DENVER, Aug. 26, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings (NASDAQ:NTHI) has reached a point where the market conversation can move toward a much more consequential question: What happens if NEO100’s clinical results translate into a viable regulatory pathway for a difficult-to-treat form of brain cancer?

On August 12, NeOnc reported positive topline Phase 2a results from its NEO100-01 study in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The study met its primary endpoint, with 48.9% six-month progression-free survival versus a pre-specified 20% benchmark, producing a reported p-value of 0.0047. NeOnc also reported median overall survival of 26.09 months, with 86.7% of patients alive at six months. Five of the 24 patients remained on treatment, including one partial response continuing beyond 114 days.

Those numbers do not eliminate the risks of developing a cancer therapy, particularly from an open-label Phase 2a study. They do, however, give NTHI investors a substantially different dataset from the one they had before the readout. The company is now preparing to request a Type B meeting with the FDA to discuss a potential registrational path in a setting where NeOnc says there is no approved targeted therapy. That regulatory conversation may become the next major inflection point for the stock.

The Clinical Story Is Now the Main Event

The significance of NEO100 is tied not only to the headline percentage but to the disease being targeted. NeOnc is developing an intranasal formulation of purified perillyl alcohol intended to address CNS cancers while tackling one of oncology's longstanding challenges: getting therapeutics where they need to go in the brain. The company describes its broader platform as focused on CNS therapeutics and the persistent challenges associated with the blood-brain barrier.

The latest data therefore provide investors with something considerably more tangible than a platform story. NeOnc now has a completed Phase 2a dataset, a primary endpoint it says was achieved, survival data and a defined regulatory objective. The company's August 10 update had already characterized the upcoming readout as "one of the most important clinical milestones in NeOnc’s history."

The company also reported that no major toxicities were observed across the cohort, with adverse events predominantly low-grade. Again, that is encouraging rather than definitive, but safety and tolerability will be important components of any future regulatory discussion.

Plus, there is a broader development pipeline behind NEO100. NeOnc has been advancing NEO212, which completed Phase 1 and established a recommended Phase 2 dose of 610 mg. Management has indicated plans for further FDA engagement around the potential development of that program as well.

Now Comes the FDA Test

The next chapter should be more important than the initial market reaction to the Phase 2a data.

NeOnc says it plans to request a Type B FDA meeting specifically to align on a potential registrational pathway for NEO100. That means investors now have a relatively clear catalyst to watch: the regulatory discussion should help clarify what additional clinical evidence the FDA would require and how the company might structure its next stage of development.

This is where the story becomes potentially much bigger than a single positive trial announcement.

If the FDA provides a workable path toward registration, the investment narrative could begin shifting from "Can NEO100 produce meaningful clinical data?" to "How quickly can NeOnc advance NEO100 toward a potential approval?"

NeOnc has also been expanding the geographic scope of its development efforts. In June, the company announced UAE IND approvals covering NEO100 and NEO212, including adult and pediatric programs. Management said the breadth of the NEO100 authorization covers three clinical programs ranging from Phase 1 through Phase 2.

Insider Buying Adds Another Layer

The insider activity is worth watching, but it should be viewed as confirmation of management conviction rather than the primary investment thesis.

CEO Amir Heshmatpour has continued purchasing NTHI shares on the open market following the clinical catalyst. SEC Form 4 filings show additional purchases during August, following earlier purchases in the spring. Heshmatpour had previously said his conviction in NeOnc's clinical direction was reflected in more than $500,000 of open-market NTHI purchases.

NTHI Board Director, Thomas Chen MD, PhD, who is a board-certified neurosurgeon and the Director of Surgical Neuro-Oncology at USC, reported purchases of 33,787 shares at $3.8477 on August 14 and another 2,472 shares at $4.0445 on August 17. Those transactions bring his direct holdings to 583,531 shares, according to the filing information provided.

That is noteworthy because the latest buying is occurring after the Phase 2a results, not before them. But ultimately, the data and regulatory path will matter far more than any insider transaction.

Nasdaq data also reported 597,816 NTHI shares sold short as of August 14, 2026. That is useful market context, but it should not be allowed to dominate the story. The more important development is that NTHI now has a clinical dataset that could potentially change how the company is valued.

NTHI's story has clearly advanced

NeOnc remains a clinical-stage biotechnology company. Phase 2a results do not guarantee success in later development, FDA approval or commercial viability. Additional studies, regulatory review, financing requirements and execution all remain significant variables.

NEO100 met its Phase 2a primary endpoint. The six-month PFS result substantially exceeded the company's prespecified historical benchmark. Median overall survival was 26.09 months. Management is moving toward an FDA discussion about a potential registrational pathway. And the company continues developing additional CNS programs.

The market has been given a meaningful dataset. The next question is whether NeOnc can turn that dataset into regulatory momentum and ultimately into a therapy capable of addressing a serious unmet need in brain cancer.

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This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company's ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Actual results could differ materially from those described in these forward-looking statements due to a number of factors, including without limitation, the Company's ability to continue as a going concern, general economic conditions, and other risk factors detailed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update such forward-looking statements except in accordance with applicable law.