NeOnc Technologies Holdings, Inc. – Key Developments in 2026
Company Overview
- Ticker: NTHI (Nasdaq)
- Sector: Health Care – Clinical‑stage biopharmaceutical
- Headquarters: Calabasas, California
- Market Capitalization: $95,345,808 (USD)
- Recent Share Price: $3.31 on 2026‑09‑24 (52‑week low $2.955, high $12.99)
NeOnc focuses on therapies for intracranial malignancies. Its primary pipeline includes:
- NEO100 – purified pre‑illyl acid, in Phase IIa trials.
- NEO212 – an oral conjugate of temozolomide with perillyl alcohol, in Phase I/II trials for primary brain cancers (meningioma, high‑grade glioma, glioblastoma) and secondary brain cancers.
FDA End‑of‑Phase 1 Meeting – NEO212
- Meeting Date: 17 November 2026, FDA White Oak campus, Silver Spring, MD.
- Purpose: In‑person End‑of‑Phase 1 Type B discussion to gather feedback on NEO212’s development program, including patient population, trial design, endpoints, dose selection, and evidence for future marketing applications.
- Context: The meeting follows the completion of the Phase 1 dose‑escalation segment of the NEO212‑01 Phase 1/2 trial.
- Regulatory Status (September 2025): FDA authorized progression to Phase 2a and Phase 2b of NEO212‑01.
Phase 1 Dose‑Escalation Outcomes
- Dose‑Limiting Toxicity (DLT): Occurred at 810 mg once daily for Days 1‑5 of a 28‑day cycle.
- Recommended Phase 2 Dose: 610 mg daily.
Clinical Activity Observed
| Patient | Disease | Response | Duration |
|---|---|---|---|
| 1 | Recurrent IDH1‑wild type, MGMT‑methylated glioblastoma (GBM) | Partial response (~60 % tumor reduction) | 21 months of disease control |
| 2 | Lung cancer metastatic to brain (post‑immune checkpoint inhibitors) | Stable disease | ~16 months |
These individual outcomes, while not definitive proof of efficacy, demonstrate durable disease control in populations with limited treatment options. They provide a clinical rationale for advancing NEO212 into Phase 2 of the NEO212‑01 trial.
Strategic Implications
- The scheduled FDA meeting offers an opportunity to refine the registration strategy and explore accelerated‑approval pathways.
- Feedback on population selection, study design, and endpoints may shape the next phase of development and potential market positioning.
Market Context
- NeOnc’s share price has ranged from a 52‑week low of $2.955 to a high of $12.99.
- The company’s market cap of roughly $95 million reflects its clinical‑stage status and the high level of investment required for CNS oncology development.
This article synthesizes publicly disclosed information as of 28 September 2026 and does not include forward‑looking statements beyond those provided in the sources.
