NeOnc Technologies Updates Clinical Results for NEO100
NeOnc Technologies announced updated clinical results from its ongoing Phase 1/2a and compassionate-use experience evaluating intranasal NEO100 in patients with recurrent WHO Grade III/IV IDH1-mutant astrocytoma. Since the Company's prior announcement and 8K event on November 12, 2025, an additional patient has achieved both durable long-term survival and radiographic remission, further strengthening the clinical signal observed with intranasal NEO100. With this update, the expanded clinical cohort now includes 25 patients, reinforcing the reproducibility and durability of treatment benefit. Updated results demonstrate that treatment with intranasally delivered NEO100 has resulted in significant radiographic remission in 6 of 25 patients, representing 3X increase over the 8% response rates typically reported with salvage therapies in recurrent high-grade gliomas. Additionally, 44% of patients achieved six-month progression-free survival, exceeding historical benchmarks of 21-31% for IDH1-mutant recurrent high-grade gliomas. Importantly, 9 of 25 patients remain alive greater than or equal to18 months following initiation of NEO100, providing further evidence of meaningful long-term survival in this heavily pretreated population. No significant toxicity has been observed with intranasal administration of NEO100, even with prolonged and chronic dosing.
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- Financing Agreement: NeOnc Technologies Holdings, Inc. announced a securities purchase agreement with Cinctive Capital Management to sell up to 2,222,222 shares through a PIPE, expected to generate approximately $16 million in gross proceeds, which will be used for debt repayment and working capital.
- Investor Confidence Boosted: The $10 million investment from Cinctive Capital reflects strong confidence in NeOnc's technology and clinical assets, particularly underscored by the leadership of Co-Founder Rich Schimel, enhancing the strategic significance of this investment and market recognition of the company.
- Clinical Trials Acceleration: NeOnc stated that this funding will provide essential capital to accelerate its clinical trials, especially for its NEO100 and NEO212 therapies in Phase II, which aim to bypass the blood-brain barrier and address significant challenges in CNS cancer treatment.
- Patent Protection Advantage: NeOnc's NEO™ drug development platform, with patent protections extending to 2038, demonstrates the company's long-term potential in innovative drug development, which is expected to provide strong support for future market competition.

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- Clinical Results Update: NeOnc Technologies reports that its NEO100 therapy achieved a significant radiographic remission rate of 24% in 25 patients, which is a 300% increase over the typical 8% seen with salvage therapies, indicating strong efficacy and competitive potential in the market.
- Survival Rate Improvement: Among patients treated with NEO100, 36% remained alive 18 months post-treatment, suggesting that this therapy may provide durable survival benefits in heavily pretreated populations, thereby altering treatment strategies.
- No Significant Toxicity: The intranasal administration of NEO100 has shown no significant toxicity even with prolonged use, ensuring patient safety and providing strong support for its clinical application.
- Broad Treatment Prospects: As the dataset expands, NEO100 is emerging as a potential first-in-class CNS-penetrant metabolic therapy, marking a possible paradigm shift in the treatment of IDH1-mutant high-grade gliomas and pushing the industry towards more effective treatment options.

- Significant Efficacy: Among 25 patients treated with NEO100, 6 (24%) achieved significant radiographic remission, representing a 300% increase over the typical 8% response rate seen with salvage therapies, indicating NEO100's potential as an effective option for recurrent IDH1-mutant high-grade gliomas.
- Survival Rate Improvement: 36% of patients demonstrated survival of 18 months or longer post-NEO100 treatment, showcasing the therapy's potential for long-term survival in heavily pretreated populations, which may shift treatment paradigms in this field.
- No Significant Toxicity: The intranasal administration of NEO100 has shown no significant toxicity even with prolonged and chronic dosing, indicating a high safety profile that could enhance patient treatment experiences.
- Expanded Clinical Data: The growing clinical cohort reinforces the treatment's effectiveness, bolstering confidence in NEO100 as a first-in-class CNS-penetrant metabolic therapy, potentially driving significant advancements in neuro-oncology.

- Research Collaboration Findings: A study from the University of Southern California demonstrates that ultrasound significantly enhances NEO100's therapeutic potency, driving strong antitumor effects across various brain tumor types, indicating its potential for clinical application.
- Technological Innovation: Utilizing an AI-driven, 3D bioprinting New Approach Methodology, researchers rapidly generate physiologically relevant patient-derived tumor organoids within hours, significantly accelerating biomedical research and aligning with NIH objectives to reduce animal testing.
- Clinical Trial Prospects: Validation studies reveal that NEO100 exhibits markedly enhanced tumor-killing activity when combined with focused ultrasound, supporting its advancement into future clinical trials for a wide range of brain tumors, thereby broadening its commercial and clinical opportunities.
- Market Potential: The breakthrough provides strong external validation for NEO100's potential as a first-in-class, noninvasive sonodynamic therapy, significantly expanding its market opportunities beyond current indications through the integration of AI, 3D bioprinting, and ultrasound technology.







