Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — BiondVax Pharmaceuticals — Investor Presentation (April 2019)
26 slides from Scinai Immunotherapeutics's investor presentation, Apr 8, 2019
Slide 1: The Phase 3 Universal Flu Vaccine
The Phase 3 Universal Flu Vaccine J OSHUA P HILLIPSON A PRIL 2 , 2019
Slide 2: Forward-looking statements disclaimer
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 of
Slide 3: The Flu: A Serious Public Health Challenge
Flu cases: up to 20% or 1.5 billion Severe illness: 3 – 5 million Deaths : up to 650,000 2 The Flu: A Serious Public Health Challenge A S EASONAL P ROBLEM … A P ANDEMIC T HREAT □ At - risk Seniors: 80 % of deaths & most hospitalizations 3 □ High economic burden: Over $ 87 B including $ 56 B in elder
Slide 4: Current Vaccine Falls Short: The Mismatch
38 % 40% 48 % 19 % 52 % 49 % 47 % 60 % 56 % 41% 37 % 52 % 21 % 10 % 2017-18 2016-17 2015-16 2014-15 2013-14 2012-13 2011-12 2010-11 2009-10 2008-09 2007-08 2006-07 2005-06 2004-05 C URRENT V ACCINE F ALLS S HORT : T HE M ISMATCH 1 VE data: CDC, including http://www.cdc.gov/flu/professionals/vaccinat
Slide 5: Milestones & Catalysts
BiondVax operational 2005 Technology developed by Prof. Ruth Arnon Head BiondVax ’ s SAB Mid 90 ’ s Co - Inventor of One • For All : The Universal Flu Vaccine 2018 - Pivotal Clinical Efficacy Phase 3 trial (EU) - Mid - size manufacturing plant construction - USA NIH - sponsored Phase 2 Solid Science
Slide 6: M-001: A Common Denominator of Flu Viruses
M - 001: A C OMMON D ENOMINATOR OF F LU V IRUSES Target Common Regions: Nine common flu regions (epitopes) connected to make one recombinant protein (M - 001 ) produced in E.coli H em A gglutinin (HA) N ucleo P rotein (NP) M atrix protein (M 1 ) One • For All : The Universal Flu Vaccine BiondVax ’ s
Slide 7: M-001: The Universal Flu Vaccine
• Flu viruses are intracellular parasites • Most of their lifecycle occurs inside our cells, thus are out of the reach of antibodies • Our immune system mainly fights viral infection with cellular immunity via cytokines M - 001 : T HE U NIVERSAL F LU V ACCINE e.g. T - Helper, CD 4 , CD 8 Produce ant
Slide 8: Advanced Clinical Development
A DVANCED C LINICAL D EVELOPMENT Results Status Total Participants Population (age) Year Trial Phase M - 001 was well tolerated and a cellular (CMI) and humoral (priming effect) immune response was observed Completed 63 Younger Adults (18 - 49) 2009 BVX - 002 1/2 Completed 60 Older Adults (55 - 75)
Slide 9: M-001: Induces Cell Mediated Immunity (CMI)
6.8* 3.8 5.3* 4.7 0.4 * - 0.2 -200 0 200 400 600 800 1000 high INF low INF highIL2 low il2 high tnfa low tnfa Fold change over placebo 0 0.05 0.1 0.15 0.2 0.25 0.3 A/Brisbane/10/07 H3N2 A/California/7/09 H1N1 A/Perth/16/09 H3N2 B/Brisbane/60/08 Flumist 2011 % positive cells (Mean + SE) M-001 twice D
Slide 10: M-001: Enhances Humoral Immunity (HAI)
H 1 N 1 pandemic swine flu M - 001: E NHANCES H UMORAL I MMUNITY (HAI) 0 10 20 30 40 50 60 70 TIV 2011/12 M-001 & TIV 2011/12 % Seroprotection (HAI) * “M - 001 can provide broadened enhanced immunity extending even to influenza strains destined to circulate in future years.” – Vaccine 2 In 2011 we a
Slide 11: More Information
M ORE I NFORMATION Articles • Atsmon Jacob et 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 • Lowell GH et al. Back to the future: Immunization with M - 001 prior to trivalent i
Slide 12: 2018: Started Pivotal Clinical Efficacy Phase 3 Trial
2018: S TARTED P IVOTAL C LINICAL E FFICACY P HASE 3 Trial Design: Flexible enrollment Cohort 1 ( 4,094 enrolled Aug - Oct 2018 ) Cohort 2 ( 6,000 + to be enrolled July - Nov 2019 ) Day 1 Day 21 Day 202 10K+ participants Age 50+ (half 65+) Two flu seasons Results 2 nd H - 2020 Experimental 1mg M - 0
Slide 13: Phase 3 Cohorts
P HASE 3 Cohort 1: 2018/19 Cohort 2: 2019/20 • 4 countries • 54 sites • 4,094 participants enrolled • 7 countries planned • 85 sites planned • > 6,000 participants planned One • For All : The Universal Flu Vaccine
Slide 14: Ongoing Phase 2 Trial
O NGOING P HASE 2 • NIAID sponsored • 120 participants (18 - 49 yo ) • 3 centers: Houston, Iowa, Cincinnati • Trial Design: • Spring time – 2 doses (M - 001 or placebo) 3 weeks apart • Autumn – standard QIV • Endpoints : Safety, T cell responses • Details: https://clinicaltrials.gov/ct2/show/NCT0305
Slide 15: BiondVax's New Manufacturing Facility
B IOND V AX ’ S N EW M ANUFACTURING F ACILITY • Funding: EIB, BiondVax, and Israel ’ s Ministry of Economy & Industry • Target annual capacity: up to 20 million doses in bulk with up to 10 million single dose syringes • Goal: Year - round production & stockpile per market demand From Lab to Pilot Mi
Slide 16: Summary Financial Data
S UMMARY F INANCIAL D ATA Financial Data Highlights • Lean structure with 16 employees, current operating burn ~$ 380 K/month (excl. clinical phase 3 trial and facility construction) • 6.5 M outstanding ADS ( 8.7 M fully diluted) Balance Sheet Highlights • $14.6M cash on hand, no debt (Q3 2018) • €2
Slide 17: Flu Vaccines – A Large and Growing Market
F LU V ACCINES – A L ARGE AND G ROWING M ARKET Global Flu Vaccine Sales – 2017 Flu Vaccine Market Seasonal Flu o Worldwide : ~$ 4.3 B global market in 2016 1 ; expected to grow to $ 5.9 B 1,2 by 2021 o US : $ 1.6 B in 2015 growing to $ 2.6 B by 2022 1 ; ~ 175 M doses/year 1 o Forecasted CAGR of > 7
Slide 18: IP: Comprehensive and Expanding Coverage
IP: C OMPREHENSIVE AND E XPANDING C OVERAGE 1 =Australia, 2 =Austria, 3 =Belgium, 4 =Brazil, 5 =Canada, 6 =China, 7 =Croatia, 8 =Czech Republic, 9 =Denmark, 10 =Europe, 11 =Finland, 12 =France, 13 =Germany, 14 =Greece, 15 =Hong Kong, 16 =Hungary, 17 =India, 18 =Ireland, 19 =Israel, 20 =Italy, 21 =Ja
Slide 19: Management
M ANAGEMENT One • For All : The Universal Flu Vaccine Ron Babecoff DVM, MEI Tamar Ben - Yedidia PhD Uri Ben - Or CPA, MBA Shimon Hassin PhD Elad Mark BSc Engineering, MBA Joshua Phillipson Hon. BSc Founder, President & CEO CSO & Clinical Trial Leader CFO COO Site Head & Process Development BD Manage
Slide 20: Board of Directors
One • For All : The Universal Flu Vaccine B OARD OF D IRECTORS Biodar (CEO), Rodar (Founder), Israel Biotech Organization (Chairman, Steering committee) Prof. Avner Rotman, PhD Chairman of the Board Aentib Group (Managing Director), Pluristem (Director). Founder, director, chairman, and/or investor
Slide 21: Contact
One • For All : The Universal Flu Vaccine Contact: Joshua E. Phillipson • j.phillipson@biondvax.com • +972 - 8 - 930 - 2529 • www.biondvax.com • 6 completed clinical trials: Safe and immunogenic • Ongoing NIAID/NIH sponsored Phase 2 trial • Ongoing pivotal, clinical efficacy Phase 3 trial • Nasdaq:
Slide 22: Archive
A RCHIVE
Slide 23: BiondVax on the Radar
One • For All : The Universal Flu Vaccine B IOND V AX ON THE R ADAR More News: http://www.biondvax.com/press - releases/in - the - news/
Slide 24: The Elderly – At Risk and In Need
T HE E LDERLY – A T R ISK AND I N N EED • ~ 80 % of seasonal flu related death occurs in elderly 1 • Seasonal vaccine effectiveness as low as 9 % for elderly 2 • 80 % of older adults have at least one chronic condition 3 • Influenza worsens outcomes of chronic illness • Elderly flu cost in US estima
Slide 25: Conserved epitopes with wide coverage of influenza strains
Table 1- Conserved epitopes with wide coverage of influenza strains Epitope | Epitope Site & Sequence Homology to Influenza Strains* Type T helper HA 307-319 | H3N2 HSN1, HSN8, H7N9, H10N8. PKYVKQNTLKLAT T helper NP 206-229 | H1N1, H3N2, HSN1, HSN8, H7N7, H7N9, H1ON8, HON7 FWRGENGRKTRSAYERMCNILKGK C
Slide 26: Contact Information
C ONTACT I NFORMATION : J OSHUA P HILLIPSON j.phillipson@biondvax.com +972 - 8 - 930 - 2529 www.biondvax.com The Universal Flu Vaccine Multi - Season Multi - Strain Flu Vaccine
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