ProKidney advances to late-stage trial, widens Q1 loss to $42.6M on pivotal study ramp-up

Filed May 15, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 12, 2025 · ~2 min read

Key Changes

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  Company now describes itself as 'late-clinical-stage' with rilparencel as the only Phase 3 cell therapy for advanced CKD and diabetes; PROACT 1 trial narrowed to Stage 4 and late Stage 3b patients with topline surrogate endpoint data expected Q2 2027 and confirmatory endpoint H2 2029.

  MD&A: Company Stage & PROACT 1 Timeline verify on EDGAR →
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  Q1 2026 net loss widened to $42.6M from $38.0M prior year, driven by $6.6M increase in R&D spending for PROACT 1 enrollment and manufacturing; cash runway remains 'into mid-2027' despite one calendar year elapsed since prior guidance.

  MD&A: Financial Results verify on EDGAR →
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  New risk factor warns FDA workforce cuts (3,500 employees fired April 2025, proposed 30% HHS budget reduction) and regulatory reform under Trump Administration could delay guidance and approval timelines for product candidates.

  Risk Factors: FDA Disruptions verify on EDGAR →