Announcement • Apr 12
NeOnc Technologies Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $75 million. NeOnc Technologies Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $75 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Announcement • Mar 13
NeOnc Technologies Holdings, Inc. Appoints David Choi as Chief Accounting Officer NeOnc Technologies Holdings, Inc. has appointed David Choi as Chief Accounting Officer . In this role, Mr. Choi is responsible for overseeing the Company’s accounting, financial reporting, internal controls, and corporate governance functions as NeOnc advances its clinical-stage biotechnology platform and expands its global operations. Mr. Choi has more than a decade of experience in accounting, financial reporting, and internal controls for both public and private companies. Prior to joining NeOnc, Mr. Choi was a Director at Blythe Global Advisors, where he advised companies across multiple industries on technical accounting matters, SEC reporting, and SOX compliance. He led engagements involving financial reporting transformation, internal control design and implementation, and accounting for complex transactions including equity instruments, debt financing, and business combinations. Earlier in his career, Mr. Choi held positions at Grant Thornton and Ernst & Young, where he provided assurance and advisory services to public and private companies. His experience includes financial statement audits, technical accounting advisory, and SOX readiness and compliance for internal controls over financial reporting. Mr. Choi is a Certified Public Accountant (CPA). He holds a Master of Professional Accountancy and a Bachelor of Arts in Business Economics with a minor in Accounting from the University of California, Irvine. Announcement • Mar 06
NeOnc Technologies Holdings Reports Phase 1 Dose-Escalation Results and Determines Recommended Phase 2 Dose for Oral Neo212 NeOnc Technologies Holdings, Inc. 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 (MTD) at Cohort 5 (810 mg, Days 1–5, 28-day cycle) 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 (RP2D) has been set at 610 mg (Cohort 4). For the Phase 2a metastasis cohort, the starting dose will be 400 mg (Cohort 3). 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. This represents the first clinical readout of NeOnc’s bioconjugated temozolomide (TMZ) 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 (End-of-Phase 1) 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. NEO212 is specifically designed to overcome a key biological limitation of TMZ: MGMT-mediated resistance. Preclinical studies have shown that NEO212 effectively inactivates and promotes the degradation of O6-methylguanine-DNA methyltransferase (MGMT), a crucial DNA repair enzyme that causes TMZ resistance. Standard TMZ treatment does not significantly lower MGMT levels and remains vulnerable to MGMT-driven DNA repair in brain tumors. This mechanistic difference may be especially important for TMZ-resistant and MGMT-high recurrent glioblastoma patients, offering a strong biological reason to advance NEO212 into Phase 2 development in the post-TMZ setting. NEO212 is NeOnc’s first oral chemical conjugated chemotherapy drug, uniquely combining Temozolomide (TMZ), the current standard of care for glioblastoma and other brain cancers (marketed as Temodar®), with NEO100 (a proprietary form of perillyl alcohol (POH), which is owned and patented by NeOnc). This proprietary conjugation is designed to overcome the limitations of TMZ, including resistance and limited efficacy, by enhancing blood-brain barrier penetration and antitumor activity. 
