Amir Heshmatpour, Chief Executive Officer, Executive Chairman, and President, commented:
"The first quarter of 2026 marked a transformational period for NeOnc as we advanced both of our lead clinical programs toward important regulatory and value-creation milestones. We successfully completed the Phase 1 dose-escalation portion of NEO212 and established 610 mg as the recommended Phase 2 dose. Importantly, we observed encouraging early signs of clinical activity and potential durable disease stabilization in heavily pretreated recurrent GBM and brain metastasis patients, despite the study being primarily designed to evaluate safety.
We are now preparing to request a Type B End-of-Phase 1 meeting with the FDA to align on the design of a potentially pivotal registrational Phase 2 study and evaluate potential pathways toward accelerated regulatory review.
For NEO100, our fully enrolled Phase 2a study in recurrent IDH1-mutant high-grade glioma continues progressing toward an anticipated interim data readout later this year. Previously reported results, including a 24% radiographic remission rate, 44% six-month progression-free survival, and the absence of significant toxicity, continue to reinforce our confidence in the therapeutic potential of NEO100 as we approach this important milestone.
Operationally, we strengthened our balance sheet through a PIPE financing anchored by a $10 million commitment from Cinctive Capital, expanded our executive leadership team with the appointment of David Choi as Chief Accounting Officer, and continued advancing our Middle East strategic initiatives through NuroMENA.
We believe the anticipated FDA engagement for NEO212 and the upcoming NEO100 interim data readout position NeOnc for what could become one of the most significant periods of clinical and strategic inflection in the Company's history. My conviction in NeOnc's long-term opportunity and clinical direction is reflected in my recent open-market purchase of more than $500,000 of NTHI shares."
First Quarter and Recent Highlights
Clinical Milestones & Data
NEO212, Phase 1 Complete, Recommended Phase 2 Dose (RP2D) Set at 610 mg:
Early signs of possible clinical efficacy, including potential durable disease control in heavily pretreated recurrent GBM and brain metastasis patients, observed even within the safety-focused phase
The company intends to request a Type B End-of-Phase 1 FDA meeting to align on a potential pivotal, registrational Phase 2 study
Exploring an Accelerated Approval pathway
NEO100, Phase 2a Fully Enrolled: Phase 2a trial for IDH1-mutant recurrent high-grade glioma, with an interim data readout expected in approximately August 2026.
Strengthening Leadership & Securing Growth Capital
PIPE Financing: Raised a ...
