DALLAS, TX -- August 13, 2026 -- NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI). Stonegate Capital Partners Updates Coverage on NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI). 2Q26 meaningfully improves the clinical setup for NTHI, with NEO100 delivering a positive Phase 2a readout and NEO212 gaining regulatory clarity. NEO100 met its primary endpoint with six-month PFS of 48.9% by RANO 2.0 using Kaplan-Meier estimation versus a pre-specified 20% benchmark (p=0.0047), while median OS reached 26.09 months and no major toxicities were reported. We view the survival signal as the more important read through, with management citing 6–9 months for current salvage therapy in recurrent brain cancer, although confirmation in a randomized study remains the next test. The readout moves NEO100 into a potential registrational program, with the Company intending to request a Type B FDA meeting. Financial results are secondary, with R&D increasing to $2.6M vs. $0.7M y/y.
NEO100-01: The Phase 2a data provide the clearest validation to date for NEO100 in recurrent IDH1-mutant high-grade glioma. PFS-6 of 48.9% exceeded the 20% study benchmark, while six-, 12-, and 24-month OS rates were 86.7%, 60.9%, and 54.1%, respectively. Five of 24 patients remain on treatment, including one progression-free for roughly 19 months, while ORR was 8.3%. Tolerability remained favorable, with no major toxicities reported. We recognize that four-times-daily dosing could become onerous over time, although the favorable safety profile and at-home administration could support treating recurrent high-grade glioma as a more chronic disease rather than a terminal recurrence. Management is evaluating device/formulation improvements that could improve compliance over time. The study was single-arm and enrolled 24 of a planned 28 patients, making FDA feedback on trial design and registrational pathway the next determinant.
NEO212: Regulatory visibility improved versus 1Q26. FDA provided written feedback on CMC development and the capsule-to-tablet transition, and NeOnc is incorporating that feedback into its Phase 2 strategy, with meeting minutes expected in August. The planned Phase 2 design now focuses on recurrent IDH1-wildtype GBM. Management has indicated it believes the program may be eligible for an accelerated approval-oriented development path, subject to FDA alignment. UAE approvals for both programs broaden the clinical footprint.
Upcoming Catalyst: Near-term focus shifts to: (1) requesting a Type B FDA meeting for NEO100 to align on a registrational path, (2) NEO100 analyses including Grade III versus Grade IV subgroups, PK, quality-of-life and full safety data, and (3) advancement toward Phase 2 for NEO212. Cash was $2.0M at June 30, alongside an undrawn $10.0M related-party LOC and approximately $44.5M available under the Mast Hill facility, subject to its terms and limitations. With six-month operating cash use of $11.8M and a going concern disclosure, access to capital remains important as development expands.
Valuation: We use a probability-adjusted Discounted Cash Flow Model when valuing NTHI. Our valuation model returns a valuation range of $11.40 to $16.61 with a midpoint of $13.70 based on a discount rate range of 17.50% to 22.50%. Further details on our model can be found on page 2 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.
