Transcript Document

Presented by:
Alex Shneider, Ph.D., Founder and CEO
Gene Froelich, CFO/COO
Jeffery East, EVP of Business Development
http://curelaboncology.com/
+1-609-841-1201
+7-905-570-3725s
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Safe Harbor Statement
Safe Harbor Statement Under the Private Securities Litigation Reform Act of
1995. In accordance with the safe harbor provisions of the Private Securities
Litigation reform Act of 1995, the Company notes that statements in this web site,
and elsewhere, that look forward in time, which include everything other than
historical information, involve risks and uncertainties that may affect the
Company's actual results of operations. The following important factors
could cause actual results to differ materially from those set forth in
the forward-looking statements: project financing; new scientific findings; our
products may not be accepted by the market; and we may have difficulty in hiring
and retaining key personnel.
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Cure Lab Oncology Mission
To overcome the worldwide problem
of cancer by developing and utilizing
novel anti-cancer vaccines and
oncolytic viruses
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Cure Lab’s Executive Summary
Competitive advantage
 Novel oncolytic virus and product pipeline
 Novel anticancer immunostimulant and the product pipeline
 Novel technologies to increase vaccine and oncolytic virus efficiency
 Anti-cancer vaccine and oncolytic virus may eventually merge into a single
product
Anticipated Investment and Results by 2015
 $10 M of investment
 Finalize clinical testing in the Former USSR
 Licensing to big pharma for >$1B
Valuation of the Company by mid-2014
 >1B
 Multiple of 100X
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Cancer in Russia
300,000 people die each year due to cancer
2,500,000 people are diagnosed with cancer
From 1997 to 2007 the number of cancer patients
has increased 13%
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Oncolytic Viruses
Oncolytic Viruses – viruses that selectively destroy tumors without
impacting normal tissue
 Benefits




Selectivity
Effective tumor removal
Limited or no side-effects
Cost-efficiency
 For some cancers, oncolytic viruses are the only life-saving option
 China has approved world's first oncolytic virus therapy for cancer
treatment
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Paradigm Shift in oncolitic viruses
development
Empirical
Studies of whole
tumor
Empirically found
oncolytic viruses
(MTH68)
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Paradigm Shift in oncolitic viruses
development
Empirical
Studies of whole
tumor
Unique molecular
properties of
cancer cells
Empirically found
oncolytic viruses
(MTH68)
Oncolytic viruses in
clinical trials now
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Selective Targeting of Cancer
Cells
Normal cell
Cancer cell
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Selective Pressure and Clonal Selection
Due to Anti-Cancer Therapy
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Paradigm Shift in oncolitic viruses
development
Empirical
Studies of whole
tumor
Unique molecular
properties of
cancer cells
Unique molecular
properties of tumor
(as a tissue/organ)
Empirically found
oncolytic viruses
(MTH68)
Oncolytic viruses in
clinical trials now
Hipoxia-induced
virus
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HIF-Ad-IL4 has potent anti-tumor activity against
orthotopic human brain tumor in athymic nu/nu mice model
1
8
implant
tumor i.c.
image
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Virus
survival
image
2 x 108 IFU
A. Day 8
PBS
B. Day 35
HIF-Ad-IL4
C. luciferase expression
PBS
HIF-Ad-IL4
D. Survival Curve
p=0.001
75
60
45
30
15
Percent survival
100
90
Fold Increase
(Day 35/Day 8)
athymic nu/nu mice
HIF-Ad-IL4 (n=10)
(median=160 days)
75
PBS (n=10)
(median=55 days)
50
25
0
PBS
HIF-Ad-IL4
D.E. Post et al., unpublished data
0
0
50
100
150
Days Post tumor implant
200
p=.0001
Kidney Caner in Russia
17,600 diagnosed cases in 2008
47% increase compared with 2000
Significant increase in disease is reported for
patients starting 35-39 years old and max at 65-69
High level of HIF (hypoxia induced factor), which
activated our oncolytic virus. This makes the project
of relatively low risk.
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Prostate Cancer in Russia
1 out of 7 men over 50 suffer prostate cancer
>15% lethality rate
Current treatment methods lead to impotency
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Breast Cancer in Russia
50,000 women per year suffer breast cancer
41% of the cases are diagnosed at late stages
20,000 women die each year
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Cancer Vaccines
Induce tumor-specific protective immune response
 Anti-tumor therapeutic agents
 Preventive means to preclude tumor relapse after
surgical removal
 Future use: preventive vaccination for high risk groups
(genetic markers, family history, occupational hazard)
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a
c
nt
b
a; T5 tumors in control
treated (pcDNA3.1) rats
b&c; T5 tumors after pCL DNA
therapy
nt; necrotic tumor
Intellectual Property
 Issued US, Australian and European patents for the product
(both umbrella and application coverage)
 Russia patent application submitted with Skolkovo’s assistance
 A pipeline of the follow-up patent applications to be submitted
for product modifications
 Cure Lab’s technological and clinical know-how developed over
the years
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US Market Size for Cancer Drugs
$40.3B in 1990
$216B in 2006
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Market Comparables
(Yervoy)
Antibody blocking CTLA-4 inactivating lymphocytes
 CTLA-4 discovered in UC Berkley in the mid 1990th. No pharm
company was interested in “too new” idea.
 1998 Berkley licenses it to NeXstar Pharmaceuticals
 1999 NeXstar Pharmaceuticals sublicenses it to Medarex for
$8.5M
 2009 Medarex acquired by Bristol-Myers for $2.4B based on its
anti-CTLA-4 antibody product (no clinical trial results yet)
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Market Comparables
Bevacizumab (Avastin)
 Monoclonal antibody blocking growth of blood vessels in
tumors (Genentech ).
 Used for colon, breast and lung cancer.
 $4,000-9,000/moth/patient
 Insurance paid $100,000/year per patient
 2007 sales:
 $2.3B USA
 $3.5B worldwide
 Prolongs life for 4.7 month in average
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Competition




Developers of chemical anti-cancer drugs
Developers of biological anti-cancer drugs
Anti-cancer vaccines
Other companies working on oncolytic viruses (Israel, Japan, USA, EU)
“Cancer” is a composite name for multiple diseases (different mechanisms with
similar clinical manifestations). Thus, there are several applications for our
approach with no real competition but with compelling market need.
Major pharmaceutical companies run out of patent protection on their anti-cancer
drugs. Thus, demand for new anti-cancer medicine greatly exceeds supply.
Different treatments are typically used in combination, thus they do not
compete but complement each other
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Timeline and Operational Capital
Requirements
Task and Timeline in Months
University
2 Permission To Import Virus to Russia
1 Licensing from Emory
Appr Cost ($ M) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
0.125
3 Specific List of Documents Required to Get Permission for
Clinical Trails in Russia
4 Manufacture Virus for Pre-clinical Trails
5 Pre-clinical Toxicity Tests
6 Develop and
Approve Clinical Trail Protocol(s)
0.1
0.1
0.25
7 Obtain Permission for Clinical Trials
8 Manufacture Virus for Clinical Trials
0.375
9 Import
the Virus for Clinical Trials
10 Preliminary Clinical Trials (10 patients)
11 Clinical Trails
12 Prepare a
Report for UA Pharm Center and FDA
0.4
0.8
0.35
13 Permit for Clinical Use
in UA
14 Organize Profitable Clinical Use in UA
15 Continue R&D as 2-5
Management & Administrative
Miscellaneous
TOTAL ($M)
1
0.5
0.5
$ 4.5
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Combining The Best Of Both Worlds
It is the most feasible to develop future models of the
product in the US in active collaboration with institutions
in EU and Former USSR
It is the most feasible to conduct pre-clinical and clinical
testing of the existing product in the Former USSR
Cure Lab has developed an international network allowing
to conduct each part of the project in the country it is the
most feasible, minimizing expanses and need for capital
while maximizing results
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Collaborations
 USA:
Harvard, Emory University, Boston University, Northeastern
University, University of Arkansas, UCSD
 Europe:
Technical University of Munich, University of Camerino (Italy)
 Former USSR:
Ivanovsky Institute of Virology, Institute of Viral Preparations,
Institute of Gene Biology , Institute of Influenza and other Viral
Desiases, Kavetsky Institute of Oncology
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Scientific Advisory Board
 Prof. Aaron Ciechanover – Nobel Prize Laureate in Chemistry, 2004.
Technion, Haifa, Director of Cancer Control Center, Israel.
 Barry Straube, M.D., Senior Medical Advisor, Cure Lab; Immediate Past Chief
Medical Officer, Centers for Medicare and Medicaid Services.
 Kim Lewis, Ph.D., Professor of Biology, Northeastern University
 Michael Sherman, Ph.D., Professor of Biochemistry, Boston University School of
Medicine
 Stuart Calderwood, Ph.D., Associate Professor, Beth Israel Deaconess Medical
Center, Harvard Medical School.
 Herbert T. Cohen, M.D., Professor of Medicine, Boston University School of
Medicine
 Mikhail Blagosklonny, M.D., Ph.D., Member/Professor, Roswell Park Cancer
Institute, Editor-in-chief of journals Cell Cycle and Aging
 Valeria Povolotskaya, Ph.D., Ex-Director of International Licensing Department of
La Roche
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Scientific Advisory Board, Russia
 Prof. Anatoly Tsib, Director of Medical Radiological Research Center of RAMS, Active
member of Russian National Academy of Medical Science.
 Prof. Valeriy Charushin, Deputy of Russian Federation State Duma, Director of Institute of
Organic Synthesis named after I.Ya. Postovsky (http://www.ios.uran.ru/), Chairman of Board
of Ural Branch of Russian Academy of Sciences, member of the board of Russian Academy
of Sciences, International Society of Heterocyclic Chemistry and International Society for
Antiviral Research, International Union of Pure and Applied Chemistry (IUPAC), American
Chemical Society, State Duma Committee on Science and High Technology.
 Prof. Sergey Kolesnikov, Deputy of Russian Federation State Duma, Chairman of the Board
of East-Siberian Scientific Center, Siberian Division of Russian Academy of Medical
Sciences, Deputy-Chairman of Committee for Health Care, Distinguished Scientist of Russian
Federation, Active member of Russian National Academy of Medical Science.
 Prof. Oleg Kiselev, Director of Research Institute of Influenza of Ministry of Health and
Social Development of Russian Federation (Saint Petersburg) (http://www.influenza.spb.ru/),
member of WHO, Active member of Russian National Academy of Medical Science.
 Prof. Nikolay Kaverin, Chief of Applied Virology Laboratory of Ivanovsky Institute of
Virology (Moscow), Active member of Russian National Academy of Medical Science.
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Management Profiles, USA
Alex Shneider, Ph.D. – Founder and CEO
 20 years of experience in fundamental and applied bio-medical
research.
 Section editor of International Review of Immunology
 Senior Research Fellow at the Center for History and Philosophy
of Science, Boston University
 Member of the Board of Trustees of St. Petersburg Institute of
Technology
 Author of the best selling book on business analysis in Eastern
Europe.
 Ph.D. in life science form Roskilder University, Denmark.
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Management Profiles, USA
Eugene L. “Gene” Froelich, CPA – CFO/COO
Over 30 years of successful business experience
Ex- CEO MCA Records Group
Ex-CFO and EVP of Maxicare Health Plans Inc
Ex-COO and CFO at Wizshop.com
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Management Profiles, USA
Victor Shifrin, Ph.D., Director of R&D
 Over 20 years of experience in academia and biotech industry.
 Formerly Director of Pharmacology at Surface Logix. Worked in
various capacities at Scriptgen (Anadys) and Eisai Research
Institute.
 Led discovery biology at CombinatoRx, where he studied the
combinatorial effects of the approved drugs.
 Ph.D. in Cell and Molecular Biology from Harvard University.
Postdoctoral training at the Harvard-affiliated Dana Farber Cancer
Institute, and Brigham and Women’s Hospital, Harvard Medical
School.
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Management Profiles, USA
Jeff East - Executive Vice President, Strategy/Business Development
 25 years of executive level experience across the healthcare
industyr.
 Former CEO of sister company to New England Journal of
Medicine, Masspro.
 Former leader of $2 billion hospital medical device and
pharmaceutical distribution company
 Former senior executive at Massachusetts Department of Public
Health
 Various health care company board officer and director experience.
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THANK YOU!