---
schema_version: "secwatch.filing_event.v1"
accession: "0001683168-25-004117"
form_type: "8-K"
ticker: "ACTU"
cik: "0001652935"
company_name: "ACTUATE THERAPEUTICS, INC."
filed_at: "2025-06-02T23:59:59+00:00"
generated_at: "2026-05-20T02:58:45.456563+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Actuate reports Phase 2 elraglusib/GnP meets primary OS endpoint in mPDAC

## Summary
- mOS 10.1 months vs 7.2 months for GnP alone, HR=0.63, log-rank p=0.01, 37% risk reduction.
- 12-month OS rate 44.1% vs 22.3% (p=0.0005); 24-month OS rate 13.8% vs 0%.
- ORR 29.0% vs 21.8%; DCR 61.3% vs 56.4%; mPFS 5.6 vs 5.1 months (HR=0.90, not significant).
- Safety profile similar between arms; transient, reversible visual impairments most common TRAEs.
- Company plans to request pre-NDA meeting with FDA in 2H 2025 for registration path.

## SEC filing metadata
- accession: 0001683168-25-004117
- form_type: 8-K
- ticker: ACTU
- cik: 0001652935
- company_name: ACTUATE THERAPEUTICS, INC.
- filed_at: 2025-06-02T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1652935/000168316825004117/0001683168-25-004117-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1652935/000168316825004117/actuate_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001683168-25-004117
- JSON: https://secwatch.observer/filing/0001683168-25-004117.json
- Plain text: https://secwatch.observer/filing/0001683168-25-004117.txt

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