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Flu infects up to 20% of the population each year and kills 4 - PowerPoint PPT Presentation

Dec 15, 2023 •118 likes •373 views

1 T HE U NIVERSAL F LU V ACCINE C ORPORATE P RESENTATION A UGUST 2016 2 S AFE H ARBOR S TATEMENT This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction. All statements in this communication,

  1. 1 T HE U NIVERSAL F LU V ACCINE C ORPORATE P RESENTATION A UGUST 2016

  2. 2 S AFE H ARBOR S TATEMENT 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 1995.You can identify forward-looking statements by terms including ‘‘anticipates,’’ ‘‘believes,’’ ‘‘could,’’ ‘‘estimates,’’ ‘‘expects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘plans,’’ ‘‘potential,’’ ‘‘predicts,’’ ‘‘projects,’’ ‘‘should,’’ ‘‘will,’’ ‘‘would,’’ and similar expressions intended to identify forward-looking statements. These forward- looking statements relate to our business and financial performance and condition, as well as our plans, strategies, objectives and expectations for our business, operations and financial performance and condition. However, these forward-looking statements are not guarantees of future performance and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results to differ materially from our expectations include, among others: the risk that drug development involves a lengthy and expensive process with uncertain outcome; BiondVax's ability to successfully develop and commercialize its pharmaceutical product; the length, progress and results of any clinical trials; the introduction of competing products; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals to commercialize BiondVax's products; the difficulty in evaluating business prospects; lack of sufficient funding to finance the clinical trials; termination of license agreement with Yeda which is the owner of certain patents, patent applications and other intellectual property, as a result of dispute that can arise with Yeda or the failure of BiondVax to comply with financial and other terms of the license; the difficulty of predicting actions of the U.S.A FDA; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; changes in the global pharmaceutical industry; changes in customers’ budgeting priorities; European Medicines Agency and other regulatory authority approvals; natural disasters; labor disputes; rising interest rates; general market, political or economic conditions in the countries in which we operate; pension and health insurance liabilities; volatility or crises In the financial market; arbitration, litigation and regulatory proceedings; and war or acts of terror; Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. You should not unduly rely on any forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus which was declared effective on May 11, 2015. Readers are urged to carefully review and consider the various disclosures made in the Company’s SEC reports, which are designed to advise interested parties of the risks and factors that may affect its business, financial condition, results of operations and prospects. These forward-looking statements speak only as of the date of this presentation, and we assume no obligation to update or revise these forward-looking statements for any reason. whether as a result of new information, future events or otherwise, except as required by law. One • For All : The Universal Flu Vaccine

  3. Flu infects up to 20% of the population each year … and kills

  4. 4 A S EASONAL P ROBLEM … A P ANDEMIC T HREAT The Flu Virus: Unpredictable, Fast Mutating S EASONAL F LU P ANDEMIC F LU • When?… Where?... Which?… pandemic strain • Per year: 23,000 deaths 1 (21,000 elderly) & • Pandemic strain: a new to Humans 200,000 hospitalizations 2 in just the US • Past century: 4 major pandemics with over • 8 th leading cause of death 3 (US), Worldwide death 100M deaths 5 toll of 250,000-500,000 annually 4 • The 1918 Spanish Flu cost to global GDP 6 was 4.8% • $87B economic burden 5 in the US of which $56B or over $3T in today’s dollars is in the elderly Bill Gates interviewed by Ezra Klein on VOX “I rate the chances of a widespread epidemic in my lifetime at well over 50 %” https://youtu.be/9AEMKudv5p0 1 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5933a1.htm#tab2; 2 http://www.cdc.gov/flu/about/qa/disease.htm; 3 http://www.cdc.gov/nchs/fastats/deaths.htm; 4 http://www.who.int/mediacentre/factsheets/fs211/en / 5 Molinari et. al, The annual impact of seasonal influenza in the US, Vaccine 25 (2007) 5086 – 5096; 6 1918 Influenza: the Mother of All Pandemics, Volume 12, Number 1 — January 2006, CDC; 7 World Bank 2014:Pandemic Risk

  5. 5 C URRENT V ACCINE F ALLS S HORT : T HE M ISMATCH Seasonal Flu Vaccine Effectiveness (VE) 1 , flu seasons 2004-2016 CDC data 2004-05 10% Average 2005-06 21% 40% VE in 2006-07 52% general 2007-08 37% population 2008-09 56% Why current solutions fall short… 2010-11 60% • Past strains selection  Mismatch 2011-12 47% phenomenon As low as 2012-13 49% • Previous season’s vaccine will not necessarily 9% VE 2013-14 51% protect against next season’s flu strains in elderly 2 2014-15 23% • 4-6 month production lag 2015-16 47% 1 Center for Disease Control: http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm 2 World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf

  6. 6 T HE E LDERLY – A T R ISK AND I N N EED • ~90% of seasonal flu related death occurs in elderly • Seasonal vaccine effectiveness is only 9% for elderly 1 • ~80% of elderly 65+ suffer chronic illnesses 2 • Influenza worsens outcomes of chronic illness Elderly flu cost in US estimated 3 at $56B per year • (hospitalization, mortality, lost earnings) NIH: “ During the period from 1989 to 1997 the vaccination rate for elderly persons ≥ 65 years of age in the US increased from 30 to 67% . Despite this increase in coverage, mortality and hospitalization rates continued to increase rather than decline as would be expected ... ” International Journal of Epidemiology 4 (Vol. 35, Issue 2, P352-353) 1 World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf 2 https://www.ncoa.org/healthy-aging/chronic-disease/ 3 Molinari et. al, The annual impact of seasonal influenza in the US, Vaccine 25 (2007) 5086 – 5096 4 http://ije.oxfordjournals.org/content/35/2/352.short

  7. 7 M EETING M ILESTONES & C ATALYSTS Solid Science, Advanced Clinical Stage, Strong IP EU Phase 2b results June 2007 May 2015 USA NIH Phase 2 TASE:BVXV Nasdaq: BVXV USA CMO Phase 3 material Technology developed by Prof. Ruth Arnon 2005 2008 2010 2016 2017/18 1 st of two Phase 1 st of three FDA EOP2M 1 Mid 90 ’s 1/2 (IL) Phase 2 (IL) accepts Phase 3 ready IND BiondVax Operational The Vaccine is Safe and Immunogenic • 479 young adult to elderly have participated in clinical trials Well known for the development of • The vaccine was shown to be safe and immunogenic in all studies 1 End of Phase 2 Meeting with the FDA prior to phase 3 One • For All : The Universal Flu Vaccine

  8. 8 T HINKING O UTSIDE THE B OX Target Common Regions The Influenza Virus Nine common regions (epitopes) of flu strains are connected to make one recombinant protein called M-001 produced in E.coli BiondVax’s Key Advantages BiondVax’s M -001 Existing vaccines Universal Flu Vaccine Universal: Broad coverage Strain specific A common denominator for H em A gglutinin (HA) Seasonal & Pandemic strains Single formulation covering all flu New vaccine every strains & year-round vaccination year N ucleo P rotein (NP) M atrix protein (M 1 ) Quick, robust year-round production Long (4-6 month) (6-8 weeks) production cycle Activates both arms of the immune Limited effect system , enhances existing vaccines Non allergenic Hen egg allergy One • For All : The Universal Flu Vaccine

  9. 9 P ROTECTING THE F UTURE Significant Protective Response to a Future Strain In 2011 we administered M-001 to seniors 65+ 70 * (BVX005) 60 % Seroprotection 50 4 years later, 5 times 40 more seniors were 30 seroprotected from a 20 new epidemic strain 10 * p≤ 0.05 (A/Swiss) that didn’t 0 exist in 2011! TIV 2011/12 M-001 & TIV 2011/12 One • For All : The Universal Flu Vaccine

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