Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — BiondVax Pharmaceuticals — Investor Presentation (September 2020)
23 slides from Scinai Immunotherapeutics's investor presentation, Sep 1, 2020
Slide 1: The New Paradigm: The Universal Flu Vaccine
THE NEW PARADIGM : THE UNIVERSAL FLU VACCINE September 2020
Slide 2: Forward-looking statements disclaimer
2 This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction . All statements in this communication, other than those relating to historical facts, are "forward - looking statements" within the meaning of the United States Private Litigation Reform Act
Slide 3: BiondVax Overview
3 B IOND V AX OVERVIEW 1. Angels Investments in High Tech Ltd. is fully owned by Marius Nacht, an Israeli entrepreneur, social activist, investor & fo under of the Moon Fund | 2. European Investment Bank (EIB) €24M support for M - 001 P3 trials & commercial production also includes: Milestone based
Slide 4: M-001 Value Drivers
4 THE NEW PARADIGM : Addresses a vast unmet need with novel design Targeting superior efficacy Constant formulation: No annual change Comparable safety Experienced leadership Highly scalable production 1 2 3 4 5 6 M - 001 VALUE DRIVERS THE UNIVERSAL FLU VACCINE
Slide 5: The Burden of Seasonal Flu
5 THE BURDEN OF SEASONAL FLU Currently marketed vaccines offer only average effectiveness ( 1 ) ~1.5B Global flu cases annually ~4M Global cases that result in severe illness with up to 810K (5) hospitalizations / year in the U.S. alone 650K Flu - related deaths globally; 61K (5) in the U.S. >$361B
Slide 6: The Threat of Pandemic Flu
6 2015 2016 2017 2018 2019 2020E THE THREAT OF PANDEMIC FLU COVID - 19 pandemic emphatically highlights the need for proactive solutions • Raising awareness of the importance of infectious disease prevention and increasing demand for vaccines as preventative measure • Co - occurrence of flu and COVI
Slide 7: Immune System Science
7 IMMUNE SYSTEM SCIENCE Cellular immune responses are critical in fighting viral infections the immune system has two arms Cellular (CMI) 1 Works against infected cells T - cell 1 e.g. T - Helper, CD4, CD8 produce anti - viral cytokines such as: IL - 2 IFN - g B - cell Humoral (HAI) 2 Works outside
Slide 8: Flu Vaccine Science
8 FLU VACCINE SCIENCE Current vaccines target only 3 to 4 strains out of known strains Four to six month cycle Formulations are based on previously existing strains – future strains cannot be targeted virus - vaccine mismatch current vaccines target old strains long production cycle Vaccines don’t t
Slide 9: M-001: Constant Structure
9 9 regions common to most seasonal and pandemic flu strains connected into one recombinant protein, called M - 001 M - 001: CONSTANT STRUCTURE Designed to be the common denominator of influenza A&B viruses Image adapted from CDC. • Consists of nine epitopes (small immunogenic protein segments) that
Slide 10: M-001: Dual Mode of Action
10 Cellular (CMI) Works against infected cells T - cell 1 B - cell Humoral (HAI) Works outside cells 2 Directly induces T - cells Dual mode of action M - 001 : DUAL MODE OF ACTION T - cell priming effect enhances B - cell responses significantly amplifies cellular immune response , an essential anti
Slide 11: Induces Cellular Response
11 0% 5% 10% 15% 20% 25% 30% A/Brisbane/ 10/07 H3N2 A/California/ 7/09 H1N1 A/Perth/ 16/09 H3N2 B/Brisbane/ 60/08 Flumist Day 0 Day 42 Day 0 Day 42 * * * * ** Sources: 1 . BVX 005 : Jacob Atsmonet al. Priming by a novel universal influenza vaccine ( Multimeric - 001 ) — A gateway for improving immun
Slide 12: Enhances Humoral Response
12 Sources: 1 . BVX 005 : Jacob Atsmonet al. Priming by a novel universal influenza vaccine ( Multimeric - 001 ) — A gateway for improving immune response in the elderly population. Vaccine 32 ( 2014 ) 5816 – 5823 | 2 . Lowell GH et al. Back to the future: Immunization with M - 001 prior to trivalen
Slide 13: Phase 3 Study Design
13 Day 1 Day 21 Day 202 Experimental 1mg M - 001 1mg M - 001 Safety, RT - PCR or culture on any ILI* (during flu season) Control Placebo Placebo PHASE 3 STUDY DESIGN Targeting a higher threshold of effectiveness than existing licensed vaccines • A pivotal, multicenter, randomized, modified double -
Slide 14: Protection at Any Age
14 PROTECTION AT ANY AGE • Seven completed studies in multiple age groups have demonstrated intended immunogenicity • M - 001 may provide unprecedented coverage to older adults and elderly – the group involved in current pivotal Phase 3 • Older adults are typically more vulnerable to flu illness and
Slide 15: Safe and Well-Tolerated
15 S AFE AND WELL - TOLERATED • Safety profile comparable to current non - adjuvanted seasonal flu vaccines • Treatment related adverse events were mild to moderate and transient • M - 001 was well tolerated, shown to be safe and immunogenic in all studies COMPARABLE SAFETY 3 No treatment - related
Slide 16: Year-Round Availability
16 YEAR - ROUND AVAILABILITY 5 The new paradigm for flu vaccination no need for annual strain selection year - round production can be stockpiled 365 Unique constant structure covers flu A & B and pandemic strains; would obviate the risk of mismatch for seasonal & pandemic flu Multi - year shelf - l
Slide 17: Scalable Manufacturing
17 SCALABLE MANUFACTURING From lab to new commercial scale facility • 10M to 20M annual bulk dose capacity • Goal: year - round production & demand - based stockpile • Funded by EIB, BiondVax and Israel’s Ministry of Economy & Industry • Exploring collaborations with international CMOs for large com
Slide 18: Global, Top-Tier Management
18 GLOBAL , TOP - TIER MANAGEMENT Ron Babecoff DVM, MEI Tamar Ben - Yedidia PhD Uri Ben - Or CPA, MBA Elad Mark BSc Engineering, MBA Joshua E. Phillipson Hon. BSc, MBA Founder, President & CEO CSO & Clinical Trial Leader CFO COO Director of Business Development & IR ▪ Omrix Biopharmaceuticals Ltd (M
Slide 19: Board Brings Significant Expertise
19 BOARD BRINGS SIGNIFICANT EXPERTISE EXPERIENCED LEADERSHIP 6 EXPERIENCED LEADERSHIP 6 Mark Germain Chairman Aentib Group (Managing Director), Pluristem (Director). Founder, director, chairman, and/or investor in over 20 biotech companies Samuel Moed Director Bristol Myers Squibb (NYSE: BMY) (Senio
Slide 20: Comprehensive, Long-Term I.P.
20 COMPREHENSIVE , LONG - TERM I . P . • Covering polypeptides, polynucleotides, compositions, uses, formulations and production • Expiration to 2035 Expiry Status Subject Matter Title USA: Aug 2020 Granted: USA Expired: 1, 3, 5, 12, 13, 15, 19, 20, 22, 24, 25, 26, 31, 33, 35, 36 Vaccine comprising
Slide 21: Financial
21 F INANCIAL • Lean structure with 25 employees. • Manufacturing scale - up and operating burn ~$ 700 K/month • Government of Israel support from Ministry of Economy and Industry ’ s Israel Investment Center, and royalty - based grants from the Israel Innovation Authority (formerly Office of the Ch
Slide 22: M-001 Value Drivers
22 Addresses a vast unmet need with novel design Targeting superior efficacy Constant formulation: No annual change Comparable safety Experienced leadership Highly scalable production 1 2 3 4 5 6 M - 001 VALUE DRIVERS THE NEW PARADIGM : THE UNIVERSAL FLU VACCINE
Slide 23: Contact: Joshua Phillipson
23 THE NEW PARADIGM : THE UNIVERSAL FLU VACCINE C ONTACT : J OSHUA P HILLIPSON J . PHILLIPSON @ BIONDVAX . COM +972 - 8 - 930 - 2529 WWW . BIONDVAX . COM
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