DALLAS, TX -- January 9th, 2026 -- NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI). Stonegate Capital Partners initiates their coverage on NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI). NeOnc Technologies Holdings, Inc. is a clinical-stage life sciences company developing central nervous system therapeutics designed to overcome the blood–brain barrier. The Company has numerous assets in its pipeline, highlighted by NEO100 which is a patented, pure pharmaceutical compound produced via proprietary synthesis for pharmaceutical-grade purity and reproducibility. NeOnc’s intranasal administration strategy is designed to access the brain via olfactory and trigeminal pathways, offering a non-invasive route intended to improve adherence and enable more direct delivery. We view NTHI as a differentiated platform, supported by favorable tolerability with prolonged dosing and multiple near-term catalysts as the program advances toward a 2026 readout.
NEO100-01: NeOnc has disclosed an expanded dataset (25 patients) showing a 24% radiographic response rate (6/25), 44% PFS-6, and 36% ≥18- month survival following initiation of intranasal NEO100, versus historical salvage benchmarks cited by the Company (e.g., <8% response; 21–31% PFS-6). Phase 2a enrollment is complete, with a top-line readout expected in 2026 (company communications have referenced May 2026).
NEO212: NeOnc reports FDA authorization to proceed with a Phase II clinical trial of NEO212 (a first-in-class oral chemical conjugate chemotherapy candidate). The final Phase I cohort is described as on track to complete dosing in 2025, positioning NEO212 as a second clinical driver with potential applicability across primary brain tumors and brain metastases.
Additional pipeline (NEO100-02 / NEO100-03): The Company highlights additional intranasal opportunities in CNS tumors, including NEO100-02 (meningioma) and NEO100-03 (pediatric brain tumors), reinforcing a platform narrative beyond a single lead indication.
Strategic and Corporate Developments: NeOnc is building a broader strategic framework around its clinical programs, emphasizing partnership-driven expansion and non-dilutive funding avenues. In 2025, the Company developed a proposed $50 million strategic partnership with Quazar Investment aimed at strengthening Abu Dhabi–U.S. collaboration in brain cancer treatment. NeOnc also reported $2.5 million in NIH STTR grants to advance NEO212 for gliomas and leukemia, supporting continued translational development and external validation.
Upcoming Catalyst: Key near-term milestones include: (1) completion of the NEO212 Phase I final cohort dosing (2025), (2) NEO100-01 Phase 2a top-line readout in 2026 (company communications have referenced May 2026), and (3) potential closing/funding of the proposed Quazar strategic partnership. Collectively, these events represent the primary catalysts that could drive a step-change in clinical and strategic visibility over the next several quarters.
Valuation: We use a probability-adjusted Discounted Cash Flow Model when valuing NTHI. Our valuation model returns a valuation range of $17.27 to $25.09 with a midpoint of $20.75 based on a discount rate range of 17.50% to 22.50%. Further details on our model can be found on page 10 of this report. We note that this model is highly levered to the out years due to the long term nature of NTHI's industry, leading to the potential for dramatic re-ratings as new information becomes available.
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