the universal flu vaccine...protein called m-001 produced in e.coli h em a a) n leo p) m (m 1) the...
TRANSCRIPT
The UniversalFlu Vaccine
Multi-SeasonMulti-Strain Flu Vaccine
CORPORATE PRESENTATION
JANUARY 2018
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 StatesPrivate 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 notguarantees 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 materiallyfrom our expectations include, among others: the risk that drug development involves a lengthy and expensive process with uncertain outcome; BiondVax'sability to successfully develop and commercialize its vaccine; the length, progress and results of any clinical trials; the introduction of competing products; theimpact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals tocommercialize BiondVax's products; the difficulty in evaluating business prospects; the adequacy of available cash resource and the ability to raise capitalwhen needed; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; changes in the globalpharmaceutical 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 insuranceliabilities; 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. Youshould not unduly rely on any forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements arereasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-lookingstatements will be achieved or will occur. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with theSecurities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities andExchange 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 tocarefully review and consider the various disclosures made in the Company’s SEC reports, which are designed to advise interested parties of the risks andfactors that may affect its business, financial condition, results of operations and prospects. These forward-looking statements speak only as of the date ofthis 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.
SAFE HARBOR STATEMENT
One • For All : The Universal Flu Vaccine
2
BIONDVAX’S 2017 HIGHLIGHTS
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/
3
Israeli government support mid-size commercial facility2 – March 30Ministry of Economy granted 20% of a NIS 20m budget towards construction
€20 million non-dilutive funding3 – June 19The European Investment Bank (EIB) signed an agreement to support commercial scale production and Phase 3
BiondVax successfully meets Phase 2b clinical trial endpoints4 – July 20 M-001 showed statistically significant elevated T-cell immune responses, good safety profile and well-tolerated
$10 million secondary offering5 – September 18Following the placement, BiondVax has 3 large strategic investors, each holding 5% to 20%
European Medicines Agency (EMA) Allows Phase 3 Trial Plan6 – December 27EMA Scientific Advice accepts the placebo controlled trial design, facilitating procedures towards Phase 3
“…We now have the resources to launch our Phase 3 program towards commercialization.” 1
4
Anthony Fauci, NIAID Director
NEJM 29 November 2017.DOI 10.1056/NEJMp1714916
“…need to strive toward a ‘universal’ influenza vaccine that will protect against seasonal influenza drift variants as well as potential pandemic strains…”
Fluinfects up to 20% of the population each year
… and kills
The Flu Virus: Frequent and Unpredictable Mutations
A SEASONAL PROBLEM… A PANDEMIC THREAT
SEASONAL FLU
• Per year: 23,000 deaths1 (21,000 elderly) &
200,000 hospitalizations2 in just the US
• Worldwide annual death toll of 291,000-646,0004; Flu & pneumonia are 8th leading cause
of death3 in the US
• $87B economic burden5 in the US of which $56B is in the elderly
PANDEMIC FLU
• When?… Where?... Which?… pandemic strain
• Pandemic strain: a new to humans
• Past century: 4 major pandemics with over
100M deaths5
• The 1918 Spanish Flu cost to global GDP6 was 4.8%
or over $3T in today’s dollars
“I rate the chances of a widespread epidemic in my lifetime at well over 50%” – Bill Gates
https://youtu.be/9AEMKudv5p0
6
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;
CURRENT VACCINE FALLS SHORT: THE MISMATCH
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
Seasonal Flu Vaccine Effectiveness (VE)CDC data
1, flu seasons 2004-2017
Why current solutions fall short…
• Past strains selection Mismatch phenomenon
• Previous season’s vaccine will not necessarily protect against next season’s flu strains
• 4-6 month production lag
As low as
9% VE in elderly2
Average 40% VE in general
population
7
39%
48%
19%
52%
49%
47%
60%
56%
41%
37%
52%
21%
10%
2016-17
2015-16
2014-15
2013-14
2012-13
2011-12
2010-11
2009-10
2008-09
2007-08
2006-07
2005-06
2004-05
THE ELDERLY – AT RISK AND IN NEED
• ~90% of seasonal flu related death occurs in elderly
• Seasonal vaccine effectiveness as low as 9% for elderly1
• 86% of adults 65+ have chronic conditions2
• Influenza worsens outcomes of chronic illness
• Elderly flu cost in US estimated3 at $56B per year (hospitalization, mortality, lost earnings)
1 World Health Organization: http://www.who.int/immunization/research/meetings_workshops/2a_Graham_pdvac_sept14.pdf2 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) 5086–50964 http://ije.oxfordjournals.org/content/35/2/352.short
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 Epidemiology4 (Vol. 35, Issue 2, P352-353)
8
MEETING MILESTONES & CATALYSTS
2008
1st of two Phase 1/2 (IL)
May 2015Nasdaq: BVXV
2010
1st of four Phase 2 (IL, EU)
Technology developed by Prof. Ruth Arnon
Mid 90’s
June 2007TASE:BVXV
BiondVax Operational
2005 2018
Well known for the development of
Solid Science, Advanced Clinical Stage, Strong IP
FDA accepts IND
One • For All : The Universal Flu Vaccine
The Vaccine is Safe and Immunogenic
• 698 young adult to elderly have participated in clinical trials
• The vaccine was shown to be safe and immunogenic in all studies
2017
9
June 2017€20M EIB
EMA Scientific Advice accepts
Phase 3 trial design
- USA NIH Phase 2- USA CMO Ph3 material- Mid-size manufacturing
plant construction- Phase 3 trial
M-001: A COMMON DENOMINATOR OF FLU VIRUSES
BiondVax’s M-001 Existing vaccines
Universal: Broad coverage Strain specific
Single formulation enabling year-round vaccination
New vaccine every year
Quick, robust year-round production (6-8 weeks)
Long (4-6 month)production cycle
Induces cellular (CMI) and enhances humoral (HAI priming effect) immune response to flu
Limited vaccine effectiveness
Shelf life up to 24 months at 2-8⁰C(testing is ongoing) and 6 months at ~25⁰C (room temperature)
Not applicable, since new vaccine every season
Target Common Regions
Nine common regions (epitopes) of flu strains are connected to make one recombinant protein called M-001 produced in E.coli
Hem
Agg
luti
nin
(H
A)
Nu
cleo
Pro
tein
(N
P)
Mat
rix
pro
tein
(M
1)
The Influenza Virus
Universal Flu VaccineA common denominator forSeasonal & Pandemic strains
M-001’s Key Advantages
One • For All : The Universal Flu Vaccine
10
• 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
M-001: THE UNIVERSAL FLU VACCINE
11
e.g. T-Helper, CD4, CD8Produce anti-viral cytokines such as
IFN-GIL-2
Produce Antibodies
Directly inducesT-Cells
T-cell priming effect enhancesB-Cell responses
Current vaccines mainly induce only flu strain-specific antibodies.
BiondVax’s M-001Dual Mode of Action
M-001’s dual mode of action potentially offers multi-season and multi-strain protection
One • For All : The Universal Flu Vaccine
Cellular (CMI)Works inside infected cells
Humoral (HAI)Works outside cells
Our immune system has 2 arms:
B-cellT-cell
In the clinical trials we looked for the intrinsic CMI M-001 immunogenicity compared to baseline and its priming effect
SUCCESSFUL CLINICAL TRIALS
ResultsStatusTotal
ParticipantsPopulation (age)YearTrialPhase
M-001 was well
tolerated and a
cellular (CMI) and
humoral (priming
effect) immune
response was
observed
Completed63Younger Adults (18-49)2009BVX-0021/2
Completed60Older Adults (55-75)2010BVX-0031/2
Completed200Younger Adults (18-49)2011BVX-0042
Completed120Elderly (65+)2012BVX-0052
Completed36Older Adults (50-65)2015BVX-0062
Completed219EU Adults (18-60)2015-16BVX-007*2b
698
Ongoing collaboration with NIH180USA Adults (18-45)2017BVX-0082
In preparation~7,700East EU Adults (50+)2018BVX-0103
One • For All : The Universal Flu Vaccine
M-001: Safe and Immunogenic in Young Adults to Elderly
12
* BVX-007 was conducted in collaboration with the EU’s UNISEC consortium
• No treatment-related severe adverse events
• Adverse events were mild to moderate
• All adverse events observed were transient
• Both cellular and humoral immunity were induced
0
0.05
0.1
0.15
0.2
0.25
0.3
A/Brisbane/10/07H3N2
A/California/7/09H1N1
A/Perth/16/09H3N2
B/Brisbane/60/08 Flumist
% P
osi
tive
of
all c
ells Baseline Day 42 (after M-001 x2)*
*
0
0.05
0.1
0.15
0.2
0.25
0.3
A/Brisbane/10/07H3N2
A/California/7/09H1N1
A/Perth/16/09H3N2
B/Brisbane/60/08 Flumist 2011% p
osi
tive
cel
ls (
Mea
n +
SE) M-001 twice Day 0
M-001 twice Day 42* *
* *
**
M-001: DESIGNED FOR CELL MEDIATED IMMUNITY
* P<0.05 **P<0.07
13
**
*
1 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
Direct Evidence: CD8, CD4 T-cell Activated Cells Produce TH1 Cytokines (IFN-gamma, IL-2 & TNF-alpha)
BVX0051: CD8 & IFN-gamma in ElderlyBVX0051: CD4 & IFN-gamma in Elderly
“Multiple-Cytokine-Producing Antiviral CD4 T Cells Are FunctionallySuperior to Single-Cytokine-Producing Cells”S Kannanganat et al, J VIROL, 2007, 81(16)8468–76
211
134
1347
663
3470
-200
0
200
400
600
800
1000
1200
1400
highany
lowany
high2/3
low 2/3 highcombi
lowcombi
% o
ver
pla
ceb
o
*
*
*
*
Single Double Triple
M-001: 1mg 0.5mg 1mg 0.5mg 1mg 0.5mg
UNISEC (EU): 13 fold increase in responders expressing 2 cytokines (18-60 Y)
678
380
530474
38
-23
-200
0
200
400
600
800
1000
high INF low INF highIL2 low il2 hightnfa
low tnfa
% o
ver
pla
ceb
o
M-001: 1mg 0.5mg 1mg 0.5mg 1mg 0.5mg
IFN-gamma IL-2 TNF-alpha
UNISEC (EU): statistically significant anti viral cytokines
* P<0.05 * P<0.05* P<0.05
H1N1 pandemic swine flu
M-001: DESIGNED FOR CELL MEDIATED IMMUNITY
14
0
10
20
30
40
50
60
70
TIV 2011/12 M-001 & TIV 2011/12
% S
ero
pro
tect
ion
(H
AI) *
“M-001 can provide broadened enhanced immunity extending even to influenza strains destined to circulate in future years.” – Vaccine 2
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!
1. 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) 5816–58232. 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)
Indirect Evidence: Extending T-Cell Priming Effect for Enhanced HAI Responses to Current Flu Vaccines
BVX0051: 2012, age 65+ YO
BVX003: 2009, age 55-75 YO
0
10
20
30
40
50
60
70
A/California/7/09 A/Perth/16/09 B/Brisbane/60/08
% S
ero
con
vers
ion TIV Twice M-001 + TIV
*
0
10
20
30
40
50
60
70
80
A/Brisbane/59/07 A/Brisbane/10/07 B/Brisbane/60/08
% s
ero
con
vers
ion
TIV Twice M-001 + TIV
* P<0.05
PIVOTAL CLINICAL EFFICACY PHASE 3 DESIGN
15
• Sample size: ~7,700 participants with flexible enrollment (TBD)
• Population: 50+ years old; stratification to <65> years old (TBD)
• Endpoint: Clinical efficacy by reduction of illness rate and severity
• Phase 3 ready: First participant group enrollment expected autumn 2018
Proposed Trial Design Season 1 Season 2 Season 3 (optional)
Day 1 Day 21 Day 180 Follow up Follow up
Experimental 1mg M-001 1mg M-001 Safety, PCR
and culture on
any ILI
(flu season)
PCR and culture
on any ILI
(flu season)
PCR and culture on
any ILI
(flu season)Control Placebo Placebo
Opportunity: Financing and Phase 2 Trial Results Leads to Clinical Efficacy Phase 3
One • For All : The Universal Flu Vaccine
Study title: A pivotal multicenter, randomized, double-blind, placebo-controlled phase 3 trial to assess the safety and clinical efficacy of a M-001 influenza vaccine administered intramuscularly twice in old adults and elderly (≥50 YO)
PRODUCTS NEED PRODUCTION
16
• From pilot GMP to mid-size GMP manufacturing facility (Israel)*
• Funding: EIB, BiondVax, and Israel’s Ministry of Economy & Industry
• Capacity: up to 20 million single-doses or 40 million doses (bulk) per year
• Year-round Production & Stockpile per market demand
Goal: Fully Integrated Pharma Operating Under International GMP Standards
* BiondVax is collaborating with a US-based contract manufacturer organization (CMO) for upscaling and optimization
BIONDVAX: FIRST-IN-CLASS, BEST-IN-CLASS
One • For All : The Universal Flu Vaccine
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Player Technology StrengthPhase
Progress ReportedPre-clinical
I II III
Synthetic proteinB- & T-cell peptides(HA, M1, NP)
• Broad coverage• Large # of human clinical
trials• Young to elderly
Q3-2017: Statistically significant European Ph2b trial UNISEC consortium. NIAID/NIH sponsored ongoing collaboration Phase 2 in USA.Preparing for Phase 3 in the EU.
4 T-cell peptides adjuvantedformulation
• Small challenge trialParticipated in UNISEC consortium. 2016: Created Imutex with hVIVO; Phase 2b challenge study
Adenovirus vector expressing Influenza A conserved NP and M1 proteins
• T-cell boost when administered with TIV
Preparing for Ph2 in 2000 participants. Oxford University spinoff, raised £10m in 2016.
Broad seasonal and pandemic candidate. T-cell booster
• Intranasal, replication deficient adenovirus
Formerly ITS then Vaxin. Phase 2 expected start Q3-2017. Merged PharmaAthene, listed on NASDAQ
DNA constructs encoding HA proteins
• Versatile technology of mix and match
Q3-2012 Phase 1
Single replication virus, M2SR; Broadening immunogenicity to flu sub type H3N2
• Immunogenic in miceQ3-2016 Phase I, H3N2 Raised $27m, including $5.5m Aug 2017
Stem-only immunogens based on rational design; DNA vaccines
• Innovative approach,heterosubtypic protection in mice, ferrets, primates
2017: Results in animalsAcademic labs
N=698
N=373
N=150
N=60
N=49
N=96
SUMMARY FINANCIAL DATA
Financial Data Highlights
• Lean structure with 15 employees, current burn ~$250K/month
• 6.5M outstanding ADS1 (8.7M fully diluted)
• Clinical studies sponsored by 3rd parties (UNISEC, NIH/NIAID)
• $4.8M royalty-based liabilities from OCS grants (Office of the Israeli Chief Scientist grants, off balance sheet)
Balance Sheet Highlights
• >$22M cash on hand, no debt (~$32M invested to date)
• €20M EIB non-dilutive funding agreement2 signed June 2017
• Secondary offering Sept 2017, $10M gross proceeds
BVXVBVXVW
American Depository Shares ticker:
18
1 1 ADS = 40 ordinary shares2 European Investment Bank (EIB) €20M support for M-001 Phase 3 trials and commercial production also includes:
• Zero-percent fixed interest loan for five years after each of the 3 drawdowns• Variable remuneration based on royalties of net sales• Milestone based drawdowns. Ultimate milestone includes regulatory authorization to launch Phase 3 trial
BVXVOrdinary Shares ticker:
Voluntarily delisting from TASE: Last trading day January 18, 2018
Delisting January 22, 2018
GSK13%
Sanofi38%Seqirus
21%
AZ 2%
Others25%
FLU VACCINES – A LARGE AND GROWING MARKET
Global Flu Vaccine Sales - 2016
$538M5
$104M8
Flu Vaccine Market
Seasonal Fluo Worldwide: ~$4.3B global market in 20161;
expected to grow to $5.3B2 by 2021
o US: $1.6B in 2015 growing to $2.6B by 20221; ~175M doses/year1
o Forecasted CAGR of 5.7%2
Pandemic Fluo Swine Flu (A/H1N1) 2009 + first half of 2010
sales: ~$6.4B worldwide by Novartis, GSK and Sanofi (on top of seasonal flu vaccine sales)3
“…part of the national strategy for pandemic influenza, the United States’ plan is to stockpile enough pre-pandemic influenza vaccines to cover 20 million in the critical workforce.”4
“The United States has spent approximately $1 billionin these [H5N1 flu vaccine stockpile] efforts to date.”4
Others~$1,068M1
19
$900M7
2014/5: CSL bought Novartis’ Flu vaccine unit, rebranded to Seqirus
(1) We assume 5.7% CAGR from $4B in 2015 http://www.cnbc.com/2015/10/19/the-16-billion-business-of-flu.html (2) Datamonitor report: DMKC0107117, Publication Date: 18/11/2013 (3) http://www.reports-research.com/news/datamonitor-vaccine-market-overview-2010.html [Accessed 20 Nov 2016] (4) http://www.who.int/immunization/sage/meetings/2013/november/SAGE_WG_H5vaccine_background_paper_16Oct2013_v4.pdf (5) GSK, http://annualreport.gsk.com/assets/downloads/1_GSK.AR.FULL.V4.pdf, page 62 [At exchange rate 1.30] (6) Sanofi, https://en.sanofi.com/Images/49165_FY2016_slides.pdf, slide 9 [At exchange rate 0.94] (7) CSL/Seqirus, http://annualreport.csl.com.au/year-in-review/business-highlights.htm (8) AZ, https://www.astrazeneca.com/content/dam/az/Investor_Relations/Annual-report-2016/AZ_AR2016_Full_Report.pdf - page 147 [5,6,7,8 Accessed 27 November 2017]
$1,618M6
2017: Acquired Protein Sciences for $750M
MANAGEMENT
One • For All : The Universal Flu Vaccine
Ron BabecoffDMV, MEI
Tamar Ben-Yedidia
PhD
Uri Ben-OrCPA, MBA
Shimon HassinPhD
Joshua Phillipson
Hon. BSc
Kenny GreenMsc, Mres
Founder,President & CEO
CSO CFO COO BD Manager Investor Relations
•Degree from University of Liège (ULG)
•Master inEntrepreneurship & Innovation (ISEMI, Swinburne)
•Omrix Biopharmaceuticals Ltd (Marketing Manager)
•Dexcel Pharma (Regional Export Manager)
• Co-inventor of the universal flu vaccine
• Degree from Weizmann Institute of Science
• Biotechnology General Ltd.
• Degree from College of Administration
• Glycominds Ltd. (VP Finance)
• Menorah Capital Markets (Comptroller)
• Degree from University of Maryland Biotechnology Institute
• Kadimastem (CEO)
• InSightBiopharmaceuticals (Head of Bioprocessing)
• Hon. BSc. from Universityof Toronto
• Accenture (Business Management Consultant)
• BioData Ltd. (Marketing Manager)
• Masters in Management Degree from Cambridge University & Master of Research from University of London
• IR for leading public Israeli companies including Elbit Systems and Tower Semiconductor
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One • For All : The Universal Flu Vaccine
BOARD OF DIRECTORS
Biodar (CEO), Rodar (Founder), Israel Biotech Organization (Chairman,Steering committee)
Prof. Avner Rotman, PhDChairman of the Board
Rosen Partners LLC (Founder), CompreMedx Chairman), Kuala Healthcare (CEO & President), Fusion Telecommunications (Director)
Mr. Jack RosenDirector
ID Biomedical (CSO), Intellivax (Founder), Walter Reed General Hospital (Consultant)
Dr. George Lowell, MDDirector
Omrix Pharmaceuticals Ltd (Marketing Manager), Dexcel Pharma Technologies Ltd. (Formerly Dexxon, Regional Export Manager))
Ron Babecoff, DMV, MEIFounder, President and CEO
Credit Suisse First Boston (Investment Banking), Private equity and venture capital funds (Founder)
Mr. Isaac Devash, MBADirector
Linkury Technology International Group (CFO), Union Bank, Spectronix, Biomedix incubator, ADO group, Arko holdings, Algomizer (Director)
Mrs. Michal Marom Brikman, CPADirector
Mor Langermann (Co-CEO), Medical Compression Systems Ltd (CFO), Excellence Gemel & Pension Funds (External Director)
Mr. Ori MorDirector
BioSight Ltd (CEO, Director), SHL Telemedicine (Director), CellectBiotechnology (Director)
Dr. Ruth Ben Yakar, PhDDirector
BioLineRx (CEO, Director), OurCrowd (Partner), Clil Medical (CEO), Vital Spark (CEO), Kitov Pharmaceuticals (Co-founder, Director)
Dr. Morris C. Laster, MDDirector
21
One • For All : The Universal Flu Vaccine
22
ExpirationDate
ADSEquivalent
Exerciseprice
NIS ($)
%ADS
EquivalentShares
Outstanding30 Oct 2017
ADS-Shares 1:40 ratio
75.18%6,535,490261,419,599Ordinary shares
EmployeesVariable
$ 7.20NIS 0.70($ 0.18)
3.79%329,45713,178,272Options
May 5, 2020$ 6.2520.28%1,762,89770,515,880ADS Warrants
May 11, 2020$ 6.250.75%65,4252,617,000Warrants issued to underwriters
100.00%8,693,269347,730,751Fully Diluted Shares Outstanding
CAP TABLE
IP: COMPREHENSIVE AND EXPANDING COVERAGE
Updated: December 2017
One • For All : The Universal Flu Vaccine
23 23
ExpiryStatusPriority & Assignee
Subject MatterInternational
PublicationTitle
Nov 2019
(Aug 2020
for US)
Granted: USA, Israel, Australia, Korea, Mexico, New Zealand, Canada, Hong Kong, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, UK
11/30/1998
Yeda R&D
licensed to
BiondVax
Vaccine comprising different epitopes of the virus
WO 00/032228Peptide-Based Vaccine for Influenza
Dec 2026
(Jan 2027
for US)
Granted: USA, Australia, Austria, Belgium, Canada, Denmark,
France, Germany, Greece, Ireland, Israel, Italy, Luxembourg,
Netherlands, Portugal, Sweden, Spain, Switzerland, UK
12/6/2005
Yeda R&D
licensed to
BiondVax
Wide–range vaccines – broad strain and extended protection
WO 2007/066334Improved Influenza Vaccine
Aug 2028
(Aug 2031
for US)
Granted: USA, Mexico, Russia, Australia, China, Hong Kong, Japan,
Austria, Belgium, Canada, Croatia, Czech Republic, Denmark,
Finland, France, Germany, Hungary, India, Ireland, Italy,
Luxembourg, Netherlands, Poland, Portugal, Romania, Spain,
Sweden, Switzerland, Turkey, UK, Korea, Israel
Filed: Brazil
8/2/2007
BiondVax
Vaccines comprising multiple copies of several epitopes – current product
WO 2009/016639Multimeric Multi-Epitope Influenza Vaccines
Feb 2031Granted: USA, Australia
Under Examination: CanadaBiondVax
Use of Multimeric as a primer to conventional vaccines
WO 2012/114323
Multimeric Multi-Epitope Polypeptides in improved Seasonal and Pandemic Influenza Vaccines
April 2035Filed: Australia, Canada, Europe, India, China, Hong Kong, Japan,
Israel, USA
4/3/2014
BiondVax
Production & formulation
WO 2015/151103
Vaccine Compositions of Multimeric Multi-epitope Influenza Polypeptides and their Production
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