Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — Investor Presentation (April 2024)
45 slides from Scinai Immunotherapeutics's investor presentation, Apr 25, 2024
Slide 1: Corporate Presentation April 2024
CLICK TO EDIT MASTER TITLE STYLE CORPORATE PRESENTATION | APRIL 2024 | NASDAQ: SCNI NON - CONFIDENTIAL PUBLIC INFORMATION
Slide 2: Safe Harbor Statement
CLICK TO EDIT MASTER TITLE STYLE 2 SAFE HARBOR STATEMENT This communication contains forward - looking statements within the meaning of the Private Litigation Reform Act of 1995 . Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions ar
Slide 3: 2024: Building on 2023's Momentum
CLICK TO EDIT MASTER TITLE STYLE 3 2024: BUILDING ON 2023’S MOMENTUM 2023 2024 BUSINESS DEVELOPMENT • Launched Scinai Bioservices CDMO • Capital infusions • New name, new brand • More CDMO clients • Pursue partnerships PIPELINE DEVELOPMENT • Licensed anti - IL - 17 NanoAb • Completed ex - vivo study
Slide 4: Two Complementary Business Units
CLICK TO EDIT MASTER TITLE STYLE 4 TWO COMPLEMENTARY BUSINESS UNITS End - to - end boutique CDMO services to help bring products to market by leveraging Scinai’s GMP and non - GMP drug development and manufacturing capabilities Development of inflammation and immunology (I&I) biological therapeutic
Slide 5: Alpaca-derived nanosized antibodies (NanoAbs)
CLICK TO EDIT MASTER TITLE STYLE 5 Alpaca - derived nanosized antibodies (NanoAbs) are also known as VHH antibodies or nanobodies 1 mAb therapeutic market size is ~ $205 billion 2 including Cosentyx for psoriasis $4.8 billion (2022) 3 NanoAbs: Human monoclonal antibody (mAb)’s biobetter 1. VHH antib
Slide 6: The Max Planck Institute & UMG bring
CLICK TO EDIT MASTER TITLE STYLE 6 The Max Planck Institute & UMG 1 bring… • Recombinant protein drug development experience from lab to Phase 3 clinical trial • Manufacturing, quality, international regulatory experience • GMP biologics manufacturing facility • Best - in - class equipped labs • Top
Slide 7: NanoAbs' advantages vs human monoclonal antibodies
CLICK TO EDIT MASTER TITLE STYLE 7 NanoAbs’ unique physicochemical attributes can generate multiple crucial advantages vs human monoclonal antibodies (mAbs) Manufacturing • 10 - times more active pharmaceutical ingredients (API) per gram of manufactured protein vs. mAbs • Faster and lower cost produ
Slide 8: Derisked Drug Development
CLICK TO EDIT MASTER TITLE STYLE 8 Source of Risk Molecular Target Mechanism of Action Composition of Matter TBD Commercial Validated by existing but sub - optimal mAb therapies Well understood Assessing safety & efficacy of alpaca - derived NanoAbs Strong demand for available mAbs and underserved p
Slide 9: Superior Routes of Administration
CLICK TO EDIT MASTER TITLE STYLE 9 SUPERIOR ROUTES OF ADMINISTRATION P aper covers several aspects of Scinai’s anti - COVID - 19 NanoAbs, including: • S tructure • Mechanism of action • Neutralization of a wide range of SARS - CoV - 2 variants including Omicron • Production in yeast • Formulation in
Slide 10: Pipeline Molecular Targets
CLICK TO EDIT MASTER TITLE STYLE 10 RBD IL - 4R α ANG - 2 IL - 17A/F • Strong in vivo data for inhaled therapeutic and prophylactic in a challenge study conducted with Fraunhofer ITEM and TiHO • Single compound targeting IL - 17A and IL - 17F and IL - 17AF • Novel local use • Larger target populatio
Slide 11: Pipeline Addressing Large Markets with Underserved Needs
CLICK TO EDIT MASTER TITLE STYLE 11 Psoriasis $17.4B Macular Degeneration (AMD) $6.9B Psoriatic arthritis $8.1B $10.4B Asthma Autoimmune Market Sizes • Validated targets of existing mAb treatments • Short time to value generation, lower risk than mAbs • Large markets growing at attractive CAGRs PIPE
Slide 12: Pipeline Development: Status & Upcoming Milestones
CLICK TO EDIT MASTER TITLE STYLE 12 PIPELINE DEVELOPMENT: STATUS & UPCOMING MILESTONES Anti - IL - 17 psoriasis treatment in - vivo proof - of - concept in 2024, clinical trial H1 2025 Clinical Phase 1/2 Toxicology In Vivo Proof - of - Concept In vitro / Ex vivo Manufacturing Process & Analytical Me
Slide 13: R&D Unit Strategic Guiding Principles
CLICK TO EDIT MASTER TITLE STYLE 13 R&D UNIT STRATEGIC GUIDING PRINCIPLES • Inflammation and Immunology • Platform: NanoAbs • Research Collaboration Agreement (RCA) with MPG/UMG • CMC activities done in - house using Scinai’s CDMO business unit • Leverage learnings, Route of Administration experienc
Slide 14: Psoriasis: 78% Underserved Population
CLICK TO EDIT MASTER TITLE STYLE 14 PSORIARIS: 78% UNDERSERVED POPULATION Psoriasis prevalence and severity SEVERE MODERATE MILD 22% of patients. 28% of patients. 50% of patients. >10% of the body Typically has a severe impact on quality of life 3 - 10% of the body Generally affects quality of life
Slide 15: Current Plaque Psoriasis Treatments
CLICK TO EDIT MASTER TITLE STYLE 15 CURRENT PLAQUE PSORIASIS TREATMENTS Corticosteroid creams, vitamin E+A, vitamin D derivatives Phototherapy 1 st line systemic immunosuppressants (Methotrexate and Cyclosporine) & Immunomodulators (Otezla) 2 nd line systemic Immunomodulators (e.g. Sotyktu ) Injecta
Slide 16: NanoAbs Address Unmet Need
CLICK TO EDIT MASTER TITLE STYLE 16 NANOABs ADDRESS UNMET NEED Designed to be convenient, safe, affordable, effective biologic for mild and moderate patients Current treatment shortcomings Corticosteroids • Side effects include: • Skin thinning (bruising) & Lightening of skin color • Development of
Slide 17: Why do we need more?
CLICK TO EDIT MASTER TITLE STYLE Why do we need more? ▪ Not all patients achieve complete clearance (PASI90 or PASI100) and some suffer from recalcitrant lesions that do not respond adequately ▪ Some patients have psoriasis in difficult - to - treat areas such as hands, feet, scalp, genitals... ▪ Ev
Slide 18: Hard-to-treat lesions: scalp
CLICK TO EDIT MASTER TITLE STYLE Hard - to - treat lesions: scalp pat . #1 pat . #2 pat . #3 Credit: Prof. Michael P. Schön, Department of Dermatology, Venereology and Allergology Lower Saxony Institute of Occupational Dermatology, University Medical Center Göttingen, Germany https://hautklinik.umg.
Slide 19: Hard-to-treat lesions: scalp
CLICK TO EDIT MASTER TITLE STYLE pat . #4 pat . #5 Hard - to - treat lesions: scalp Credit: Prof. Michael P. Schön, Department of Dermatology, Venereology and Allergology Lower Saxony Institute of Occupational Dermatology, University Medical Center Göttingen, Germany https://hautklinik.umg.eu
Slide 20: Visible areas with high burden of disease: face
CLICK TO EDIT MASTER TITLE STYLE Visible areas with high burden of disease: face pat . #6 pat . #7 pat . #8 pat . #9 Credit: Prof. Michael P. Schön, Department of Dermatology, Venereology and Allergology Lower Saxony Institute of Occupational Dermatology, University Medical Center Göttingen, Germany
Slide 21: Hard-to-treat lesions: hands
CLICK TO EDIT MASTER TITLE STYLE Hard - to - treat lesions: hands pat . #10 pat . #11 Credit: Prof. Michael P. Schön, Department of Dermatology, Venereology and Allergology Lower Saxony Institute of Occupational Dermatology, University Medical Center Göttingen, Germany https://hautklinik.umg.eu
Slide 22: Sensitive areas: ano-genital region
CLICK TO EDIT MASTER TITLE STYLE Sensitive areas with high burden of disease: ano - genital region pat . #9 pat . #12 Credit: Prof. Michael P. Schön, Department of Dermatology, Venereology and Allergology Lower Saxony Institute of Occupational Dermatology, University Medical Center Göttingen, German
Slide 23: Special locations: navel and nipples
CLICK TO EDIT MASTER TITLE STYLE Special locations: navel and nipples image courtesy of Prof. D. Thaci, Lübeck pat . #13 pat . #14 Right nipple healthy Left nipple with psoriasis Navel with psoriasis Credit: Prof. Michael P. Schön, Department of Dermatology, Venereology and Allergology Lower Saxony
Slide 24: Recalcitrant isolated lesions
CLICK TO EDIT MASTER TITLE STYLE Recalcitrant isolated lesions pat . #15 pat . #16 pat . #17 Credit: Prof. Michael P. Schön, Department of Dermatology, Venereology and Allergology Lower Saxony Institute of Occupational Dermatology, University Medical Center Göttingen, Germany https://hautklinik.umg.
Slide 25: Pretreated lesions with therapy side effects: soles
CLICK TO EDIT MASTER TITLE STYLE Pretreated lesions with therapy side effects: soles pat . #18 pat . #19 After treatment with Corticosteroids Before treatment with Corticosteroids Credit: Prof. Michael P. Schön, Department of Dermatology, Venereology and Allergology Lower Saxony Institute of Occupat
Slide 26: Why Develop an Anti-IL-17 NanoAb?
CLICK TO EDIT MASTER TITLE STYLE 26 WHY DEVELOP AN ANTI - IL - 17 NANOAB? Rationale Success Factor IL - 17 as a molecular target in psoriasis is well understood and validated by existing therapies, e.g., Cosentyx, Siliq , Taltz and Bimzelx . IL - 17 is a well - established psoriasis target IL - 17 F
Slide 27: Local ID injection of Anti-IL-17A/F VHH antibody fragment
CLICK TO EDIT MASTER TITLE STYLE 27 Local ID injection of Anti - IL - 17A/F VHH antibody fragment A novel way to using VHH antibodies - Most other entities working with VHHs (nanobodies®) aim to mimic mAbs “playbook” and hence are competing for the same patient populations and are using the same rou
Slide 28: The product
CLICK TO EDIT MASTER TITLE STYLE 28 The product An intradermal pen filled with a liquid, sustained release formulation of Scinai’s anti - IL - 17A/F nanoAb given every 3 to 6 months at the doctor’s office. • Upon a patient’s visit, a reusable pen injector with a sterile cartridge filled with 1.5 to
Slide 29: Generating incentives for the customers – the three P's
CLICK TO EDIT MASTER TITLE STYLE 29 Generating incentives for the customers – the three P’s Patients: Mild to moderate plaque psoriasis patients. • Currently treated with corticosteroids and are unhappy : • Inconvenience of use (e.g. twice a day, use of ointments/creams). • Development of tolerance
Slide 30: Where is the money?
CLICK TO EDIT MASTER TITLE STYLE 30 Where is the money? • Total sales of drugs in the 7MM for mild psoriasis expected to be $1.8B in 2030 • $1.3B is expected to come from prescription of biologics and $259M from TYK2 inhibitor • This is the market where the topicals and phototherapy do not help. • T
Slide 31: Anti-IL-17 NanoAb: A better neutralizer
CLICK TO EDIT MASTER TITLE STYLE 31 Anti - IL - 17 Nanoab: A better neutralizer Secukinumab* NanoAb Cytokine 0.2nM 0.56nM IL17A m M 1.00nM IL17F 2.0nM 0.25nM IL17AF Single NanoAb neutralizes IL - 17 A, F, and AF complex IL - 17 A IL - 17 F IL - 17 AF COMPLEX * Cosentyx, INN - sekukinumab (europa.eu)
Slide 32: Ex-vivo proof of concept: NanoAbs shown to block IL-17
CLICK TO EDIT MASTER TITLE STYLE 32 EX - VIVO PROOF OF CONCEPT: NANOABS SHOWN TO BLOCK IL - 17 Impact of ID injected nanoAb in comparison to current leading treatments Betamethasone and Cosentyx Designed to be local, less frequent use, safer, more convenient and more affordable *** = p<0.001 **** =
Slide 33: Preliminary PK: limited systemic exposure
CLICK TO EDIT MASTER TITLE STYLE 33 Preliminary PK: limited systemic exposure PK Study design Implications: Healthy mice were injected ID with biotinylated anti IL - 17 nanoAbs, blood samples removed periodically post administration. Limited systemic exposure will contribute to safety T1/2 in the de
Slide 34: In vivo PoC: Human xenograft skin (1/2)
CLICK TO EDIT MASTER TITLE STYLE 34 In vivo PoC: Human xenograft skin (1/2) Animal model: Normal human skin will be engrafted into SCID BEIGE mouse and disease will be induced by injection of IL - 2 activated PBMC's from psoriatic patients Study design Major outcome measures Follow up (3 weeks) Trea
Slide 35: In vivo PoC: Human xenograft skin (2/2)
CLICK TO EDIT MASTER TITLE STYLE 35 In vivo PoC: Human xenograft skin (2/2) What is being studied? The impact of local psoriasis treatments by efficacy parameters: x Clinical evaluation by medical photographs. x Macroscopic evaluation, epidermis thickness scoring & Histological analysis. x IHC analy
Slide 36: IL-17 NanoAb program summary
CLICK TO EDIT MASTER TITLE STYLE 36 IL - 17 nanoAb program summary • T here is a need for a better treatment for patients with mild to moderate Psoriasis and for specific lesions that are hard to treat with current therapies. • Biological drugs are the safest and most efficient, yet – they are admin
Slide 37: IP Status Anti-IL-17 NanoAb
CLICK TO EDIT MASTER TITLE STYLE 37 IP STATUS ANTI IL - 17 NANOAB Status • Priority patent application: Filed Dec. 28, 2022 • International patent application (PCT): Filed December 27, 2023 Covers • The patent application encompasses novel VHH antibodies directed against IL - 17 isomers and their us
Slide 38: Boutique CDMO Services
CLICK TO EDIT MASTER TITLE STYLE 38 BOUTIQUE CDMO SERVICES De - risking Scinai’s internal R&D investments by leveraging internal capabilities ASEPTIC GMP MANUFACTURING SUITES STATE - OF - THE - ART R & D AND QC LABORATORIES PHARMA CMC EXPERIENCE
Slide 39: GMP Manufacturing and R&D Labs
CLICK TO EDIT MASTER TITLE STYLE 39 GMP MANUFACTURING AND R&D LABS Industry standard aseptic facility: Labs, cleanroom, warehouses, offices • Analytical methods development combined with best - in - class QC capabilities and equipment • Labs for manufacturing process development and scale - up allow
Slide 40: CDMO Strategic Guiding Principles
CLICK TO EDIT MASTER TITLE STYLE 40 CDMO STRATEGIC GUIDING PRINCIPLES Scinai’s CDMO value proposition: Experienced and professional team available to execute drug development projects at high - speed while adhering to high (EU) quality standards using new and modern equipment located in a well - mai
Slide 41: Deep Pharma Experience & Capabilities
CLICK TO EDIT MASTER TITLE STYLE 41 DEEP PHARMA EXPERIENCE & CAPABILITIES AMIR REICHMAN – CEO Senior global pharma leadership positions: Pharmaceutical engineering & supply chain at GSK Vaccines, Belgium; Large projects building vaccine manufacturing sites in Belgium, Italy, Germany, Hungary & US; N
Slide 42: Select Financials & Cap Table
CLICK TO EDIT MASTER TITLE STYLE 42 SELECT FINANCIALS & CAP TABLE • $ 6 . 4 M cash as of Sep 30 , 2023 • $ 1 . 7 M gross raised Dec 29 , 2023 • € 24 M European Investment Bank (EIB) loan payable Dec 31 , 2031 Nasdaq: SCNI 5,811,419 ORDINARY ADS OUTSTANDING 336,000 Pre - funded warrants 140,000 $5 wa
Slide 43: Board of Directors
CLICK TO EDIT MASTER TITLE STYLE 43 Mark Germain, Chairman Aentib Group (Managing Director). Founder, director, chairman, and/or investor in over 20 biotech companies including Alexion, Incyte, Neurocrine, Ariad, ChromaDex. Amir Reichman, CEO NeuroDerm Ltd (Senior Scientist), Novartis Vaccines USA (
Slide 44: Significant Potential for Value Creation
CLICK TO EDIT MASTER TITLE STYLE 44 SIGNIFICANT POTENTIAL FOR VALUE CREATION Pipeline of NanoAb - based drugs Promising preclinical results Preparing for first - in - human clinical trial of anti - IL - 17 NanoAb Collaboration with Max Planck and UMG Targeting diseases with large underserved needs a
Slide 45: Contact: www.scinai.com
CLICK TO EDIT MASTER TITLE STYLE NASDAQ: SCNI www.scinai.com JANUARY 2024 Contact: Amir Reichman, CEO ir@scinai.com +972 - 8 - 930 - 2529
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