NeOnc Technologies Completes Enrollment in Pivotal NEO100 Phase2a Trial for IDH-1 mutant Recurrent High‑Grade Glioma and Expects Interim Data Readout in SixMonths (Q22026)
CALABASAS, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NASDAQ:NTHI) ("NeOnc" or the "Company"), a multi-Phase 2 clinical-stage biopharmaceutical company pioneering therapies for central nervous system (CNS) cancers, today announced the completion of full patient enrollment in its ongoing NEO100-1 Phase 2a clinical trial. The trial is evaluating the company's lead therapeutic candidate, NEO100, for the treatment of recurrent isocitrate dehydrogenase 1 (IDH1)–mutant high-grade glioma (WHO Grade III and IV). The Company anticipates reporting preliminary data from this fully enrolled cohort in approximately six months, during the second quarter of 2026.
"Completing enrollment for our Phase 2a trial marks a defining inflection point for NeOnc Technologies," said Amir Heshmatpour, Executive Chairman, President & CEO. "This achievement follows exceptionally positive interim data and propels us into the next stage of value creation for NEO100 a novel, intranasal therapy that continues to show the potential for radiographic remission and durable survival in one of the most challenging cancers known to medicine. The enthusiasm among our investigators, partners, and shareholders is unmistakable. With this major clinical catalyst now delivered, our focus turns to the next the upcoming preliminary data readout from the fully enrolled cohort which we believe could further validate NEO100's transformative potential and unlock significant shareholder value."
Mr. Heshmatpour added: "Having now completed full enrollment, we can comprehensively assess NEO100's impact across a complete patient population. The strength of the data observed to date reinforces our confidence that our proprietary intranasal delivery platform — uniquely designed to bypass the blood-brain barrier represents a breakthrough approach for treating aggressive brain tumors. We believe these data will not only strengthen our clinical position but also strategically advance NeOnc toward becoming a global leader in CNS oncology innovation, with a first-mover advantage and a defensible moat protecting our extensive intellectual property portfolio."
This milestone follows the Company's recent announcement of positive results from a 24-patient cohort treated with NEO100. The findings were presented to the investment community during NeOnc's November 12, 2025, investor conference call, which is available for replay at: https://www.webcaster5.com/Webcast/Page/3151/53234.
ABOUT NEONC TECHNOLOGIES HOLDINGS, INC.
NeOnc Technologies Holdings, Inc. is a clinical-stage life sciences company focused on the development and commercialization of central nervous system therapeutics that are designed to address the persistent challenges in overcoming the blood-brain barrier. The company's NEO™ drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. These proprietary chemotherapy agents have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas. NeOnc's NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions.
For more about NeOnc and its pioneering technology, visit neonc.com.
Important Cautions Regarding Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as "may," "will," "should," "intend," "expect," "plan," "budget," "forecast," "anticipate," "believe," "estimate," "predict," "potential," "continue," "evaluating," or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information.
Examples of forward-looking statements include, among others, statements regarding the potential positive effects of NEO100. These statements reflect our current expectations based on information available at this time, but future events may differ materially from those anticipated. The "Risk Factors" section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, along with other cautionary language in that report or in our subsequent filings, outlines important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein. We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations.
"NEO100" and NEO "212" are registered trademarks of NeOnc Technologies Holdings, Inc.
Company Contact:
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Investor Contact:
James Carbonara
Hayden IR
(646)-755-7412
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