NTHI · Neonc Technologies Holdings, Inc.

NeOnc Technologies Holdings, Inc. disclosed Q4 and full-year 2025 financial results marked by a significantly widened net loss of $62.1 million ($3.20 per diluted share), up from $11.9 million ($0.69 per share) in Q4 2024, primarily attributable to escalated general and administrative expenses of $4.8 million (versus $1.7 million prior year) tied to marketing expansion, rent, travel, and Middle East partnership costs, alongside elevated stock-based compensation. R&D expenses rose modestly to $3.6 million from $3.0 million, reflecting active trial management for NEO100 and NEO212, including site operations, patient recruitment, and initiation of NEO100-3. CEO Amir Heshmatpour highlighted Q4 2025 and early 2026 as inflection points, emphasizing NEO212's Phase 1 completion with a 610 mg recommended Phase 2 dose and early efficacy signals in heavily pretreated recurrent GBM and brain metastasis patients, positioning it as a differentiated oral temozolomide conjugate potentially overcoming MGMT resistance. NEO100's Phase 2a trial in recurrent IDH1-mutant high-grade glioma reached full enrollment, with interim data anticipated in approximately five months (~August 2026), bolstered by updated Phase 1/2a results showing a 24% radiographic remission rate (versus ~8% historical), 44% six-month progression-free survival (versus 21-31% benchmarks), and 36% of patients surviving ≥18 months with no significant toxicity. Strategic moves included a PIPE financing led by Cinctive Capital's $10 million anchor to fund clinical priorities, leadership enhancements with Heshmatpour as CEO and David Choi as CAO, and Middle East expansion via NuroMENA under Executive Chairman His Highness Sheikh Nahyan bin Zayed Al Nahyan, featuring a Master Services Agreement with M42’s IROS. Upcoming catalysts include a Type B FDA meeting for NEO212 to align on a potential pivotal Phase 2 and accelerated approval pathway, reinforcing NeOnc's focus on CNS cancer therapies.