secwatch.observer — SEC 8-K summary
======================================

Issuer:     NEONC TECHNOLOGIES HOLDINGS, INC. (NTHI)
CIK:        0001979414
Form:       8-K
Filed at:   2025-11-12T23:59:59+00:00
Accession:  0001829126-25-009076
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

NEO100 yields 21% radiographic response & 44% 6mo PFS in recurrent IDH1-mutant gliomas
--------------------------------------------------------------------------------

- Radiographic response rate of 21% (5/24) in recurrent Grade III/IV IDH1-mutant astrocytoma, exceeding <8% benchmark for salvage therapies.
- Six-month progression-free survival (PFS-6) of 44% (8/18 evaluable) vs historical 21-31%.
- 33% of patients (8/24) alive ≥18 months post-NEO100 initiation; median overall survival 88 months.
- No significant toxicity with chronic intranasal dosing; enrollment completed at 25 patients.
- CEO calls data a potential paradigm shift; company advancing to Phase 2b/3 and global trials.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1979414/000182912625009076/0001829126-25-009076-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1979414/000182912625009076/neonctechnologies_8k.htm
  HTML page:      https://secwatch.observer/filing/0001829126-25-009076

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer