DALLAS, Sept. 29, 2026 (GLOBE NEWSWIRE) -- (www.InvestorsTape.com) -- NeOnc Technologies Holdings (NASDAQ:NTHI) is heading toward another potentially important regulatory milestone, with the U.S. Food and Drug Administration scheduled to meet with the company on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212, its oral perillyl alcohol-temozolomide conjugate being developed for aggressive central nervous system cancers.

NeOnc plans to seek agency feedback on the proposed patient population, Phase 2 trial design, endpoints, dose selection and the evidence that could ultimately support a future marketing application. The company also intends to discuss potential registrational strategies and whether a future study could potentially support an accelerated-approval pathway.

NEO212 enters that discussion with a completed Phase 1 dose-escalation program and a defined recommended Phase 2 dose of 610 mg, following dose escalation to a protocol-defined maximum tolerated dose of 810 mg. The company has reported early signals of potential activity in heavily pretreated patients, including a patient with recurrent IDH1 wild-type, MGMT-methylated glioblastoma who experienced approximately a 60% tumor reduction and 21 months of disease control. Another heavily pretreated patient with lung cancer metastatic to the brain experienced stable disease for approximately 16 months. These observations remain individual-patient findings rather than controlled evidence of efficacy, making the design and outcome of larger studies critical. NeOnc has also secured UAE IND authorization for NEO212, creating an international clinical-development pathway alongside its U.S. regulatory discussions.

NeOnc CEO Amir Heshmatpour summarized the immediate objective: "This meeting will help us understand FDA’s feedback on the population, study design and endpoints for the next stage of development." The November meeting follows FDA written feedback earlier this year concerning NEO212’s chemistry, manufacturing and controls program and the planned transition from a capsule to a tablet formulation. That makes the upcoming discussion potentially important not only for clinical strategy, but also for clarifying the practical development path toward a larger study.

The NEO212 story is unfolding alongside meaningful progress from NeOnc’s lead program, NEO100. In August, the company reported topline Phase 2a results in recurrent or progressive Grade III and Grade IV IDH1-mutant glioma, with six-month progression-free survival of 48.9% versus a prespecified 20% benchmark (p=0.0047) and median overall survival of 26.09 months. NeOnc also reported that 86.7% of patients were alive at six months, five of 24 patients remained on treatment at the data cutoff, and one partial response remained ongoing beyond 114 days. The company said it plans to request an FDA Type B meeting to discuss a potential registrational pathway in this setting.

The company has also been building its financial position around those clinical catalysts. In September, NeOnc completed a $15 million registered direct offering priced at $4.20 per share, alongside warrants with a $4.20 exercise price. The financing involved new and existing healthcare-focused institutional investors, with proceeds designated for working capital, general corporate purposes and the redemption of Series A convertible preferred stock. Days later, NeOnc announced that it had redeemed all 6,000 outstanding Series A preferred shares for $6 million in cash, stating that the transaction eliminated the related potential dilution without issuing common shares in the redemption.

There has also been notable insider activity. NeOnc reported in September that its executives had made approximately $629,000 in open-market purchases following the positive NEO100 Phase 2a results, including CEO Amir Heshmatpour's purchase of an additional 35,000 shares for approximately $115,400 and 111,000 shares purchased by Heshmatpour since the August clinical readout. These purchases are factual disclosures of insider transactions and do not establish future clinical or market performance.

Wall Street has added another layer to the story. Roth Capital analyst Jonathan Aschoff initiated coverage of NeOnc in September with a reported $20 price target, while the research firm identified potential pivotal-trial starts for NEO100 and NEO212 as future development milestones. That is an analyst view rather than a company forecast or regulatory determination.

For NTHI, the November 17 FDA meeting now sits at the center of a broader sequence of catalysts: regulatory feedback for NEO212, continued advancement of NEO100 following its Phase 2a readout, potential registrational discussions, international development in the UAE and further financing and clinical execution.

For investors tracking the CNS biotech space, that makes November 17 a date with potentially significant implications for the company's development roadmap heading into 2027.

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