DENVER, June 24, 2026 (GLOBE NEWSWIRE) -- (247marketnews.com) -- NeOnc Technologies Holdings (NASDAQ:NTHI) is entering one of the most significant periods in its corporate history after securing its second Investigational New Drug (IND) authorization from the United Arab Emirates this month, further expanding international development opportunities for its central nervous system cancer pipeline.

The latest authorization from the Department of Health – Abu Dhabi grants IND status to NEO100, NeOnc's lead intranasal therapy candidate for recurrent high-grade gliomas. Importantly, the authorization spans three separate clinical protocols, adult studies ranging from Phase 1 through Phase 2, and includes a pediatric development pathway. The approval follows a separate UAE IND authorization for the company's NEO212 program announced earlier in June, marking a rapid expansion of NeOnc's regulatory footprint outside the United States.

For investors following the clinical-stage biotechnology sector, multiple regulatory clearances within a short period can be noteworthy because they potentially create opportunities to accelerate development timelines, expand patient recruitment options, and establish additional pathways toward commercialization. The UAE's growing role as a life sciences and clinical research hub has attracted increasing attention from biotechnology companies seeking global development strategies.

The timing of the NEO100 authorization is particularly notable given that NeOnc expects to report topline results from its fully enrolled NEO100-01 Phase 2a trial by the end of July. The study is evaluating NEO100 in recurrent IDH1-mutant high-grade glioma, one of the most difficult-to-treat forms of brain cancer.

Beyond the UAE approvals, NEO100 already carries several important FDA designations, including Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation. These programs are designed to support the development of therapies targeting serious diseases with significant unmet medical need and may provide opportunities for regulatory efficiencies if future clinical data are supportive.

According to the company, upcoming Phase 2a results could potentially support discussions with regulators regarding additional development pathways. NeOnc has indicated that future regulatory opportunities may include potential consideration for Breakthrough Therapy designation, although any such determination would ultimately rest with the FDA following review of clinical evidence.

Importantly, Chairman, President, and Chief Executive Officer Amir Heshmatpour invested more than $500,000 of personal capital in open-market purchases in recent weeks, with total insider purchases approaching $1 million over the past year according to SEC filings.

Institutional visibility has continued expanding as well. Analyst reports have highlighted the company's access to a $75 million at-the-market facility and a $10 million line of credit, while institutional holders have included major financial firms such as Bank of America, State Street, and Barclays. With additional NEO100 regulatory decisions pending and multiple clinical catalysts expected during 2026, NeOnc remains one of the more closely watched emerging neuro-oncology stories.

NeOnc's underlying technology platform seeks to address one of the most challenging obstacles in neuro-oncology: the blood-brain barrier. NEO100 utilizes a non-invasive intranasal delivery approach designed to transport therapeutic compounds directly to the brain, potentially bypassing limitations associated with conventional systemic therapies.

Meanwhile, NEO212 represents a separate drug-conjugation platform targeting aggressive brain cancers and other malignancies. With both NEO100 and NEO212 now holding active UAE IND authorizations, the company has established a broader international development framework that complements its ongoing U.S. clinical efforts.

As the second half of 2026 begins, NeOnc appears positioned for multiple potential catalysts, including the anticipated Phase 2a data release, possible future FDA interactions, continued international clinical expansion, and advancement of both its NEO100 and NEO212 programs.

For biotechnology investors focused on regulatory milestones and clinical inflection points, the company's recent sequence of regulatory developments may place NeOnc among the more closely watched CNS oncology stories heading into the summer.

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Cautionary Note Regarding Forward-Looking Statements

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.

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