Neonc Technologies Holdings, Inc. NTHI
Neonc Technologies Holdings, Inc. (Nasdaq: NTHI) is an oncology drug developer. Its lead program, NEO100, is in Phase 2 for recurrent IDH-mutant grade 4 astrocytoma. Its next catalyst on record is NEO212: FDA End-of-Phase 1 Type B meeting (November 2026).
Upcoming catalysts
- November 2026NEO212 — FDA End-of-Phase 1 Type B meeting
We are scheduled to meet with the FDA on November 23, 2026 for an End-of-Phase 1 Type B meeting to seek feedback on the proposed patient populations, trial design, endpoints and dose selection for the next stage of development
- November 2026NEO100 and NEO212 — Updated NEO100 Phase 1/2a results and NEO212 Phase 1 data to be presented at the Society for Neuro-Oncology Annual Meeting on November 13, 2026.
Data from both of NeOnc's clinical programs will be presented in two posters on Friday, November 13, 2026, at the 31st Annual Meeting and Education Day of the Society for Neuro-Oncology.
Next further out: NEO212 — Presentation of Phase 1 data at Society for Neuro-Oncology 2026 Annual Meeting (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| NEO100 | recurrent IDH-mutant astrocytoma | small molecule | Phase 2 |
| NEO100-02 | residual, progressive or recurrent meningioma | small molecule | Phase 2 |
| NEO100-03 | recurrent pediatric-type high-grade glioma and other malignant pediatric brain tumors | small molecule | Phase 1 |
| NEO212 | brain metastases, IDH1-mutant astrocytoma, recurrent IDH1-wildtype glioblastoma | small molecule | Phase 1 |
Recent results and decisions
- Oct 22, 2026started Two children in Abu Dhabi are receiving investigational NEO100 through NeOnc's Compassionate Care program, with a third expected this week.
Two children in Abu Dhabi are currently receiving investigational NEO100 through NeOnc's Compassionate Care program. A third child is expected to be onboarded from India this week.
Filing - Aug 12, 2026met Phase 2a met primary endpoint: PFS-6 48.9% (95% CI 26.3-68.1) vs 20% benchmark, p=0.0047, single-arm n=24; median OS 26.09 months, ORR 8.3%.
Six-month progression-free survival (PFS-6) was 48.9% (95% CI: 26.3-68.1) by RANO 2.0 criteria using Kaplan-Meier estimation, compared with the 20% rate pre-specified in the study design as the expectation for standard of care (p = 0.0047).
Filing - Aug 1, 2026met Intranasal NEO100 met its primary endpoint in Phase 2a study with six-month progression-free survival of 48.9% versus 20% benchmark.
The study met its primary endpoint, with six-month progression-free survival of 48.9% versus a pre-specified 20% benchmark for standard of care (p = 0.0047).
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.