regulatory
confidence high
sentiment positive
materiality 0.85
FDA confirms PRGN-2012 Phase 1/2 study as pivotal for accelerated approval; cash runway into 2025
PRECIGEN, INC.
- 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.