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Presented by:
Alex Shneider, Ph.D., Founder and CEOGene Froelich, CFO/COO
Jeffery East, EVP of Business Development
WWW.CURELAB.COM
+1-609-841-1201
+7-905-570-3725
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Safe Harbor Statement
Safe Harbor Statement Under the Private Securities Litigation Reform Act of1995. In accordance with the safe harbor provisions of the Private SecuritiesLitigation reform Act of 1995, the Company notes that statements in this web site,and elsewhere, that look forward in time, which include everything other thanhistorical information, involve risks and uncertainties that may affect theCompany's actual results of operations. The following important factorscould cause actual results to differ materially from those set forth inthe forward-looking statements: project financing; new scientific findings; ourproducts may not be accepted by the market; and we may have difficulty in hiringand retaining key personnel.
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
productAnticipated Investment and Results by 2015 $10 M of investment Finalize clinical testing in the Former USSR Licensing to big pharma for >$1BValuation 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
PBS HIF-Ad-IL4 PBS HIF-Ad-IL4
B. Day 35
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implanttumor i.c.
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image
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imageVirus2 x 108 IFU
A. Day 8
HIF-Ad-IL4 has potent anti-tumor activity againstorthotopic human brain tumor in athymic nu/nu mice model
survival
C. luciferase expression
PBS HIF-Ad-IL40
15
30
45
60
75
90
Fo
ld I
nc
reas
e(D
ay
35/D
ay 8
)
p=0.001
D. Survival Curve
athymic nu/nu mice
0 50 100 150 2000
25
50
75
100
PBS (n=10)(median=55 days)
HIF-Ad-IL4 (n=10)(median=160 days)
p=.0001Days Post tumor implant
Per
cen
t s
urv
ival
D.E. Post et al., unpublished data
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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)
a; T5 tumors in control treated (pcDNA3.1) rats
b&c; T5 tumors after pCL DNA therapy
b
ca
nt
nt; necrotic tumor
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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
$3.5B worldwide
Prolongs life for 4.7 month in average
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Competition
Developers of chemical anti-cancer drugs Developers of biological anti-cancer drugs Anti-cancer vaccines Other companies working on oncolytic viruses (Israel, Japan, USA, EU)
“Cancer” is a composite name for multiple diseases (different mechanisms withsimilar clinical manifestations). Thus, there are several applications for ourapproach with no real competition but with compelling market need.
Major pharmaceutical companies run out of patent protection on their anti-cancerdrugs. Thus, demand for new anti-cancer medicine greatly exceeds supply.
Different treatments are typically used in combination, thus they do notcompete but complement each other
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Timeline and Operational Capital Requirements
Task and Timeline in Months Appr Cost ($ M) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 2 9 3 0 3 1 3 2 3 3 3 4 3 5 3 6
1Licensing from Emory University 0.125 2Permission To Import Virus to Russia
3Specific List of Documents Required to Get Permission for
Clinical Trails in Russia 4Manufacture Virus for Pre-clinical Trails
0.1 5Pre-clinical Toxicity Tests 0.1 6Develop and Approve Clinical Trail Protocol(s)
0.25 7Obtain Permission for Clinical Trials 8Manufacture Virus for Clinical Trials 0.375 9 Import the Virus for Clinical Trials
10Preliminary Clinical Trials (10 patients) 0.4
11Clinical Trails 0.8 12Prepare a Report for UA Pharm Center and FDA
0.35 13Permit for Clinical Use in UA 14Organize Profitable Clinical Use in UA 15Continue R&D as 2-5 1
Management & Administrative 0.5 Miscellaneous 0.5 TOTAL ($M) $ 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
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.
Management Profiles, USA
Alex Shneider, Ph.D. – Founder and CEO20 years of experience in fundamental and applied bio-medical
research.Section editor of International Review of ImmunologySenior Research Fellow at the Center for History and Philosophy
of Science, Boston UniversityMember of the Board of Trustees of St. Petersburg Institute of
TechnologyAuthor 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&DOver 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!