NeOnc Technologies (Nasdaq: NTHI) Announces AI-Driven Findings Showing Ultrasound Enhances the Potency of an Already Effective NEO100 in Treating Primary and Metastatic Brain Tumors

Rhea-AI Summary

NeOnc Technologies (Nasdaq: NTHI) announced preclinical findings from a University of Southern California collaboration showing focused ultrasound enhances NEO100’s antitumor potency across primary and metastatic brain tumor models.

Researchers used an AI-driven positive–unlabeled neural network trained on >200 molecular descriptors and a rapid magnetic 3D bioprinting NAM (US Patent 11,788,057) to predict and validate NEO100 as a leading sonodynamic agent. Validation on patient-derived organoids and spheroids — including glioblastoma, pediatric medulloblastoma, high-grade meningioma, and breast- and lung-to-brain metastases — showed markedly enhanced tumor-killing when NEO100 was combined with focused ultrasound. The results support advancing NEO100 plus focused ultrasound into future clinical trials across multiple brain tumor types.

Positive

• AI screening identified NEO100 as a leading sonosensitizer
• Validation across multiple tumor types including glioblastoma
• Rapid 3D bioprinting platform shortens organoid generation to hours
• Supports advancing NEO100 plus ultrasound into clinical trials

Negative

• Findings are preclinical and not yet demonstrated in humans
• No quantitative efficacy metrics disclosed for tumor-killing
• Clinical translation and safety with focused ultrasound remain unproven

Insights

Translational oncology expert

Preclinical AI/3D‑bioprinting data show ultrasound amplifies NEO100 efficacy and support clinical translation planning.

NEO100 showed markedly enhanced antitumor activity when combined with focused ultrasound across multiple primary and metastatic brain tumor models, using an AI‑driven screen and rapidly bioprinted, patient‑derived organoids created with the patented rapid magnetic 3D bioprinting method (US Patent 11,788,057).

The evidence chain combines an AI positive–unlabeled model trained on over 200 molecular descriptors, rapid NAM validation across glioblastoma, pediatric medulloblastoma, high‑grade meningioma, and breast‑ and lung‑to‑brain metastases, and consistent identification of NEO100 as a leading sonosensitizer; these elements together strengthen the rationale for advancing a sonodynamic approach but remain preclinical.

Key dependencies and risks include reproducibility in in vivo and clinical settings, regulatory acceptance of the NAM as supporting translational decisions, and operational design of combined NEO100+focused ultrasound trials; concrete items to watch are formal in vivo/toxicology endpoints, IND enabling studies, and announcements of planned clinical trial initiation or protocol details in the months following Dec. 01, 2025.

CALABASAS, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI), a clinical-stage biopharmaceutical company developing brain-penetrant therapeutics for central nervous system (CNS) cancers, today announced newly published preclinical findings from a research collaboration at the University of Southern California (USC). The study, now available on bioRxiv (https://www.biorxiv.org/content/10.1101/2025.11.25.690556v1), demonstrates that ultrasound further enhances and amplifies NEO100’s therapeutic potency, driving strong antitumor effects across multiple primary and metastatic brain tumor types.

Utilizing an AI-driven, 3D-bioprinted New Approach Methodology (NAM), researchers at USC, led by Dr. Josh Neman—Associate Professor of Neurological Surgery and Chief Clinical Officer of NTHI—identified NEO100 as a leading sonodynamic therapy agent. This NAM platform—built on NTHI-patented rapid magnetic 3D bioprinting technology (US Patent 11,788,057)—facilitates the rapid generation of physiologically relevant patient-derived tumor organoids within hours, rather than the weeks typically required by conventional methods, thereby significantly accelerating biomedical research and aligning with NIH objectives to minimize animal testing.

An AI-driven positive–unlabeled neural network, trained on over 200 molecular descriptors, was employed to predict compounds most likely to respond to focused ultrasound, penetrate the blood–brain barrier, and exhibit potent sonodynamic therapeutic activity. Throughout this extensive AI screening initiative, the platform consistently identified NEO100 as a leading predicted sonosensitizer. Validation studies on rapidly bioprinted tumor spheroids—including glioblastoma, pediatric medulloblastoma, high-grade meningioma, and breast- and lung-to-brain metastases—demonstrated that NEO100 displayed markedly enhanced tumor-killing activity when combined with focused ultrasound parameters. Together, these results support moving NEO100 combined with focused ultrasound into future clinical trials for a wide range of primary and metastatic brain tumors. 

“This breakthrough provides strong external validation for NEO100’s potential as a first-in-class, noninvasive sonodynamic therapeutic. The integration of AI, 3D bioprinting, and ultrasound significantly expands NEO100’s commercial and clinical opportunity beyond current indications,” said Amir Heshmatpour, Executive Chairman and President of NTHI.

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 whether a definitive agreement will be reached with Quazar. 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, including but not limited to the failure to finalize the agreement with Quazar, modifications to its terms, or alternative uses of proceeds.

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:
info@neonc.com

Investor Contact:
James Carbonara
Hayden IR
(646)-755-7412
James@haydenir.com

FAQ

What did NeOnc (NTHI) announce on December 1, 2025 about NEO100?

NeOnc announced preclinical USC findings showing focused ultrasound enhances NEO100’s antitumor potency across multiple brain tumor models.

How was NEO100 identified as a sonodynamic therapy agent in the NTHI study?

An AI-driven positive–unlabeled neural network trained on over 200 molecular descriptors predicted NEO100 as a leading sonosensitizer, then validated in 3D bioprinted tumor models.

Which brain tumor types showed response to NEO100 plus focused ultrasound in the NTHI research?

Validated models included glioblastoma, pediatric medulloblastoma, high-grade meningioma, and breast- and lung-to-brain metastases.

Does the December 1, 2025 announcement mean NEO100 is in clinical trials with ultrasound now?

No; the announcement reports preclinical validation and states the results support moving NEO100 plus focused ultrasound into future clinical trials.

What proprietary technology did NeOnc use in the NEO100 study (NTHI)?

The study used a rapid magnetic 3D bioprinting NAM built on a patented platform (US Patent 11,788,057) to create patient-derived tumor organoids within hours.