Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — Investor Presentation (September 2023)
39 slides from Scinai Immunotherapeutics's investor presentation, Sep 22, 2023
Slide 1: Scinai Immunotherapeutics September 2023
SCINAI IMMUNOTHERAPEUTICS smber 2023 | Nasdaq: SCNI
Slide 2: Safe Harbor Statement
SCINAI 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 are intended to identify such for
Slide 3: Advancing new pipeline of innovative VHH antibody (NanoAb) based drugs
* SCINAI SCINAI IMMUNOTHERAPEUTICS Advancing new pipeline of innovative VHH antibody (NanoAb) based drugs from R&D through commercialization Targeting autoimmune and infectious diseases with large under-served needs and attractive commercial opportunities such as: PSORIATIC ARTHRITIS
Slide 4: Nanosized Antibody Pipeline: Huge Opportunity
* SCINAI NANOSIZED ANTIBODY PIPELINE: HUGE OPPORTUNITY on © HUMAN ANTIBODY (mAb) ALPACA-DERIVED ANTIBODY (NanoAb) Alpaca-derived nanosized antibodies (NanoAbs) are also known as VHH antibodies! mAb therapeutic market size is ~$205 billion? including Cosentyx for psoriasis $4.8 billion (2022) NanoAbs
Slide 5: Max Planck and Scinai Collaboration
MAX PLANCK AND SCINAI COLLABORATION gnificant nm Scinai brings... + 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-tier big pha
Slide 6: Platform Value Proposition
SCINAI PLATFORM VALUE PROPOSITION NanoAbs' unique physicochemical attributes can generate multiple crucial advantages vs human monoclonal antibodies (mAbs) Manufacturing + 10-imes more active pharmaceutical ingredients (API) per gram of ‘manufactured protein vs. mAbs + Faster and lower cost producti
Slide 7: Derisked Drug Development
DERISKED DRUG DEVELOPMENT NanoAbs feature a favorable path to market compared to risks associated with traditional drug development Source of Risk NanoAb Molecular Target Validated by existing but sub-optimal mAb therapies eco mat Well understood Action Composition of an Assessing safety & efficacy
Slide 8: Yeast: Pichia pastoris
10 15 20 30 25 40 70 60 50 85 100 Y ea s t: P i chi a pas t or i s
Slide 9: Pipeline Molecular Targets
SCINAI PIPELINE MOLECULAR TARGETS CREO MS, HETERODIMER eOvIeaS! PSORIASIS, PSA, ATOPIC DERMATITIS, HS + Strong in vivo data for inhaled therapeutic and prophylactic, + Single compound targeting IL-17A and IL: 17F and ILA7AF + Novel local use + Larger target population than the one addressed by mAbs
Slide 10: Pipeline Addressing Large Markets with Underserved Needs
PIPELINE ADDRESSING LARGE MARKETS WITH UNDERSERVED NEEDS COVID-19 NanoAb: Proof-of- concept as therapeutic and prophylactic. Psoriasis proof-of-concept anticipated in 2023. Autoimmune Market Sizes + Validated targets of existing mAb treatments + Short time to value generation, lower risk than mAbs +
Slide 11: Pipeline Development: Status & Upcoming Milestones
CINAI PIPELINE DEVELOPMENT: STATUS & UPCOMING MILESTONES Anti-IL-17 psoriasis treatment in-vivo proof-of-concept in 2023, clinical trial 2024 Drug Discovery (Max Planck) Indication Molecular Alpacas. VHH Clones Manufacturing lavitro/——_InVivo Target Antibody Process & Analyt Exvive —_Proof.of- Selec
Slide 12: Anti-IL-17 NanoAb: Initial Focus on Psoriasis Market
ANTI-IL-17 NANOAB INITIAL FOCUS: THE LARGE AND GROWING PSORIASIS MARKET WITH UNDERSERVED NEEDS Current standards of care: + Topical (steroids, vitamin D analogues, retinoids) + Phototherapy + Systemic + Traditional systemics (e.g. methotrexate, acitretin, and ciclosporin) + Injected biologics (mAbs)
Slide 13: Four Approved IL-17 Inhibitors on the Market
CINAI FOUR APPROVED IL-17 INHIBITORS ON THE MARKET All target psoriasis, some of them target additional indications Name Company Cosentyx ! feecumumas) (NOVARTIS Siig {brodatumaty BAUS HFHealith c Source: Datemontor LEK. research and analysis Bimzelx ‘Approved Date EUS 2015, 2007 2016 2021 Indicatio
Slide 14: IL-17 is a cytokine in psoriatic lesions
IL - 17 is a cytokine that plays a key role in the development of psoriatic lesions, which are in essence an acute, local (dermis) flareup of a chronic underlying disease . It allows for local (rather than systemic) administration of anti – IL - 17 drugs to stop the cytokine cascade .
Slide 15: Anti-IL-17 NanoAb for Psoriasis: Derisked Drug Development
ANTI-IL-17 NANOAB FOR PSORIASIS: DERISKED DRUG DEVELOPMENT Attractive market potential, proven target, short time to proof-of-concept Source of Risk NanoAb Molecular Target Validated by existing therapies: Cosentyx, Siliq, Taltz and Bimzelx Mechanism of Action Well understood Composition of Matter T
Slide 16: IL-17 Signaling Pathway
IL-17 SIGNALING PATHWAY BiondVax’s anti-IL-17 NanoAb exhibits several key advantages IL-17A, -IL-17F and the heterodimer AF play a key role in the development of psoriatic lesions, which are in essence an acute, local (dermis) flareup of a chronic underlying disease. Strong scientific evidence for e
Slide 17: Our NanoAb Targets an Underserved Population
CINAI OUR NANOAB TARGETS AN UNDERSERVED POPULATION Underserved patient population 125 milion patients, including 7.5 milion US adults 80-90% is plaque psoriasis, Current therapies targeted only to moderate & severe patients, administered systemically Mild patients may suffer from considerable and vi
Slide 18: Three-Dimensional Skin Models of Psoriasis
• • • Image source: https:// www.researchgate.net/publication/272185735_Three - Dimensional_Skin_Models_of_Psoriasis
Slide 19: NanoAb to IL-17: Pre-clinical evaluation
Clinical and non-clinical NanoAb to IL-17: Pre-clinical evaluation In vitro PoC in 3D model — positive indication that the NanoAb blocks overexpression of Psoriasis markers and helps in recovering structural proteins that are essential for healthy skin structure (model establishment is ongoing) rerc
Slide 20: ID & Topical NanoAb Recovers Filaggrin
CINAI ID & TOPICAL NANOAB RECOVERS FILAGGRIN Location Level in normal skin Level in Psoriatic skin ‘Structural protein in skin Epidermis secreted by High Low (Gems Pr ear yes) barrier, organizing Keratin _Keratinocytes, flaments Filaggrin (Flg) ipa songiaan? atypia ; Destna cd Pree consi itorenicin
Slide 21: Downregulates Psoriasis Markers
DOWNREGULATES PSORIASIS MARKERS ID & topical NanoAb downregulates psoriasis markers [EI recruits more th celsinto he esion Secreted by neutophistothe dermis Low Overexpressed cci20 Recruits more Th7 cells into the lesion Secreted by Keratinocytes inthe epidermis Low overexpressed e120 Dermis €XCL1 D
Slide 22: Anti-IL-17 NanoAb: t1/2 = 4h in the Dermis
ANTI-IL-17 NANOAB: t,, = 4h IN THE DERMIS In vivo data: Single intradermal injection covers 7cm? Study design Grou Shima 13.1921 thr 6 46h 79 Shr 3 tore hr 3 15 thr 3 1648 thr 3 Total 2 2A: Injection site; 8, C: Skin sampled for analysis 15 and 3cm from injection site Treatment 10,1 Results Biotinyl
Slide 23: Anti-IL-17 NanoAb Pre-clinical Evaluation: Next Steps
ANTIIL-17 NANOAB PRE-CLINICAL EVALUATION: NEXT STEPS + In vitro PoC in human skin model (Genoskin) — to be initiated in Q4’23 * Topical formulation: with external expert consultant, the lab will prepare the formulation, permeability evaluation: in IMQ model (SIA) + In parallel: confirm efficacy and
Slide 24: Presence of Psoriasin in an InflammaSkin Model
Píesence of Psoíiasin (S100A7) in an InflammaSkin Model with ľ - Cell activation No induction ľ - cell activation leads to significant incíease in IL - 17A expíession • healthy ex vivo skin samples of one donoí, gíowing in a well • •
Slide 25: In Vitro PoC in Human Skin Model Cont.
IN VITRO POC IN HUMAN SKIN MODEL CONT. Study design “ [secukinumab (Positive control) Irrelevant VHH Intradermal (Negative control) Leadi (Rea2b04a) [Creu (EG oet Intradermal Results expected in December 2023 Daily Once, day 3 ‘Once, day 3 ‘Once, day 3 Days 3.4.5 Once Days 3,45 = SSS Objectives: 1.
Slide 26: In Vivo PoC: Humanized Skin Mouse Psoriasis
CINAI IN VIVO POC: HUMANIZED 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 Experiment timeline Human skin transplantation Tcells/NK injections Treatment Skin harve
Slide 27: First-in-Human: Phase 1/2a Clinical Trial Synopsis
FIRST-IN-HUMAN: PHASE 1/2A CLINICAL TRIAL SYNOPSIS Synopsis of trial planned for 2024 Anti-IL-17 NanoAb (36 patients, 12 per each dose) Placebo (12 patients) Visit 1 Day1 Screening, PK during 3h, every 30min after first and last injection, in n=3 (28 days for screening) Screening, PCR test & SOC tre
Slide 28: IP Status: COVID-19 Patent Families
+ COVID-19: 2 patent families IP STATUS maintained in US, EU, China, Israel; PCT for 3rd patent on Omicron will be filed in November, claims preparations is ongoing. + IL-7: PCT will be filed in Dec. 2023
Slide 29: COVID Market Potential
CINAI COVID MARKET POTENTIAL Current FDA-approved COVID treatments: + Oral antiviral pills: - Pfizer's Paxlovid (nirmatrelvir + ritonavir) - Merck's Lagevrio (molnupiravir) + Intravenous (IV) antiviral: - Gilead's Veklury (remdesivir) + Immune modulators: ~ Olumiant (baricitinib) and Actemra (tocili
Slide 30: Viral Titer Data
10 1 10 2 10 3 10 4 10 5 10 6 Titer [TCID 50 /g] limit of detection ٓٓٓٓ ٓٓٓٓ ٓٓٓٓ ٓٓٓٓ 9 8 7 6 5 4 3 2 1 SARS - CoV - 2 RNA copies/ml BALF ٓٓ ٓٓٓٓ ٓ ٓٓ de t e c t i o n limit
Slide 31: Boutique CDMO Services
BOUTIQUE CDMO SERVICES DE-RISKING SCINAI’S INTERNAL R&D INVESTMENTS BY LEVERAGING INTERNAL CAPABILITIES ASEPTIC GMP. Scinai’s CDMO business unit leverages our CGMP MANUFACTURING manufacturing facility, aseptic fermentation and fill and iO SUITES finish suites, R&D and QC laboratories, and experience
Slide 32: Analytical Methods Development and GMP Facility
+ Analytical methods development combined with best-in-class @C capabilities and equipment + Labs for manufacturing process development and scale-up allow for the implementation of quality by design and AND R&D LABS design of experiment principles + ¢GMP suites for upstream fermentation, downstream
Slide 33: 1850 m2 Facility: Labs, Manufacturing, Offices
# SCINAI 1850N? FACILITY: LABS, ole MANUFACTURING, OFFICES
Slide 34: End-to-End CDMO Offering
* SCINAI END-TO-END COMO OFFERING ANALYTICAL METHOD DEVELOPMENT & QUALITY (QC & GA) ASPEPTIC FILLING
Slide 35: Deep Pharma Experience & Capabilities
CINAI DEEP PHARMA EXPERIENCE & CAPABILITIES 35 STAFF MEMBERS »* 5 PhDs + Manufacturing, engineering, technical R&D, upstream & downstream process development, QC, QA, clinical and non-clinical, procurement * Qutsourced finance, legal, regulatory E- Bep AMIR REICHMAN — CEO Senior global pharma leader
Slide 36: Board Brings Significant Expertise
CINAI BOARD BRINGS SIGNIFICANT EXPERTISE x= No Mark Germain, Chairman ‘Aentib Group (Managing Director). Founder, director, chaliman, andior investor in over 20 biotech companies Including Alexion, Incyte, Neurocrine, Ariad, ChromaDex. Samuel Moed, Director Bristol Myers Squibb (NYSE: BMY) (Senior V
Slide 37: Select Financials & ADS Outstanding
SELECT Nasdaq: SCNI FINANCIALS & ADS OUTSTANDING Ordinary ADS 4,351,927 CAP TABLE Pre-funded ADS 4,121,552 Primary shares out 5,473,479 $5 Warrants (Expire 16 Dec 2023) 4,700 $5 Warrants (Expire 16 Dec 2025) 1,600,000 $1.16 Warrants is (Expire 15 Mar 2029) 1146,552 Options + RSUs 535,723 Updated: Se
Slide 38: Significant Potential for Value Creation
CINAI SIGNIFICANT POTENTIAL FOR VALUE CREATION * Well-positioned to bring innovative inflammation & immunology (I&) therapies to market * Demonstrated multiple biologics tech transfers, process development and optimization, scale-up, production, preclinical and clinical trials planning and execution
Slide 39: September 2023 Contact
NASDAQ: SCNI www.scinai.com SEPTEMBER 2023 SCINAI Contact: Joshua Phillipson Investor Relations. ir@scinai.com +972-8-930-2529
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