Dallas, Texas--(Newsfile Corp. - 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.
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Key Takeaways:
NEO100's Phase 2a readout materially strengthens the lead program, with PFS-6 of 48.9% versus the 20% benchmark and median OS of 26.09 months. The favorable tolerability profile and lack of major toxicities further support the potential for chronic, patient-friendly treatment and move NEO100 toward a registrational-stage opportunity.
FDA alignment is now the key near-term catalyst, with NeOnc planning a Type B meeting to determine NEO100's registrational trial design, endpoints and potential approval pathway. NEO212 also gained regulatory momentum through Phase 2 CMC clearance and FDA feedback indicating a potential accelerated approval pathway.
The investment case is broadening beyond a single trial or asset, with NEO100 extending into meningioma and pediatric brain tumors while NEO212 provides a differentiated second clinical program. This platform breadth increases longer-term optionality, although funding remains important as development activity expands.
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About Stonegate
Stonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies.
Contacts:
Stonegate Capital Partners
(214) 987-4121
info@stonegateinc.com
Source: Stonegate, Inc.
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