Scinai Immunotherapeutics Ltd. · NASDAQ:SCNI
Scinai Immunotherapeutics — BiondVax Pharmaceuticals — Investor Presentation (June 2015)
25 slides from Scinai Immunotherapeutics's investor presentation, Jun 29, 2015
Slide 1: The Universal Flu Vaccine – Corporate Presentation
THE,UNIVERSAL FLU VACCINE Biond Vax Pharmaceuticals Ltd. CORPORATE PRESENTATION Juty 2015 CONTACT INFORMATION: info@biondvax.com www.biondvax.com
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT Thispresentation is nota prospectusor offer of securities for subscription or salein any jurisdiction. All statements in this communication, other than those relating to historical fact, are “forwardooking statements" within the meaning of the United States Private Litigation R
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS * The Flu and significant limitations of current flu vaccines * BiondVax Universal Flu Vaccine - One vaccine for any and every flu * Advanced clinical stage - Progressing toward Phase 3 + Addressing a multi billion dollar market * First mover advantage and best in class potenti
Slide 4: Flu infects up to 20% of the population each year
infects up to 20% + of the Vw population & each’ year i Wwe »
Slide 5: The Washington Post
The Washington Post “sp Dog flu now in 12 states Mp, May 22, 2015 ho The New ork Cimes AVIAN FLU food ConpaniceFear Bid Tia Nay Cause Egg Shortages DEATH THRE AT Mail Online race to avert a pandemic Monday, Januar | Girl, five, dies from a strain Z of the flu she was E { vaccinated against Interview
Slide 6: A Seasonal Problem... A Pandemic Threat
A SEASONAL PROBLEM... A PANDEMIC THREAT lu Virus: Unpredictable, Fast Mutati SEASONAL FLU PANDEMIC FLU * Per year: 23,000 deaths! (21,000 elderly) * When?... Where?... Which?... pandemicstrain & 200,000 hospitalizations? in just the US * Pandemic strain: a new to Humans + 8" jeading cause of death?(
Slide 7: Current Vaccines Fall Short: The Mismatch
CURRENT VACCINE FALL SHORT: THE MISMATCH Seasonal Flu Vaccine Effectiveness (VE) CDC data , flu seasons 2004-2015 &only Why current solutions fall short... 9% VE Next year’s seasonal flu vaccineis an educated guess: in the mismatch phenomenon Elderly? A particular seasons’ vaccine will not necessari
Slide 8: Meeting Its Milestones
MEETING ITS MILESTONES Solid Science, Advance Clinical Stage, Strong IP INGTON BiondVax Toda Beale | Reainolsevaenieoel Tune 2007 May 2015 by Prof. Ruth Arnon TASE:BVXV_ Nasdaq: BVXV t a BiondVax Operational + EndotPhase2 Meetie withthe FDA prorto phase
Slide 9: BiondVax's: Thinking Outside the Box
BIONDVAX’S: THINKING OUTSIDE THE BOX The Influenza Virus vaccines Universal Flu Vaccine : Universal: Broad coverage Strain specific Acommon denominator for e Seasonal & Pandemic strains Single formulation covering all flu. New vaccine every strains & year-round vaccination year € 2 ‘Quick, robust ye
Slide 10: M-001: Enhances Seasonal & Pandemic Vaccines
4 M-001: ENHANCES SEASONAL & PANDEMIC VACCINES Human Trials Mouse Model Human Trial BVXO0S Avian HSN1 2012, age 65+ Clade 1 50) TW MMOL once +I 100 2 wo, + 8 se seroconversion ‘6 seroconversion (HAI) 8 HINT Swine “NO Human Trial BVX003 2009, age 55-75 80) OTN mt vice Moon + ‘seroconversion ‘6 seroco
Slide 11: M-001: Standalone Cell-Mediated Efficacy
M-001: STANDALONE CELL-MEDIATED EFFICACY Proliferation to M-001 (equivalent to HAI to TIV) Specific Immunity to Multiple Flu Strains Young aduts -vx002 ler adults ~vxo02 Sear qq 27 Non-adjuvanted * 2000 Non adjuvanted 4. E sw0 ] os =m i>! pa = seo | ape ex pt 5 atl ies We fee WBE fae Uses Aerts? et
Slide 12: 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 * Enhancedimmunity by elevated dose * Results: M-001 was Safe & Immunogenic Treatment N (50-65) Day 0, 21, 42 Day 63 1 M-001 0.5mg x3 TIV 12 M-001 1
Slide 13: BVX-006 Results: M-001 Is Safe & Immunogenic
BVX-006 REsuLTS: M-001 Is SAFE & IMMUNOGENIC All Adverse Events are M Comparable in Experimental & Control le Flu Strains 1 Provides Safety Net to Mul H1N1: A/Brisbane/59/07_ H3N2: A/Texas/50/12 _A/Switzerland/9715293/13 _B/Brisbane/60/08 ‘ baseline! a postinamun (Drifted strain) P 3s x is ~ Y 2 5 7
Slide 14: Five Successful Clinical Trials
Its to Elderly FIVE SUCCESSFUL CLINICAL TRIALS 01: Safe and Immunogenic in Young A * No treatment-related Severe Adverse Events * Most adverse events were mild * All adverse events observed were transient * Both Cellular & Humoral immunity were induced | 1/2 BVK-002 2009 Younger Adults (18-49) Compl
Slide 15: Clear Regulatory & Go-To-Market Strategy
CLEAR REGULATORY & GO-TO-MARKET STRATEGY One Vaccine — Multiple Indicati P Primervaccine | Pandemic primer for ‘Seasonal primer Independent universal national stockpile || forthe elderly vaccine for multiple strain ‘ —_—4 a 4 =? + Leverage existing marker + Clinical efficacy: + Smaller clinical rial
Slide 16: Pandemic Preparedness Plan (PPP)
PANDEMIC PREPAREDNESS PLAN (PPP) Pandemic Declaration Today's situation: y 3 [4 8 | 9 | months. ime = Saving lives “ NS BiondVax‘s PPP: + inttuera (HSN VaccineStocepleandlnter Pandemic Vaccnetse| WH) ‘who in/immunzation/sage/mestngs/2013/november/SAGE_WG, Hovacine. backround paps 160c12013_v4.pat
Slide 17: The Elderly – At Risk and In Need
THE ELDERLY — AT RISK AND IN NEED occurs in elderly + Seasonal vaccine effectiveness is only 9% for elderly ‘elderly 65+ suffer chronic illnesses Influenza worsens outcomes of chronicillness : at $56B per year t earnings), CDC: “How effective is the flu vaccine in the elderly? Older people with weak
Slide 18: BiondVax: First-in-Class, Best-in-Class
BIONDVAX: FIRST-IN-CLASS, BEST-IN-CLASS Phase Player Technology Strength Pre- clinical Progress reported BiondVax) $$$ sre wcemosirns Sythetie protein 8: &T-cell peptides (HA Mt, NP) ‘Teal peptides (PA, PBI, PB2, NP, Mi) ‘Broad coverage ‘No. human clinical trials ‘No. & Young to elderly Step-wise st
Slide 19: Summary Financial Data
SUMMARY FINANCIAL DATA Financial Data Highlights Successful IPO on Nasdaq in May 2015: $10M Gross TEL-AVIV STOCK EXCHANGE IFRS; calendar year basis Laan structure: Me Sraplayees Company’s ordinary shares trade under ticker: ADS / share ratio 1:40 : 3.3M outstanding ADS’ BVXV (5.9M fully diluted) Bal
Slide 20: Peer Companies
PEER COMPANIES Nasdaq: NVAX i + MCap “$2.48 based on its VLP production platform NOVAVAX for RSV vaccine and seasonal influenza (Ph2) Biond Vax Pharmaceuticals Ltd. . . NYSE:INO ® ) + Mcap “$600M based on its DNA vaccine ere INOVIO technology for HPV vaccine (Ph2) and influenza Multiple indications/
Slide 21: Flu Vaccines – A Large and Growing Market
FLU VACCINES — A LARGE AND GROWING MARKET Seasonal Flu © Worldwide: $3.28 global market in 2013; expected to grow to $5.38 by 2021. sgh © US: $1.48 in 2012 growing to $2.68 by 2022? Boxter’ Fu voecine unit sanofi pasteur © “140M doses in just the US? Forecasted CAGR of 5.7%? Pandemic Flu © Swine Flu
Slide 22: Conclusion
CONCLUSION Significant limitations of current flu vaccines — Real unmet need BiondVax Universal Flu Vaccine - One vaccine for any and every flu Advanced clinical stage - Progressing toward phase 3 Strong market opportunity - Addressing multi-billion dollar market Best in class potential - First move
Slide 23: Thank You
BiondVax) Pharmaceuticals Ltd. A GAME CHANGER FOR INFLUENZA THANK You BIONDVAX INVESTOR RELATIONS: biondvax@gkir.com 1646 291 9246
Slide 24: Management
MANAGEMENT Founder, cso cro coo Director of BD President & CEO + Degree from Universityof + Conventorof theuniversal + Degree from College of + Degree fromUniversityot Degree from Weizmann Liege (uLs) fu vaccine Administration Maryland Bitechnology Institute of Science + Master ingntrepreneurship &
Slide 25: 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
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