PROKIDNEY CORP. 8-K

What Happened

• ProKidney Corp. filed an 8-K on February 2, 2026, disclosing an updated investor presentation (Exhibit 99.1) that management will use in investor/analyst interactions. The presentation is posted at https://investors.prokidney.com/news-events/events-and-presentations.
• The company updated the total target enrollment for its Phase 3 REGEN-006 (PROACT 1) study to approximately 470 subjects, and provided revised expected topline data timing: the surrogate endpoint (eGFR slope) in Q2 2027 and the confirmatory composite time-to-event endpoint in H2 2029. Statistical powering assumptions for both analyses remain unchanged. The filing was signed by Todd Girolamo, Chief Legal Officer.

Key Details

• Updated target enrollment for PROACT 1: ~470 subjects.
• Anticipated topline readout (surrogate eGFR slope): second quarter 2027.
• Anticipated topline readout (confirmatory composite time-to-event): second half of 2029.
• Statistical powering assumptions unchanged despite enrollment update; investor presentation attached as Exhibit 99.1.

Why It Matters

• These are development timeline milestones for investors tracking ProKidney’s lead asset (REGEN-006). The Q2 2027 surrogate readout is the nearer-term clinical milestone; the 2029 confirmatory readout is the pivotal outcome for longer-term regulatory/market implications.
• The unchanged statistical powering suggests the company expects the study to remain adequately designed despite the enrollment update. The attached investor presentation provides additional context for analysts and holders planning around these clinical milestones.