---
schema_version: "secwatch.filing_event.v1"
accession: "0001829126-25-007323"
form_type: "8-K"
ticker: "NTHI"
cik: "0001979414"
company_name: "NEONC TECHNOLOGIES HOLDINGS, INC."
filed_at: "2025-09-11T23:59:59+00:00"
generated_at: "2026-05-17T06:54:45.542423+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# NeOnc receives FDA authorization to proceed with Phase II clinical trial of NEO212 for brain cancer

## Summary
- FDA cleared NEO212-01 Phase IIa/IIb after Phase I showed safe dosing up to 810 mg daily days 1–5 of 28-day cycle.
- Patient enrollment expected to begin before end of 2025 at up to 16 U.S. cancer centers including Cleveland Clinic, Duke, and USC.
- NEO212 is an oral chemical conjugate of TMZ (Temodar) and NEO100 (perillyl alcohol), designed to enhance blood-brain barrier penetration.
- Company believes NEO212 could replace TMZ as standard of care for glioblastoma, astrocytoma, and other CNS cancers.
- CEO Dr. Thomas Chen and Executive Chairman Amir Heshmatpour highlighted milestone as transformative for brain cancer treatment.

## SEC filing metadata
- accession: 0001829126-25-007323
- form_type: 8-K
- ticker: NTHI
- cik: 0001979414
- company_name: NEONC TECHNOLOGIES HOLDINGS, INC.
- filed_at: 2025-09-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1979414/000182912625007323/0001829126-25-007323-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1979414/000182912625007323/neonctechnologies_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001829126-25-007323
- JSON: https://secwatch.observer/filing/0001829126-25-007323.json
- Plain text: https://secwatch.observer/filing/0001829126-25-007323.txt

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