Vita 04.27.2012
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Vita 04.27.2012

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  • Now we will turn our attention to the number of new cancers anticipated in the US this year. It is estimated that about 1.5 million new cases of cancer will be diagnosed in 2010. Cancers of the prostate and breast will be the most frequently diagnosed cancers in men and women, respectively, followed by lung and colorectal cancers in both men and in women.
  • Lung cancer is, by far, the most common fatal cancer in men (29%), followed by prostate (11%), and colon & rectum (9%). In women, lung (26%), breast (15%), and colon & rectum (9%) are the leading sites of cancer death.

Vita 04.27.2012 Vita 04.27.2012 Presentation Transcript

  • Presented by: Alex Shneider, Ph.D., Founder and CEO Gene Froelich, CFO/COOJeffery East, EVP of Business Development WWW.CURELAB.COM +1-609-841-1201 +7-905-570-3725
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  • Safe Harbor StatementSafe 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 theCompanys 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. 3
  • Cure Lab Oncology MissionTo overcome the worldwide problemof cancer by developing and utilizingnovel anti-cancer vaccines andoncolytic viruses 4
  • Cure Lab’s Executive SummaryCompetitive 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 5
  • 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% 6
  • Oncolytic VirusesOncolytic 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 worlds first oncolytic virus therapy for cancer treatment 9
  • HIF-Ad-IL4 has potent anti-tumor activity againstorthotopic human brain tumor in athymic nu/nu mice model 1 8 35 athymic nu/nu mice survival implant image Virus imagetumor i.c. 2 x 108 IFUA. Day 8 B. Day 35 PBS HIF-Ad-IL4 PBS HIF-Ad-IL4 C. luciferase expression D. Survival Curve 90 100 HIF-Ad-IL4 (n=10) p=0.001 (median=160 days) Percent survival 75 75 (Day 35/Day 8) Fold Increase 60 PBS (n=10) (median=55 days) 45 50 30 15 25 0 PBS HIF-Ad-IL4 0 0 50 100 150 200D.E. Post et al., unpublished data Days Post tumor implant 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. 12
  • Prostate Cancer in Russia1 out of 7 men over 50 suffer prostate cancer>15% lethality rateCurrent treatment methods lead to impotency 13
  • 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 14
  • Cancer VaccinesInduce 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) 15
  • a c ntb 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 17
  • US Market Size for Cancer Drugs$40.3B in 1990$216B in 2006 18
  • 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) 19
  • Market Comparables Bevacizumab (Avastin) Monoclonal antibody blocking growth of blood vessels intumors (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  $3.5B worldwide Prolongs life for 4.7 month in average 20
  • Competition Developers of chemical anti-cancer drugs Developers of biological anti-cancer drugs Anti-cancer vaccines Other companies working on oncolytic viruses (Israel, Japan, USA, EU)“Cancer” is a composite name for multiple diseases (different mechanisms withsimilar clinical manifestations). Thus, there are several applications for ourapproach with no real competition but with compelling market need.Major pharmaceutical companies run out of patent protection on their anti-cancerdrugs. Thus, demand for new anti-cancer medicine greatly exceeds supply.Different treatments are typically used in combination, thus they do notcompete but complement each other 21
  • Timeline and Operational Capital Requirements  Task and Timeline in Months Appr Cost ($ M) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 1 Licensing from Emory University 0.125                                                                         2 Permission To Import Virus to Russia                                                                          3 SpecificList of Documents Required to Get Permission for Clinical Trails in Russia                                                                        4 Manufacture Virus for Pre-clinical Trails 0.1                                                                       5 Pre-clinical Toxicity Tests 0.1                                                                         6 Develop and Approve Clinical Trail Protocol(s) 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) 0.4                                                                         11 ClinicalTrails 0.8                                                                         12 Prepare a Report for UA Pharm Center and FDA 0.35                                                                         13 Permit for Clinical Use in UA                                                                          14 Organize Profitable Clinical Use in UA                                                                          15 Continue R&D as 2-5 1                                                                        Management & Administrative 0.5                                                                         Miscellaneous 0.5                                                                         TOTAL ($M) $ 4.5                                                                         22
  • 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 23
  • 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 24
  • 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 25
  • 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. 26
  • Management Profiles, USAAlex 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. 27
  • Management Profiles, USAEugene 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 28
  • Management Profiles, USAVictor 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. 29
  • Management Profiles, USAJeff 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. 30
  • THANK YOU!