NeOnc Technologies Holdings, Inc. Expects Full Enrollment in Promising Phase 2a Trial of NEO100-01 for Malignant Gliomas in September

-- Trial Read-Out Data Expected in Early 2026 --

/EIN News/ -- CALABASAS, Calif., April 14, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI), a clinical-stage biopharmaceutical company focused on innovative treatments for central nervous system (CNS) cancers and disorders, today announced that it expects full enrollment in its Phase 2a clinical trial for its lead therapeutic candidate, NEO100-01 in September. Only six patients remain to complete the trial’s 25-patient enrollment target.

This landmark trial, for which read-out data is expected in early 2026, investigates NEO100, a proprietary, highly purified version of perillyl alcohol, delivered intranasally, a non-invasive method designed to bypass the blood-brain barrier through the olfactory and trigeminal nerves. NEO100-01 is the first intranasal therapy of its kind evaluated in malignant gliomas, particularly targeting IDH1 mutant Grade III and IV astrocytomas. Grade IV gliomas are among the most aggressive and deadly forms of brain cancer.

“We believe our intranasal delivery mechanism can present a breakthrough in central nervous system oncology, potentially offering a practical and elegant route to circumvent the blood-brain barrier,” said Dr. Thomas Chen, Chief Executive Officer and Chief Scientific Officer at NeOnc Technologies. “Early data from our Phase 1 study provides support that patients with IDH1 mutations experienced extended survival post-recurrence with minimal side effects. We are optimistic that this approach could transform treatment outcomes for this patient population.”

“Reaching near full enrollment in the NEO100-01 trial, with only six patients remaining, is a positive and exciting development,” said Executive Chairman, Amir Heshmatpour. “Our team believes we can meet the FDA’s efficacy endpoints and deliver a positive outcome for patients battling these devastating tumors.”

NEO100 has been granted both Orphan Drug Designation and Fast Track Status by the U.S. Food and Drug Administration (FDA), reinforcing its potential as a significant advancement in the treatment of malignant gliomas.

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
All statements other than statements of historical facts included in this press release are "forward-looking statements" (as defined in the Private Securities Litigation Reform Act of 1995). Generally, such forward-looking statements include statements regarding expectations, possible or assumed future actions, business strategies, events or results of operations, including statements regarding expectations or predictions or future financial or business performance or conditions and those statements that use forward-looking words such as "projected," "expect," "possibility" and "anticipate," or similar expressions. The achievement or success of the matters covered by such forward-looking statements involve significant risks, uncertainties, and assumptions. Actual results could differ materially from current projections or implied results. The Company cautions that statements and assumptions made in this news release constitute forward-looking statements and make no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time statements are made. The information set forth herein speaks only as of the date hereof. The Company and its management are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statements following the date of this news release, whether because of new information, future events or otherwise, except as required by law.

“NEO100” is a registered trademark of NeOnc Technologies Holdings, Inc.

Company Contact:
Patrick Walters
Chief Operations Officer
NeOnc Technologies Holdings, Inc.
info@neonc.com

Investor Relations:
Roger Pondel / Laurie Berman
PondelWilkinson Inc.
(310) 279-5980
rpondel@pondel.com
lberman@pondel.com