FDA authorizes NeOnc to advance brain cancer drug to phase 2 trials

CALABASAS, Calif. - NeOnc Technologies Holdings, Inc. (NASDAQ:NTHI), a $162.47 million market cap biotechnology company, announced Wednesday that the U.S. Food and Drug Administration has authorized the company to proceed with Phase IIa/IIb of its NEO212-01 clinical trial for central nervous system cancers. The stock has shown strong momentum, gaining nearly 18% over the past week.

The authorization follows completion of a Phase I dose-escalation study that demonstrated NEO212 could be safely administered at doses up to 810 mg daily on days 1-5 of a 28-day cycle. Patient enrollment for the next phase is expected to begin before the end of 2025. According to InvestingPro analysis, the company currently operates with moderate debt levels, though its short-term obligations exceed liquid assets with a current ratio of 0.11.

NEO212 is an oral chemical conjugated chemotherapy drug that combines Temozolomide, the current standard of care for glioblastoma, with NEO100, a proprietary form of perillyl alcohol. The company designed this combination to enhance blood-brain barrier penetration and antitumor activity.

The Phase II trial will expand patient enrollment across U.S. cancer centers, building on four currently active trial sites. NeOnc is preparing to activate additional sites at several major medical institutions including Cleveland Clinic, Duke University, and NYU Langone.

"Receiving FDA authorization to advance NEO212 into Phase II is a defining milestone for NeOnc Technologies," said Amir Heshmatpour, Executive Chairman and President of NeOnc, according to the company’s press release.

NEO212 aims to address limitations of current treatments for brain cancers, including resistance and limited efficacy. The company is developing therapies for central nervous system cancers and other hard-to-treat malignancies.

The information in this article is based on a press release statement from NeOnc Technologies. InvestingPro analysis suggests the stock is currently trading above its Fair Value, with technical indicators pointing to overbought conditions. Subscribers can access 8 additional ProTips and comprehensive financial metrics to make more informed investment decisions.

In other recent news, NeOnc Technologies Holdings, Inc. announced the acquisition of a portfolio featuring artificial intelligence, 3D bioprinting, and quantum modeling technologies for $3.5 million. This acquisition includes U.S. Patent No. 11,788,057 B2 and was completed with $500,000 in cash and $3 million in common stock. The company also disclosed that it would restate its first-quarter 2025 financials due to an error in calculating non-cash share-based compensation expenses for restricted stock units granted to management. This error led to an overstatement of expenses in its previous financial statements. Furthermore, NeOnc secured a $50 million investment from Quazar Investment following the incorporation of its subsidiary, NuroMENA Holdings Ltd., in Abu Dhabi. This investment aims to accelerate the launch of NeOnc’s central nervous system platform in the Middle East and North Africa. Additionally, NeOnc received $2.5 million in grants from the National Institutes of Health to advance the development of its cancer therapeutic compound NEO212. These grants will support both preclinical studies and the expansion of clinical development for this compound.

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