Roth Capital Partners analyst Jonathan Aschoff says NeOnc Technologies Holdings’ (NeOnc Technologies Holdings Stock Quote, Chart, News, Analysts, Financials NYSE:NTHI) lead brain cancer assets could move into pivotal trials by year-end.
In a Sept. 24 initiation report, Aschoff launched coverage of NeOnc with a “Buy” rating and US$20.00 target.
NeOnc is a clinical-stage oncology company developing central nervous system therapies designed to cross the blood-brain barrier. Its lead assets are NEO100 and NEO212.
Aschoff said a key near-term catalyst is the company’s upcoming Type B end-of-Phase 2 meeting with the FDA, expected in November. NeOnc is seeking FDA agreement that both drugs are ready for pivotal trials rather than more Phase 2 work.
NEO100 is an intranasal formulation of perillyl alcohol being developed for recurrent IDH1-mutant grade 4 astrocytoma. Phase 1/2a data showed progression-free survival at six months of 49%, compared with a historical expectation of about 20%, and median overall survival of 26.1 months, compared with a historical expectation of six to nine months.
NEO212 combines perillyl alcohol with temozolomide and is being developed for recurrent glioblastoma, recurrent grade 4 astrocytoma and brain metastases. Preclinical work showed three times as much temozolomide entered the brain with NEO212 compared with equimolar doses of temozolomide.
Aschoff said perillyl alcohol is both a therapeutic agent and a drug chaperone, with potential to help escort other drugs into the central nervous system.
Near-term catalysts include the FDA meeting outcome in Q4 2026 and presentation of NEO100 and NEO212 data at the Society for Neuro-Oncology annual meeting in November.
The company is seeking accelerated approval for each drug based on a single interim analysis using overall response rate as the endpoint, with no survival detriment. Aschoff said that approach could produce potentially approvable results a couple of years earlier than going directly to full approval based on overall survival.
Aschoff projects NEO100 and NEO212 launches in 2029 and 2030, respectively.
NeOnc had pro forma cash of US$9.9-million, which Aschoff said should fund operations through 2026. The company has no debt, an at-the-market facility and an untapped US$10-million line of credit.
His US$20.00 target is based on a discounted cash flow analysis using a 20% discount rate and a five times multiple on his projected 2033 operating income of US$667-million.
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