On April 1, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, reported financial results for the quarter and year ended December 31, 2025, and provided an update on recent operational achievements and upcoming milestones.

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Amir Heshmatpour, Chief Executive Officer, Executive Chairman, and President, commented:

"Q4 2025 and early 2026 marked important inflection points for NeOnc. We completed NEO212’s Phase 1 dose escalation and established a recommended Phase 2 dose of 610 mg, with early signs of possible anti-tumor activity in heavily pretreated patients.

In parallel, the NEO100 Phase 2a study in recurrent IDH1-mutant high-grade glioma is fully enrolled. Updated Phase 1/2a data suggested a 24% radiographic remission rate, 44% six-month progression-free survival, and no significant toxicity.

We also strengthened the balance sheet through a PIPE financing anchored by Cinctive Capital’s $10 million commitment, expanded the leadership team, and advanced our Middle East strategy through NuroMENA.

Looking ahead, we plan to hold a Type B End-of-Phase 1 FDA meeting for NEO212. We also expect a preliminary NEO100 Phase 2a data readout in approximately five months. We believe these near-term catalysts position NeOnc to deliver value-creating milestones for shareholders in the months ahead."

Fourth Quarter and Recent Highlights

Clinical Milestones & Data

NEO212 — Phase 1 Complete, 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
First oral bio-conjugated temozolomide asset is mechanistically differentiated by its potential ability to overcome MGMT-mediated TMZ resistance.
NEO100 — Phase 2a Fully Enrolled: Completed enrollment in the NEO100 Phase 2a trial for IDH-1 mutant recurrent high-grade glioma, with an interim data readout expected in ~5 months (approximately August 2026).
Updated NEO100 Clinical Results Show Possible Durable Efficacy in Recurrent IDH1-Mutant Gliomas:
Expanded 25-patient cohort from Phase 1/2a and compassionate-use experience, intranasal NEO100
Suggested a 24% radiographic remission rate (6/25)—3× the ~8% historically seen with salvage therapies
44% six-month progression-free survival (vs. 21–31% historical benchmarks)
36% of patients (9/25) alive ≥18 months post-treatment initiation
No significant toxicity even under prolonged chronic dosing
Reinforces NEO100’s potential as a first-in-class, CNS-penetrant metabolic therapy for recurrent WHO Grade III/IV IDH1-mutant astrocytoma.
NEO100 & Ultrasound: Announced AI-driven findings demonstrating that ultrasound may enhance the potency of NEO100 against primary and metastatic brain tumors, pointing toward a potential combination approach.

Middle East Expansion (NuroMENA)

Executive Chairmanship: His Highness Sheikh Nahyan bin Zayed Al Nahyan assumed the role of Executive Chairman of NuroMENA, NeOnc’s UAE-based subsidiary, to advance a UAE-US partnership in brain cancer treatment.
Operational Agreements: NuroMENA executed a Master Services Agreement with M42’s IROS and expanded its Board of Directors.

Strengthening Leadership & Securing Growth Capital

PIPE Financing: Raised a PIPE investment anchored by a $10 million commitment from Cinctive Capital Management, strengthening the balance sheet to advance clinical priorities.
Chief Executive Officer: Named Amir Heshmatpour as CEO to lead the company’s next phase of clinical and corporate development.
Chief Accounting Officer: Appointed David Choi as CAO to oversee the Company’s accounting, financial reporting, internal controls, and corporate governance functions.
Scientific Advisory Board Expansion: Added two leading neuro-oncologists — Dr. David M. Ashley, Director of Duke’s Preston Robert Tisch Brain Tumor Center, and Dr. Alexandra M. Miller, Chief of Neuro-Oncology at NYU Langone’s Perlmutter Cancer Center — deepening the company’s scientific bench.

Investor & Media Engagement

Broadcast Exposure: Featured across multiple New to The Street segments on Bloomberg Television (U.S., MENA, and Latin America) and Fox Business, increasing visibility among retail and institutional audiences.
Investor Events & KOL Calls: Hosted multiple investor and key opinion leader conference calls presenting clinical data updates and participated in the New to The Street Accredited Investor Event at Hudson Yards, New York.

Financial Results for Q4 2025

G&A expenses: $4,818k vs. $1,680k in Q4 2024, reflecting expanded marketing, rent, travel, and Middle East partnership-related costs.
R&D expenses: $3,638k vs. $3,045k in Q4 2024, driven by active management of NEO100 trial sites, recruitment for NEO212, initiation of NEO100-3, and overall patient recruitment activity.
Net loss: $62.1 million or $3.20 per diluted share, compared to $11.9 million or $0.69 per diluted share in Q4 2024, primarily due to increased general and administrative expenses, as well as stock-based compensation expenses.

(Press release, Neonc, APR 1, 2026, View Source [SID1234664142])