Neonc Technologies Holdings, Inc. · NASDAQ:NTHI
Neonc Technologies — Corporate Update (August 2026)
36 slides from Neonc Technologies's corporate update, Aug 12, 2026
Slide 1: NEO100-01 Phase 2a Results
NEO100 - 01 NCT02704858: A Phase 1/2a Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 - Mutated Glioma Reporting out the Phase 2a objectives August 12, 2026
Slide 2: Our Team: Leadership, board & scientific advisors
OUR TEAM Leadership, board & scientific advisors SENIOR MANAGEMENT Amir F. Heshmatpour CEO, Exec. Chairman & President Thomas Chen, MD, PhD Founder, CMO & CSO Josh Neman, PhD Chief Clinical Officer Keithly A. Garnett Chief Financial Officer David Choi, CPA Chief Accounting Officer BOARD OF DIRECTORS
Slide 3: Disclaimer
DISCLAIMER Important cautions regarding forward - looking statements This document does not constitute or form part of an invitation or recommendation to subscribe for or purchase any securities. The distribution may be restricted by law in certain jurisdictions and persons into whose possession thi
Slide 4: Executive Summary
EXECUTIVE SUMMARY NEO100 - 1 Phase 2a met its primary endpoint — and the survival signal is the story 48.9% PFS - 6 (RANO 2.0) 26.1 mo median overall survival, measured from recurrence Vs 6 - 9 mo 5 of 24 still on treatment — the longest at ~24 months Primary endpoint met. Six - month progression -
Slide 5: Clinical Pipeline
CLINICAL PIPELINE Phase 2 development & clinical pipeline Important disclaimer: this development & clinical pipeline is subject to regulatory approval, risks and uncertainties, and potential changes beyond ou r control. Clinical Development Drug Candidate Application Indication Preclinical IND Enabl
Slide 6: NEO100 and NEO212 Platforms
6 NEO100 — Drug Delivery Platform (core technology) NEO212 — Drug Conjugation Platform (built on NEO100) PLATFORM Two platforms, one enabling technology: NEO100's BBB penetration powers both • Conjugates NEO100 to established cytotoxic agents • Inherits NEO100's BBB - penetrating chemistry as the de
Slide 7: The Starting Line Matters: U.S. Burden
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 /
Slide 8: The Clock Resets at Recurrence
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 DIAG
Slide 9: The Platform: NEO100 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 intermedi
Slide 10: Mechanism of Action
MECHANISM OF ACTION NEO100's proposed mechanism of action in resistant tumors Sources: Garcia DG et al., Mol Cell Biochem 2010; Cho HY et al., Mol Cancer Ther 2012; Marín - Ramos NI et al., Neurosurg Focus 2019; Wang W et al., Neuro - Oncology 2021; Schönthal AH et al., Neurooncol Adv 2021. Mechanis
Slide 11: 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: Second - line rationale: by inducing ER stress and inhibiting Na ⁺ /K ⁺ - ATPase while down - regulating RAS, NEO100
Slide 12: Phase 1 Foundation
PHASE 1 — FOUNDATION Intranasal NEO100 was well tolerated, with an early survival signal 1. Trial design Multi - center U.S. study, n = 12; recurrent GBM after RT + temozolomide; continuous intranasal dosing 384 – 1,152 mg/day (4 × /day) until progression. 3. Safety Generally, well tolerated at the
Slide 13: Phase 2a Objectives
PHASE 2a — OBJECTIVES What the study set out to show in recurrent disease PRIMARY OBJECTIVE & ENDPOINT SECONDARY OBJECTIVES • Overall survival (OS) and landmark OS rates • Objective response & duration (RANO 2.0) • Safety and tolerability Sources: NEO100 - 01 protocol § 11.3 — primary endpoint PFS -
Slide 14: Progression-free survival at 6 months
Key figures 6 - month PFS (KM) 48. 9 % 95% CI 26.3 - 68.1 vs 20% SOC ( † 11.3) p = 0. 0 0 47 ض significant Clock origin Recurrence — NEO100 first dose (C1D1) At recurrence: the entire PFS curve is measured from first dose at recurrence (study day 1) — not from initial diagnosis. Sources: NEO100 - 01
Slide 15: Time on Treatment Swimmer Plot
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. ᶺ = progression (RANO 2.0) ظ = death → = still on treatment
Slide 16: Overall Survival at Recurrence
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 6 0.9 % ( 36.4 - 78.4 ) OS at 24 months 54.1 % ( 29.5 - 73.4 ) ORR (RANO 2.0) 8.3% At recurrence: the entire OS curve runs from first dose at recurrence (study day 1) — median 26. 09
Slide 17: RANO 2.0 Response & Imaging
RANO 2.0 RESPONSE & IMAGING Disease control, with radiographic response 8.3% 58.3% 33.3% 66.7% disease control Partial Response 2/24 · 8.3% Stable Disease 14/24 · 58.3% Progressive Disease 8/24 · 33.3% RANO 2.0 best response (N=24) 55% long - term survivors (16 / 29, Phase 1+2) surviving > 1 year 2.
Slide 18: The Differentiation
THE DIFFERENTIATION Recurrent grade 3 – 4 is an open failure — NEO100's target Implication Grade 3 – 4 result Grade 3 – 4 studied? Trial (agent) Recurrent grade 3 – 4 unaddressed Not studied (mPFS 27.7 mo in grade 2) No — grade 2 only INDIGO (vorasidenib) Grade 4 remains an open failure No benefit i
Slide 19: Conclusions
CONCLUSIONS Phase 2a: primary endpoint met — survival is the standout signal 48.9% PFS - 6 (RANO 2.0, KM) primary endpoint MET vs H ₀ ≤20% · p=0.0047 26.09 mo median overall survival after recurrence vs 6 - 9 months current salvage benchmark 60.9% alive at 12 months OS - 12 (95% CI 36.4 – 78.4) Dura
Slide 20: Next Steps: Proposed Registrational Phase 3
NEXT STEPS Proposed registrational Phase 3 intended to seek Accelerated Approval (subject to FDA) The regulatory goal Accelerated Approval → traditional registrational approval, in one pivotal trial. Per FDA's Dec 2024 guidance, a single adequate & well - controlled trial can support Accelerated App
Slide 21: Why It Matters
WHY IT MATTERS NEO100: Impact & Significance • Primary endpoint met: PFS - 6 of 48.9% vs the 20% protocol benchmark (one - sided p = 0.0047). • Life expectancy 4 - 5x extended at recurrence: median OS 26.09 months vs a 6 – 9 - month historical benchmark (cross - trial, not head - to - head). • Build
Slide 22: 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 205 - 566 - 3026 THE FUTU
Slide 23: Appendix
NEONC Appendix
Slide 24: Leadership: 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 cl inical biotech companies. Amir F. Heshmatpour CEO, Executive Chairman & President Mr. Heshmatpour served on NeOnc Technologies Holdings,
Slide 25: Governance: Board of Directors
GOVERNANCE Board of Directors Also serving Amir F. Heshmatpour CEO, Exec. Chairman & President Thomas Chen, MD, PhD Founder, CMO & CSO Victoria Medvec, PhD Compensation Committee Chair 20+ years as CEO of Medvec & Associates, advisory firm servicing more than a third of Fortune 100. Advising on regu
Slide 26: Advisors: Scientific Advisory Board
ADVISORS Scientific Advisory Board Our Scientific Advisory Board provides objective perspective and guidance in product development, clinical trials, regulatory co mpliance, and biotech commercialization strategies. Henry S. Friedman, MD Chair, SAB Senior neuro - oncologist at Duke and deputy direct
Slide 27: Company Overview & Investment Highlights
COMPANY OVERVIEW Company overview & investment highlights Founded in 2023, NTHI is a clinical - stage life sciences company. Focused on development & commercialization of central nervous system (CNS) therapeutics. Platform for novel drug candidates & delivery tech. Designed to address the persistent
Slide 28: Strategy: Intranasal chemotherapy bypassing the BBB
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 - inva
Slide 29: Market Need
MARKET NEED The Need ~1 million Americans living with a primary brain tumor ~26% of all brain & CNS tumors are malignant #1 leading cause of cancer - related death in children (ages 0 – 14) 107,100 new primary brain & CNS tumors expected in the U.S. in 2025 ≈4,800 in children (ages 0 – 19) 18,330 de
Slide 30: Pediatric Brain Cancer
PEDIATRIC Pediatric Brain Cancer The Need #1 Brain tumors are the leading cause of cancer - related death among children (ages 0 – 14) and the most common solid tumor of childhood. ~4,800 children & adolescents (ages 0 – 19) are diagnosed with a primary brain tumor in the U.S. each year. ~40% Pediat
Slide 31: 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 spli
Slide 32: Unmet Need: 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 33: Versatility of NEO100
VERSATILITY NEO100 has potential applications across clinical and commercial settings (investigational) Designed to act as a regulator for neurologic pathways associated with tumor cell growth. When delivered intranasally, its small molecular size is designed to allow it to bypass the blood - brain
Slide 34: Footprint: 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 35: Market: Global CNS and Brain Tumor Drugs
MARKET Therapeutic innovations aligned with rapidly expanding global markets Global Market Outlook & Drivers • Global CNS treatment market is projected to grow at an 8.6% CAGR, reaching $285.7 billion by 2035.¹ • Global brain tumor drugs market is expected to grow at a 9.3% CAGR, reaching $5.2 billi
Slide 36: Intellectual Property
INTELLECTUAL PROPERTY Our expanding global patent portfolio supports a competitive position U.S. Patents 32 issued 19 pending International Patents 97 issued 31 pending Protected under exclusive global licensing agreement with USC. NEO is a proprietary platform Protected by patents in the U.S., Cana
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