---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-107357"
form_type: "8-K"
ticker: "PROK"
cik: "0001850270"
company_name: "PROKIDNEY CORP."
filed_at: "2025-08-12T23:59:59+00:00"
generated_at: "2026-05-17T14:51:52.415295+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# ProKidney Q2 net loss $37M; FDA agrees eGFR slope for accelerated approval; Phase 2 shows 78% eGFR improvement

## Summary
- FDA confirmed eGFR slope as surrogate endpoint for accelerated approval of rilparencel; topline data from PROACT 1 expected Q2 2027.
- Phase 2 REGEN-007: eGFR slope improved 78% (from -5.8 to -1.3 mL/min/1.73m²/yr) in Group 1 (n=24), p<0.001; no SAEs related.
- Cash and equivalents $294.7M as of June 30, 2025, down from $328.5M; funds operations into mid-2027.
- Q2 net loss $37.0M vs $38.5M in prior year; R&D expenses $25.9M down from $29.4M.
- More than half of ~350 patients for accelerated approval analysis enrolled in Phase 3 PROACT 1.

## SEC filing metadata
- accession: 0000950170-25-107357
- form_type: 8-K
- ticker: PROK
- cik: 0001850270
- company_name: PROKIDNEY CORP.
- filed_at: 2025-08-12T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1850270/000095017025107357/0000950170-25-107357-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1850270/000095017025107357/prok-20250812.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-107357
- JSON: https://secwatch.observer/filing/0000950170-25-107357.json
- Plain text: https://secwatch.observer/filing/0000950170-25-107357.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.