NeOnc secures $2.5M NIH STTR grants for NEO212 CNS malignancies research.

NeOnc Technologies has been awarded two NIH STTR grants totaling $2.5 million to advance its proprietary therapeutic compound NEO212. The funds will support preclinical feasibility studies of NEO212 in acute myelogenous leukemia (AML) and expand its clinical development into newly diagnosed gliomas. The grants are non-dilutive and will further the company's breakthrough therapies for CNS malignancies.

Title: NeOnc Technologies Secures $2.5 Million in NIH STTR Grants to Advance NEO212

NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI), a multi-phase 2 clinical-stage biotechnology company focused on breakthrough therapies for central nervous system (CNS) malignancies, has been awarded two NIH STTR (Small Business Technology Transfer) grants totaling $2.5 million. These non-dilutive funds will support the development of the company’s proprietary therapeutic compound NEO212, which is currently completing its Phase 1 clinical trial.

The $2.5 million in grants includes a $400,000 Phase 1 STTR grant for preclinical feasibility studies of NEO212 in acute myelogenous leukemia (AML) and a $2.1 million Phase 2 STTR grant for expanding NEO212’s clinical development into newly diagnosed gliomas. The grants are structured with 40% funding to NeOnc Technologies and 60% to its USC-based research collaborators, led by Dr. Thomas Chen as Principal Investigator.

The NIH STTR grants provide crucial non-dilutive capital as NeOnc approaches the end-of-Phase 1 milestone for NEO212, a critical inflection point for clinical-stage biotechs where capital requirements typically increase substantially. The grants will support the company's transition into Phase 2 development, potentially leading to regulatory engagement.

The funding will enable NeOnc to explore the feasibility of NEO212 in AML, a high-mortality hematologic malignancy with limited treatment options for refractory cases, and to expand its clinical development into newly diagnosed gliomas. The involvement of USC's Glioma Research Group, led by Dr. Axel H. Schönthal, provides specialized expertise in glioma biology and translational research.

The grants are particularly significant for three key reasons: they expand NEO212's development into new indications, provide third-party scientific validation from the highly selective NIH grant review process, and leverage academic expertise while minimizing NeOnc's internal resource requirements.

NeOnc Technologies has secured $2.5 million in competitive NIH STTR grants, providing crucial non-dilutive capital as the company approaches completion of its Phase 1 trial for NEO212. The funding is strategically timed to support the company's transition into Phase 2 development, a critical inflection point for clinical-stage biotechs where capital requirements typically increase substantially. The grants are particularly significant for three key reasons: they expand NEO212's development into acute myelogenous leukemia (AML) and newly diagnosed gliomas, broadening the potential market opportunity beyond the initial indications; they provide third-party scientific validation from the highly selective NIH grant review process, which typically funds less than 20% of applications; and the collaborative structure with USC (with 60% of funds directed to academic partners) leverages academic expertise while minimizing NeOnc's internal resource requirements.

For a small biotech, these grants represent more than just capital—they reduce cash burn while expanding clinical potential. The $2.5 million provides breathing room as NeOnc approaches the critical end-of-Phase 1 milestone, where clinical data will determine advancement pathways. The diversification into AML is particularly noteworthy, as it demonstrates potential application beyond CNS malignancies and expands the addressable market substantially.

The grant timing suggests confidence in preliminary Phase 1 data, though specific efficacy signals weren't disclosed in this announcement. NIH funding validates NEO212's scientific potential across multiple cancer types, supporting its development as the compound transitions from Phase 1 to Phase 2 trials. The NIH's substantial investment in NEO212 through two separate STTR grants suggests the compound has demonstrated meaningful preclinical and early clinical promise. The expansion into AML represents a significant broadening of NEO212's potential applications beyond the blood-brain barrier, suggesting the mechanism of action may have wider utility than initially targeted CNS malignancies.

These grants support two distinct but complementary research paths: the $400,000 Phase 1 grant explores feasibility in AML—a high-mortality hematologic malignancy with limited treatment options for refractory cases—and the $2.1 million Phase 2 grant supports expansion into newly diagnosed gliomas, complementing NeOnc's existing work in recurrent glioblastoma. The involvement of USC's Glioma Research Group, led by Dr. Schönthal, provides specialized expertise in glioma biology and translational research. The collaborative structure reflects the translational nature of the research—bridging fundamental science with clinical application.

While specific mechanisms weren't detailed, NEO212 likely builds on known temozolomide chemistry with novel modifications to enhance efficacy or reduce resistance. The grant reviewer confidence suggests the compound may address key limitations of current standard-of-care treatments. The dual-indication approach is particularly strategic, as positive signals in either pathway would maintain momentum for the development program. The timing of these grants as NEO212 completes Phase 1 suggests preliminary safety data is encouraging enough to warrant expansion into additional indications.

References:
[1] https://www.globenewswire.com/news-release/2025/08/07/3129304/0/en/NeOnc-Technologies-Awarded-2-5-Million-in-NIH-STTR-Grants-to-Advance-NEO212-in-Gliomas-and-Leukemia.html
[2] https://www.stocktitan.net/news/NTHI/ne-onc-technologies-awarded-2-5-million-in-nih-sttr-grants-to-3yfcpnv1wbs0.html