Neonc Technologies Holdings, Inc. · NASDAQ:NTHI
Neonc Technologies — Investor Presentation (August 2026)
57 slides from Neonc Technologies's investor presentation, August 2026
Slide 1: NeOnc Technologies Holdings, Inc. Corporate Presentation
NeOnc Technologies Holdings, Inc. Corporate Presentation Clinical-stage CNS therapeutics. Intranasal delivery designed to bypass the blood–brain barrier, with two platforms — NEO100 and NEO212 — in clinical development for primary brain tumors and brain metastases. NASDAQ: NTHI CNS oncology focus &
Slide 2: Leadership, board & scientific advisors
OUR TEAM Leadership, board & scientific advisors SENIOR MANAGEMENT Amir F. Heshmatpour Thomas Chen, MD, PhD Josh Neman, PhD Keithly A. Garnett David Choi, CPA CEO, Exec. Chairman & President Founder, CMO & CSO Chief Clinical Officer Chief Financial Officer Chief Accounting Officer BOARD OF DIRECTORS
Slide 3: Important cautions regarding forward-looking statements
DISCLAIMER Important cautions regarding forward-looking statements This document does not constitute or form part of an invitation or recommendation to We have based the forward-looking statements on our current expectations and subscribe for or purchase any securities. The distribution may be restr
Slide 4: Clinical development & pipeline
CLINICAL PIPELINE Clinical development & pipeline Important disclaimer: this development & clinical pipeline is subject to regulatory approval, risks and uncertainties, and potential changes beyond our control. Clinical Development Drug Application Indication Preclinical IND Enabling* Phase I Phase
Slide 5: Two platforms, one enabling technology
PLATFORM Two platforms, one enabling technology: NEO100's BBB penetration powers both NEO100 — Drug Delivery Platform (core technology) NEO212 — Drug Conjugation Platform (built on NEO100) • Designed as a direct, non-invasive CNS delivery patented technology • Conjugates NEO100 to established cytoto
Slide 6: NEO100 — ultra-pure perillyl alcohol, delivered nose-to-brain
PLATFORM 1 · INTRANASAL DELIVERY NEO100 — ultra-pure perillyl alcohol, delivered nose-to-brain NEO100 Phase 2a complete in recurrent IDH1-mutant grade III–IV glioma (NCT02704858) — self-administered intranasally, four times daily 5 of 24 — remained on treatment at 48.9% — PFS-6 (RANO 2.0) 26.09 mo —
Slide 7: IDH1-mutant survival is quoted from diagnosis — in years
THE STARTING LINE MATTERS · U.S. BURDEN IDH1-mutant survival is quoted from diagnosis — in years IDH1-mutant grade 3–4 astrocytomas are the “long-survivor” subset of glioma — but that survival is measured from initial diagnosis, and the treated U.S. population is large and growing. 26,480 / yr ~2,40
Slide 8: At recurrence, prognosis collapses to 6–9 months
THE CLOCK RESETS At recurrence, prognosis collapses to 6–9 months — grade 3 and 4 High-grade gliomas virtually always recur despite maximal therapy. Once the tumor progresses after radiation and temozolomide, the survival clock no longer runs from diagnosis — it restarts at recurrence. FROM DIAGNOSI
Slide 9: NEO100: ultra-pure perillyl alcohol, delivered nose-to-brain
THE PLATFORM NEO100: ultra-pure perillyl alcohol, delivered nose-to-brain Ultra-pure, patented POH NEO100 is a pharmaceutical-grade form of perillyl alcohol (POH), a natural monoterpene from citrus and peppermint oils. Proprietary synthesis Manufactured via a patented crystalline intermediate design
Slide 10: NEO100's proposed mechanism of action in resistant tumors
MECHANISM OF ACTION NEO100's proposed mechanism of action in resistant tumors ER Stress Induction Na/K -ATPase Inhibition RAS Inhibition In vivo Sources: NEO100 is an investigational product candidate; it has not been approved by the FDA or any other regulatory authority and its safety and efficacy
Slide 11: NEO100's proposed mechanism of action in resistant tumors
MECHANISM OF ACTION NEO100's proposed mechanism of action in resistant tumors In preclinical models, NEO100 is proposed to act on resistant glioma through three convergent mechanisms: NEO100 1 3 2 Na/K- Cytoplasmic RAS Oncoprotein ATPase Memb rane Inhibition Inhibition Disruption Electrolyte Imbalan
Slide 12: Intranasal NEO100 was well tolerated, with an early survival signal
PHASE 1 — FOUNDATION Intranasal NEO100 was well tolerated, with an early survival signal 1. Trial design 3. Safety Multi-center U.S. study, n = 12; recurrent GBM after RT + Generally, well tolerated at the dose levels studied; no dose- temozolomide; continuous intranasal dosing 384–1,152 limiting to
Slide 13: What the study set out to show in recurrent disease
PHASE 2a — OBJECTIVES What the study set out to show in recurrent disease Why this population PRIMARY OBJECTIVE & ENDPOINT Recurrent / progressive IDH1-mutant grade III–IV Progression-free survival at 6 months (PFS-6) — the percentage of glioma is the setting of greatest unmet need. patients progres
Slide 14: Primary objective met: PFS-6 of 48.9% vs the 20% benchmark
PHASE 2a · PROGRESSION-FREE SURVIVAL AT 6 MONTHS Primary objective met: PFS-6 of 48.9% vs the 20% benchmark Key figures 6-month PFS (KM) 48.9% 95% CI 26.3-68.1 vs 20% SOC (§11.3) p = 0.0047 ✓ significant Recurrence — NEO100 Clock origin first dose (C1D1) At recurrence: the entire PFS curve is measur
Slide 15: Swimmer plot — Durable tail past 20 months from recurrence
PHASE 2a · TIME ON TREATMENT AT RECURRENCE Swimmer plot — Durable tail past 20 months from recurrence (first dose) Reading the plot Each bar = time on study from first dose at recurrence for each patient, colored by RANO 2.0 best response. ◆ = progression (RANO 2.0) ✕ = death → = still on treatment
Slide 16: Median OS 26.09 months from recurrence
PHASE 2a · OVERALL SURVIVAL AT RECURRENCE Median OS 26.09 months from recurrence — vs a 6–9-month benchmark Survival summary Deaths / N 12 / 24 Median OS (KM) 26.09 months OS at 6 months 86.7% (64.3-95.5) OS at 12 months 60.9% (36.4-78.4) OS at 24 months 54.1% (29.5-73.4) ORR (RANO 2.0) 8.3% Recurre
Slide 17: RANO 2.0 response & imaging
RANO 2.0 RESPONSE & IMAGING Disease control, with radiographic response Radiographic remission — representative long-term survivor Before NEO100 Month 35 on NEO100 Perfusion rCBV 8.3% 55% 33.3% long-term survivors 66.7% (16 / 29, Phase 1+2) surviving > 1 year disease 2.2 yr control 58.3% median OS a
Slide 18: Recurrent grade 3–4 is an open failure — NEO100's target
THE DIFFERENTIATION Recurrent grade 3–4 is an open failure — NEO100's target Trial (agent) Grade 3–4 studied? Grade 3–4 result Implication Recurrent grade 3–4 INDIGO (vorasidenib) No — grade 2 only Not studied (mPFS 27.7 mo in grade 2) unaddressed STELLAR (eflornithine + Yes — IDH-mut & No benefit i
Slide 19: Conclusions
CONCLUSIONS Phase 2a: primary endpoint met— survival is the standout signal 48.9% 26.09 mo 60.9% median overall survival PFS-6 (RANO 2.0, KM) alive at 12 months after recurrence primary endpoint MET vs H₀ ≤20% · vs 6-9 months current salvage OS-12 (95% CI 36.4–78.4) p=0.0047 benchmark Durable diseas
Slide 20: Proposed registrational Phase 3 intended to seek Accelerated Approval
NEXT STEPS Proposed registrational Phase 3 intended to seek Accelerated Approval (subject to FDA) The regulatory goal Proposed Phase 3 design Accelerated Approval → traditional registrational • Randomized, NEO100 vs lomustine approval, in one pivotal trial. • Population: recurrent IDH1-mutant WHO gr
Slide 21: NEO212 — built on NEO100, aimed at TMZ resistance
PLATFORM 2 · DRUG CONJUGATION NEO212 — built on NEO100, aimed at TMZ resistance NEO212 Brain-optimized temozolomide bioconjugate designed to enhance brain tumor targeting MGMT — degraded in preclinical ~3× — brain:serum ratio vs TMZ, Phase 1 — dose escalation complete models preclinical The gap NEO2
Slide 22: Temozolomide validated the market — and defined its own limits
THE TMZ CEILING Temozolomide validated the market — and defined its own limits RECURRENCE TMZ RESISTANCE MGMT MARROW SUPPRESSION ~70–80% ~6–9 mo ~35–45% Dose-limiting of patients progress within 12 months median survival after recurrence — are MGMT-methylated; the systemic AIC exposure drives of fro
Slide 23: NEO212: brain-optimized temozolomide bioconjugate
THE MOLECULE NEO212: brain-optimized temozolomide bioconjugate Novel bioconjugate — NEO100 covalently linked to temozolomide in a NEO212 bioconjugated molecule single molecule. Dual mechanism — complementary activity from NEO100 and TMZ in one agent. Built on the GBM standard — a TMZ backbone engine
Slide 24: NEO212 degrades MGMT and overcomes TMZ resistance in GBM
PRECLINICAL — RESISTANCE Results suggest NEO212 degrades MGMT and overcomes TMZ resistance in GBM Clinical results suggest NEO212 degrades MGMT and kills TMZ-resistant GBM Clinical results suggest NEO 212 may have greater cytotoxicity without O⁶BG than TMZ in human GBM cell lines Clinical results su
Slide 25: NEO212: enhanced brain delivery and antitumor activity in TMZ-resistant GBM
PRECLINICAL — BRAIN DELIVERY NEO212: results suggest enhanced brain delivery and antitumor activity in TMZ- resistant GBM Clinical results suggest ≈3× higher Clinical results suggest rising NEO212 and Clinical results suggest Intracranial xenograft — patient- brain-to-serum ratio vs metabolite (PA,
Slide 26: NEO212 proposed mechanism of action in resistant tumors
MECHANISM OF ACTION NEO212 proposed mechanism of action in resistant tumors Sources: NEO212 is an investigational product candidate. It has not been approved by the FDA or any other regulatory authority, and it s safety and efficacy have not been established. Chen TC et al., Cancer Lett 2015;358(2):
Slide 27: NEO212: novel alkylating therapy in clinical development for brain tumors
PROGRAM SNAPSHOT NEO212: novel alkylating therapy in clinical development for brain tumors Broad scope Differentiation vs TMZ Primary brain tumors and brain metastases, as monotherapy and in Up to 10× greater activity than TMZ in preclinical models, including combination with SOC MGMT-positive (TMZ-
Slide 28: Phase 1: safety and efficacy of NEO212
PHASE 1 — DESIGN Phase 1: safety and efficacy of NEO212 in astrocytoma IDH-mutant, glioblastoma IDH- wildtype or brain metastasis Primary objectives (dose escalation) Secondary objectives • Safety and tolerability of increasing dose levels of oral NEO212 in • Characterize the pharmacokinetics (PK) o
Slide 29: Low peripheral blood detection of NEO212 metabolites
PHASE 1 — PHARMACOKINETICS Low peripheral blood detection of NEO212 metabolites (AIC and PA) NEO212 metabolic pathway Plasma metabolite levels by cohort — Phase 1 PK samples Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 (170 mg/QD) (220 mg/QD) (400 mg/QD) (610 mg/QD) (810 mg/QD) N (evaluable) 3 3 3 3
Slide 30: 39× lower AIC levels with NEO212 vs temozolomide
PHASE 1 — SYSTEMIC EXPOSURE Clinical results suggest 39× lower AIC levels with NEO212 vs temozolomide Adjusted for body weight, cliical results suggest NEO212 achieves higher CNS delivery vs TMZ Brain-adjusted exposure NEO212 vs TMZ 200 mg/m² (Cycle 2+) NEO212 total over 5 NEO212 total 5-day dose (T
Slide 31: No clinically meaningful myelosuppression observed in Phase 1
PHASE 1 — HAEMATOLOGY No clinically meaningful myelosuppression observed in Phase 1 Sources: NEO212 is an investigational product candidate. It has not been approved by the FDA or any other regulatory authority, and it s safety and efficacy have not been established. NEO212 Phase 1 dose -escalation
Slide 32: No hepatic or renal/urinary toxicity signal observed in Phase 1
PHASE 1 — HEPATIC & RENAL No hepatic or renal/urinary toxicity signal observed in Phase 1 Sources: NEO212 is an investigational product candidate. It has not been approved by the FDA or any other regulatory authority, and it s safety and efficacy have not been established. NEO212 Phase 1 dose -escal
Slide 33: MTD cohort 5 (810 mg QD) — key learnings
PHASE 1 — SAFETY MTD cohort 5 (810 mg QD) — key learnings Observed SAEs were consistent with complications commonly seen in advanced recurrent GBM and reported during temozolomide Phase 1 dose-escalation studies. Brain-adjusted exposure NEO212 vs TMZ 200 mg/m² (Cycle 2+) NEO212 total over 5 NEO212 t
Slide 34: Measurable antitumor activity observed in NEO212 Phase 1
PHASE 1 — ANTITUMOR ACTIVITY Antitumor activity observed in Phase 1 Measurable antitumor activity was observed in the NEO212 Phase 1 study The two cases that follow are individual investigator-assessed responses from an open-label, uncontrolled dose-escalation study (N = 14). Sources: NEO212 is an i
Slide 35: Partial response in recurrent IDH1 wild-type, MGMT-methylated GBM
PHASE 1 — CASE 1 Partial response in recurrent IDH1 wild-type, MGMT-methylated GBM Screen Cycle 21 Primary diagnosis: 8/25/2023 Prior therapy: XRT + TMZ (10/23–4/24) Progressed on TMZ after 6 cycles NEO212 C1D1: 6/10/2024 On Cycle 22 of NEO212 Contrast FLAIR Sources: NEO212 is an investigational pro
Slide 36: Lung-to-brain metastasis — last 16 months on NEO212
PHASE 1 — CASE 2 Lung-to-brain metastasis — 55 months since diagnosis, last 16 months on NEO212 Brain met diagnosis: squamous NSCLC (7/20/2021) NEO212 C1D1: 3/25/2024 Prior therapy: Taxol/carboplatin (7/2018); Keytruda, Alimta (5/2020) On Cycle 16 Screen Cycle 7 Contrast FLAIR Sources: NEO212 is an
Slide 37: Proposed next steps and Accelerated Approval strategy
NEO212 — NEXT STEPS Proposed next steps and Accelerated Approval strategy Proposed advancement into two randomized Phase 2 clinical trials, subject to FDA feedback: Trial 1 — recurrent GBM Trial 2 — brain metastases Randomized evaluation of single-agent NEO212 versus standard- Randomized evaluation
Slide 38: Phase 1 data informing a proposed Phase 2 strategy
NEO212 — DEVELOPMENT STRATEGY Phase 1 data informing a proposed Phase 2 strategy in TMZ-resistant GBM and brain metastases Early signals of activity in Phase 2 targets the highest-value 1 Safety foundation established 2 recurrent GBM 3 unmet segment • Systemic tolerability was favorable at the • Dis
Slide 39: NEO100 and NEO212: impact and significance
WHY IT MATTERS NEO100 and NEO212: impact and significance NEO100 — intranasal ultra-pure perillyl alcohol NEO212 — temozolomide bioconjugate 48.9% 26.09 mo 66.7% ~3× 39× N = 14 PFS-6 (RANO 2.0) median OS from recurrence disease control brain:serum ratio, preclinical lower AIC than TMZ Phase 1 dose e
Slide 40: NeOnc's positioning in refractory neuro-oncology
THE OPPORTUNITY NeOnc's positioning in refractory neuro-oncology Delivery approach Intellectual property Non-invasive intranasal delivery for central nervous system disease, Global portfolio of 179 patents issued and pending currently in clinical development Near-term milestones Global expansion Q4
Slide 41: Contact Us
Contact Us Company Contact NeOnc Technologies Holdings, Inc. 23975 Park Sorrento, Suite 205 Calabasas, CA 91302 Tel +1 (818) 470-NTHI Info@neonc.com · www.neonc.com Investor Relations Jon Nugent Communications Jon Nugent — President & CEO jonnugent.com · jon@jonnugent.com THE FUTURE OF DRUG DELIVERY
Slide 42: Appendix
Appendix
Slide 43: Senior Management Team
LEADERSHIP Senior Management Team Our management team possesses significant experience in capital markets, with a track record of building shareholder value in clinical biotech companies. Amir F. Heshmatpour Thomas Chen, MD, Ph.D. Josh Neman, PhD Keithly A. Garnett David Choi, CPA CEO, Executive Cha
Slide 44: Board of Directors
GOVERNANCE Board of Directors Also serving Victoria Medvec, PhD Bader Al Monawer Steven L Giannotta, MD Jim Delshad Nasim Shomali, MBA Compensation Committee Chair Audit Committee Chair Corporate Governance Chair Amir F. Heshmatpour 20+ years as CEO of Medvec & More than a decade of experience in Ch
Slide 45: Scientific Advisory Board
ADVISORS Scientific Advisory Board Our Scientific Advisory Board provides objective perspective and guidance in product development, clinical trials, regulatory compliance, and biotech commercialization strategies. Henry S. Friedman, MD Axel H. Schönthal, PhD Steven L. Giannotta, MD Alexandra M. Mil
Slide 46: Company overview & investment highlights
COMPANY OVERVIEW Company overview & investment highlights Founded in 2023, NTHI is a Platform for novel drug Robust IP portfolio. Non-invasive intranasal CNS clinical-stage life sciences candidates & delivery. company. delivery tech. Focused on development & Designed to address the persistent Holds
Slide 47: Intranasal chemotherapy designed to bypass the blood-brain barrier
STRATEGY Intranasal chemotherapy designed to bypass the blood-brain barrier and target brain tumors Direct brain access: Intranasal delivery is designed to enable small-molecule therapeutics to bypass the BBB via the olfactory and trigeminal nerves, reaching the brain through the CSF. Non-invasive &
Slide 48: The Need
MARKET NEED The Need ~1 million ~26% #1 Americans living with a primary of all brain & CNS tumors are leading cause of cancer-related brain tumor malignant death in children (ages 0–14) 107,100 18,330 1 in 143 new primary brain & CNS tumors deaths from malignant brain & lifetime risk of a malignant
Slide 49: Pediatric Brain Cancer
PEDIATRIC Pediatric Brain Cancer The Need The Challenge Our Solution Brain tumors are the leading Radiation & chemotherapy for children NEO100: our first therapeutic being #1 cause of cancer-related death among children (ages with high-grade gliomas are: developed for pediatric patients diagnosed wi
Slide 50: Primary brain tumors and the IDH1 divide
PRIMARY BRAIN TUMORS · WHO CNS5 (2021) Primary brain tumors and the IDH1 divide Primary brain tumors start in the CNS itself. Adult-type diffuse gliomas are the most common malignant kind — and since WHO 2021 they are defined first by IDH mutation status, not by appearance alone. IDH1 status splits
Slide 51: The Challenge
UNMET NEED The Challenge While the FDA has approved many drugs for treating malignant glioblastomas (GBM), survival rates remain low with no significant improvement in prognosis over the past 50 years. Lack of progress primarily due to natural resistance mechanisms that limit efficacy of GBM treatme
Slide 52: NEO100 has potential applications across clinical and commercial settings
VERSATILITY NEO100 has potential applications across clinical and commercial settings (investigational) Designed to act as a regulator When delivered intranasally, When delivered intra-arterially, for neurologic pathways associated its small molecular size is designed to it may create a temporary op
Slide 53: Clinical Trial Sites
FOOTPRINT Clinical Trial Sites Pending Sites Penn State Washington University Johns Hopkins Harvard / Mass General Hospital New York University Tampa General University of South Carolina Northwestern University Beverly Hills Cancer Center University of Vermont Westchester Medical Center Michigan Uni
Slide 54: Therapeutic innovations aligned with rapidly expanding global markets
MARKET Therapeutic innovations aligned with rapidly expanding global markets Global Market Outlook & Drivers CNS Treatment Market Brain Tumor Drugs Market Global, USD billions ¹ Global, USD billions ² • Global CNS treatment market is projected to grow at an 8.6% CAGR, reaching $285.7 billion by 2035
Slide 55: Middle East expansion plan
MIDDLE EAST Middle East expansion plan Integrated GCC/MENA platform Government engagement NuroMENA and NuroCure (controlled by NuroMENA) hold the exclusive Partnership with GCC government stakeholders; access to sovereign sub-license to 178 NTHI patents in the GCC and MENA. NTHI retains 20% wealth f
Slide 56: Acquisition of SilicoVitro technology from McMaster University & USC
TECHNOLOGY ACQUISITION Acquisition of SilicoVitro technology from McMaster University & USC Adds SilicoVitro's AI engine and patented 3D bioprinting platform (US Patent No. 11,788,057 B2), intended to expand NeOnc's R &D capability in CNS cancer research and broaden its intellectual property portfol
Slide 57: Our expanding global patent portfolio supports a competitive position
INTELLECTUAL PROPERTY Our expanding global patent portfolio supports a competitive position U.S. Patents NEO is a proprietary platform Composition & Method Claims Protected by patents in the U.S., Canada, China, UK & EU Issued & pending patent applications 32 issued • Patents cover agent composition
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