Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — BiondVax Pharmaceuticals — Investor Presentation (August 2023)
21 slides from Scinai Immunotherapeutics's investor presentation, Aug 23, 2023
Slide 1: Nonconfidential presentation, August 22, 2023
N o n c o n f i d e n t i al p r e s e n t at i o n | A u g u s t 22, 2023
Slide 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 are intended to identify forward - looking statements . All
Slide 3: Executive Leadership: Deep Pharma Experience
Amir Reichman MSc, MBA | CEO Senior leadership positions at GSK Vaccines, Belgium; Global pharmaceutical engineering & supply chain leadership, including large capital expenditure projects building vaccines manufacturing sites in Belgium, Italy, Germany, Hungary and USA. Dr. Tamar Ben - Yedidia PhD
Slide 4: Technical R&D and process development team
20+ years of recombinant protein process development from bench to Phase 3; cGMP manufacturing from preclinical through Phase 3 clinical trials; Startups and big pharma leadership, in USA, Israel, Europe, China, and Singapore; Decades of accumulated knowledge in process development, analytical metho
Slide 5: Board of Directors
NeuroDerm Ltd (Senior Scientist), Novartis Vaccines USA (R&D and Global Supply chain), GSK Vaccines Belgium (Global Supply Chain and Global Engineering) Amir Reichman, MBA CEO BioLineRx (CEO, Director), OurCrowd (Partner), Clil Medical (CEO), Vital Spark (CEO), Kitov Pharmaceuticals (Co - founder, D
Slide 6: Max Planck & BiondVax Collaboration
MAX PLANCK & BIONDVAX COLLABORATION Designed to create significant clinical and commercial advantages • World - class science & access to leading scientists • NanoAb platform for development of promising potent therapeutics • Patents covering NanoAbs & their manufacturing MAX PLANCK & UMG 1 BIONDVAX
Slide 7: The Technology: NanoAbs
THE TECHNOLOGY : N ANO A BS * Also trademarked by ABLYNX N.V., a wholly owned subsidiary of Sanofi, as Nanobody. BiondVax has no affiliation with and is not endorsed by Sanofi. HU M AN A N T I BO D Y A L P A C A - D ERI V E D N A N O A B Alpaca - derived antibody (V H H) fragments (NanoAbs)*
Slide 8: Platform Value Proposition
PLATFORM VALUE PROPOSITION NanoAbs ’ unique physicochemical attributes can generate multiple crucial advantages vs human monoclonal antibodies (mAbs) Manufacturing • X10 active pharmaceutical ingredient (API) per gram of manufactured protein vs. mAbs • Faster and lower cost production in yeast (pich
Slide 9: Derisked Drug Development
ME CH A N I S M OF A CT I ON COMPOSITION O F M A TTE R COMME R CI A L ض ض Validated by existing but sub - optimal mAb therapies Well understood Assessing safety & efficacy of alpaca - derived NanoAbs TBD + Solid demand for available mAbs, and underserved populations NanoAbs feature a favorable path
Slide 10: Pipeline Molecular Targets
PIPELINE MOLECULAR TARGETS Psoriasis, PSA, Atopic Dermatitis, HS Asthma, Atopic Dermatitis Wet AMD IL - 17A IL - 17F IL - 17A/F IL - 4Ra IL - 13 TSLP VEGF - A ANG - 2 HETERODIMER COVID - 19 RBD • Single compound targeting IL - 17A and IL - 17F and IL - 17AF • Novel local use • Novel and larger targe
Slide 11: Pipeline Development Status & Plans
Clinical Phase 1/2 Toxicology In - Vitro/In vivo proof - of - concept Manufacturing Process & Analytical Method Development Drug discovery (Max Planck) Molecular Target (by priority) Indication Clones generated VHH antibody fragment selected Alpacas immunized Ready for partnering RBD COVID - 19 ther
Slide 12: Proof of Concept: Inhaled Anti-COVID-NanoAb
P ROOF OF C ONCEPT : INHALED ANTI - COVID - 19 NANOAB • High dose of infective virus: 1x10^4 TCID50 unit of SARS - CoV - 2 (isolate Germany/BavPat1/2020); considered as severe disease model as it leads to 12% weight loss in the control • Study design: N Time period in days post - infection Total amo
Slide 13: Inhaled Anti-COVID NanoAb Protected Hamsters from Severe Disease
INHALED ANTI - COVID - 19 NANOAB PROTECTED HAMSTERS FROM SEVERE DISEASE Weight loss of infected animals. Data are shown as mean “ SD. Statistical analysis using ANOVA with Šídák's multiple comparisons test with statistically significant difference between control and experimental group on days 3 - 6
Slide 14: Inhaled Anti-COVID NanoAb Virtually Eliminated Viral Load in the Lungs
INHALED ANTI - COVID - 19 NANOAB VIRTUALLY ELIMINATED VIRAL LOAD IN THE LUNGS Virus quantification, a measure of viral titer per gram lungs by: TCID50 (left) & PCR (RNA copies, right) Over a week after infection, compared to placebo group, hamsters treated with BiondVax’s NanoAb had over 30 times lo
Slide 15: Next NanoAb: Anti-Interleukin A/F
NEXT NANOAB: ANTI - I NTERLEUKIN 17 A/F Large and growing psoriasis market with underserved needs The opportunity: • Current biologics and new oral treatments are systemic, not topical • Recently developed systemic treatments target mostly severe psoriasis, which is 15% of the psoriatic patients (du
Slide 16: Why an Anti-IL-17 NanoAb?
W HY AN ANTI - IL - 17 NANO A B ? • IL - 17 as a target achieved a high score by L.E.K consulting triaging over 800 potential targets for nanoAbs: • Relative development risk: Medium to low • Strong scientific evidence for efficacy by mAbs • Time to PoC: 1Y for pre - clinical, 2Y for clinical PoC •
Slide 17: Anti-IL-17 NanoAb for Psoriasis
ANTI - IL - 17 NANOAB FOR PSORIASIS M O L EC UL A R T A RG ET M E C HANI S M OF A CT I ON COMPOS I T I ON O F M A TTE R COMME R CI A L Attractive market potential, proven target, short time to POC Validated by existing therapies: Cosentyx, Siliq, Taltz and bimekizumab Moonlake’s (MLTX) Sonelokimab N
Slide 18: GMP Manufacturing and R&D Laboratories
GMP MANUFACTURING AND R & D LABORATORIES • Analytical methods development combined with best - in - class QC capabilities and equipment • Labs for manufacturing process development and scale up allow for implementation of quality by design and design of experiment principles • GMP suites for up stre
Slide 19: CDMO Services
CDMO SERVICES De - risking R&D investments by leveraging internal capabilities While NanoAb pipeline development is our core focus, we offer CDMO services, leveraging our cGMP manufacturing facility, aseptic fermentation and fill and finish suites, R&D and QC laboratories, and experienced profession
Slide 20: Select Financials & Cap Table
SELECT FINANCIALS & CAP TABLE • $7.6M cash as of June 30, 2023 ADS OUTSTANDING CAP TABLE As of July 31, 2023 3,651,927 Ordinary ADS 675,000 Pre - funded ADS 4,3 26 , 927 Primary shares out 4,700 $5 Warrants (Expire 20 Dec 2023) 1,600,000 $5 Warrants (Expire 22 Dec 2025) 277,448 ESOP BVXV 20 €24M Eur
Slide 21: BiondVax.com Contact
B I ON DV A X . C OM Contact: Joshua Phillipson, Investor Relations j.phillipson@biondvax.com +972.8.930.2529 N A SD A Q : BV XV | A ug us t 2023
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