Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — BiondVax Pharmaceuticals — Investor Presentation (October 2015)
28 slides from Scinai Immunotherapeutics's investor presentation, Oct 7, 2015
Slide 1: BiondVax: The Universal Flu Vaccine Corporate Presentation
BiondVax Pharmaceuticals Ltd. THE UNIVERSAL FLU VACCINE CORPORATE PRESENTATION OcToBeR 2015
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT ‘This presentation is nota prospectus or offer of securities for subscription orslen any jurisdiction. All statements In this communication, other than those rating to Historical fects, are “Torward-looking statements” within the meaning ofthe United states Private Utigation Re
Slide 3: Flu infects up to 20% of the population each year
infects up to 20% of the population “& each'year “_
Slide 4: A Seasonal Problem... A Pandemic Threat
A SEASONAL PROBLEM... A PANDEMIC THREAT The Flu Virus: Unpredictable, Fast Mutating SEASONAL FLU PANDEMIC FLU * Per year: 23,000 deaths! (21,000 elderly) & * When?... Where?... Which?... pandemic strain 200,000 hospitalizations? in just the US * Pandemic strain: a new to Humans * 8th leading cause o
Slide 5: Current Vaccine Falls Short: The Mismatch
CURRENT VACCINE FALLS SHORT: THE MISMATCH Seasonal Flu Vaccine Effectiveness (VE) CDC data’, flu seasons 2004-2015 As low as 9% VE in Elderly? Next year’s seasonal fluvaccineis an educated gues: the mismatch phenomenon A particular seasons’ vaccine will not necessarily protect against the next seaso
Slide 6: The Elderly — At Risk and in Need
THE ELDERLY — AT RISK AND IN NEED + ~90% of seasonal flu related death occurs in elderly * Seasonal vaccine effectiveness is only 9% for elderly? ~80° derly 65+ suffer chronicillnesses Influenza worsens outcomes of chronicillness Elderly fl ? at S56B per year (hospital . . NIH: “During the period fr
Slide 7: Meeting Milestones
MEETING MILESTONES Science, Advance Clinical Stage, g IP HREMANN BiondVax Today Pecued j| ly Technology developed Tune 2007 May2015 by Prof. Ruth Arnon TASE:BVXV Nasdaq: BVKV Mid 90's a. FDA = Se 2 (WL) Phase2 (IL) accepts US& — Phase3ready BiondVax IND European Operational trials was Safe and Immun
Slide 8: Upcoming Catalysts
UPCOMING CATALYSTS 7 Standalone Vaccine [ Independent universal vaccine for multiple strain . Primer Vaccine 2017-18 ane H2 2016 H2 2016 H2 2016 2016 Q42015 H2 2015 y Q42015 ov 2015 Q2 2015 Pandemic primer: for national stockpile Seasonal primer? for the elderly Phase 3 ready (EO2PM") BVX-008 trial
Slide 9: Thinking Outside the Box
THINKING OUTSIDE THE BOX The Influenza Virus Universal Flu Vaccine A common denominator for Seasonal & Pandemic strains Ns One ‘Nine common regions (epitopes) of strains are connected to make one recombinant protein called M-0 produced in E.coli Universal: Broad coverage Strain specific Single formu
Slide 10: Significant Protective Response to Future Strain
Significant Protective Response to “Future Strain” PROTECTING THE FUTURE In 2011, 120 elderly participants took BiondVax’s vaccine This was BVX-005 trial 70 * 60 50 40 In 2015, an unpredicted ‘Swiss’ epidemic flu strain emerged This strain did not exist in 2011 o+ % Seroprotection 7) * ps0.05 tiv201
Slide 11: Pandemic Preparedness Plan (PPP)
PANDEMIC PREPAREDNESS PLAN (PPP) Pandemic Declaration Be Today's situation: aS Saving time = Saving lives BiondVax‘s PPP: “eran, ~Y f population ulations 2on any pandemic More subjects reach level of protection and evolvingstrai only one boost
Slide 12: Phase Progress
Phase Progress clinical ‘Synthetic protein i Mecadeosertee peas > Large of ae na een ora real pees Ze ms] = teretecter | BiondVax) waw.ne | Sate etaiicmal covering372 patients: | Pharmaceuticals Led. analy Inthe US under MAID/NIH & in Europe 01-15 Acquired by Yaxin (notin pipeline) ‘Teel peptides (P
Slide 13: Clear Regulatory & Go-to-Market Strategy
CLEAR REGULATORY & GO-TO-MARKET STRATEGY One Vaccine — Multiple Indications/Products | standalone Vaccine } Pandemic primer! for | sees | Independent universal national stockpile for the elderly vaccine for multiple strain s — _7 4 d *+ Leverage existing marker + Clinical efficacy: + Smaller clinica
Slide 14: Summary Financial Data
SUMMARY FINANCIAL DATA Financial Data Highlights TEL-AVIV STOCK EXCHANGE * Successful IPO on Nasdaq in May 2015 Company's ordinary shares ticker: $10M gross proceeds * Lean structure with 16 employees BVXV * 3.3M outstanding ADS (5.9M fully diluted) * IFRS; calendar year basis e NASDAQ Company's Ame
Slide 15: Peers
PEERS Publicly Traded Peers Nasdaq: NVAX + MCap~$2B based on its VLP production platform NOWVAVAX forrsvvaccineand seasonalinfluenca (Ph2) j one d Va x Pharmaceuticals Ltd. . * NYSE:INO in AVIO + MCap “$500M based on its DNA vaccine eee. technology for HPV vaccine (Ph2) and influenza vaccine (Ph1) R
Slide 16: Flu Vaccines — A Large and Growing Market
FLU VACCINES — A LARGE AND GROWING MARKET Seasonal Flu © Worldwide?: $3.2B global market in 2013; oth expected to grow to $5.38 by 2021 thers 2014: Pfizer bought © US: $1.4B in 2012 growing to $2.6B by 2022? Baxter’ Flu vaccine unit sanofipasteur ~140M doses in just the US? steur © Forecasted CAGR o
Slide 17: Investment Highlights
INVESTMENT HIGHLIGHTS Game Change for the World Health System Solves Significant limitations of current flu vaccines Impossibility of predicting future flu strains leads to new vaccines each season but often mismatched Results in low vaccine effectiveness- particularly in the elderly BiondVax Univer
Slide 18: Thank You! Contact Information
BiondVax ) Pharmaceuticals Ltd. *S,,\ t I) i AQ LISTED yas [by Vx, JULY 10, 2075 s. s6f THANK You! ConTAcT INFORMATION: info@biondvax.com www.biondvax.com INVESTOR RELATIONS: Kenny@biondvax.com 1 646 201 9246
Slide 19: Management
MANAGEMENT U Shimon Hi DM, ME \, MBA PhD Founder, . . g cso CFO coo Director of BD President & CEO + Degree romUniversityot + Cornvontorof the universal + Degree fromCollege of + Degree fromUniversityof + Degree fromm Weizmann Uege (uLs) flu vacine Administration ‘Maryland Biotechnology Institute of
Slide 20: Board of Directors
BOARD OF DIRECTORS Prof, Avner Rotman, PhD Chairman of the Board Mr. Jack Rosen Director Dr. George Lowell, MD Director Prof. Moshe Many, MD, PhD Director Ron Babecoff, DMV, MEI Founder President and CEO Mrs. Michal Marom Brikman, CPA, Director Prof. Liora Katzenstein External Director Mrs. Irit Ben
Slide 21: Cap Table
CAP TABLE ae nat “yen Outstanding Equivalent xX i Sep 30, 2015 % Price | Equivalent Date ADS-Shares 1:40 ratio Nis ($) Ordinary shares 135,097,367 3,377,434 53.76% Nis0.70 Employees Options 13,215,367 330,384 5.26% (Gah $7.20 regis MIs 1.80 Options (Series 3) 5,650,000 141,250 2.25% 046) $18.40 Nov
Slide 22: IP: Comprehensive and Expanding Coverage
IP: COMPREHENSIVE AND EXPANDING COVERAGE bod International Priority & 11/30/1998 Granted: USA, Israel, Australia, Korea, Mexico, New. Vaccine comprising Nov2019 Peptide-Based Vaccinefor a r YedaR&D Zealand, Canada, Hong Kong, Astra Belgium, France, Influenza es r228 SM PE icensedto Germany, tal, Net
Slide 23: Trial Data
Biond Vax) Pharmaceuticals Ltd. TRIAL DATA
Slide 24: Successful Clinical Trials
SUCCESSFUL CLINICAL TRIALS M-001: Safe and Immunogenic in Young Adults to Elderly * Notreatment-related Severe Adverse Events * Adverse events were mild * All adverse events observed were transient * Both Cellular & Humoral immunity were induced Phase | Trial | Year Population (age) mae ‘Status Resu
Slide 25: M-001: Enhances Seasonal & Pandemic Vaccines
M-001: ENHANCES SEASONAL & PANDEMIC VACCINES Human Trials Mouse Model Human Trial BVXO0S i AvianHSN1 (Clade 1) 2012, age 65+ OT @Mo01+TIV a 100 z« | zo re 5 «0 $ 20 | 3 0 bo bn Bo Zot 3° Nestriine na” Aerie” sae wamecne Wedd on cane HANI Swine Human Trial BVX003 Broadened coverage to HS and H7 Strai
Slide 26: M-001: Standalone Cell-Mediated Efficacy
M-001: STANDALONE CELL-IMEDIATED EFFICACY Proliferation to M-001 (equivalent to HAl to TIV) Specific Immunity to Multiple Flu Strains 7” Young dute-BVX002 oq) older acuits-avxces en Non-adjuvanated ‘Non-adjuvanated 100% 35000 ‘et 500 % £200 9000 ” ay S som) 25000 = S00 now oan gS som sono Bos 2 nee
Slide 27: BVX-006 Trial 2014/15
BVX-006 TRIAL 2014/15 * Trial Rationale: confirm safety and immunogenicity with Img dose * M-001 is intended for the elderly and for pandemic outbreaks * Enhanced immunity by elevated dose * Results: M-001 was Safe & Immunogenic Grou; le Day0, 21, 42 Day 63 M-001 0.5mg x3 12 2 M-001 1.0mg x3 TIv 12
Slide 28: BVX-006 Results: M-001 Is Safe & Immunogenic
ww BVX-006 RESULTS: M-001 Is SAFE & IMMUNOGENIC All Adverse Events (AEs) are Mild, Comparable in Experimental & Control Possibly/related Mild AEs (# participants) M-001 Provides Safety Net to Mu H1N1: A/Brisbane/59/07 A/Texas/50/12 A/Switzerland/9715293/13 _B/Brisbane/60/08 *ps0.05 (H3N2 Vaccine str
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