NTHI News & Events

NeOnc Technologies Holdings announced data from the dose-escalation portion of its Phase 1/2 clinical trial for NEO212, the Company's novel oral bio-conjugated therapy and will host a conference call to discuss the data today at 9:00am ET. NeOnc has formally notified the FDA that the Phase 1 dose-escalation portion of the NEO212-01 Phase 1/2 clinical trial has reached Maximum Tolerated Dose at Cohort 5 following a second Dose-Limiting Toxicity. In accordance with protocol-defined stopping rules, dose escalation has been halted, no further patients will be enrolled at 810 mg, and the Recommended Phase 2 Dose has been set at 610 mg. For the Phase 2a metastasis cohort, the starting dose will be 400 mg, Notably, although Phase 1 was mainly designed to assess safety, tolerability, and identify the MTD, promising signs of clinical efficacy appeared during this phase of the study. These efficacy signs-including indications of lasting disease control in heavily pretreated patients with recurrent GBM and brain metastases-were observed within the dose-escalation groups. The emergence of measurable anti-tumor activity in Phase 1 offers early clinical confirmation of NEO212's therapeutic potential and supports the Company's progress into the Phase 2 segment of the trial. The transition into Phase 2 will focus on further assessing efficacy at the RP2D in specific expansion cohorts, aiming to generate strong clinical data to support potential accelerated development pathways in recurrent CNS cancers. Importantly, this represents the first clinical readout of NeOnc's bioconjugated temozolomide platform in an oral formulation, demonstrating NeOnc's drug-engineering capabilities beyond its established intranasal delivery platform. The data validate the Company's ability to optimize CNS penetration and therapeutic exposure across both intranasal and oral modalities. NeOnc intends to request a Type B FDA meeting to review safety, PK/PD, preliminary efficacy, RP2D justification, Phase 2 design modifications, and a potential Accelerated Approval pathway. Supporting regulatory materials, including MedWatch Form FDA 3500A and Form FDA 1571, have been submitted via eCTD, ensuring regulatory transparency and alignment as the program transitions into Phase 2 development.

NeOnc Technologies files to sell 2.95M shares of common stock for holders

NeOnc Technologies announced that it has entered into a securities purchase agreement for a private investment in public equity for the purchase and sale of up to 2,222,222 shares of common stock and five-year warrants to purchase up to 2,222,222 shares of common stock at a per share exercise price of $9.00 at a combined purchase price of $7.20, that is expected to result in gross proceeds of up to approximately $16 million to the Company. NeOnc currently intends to use the net proceeds from the offering for repayment of indebtedness, and for working capital and corporate purposes

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.