NEONC TECHNOLOGIES HOLDINGS, INC.

NEONC Technologies announced positive top-line results from the Phase 2a portion of its NEO100-01 clinical trial for recurrent IDH1 mutant high-grade glioma. The study met its primary endpoint with a Progression-Free Survival at 6 months (PFS6) of 48.9% against a 20% benchmark. Patients treated with NEO100-01 demonstrated a median overall survival of 26.1 months, significantly extending life expectancy compared to the 6-9 months typically seen with current salvage therapies. The company plans to seek FDA guidance for a Phase 3 accelerated approval pathway.

NeOnc Technologies Holdings announced positive Phase 2a results for its intranasal drug NEO100 in recurrent IDH1-mutant high-grade glioma. The study demonstrated a 48.9% six-month progression-free survival rate, significantly exceeding the 20% historical benchmark, and a median overall survival of 26.09 months. The company also highlighted the potential of its intranasal delivery platform, which could extend beyond NEO100 to other CNS therapies, supported by a robust patent portfolio and the advancement of its NEO212 program.

NeOnc Technologies announced positive Phase 2a clinical trial results for its intranasal drug NEO100 in recurrent IDH1-mutant high-grade glioma. The study met its primary endpoint with a six-month progression-free survival rate of 48.9%, significantly exceeding the 20% benchmark (p=0.0047). The company also reported a median overall survival of 26.09 months and a favorable safety profile with no major toxicities. NeOnc plans to request a Type B meeting with the FDA to discuss a registrational development path for NEO100.

NeOnc Technologies Holdings, Inc. announced positive topline results from the Phase 2a portion of its NEO100-01 study for intranasal NEO100 in recurrent IDH1-mutant high-grade glioma. The study met its primary endpoint with a six-month progression-free survival (PFS-6) of 48.9%, significantly exceeding the pre-specified 20% benchmark for standard of care. The drug demonstrated encouraging survival outcomes, including a median overall survival of 26.09 months from recurrence, and was well-tolerated with no major toxicities. The company plans to engage with the FDA to discuss a registrational study path.

NeOnc Technologies is set to announce topline Phase 2a results for its investigational treatment NEO100 on August 12, 2026. This significant clinical readout for recurrent IDH1-mutant high-grade glioma is considered a major near-term catalyst, with the company having secured Orphan Drug, Fast Track, and Rare Pediatric Disease designations for NEO100. The announcement follows substantial insider buying, with the CEO investing over $500,000, and increasing institutional ownership, alongside international expansion with a new IND authorization in Abu Dhabi.

NeOnc Technologies Holdings, Inc. reported a net loss of $14.2 million, or $(0.58) per diluted share, for Q2 2026, compared to $5.7 million in Q2 2025, primarily due to increased R&D investment. The company announced the completion of topline analysis for its Phase 2a NEO100 study, with results to be presented on August 12, 2026. NeOnc also secured UAE IND approvals for both NEO100 and NEO212, expanded its Board with Nasim Shomali, and maintained access to capital resources including a $10.0 million line of credit.

NEONC TECHNOLOGIES HOLDINGS, INC. reported a net loss of $(14,240,044) for the second quarter of 2026 and $(23,059,976) for the six months ended June 30, 2026. The company's cash and cash equivalents stood at $1,973,420, with an accumulated deficit of $(135,814,631), leading to a going concern warning. Despite securing $15.1 million from PIPE financing and $5 million from Series A Convertible Preferred Stock, the company lacks sufficient capital to fund operations for the next year. Clinical trials for lead products NEO100 and NEO212 are ongoing.

NeOnc Technologies Holdings, Inc. announced it received detailed written feedback from the U.S. Food and Drug Administration (FDA) regarding the chemistry, manufacturing and controls (CMC) development program for its drug candidate, NEO212. This feedback was sufficiently clear, allowing the company to cancel its scheduled Type B End-of-Phase 1 meeting. The FDA's comments provide greater clarity on manufacturing, formulation, and bioavailability requirements, particularly for the transition from a capsule to a tablet formulation, which NeOnc is now integrating into its development plan.

NEONC TECHNOLOGIES HOLDINGS, INC. announced a change to its Board of Directors. Dr. Ming-Fu (Alan) Chiang resigned from his position as a Class II director and from the Scientific Advisory Board, effective June 27, 2026. Subsequently, on July 1, 2026, the Board elected Nasim Shomali as a new Class II director. Ms. Shomali, a former Strategy Executive at Accenture, is the niece of the Company's President, CEO, and Executive Chairman, Amir Heshmatpour.

NeOnc Technologies Holdings has secured its second Investigational New Drug (IND) authorization from the United Arab Emirates for NEO100, its lead intranasal therapy candidate for recurrent high-grade gliomas. This approval, which spans adult Phase 1-2 studies and a pediatric development pathway, follows an earlier UAE IND for its NEO212 program, significantly expanding its international regulatory footprint. The company anticipates reporting topline results from its fully enrolled NEO100-01 Phase 2a trial by the end of July. Additionally, insider purchases by the CEO and institutional interest highlight growing confidence in the company's prospects.