
poten  al and validated key elements of our Phase 3 design, including bilateral dosing and the use of
cryopreserved product.
Our regulatory progress was equally signi  cant. In a July 2025 Type B mee  ng, the FDA con  rmed that
eGFR slope from the ongoing Phase 3 PROACT 1 study may serve as the surrogate endpoint and primary
basis for a Biologics License Applica  on (BLA) under the accelerated approval pathway. Importantly, the
FDA also con  rmed that PROACT 1 may support both accelerated and con  rmatory approval of
rilparencel. We con  nue to engage with the FDA under our Regenera  ve Medicine Advanced Therapy
(RMAT) designa  on as we work to bring this novel therapy to pa  ents as e  ciently as possible.
Enrollment in the Phase 3 PROACT 1 study accelerated throughout 2025, posi  oning us to complete full
enrollment in the second half of 2026 and to expect a pivotal eGFR slope topline readout in the second
quarter of 2027. These milestones represent important steps toward the poten  al commercializa  on of
rilparencel.
I remain deeply grateful to our employees for their unwavering commitment, to our inves  gators and
clinical study par  cipants for their essen  al partnership, and to our shareholders for their con  nued
support. Together, we are advancing toward a poten  al new treatment op  on for pa  ents with
signi  cant unmet need, and we look forward to sharing our progress as this important work con  nues.
Best regards,
Bruce Culleton, M.D.
Chief Execu  ve O  cer and Director

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shareholder letter icon 4/17/2026 Letter Continued (Full PDF)
 

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