NEONC TECHNOLOGIES HOLDINGS, INC. 8K

NeOnc Technologies disclosed positive Phase 2a results for its intranasal NEO100 therapy in recurrent IDH1 mutant high‑grade glioma and plans to pursue a Phase 3, potentially accelerated, approval pathway with the FDA.

NeOnc Technologies Holdings, Inc. held an investor conference call, furnished as Exhibit 99.1 to its Form 8-K, to present top-line Phase 2a results from its NEO100-01 trial in recurrent IDH1 mutant high-grade glioma, reporting that the study met its primary endpoint with a six‑month progression‑free survival rate of 48.9% versus a 20% historical benchmark and a median overall survival of approximately 26.1 months compared with historical six‑to‑nine‑month salvage therapy outcomes, together with supportive safety and disease‑control data. Management and external key opinion leaders discussed NEO100’s intranasal delivery platform, multi‑mechanism mode of action, and comparative context versus other IDH1‑targeted and salvage regimens, and outlined plans to seek FDA guidance in a Type B meeting on a randomized Phase 3 trial against lomustine designed for potential accelerated approval, while also noting international trial expansion and ongoing compassionate‑use programs, particularly in pediatrics.

Filing Facts

CIK

1979414

Ticker

-

Form

8K

Source Type

sec

Accession

0001829126-26-008773

Alert Tier

7