2
SAFE HARBOR STATEMENT
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, 2019 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
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BIONDVAX ON THE RADAR
More News: http://www.biondvax.com/press-releases/in-the-news/
One • For All : The Universal Flu Vaccine
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A SEASONAL PROBLEM… A PANDEMIC THREAT
The Flu: A Serious Public Health Challenge
SEASONAL FLU - DESPITE ANNUAL VACCINE PRODUCTION (500 MILLION DOSES1)
Flu cases: | Severe illness: | Deaths: |
up to 20%2 | ||
3 - 5 million3 | 650,0003 | |
or 1.5 billion | ||
- At-riskSeniors: 89% of deaths & most hospitalizations4
- High economic burden: Over $361B in the USA4
- USA: Up to 80,000 deaths and 900,000 hospitalizations5
PANDEMIC FLU
- New pandemic strain: When?… Where?... Which?
- Higher morbidity & mortality worldwide
- Estimated cost in US $413B to $3.79T4
1 WHO: http://www.who.int/influenza_vaccines_plan/objectives/objective2/en/ and https://en.wikipedia.org/wiki/Influenza_vaccine#Uptake; 2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5596521/;
3 WHO: http://www.who.int/news-room/detail/14-12-2017-up-to-650-000-people-die-of-respiratory-diseases-linked-to-seasonal-flu-each-year (varies annually); 4 White House Council of Economic Advisors (CEA), Mitigating the Impact of Pandemic Influenza through Vaccine Innovation, September 2019.; 5CDC: www.cdc.gov/flu/about/disease/burden.htm and https://www.nytimes.com/2018/10/01/health/flu- deaths-vaccine.html
5
CURRENT VACCINE FALLS SHORT: THE MISMATCH
The Flu Virus: Frequent and Unpredictable Mutations
Why current solutions fall short…
- Past strains selection → Mismatch phenomenon
- Previous season's vaccine will not necessarily protect against next season's flu strains
- 4-6month production lag
Seasonal Flu Vaccine Effectiveness1
Average 40%, Elderly as low as 9%2
2004-05 | 10% | |
2005-06 | 21% | |
2006-07 | 52% | |
2007-08 | 37% | |
2008-09 | 41% | |
2009-10 | 56% | |
2010-11 | 60% | |
2011-12 | 47% | |
2012-13 | 49% | |
2013-14 | 52% | |
2014-15 | 19% | 100% |
2015-16 | 48% | Protection |
2016-17 | 40% | |
2017-18 | 38% | |
2018-19 | 29% | |
Measles, Rubella, Diphtheria, Tetanus, etc. 95%-99%
- VE data: CDC, including https://www.cdc.gov/flu/vaccines-work/effectiveness-studies.htm [Retrieved 29 October 2019]
- World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf
6
THE ELDERLY - AT RISK AND IN NEED
- ~80% of seasonal flu related death occurs in elderly1
- Seasonal vaccine effectiveness as low as 9% for elderly2
- 80% of older adults have at least one chronic condition3
- Influenza worsens outcomes of chronic illness
- Elderly flu cost in US estimated4 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 Epidemiology5 (Vol. 35, Issue 2, P352-353)
- Vaccine journal: www.sciencedirect.com/science/article/pii/S0264410X15002315, Table 3; 2 WHO: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf
- https://www.ncoa.org/healthy-aging/chronic-disease/;4 Molinari et. al, The annual impact of seasonal influenza in the US, Vaccine 25 (2007) 5086-5096;5 https://academic.oup.com/ije/article/35/2/352/694736;
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MEETING MILESTONES & CATALYSTS
Solid Science, Phase 3 Clinical Stage, Strong IP
Ongoing Pivotal Clinical | |||||||
Technology developed | Efficacy Phase 3 trial | ||||||
TASE June 2007 | Nasdaq: BVXV | Commercial | |||||
by Prof. Ruth Arnon | (Europe) | ||||||
Head BiondVax's SAB | Delisted 2018 | 2015 | pilot facility | ||||
2005
Mid 90's | 2020 | |||||
BiondVax | 7 Successful Clinical Trials | |||||
operational | • | Two Phase 1/2 & Five Phase 2 | ||||
• | Israel, Europe, USA (NIH) | . | ||||
- FDA IND / EMA SA
Co-Inventor of | • 818 young adult to elderly participants |
• M-001 shown to be safe and | |
immunogenic in all studies |
One • For All : The Universal Flu Vaccine
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M-001:A COMMON DENOMINATOR OF FLU VIRUSES
) | PucleoNrotein(NP) | AemHgglutinin(HA) |
proteinatrixM (M | ||
1 |
Now in prefilled syringes
Target Common Regions: Nine common flu regions (epitopes) connected to make one recombinant protein (M-001) produced in E.coli
BiondVax's M-001 Key Advantages | Existing vaccines |
Universal: Broad coverage types A&B | Strain specific |
Single formulation enabling | New vaccine every |
year-round vaccination | year |
Quick, robust year-round production | Long (4-6 month) |
through E.coli fermentation (6-8 weeks) | production cycle |
Induces cellular (CMI) and enhances | Limited vaccine |
humoral (HAI priming effect) immune | |
effectiveness | |
response to flu | |
Shelf life up to 24 months at 2-8⁰C | Not applicable, since |
(testing is ongoing) and 6 months at ~25⁰C | new vaccine every |
(room temperature) | season |
One • For All : The Universal Flu Vaccine
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M-001:THE UNIVERSAL FLU VACCINE
M-001's dual mode of action potentially offers multi-season and multi-strain protection
- 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
Our immune system has 2 arms:
Cellular (CMI) | Humoral (HAI) | ||||
Works inside infected cells | BiondVax's M-001 | Works outside cells | |||
T-cell | Dual Mode of Action | B-cell | |||
Directly | T-cell | ||||
induces | priming | ||||
e.g. T-Helper, CD4, CD8 | T-Cells | effect | Produce | ||
enhances | |||||
Produce anti-viral | Antibodies | ||||
B-Cell | |||||
cytokines such as | |||||
responses | |||||
IL-2 | IFN-g | ||||
Current vaccines mainly induce only flu strain-specific antibodies
One • For All : The Universal Flu Vaccine
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ADVANCED CLINICAL DEVELOPMENT
M-001: Safe and Immunogenic in Young Adults to Elderly
• No treatment-related severe adverse events | |||||||
Group | Day 0 | Day 21 | Day 42 | ||||
• Adverse events were mild to moderate | |||||||
Treatment | M-001 | M-001 | Seasonal or Pandemic HA | ||||
• All adverse events observed were transient | |||||||
Control | Saline | Saline | vaccine to all participants | ||||
• Immunity: Cellular induced, humoral enhanced | Baseline | CMI | HAI | ||||
Phase | Trial | Year | Population (age) | Total | Results | ||
Participants | |||||||
1/2 | BVX-002 | 2009 | Younger Adults (18-49) | 63 | |||
1/2 | BVX-003 | 2010 | Older Adults (55-75) | 60 | M-001 was well tolerated and a cellular | ||
2 | BVX-004 | 2011 | Younger Adults (18-49) | 200 | (CMI) and humoral (priming effect) | ||
2 | BVX-005 | 2012 | Elderly (65+) | 120 | immune response was observed | ||
2 | BVX-006 | 2015 | Older Adults (50-65) | 36 | |||
2b | BVX-007a | 2015-16 | EU Adults (18-60) | 219 | |||
2 | BVX-008b | 2018 | USA Adults (18-49) | 120 | Safe and significant T cell responses | ||
818 | |||||||
3 | BVX-010 | 2018 | E. European Adults (50+) | 12,463 | Results expected by end of Oct. 2020 |
- BVX-007was conducted in collaboration with the EU's UNISEC consortium.
b BVX-008 conducted and led by NIAID/NIH. Clinical study report submitted June 2020.
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M-001:INDUCES CELL MEDIATED IMMUNITY (CMI)
Direct Evidence: CD8, CD4 T-cell Activated Cells Produce TH1 Cytokines (IFN-gamma,IL-2 & TNF-alpha)
BVX0051: CD4 & IFN-gamma in Elderly
SE)+ | 0.3 | M-001 twice Day 0 | ** | |||||||||||||||||||||||||||||||||||||||||||||
0.25 | * | * | ||||||||||||||||||||||||||||||||||||||||||||||
M-001 twice Day 42 | ||||||||||||||||||||||||||||||||||||||||||||||||
(Mean | 0.2 | |||||||||||||||||||||||||||||||||||||||||||||||
cells | 0.15 | * | * | |||||||||||||||||||||||||||||||||||||||||||||
0.1 | ||||||||||||||||||||||||||||||||||||||||||||||||
positive% | ||||||||||||||||||||||||||||||||||||||||||||||||
0 | ||||||||||||||||||||||||||||||||||||||||||||||||
0.05 | ||||||||||||||||||||||||||||||||||||||||||||||||
A/Brisbane/10/07 A/California/7/09 | A/Perth/16/09 B/Brisbane/60/08 Flumist 2011 | |||||||||||||||||||||||||||||||||||||||||||||||
H3N2 | H1N1 | H3N2 |
% positive cells (Mean + SE)
BVX0051: CD8 & IFN-gamma in Elderly
0.3 | * | M-001 twice Day 0 | * | ||||||||||||||||||||||||||||||||||||||||||||||
M-001 twice Day 42 | |||||||||||||||||||||||||||||||||||||||||||||||||
0.25 | |||||||||||||||||||||||||||||||||||||||||||||||||
0.2 | |||||||||||||||||||||||||||||||||||||||||||||||||
0.15 | |||||||||||||||||||||||||||||||||||||||||||||||||
0.1 | * P<0.05 | ||||||||||||||||||||||||||||||||||||||||||||||||
0.05 | |||||||||||||||||||||||||||||||||||||||||||||||||
**P<0.07 | |||||||||||||||||||||||||||||||||||||||||||||||||
0 | |||||||||||||||||||||||||||||||||||||||||||||||||
A/Brisbane/10/07 | A/California/7/09 | A/Perth/16/09 B/Brisbane/60/08 | Flumist | ||||||||||||||||||||||||||||||||||||||||||||||
H3N2 | H1N1 | H3N2 |
UNISEC (EU): Statistically significant anti viral cytokines NIAID/NIH: "M-001 induced significant polyfunctional T cell responses"
placebooverchangeFold | 10 | * P<0.05 | SubsetsCellTCD4+%Mean MarkersExpressing | 0.015 | |||||||||||||||||||||||||||||||||||||||||||||
0 | 0 | ||||||||||||||||||||||||||||||||||||||||||||||||
8 | 6.8* | 5.3* | 0.01 | Placebo | M-001 | ||||||||||||||||||||||||||||||||||||||||||||
6 | 3.8 | 4.7 | |||||||||||||||||||||||||||||||||||||||||||||||
4 | 0.005 | ||||||||||||||||||||||||||||||||||||||||||||||||
2 | 0.4* | -0.2 | |||||||||||||||||||||||||||||||||||||||||||||||
M-001: | 1mg 0.5mg | 1mg | 0.5mg | 1mg 0.5mg | Baseline | Day 36 | |||||||||||||||||||||||||||||||||||||||||||
IFN-gamma | IL-2 | TNF-alpha | IL-2 + TNF-alpha + IFN-gamma | ||||||||||||||||||||||||||||||||||||||||||||||
Sources:
- BVX005: Jacob Atsmon 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
- NIAID/NIH-supportedPhase 2 BVX008 clinical trial: https://clinicaltrials.gov/ct2/show/results/NCT03058692 & Clinical Study Report
* P<0.001
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M-001:ENHANCES HUMORAL IMMUNITY (HAI)
Indirect Evidence: Extending T-Cell Priming Effect for Enhanced HAI Responses to Current Flu Vaccines
BVX0051: 2011/12, age 65+ YO
70 | * | |||||||||||
Seroconversion | 60 | TIV | Twice M-001 + TIV | |||||||||
50 | ||||||||||||
40 | ||||||||||||
30 | ||||||||||||
20 |
"M-001 can provide broadened enhanced immunity extending even to influenza strains destined to circulate in future years." - Vaccine 2
% | 10 |
0 |
A/California/7/09 A/Perth/16/09 B/Brisbane/60/08
H1N1 pandemic swine flu
BVX003: 2009, age 55-75 YO
80 | TIV | Twice M-001 + TIV | |||||||||||||
seroconversion | 70 | ||||||||||||||
60 | |||||||||||||||
50 | |||||||||||||||
40 | |||||||||||||||
30 | |||||||||||||||
20 | |||||||||||||||
% | |||||||||||||||
10 | |||||||||||||||
0 | |||||||||||||||
In 2011 we
administered M-001 to seniors 65+ (BVX005)
4 years later, 5 times more seniors were seroprotected from a new epidemic strain (A/Swiss) that didn't exist in 2011!
70 | ||
* | ||
(HAI) | 60 | |
50 | ||
% Seroprotection | 40 | |
30 | ||
20 | ||
10 | ||
0 | ||
TIV 2011/12 | M-001 & TIV 2011/12 |
A/Brisbane/59/07 | A/Brisbane/10/07 | B/Brisbane/60/08 |
* P<0.05
- Jacob Atsmon 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 influenza vaccine in 2011/12 enhanced protective immune responses against 2014/15 epidemic strain. Vaccine (2017)
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PIVOTAL CLINICAL EFFICACY PHASE 3 TRIAL (EUROPE)
- pivotal, multicenter, randomized, modified double-blind,placebo-controlled phase 3 trial to assess the safety and clinical efficacy of M-001, an influenza vaccine, administered intramuscularly
twice in older adults and the elderly (≥50 years of age)
Trial Design: | Cohort 1 (4,042 enrolled & randomized Aug-Oct 2018) | |||
Flexible | Cohort 2 (8,421 enrolled & randomized July-Nov 2019) | |||
enrollment | ||||
Day 1 | Day 21 | Day 202 | ~12,400 participants | |
Age 50+ (half 65+) | ||||
Experimental | 1mg M-001 | 1mg M-001 | ||
Safety, RT-PCR or | ||||
Two flu seasons | ||||
culture on any ILI | ||||
Control | Placebo | Placebo | (during flu season) | Results by end of |
October 2020 | ||||
- ILI symptoms active surveillance throughout both flu seasons
- Primary endpoints: Safety & clinical efficacy by reduction of illness rate
- Secondary endpoint: Reduced severity of influenza illness
Professor Shai Ashkenazi, MD
BiondVax's Medical Director
- Dean of Medicine, Ariel University
- Former Director of Pediatrics at Schneider Children's Medical Center of Israel
- Former Lea and Arieh Pickel Chair for Pediatric Research, Sackler Faculty of Medicine
- Experienced clinician-researcher; guided vaccines through clinical and regulatory approval to market
One • For All : The Universal Flu Vaccine
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BIONDVAX'S NEW MANUFACTURING FACILITY
From Lab to Pilot Mid-Size Commercial Scale Facility
- Funding: EIB, BiondVax, and Israel's Ministry of Economy & Industry
- Target annual capacity: Up to between 10 and 20 million doses in bulk
- Goal: Year-round GMP production & stockpile per market demand
Jerusalem BioPark
Hadassah Ein Kerem Campus
Jerusalem, Israel
One • For All : The Universal Flu Vaccine
15 | |||||
BIONDVAX: FIRST-IN-CLASS, BEST-IN-CLASS | |||||
Phase | |||||
Player | Technology | Pre- | I | II | Status |
clinical | III | ||||
BiondVax | M-001: Synthetic protein B- & T-cell peptides (HA, M1, | Statistically significant European Ph2b trial UNISEC | |||
consortium. NIAID/NIH sponsored ongoing collaboration | |||||
NP). Broad coverage, 6 completed clinical trials in adults | N=13,281 | ||||
Phase 2 in USA. | |||||
18 to 65+ | |||||
Ongoing pivotal, clinical efficacy Phase 3 trial (Europe). | |||||
Imutex + | FLU-V: 4 T-cell peptides adjuvanted formulation | 2016: Seek created Imutex with hVIVO | |||
N=408 | 2020: hVIVO acquired by Open Orphan (AIM: ORPH) | ||||
Challenge and immunogenicity trials | |||||
Phase 2 trials (field, challenge) positive results | |||||
M2SR (RedeeFlu): Single replication virus; Broadening | Phase 2 challenge, intranasal, 2019 interim results | ||||
immunogenicity to flu sub type H3N2. | N=389 | 'serum antibody response.' Equity funding $27m, | |||
First in human results reported 2018. Immunogenic in | including $5.5m Aug 2017; $27m gov't grants. | ||||
mice | NIAID sponsored Phase 1, began 2019. | ||||
2019: Phase 1 CD8 T Cell response. Phase 2a results | |||||
OXV836: Recombinant poly-Arg NP (H1 strain) in VLP, | N=372 | expected 2021. Raised total €14.3m + up to €32.6m | |||
produced in E.coli. CD8 T-cell activation | grants and equity (also towards corona vaccine | ||||
candidate, 2020). | |||||
Phase 1 interim results (2019), elicited cross reactive | |||||
Chimeric H1 targeting stalk of group 1 (H1,H2,H5) | N=108 | anti-stalk serum IgG antibodies. NIAID-sponsored Phase | |||
1 in children. | |||||
H1ssF_3928: H1 HA stem + ferritin nanoparticle. | N=70 | Phase 1 began 2019, results expected 2020. | |||
NIH infrastructure | |||||
Academic labs | Stem-only immunogens based on rational design; DNA | ||||
and RNA vaccines. Heterosubtypic protection in mice, | Results in animals. | ||||
ferrets, primates |
One • For All : The Universal Flu Vaccine
Based on publicly available information. Last updated February - July 2020
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SUMMARY FINANCIAL DATA
- Lean structure with 25 employees. Manufacturing scale-up and operating burn ~$700K/month
- Fully funded through end of ongoing Phase 3 clinical trial:
- €24M EIB non-dilutiveco-funding agreement1
- Rights offering July 2019, $20M gross proceeds2
- Secondary offering Sept 2017, $10M gross proceeds
- Government of Israel support from Ministry of
Economy and Industry's Israel Investment Center, and royalty-based grants from the Israel Innovation Authority (formerly Office of the Chief Scientist)
American Depository Shares ticker:
BVXV
1 European Investment Bank (EIB) €24M support for M-001 Phase 3 trials and commercial production also includes:
- Milestone based drawdowns received in 2018 and 2019
- Zero-percentfixed interest loan for five years after each of the 4 drawdowns
- Variable remuneration based on royalties of net sales
2 http://www.biondvax.com/2019/07/biondvax-announces-rights-offering-fully-subscribed-at-us20-million/
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FLU VACCINES - A LARGE AND GROWING MARKET
The Big Four Flu Vaccine 2019 Revenue
Flu Vaccine Market
Seasonal Flu
- Worldwide: Up to $5.2B global market in 2018;
$0.69B6 | |
GSK | |
$0.11B9 | 17% |
3% |
Seqirus
29%
$1.20B8
2014/5: CSL bought Novartis' Flu vaccine unit, rebranded to Seqirus
Sanofi
51%
$2.12B7
2017: Acquired Protein Sciences for $750M
expected to grow to $7.5B by 20241
- USA: $2.6B in 20192; ~174M doses in 2019/2010 o Forecasted CAGR of 6.37%1
Pandemic Flu
- Swine Flu (A/H1N1) 2009 + first half of 2010 sales: $5-6B worldwide by Novartis, GSK and Sanofi (on top of seasonal flu vaccine sales)4
- >1B pandemic vaccines doses ordered in 200911
"The United States has spent approximately $1 billion in these [H5N1 flu vaccine stockpile] efforts to date."5
"…part of our nation's overall pandemic preparedness strategy…stockpile of bulk vaccine…for influenza viruses with pandemic potential to vaccinate 26 million people immediately after a pandemic is declared."12
- https://www.researchandmarkets.com/research/5q8dvw/ (2) https://www.coherentmarketinsights.com/market-insight/us-influenza-vaccines-market-1127(3) https://www.marketwatch.com/press- release/united-states-influenza-vaccine-market-size-global-industry-analysis-segments-top-key-players-drivers-and-trends-to-2022-2019-02-27(4) www.vaczine-analytics.com/ER_January_100128s.pdf(5) http://www.who.int/immunization/sage/meetings/2013/november/SAGE_WG_H5vaccine_background_paper_16Oct2013_v4.pdf (6) https://www.gsk.com/en-gb/investors/corporate-reporting/annual-report-2019#tab-1-4 [At exchange rate 1.28] (7) https://www.sanofi.com/en/media-room/press-releases/2020/2020-02-06-07-30-00 [At exchange rate 1.12] (8) YE June 2019 https://medialib.csl.com/- /media/shared/documents/results/2019-fy-analyst.pdf(9) https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2018/PDF/AstraZeneca_AR_2018.pdf,page 69. Likely less than $0.11B in 2019, was not detailed in AZ FY19 annual report (10) https://www.cdc.gov/flu/prevent/vaccine-supply-distribution.htm(11) https://www.theglobeandmail.com/life/health-and-fitness/health/conditions/how-vaccines-became-big-business/article572731/(12) https://www.phe.gov/ASPRBlog/Lists/Posts/Post.aspx?ID=322
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MANAGEMENT
Ron Babecoff | Tamar | Uri Ben-Or | Elad Mark | Joshua Phillipson |
Ben-Yedidia | ||||
DVM, MEI | CPA, MBA | BSc Engineering, MBA | Hon. BSc, MBA | |
PhD | ||||
Founder, | CSO & Clinical Trial | CFO | COO | Director of Business |
President & CEO | Leader | Development & IR | ||
• DVM (University of Liège) | • Co-inventor of the universal | • BA Business (College of | • BSc. Engineering (Afeka Tel | • Hon. BSc. (University of |
• Master in Entrepreneurship & | flu vaccine | Administration) | Aviv College of Engineering) | Toronto) |
Innovation (ISEMI, Swinburne) | • PhD (Weizmann Institute of | • MBA (Bar Ilan University) | • MBA (Open University of Israel) | • MBA (Ben Gurion University |
• Omrix Biopharmaceuticals Ltd | Science) | • Certified Public Accountant | • Principal bioprocess engineer | of the Negev) |
• Biotechnology General Ltd. | ||||
(Marketing Manager) | (CPA) | • Novartis (Technical Project | • Accenture (Business | |
• Dexcel Pharma (Regional | • Glycominds Ltd. (VP | Manager - Process) | Management Consultant) | |
Export Manager) | Finance) | • BioData Ltd. (Marketing | ||
• Menorah Capital Markets | Manager) | |||
(Comptroller) | ||||
One • For All : The Universal Flu Vaccine
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BOARD OF DIRECTORS
Mr. Mark Germain | Aentib Group (Managing Director), Pluristem (Director). Founder, director, chairman, |
Chairman of the Board | and/or investor in over twenty biotech companies |
Ron Babecoff, DVM, MEI | Omrix Pharmaceuticals Ltd (Marketing Manager), Dexcel Pharma Technologies Ltd. |
Founder, President and CEO | (Formerly Dexxon, Regional Export Manager) |
Mr. Isaac Devash, MBA | Credit Suisse First Boston (Investment Banking), Private equity and venture capital funds |
Director | (Founder) |
Dr. Morris C. Laster, MD | BioLineRx (CEO, Director), OurCrowd (Partner), Clil Medical (CEO), Vital Spark (CEO), |
Director | Kitov Pharmaceuticals (Co-founder, Director) |
Dr. George Lowell, MD | ID Biomedical (CSO), Intellivax (Founder), Walter Reed General Hospital (Consultant) |
Director | |
Dr. Yael Margolin, PhD | Gamida Cell Ltd. (Nasdaq: GMDA) (President, CEO, Director), Denali Ventures LLC (VP) |
External Director | |
Mr. Samuel Moed | Bristol Myers Squibb (NYSE: BMY) (Senior Vice President, Corporate Strategy) |
Director | |
Mr. Adi Raviv, MBA | Capacity Funding LLC (Principal) |
External Director | |
Prof. Avner Rotman, PhD | Biodar (CEO), Rodar (Founder), Israel Biotech Organization (Chairman, Steering |
Director | committee) |
Dr. Ruth Ben Yakar, PhD | BioSight Ltd (CEO, Director), SHL Telemedicine (Director), Cellect Biotechnology (Director) |
Director | |
One • For All : The Universal Flu Vaccine
20 | ||||||
CAP TABLE | ||||||
Nasdaq: BVXV | ADS | % | ADS | Expiration | ||
July 15, 2020 | Outstanding | Price | Date | |||
Ordinary ADS | 11,520,566 | 95% | ||||
Options + RSUs | 599,902 | 5% | Variable | Variable | ||
Fully Diluted Shares | 12,120,468 | 100.00% | ||||
Outstanding | ||||||
- Voluntarily delisted from Tel Aviv Stock Exchange January 22, 2018. (ADS-Shares 1:40 ratio)
- Warrants issued to investors in connection with BiondVax's IPO on Nasdaq in 2015 and traded under symbol BVXVW expired in May 2020.
One • For All : The Universal Flu Vaccine
21
IP: COMPREHENSIVE AND EXPANDING COVERAGE
- 74 Patents & 11 Pending Applications
- Covering polypeptides, polynucleotides, compositions, uses, formulations, production
- Expiration to 2035
Title | International | Subject Matter | Priority & | Status | Expiry |
(updated: March 2020) | Publication | Assignee | |||
Peptide-Based Vaccine for | Vaccine comprising | 11/30/1998: Yeda | Granted: USA | ||
WO 00/032228 | different epitopes of | R&D licensed to | Expired: 1, 3, 5, 12, 13, 15, 19, 20, | USA: Aug 2020 | |
Influenza | |||||
the virus | BiondVax | 22, 24, 25, 26, 31, 33, 35, 36 | |||
Wide-range vaccines | 12/6/2005: Yeda R&D | Granted: 1, 2, 3, 5, 9, 12, 13, 14, 18, | Dec 2026 | ||
Improved Influenza Vaccine | WO 2007/066334 | - broad strain and | |||
licensed to BiondVax | 19, 20, 23, 25, 28, 31, 32, 33, 35, 36 | USA: Jan 2027 | |||
extended protection | |||||
Vaccines comprising | Granted: 1, 2, 3, 4, 5, 6, 7, 8, 9, 11, | Aug 2028 | |||
Multimeric Multi-Epitope Influenza | multiple copies of | 12, 13, 15, 16, 17, 18, 19, 20, 21, 22, | |||
WO 2009/016639 | 8/2/2007: BiondVax | Brazil: Nov 2029 | |||
Vaccines | several epitopes - | 23, 24, 25, 27, 28, 29, 30, 31, 32, 33, | |||
USA: Aug 2031 | |||||
current product | 34, 35, 36 | ||||
Multimeric Multi-Epitope | Use of Multimeric as | Feb 2031 | |||
Polypeptides in improved Seasonal | WO 2012/114323 | a primer to | BiondVax | Granted: 1, 5, 36 | |
USA: May 2031 | |||||
and Pandemic Influenza Vaccines | conventional vaccines | ||||
Vaccine Compositions of | Production & | Allowed: 1, 21, 36 | |||
Multimeric Multi-epitope Influenza | WO 2015/151103 | 4/3/2014: BiondVax | April 2035 | ||
formulation | Pending: 5, 6, 10, 15, 17, 19 | ||||
Polypeptides and their Production | |||||
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=Japan, 22=Korea, 23=Luxembourg, 24=Mexico, 25=Netherlands, 26=New Zealand, 27=Poland, 28=Portugal, 29=Romania, 30=Russia, 31=Spain, 32=Sweden, 33=Switzerland, 34=Turkey, 35=UK, 36=USA.
The Universal
Flu Vaccine
Multi-Season
Multi-Strain
Flu Vaccine
CONTACT INFORMATION:
JOSHUA PHILLIPSON
j.phillipson@biondvax.com +972-8-930-2529
www.biondvax.com
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BiondVax Pharmaceuticals Ltd. published this content on 17 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 August 2020 13:02:05 UTC