NeOnc Showcases Two Brain Cancer Drug Programs at SNO as FDA Meetings Approach

DENVER, Nov. 13, 2026 (GLOBE NEWSWIRE) -- (247MarketNews) — NeOnc Technologies Holdings (NASDAQ: NTHI) reaches an important clinical-development milestone today as it presents updated findings from two investigational brain cancer programs at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO) in Philadelphia. The presentations put the company's intranasal NEO100 and oral NEO212 programs in focus, with additional clinical evidence arriving as NeOnc prepares for important FDA discussions and continues to attract substantial insider buying.

The first presentation, abstract CTNI-26, titled Durable Radiographic Remission and Prolonged Survival with Intranasal NEO100 in Recurrent WHO Grade III/IV IDH1-Mutant Astrocytoma, provides updated Phase 1/2a and compassionate-use experience. Presented by Chief Medical Officer Thomas C. Chen, MD, PhD, the findings are particularly important because they build on previously reported survival and progression-free survival results in a difficult-to-treat patient population.

In August, NeOnc reported that its Phase 2a study achieved six-month progression-free survival of 48.9%, versus a prespecified historical benchmark of 20% (p=0.0047). Median overall survival was 26.1 months, with estimated survival of 86.7% at six months, 61.5% at 12 months and 54.7% at 24 months. The efficacy population included 24 patients, 21 with grade 4 and three with grade 3 IDH1-mutant astrocytoma. Five patients remained on treatment at the interim database lock.

The company reported no treatment-related Grade 3 or higher adverse events, treatment-related serious adverse events or discontinuations due to treatment-related adverse events. These results provide the clinical foundation for NeOnc's effort to advance NEO100 toward a potential accelerated approval pathway.

The compassionate-use component provides an additional dimension. In October, NeOnc reported that a critically ill three-year-old boy receiving investigational NEO100 in Abu Dhabi began breathing independently without ventilator support and moving his legs, according to his treating physicians.

The second presentation, abstract CTNI-27, examines oral NEO212 in temozolomide-resistant recurrent glioblastoma and brain metastases. Its focus is Phase 1 safety, pharmacokinetics and early activity.

NEO212 combines temozolomide with perillyl alcohol in an oral formulation intended to improve drug delivery to the brain and address temozolomide resistance. NeOnc reports that Phase 1 dose escalation is complete, with no observed myelosuppression. The company also disclosed two objective responses: one in recurrent glioblastoma and another in a patient with lung-cancer brain metastasis. Both patients reportedly remained on treatment for more than 20 months.

These observations are particularly interesting given the hematologic toxicity associated with conventional temozolomide. NEO212 now represents a second potential clinical opportunity, distinct from NEO100's intranasal delivery strategy.

NeOnc’s regulatory calendar is becoming increasingly important. The FDA granted a Type B End-of-Phase meeting scheduled for early January 2027 to discuss NEO100's potential accelerated approval pathway, a proposed randomized Phase 3 trial and the adequacy of its nonclinical safety package. The proposed NEO100-012 study would compare intranasal NEO100 with investigator's-choice chemotherapy, using overall survival as its primary endpoint.

NEO212 has its own upcoming regulatory milestone: an End-of-Phase 1 Type B FDA meeting scheduled for November 23. NeOnc intends to discuss patient populations, dosing, endpoints and a proposed randomized Phase 2 design covering brain metastases, IDH1-mutant astrocytoma and recurrent IDH1-wildtype glioblastoma.

The clinical developments coincide with continued insider buying. CEO Amir Heshmatpour reported approximately $333,100 in additional open-market purchases across 80,000 shares acquired November 9–11. His directly held position increased to 3,333,000 shares. Chief Medical Officer Chen also purchased 5,016 shares through his IRA for approximately $20,000. The latest activity brings reported 2026 insider purchases to approximately 341,000 shares.

Other factors adding to investor interest include four analyst Buy ratings, with reported price targets ranging from $13 to $20, and short interest exceeding 920,000 shares as of October 30, according to the market data.

International expansion is another developing opportunity. An October memorandum of understanding with the Department of Health – Abu Dhabi establishes a framework for CNS oncology research, clinical collaboration, training and real-world evidence, building on previously granted investigational authorizations for NEO100 and NEO212.

For investors, today's SNO presentations matter because they bring two distinct clinical programs into the spotlight at the same time. The next tests are whether the updated NEO100 findings strengthen the case for further development, whether NEO212's early safety and activity observations translate into controlled clinical evidence, and how the FDA responds to both development strategies.

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