공시 • Jul 03
NeOnc Technologies Holdings, Inc. Announces Board and Committee Changes NeOnc Technologies Holdings, Inc. announced that Ming-Fu (Alan) Chiang, M.D., Ph.D., MBA, a Class II director, resigned as a member of the Company's Board of Directors, effective June 27, 2026. In connection with his resignation, Dr. Chiang also resigned from the Company's Scientific Advisory Board. Dr. Chiang's resignation was not the result of a disagreement with the Company on any matter relating to the Company's operations, policies, or practices. The company announced that on July 1, 2026, the Board of the Company elected Nasim Shomali as a director of the Company, effective July 1, 2026, to serve as a Class II director until the Company's 2027 annual meeting of stockholders. From April 2013 to April 2026, Ms. Shomali served as a Strategy Executive at Accenture. In this capacity, she advised senior executives at Fortune 20 companies on enterprise strategy, operating-model development, and large-scale transformation initiatives. Her work included leading corporate strategy programs, supporting product redesign and new-product introduction, guiding market-expansion strategies, and developing automation and efficiency roadmaps across global business units. She also managed and expanded Accenture's U.S. Software, Platform, and Technology sustainability portfolio. Ms. Shomali earned her M.B.A., with a concentration in finance, from the UCLA Anderson School of Management. She holds dual bachelor's degrees in Bioengineering and Mathematics from the University of Washington and completed the Sustainable Leadership Development Executive Program at the Yale School of Management. 공시 • Jun 26
NeOnc Technologies Holdings, Inc. announced that it has received $5.00004 million in funding On June 25, 2026, the company has received the funding of $5,000,000. The company pays the sales commission of $500,000. The transaction is closed pursuant to Regulation D. 공시 • Jun 25
NeOnc Technologies Holdings, Inc., Annual General Meeting, Aug 14, 2026 NeOnc Technologies Holdings, Inc., Annual General Meeting, Aug 14, 2026. 공시 • Jun 23
NeOnc Technologies Holdings, Inc. Receives UAE IND Approval For NEO100, Expanding Global Development Ahead Of Anticipated Phase 2 Data Milestone NeOnc Technologies Holdings, Inc. announced that the Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) status for NEO100, the Company’s lead candidate, an intranasally administered formulation of purified perillyl alcohol designed for non-invasive nose-to-brain delivery. The authorization covers the Company’s NEO100-01, NEO100-02, and NEO100-03 protocols across Phase 1, Phase 1b, and Phase 2 studies in adults, together with pediatric studies authorized for Phase 1 and Phase 1b pending further protocol review. The authorized indication is progressive or recurrent Grade III or IV gliomas. The breadth of the UAE authorization, spanning three protocols and adult studies from Phase 1 through Phase 2 alongside a defined pediatric pathway, is intended to allow NeOnc to advance multiple stages of clinical development in parallel. The authorization follows the DOH’s recent IND clearance for the Company’s NEO212 program, announced in June 2026, and extends NeOnc’s clinical development footprint in the UAE across both of its lead platforms, the intranasal delivery platform represented by NEO100 and the drug-conjugation platform represented by NEO212. In the United States, NEO100 has received FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations, and its lead clinical study, the NEO100-01 Phase 2a trial in recurrent IDH1-mutant high-grade glioma, is fully enrolled. The Company expects to report top-line data from the fully enrolled NEO100-01 Phase 2a trial by the end of July 2026, representing what NeOnc believes may be one of the most important clinical milestones in the Company’s history. NEO100 uses intranasal delivery to reach the brain directly, a practical route that circumvents the blood-brain barrier without surgery or systemic chemotherapy. Because it is non-invasive, this approach can enable studies in difficult groups, including children with high-grade gliomas that have few options today. An authorization spanning Phase 1 through Phase 2 with a pediatric pathway lets the company pursue that work where it is needed most. The upcoming Phase 2a readout represents the first controlled evaluation of NEO100 in recurrent IDH1-mutant high-grade glioma following encouraging earlier clinical observations. High-grade gliomas, including WHO Grade III and IV disease, are among the most aggressive brain cancers, with limited treatment options after recurrence. The Company expects to work with healthcare institutions, investigators, and regulatory authorities in the UAE as clinical development activities advance. The UAE authorization further positions NeOnc to rapidly expand clinical development activities internationally as the Company prepares for multiple anticipated regulatory and clinical milestones throughout the second half of 2026. 공시 • Jun 19
Neonc Technologies Holdings Receives Abu Dhabi Ind Authorization for Neo212 and Completes Phase 1 Dose-Escalation Study NeOnc Technologies Holdings received Investigational New Drug (IND) authorization from the Department of Health – Abu Dhabi for NEO212, an oral perillyl alcohol-temozolomide conjugate being developed for aggressive brain tumors, including glioblastoma. The authorization marks the first international regulatory clearance for NEO212 and follows completion of the company's Phase 1 dose-escalation study, which established 610 mg as the recommended Phase 2 dose. The approval provides NeOnc with an additional clinical development pathway outside the United States. NeOnc continues active discussions with the U.S. Food and Drug Administration regarding a potential registrational strategy and future development plans. NeOnc's platform is specifically designed to overcome the blood-brain barrier through proprietary delivery technologies intended to improve therapeutic access to the brain while potentially reducing systemic toxicity. Among NeOnc's most closely watched programs is NEO100, a patented intranasal formulation of proprietary perillyl alcohol designed for direct nose-to-brain delivery. The program has completed enrollment in its Phase 2a study evaluating recurrent IDH1-mutant high-grade glioma and related brain cancers. Previous updates highlighted encouraging clinical observations, including tumor remission reported in approximately 24% of recurrent glioblastoma patients treated with NEO100. NEO212 combines NEO100 with temozolomide, the current standard chemotherapy commonly used in glioblastoma treatment. Preclinical and early-stage findings suggest NEO212 may achieve approximately three times greater brain exposure than temozolomide alone. Following completion of the Phase 1 dose-escalation study and the selection of the recommended Phase 2 dose, NeOnc is preparing for a Type B End-of-Phase 1 meeting with the FDA to discuss future development plans and potential Phase 2 pathways. The recent Abu Dhabi IND authorization provides an additional opportunity to expand clinical evaluation internationally while potentially generating additional data that could support future regulatory discussions.