ProKidney Raises PROACT 1 Enrollment Target to Over 500

The Tip Desk · November 13, 2026 · 3 min read

Cash, cash equivalents and marketable securities stood at $141.9 million at September 30, 2026, which the company said supports operations into mid-2027.

ProKidney Corp. (PROK), a late clinical-stage cell therapy company focused on chronic kidney disease, said it now anticipates completing full enrollment for the PROACT 1 confirmatory analysis in the first quarter of 2027 with over 500 patients, up from a prior target of 470, after an acceleration in recruitment in mid-2026.

The company said it remains on track to deliver topline results for the pivotal Phase 3 PROACT 1 surrogate endpoint, annualized eGFR slope, in the second quarter of 2027. The efficacy analysis set is expected to include approximately 320 patients. The confirmatory composite time-to-event endpoint readout remains expected in the second half of 2029.

In the second quarter, ProKidney had said it had completed enrollment of patients contributing to the accelerated-approval efficacy analysis and was on track to finish full enrollment of about 470 patients in the second half of 2026. The third-quarter update moved that full-enrollment finish earlier and larger.

Chief Executive Bruce Culleton said the third quarter marked continued progress, with PROACT 1 advancing toward full enrollment and the eGFR slope topline readout remaining on track for the second quarter of 2027. He said data presented at Kidney Week further build the mechanistic and clinical evidence supporting rilparencel.

The company presented eight abstracts at ASN Kidney Week 2026, including seven spanning CKD translational models and drug product characterization and one pooled Phase 2 clinical analysis. After the meeting it hosted a virtual key-opinion-leader event with nephrology researcher Katherine Tuttle, M.D., on mechanism-of-action findings and rilparencel’s potential role in advanced CKD and type 2 diabetes.

Research and development expenses were $40.8 million for the three months ended September 30, 2026, compared with $26.8 million a year earlier. The company said the $14.0 million increase was driven by a $7.4 million rise in clinical study and related manufacturing costs, primarily related to PROACT 1, plus $1.3 million in professional fees and $3.5 million in other operational costs tied to continued enrollment, ongoing activities and preparation for regulatory filings. Compensation costs rose about $1.8 million on additional hires.

General and administrative expenses were $13.1 million for the three months ended September 30, 2026, compared with $11.9 million a year earlier. The company said a $1.7 million increase in compensation costs related to hiring was partially offset by decreases in professional fees and impairment charges.

Net loss before noncontrolling interest was $51.8 million for the three months ended September 30, 2026, compared with $35.8 million a year earlier. Net loss available to Class A common stockholders was $35.6 million, or $0.17 a share, versus $16.5 million, or $0.12 a share, a year earlier. Weighted-average Class A shares outstanding were 207.8 million. Class A and Class B common stock outstanding totaled 302,371,200 shares at September 30, 2026.

Cash, cash equivalents and marketable securities totaled $141.9 million as of September 30, 2026, compared with $181.6 million as of June 30, 2026. The company said the cash balance supports operations into mid-2027.

REGEN-006 is a Phase 3, randomized, blinded, sham-controlled study of rilparencel in subjects with advanced CKD and type 2 diabetes. The protocol was amended in the first half of 2024 to focus on Stage 4 CKD (eGFR 20–30 mL/min/1.73 m²) and late Stage 3b CKD (eGFR 30–35 mL/min/1.73 m²) with accompanying albuminuria. Subjects are randomized 1:1 to treatment or sham. The primary objective is to assess up to two rilparencel injections, one in each kidney, using a minimally invasive percutaneous approach. The surrogate endpoint for accelerated approval is eGFR slope; the primary composite endpoint is the time from first injection to the earliest of at least a 40% reduction in eGFR, eGFR below 15 mL/min/1.73 m², chronic dialysis, renal transplant, or renal or cardiovascular death.