Welcome to our dedicated page for NeOnc Technologies Holdings news (Ticker: NTHI), a resource for investors and traders seeking the latest updates and insights on NeOnc Technologies Holdings stock.
NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) news coverage focuses on its progress as a clinical-stage life sciences and biopharmaceutical company developing central nervous system therapeutics designed to overcome the blood-brain barrier. News releases frequently highlight updates from Phase 1/2a and Phase 2a clinical trials of intranasal NEO100 in recurrent WHO Grade III/IV IDH1‑mutant astrocytoma and other high-grade gliomas, as well as regulatory and operational milestones across its CNS oncology pipeline.
Investors following NTHI news can expect detailed reports on radiographic response rates, progression-free survival and long-term survival outcomes from NEO100 studies, along with safety and tolerability findings associated with prolonged intranasal dosing. Additional news items describe the advancement of NEO212, a bio-conjugated chemotherapy candidate for primary and metastatic brain tumors, including U.S. Food and Drug Administration authorization to proceed with Phase IIa/IIb clinical development.
Company announcements also cover strategic partnerships and corporate developments, such as the establishment of the NuroMENA subsidiary in the United Arab Emirates, a Master Services Agreement with IROS (an M42-affiliated contract research organization), and share exchange or acquisition transactions disclosed in Form 8‑K filings. Updates on non-dilutive NIH STTR funding, intellectual property expansion, and NeOnc’s AI and 3D bioprinting initiatives for sonodynamic therapy research with NEO100 are also common themes.
By monitoring this NTHI news feed, readers can track NeOnc’s clinical data readouts, regulatory interactions, regional expansion efforts and financing-related disclosures as they are released through press announcements and SEC-referenced communications.
NeOnc Technologies Holdings (Nasdaq: NTHI) highlighted how its Nasdaq Global Market listing interacts with new Phase 2a data for lead candidate NEO100 in recurrent IDH1‑mutant high‑grade glioma. The company reported a six‑month progression‑free survival rate of 48.9% versus a 20% historical benchmark (p=0.0047), median overall survival of about 26.1 months, and six‑, 12‑ and 24‑month overall‑survival rates of approximately 86.7%, 60.9% and 54.1%, respectively, with no major toxicities reported.
According to NeOnc, the open‑label, single‑arm Phase 2a study provides an encouraging clinical signal but not definitive proof of efficacy, making a larger registrational trial and FDA discussions the next focus. The company emphasized its existing $75 million at‑the‑market equity facility with BTIG and A.G.P./Alliance Global Partners as a flexible financing tool, not cash already on the balance sheet. NeOnc also noted second‑quarter R&D expense of approximately $2.6 million, up from about $0.7 million a year earlier, and referenced additional pipeline work on NEO212 and UAE IND approvals for both NEO100 and NEO212.
NeOnc Technologies (NASDAQ: NTHI) received an updated coverage report highlighting stronger clinical and regulatory positioning in 2Q26. Lead asset NEO100 achieved its Phase 2a primary endpoint, with six‑month PFS of 48.9% by RANO 2.0 versus a 20% benchmark (p=0.0047), median OS of 26.09 months, and no major toxicities. The company plans to seek an FDA Type B meeting to discuss a potential registrational program. NEO212 advanced through Phase 2 CMC clearance and FDA feedback indicating a possible accelerated approval pathway. R&D expenses rose to $2.6M from $0.7M year over year, while management expands development into meningioma and pediatric brain tumors, noting that funding remains important as activity increases.
NeOnc Technologies (NASDAQ:NTHI) is highlighting its patented intranasal, nose‑to‑brain delivery platform built around NEO100, a purified perillyl alcohol formulation, following encouraging Phase 2a data in recurrent IDH1‑mutant high‑grade glioma.
According to NeOnc, its exclusive University of Southern California license spans 28 issued and 14 pending U.S. patents plus 65 issued and 28 pending international patents, covering NEO100, NEO212 and related assets, with claims that include intranasal, combination and other brain‑targeted delivery approaches. Preclinical work suggests intranasal NEO100 may help deliver other drugs, and a USC/NeOnc patent application addresses enhanced intranasal levodopa delivery.
The Phase 2a NEO100 study reported 48.9% six‑month PFS versus a 20% historical benchmark (p=0.0047), median overall survival of 26.09 months and 24‑month survival of 54.1%, with five of 24 patients still on treatment. NEO100 holds FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations, and NeOnc plans to request a Type B FDA meeting on a registrational path. NEO212 has completed Phase 1 dose escalation with a recommended Phase 2 dose of 610 mg.
NeOnc Technologies Holdings (NASDAQ:NTHI) reported Phase 2a data for intranasal NEO100 in recurrent IDH1‑mutant high‑grade glioma. The study met its primary endpoint, with six‑month progression‑free survival of 48.9% versus a pre‑specified 20% benchmark (p=0.0047) in 24 patients.
According to the company, median overall survival was 26.09 months, with survival rates of 86.7% at six months, 60.9% at 12 months and 54.1% at 24 months. Five patients remained on treatment, including one progression‑free for about 19 months. Objective response rate by RANO 2.0 was 8.3% (two of 24 patients).
NeOnc reported no major toxicities, with predominantly low‑grade adverse events, and intranasal home administration four times daily in 28‑day cycles. Based on these early, open‑label data, the company plans to request an FDA Type B meeting to discuss a potential registrational development path.
NeOnc Technologies (Nasdaq:NTHI) reported positive topline Phase 2a data from NEO100-01, an open-label study of intranasal NEO100 in 24 patients with recurrent or progressive Grade III/IV IDH1‑mutant glioma who had failed radiation and temozolomide. The trial met its primary endpoint, with six‑month progression‑free survival of 48.9% (95% CI: 26.3‑68.1) by RANO 2.0 versus a pre‑specified 20% benchmark for standard of care (p=0.0047).
According to NeOnc, median overall survival was 26.09 months, with overall survival of 86.7% at six months, 60.9% at 12 months and 54.1% at 24 months. Five of 24 patients remain on therapy; two achieved objective responses (8.3%), including one ongoing partial response beyond 114 days. No major toxicities were reported, with predominantly low‑grade adverse events during long‑term, at‑home intranasal dosing. The company plans to request a Type B FDA meeting to discuss a registrational development path.
NeOnc Technologies (NASDAQ: NTHI) is approaching a key event, with topline Phase 2a results for intranasal NEO100 in recurrent or progressive Grade III/IV IDH1-mutant high-grade glioma scheduled for release on Wednesday, August 12, 2026. The open-label study evaluates efficacy and safety in a fully enrolled patient population.
According to NeOnc, NEO100 is a patented, purified perillyl alcohol formulation positioned within multiple expedited FDA programs, including Orphan Drug, Fast Track and Rare Pediatric Disease designations. The company notes insider open-market purchases exceeding $500,000 by its CEO over the past year and identifies major institutions among shareholders. NeOnc has also secured a second IND authorization in Abu Dhabi for additional NEO100 studies and highlights NEO100’s potential to bypass or transiently open the blood-brain barrier via intranasal, permeable BBB and intra-arterial delivery routes.
NeOnc Technologies (Nasdaq: NTHI) reported second quarter 2026 results and clinical progress for its NEO100 and NEO212 brain cancer programs. For Q2 2026, G&A expenses were $0.9 million versus $1.0 million a year earlier, while R&D rose to $2.6 million from $0.7 million as the company expanded clinical trial sites, manufacturing and pediatric development. Net loss increased to $14.2 million, or $(0.58) per diluted share, compared with $5.7 million, or $(0.30) per share, with approximately $5.7 million of Q2 operating expenses from noncash stock-based compensation, leading to non-GAAP operating expenses of about $8.4 million.
As of June 30, 2026, NeOnc held $2.0 million in cash and cash equivalents and an undrawn $10.0 million related-party credit line, plus access to an equity facility and ATM program. The company received UAE IND approvals for NEO100 and NEO212, completed topline analysis of its fully enrolled Phase 2a NEO100 trial in recurrent IDH1-mutant high-grade glioma, and will present results on August 12, 2026 via investor webcast.
NeOnc Technologies (Nasdaq: NTHI) will host an investor conference call and live webcast on Wednesday, August 12, 2026 at 5:30 a.m. Pacific / 8:30 a.m. Eastern. Management will present topline Phase 2a results from the open-label NEO100-01 trial of intranasal NEO100 in recurrent or progressive Grade III/IV IDH1-mutant glioma.
The call will cover efficacy and safety observations and planned regulatory next steps, followed by Q&A. A live webcast and replay will be available via the NeOnc investor website. NeOnc is a clinical-stage CNS oncology company with NEO100 and NEO212 in Phase II trials.
NeOnc Technologies (Nasdaq: NTHI) has appointed strategy and finance executive Nasim Shomali to its Board of Directors, effective July 1, 2026. The company describes the appointment as strengthening Board-level strategic and financial oversight as it advances its multi-Phase 2 NEO platform for CNS cancers.
According to NeOnc, Shomali brings more than a decade of experience in corporate strategy, operating models, and financial planning, with prior roles at Accenture, Maybrook Capital Partners, and InBios International. She holds degrees in bioengineering, mathematics, and finance, and has advised Fortune-100 and multinational enterprises, including in life sciences.
NeOnc Technologies (NASDAQ: NTHI) reported receiving detailed written feedback from the U.S. FDA on the chemistry, manufacturing and controls (CMC) program for NEO212, its temozolomide–perillyl alcohol conjugate, ahead of a scheduled Type B End-of-Phase 1 meeting on July 9, 2026.
The FDA said NeOnc’s proposed CMC development approach appears reasonable, outlined conditions for changes in drug-substance manufacturing, and confirmed that drug-product development may proceed in parallel with the planned late-stage clinical program, supported by appropriate data. The agency endorsed a staged stability strategy and required an in vivo relative bioavailability study for the capsule-to-tablet transition, plus specified CMC tasks before using tablet material in a confirmatory phase. NeOnc is integrating this guidance and plans to provide an updated development plan. The feedback does not represent FDA approval or agreement on any future registrational trial.