Slide 1: Transforming the Future of Chronic Kidney Disease Treatment
Transforming the Future of Chronic Kidney Disease Treatment Corporate Presentation January 2026 Preserving Kidney Function in Patients at High Risk of Kidney Failure Exhibit 99.1
Slide 2: Forward-looking statements
This presentation includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. ProKidney’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these fo
Slide 3: Advanced CKD Patients Want More Time
Advanced CKD Patients Want More Time More time before dialysis More time for life’s moments More time and flexibility with the people who matter most Time for Hope
Slide 4: Rilparencel: Buying Meaningful Time
Rilparencel: Buying Meaningful Time NOVEL autologous cell therapy made from a patient’s own kidney cells CLINICAL DATA shows kidney function stabilization in multiple Phase 2 studies WELL-TOLERATED with no preconditioning or immunosuppression required PHASE 3 STUDY is ongoing with pivotal topline re
Slide 5: 2025 was a Pivotal Year for ProKidney
ProKidney 2025 was a Pivotal Year for ProKidney Aligned with FDA on an accelerated approval pathway for rilparencel using eGFR slope as the surrogate endpoint Presented positive Phase 2 REGEN-007 data as a late-breaking clinical trial at American Society of Nephrology (ASN) Kidney Week 2025 Generate
Slide 6: 2026 will be a Year of Highly Focused Execution
ProKidney 2026 will be A Year of Highly Focused Execution Complete enrollment for the accelerated approval efficacy analysis by mid-2026 Present results from ongoing mechanism of action studies at key medical & scientific conferences Maintain dialogue with FDA under RMAT designation to prepare for B
Slide 7: Transforming CKD Care with Innovation and Execution
ProKidney Transforming Chronic Kidney Disease (CKD) Care with Innovation and Execution Building a future where advanced CKD treatment means more options and more hope. First-in-class autologous cell therapy (RMAT designation) Rilparencel Pivotal Phase 3 trial in Stage 3b/4 CKD (Type 2 Diabetes) Thre
Slide 8: Rilparencel: A Patient's Own Cells—From Biopsy to Kidney Therapy
Rilparencel: A Patient’s Own Cells—From Biopsy to Kidney Therapy NOT ALL CELL THERAPIES ARE CREATED EQUAL Rilparencel: Made from a patient’s own kidney cells No genetic modification No preconditioning No lifelong immunosuppression Well-tolerated with favorable safety profile Then frozen for preserva
Slide 9: Continued Expansion of In-House Manufacturing Facilities
Purchased two adjacent buildings in Winston-Salem, NC in November 2024, totaling approximately 180,000 square feet Currently supports Phase 3 PROACT 1 clinical manufacturing, with capacity to accommodate future commercial supply Ongoing capital investment in manufacturing infrastructure and systems
Slide 10: Significant Unmet Need and Limitations with Standard-of-Care
CHRONIC KIDNEY DISEASE Significant Unmet Need and Limitations with Standard-of-Care
Slide 11: CKD risk categories and standard of care
Persistent albuminuria categories Description and range A1 A2 A3 <30 mg/g <3 mg/mmol 30–300 mg/g 3–30 mg/ mmol >300 mg/g >30 mg/ mmol Normal to mildly increased Moderately increased Severely increased GFR categories (mL/min/1.73m2) Description and range G1 ≥90 Normal or high G2 60–89 Mildly decrease
Slide 12: Limited Therapeutic Options that Delay Dialysis in Stage 4 CKD
Limited Therapeutic Options that Delay Dialysis in Patients with Stage 4 CKD All recent landmark clinical trials in CKD primarily focus on Stage 2 and 3 CKD Study Active Product Subjects with Stage 4 CKD Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy1 Canagliflozin (SGLT2 inhibi
Slide 13: Standard of Care Has Limitations
Dapagliflozin: 19 patients required treatment to prevent one primary outcome event While New Therapies Are a Step Forward, Patients Still Lose Kidney Function and Experience Clinically Significant Events Standard of care includes ACE inhibitors, angiotensin receptor blockers and SGLT2 inhibitors Hee
Slide 14: Rilparencel: Transforming the CKD Treatment Landscape
RILPARENCEL RENAL AUTOLOGOUS CELL THERAPY Transforming the Chronic Kidney Disease Treatment Landscape
Slide 15: Advancing Kidney Care: Rilparencel Trials at a Glance
Advancing Kidney Care: Rilparencel Trials at a Glance 006/PROACT 1 PRECLINICAL IND PHASE 1 PHASE 2 PHASE 3 STATUS Pivotal Trial Program Diabetes Type II – Prevent/Delay ESKD in Stage 3b/4 CKD (20-35 mL/min/1.73m2) 008 002 007 003 004 Ongoing Long term follow-up study for patients previously treated
Slide 16: REGEN-006 (PROACT 1) Rilparencel Registrational Program
Day –60 to Day 0 Screening Visit Sham Cohort Sham 1st Rilparencel Injection Sham 2nd Rilparencel Injection Sham Biopsy End of Study (EOS) 1st Rilparencel Injection 2nd Rilparencel Injection Biopsy End of Study (EOS) REGEN-006 (PROACT 1) Rilparencel Registrational Program Topline results for the eGFR
Slide 17: PROACT 1 Enrollment Momentum Supports Q2 2027 Readout
REGEN-006 (PROACT 1) 2025 Enrollment Momentum Gives Confidence in Q2 2027 Pivotal Readout Timing > 80% power > 85% power ~90% power Enrolled and Treated Projected Accelerated approval is dependent upon the comparison of eGFR slope between the treated group and the sham group in PROACT 1 Assuming con
Slide 18: Mechanism of Action Studies: Anticipated Results
Anticipated Results Whole genome expression profile in diseased & normal kidney cells +/- rilparencel treatment Confirmation of key factors expressed by rilparencel, & the disease pathways they act upon, which are necessary & sufficient for its therapeutic effect Whole genome expression profile in d
Slide 19: Rilparencel Clinical Results
RILPARENCEL CLINICAL RESULTS Advancing Cell Therapy For Chronic Kidney Disease
Slide 20: Clinical Progression: From Proof to Pivotal Phase
2024 Clinical Progression: From Proof to Pivotal Phase 2 RMCL-002: Full results presented at ERA Stockholm 2024 SIGNAL Potential to preserve kidney function for 18 months; benefit to kidney function was most notable in subjects who had the highest risk of kidney failure SAFETY Comparable to kidney b
Slide 21: REGEN-007 Trial Design
REGEN-007 Trial Design Group 1 Dosing Regimen and Use of Cryopreserved Product Mirrors Phase 3 Program Type 1 or type 2 diabetes and CKD Subjects 30-80 years of age eGFR ≥20 and ≤50 mL/min/1.73m2 UACR 30-5000 mg/g HbA1c <10% Key Entry Criteria Day –60 to Day –7 Screening Visit u = Follow-up Visit Af
Slide 22: REGEN-007 Objectives and Endpoints
REGEN-007 Objectives and Endpoints Study Objective Evaluate the efficacy, safety, and durability of up to two rilparencel injections on progression of kidney disease in two patient groups using different dosing regimens Primary Efficacy Endpoint Difference in annual eGFR slope in the pre-injection p
Slide 23: REGEN-007 Baseline Characteristics
REGEN-007 Baseline Characteristics REGEN-007 (n=49) Group 1 (n=24) Group 2 (n=25) Age, years (mean +/- SD) 62 +/- 11 58 +/- 11 Female : Male, % 33% : 67% 28% : 72% Hispanic or Latino, % 0% 4% Race, % Black or African American 8% 16% White 92% 84% Other 0% 0% Type 1 Diabetes : Type 2 Diabetes, % 13%
Slide 24: REGEN-007 Kidney Function Stabilized in Both Groups
REGEN-007 Kidney Function Stabilized in Both Groups After Treatment with Rilparencel Annual decline in eGFR slope1 improved by 78% from -5.84 in the pre-injection period to -1.27 in the period following the last rilparencel injection. This 4.57 (1.95, 7.18)* mL/min/1.73m2 per year difference was sta
Slide 25: REGEN-007 Kidney Function Stabilizes for Months After Treatment
REGEN-007 Kidney Function Stabilizes for 18 Months After Treatment with Rilparencel 15 10 5 0 -5 -10 -2 -1 0 1 2 Time (years) eGFR Change from Baseline (mL/min/1.73m2) Group 1 (n=24) Group 2 (n=25) 15 10 5 0 -5 -10 -2 -1 0 1 2 Time (years) eGFR Change from Baseline (mL/min/a1.73m2) Pre First-Injecti
Slide 26: REGEN-007 Subgroup Analysis
Group 1 (n=24) Group 2 (n=25) Slope Difference (95% CI) No. of Participants (%) 2.6 (-1.2, 6.4) 3 (13) 4.9 (2.0, 7.9) 21 (88) Not evaluable 0 Not evaluable 2 (8) 3.6 (0.5, 6.6) 9 (38) 5.6 (1.5, 9.8) 13 (54) Not evaluable 0 5.2 (1.4, 8.9) 3 (13) 9.5 (3.2, 15.8) 7 (29) 0.2 (-2.3, 2.8) 14 (58) 6.7 (1.9
Slide 27: REGEN-007 Group 1 SGLT2i Use Summary
REGEN-007 Group 1 | SGLT2i Use Summary Ten patients (42%) were on SGLT2i at baseline; 3 of these 10 patients discontinued SGLT2i after receiving rilparencel An additional 8 patients (33%) initiated SGLT2i after receiving rilparencel In total, 18 patients (75%) received SGLT2i at some point during th
Slide 28: REGEN-007 Baseline Characteristics: Patients Meeting PROACT 1 Criteria
REGEN-007 Baseline Characteristics: Patients Meeting Key Phase 3 PROACT 1 Inclusion Criteria HbA1c = hemoglobin A1c; ACE = angiotensin converting enzyme; ARB = angiotensin II receptor blockers; SGLT2i = sodium-glucose cotransporter-2 protein inhibitor; GLP-1 RA = glucagon-like peptide-1 receptor ago
Slide 29: Similar Efficacy in Patients Meeting PROACT 1 Inclusion Criteria
REGEN-007 Similar Efficacy Results Were Observed in Patients Meeting Key Phase 3 PROACT 1 Inclusion Criteria 1. Annual eGFR slope calculated in mL/min/1.73m2 using a linear mixed effects model *(95% CI) Annual decline in eGFR slope1 improved by 85% from -6.46 in the pre-injection period to -0.95 in
Slide 30: No Rilparencel-Related Serious Adverse Events Observed
Adverse Event Biopsy # of SAEs (n=51) Rilparencel Injection # of SAEs (n=49) Rilparencel # of SAEs (n=49) Acute Kidney Injury 2 - - Death - - - Hematoma 2 1 - Hematuria 1 - - Hydronephrosis 1 - - REGEN-007 No Rilparencel-Related Serious Adverse Events Were Observed
Slide 31: Next Steps: Clinical Confidence, Strategic Path Forward
Next Steps FOCUS on the continued enrollment of patients in our registrational Phase 3 PROACT 1 study COMPLETE mechanism of action studies PREPARE for BLA submission and commercial launch Key Findings Bilateral dosing of cryopreserved product (which mirrors the Phase 3 study dosing regimen) resulted
Slide 32: Executing with Strength: Financial Snapshot
EXECUTING WITH STRENGTH Financial Snapshot
Slide 33: Strong Balance Sheet, Clear Path to Value Creation
MILESTONES KEY FINANCIALS Strong Balance Sheet, Clear Path to Value Creation Shares Outstanding 300,834,379* Cash Position $272M** Runway Expected to fund operations into mid-2027 Analyst Coverage 8 Firms Mid-2026 2026-2027 Q2 2027 Complete accelerated approval enrollment in Phase 3 PROACT 1 Topline
Slide 34: Patients Want More Time
Patients Want More Time We are building a future where advanced CKD treatment means more options and more hope