Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — Investor Presentation (January 2024)
33 slides from Scinai Immunotherapeutics's investor presentation, Jan 9, 2024
Slide 1: Corporate Presentation January 2024
CLICK TO EDIT MASTER TITLE STYLE CORPORATE PRESENTATION | JANUARY 2024 | NASDAQ: SCNI
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: Nanosized Antibody Pipeline: Huge Opportunity
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: Platform Value Proposition: NanoAbs vs mAbs
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: De-risked 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 • Single compound targeting IL - 17A and IL - 17F and IL - 17AF • Novel local use • Larger target population than the one addressed by mAbs such as Cosentyx or Taltz an
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 Strategic Guiding Principles
CLICK TO EDIT MASTER TITLE STYLE 13 R&D 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 experience • P
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, antibiotics Phototherapy Immunosuppressants (Methotrexate and Cyclosporine) New orals (JAK, TYK2) Injectable biologics MILD SEVERE
Slide 16: NanoAbs Address Unmet Need
CLICK TO EDIT MASTER TITLE STYLE 16 NANOABs ADDRESS UNMET NEED 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 tolerance Photo
Slide 17: Why Develop an Anti-IL-17 NanoAb?
CLICK TO EDIT MASTER TITLE STYLE 17 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 18: Scinai's NanoAbs Shown to Improve Psoriatic Skin
CLICK TO EDIT MASTER TITLE STYLE 18 SCINAI’S NANOABS SHOWN TO IMPROVE PSORIATIC SKIN Ex - vivo study: Potential of anti - IL - 17 NanoAb to effectively address mild to moderate plaque psoriasis • Skin viability and structural integrity noticeably improved • Significantly reduced IL - 17 release (p<0
Slide 19: Ex-Vivo Proof of Concept: NanoAbs Shown to Block IL-17
CLICK TO EDIT MASTER TITLE STYLE 19 EX - VIVO PROOF OF CONCEPT: NANOABS SHOWN TO BLOCK IL - 17 Similar impact as current leading treatments Betamethasone and Cosentyx Designed to be safer, more convenient *** = p<0.001 **** = p<0.0001 ** = p<0.01 **** *** **** *** Healthy skin Betameth - asone Cosen
Slide 20: Scinai's Anti-IL-17 NanoAb Therapeutic Potential
CLICK TO EDIT MASTER TITLE STYLE 20 SCINAI’S ANTI - IL - 17 NANOAB THERAPEUTIC POTENTIAL Scinai’s NanoAbs displayed “potential as anti - inflammatory agents in psoriasis, particularly in improving skin viability and structure.” Genoskin study results indicated that just a single dose “might have bee
Slide 21: Psoriasis In-Vivo Study: Results in Q2'24
CLICK TO EDIT MASTER TITLE STYLE 21 PSORIASIS IN - VIVO STUDY: RESULTS IN Q2’24 What is being studied? Impact of psoriasis treatments on in - vivo xenograft mouse model of human skin. Why is it important? Genoskin’s ex - vivo study showed Scinai’s anti - IL - 17 NanoAb reduces IL - 17 and improves s
Slide 22: In Vivo POC: Human Xenograft Skin Mouse Psoriasis
CLICK TO EDIT MASTER TITLE STYLE 22 IN VIVO POC: HUMAN XENOGRAFT SKIN MOUSE PSORIASIS 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 Proposed study design Major outcome measures Skin
Slide 23: IP Status Anti-IL-17 NanoAb
CLICK TO EDIT MASTER TITLE STYLE 23 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 24: Boutique CDMO Services
CLICK TO EDIT MASTER TITLE STYLE 24 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 25: GMP Manufacturing and R&D Labs
CLICK TO EDIT MASTER TITLE STYLE 25 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 26: First Two CDMO Clients Signed Q4'23
CLICK TO EDIT MASTER TITLE STYLE 26 FIRST TWO CDMO CLIENTS SIGNED Q4’23 OHAD LAVI, CEO VOYAGER MEDICAL RESEARCH, LTD. We are excited about the collaboration between Voyager Medical Research and Scinai Bioservices . In our experience so far, Scinai has demonstrated a very high level of professionalis
Slide 27: CDMO Strategic Guiding Principles
CLICK TO EDIT MASTER TITLE STYLE 27 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 28: CDMO Expected Challenges and Next Steps
CLICK TO EDIT MASTER TITLE STYLE 28 CDMO EXPECTED CHALLENGES AND NEXT STEPS Challenges: • Cash flow • Capital for investments • Building a track record • Developing a service provider culture for the CDMO BU Focus areas: • Expand the business beyond Israel into the EU and the USA • Business developm
Slide 29: Deep Pharma Experience & Capabilities
CLICK TO EDIT MASTER TITLE STYLE 29 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 30: Board of Directors
CLICK TO EDIT MASTER TITLE STYLE 30 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 31: Select Financials & Cap Table
CLICK TO EDIT MASTER TITLE STYLE 31 4,814,425 ORDINARY ADS OUTSTANDING 1,121,552 Pre - funded warrants 140,000 $5 warrants (Expire 16 Dec 2025) 2,920,000 $0.65 warrants (Expiry 2027) 87,600 $0.81 warrants (Expiry 2027) 2,293,104 $0.65 warrants (Expiry 2029) 68,793 $0.81 warrants (Expiry 2029) 2,435,
Slide 32: Significant Potential for Value Creation
CLICK TO EDIT MASTER TITLE STYLE 32 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 33: Contact
CLICK TO EDIT MASTER TITLE STYLE NASDAQ: SCNI www.scinai.com JANUARY 2024 Contact: Joshua Phillipson Investor Relations ir@scinai.com +972 - 8 - 930 - 2529
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