NEO100-01
- Indication
- Malignant recurrent WHO Grade 3 /4 IDH1 Astrocytoma
- Stage
- phase2
- Event
- Topline Data
- Details
May 18, 2026: NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) reported Q1 2026 results and outlined upcoming clinical/regulatory catalysts for its CNS cancer programs.
NEO212 (recurrent glioblastoma and brain metastases): The company completed the Phase 1 dose-escalation portion and set 610 mg as the recommended Phase 2 dose. It reported “encouraging” early signs of clinical activity and potential durable disease control in heavily pretreated patients (study primarily safety-focused). NeOnc plans to request an FDA Type B End-of-Phase 1 meeting to align on the design of a potentially pivotal/registrational Phase 2 study and to evaluate an accelerated approval pathway.
NEO100 (recurrent IDH1-mutant high-grade glioma): The Phase 2a study is fully enrolled, with an interim data readout expected around August 2026. The release reiterates previously reported results: 24% radiographic remission rate, 44% six-month progression-free survival, and no significant toxicity.
Business/financing: Completed a PIPE financing anchored by a $10 million commitment from Cinctive Capital Management. Cash and cash equivalents were $138,601 as of March 31, 2026; with PIPE proceeds and an undrawn $10 million line of credit, funding is expected into September 2026.
- Source
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