NeOnc Technologies Holdings, Inc.

Clinical-stage neuro-oncology

The brain has a wall.
NeOnc found a way
around it.

The blood-brain barrier blocks most cancer drugs from ever reaching a brain tumor. NeOnc's lead candidate, intranasal NEO100, is designed to travel the nerve pathways straight toward the tumor, around the barrier that stops most drugs.

107,100
new primary brain and CNS tumor cases estimated in the U.S. this year1
6 to 9 mo
typical survival after a high-grade tumor returns2
0
FDA-approved targeted therapies for recurrent IDH1-mutant Grade III/IV glioma3
Anatomical rendering: an intranasal delivery route travelling from the nose toward a brain tumor
NEO100 · intranasal routeIllustrative rendering
2
Lead drug candidates
NEO100 & NEO212
4
Programs in the clinic
Phase I to II
~179
Issued patents & pending
applications; protection to 20384
2026
Positive Phase 2a data reported;
FDA Type B meeting planned
The problem

When a brain tumor returns, patients run out of options.

Recurrent high-grade brain tumors are among the hardest cancers in medicine. Two obstacles stack on top of each other: the tumors come back aggressively, and most drugs physically can't reach them.

~90%

Relapse is expected

Most high-grade glioma patients recur within 6 to 9 months despite maximal surgery, radiation and chemotherapy.

6-9 mo

Survival after recurrence

Median survival once the tumor returns is roughly 6 to 9 months, and for recurrent IDH1-mutant high-grade glioma there is no FDA-approved targeted therapy.

THE BBB

The delivery wall

The blood-brain barrier blocks most oncology drugs from ever reaching therapeutic levels inside the central nervous system.

The approach

Go around the wall,
not through it.

NeOnc's NEO drug-development platform has produced two lead candidates. The lead program, intranasal NEO100, is designed to travel the olfactory and trigeminal nerve pathways directly toward the brain, bypassing the bloodstream and the barrier that stops most drugs.

NEO100 · lead candidate

Intranasal, brain-targeted

An ultra-pure pharmaceutical grade of perillyl alcohol (a monoterpene from citrus and peppermint oils), self-administered intranasally to deliver therapy along nerve pathways toward the brain.

NEO212 · oral candidate

Brain-optimized chemo

An orally administered conjugate that links perillyl alcohol to temozolomide (the established chemotherapy standard), designed for better brain penetration than temozolomide alone.

The science, in numbers
3×
Higher brain penetration vs temozolomide (brain-to-serum ratio)
Preclinical
10×
Greater potency vs temozolomide in tumor-cell models
Preclinical
39×
Lower systemic chemo metabolite vs temozolomide
Preclinical
63
Peer-reviewed studies on the platform's active compound
Preclinical and pharmacokinetic findings drawn from the Company's 2026 presentation.6 Laboratory and animal results may not translate to humans.
The pipeline

Four clinical programs across CNS cancers.

The pipeline spans the lead intranasal candidate NEO100, in recurrent glioma with expansion into meningioma and pediatric brain tumors, and the oral conjugate NEO212. Development stage and timing are subject to regulatory review and can change.

NEO100-01
Recurrent / progressive IDH1-mutant Grade III-IV glioma
Intranasal · Phase 2a met primary endpoint
PreclinicalPhase IPhase IIPhase III
NEO100-02
Recurrent meningioma, the most common primary brain tumor
Intranasal · expansion program
PreclinicalPhase IPhase IIPhase III
NEO100-03
Pediatric high-grade glioma (FDA Rare Pediatric Disease designation)
Intranasal · pediatric pathway in development
PreclinicalPhase IPhase IIPhase III
NEO212
Primary brain tumors & brain metastases (610 mg recommended Phase 2 dose)
Oral · Phase I complete
PreclinicalPhase IPhase IIPhase III
Lead program results

Phase 2a: NEO100 met its primary endpoint.

In the Phase 2a portion of NEO100-01, intranasal NEO100 was studied in 24 patients with recurrent or progressive IDH1-mutant Grade III and IV glioma who had progressed after radiation and temozolomide. Read the results as an encouraging single-arm signal that still needs confirmation in a randomized trial.5

Six-month progression-free survival (PFS-6), RANO 2.0
NEO100Phase 2a, n=24
48.9%
Pre-specified benchmarkstandard-of-care assumption
20%
Difference versus the pre-specified benchmark was statistically significant (p = 0.0047).

Also reported

Median overall survival was 26.09 months, with overall survival of 86.7% at 6 months, 60.9% at 12 months and 54.1% at 24 months. NEO100 was well tolerated, with no dose-limiting toxicities and predominantly low-grade adverse events.

Next step: the Company intends to request an FDA Type B meeting to align on a potential registrational path.

How to read this: n=24, single-arm, open-label study. The 20% figure is a pre-specified assumption for standard of care, not a concurrent randomized control, and these results need confirmation in a larger randomized trial. Cross-study comparisons are not head-to-head. NEO100 is investigational and not approved by the FDA.
Why it could matter

The case beyond a single trial.

Reasons an investor might follow this story, alongside the risks, which are real and detailed at the bottom of this page.

Patent portfolio

A global portfolio of approximately 179 issued patents and pending applications, licensed from USC, with protection extending to 2038.4

Large, growing CNS market

Operates within the broad CNS therapeutics market, valued at about $127B in 2025 and projected to reach ~$286B by 2035 (Precedence Research, Feb 2026). NeOnc's addressable brain-cancer indications are a subset.7

USC-rooted science

Founded on research led by a USC neurosurgeon, with an advisory board drawn from Duke, NYU, USC and others.

Global expansion

A regional licensing and affiliate structure designed to expand clinical development and trial enrollment across the GCC and MENA region.

Milestones and what's next

Where NeOnc stands now.

Clinical-stage stories move on data. Here is what has been reported and what the Company has said comes next. Timing is a plan, not a promise, and can change.

Reported Aug 2026

NEO100-01 Phase 2a positive

Met its primary endpoint: PFS-6 of 48.9% versus a pre-specified 20% benchmark (p=0.0047), with median overall survival of 26.09 months.5

Next

FDA Type B meeting

The Company intends to request a Type B meeting with the FDA to align on a registrational path for NEO100 in recurrent IDH1-mutant high-grade glioma.

In development

NEO212 (oral)

Completed Phase 1 dose escalation (610 mg recommended Phase 2 dose); the Company has cited FDA feedback pointing to a possible accelerated approval pathway.

Expanding

Meningioma & pediatric

NEO100 is expanding into meningioma and pediatric brain tumors; it holds FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations.

Do your own diligence

Read the filings,
not just the pitch.

The best way to evaluate any clinical-stage company is its own primary disclosures. Start with NeOnc's SEC filings and investor materials, and decide for yourself.

Open NeOnc's investor materials →

Important disclosures, please read

This page is issued by NeOnc Technologies Holdings, Inc. for general informational purposes only. It is not investment advice or a recommendation, and it is not an offer to sell, or the solicitation of an offer to buy, any security. Nothing here should be relied upon as the basis for an investment decision. Any decision to invest should be made only after reviewing the Company's filings with the U.S. Securities and Exchange Commission.

Forward-looking statements. Statements about the Company's pipeline, clinical plans, expected data timing, potential markets, regulatory strategy and future prospects are forward-looking statements based on current expectations. They involve known and unknown risks and uncertainties, and actual results may differ materially. The Company undertakes no obligation to update forward-looking statements except as required by law.

Clinical and investment risk. NeOnc is a clinical-stage company with no FDA-approved products and no product revenue. Its therapies are investigational. Early-stage and small-sample clinical results may not predict later results, and most drug candidates that enter clinical trials are never approved. The Company expects to need substantial additional capital, which may dilute existing shareholders. NTHI shares may be volatile and illiquid. You could lose your entire investment. Clinical data on this page are drawn from the Company's August 12, 2026 Phase 2a topline press release and its 2026 corporate presentation. The Phase 2a study was single-arm and open-label (n=24); its pre-specified 20% benchmark is a study-design assumption, not a concurrent randomized control, and the results require confirmation in a randomized trial. Preclinical results are laboratory or animal findings that may not translate to humans. See sources below.

Full risk factors are described in NeOnc's SEC filings, available on EDGAR (NeOnc Technologies Holdings, CIK 0001979414) and at investors.neonc.com. Investor relations: Hayden IR. Consult a licensed financial professional before making any investment decision.

Sources & notes

  1. New primary brain and other CNS tumor cases (US, ~107,100 this year): CBTRUS 2025 Statistical Report (2018-2022 data).
  2. Survival after recurrence (~6-9 months for current salvage therapy) and no approved targeted therapy for recurrent IDH1-mutant high-grade glioma: NeOnc Technologies Phase 2a press release, August 12, 2026.
  3. No FDA-approved targeted therapy for the recurrent IDH1-mutant Grade III/IV glioma population: NeOnc Technologies Phase 2a press release, August 12, 2026.
  4. Patent portfolio (~179 issued and pending; protection to 2038): NeOnc Technologies corporate disclosures, 2026.
  5. Phase 2a NEO100-01 results (PFS-6 48.9% vs 20% pre-specified benchmark, p=0.0047; median OS 26.09 months; OS 86.7%/60.9%/54.1% at 6/12/24 months; well tolerated; planned FDA Type B meeting): NeOnc Technologies press release, August 12, 2026, and Form 8-K on SEC EDGAR.
  6. Preclinical and pharmacokinetic figures (3x, 10x, 39x) and published-studies count (63): NeOnc Technologies 2026 corporate presentation; preclinical and laboratory data.
  7. CNS therapeutics market size: Precedence Research, Central Nervous System Therapeutic Market, February 2026 (~$127B in 2025, projected ~$286B by 2035). This is the broad CNS market, not NeOnc's directly addressable brain-cancer market.