Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — BiondVax Pharmaceuticals — Biotech Showcase January 2023
25 slides from Scinai Immunotherapeutics's conference presentation, Jan 11, 2023
Slide 1: Amir Reichman, CEO – Biotech Showcase, January 2023
AMIR REICHMAN, CEO BIOTECH SHOWCASE | JANUARY 2023
Slide 2: Forward-looking statements disclaimer
2 This communication is not a prospectus or offer of securities for subscription or sale in any jurisdiction. 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,” “m
Slide 3: Collaboration with Max Planck & UMG, pharma leadership, GMP facility
3 Collaboration with Max Planck & UMG Top - tier pharma leadership GMP biologics manufacturing facility Extensive drug development expertise Uniquely positioned to advance nanosized antibody innovation from R&D through commercialization
Slide 4: The Science of Nanosized Antibodies (NanoAb)
4 THE SCIENCE OF NANOSIZED ANTIBODIES ( NANOAB ) * VHH - antibody is trademarked by ABLYNX N. V., a wholly owned subsidiary of Sanofi, as Nanobody. BiondVax has no affiliation with and is not endorsed by Sanofi. HUMAN ANTIBODY ALPACA - DERIVED NANOAB Alpaca - derived nanosized antibodies (NanoAbs) a
Slide 5: NanoAb Value Proposition
5 N ANO A B VALUE PROPOSITION Multiple crucial advantages compared to monoclonal antibodies (mAbs) & oral therapies CLINICAL BENEFITS CONVENIENT & FLEXIBLE • Hyper - thermostable = longer shelf life, easier storage & distribution • Multiple, easier routes of administration • Faster antibody discover
Slide 6: Derisked NanoAb Pathway
6 DERISKED NANOAB PATHWAY MOLECULAR TARGET MECHANISM OF ACTION COMPOSITION OF MATTER COMMERCIAL ض ض + TBD Validated by existing but sub - optimal mAb therapies Well understood Assessing safety & efficacy of alpaca - derived NanoAbs Solid demand for available mAbs, and underserved populations NanoAbs
Slide 7: Collaboration with Max Planck
7 COLLABORATION WITH MAX PLANCK • World - class science & access to leading scientists • NanoAb platform for development of promising potent therapeutics • Patents covering NanoAbs & their manufacturing BIONDVAX MAX PLANCK & UMG 1 Designed to create significant clinical and commercial advantages 1 .
Slide 8: COVID-NanoAb Candidate Has a Strong Competitive Edge
8 COVID - 19 NANOAB CANDIDATE HAS A STRONG COMPETITIVE EDGE 1 . In - vitro data shows neutralization of all COVID variants of concern including Delta and Omicron | 2 . EMBO J ( 2021 ) 40 : e 107985 https://doi.org/ 10.15252 /embj. 2021107985 . | PROF. DR. DIRK GÖRLICH • Director Max Planck Institute
Slide 9: Inhaled Anti-COVID-19 NanoAb Protected Hamsters from Severe Disease
9 85 90 95 100 0 1 2 3 4 5 6 Weight (%) Day INHALED ANTI - COVID - 19 NANOAB PROTECTED HAMSTERS FROM SEVERE DISEASE Significantly milder disease course measured by weight loss in hamsters infected with SARS - COV - 2 and then treated with inhaled anti - COVID - 19 NanoAbs compared to placebo Highly
Slide 10: Inhaled Anti-COVID NanoAb Resulted in Milder and Shorter Illness
10 INHALED ANTI - COVID - 19 NANOAB RESULTED IN MILDER AND SHORTER ILLNESS BiondVax ’ s nanosized antibodies (NanoAbs) are being formulated as convenient self - administered inhaled COVID - 19 therapy The inhaled COVID - 19 therapy is BiondVax ’ s first in a new pipeline of innovative alpaca - deriv
Slide 11: Inhaled Anti-COVID NanoAb Eliminated Viral Load in the Lungs
11 INHALED ANTI - COVID - 19 NANOAB E LIMINATED VIRAL LOAD IN THE LUNGS TCID 50 * is a measure of viral titer (the amount of virus) in lung cells Over a week after infection, compared to placebo group, hamsters treated with BiondVax ’ s NanoAb had over 30 times lower SARS - COV - 2 viral titers in t
Slide 12: Targeting a Maturing Market for COVID-19 Therapy
12 Initial waves Mar. 2020 Jan 2021 June Jan 2022 June Dec 23 , 2022 : 779 K cases ( 3 ) TARGETING A MATURING MARKET FOR COVID - 19 THERAPY 1 . New England Journal of Medicine. https://www.nejm.org/doi/full/ 10.1056 /NEJMp 2118468 . | 2 . WHO | 3 . Some countries reportedly significantly under repor
Slide 13: Pipeline Market Potential
13 € 2.6 B asthma € 10.4 B psoriasis €5.0B macular degeneration €4.5B psoriatic arthritis PIPELINE MARKET POTENTIAL INITIAL FOCUS 1 . EvaluatePharma (via Zacks); 2 . 2021 , LEK; 3 . Based on laboratory research at Max Planck Institute for Biophysical Chemistry (MPG) and University Medicine Göttingen
Slide 14: NanoAb Development Milestones
14 N ANO A B D EVELOPMENT M ILESTONES * Paul Ehrlich Institute (PEI) Scientific Advice Tech transfer: In - house production of COVID NanoAb COVID - 19 neutralization through inhaler Omicron neutralization demonstrated at Max Planck; NanoAb to be used in our first - in - human clinical trial European
Slide 15: Uniquely positioned to advance nanosized antibody innovation
15 Uniquely positioned to advance nanosized antibody innovation from R&D through commercialization GMP biologics manufacturing facility Top - tier pharma leadership Collaboration with Max Planck & UMG Extensive drug development expertise
Slide 16: GMP Manufacturing and R&D
16 GMP MANUFACTURING AND R & D • 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 stream ferment
Slide 17: NanoAb Production: High Yield, Low Cost, In-House
17 NANOAB PRODUCTION : HIGH YIELD , LOW COST , IN - HOUSE COVID NanoAb 10 15 20 25 30 40 50 60 70 85 100 kDa 0.5 µl Supernatant Yeast: Pichia pastoris Demonstrating efficient, extremely clean process in yeast Batch fermentation yields up to 9 g / litre, indicating kg yields in standard 1000 litre fe
Slide 18: CDMO Services
18 CDMO SERVICES While NanoAb pipeline development is BiondVax ’ s core focus, we also offer CDMO services by leveraging our cGMP manufacturing facility, aseptic fermentation and fill and finish suites, R&D and QC laboratories and experienced professionals. Our CDMO services may support: • Pharmaceu
Slide 19: Top-tier pharma leadership
19 Top - tier pharma leadership Collaboration with Max Planck & UMG GMP biologics manufacturing facility Extensive drug development expertise Uniquely positioned to advance nanosized antibody innovation from R&D through commercialization
Slide 20: Experienced Leadership
20 EXPERIENCED LEADERSHIP COO Built manufacturing sites for recombinant protein in China and mABs for Novartis Singapore • Principal bioprocess engineer • Novartis (Technical Project Manager - Process) CSO Co - invented and guided BiondVax ’ s original vaccine candidate through 8 clinical trials inc
Slide 21: Board Brings Significant Expertise
21 Amir Reichman, MBA CEO NeuroDerm Ltd (Senior Scientist), Novartis Vaccines USA (R&D and Global Supply chain), GSK Vaccines Belgium (Global Supply Chain and Global Engineering) Morris C. Laster, MD Director BioLineRx (CEO, Director), OurCrowd (Partner), Clil Medical (CEO), Vital Spark (CEO), Kitov
Slide 22: Extensive drug development expertise
22 Extensive drug development expertise Top - tier pharma leadership Collaboration with Max Planck & UMG GMP biologics manufacturing facility Uniquely positioned to advance nanosized antibody innovation from R&D through commercialization
Slide 23: In-House Experience & Assets
23 IN - HOUSE EXPERIENCE & ASSETS Developed flu vaccine initiated in the Weizmann Institute of Science lab of Prof. Ruth Arnon Seven Phase 1 / 2 and 2 clinical trials conducted in Israel, Europe, and USA, each with promising results. US trial funded and conducted by NIH . GMP Manufacturing: Construc
Slide 24: Select Financials & Cap Table
24 SELECT FINANCIALS & CAP TABLE • $ 8.3 M cash as of Sept 30 , 2022 • $ 7.3 M net raised in Dec 2022 • ‘ Fully Diluted Shares Out ’ assumes warrants are not exchanged and are exercised, generating an additional $ 15 M cash to the company CAP TABLE As of January 8, 2023 ADS OUTSTANDING Ordinary ADS
Slide 25: Significant Potential for Value Creation
25 SIGNIFICANT POTENTIAL FOR VALUE CREATION Creating pipeline of therapeutic drugs based on NanoAb platform Five - year research collaboration with Max Planck & UMG , world - leading research organizations, including exclusive option for exclusive license for additional NanoAbs De - risked R&D strat
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