The Universal Flu Vaccine Multi-Season Multi-Strain Flu Vaccine C ORPORATE P RESENTATION J ANUARY 2018
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 vaccine; 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; the adequacy of available cash resource and the ability to raise capital when needed; 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 Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC ’ s website, www.sec.gov, and in the Company ’ s periodic filings with the SEC. 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 B IOND V AX ’ S 2017 H IGHLIGHTS “… We now have the resources to launch our Phase 3 program towards commercialization. ” 1 Israeli government support mid-size commercial facility 2 – March 30 Ministry of Economy granted 20% of a NIS 20m budget towards construction € 20 million non-dilutive funding 3 – June 19 The European Investment Bank (EIB) signed an agreement to support commercial scale production and Phase 3 BiondVax successfully meets Phase 2b clinical trial endpoints 4 – July 20 M-001 showed statistically significant elevated T-cell immune responses, good safety profile and well-tolerated $10 million secondary offering 5 – September 18 Following the placement, BiondVax has 3 large strategic investors, each holding 5% to 20% European Medicines Agency (EMA) Allows Phase 3 Trial Plan 6 – December 27 EMA Scientific Advice accepts the placebo controlled trial design, facilitating procedures towards Phase 3 1. http://www.biondvax.com/2017/06/biondvaxs-ceo-provides-first-half-2017-general-corporate-update/ 2. http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/ 3. http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/ 4. http://www.biondvax.com/2017/07/biondvax-reports-positive-phase-2b-clinical-trial-results-for-its-universal-flu-vaccine/ 5. http://www.biondvax.com/2017/09/biondvax-announces-closing-of-10-million-public-offering-of-american-depositary-shares-and-exercise-of-over-allotment-option/ 6. http://www.biondvax.com/2017/12/biondvax-plans-phase-3-clinical-trial-following-receipt-of-scientific-advice-from-the-european-medicines-agency-ema/
4 “… need to strive toward a ‘ universal ’ influenza vaccine that will protect against seasonal influenza drift variants as well as potential pandemic strains …” Anthony Fauci, NIAID Director NEJM 29 November 2017 . DOI 10.1056/NEJMp1714916
Flu infects up to 20% of the population each year … and kills
6 A S EASONAL P ROBLEM … A P ANDEMIC T HREAT The Flu Virus: Frequent and Unpredictable Mutations 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 • Worldwide annual death toll of 291,000- 100M deaths 5 646,000 4 ; Flu & pneumonia are 8 th leading cause • The 1918 Spanish Flu cost to global GDP 6 was 4.8% of death 3 in the US or over $3T in today ’ s dollars • $87B economic burden 5 in the US of which $56B is in the elderly “ I rate the chances of a widespread epidemic in my lifetime at well over 50% ” – Bill Gates 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 CDC, https://www.cdc.gov/media/releases/2017/p1213-flu-death-estimate.html [13 Dec. 2017]; 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 C URRENT V ACCINE F ALLS S HORT : T HE M ISMATCH Seasonal Flu Vaccine Effectiveness (VE) 1 , flu seasons 2004-2017 CDC data 2004-05 10% Average 2005-06 21% 40% VE in 2006-07 52% general 2007-08 37% population 2008-09 41% 2009-10 56% Why current solutions fall short … 2010-11 60% • Past strains selection Mismatch 2011-12 47% phenomenon 2012-13 49% • Previous season ’ s vaccine will not necessarily 2013-14 52% As low as protect against next season ’ s flu strains 2014-15 19% 9% VE • 4-6 month production lag 2015-16 48% in elderly 2 2016-17 39% 1 Center for Disease Control: http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm [Retrieved 4.Jan.2018] 2 World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf
8 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 as low as 9% for elderly 1 • 86% of adults 65+ have chronic conditions 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/flu-you/flu-facts/ 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
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