NeOnc Receives FDA Written Feedback on NEO212 CMC Development and Capsule-to-Tablet Transition

About this update from Neonc Technologies Holdings, Inc.

FDA feedback provides detailed manufacturing and formulation requirements for continued late-stage development of NEO212 CALABASAS, Calif., July 15, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) ("NeOnc" or the "Company"), a clinical-stage life sciences company focused on the development of treatments for central nervous system cancers, today announced that it has received written feedback from the U.S. Food and Drug Administration ("FDA") regarding the chemistry, manufacturing and controls ("CMC") development program for NEO212, the Company's novel temozolomide-perillyl alcohol conjugate. The written feedback was provided in advance of a Type B End-of-Phase 1 meeting scheduled for July 9, 2026. FDA's preliminary comments expressly provided NeOnc the option to cancel the meeting if the written responses were sufficiently clear, in which case the written responses would constitute the official record of the meeting. After reviewing the detailed responses, the Company determined that an additional meeting discussion was not required at this stage and canceled the July 9 meeting. Key elements of the FDA's written feedback include: NeOnc is incorporating the FDA's feedback into its NEO212 development plan and is evaluating the associated study design, manufacturing activities, timelines and costs. The Company expects to provide an updated development plan after completing this assessment.

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