---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-124585"
form_type: "8-K"
ticker: "PROK"
cik: "0001850270"
company_name: "PROKIDNEY CORP."
filed_at: "2024-11-12T23:59:59+00:00"
generated_at: "2026-05-30T02:14:04.142269+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA confirms PROACT 1 Phase 3 may support full approval; Q3 cash $406.8M

## Summary
- FDA Type B meeting confirms PROACT 1 Phase 3 could be sufficient for BLA; accelerated approval pathway available using eGFR slope as surrogate endpoint.
- Cash, equivalents and marketable securities $406.8M at Sept 30, 2024, expected to fund operations into 2027.
- Q3 2024 net loss before noncontrolling interest $41.1M vs $42.0M in Q3 2023; R&D $31.3M, G&A $17.7M including $5.3M impairment.
- Presented five posters at ASN Kidney Week including Phase 2 REGEN-007 late-breaking data.
- Shares outstanding: 291,661,950 Class A and B ordinary shares.

## SEC filing metadata
- accession: 0000950170-24-124585
- form_type: 8-K
- ticker: PROK
- cik: 0001850270
- company_name: PROKIDNEY CORP.
- filed_at: 2024-11-12T23:59:59+00:00
- event_type: regulatory
- 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/1850270/000095017024124585/0000950170-24-124585-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1850270/000095017024124585/prok-20241112.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-124585
- JSON: https://secwatch.observer/filing/0000950170-24-124585.json
- Plain text: https://secwatch.observer/filing/0000950170-24-124585.txt

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