Newcelx Ltd. · NASDAQ:NCEL
Newcelx — Investor Presentation (November 2025)
43 slides from Newcelx's investor presentation, Nov 3, 2025
Slide 1: Innovative Therapies Transforming Lives
INNOVATIVE THERAPIES TRANSFORMING LIVES N OVEMBER 2025 ( NASDAQ : NCEL ) ©2025 NewCelX Ltd.
Slide 2: Disclaimer
Disclaimer This presentation contains express or implied forward - looking statements within the Private Securities Litigation Reform Act of 1995 and other U . S . Federal securities laws . For example, NewCelX Ltd . (“ NewCelX ,” “we,” “our” or “us”) is using forward - looking statements when we di
Slide 3: Who We Are: A Strategic Merger Uniting Strength and Innovation
Who We Are NewCelX Ltd. (Nasdaq: NCEL) is a biotechnology company created following the merger of NLS Pharmaceutics (Nasdaq: NLSP) and Kadimastem (TASE: KDST). The merger combines Kadimastem’s world - class stem - cell and regenerative - medicine platforms and NLS’s expertise in central nervous syst
Slide 4: NewcelX: A Platform Biotech Built on a Hub-and-Spoke Model
NewcelX : A Platform Biotech Built on a Hub - and - Spoke Model Integrating Science, Structure, and Scale Objective: Accelerate innovation while de - risking each development path . Cell Therapy – Diabetes CNS / ALS Orexin / Metabolic Programs Core science, CMC, Corporate Governance , and Financing
Slide 5: Strategic Benefits for Investors and Partners
Multiple therapeutic programs shared through a single platform CAPITAL EFFICIENCY DE - RISKED PORTFOLIO DIVERSIFIED VALUE CREATION PARTNERSHIP OPTIONALITY Success in one spoke reinforces platform validation Shared infrastructure between clinical programs, flexible financing Each spoke can attract it
Slide 6: Scientific Innovation in Multitarget Cellular Therapies
6 Scientific Innovation leading the field in multitarget cellular therapies, with a focus on groundbreaking regenerative treatments Dedicated to developing cellular therapies for a range of complex diseases, and utilizing innovative Orexin receptor platform 6
Slide 7: Product Platform Pipeline
Product Platform Pipeline DOXA DIABETES (Insulin dependent) CELL THERAPIES ASTRORX ® & ISLETRX RESEARCH PRE - CLINICAL PHASE 1 PHASE 2 a PHASE 3 MARKET Glaucoma and other NDD 1 st Generation – Microencapsulation + Orexin * 2 nd Generation - immune evasion (iTOL102) Multiple Sclerosis ALS - demonstra
Slide 8: CNS and Diabetes Pipeline Stages
Our CNS pipeline features innovative therapeutic solutions currently in US multi - site phase IIa clinical stage for ALS treatment AstroRx ® and in advanced preclinical stages with Dual Orexin Agonist platform (DOXA) for other neurological disorders. In our Diabetes Program, (pre - IND stage), Islet
Slide 9: Patent Protection
Patent Protection Patents in major countries/markets such as the US, EU and other countries providing NewCelX with robust technology protection Directed differentiation of astrocytes from human pluripotent stem cells for use in drug screening and the treatment of amyotrophic lateral sclerosis (ALS)
Slide 10: An Active Market – Key Recent Transactions & Developments
2019 Semma Therapeutics September 2019 Acquisition by Vertex $950M. 2 Diabetes Preclinical stage 20 21 Regenerative Cell Technology Preclinical stage Sana Biotechnology, Inc. February 2021 20 20 ALS Drug Amylyx IPO – Nasdaq Raised $190 Million at Pre - money evaluation of $1B 4 January 2022 Regenera
Slide 11: Technology Competition
Technology Competition Technology Cell source Development stage Product Company Cell Therapy Technology Competition Liver infusion + immunosuppression Stem cells - derived Islets Phase 1 VX - 880 Vertex 1 Omentum + immunosuppression Stem cells - derived Islets Phase 1 SR - 02 Seraxis 2 Microencapsul
Slide 12: Proprietary Innovative Platform
Proprietary Innovative Platform Mature and functional target cells Treatment of a wide range of diseases Differentiation Committed progenitor cell s Cell product AstroRx® IsletRx Expansion Expand indefinitely Starting material clinical grade human embryonic stem cells or hiPSC (Pluripotent stem cell
Slide 13: Astrocytes - Cell Therapy Treatment for Neurodegenerative Diseases: AstroRx
Astrocytes - Cell Therapy Treatment for Neurodegenerative Diseases AstroRx ® AstroRx® Cell Product AstroRx ® has Orphan drug designation from the U.S. Food and Drug Administration (“FDA”)
Slide 14: ALS – Market and Facts
• ALS is a fatal rare disorder with no cure 2 • About 450,000 ALS patients estimated worldwide , 30,000 patients in the US 2 • Global ALS treatment market valued at $ 300 million in 2023 3 North America is the largest market , with a share of about 60 %, followed by Japan, and Europe ( both > 20 %).
Slide 15: Why Use Astrocytes for ALS - AstroRx
15 15 Why Use Astrocytes for ALS - AstroRx ® AstroRx ® contains functional healthy astrocytes to protect ALS - diseased motor neurons using multiple mechanisms of action In ALS, the patient’s own astrocytes fail to support motor neuron survival 1. Izrael et al, 2020 Front Neurosci . 2020; 14: 824. d
Slide 16: First In Human Clinical Trials Using AstroRx
16 16 First In Human Clinical Trials Using AstroRx ® 16
Slide 17: AstroRx Phase 1/2a FIH Trial: Good Clinical Safety Profile
• 5 patients in Cohort A (dose 100M cells ) and 5 patients in Cohort B (dose 250M cells ). • 12 - month follow up. • Planned C ohorts C&D were discontinued following Data Safety Monitoring Board (DSMB) recommendation due to COVID - 19 pandemic . AstroRx ® Phase 1/2a FIH clinical trial Good Clinical
Slide 18: AstroRx Follow-up Results: Clinically Meaningful Decline in Disease Progression
18 18 AstroRx ® 3 - month Follow - up Results Demonstrated a Clinically Meaningful Decline in Disease Progression Clinical results are consistent between Cohorts A and B ALSFRS - R slope difference between 3 months pre - and post - treatment in Cohorts A and B ALSFRS - R is a Clinically Accepted Mea
Slide 19: AstroRx Efficacy Among ALS Rapid Progressors
19 19 AstroRx ® Efficacy Among ALS Rapid Progressors (3 - month Follow - up) * p = 0.0003 (MMRM analysis) ALSFRS - R Slope A nalysis - 1.58 - 0.65 -2 -1.8 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 Rapid Progressors (A+B) ALSFRS - R slope Slope pre Slope post * • Rapid progressors are defined as patien
Slide 20: AstroRx Study: Follow-up Results
20 20 AstroRx ® study: 1 - year Follow - up Results • S afe and well tolerated in both treatment doses over 12 months • No treatment - related SAEs nor dose - limiting toxicities were reported The results support our plan for a further clinical trial with repeated intrathecal administrations of Astr
Slide 21: AstroRx Clinical and Regulatory Plan
21 21 • FDA has approved the IND* for AstroRx® for its planned phase IIa clinical trail • To commence the phase IIa clinical trial in the US at multiple sites • A clinical development strategy to support the product intended use • A RMAT* designation application is planned, to enable expedited devel
Slide 22: Functional Islet Cells – Potential Cure for Type 1 Diabetes: IsletRx
Functional Islet Cells – Potential Cure for Type 1 Diabetes IsletRx
Slide 23: Unmet Need in Insulin Dependent Diabetes
• Healthy and functional islet cells can produce and secrete insulin in a regulated manner • Cadaveric donor islet cell therapy is a safe and clinically validated treatment for Insulin - Dependent Diabetes 1 • Patients treated achieved Insulin independence for ~2 years following treatment 4 • Main c
Slide 24: What Happens in Type 1 Diabetes
Healthy β - cells Type 1 Diabetes : β - cells are destroyed due to immune attack Physiological insulin secretion from β - cells Pancreas No insulin secretion of due to β - cells death Destroyed β - cells High sugar levels Hyperglycemia Normal sugar levels Normoglycemia What Happens in Type 1 Diabete
Slide 25: Potential Cure for Insulin Dependent Diabetes Using IsletRx
POTENTIAL CURE FOR INSULIN DEPENDENT DIABETES USING ISLETRX
Slide 26: iTOL-102: Kadimastem & iTolerance Co-development
• Regenerative medicine without the need for life - long immunosuppression • Leverages the naturally occurring protein , Fas Ligand ( FasL ) • Creates localized immune privilege environment • BIRD Grant funded (~$1M) • INTERACT Meeting with the FDA ( January 2024) • Successful POC results (June 2024
Slide 27: In-Scaffold IsletRx Plus
Insulin secretion from IsletRx seeded in bio - engineered scaffold Intact IsletRx cells • Bioengineered 3D Printed Device: IsletRx cells can be implanted in a bioengineered device featuring a 3D printed scaffold for easier surgical retrieval and immuno - isolation • Innovative 3D Printing Process: T
Slide 28: Encap-IsletRx Plus Preclinical Efficacy
• Long - term therapeutic effect was achieved in an immunocompetent animal model (C57BL/6 mice ) • IsletRx Plus cells well protected from host immune system Encap - IsletRx Plus Preclinical Efficacy Encap - IsletRx Plus treated diabetic mice (STZ) demonstrated balanced and normal blood glucose level
Slide 29: Transformative Potential in Diabetes Treatment with IsletRx and DOXA
Comprehensive Multi - Target Strategy Integration of technologies Leveraging combined platforms to address multiple facets of diabetes management, including blood sugar regulation, metabolic health, and neurological support Focus on systemic health Targeting not just glucose control, but also optimi
Slide 30: Comprehensive Diabetes Care
Comprehensive Diabetes Care Strategic Context The merger of Kadimastem and NLS Pharmaceutics unites regenerative medicine and pharmaceutical innovation under NewCelX — a shared platform developing transformative therapies for metabolic and neurological diseases. IsletRx and DOXA serve as synergistic
Slide 31: IsletRx Clinical and Regulatory Next Steps
• Expand Collaboration • Pre - IND meetings with FDA • Upscaling and GMP production • IND for Clinical Trial • Q1 2025 – Pre - IND Microencapsulation Immune protection through collaborations IsletRx Clinical and Regulatory Next Steps 31
Slide 32: DOXA Platform (Dual Orexin Receptor Agonist)
32 32 DOXA Platform (Dual Orexin Receptor Agonist) Target indications: Rare Sleep Disorders (Narcolepsy, Idiopathic Hypersomnia) Neurodegenerative / neuroinflammation diseases (such as ߙ - synucleinopathies ) Diabetes - Associated Neurological Disorders (DANS)
Slide 33: Narcolepsy Market Data and Unmet Medical Need
Narcolepsy Market Data and Unmet Medical Need • The Neurodegenerative Disease Market was valued at USD 45.2 billion in 2024 and is projected to reach USD 78.9 billion by 2034, registering a CAGR of 5.7 %. 1 • Key unmet needs include better symptom management, neuroprotection, and slowing disease pro
Slide 34: Dual Orexin Receptor Agonists (DOXA) for Narcolepsy
• Comprehensive symptom management • Addressing autoimmune and neuroinflammatory aspects • Reducing risk of receptor desensitization in targeting both OX1R/OX2R • Innovative Therapeutics : • A portfolio centered on dual orexin receptor agonists , targeting both OX1R and OX2R, critical in managing sl
Slide 35: Pre-Clinical Results
80.21 52.80 109.21 89.04 0 20 40 60 80 100 120 Tot / Duration (min) Mean / Duration (min) Vehicule AEX41 40mg/kg Average Wake Duration (min) AEX - 41 Results: • Increased wakefulness by 75 % at optimal doses in preclinical narcolepsy models. • Reduced slow - wave and REM sleep interruptions by over
Slide 36: Preliminary AEX-41 Results
AEX - 41 80 mg/kg AEX - 41 40 mg/kg AEX - 41 5 mg/kg Vehicle (V) Baseline (BL) Parameter 48 min (+118.2%) 40 min (+81.8%) 28 min (+27.3%) 22 min 20 min Wakefulness (1H) 170 min (+112.5%) 140 min (+75.0%) 110 min (+31.0%) 84 min 80 min Wakefulness (4H) 4.5 min ( - 43.8%) 5.0 min ( - 37.5%) 6.2 min (
Slide 37: DOXA Clinical and Regulatory Next Steps
DOXA Clinical and Regulatory Next Steps • Planned studies will evaluate chronic dosing regimens, extending beyond the single - dose studies in orexin KO mice • IND submission for Phase 1 trials IND - ENABLING STUDIES ( SAFETY , TOXICOLOGY , PK / PD ): 37
Slide 38: Strengths and Value Proposition
Strengths and Value Proposition • Enhanced Capabilities: We leverage advanced cell therapy solutions and innovative approaches to treating rare neurological disorders. This integration facilitates the development of novel therapies that address the multifaceted challenges of conditions such as ALS a
Slide 39: Scientific Opportunities and Innovation
Scientific Opportunities and Innovation This strategic alignment presents unique scientific opportunities that accelerate our research and development capabilities, benefiting patients and healthcare systems alike. Strategic Alignment Driving Innovation & Scale Unified Strengths: Merging regenerativ
Slide 40: Leadership Team
Leadership Team Prof. Michel Revel Director & CSO Ronen Twito CPA Executive Chairman & CEO Prof. Ariel Revel, MD Medical Director Alex Zwyer , MBA Director Eric Konofal , MD, PhD Head of DOXA Program Kfir Molakandov , PhD VP of R&D Expertise The leadership brings extensive knowledge and experience i
Slide 41: The Circle | P.O. Box CH - 8058 Zurich Switzerland Headquarter in Switzerland :
41 41 The Circle 6 | P.O. Box CH - 8058 Zurich Switzerland Headquarter in Switzerland : +41 44 512 21 50 Main office in Israel : +972 - 73 - 797 - 1613 info@newcelx.com
Slide 42: Appendix: DOXA Potential Innovative Platform Other Indications
Apendix DOXA Potential Innovative Platform other indications Therapeutic Area Relevance Target Narcolepsy, Idiopathic Hypersomnia, Parkinson’s Disease Regulate sleep - wake cycles, arousal, and energy homeostasis. Orexin Receptors (OX1R & OX2R) Parkinson’s Disease , Synucleinopathies Key in protein
Slide 43: References
References page 1. https://www.bayer.com/media/en - us/bayer - acquires - bluerock - therapeutics - to - build - leading - position - in - cell - therapy/ 2. https://investors.vrtx.com/news - releases/news - release - details/vertex - acquire - semma - therapeutics - goal - developing - curative - c