NeOnc Technologies Holdings, Inc.

NeOnc is a clinical-stage biopharmaceutical company focused on developing treatments for aggressive cancers located in the brain, known as intracranial malignancies. These include primary brain cancers like meningioma, high grade gliomas, and glioblastoma, as well as secondary brain cancers that have spread from other parts of the body, such as melanoma or breast and lung cancer. Brain malignancies are challenging to treat because the blood-brain barrier restricts most drug entry into the brain, leading to poor prognoses and shortened life expectancy for patients. NeOnc is developing new drug delivery methods to be used with novel drug candidates. The company has two lead products in development: NEO100 and NEO212. NEO100 is a purified form of perillyl alcohol ("POH") administered to brain cancer patients through intranasal delivery. For intranasal NEO100, NeOnc has completed human testing in a Phase I clinical trial and is now conducting a Phase IIa trial for patients with recurrent malignant glioma (WHO Grade III, IDH1 mutant, and WHO Grade IV, IDH1 mutant). A separate Phase IIa trial of intranasal NEO100 (NEO 100-02) for patients with malignant skull-based meningioma is also ongoing. This trial was launched in July 2023, and NeOnc received FDA approval for a Phase II trial within 30 days, bypassing Phase I due to NEO100 using the same treatment platform as for malignant gliomas. Beyond its single-drug application, NEO100 is also being investigated as a drug delivery vehicle, with preclinical studies suggesting it may improve brain tumor delivery of other drugs via the intranasal route.