Earnings summaries and quarterly performance for PROKIDNEY.
Research analysts who have asked questions during PROKIDNEY earnings calls.
Recent press releases and 8-K filings for PROK.
ProKidney Corp. Updates Phase 3 Trial Enrollment and Data Readout Timelines
PROK
Guidance Update
New Projects/Investments
- ProKidney Corp. has updated the total target enrollment for its Phase 3 REGEN-006 ("PROACT 1") study to approximately 470 subjects.
- The company continues to anticipate topline data readout of the surrogate endpoint (eGFR slope) in the second quarter of 2027, but now expects the topline data readout of the confirmatory endpoint (composite time-to-event) in the second half of 2029.
- ProKidney anticipates completing enrollment for the PROACT 1 accelerated approval efficacy analysis (n=~360) by mid-2026 and expects potential BLA approval and commercial launch of rilparencel in 2H 2028.
- As of September 30, 2025, ProKidney reported a cash position of $272 million, which is expected to fund operations into mid-2027.
4 days ago
ProKidney Provides Update on Rilparencel Clinical Development and Financial Outlook
PROK
New Projects/Investments
Guidance Update
- ProKidney is advancing rilparencel, an autologous cell therapy, to treat advanced chronic kidney disease and prevent kidney failure.
- The company reported positive Phase 2 REGEN-007 data in November 2025, demonstrating a 78% improvement in annual eGFR slope decline in the group mirroring the Phase 3 program, with a favorable safety profile.
- ProKidney has aligned with the FDA for an accelerated approval pathway using eGFR slope for its pivotal Phase 3 PROACT 1 study.
- Enrollment for the accelerated approval efficacy analysis in PROACT 1 is expected to be completed by mid-2026, with the top-line readout anticipated in Q2 2027.
- As of September 2025, ProKidney held $270 million in cash, providing a financial runway past the Q2 2027 data readout into mid-2027.
Jan 14, 2026, 4:15 PM
ProKidney Provides Update on Rilparencel Phase 3 Progress and Financial Runway
PROK
New Projects/Investments
Guidance Update
- ProKidney is advancing rilparencel, an autologous cell therapy for advanced chronic kidney disease, with the pivotal Phase 3 PROACT 1 study readout anticipated in Q2 2027.
- The company has aligned with the FDA on an accelerated approval pathway using eGFR slope as a surrogate endpoint and expects to complete enrollment for this analysis by mid-2026.
- Positive Phase 2 REGEN-007 data, presented in November 2025, demonstrated a 78% improvement in annual eGFR slope decline in the group designed to mirror the Phase 3 program.
- ProKidney reported $270 million in cash at the end of September (2025), providing a cash runway into mid-2027, beyond the top-line data readout.
- The company is also expanding its in-house manufacturing footprint in Winston-Salem, North Carolina, to support future commercial launch.
Jan 14, 2026, 4:15 PM
ProKidney Provides Update on Rilparencel Clinical Development and Financials
PROK
Guidance Update
New Projects/Investments
Product Launch
- ProKidney anticipates pivotal topline results for the eGFR slope surrogate endpoint from its Phase 3 REGEN-006 (PROACT 1) trial in Q2 2027, with enrollment for the accelerated approval efficacy analysis expected to complete by mid-2026.
- The company reported a cash position of $272 million as of September 30, 2025, which is expected to fund operations into mid-2027.
- Positive Phase 2 REGEN-007 data, presented at ASN Kidney Week 2025, showed that the Phase 3 dosing regimen group experienced a 78% improvement in the annual decline of eGFR slope, with no rilparencel-related serious adverse events.
- ProKidney is expanding its in-house manufacturing footprint, having purchased two adjacent buildings in November 2024 totaling approximately 180,000 square feet, to support Phase 3 manufacturing and future commercial supply.
Jan 14, 2026, 4:15 PM
PROKIDNEY CORP. Provides Update on Rilparencel Phase 3 Trial Progress and Financial Outlook
PROK
New Projects/Investments
Guidance Update
Product Launch
- PROKIDNEY CORP. (PROK) released an investor presentation in January 2026 detailing the progress of its autologous cell therapy, Rilparencel, for Chronic Kidney Disease (CKD).
- The Phase 3 PROACT 1 study is ongoing, with enrollment for accelerated approval efficacy analysis expected by mid-2026 and topline results anticipated in Q2 2027. The FDA has aligned on eGFR slope as a surrogate endpoint for accelerated approval.
- Positive Phase 2 REGEN-007 data demonstrated a statistically significant 78% improvement in annual eGFR slope in Group 1, from -5.84 to -1.27, and no rilparencel-related serious adverse events.
- As of September 30, 2025, the company reported a cash position of $272 million, which is expected to fund operations into mid-2027, and is expanding its manufacturing facilities.
Jan 12, 2026, 12:54 PM
ProKidney Provides Update on Rilparencel Phase 3 Trial and Financial Position
PROK
New Projects/Investments
Guidance Update
Product Launch
- ProKidney is developing rilparencel, an autologous cell product in a Phase 3 trial for advanced chronic kidney disease, with an accelerated approval readout expected in Q2 2027 using eGFR slope.
- The company reported positive Phase 2 data from its 007 study, demonstrating a 78% improvement in the decline of kidney function in the treatment group that mirrors the Phase 3 paradigm.
- As of September 30th, ProKidney held $272 million in cash, providing a runway to mid-2027, which covers the anticipated Phase 3 data readout for accelerated approval.
- The Phase 3 trial is currently over 50% enrolled, with full enrollment for the surrogate endpoint anticipated in 2026.
- The target market for rilparencel includes 1 to 1.5 million stage 3B and 4 CKD patients with diabetes in the U.S., with the potential to deliver $150,000 of value per patient annually by delaying dialysis.
Nov 12, 2025, 3:00 PM
ProKidney Reports Third Quarter 2025 Financial Results and Clinical Updates
PROK
Earnings
Guidance Update
New Projects/Investments
- ProKidney Corp. ended the third quarter of 2025 with $271.7 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into mid-2027.
- For the three months ended September 30, 2025, Research and development expenses were $26.8 million (compared to $31.3 million in Q3 2024) and General and administrative expenses were $11.9 million (compared to $17.7 million in Q3 2024).
- The company presented full results from the Phase 2 REGEN-007 study, which showed a 78% improvement in the annual decline in eGFR slope in Group 1 patients with advanced CKD and diabetes.
- More than half of the patients required for the Phase 3 REGEN-006 (PROACT 1) accelerated approval analysis have been enrolled, with topline results anticipated in Q2 2027. The FDA has confirmed eGFR slope as the surrogate endpoint for a Biologics License Application (BLA) submission under the accelerated approval pathway.
Nov 10, 2025, 9:20 PM
PROKIDNEY Discusses Positive Phase II Data and Phase III Progress for Roperinsel
PROK
New Projects/Investments
Guidance Update
- ProKidney's autologous cell therapy, roperinsel, demonstrated a 78% improvement in the decline of kidney function in Group 1 of its Phase II REGEN-seven trial, with top-line results announced in July. Full data, including subgroup analyses and safety, will be presented at ASN Kidney Week in early November.
- The Phase III PROACT one study, targeting patients with eGFR 20 to 35, is over 50% enrolled for accelerated approval, which is expected to read out in 2027.
- The company holds an RMAT designation from the FDA, making a single Phase III study sufficient for approval.
- ProKidney has a cash runway into mid-2027, covering the accelerated approval readout, but will require additional funding for the full approval confirmatory analysis.
- The company is expanding its manufacturing capabilities and anticipates that demand for roperinsel could outstrip supply in the initial years post-launch if Phase III efficacy mirrors Phase II results.
Sep 3, 2025, 3:44 PM
Quarterly earnings call transcripts for PROKIDNEY.
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