secwatch.observer — SEC 8-K summary
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Issuer:     PRECIGEN, INC. (PGEN)
CIK:        0001356090
Form:       8-K
Filed at:   2025-05-14T23:59:59+00:00
Accession:  0000950103-25-006004
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Precigen Q1 net loss $54.2M; PRGN-2012 BLA under FDA priority review with PDUFA Aug 27
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- Net loss of $54.2M ($0.18/share) vs $23.7M ($0.10) YoY; includes $32.5M non-cash warrant liability fair value change.
- Cash and investments $81.0M as of March 31, 2025; Q1 cash burn $16.9M; runway into 2026.
- BLA for PRGN-2012 (RRP) under FDA priority review; PDUFA target action date August 27, 2025.
- Pivotal study: 51% complete response, 86% reduction in surgeries; median follow-up 30 months.
- Selected EVERSANA for commercialization support; advancing launch readiness for potential 2025 launch.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1356090/000095010325006004/0000950103-25-006004-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1356090/000095010325006004/dp228863_8k.htm
  HTML page:      https://secwatch.observer/filing/0000950103-25-006004

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