1. NTHI reports 24% radiographic remission with NEO100 in recurrent gliomas. 2. 36% of patients survived over 18 months post-treatment, indicating long-term benefits. 3. NEO100's response rates significantly exceed standard salvage therapy results. 4. No significant toxicity observed with NEO100 administration. 5. Findings may shift treatment approaches in recurrent IDH1-mutant gliomas.
FAQ
Why Very Bullish?
The significant clinical results and safety profile suggest strong market potential, similar to prior successful biotech advancements that resulted in stock surges.
How important is it?
The compelling data reveals strong clinical efficacy which could transform treatment standards, thus significantly impacting NTHI’s valuation.
Why Long Term?
Continued efficacy data may lead to increased investor confidence and market interest in NTHI over time, similar to historical trends with successful drug approvals.
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NeOnc Technologies Updates Clinical Results for NEO100 in Recurrent IDH1-Mutant Astrocytoma
CALABASAS, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI), a clinical-stage biopharmaceutical company focused on innovative therapies for central nervous system (CNS) cancers, has announced favorable updates from its ongoing clinical studies of intranasal NEO100. This treatment is being evaluated for patients with recurrent World Health Organization (WHO) Grade III/IV IDH1-mutant astrocytoma. The latest findings reveal additional long-term survival and radiographic remission in patients, strengthening the evidence of NEO100's efficacy.
Clinical Trial Highlights
Since the previous reporting on November 12, 2025, one more patient has achieved durable long-term survival and radiographic remission, bringing the total number of participants in this expanded clinical cohort to 25. Key results include:
- Radiographic Response: 24% of patients (6 of 25) demonstrated significant radiographic remission, a threefold increase compared to the <8% response rate typically seen with salvage therapies for recurrent high-grade gliomas.
- Progression-Free Survival (PFS-6): 44% of patients achieved six-month progression-free survival, surpassing historical benchmarks of 21–31% for this patient population.
- Long-Term Survival: 36% of participants (9 of 25) have survived for ≥18 months post-initiation of NEO100.
- Tolerability: No significant toxicity has been reported with intranasal administration of NEO100, even with prolonged dosing.
Expert Commentary
Amir F. Heshmatpour, Executive Chairman, President & CEO of NeOnc Technologies, remarked, “The addition of another patient achieving both long-term survival and radiographic remission further validates what we believe is a highly compelling therapeutic signal. With radiographic responses now 300% higher than previously reported rates, these updated data reinforce our belief that NEO100 may significantly advance treatment options for patients with recurrent IDH1-mutant high-grade gliomas.”
Dr. Thomas Chen, Founder and Chief Medical Officer, emphasized the potential of NEO100, stating, “The increasing number of durable responders supports our hypothesis that NEO100 is a first-in-class, CNS-penetrant metabolic therapy capable of inducing sustained radiographic remission and multi-year survival in this challenging patient group.”
Dr. Henry Friedman from Duke University highlighted the implications, noting that “the results from NEO100 signify a potential paradigm shift in how we treat recurrent IDH1-mutant gliomas.”
Study Context and Methodology
The comprehensive analysis included all patients from the compassionate-use protocol, along with participants from Phase 1 and Phase 2a studies. Eligible patients demonstrated confirmed WHO recurrent Grade III/IV IDH1-Mutant Astrocytoma and had been part of the study for at least six months prior to data evaluation. The efficacy of NEO100 was assessed utilizing the Response Assessment in Neuro-Oncology (RANO) criteria.
Future Implications
These promising results indicate that NEO100 could potentially provide significant advancements in treatment, moving beyond traditional palliative approaches to offering prolonged disease control for patients with recurrent high-grade gliomas.
About NeOnc Technologies Holdings, Inc.
NeOnc Technologies Holdings, Inc. is dedicated to developing novel CNS therapeutics, leveraging their proprietary NEO™ drug development platform. The company continues to advance its clinical programs, including NEO100™ and NEO212™, which are both currently in Phase II trials under FDA Fast-Track status. For more information on NeOnc and its innovative therapies, visit neonc.com.
Important Note: This press release contains forward-looking statements concerning NeOnc technologies. These statements may involve risks and uncertainties that could cause actual results to differ materially.