perillyl alcohol (NEO100) / NeOnc Technologies - LARVOL DELTA

A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Neonc Technologies, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2026 ➔ Jul 2027 | Trial primary completion date: Oct 2026 ➔ Jun 2027

Enrollment open • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Diffuse Midline Glioma • Glioma • High Grade Glioma • Oncology • Pediatrics • Solid Tumor

Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma (clinicaltrials.gov) - P1/2 | N=49 | Active, not recruiting | Sponsor: Neonc Technologies, Inc. | Trial completion date: Aug 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Durable Radiographic Remission and Prolonged Survival with Intranasal NEO100 in Recurrent WHO Grade III/IV IDH1-Mutant Astrocytoma: Updated Results from a Phase 1/2a Study and Compassionate Use Experience (SNO 2026) - No abstract available

Clinical • P1/2 data • Astrocytoma • Brain Cancer • Oncology • Solid Tumor • IDH1

NeOnc Technologies Reports Positive Topline Phase 2a Results for Intranasal NEO100 in Recurrent IDH1-Mutant High-Grade Glioma (NeOnc Press Release) - "The study met its primary endpoint. Six-month progression-free survival (PFS-6) was 48.9% (95% CI: 26.3-68.1) by RANO 2.0 criteria using Kaplan-Meier estimation, compared with the 20% rate pre-specified in the study design as the expectation for standard of care (p = 0.0047)....Secondary survival endpoints were supportive. Median overall survival was 26.09 months, with 12 deaths among 24 patients. Overall survival was 86.7% at six months (95% CI: 64.3-95.5), 60.9% (95% CI: 36.4-78.4) at 12 months and 54.1% (95% CI: 29.5-73.4) at 24 months....Company to request a Type B meeting with the FDA to align on a registrational path in a setting with no approved targeted therapy."

P2a data • High Grade Glioma

NeOnc Technologies to Host Investor Conference Call to Discuss Topline Phase 2a Results for Intranasal NEO100 in Recurrent IDH1-Mutant High-Grade Glioma (Yahoo Finance)

P2a data • High Grade Glioma

Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma (clinicaltrials.gov) - P1/2 | N=49 | Active, not recruiting | Sponsor: Neonc Technologies, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2026 ➔ Jul 2026

Enrollment closed • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

NeOnc Technologies Receives UAE IND Approval for NEO100, Expanding Global Development Ahead of Anticipated Phase 2 Data Milestone (GlobeNewswire) - "The authorization covers the Company’s NEO100-01, NEO100-02, and NEO100-03 protocols across Phase 1, Phase 1b, and Phase 2 studies in adults, together with pediatric studies authorized for Phase 1 and Phase 1b pending further protocol review. The authorized indication is progressive or recurrent Grade III or IV gliomas...The Company expects to report top-line data from the fully enrolled NEO100-01 Phase 2a trial by the end of July 2026....The UAE authorization further positions NeOnc to rapidly expand clinical development activities internationally as the Company prepares for multiple anticipated regulatory and clinical milestones throughout the second half of 2026."

P2a data • Regulatory • Trial status • Glioma

The Company has also submitted applications to the Department of Health - Abu Dhabi for its NEO100 clinical programs, including NEO100-01, NEO100-02, and NEO100-03, and is currently awaiting regulatory decisions. (The Manila Times)

Non-US regulatory • Trial status • Brain Cancer

Pharmacokinetics assessment of intranasal NEO100 treatment on blood-brain barrier disruption and brain penetration of drugs in rodent brain (AACR 2024) - "Co-administration of IN NEO100 with ZN-c3, everolimus, and infigratinib increases their brain and plasma exposure. As a result, no significant increase in brain-to-plasma partition was registered for any of the three drugs tested in this study. IN NEO100-mediated increase in brain drug concentration was independent of BBB disruption"

PK/PD data • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Protocol for a pilot-randomized trial in newly diagnosed glioblastoma: standard care with or without daily intranasal perillyl alcohol. (PubMed, Future Oncol) - "Standard treatment, surgery followed by chemoradiation with temozolomide (TMZ), yields an average survival of 18 months. This study evaluates an adjunct protocol combining intranasal POH with standard therapy in newly diagnosed GB patients. This randomized clinical trial aims to support future research and guide clinical practice.Clinical trial registration: RBR-4ngc9n5 (www.ensaiosclinicos.gov.br)."

Clinical • Journal • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Updated NEO100 Clinical Results Show Possible Durable Efficacy in Recurrent IDH1-Mutant Gliomas (The Manila Times) - "Expanded 25-patient cohort from Phase 1/2a and compassionate-use experience, intranasal NEO100; Suggested a 24% radiographic remission rate (6/25)-3× the ~8% historically seen with salvage therapies; 44% six-month progression-free survival (vs. 21-31% historical benchmarks); 36% of patients (9/25) alive ≥18 months post-treatment initiation; No significant toxicity even under prolonged chronic dosing."

P1/2 data • Glioblastoma • Glioma

NEO100 - Phase 2a Fully Enrolled (The Manila Times) - "Completed enrollment in the NEO100 Phase 2a trial for IDH-1 mutant recurrent high-grade glioma, with an interim data readout expected in ~5 months (approximately August 2026)."

Enrollment closed • P2a data • Glioma

Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma (clinicaltrials.gov) - P1/2 | N=49 | Recruiting | Sponsor: Neonc Technologies, Inc. | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • IDH1

NEO100-02: NEO100 and High-Grade Meningioma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Neonc Technologies, Inc. | Trial completion date: Sep 2026 ➔ Jun 2027 | Trial primary completion date: Sep 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Brain Cancer • Meningioma • Oncology • Solid Tumor

NeOnc Technologies Holdings, Inc…announced updated clinical results from its ongoing Phase 1/2a and compassionate-use experience evaluating intranasal NEO100 in patients with recurrent WHO Grade III/IV IDH1-mutant astrocytoma. (GlobeNewswire) - "Radiographic Response: 24% (6 of 25 patients) achieved significant radiographic remission confirmed by contrast-enhanced, T2-FLAIR, and perfusion MRI. This response rate exceeds the <8% typically observed with salvage therapies for recurrent gliomas. Progression-Free Survival (PFS-6): 44% of patients achieved 6-month progression-free survival (PFS-6), outperforming historical benchmarks of 21–31% for IDH1-mutant recurrent high-grade gliomas. Long Term Survival: 36% (9 of 25) demonstrated durable survival ≥18 months post-initiation of NEO100."

P1/2 data • Astrocytoma

A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Neonc Technologies, Inc. | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Oct 2025 ➔ Oct 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Diffuse Midline Glioma • Glioma • High Grade Glioma • Oncology • Pediatrics • Solid Tumor

Intranasal novel compound NEO100-facilitated steroid delivery in managing peritumoral edema in rat glioma animal model (SNO 2025) - " The pharmacokinetic (pK) study was performed to compare the efficacy of oral and IN Dexamethasone (Dex) with and without NEO100. IN NEO100-mediated Dex delivery shows great promise compared to oral administration and is also effective in managing peritumoral edema. Other effects on animal survival, blood sugar levels, liver function, metabolite rates, as well as T3/T4 levels, are under investigation."

Preclinical • Astrocytoma • Brain Cancer • CNS Disorders • Cushing’s Disease • Endocrine Disorders • Gastrointestinal Disorder • Glioma • Oncology • Solid Tumor • IDH1

NEO100 facilitates delivery of blood-brain barrier impenetrable drugs (SNO 2025) - "We have shown that NEO100 significantly enhances the brain tumor specific uptake and retention of doxorubicin, dexamethasone, and remdesivir when administered via an intra-nasal route in a formulation that contains NEO100 at concentrations as low as 1%, when compared to traditional oral or IV routes of administration. Understanding how NEO100 functions in manipulating the barrier's physiology is crucial for developing next-generation therapeutics capable of treating CNS diseases effectively. Continued innovation in drug design and delivery technologies is essential for expanding the range of treatable neurological conditions"

Brain Cancer • CNS Disorders • Glioma • Solid Tumor

Intranasal novel compound NEO100-facilitated steroid delivery in managing peritumoral edema in rat glioma animal model (WFNOS 2025) - " The pharmacokinetic (pK) study was performed to compare the efficacy of oral and IN Dexamethasone (Dex) with and without NEO100. IN NEO100-mediated Dex delivery shows great promise compared to oral administration and is also effective in managing peritumoral edema. Other effects on animal survival, blood sugar levels, liver function, metabolite rates, as well as T3/T4 levels, are under investigation."

Preclinical • Astrocytoma • Brain Cancer • CNS Disorders • Cushing’s Disease • Endocrine Disorders • Gastrointestinal Disorder • Glioma • Solid Tumor • IDH1

A Validated UPLC-MS/MS Method for Monitoring Temozolomide and Perillyl Alcohol Metabolites in Biological Matrices: Insights From a Preclinical Pharmacokinetic Study. (PubMed, Biomed Chromatogr) - "PA was mainly distributed to liver and kidneys, with limited brain penetration. The validated method enables preclinical pharmacokinetic and tissue distribution studies, offering valuable insights into TMZ and POH behavior for GBM treatment."

Journal • PK/PD data • Preclinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

NeOnc Technologies Holdings, Inc…announced the completion of full patient enrollment in its ongoing NEO100-1 Phase 2a clinical trial. (GlobeNewswire) - "The Company anticipates reporting preliminary data from this fully enrolled cohort in approximately six months, during the second quarter of 2026."

Enrollment closed • P2a data • Glioma

NEO100 facilitates delivery of blood-brain barrier impenetrable drugs (WFNOS 2025) - "We have shown that NEO100 significantly enhances the brain tumor specific uptake and retention of doxorubicin, dexamethasone, and remdesivir when administered via an intra-nasal route in a formulation that contains NEO100 at concentrations as low as 1%, when compared to traditional oral or IV routes of administration. Understanding how NEO100 functions in manipulating the barrier's physiology is crucial for developing next-generation therapeutics capable of treating CNS diseases effectively. Continued innovation in drug design and delivery technologies is essential for expanding the range of treatable neurological conditions"

Brain Cancer • CNS Disorders • Solid Tumor

NeOnc Technologies…to Host Investor Conference Call to Present Data Updates from Ongoing NEO100-1 Phase 1/2a Clinical Trial and Compassionate Use Program (GlobeNewswire) - "During the call, members...will present data updates from the Company’s ongoing Phase 1/2a NEO100-1 clinical trial and compassionate use program, evaluating intranasal delivery of NEO100 (high-purity perillyl alcohol) in patients with recurrent high grade malignant glioma. The discussion will highlight MRI-based radiographic response data, progression-free survival (PFS), and overall survival (OS) trends observed to date, providing important insights into long-term clinical outcomes for patients treated with NEO100."

Clinical • P1/2 data • Glioma

Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma (clinicaltrials.gov) - P1/2 | N=49 | Recruiting | Sponsor: Neonc Technologies, Inc. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • IDH1

Intranasal Terpene Treatment for Glioblastoma: the Neuro-Oncological Potential of Perillyl Alcohol. (PubMed, Neurochem Res) - "This review aims to evaluate the potential of intranasal terpene treatment (ITT) as a novel and non-invasive strategy to bypass the BBB and improve glioblastoma treatment outcomes. A review of recent preclinical and clinical studies on intranasally administered compounds (especially terpenes such as Perillyl alcohol (POH)) is presented in terms of their molecular mechanisms, bioavailability, and clinical effects in the central nervous system (CNS)."

Journal • Review • Brain Cancer • Glioblastoma • Oncology • Solid Tumor