---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-038607"
form_type: "8-K"
ticker: "PHIO"
cik: "0001533040"
company_name: "Phio Pharmaceuticals Corp."
filed_at: "2025-12-23T23:59:59+00:00"
generated_at: "2026-05-16T12:15:18.781701+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Phio Pharma gets FDA acceptance of PH-762 nonclinical study design; tox study Q1 2026

## Summary
- FDA accepted nonclinical protocol study design for PH-762; toxicology study to begin Q1 2026.
- Interim Phase 1b results: 6 complete responses among 16 evaluable cSCC patients; no dose-limiting toxicities.
- Company advancing cGMP drug product delivery in 2026, partially funded by recent financing.
- PH-762 well tolerated in all enrolled patients across five dose cohorts.

## SEC filing metadata
- accession: 0001437749-25-038607
- form_type: 8-K
- ticker: PHIO
- cik: 0001533040
- company_name: Phio Pharmaceuticals Corp.
- filed_at: 2025-12-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1533040/000143774925038607/0001437749-25-038607-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1533040/000143774925038607/phio20251222_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-038607
- JSON: https://secwatch.observer/filing/0001437749-25-038607.json
- Plain text: https://secwatch.observer/filing/0001437749-25-038607.txt

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