secwatch.observer — SEC 8-K summary
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Issuer:     PROKIDNEY CORP. (PROK)
CIK:        0001850270
Form:       8-K
Filed at:   2025-11-10T23:59:59+00:00
Accession:  0001193125-25-274314
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

ProKidney reports Q3 net loss $35.8M, cash $271.7M; Phase 3 PROACT 1 enrollment >50%, topline Q2 2027
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- Q3 net loss before noncontrolling interest $35.8M vs $41.1M YoY; R&D expenses $26.8M.
- Cash and equivalents $271.7M, expected to fund operations into mid-2027.
- Phase 3 PROACT 1 accelerated approval analysis: >50% of ~360 patients enrolled, topline results Q2 2027.
- FDA confirmed eGFR slope as surrogate endpoint for BLA under accelerated approval; RMAT designation continues.
- Phase 2 REGEN-007 data at ASN: 78% improvement in eGFR decline (p<0.001); well tolerated.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1850270/000119312525274314/0001193125-25-274314-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1850270/000119312525274314/prok-20251110.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-274314

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer