Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — BiondVax Pharmaceuticals — Investor Presentation (May 2023)
28 slides from Scinai Immunotherapeutics's investor presentation, May 4, 2023
Slide 1: BiondVax Pharmaceuticals Ltd.
Biond Vax Pharmaceuticals Ltd. NASDAQ: BVXV | May 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: Uniquely positioned to advance new pipeline of NanoAb-based drugs
3 Uniquely positioned to advance new pipeline of innovative VHH antibody (NanoAb) based drugs from R&D through commercialization Targeting diseases with large underserved needs + attractive commercial opportunities such as: Psoriasis Asthma Psoriatic arthritis Wet AMD COVID - 19AR0 AR1
Slide 4: Max Planck & BiondVax Collaboration
4 MAX PLANCK & BIONDVAX COLLABORATION • 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 advantag
Slide 5: The Technology: NanoAbs
5 THE TECHNOLOGY : N ANO A BS * 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) are also known as VH
Slide 6: Platform Value Proposition
6 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 p roduction in yeast (p
Slide 7: Derisked Drug Development
7 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 feature a favorable pat
Slide 8: Pipeline Molecular Targets
8 PIPELINE MOLECULAR TARGETS Psoriasis, PSA, Atopic Dermatitis, HS Asthma, Atopic Dermatitis Wet AMD IL - 17 A 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 ta
Slide 9: Pipeline Development Status & Plans
9 Indication Molecular Target (by priority) Drug discovery (Max Planck) Manufacturing Process & Analytical Method Development In vivo proof - of - concept Toxicology Clinical Phase 1/2 Alpacas immunized VHH antibody selected Clones generated COVID - 19 therapeutic RBD Ready for partnering COVID - 19
Slide 10: Pipeline Addressing Large Markets with Underserved Needs
10 € 2.6 B asthma €9B psoriasis €5.0B macular degeneration €4.5B psoriatic arthritis PIPELINE ADDRESSING LARGE MARKETS WITH UNDERSERVED NEEDS INITIAL FOCUS 1 . Pfizer ’ s estimate for Paxlovid revenues; 2 . 2020 or 2021 , LEK; $8B+ COVID - 19 FUTURE DERISKED TARGETS CURRENT MARKET SIZES 2 2023 PROJE
Slide 11: Vast & Growing Market for COVID-19 Therapies
11 Need for treatment is growing … • Current COVID therapies experiencing MASSIVE demand – 110 million infections excluding China in 2022 with 15% requiring anti - virals . • 2023 demand is projected to increase (112 million infections with 17% requiring anti - virals ) as with fewer protected by va
Slide 12: COVID Market Potential
12 COVID MARKET POTENTIAL Current FDA - approved COVID treatments: [1] • 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 (t
Slide 13: Inhaled Anti-COVID NanoAb Protected Hamsters from Severe Disease
13 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, administered 24 hours post infection, compared to placebo Highly st
Slide 14: Inhaled Anti-COVID NanoAb Resulted in Milder and Shorter Illness
14 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 - derived N
Slide 15: NanoAb Virtually Eliminated Viral Load in the Lungs
15 0 400 800 1200 1600 2000 Placebo NanoAb Median TCID 50 /ml INHALED ANTI - COVID - 19 NANOAB VIRTUALLY ELIMINATED VIRAL LOAD IN THE LUNGS TCID50 * 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’
Slide 16: Inhaled Anti-COVID NanoAb Prophylactic Protection
16 INHALED ANTI - COVID - 19 NANOAB PROPHYLACTIC PROTECTION COVID - 19 illness was virtually prevented in hamsters administered BiondVax ’ s inhaled NanoAb on Day 0 and infected three hours later with SARS - CoV - 2 Highly statistically significant difference ( p<0.0005 ) Inhaled NanoAb group ’ s we
Slide 17: Next NanoAb: IL-17 for Psoriasis
17 NEXT NANOAB: IL - 17 FOR PSORIASIS 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 (due to costs and risk vs. benefit for patien
Slide 18: Anti-IL-17 NanoAb for Psoriasis
18 ANTI - IL - 17 NANOAB FOR PSORIASIS MOLECULAR TARGET MECHANISM OF ACTION COMPOSITION OF MATTER COMMERCIAL Attractive market potential, proven target, short time to POC Validated by existing but sub - optimal therapies: Cosentyx, Siliq , Taltz and bimekizumab Moonlake’s (MLTX) Sonelokimab NanoAb “
Slide 19: Anti-IL-17 NanoAb Advantages
19 ANTI - IL - 17 NANOAB ADVANTAGES IL - 17 NanoAb Other treatments Intended Advantage Molecular Target Single NanoAb neutralizes IL - 17 forms A, F, and AF complex IL - 17A and IL - 17F as targets have been validated by different mAbs Efficient production Affinity pM range nM range (Sonelokimab) Lo
Slide 20: Development Milestones
20 D EVELOPMENT M ILESTONES In - house tech - transfer and production of NanoAbs used in POC trial. Successful proof of concept (POC) in - vivo trial: Inhaled NanoAb virtually prevented illness when administered prophylactically; eliminated the virus in lungs and led to shorter and milder illness wh
Slide 21: GMP Manufacturing and R&D
21 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 22: NanoAb Production: High Yield, Low Cost, In-House
22 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 9g / litre, indicating kg yields in standard 1000 litre fer
Slide 23: CDMO Services
23 CDMO SERVICES 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 professionals. Our CDMO services may support: • Pharmaceutical and biote
Slide 24: Experience + Deep Capabilities
24 EXPERIENCE + DEEP CAPABILITIES Amir Reichman CEO Tamar Ben - Yedidia CSO Elad Mark COO Led scale - up, tech transfer, manufacturing of recombinant proteins in China, mAbs for Novartis Singapore • Principal bioprocess engineer • Novartis (Technical Project Manager - Process) Co - invented and guid
Slide 25: Board Brings Significant Expertise
25 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 26: Select Financials & Cap Table
26 SELECT FINANCIALS & CAP TABLE • $ 14 M cash as of Dec 31 , 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 March 31, 2023 ADS OUTSTANDING Ordinary ADS 3,2
Slide 27: Significant Potential for Value Creation
27 SIGNIFICANT POTENTIAL FOR VALUE CREATION • Targeting diseases with large underserved needs + attractive commercial opportunities • 5 - year research collaboration with Max Planck & UMG, includes exclusive option for exclusive licenses for additional NanoAbs • De - risked R&D strategy targets mass
Slide 28: BiondVax.com Contact
28 BIONDVAX.COM Contact: Joshua Phillipson, Investor Relations j.phillipson@biondvax.com +972.8.930.2529 NASDAQ: BVXV | MAY 2023
BiondVax Pharmaceuticals — Investor Presentation (May 2023) on 6ix