---
schema_version: "secwatch.filing_event.v1"
accession: "0000950103-23-011755"
form_type: "8-K"
ticker: "PGEN"
cik: "0001356090"
company_name: "PRECIGEN, INC."
filed_at: "2023-08-09T23:59:59+00:00"
generated_at: "2026-06-11T21:38:51.995617+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA confirms PRGN-2012 Phase 1/2 study as pivotal for accelerated approval; cash runway into 2025

## Summary
- FDA confirmed ongoing Phase 1/2 single-arm study of PRGN-2012 for RRP as pivotal for accelerated approval; no placebo trial needed.
- Retired all outstanding convertible notes in Q2; cash, equivalents, and investments totaled $95.6M as of June 30, 2023.
- Q2 2023 loss from continuing operations was $20.3M ($0.08/share), improved from $26.1M loss in Q2 2022.
- SG&A expenses decreased 27% Q2 vs prior year; revenue fell 39% due to reduced services at Exemplar.
- Projected cash runway into 2025; Phase 2 enrollment complete, data collection by Q2 2024.

## SEC filing metadata
- accession: 0000950103-23-011755
- form_type: 8-K
- ticker: PGEN
- cik: 0001356090
- company_name: PRECIGEN, INC.
- filed_at: 2023-08-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1356090/000095010323011755/0000950103-23-011755-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1356090/000095010323011755/dp198223_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950103-23-011755
- JSON: https://secwatch.observer/filing/0000950103-23-011755.json
- Plain text: https://secwatch.observer/filing/0000950103-23-011755.txt

## Key facts
- Earnings Releases
  PRECIGEN, INC. reported financial results for the quarter ended June 30, 2023.
  - Period: the quarter ended June 30, 2023
  - Result: reported results
  source text: Attached as Exhibit 99.1 is a copy of a press release of Precigen, Inc., dated August 9, 2023, reporting its financial results for the quarter ended June 30, 2023.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1356090/000095010323011755/0000950103-23-011755-index.htm

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