Metastat pp


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Metastat pp

  1. 1. www.metastat.com1UnderstandingThe Spread of CancerUnderstanding and Treatingthe Spread of CancerMetaStat, Inc. (MTST)Investor PresentationDecember 2012
  2. 2. www.metastat.com2Forward-Looking StatementsThis presentation contains “forward-looking statements” within the meaning of the Securities Act of 1933,as amended, the Securities Exchange Act of 1934, as amended, and the Private Securities LitigationReform Act of 1995, which are intended to be covered by the safe harbor created thereby. You can identifyforward-looking statements by words such as “anticipates,” “expects,” “intends,” “plans,” “projects,”“believes,” “estimates,” and similar expressions. Specifically, statements regarding MetaStat’s futurebusiness, including any revenue projections, costs, earnings or other financial items, as well as statementsrelating to the objectives of management and other business plans, including anticipated new products andinvestments, are forward looking statements. These forward-looking statements are not guarantees offuture performance but are rather based upon managements current expectations and assumptions as tofuture events that may not prove to be accurate. Actual results may differ materially from those projected asa result of certain risks and uncertainties, including but not limited to: the demand for cancer diagnosticsand therapeutics; the growth of the markets addressed by our products; the demand for and marketacceptance of our products; our ability to successfully compete in the markets in which we do business; ourability to successfully address the cost structure of our products; the ability to develop and implement newtechnologies and to obtain protection for the related intellectual property; and our ability to realize financialand strategic benefits of past and future transactions. Other factors that could cause actual results to differmaterially from those described in the forward-looking statements include other economic, business,competitive and/or regulatory factors affecting MetaStat’s business generally. These risks anduncertainties, and others, that relate to MetaStat’s business and financial condition are detailed from timeto time in MetaStat’s Securities and Exchange Commission filings. These forward-looking statements aremade only as of the date indicated, and MetaStat disclaims any obligation to update or revise theinformation contained in any forward-looking statements, whether as a result of new information, futureevents or otherwise.
  3. 3. www.metastat.com3MetaStat At-a-GlanceTHE COMPANYCORE EXPERTISETWO ACTIVE DIAGOSTICPROGRAMSACTIVE THERAPEUTICPROGRAMCLINICAL BENEFITS•  MetaStat, Inc. (OTCBB: MTST)•  21,054,418 common shares out.*•  Market Cap: $77.3M*•  Understanding the pathways, mechanics and genetics ofsystemic metastasis•  MetaSite Breast™•  MenaCalc™•  MenaBloc™•  Addressing metastasis, the cause of 90% of cancer fatalities•  Understanding and treating the spread of cancer•  Providing new and better diagnostic information•  Improving the quality of treatment decisions and theeconomics of cancer careProbability of metastasisor “Metastasis Score”Prevent or eliminatemetastasis* As of December 3, 2012
  4. 4. www.metastat.com4Why We Are ImportantMetastasis is the most significant issue in cancer today•  90% of fatalities from solid epithelial cancers are caused by systemic metastasis•  Currenlty patients’ are misclasified because their true metastatic potential cant bequantified resulting in over-treatment for some and under-treatment for othersOur products target the 4 largest cancer indications•  Breast, prostate, lung and colerectal cancers•  Collectively 840,000+ new cases per year in the U.S. alone•  Over 50% of all new cancer cases•  Initial focus on breast cancerNo approved or commercially available products specific to metastasis•  No product(s) to specifically diagnose or predict systemic metastasis•  No product(s) to specifically treat or prevent systemic metastasisPersonalized medicine•  We provide clinically useful information according to each patient’s specific cancerbiology to better “customize” treatments•  Targeted therapeutics
  5. 5. www.metastat.com5Our Technology is DifferentiatedTHE COMPETITION METASTAT•  Multiphoton Microscope(Focus 50 cell diameters)•  Light Microscope(Focus one cell diameter)•  Small fixed paraffin embedded specimensto observe dead tumor tissue•  Intra-vital imaging windowto observe live functioning human tumors•  MetaSite (TMEM), the site of metastasis•  Whole tumor collection ofproliferative, structural and metastatic cells•  Artificial blood vessel collection ofpure population of metastatic cells•  Current gene tests use mixture of cellsof which a small minority are metastatic cells•  MetaStat’s Invasion Signature ofhighly metastatic cells or “cancer stem cells”•  Mena protein and its isoforms•  Most overexpressed (up to 17x) in metastasis•  Central regulator of metastatic process•  Isoform balance predicts metastatic potential
  6. 6. www.metastat.com6metastasis (me•tas•ta•sis)•  The transmission of cancerous cells from a primary tumor or siteto one or more non-adjacent organs or sitesCancer spreads three ways•  1. Local infiltration•  2. Lymphatic system•  3. Hematogenous (blood borne) or “systemic” metastasisSystemic metastasis is responsible for 90% of cancer deathsMetaStat has expanded the understanding of metastasis•  Mechanisms of invasion and migration•  Molecular and behavioral phenotypes•  Ability for specific detection and prognosis•  Treatment endpointsMetastasisBreast Cancer Metastasized to Lung
  7. 7. www.metastat.com7Enormous Market OpportunityProstateLung & bronchusColon & rectumUrinary bladderSkin/melanomaLymphoma (all)KidneyLeukemia (all)PancreasLiverEsophagusAll other sitesTotalBreastLung & bronchusColon & rectumUterineThyroidLymphoma (all)Skin/melanomaKidneyOvaryPancreasLeukemia (all)All other sitesTotal28.5%13.7%8.7%6.6%5.5%5.1%4.7%3.2%2.6%2.5%1.6%17.3%100%28.7%13.9%8.9%6.0%5.5%4.6%4.3%3.1%2.8%2.8%2.6%17.0%100%241,740116,47073,42055,60046,89043,12040,25026,83022,09021,37013,950146,440848,170226,870109,69070,04047,13043,21036,07034,35024,52022,28021,83020,320134,430790,740Male Female•  Targeting the 4 largest cancer indications•  Over 50% of all new cancer cases with 840,000 new cases per year in the U.S. alone•  Initial focus on breast cancer, the second most prevalent cancerSource: American Cancer Society, Cancer Facts & Figures 2012Estimated New Cancer Cases by Sex, U.S., 2012
  8. 8. www.metastat.com8Personalized MedicineMEDICINE TOMORROWmust be personalizedRight Treatment for theRight Patient at theRight Time for theRight OutcomePersonalized medicine begins withthe right diagnosisBefore it spreads,We can predict it,So you can treat it properly
  9. 9. www.metastat.com9ageClinical and Histopathological Measures-  Subjective and qualitative information-  Independent of metastatic potential•  Tumor grade•  Tumor size•  Lymph node involvement (# of nodes)•  Hormone status (estrogen (ER), progesterone (PR), HER-2/neu)•  Patients ageOncotype DX (Genomic Health)CURRENTDIAGNOSTICMETHODOLOGIESUnmet Need for Better Diagnosis-  Proliferation•  Early-stage breast cancer•  Recurrence Score and likelyhood of chemotherapy benefit•  ASCO and NCCN breast cancer guidelines (N-, ER+ or PR+)•  Applicable on approx. 55% of all breast cancer patients currentlyProliferation (risk of recurrence)is valuable but only a part of thewhole diagnostic pictureMetastatic Risk ???Other Assays incl. MammaPrint and IHC4-  Proliferation•  Results similar to (in cocordance with) the Oncotype DX RS•  IHC4 - Cuzick et al., Journal of Clinical Oncology, Oct. 2011•  MammaPrint – Fan et al., N Engl J Med, Nov. 2006
  10. 10. www.metastat.com10Metastat Enables Better Personalized DiagnosisMetaStat’s diagnostics accurately predict the probability of cancer metastasizing•  Improve Quality of Treatment Decisions•  Improve Economics of Cancer Care•  Provide “Metastasis Score” or probability of systemic metastasis•  Classify patients into low, medium and high risk groups•  Anticipate personalized treatment recommendations based on response tochemotherapy in future (TBD)*Properly identify and differentiate the metastatic risk of:•  High-risk patients who need aggressive therapy•  Low-risk patients who can be spared from the harmful sideeffects and expense of chemotherapy and/or radiationDeliver report to the treating oncologist(s)* Further studies needed
  11. 11. www.metastat.com11Understanding and Treating MetastasisMetaSite Breast™DiagnosticQuantifies the MechanicsOf Metastasis•  The number of MetaSitespredicts the probability ofmetastasis in breast cancer•  2 successful trials to date•  Published results in ClinicalCancer Research (2009)•  500 patient Large PopulationValidation Study results expectedin early 2013•  Initial pilot marketing anticipatedfollowing publication of resultsMenaCalc™DiagnosticMeasures the Transitionto Metastatic Cells•  Metastatic risk can be predictedby measuring the relativeamounts of the isoforms of mena•  797 patient trialpredicts survivalin breast cancer and correlatesto MetaSite count•  Results published in BreastCancer Research (2012)•  Broad applicability in up to 80%of solid epithelial cancers incl.lung, prostate and colorectalMenaBloc™TherapeuticAnti-MetastaticTherapy•  Therapeutic with the potentialto premptively surpress oreliminate metastasis•  Pre-clinical mouse studyresultsshowed “the removal ofmena eliminated metastasis”•  Results published in BreastCancer Research (2010)•  Developing a small moleculedrug compound with targets ofintervention in key pathways
  12. 12. www.metastat.com12MetaSite Breast™ – Near Term Product OpportunitySimple test performed at our reference lab on formalin fixed parrafin embedded tissuefrom a patients’ tumor biopsy•  No FDA marketing approval required•  Central reference laboratory (CLIA GLP certification)•  No additional procedure(s) on the patient•  Easy and inexpensive to perform and generate the “Metastasis Score” report•  Deliver Metastasis Score report to treating physician in short amount of time (~3 to 5 days)•  Results from 500 patient Large Population Validation Study expected in early 2013•  Initial pilot marketing expected to commence following publication of results•  Identified additional sample cohorts for further validation studies
  13. 13. www.metastat.com13MenaCalc™ – Broad Diagnostic PlatformTissue test using small amounts of dissociated, discontinuous cells from aneedle biopsy or fine needle aspiration (FNA)Broadly applicable:•  Mena and its isoforms are a key regulator of metastatic function in solid epithelial tumors•  Encouraging data in breast, prostate and lung cancersMenaCalc BreastMenaCalc LungMenaCalc ProstateMenaCalc Colorectal•  Data in 797 patients•  Results published in Breast Cancer Research (Sept 2012)•  Conclusion: predicts survival in breast cancer•  Data in 72 patients•  Conclusion: predicts survival in adencarcinoma of the lung•  Completed initial pilot study with encouraging results•  Scientific rationale for the MenaCalc diagnostic to work incolon and rectum cancers
  14. 14. www.metastat.com14MenaBloc™ – Targeted Therapeutic PlatformAnti-metastatic therapeutic to potentially block or eliminate metastasis•  Positive pre-clinical data•  Results published in Breast Cancer Research (2010)•  Deficiency of mena increases survival in PyMT miceContinue drug development including:•  functional screening program and medicinal chemistry and lead optimization
  15. 15. www.metastat.com15Diagnostic Portfolio Market Size and OpportunitySources: 1. American Cancer Society; 2. Management estimates; 3. Assumes one test per new cancer patient@ cost of $2,595 per test. Does not include testing for any previously diagnosed patientsPatient Population(new cases/yr U.S.)1Applicable TargetMarket (%)2Implied ApplicableMarketU.S. Product MarketOpportunity3MetaSiteBreast229,060100%229,060$600M229,060100%229,060$600MMenaCalcBreastMenaCalcLungMenaCalcProstateMenaCalcColorectal241,740100%241,740$625M143,460100%143,460$375M226,16040%90,464$235M$2.4B Total Annual U.S Diagnostic Market Opportunity
  16. 16. www.metastat.com16Key AccomplishmentsExecuted 2 additional License Agreements with corresponding Intellectual PropertyProved MenaCalc diagnostic platform for additional solid epithelial cancers•  Encouraging data in adnocarcenoma of the lung and prostate cancersPositive MenaCalc data in 797 patients published in Breast Cancer Research (Sept. 2012)•  Results showed ability to predict survival in breast cancer“Human Invasion Signature” paper published in Breast Cancer Research (Oct. 2012)•  Describes our genetic profile of highly metastatic cancer cells who’s geneticsignature differs materially from the general population of proliferating tumor cellsCompleted tissue sample staining and evaluation of 500 patient Large Population ValidationStudy for the MetaSite Breast test•  Results anticipated in early 2013In 2012, MetaStat has accomplished the following:
  17. 17. www.metastat.com17Near-Term MilestonesMetaSite Breast•  Results from 500 patient Large Population Validation Study•  Setup CLIA GLP Certified Central Laboratory•  Publish data from 500 patient Large Population Validation Study in top journal•  Commence initial pilot marketing following publication of results•  Initiate additional validation studies (cohorts identified)MenaCalc•  Large scale prostate cancer “proof of concept” study•  Large scale adencarcinoma of the lung “proof of concept” study•  Pilot study colorectal cancer•  Large Population Validation Study in breast cancer with metastatic risk as primary endpointMenaBloc•  Functional screening program for small molecule mena inhibitor•  Medicinal chemistry and lead optimization•  Pre-clinical animal trials on anti-metastatic drug compound•  Continue licensing and partnering discussionsKey Milestones and Goals for the Next 12 to 24 Months
  18. 18. www.metastat.com18Warren C. Lau President, Chief Executive Officer and DirectorOscar Bronsther, M.D., FACS Chief Medical Officer and Chairman•  Chairman, Section of General Surgery at Innova Fairfax Hospital•  Clinical Professor, George Washington University•  Director, Tumor Microenvirnment and Metastasis Program, Albert Einstein Cancer CenterAlbert Einstein College of Medicine of Yeshiva University (AECOM)•  Professor and Co-Chair, Anatomy and Structural Biology, AECOM•  Judith & Burton P. Resnick Chair in Translation Research•  Professor of Biology, Massachusetts Institute of Technology (MIT)•  Gertler Lab, David H. Koch Institute for Integrated Cancer Research at MIT•  Professor, Dep’t of Medicine & Dep’t of Obstetrics, Gynecology, and Women’s Health, AECOM•  Chair of the ECOG Breast Cancer Committee•  Study Chair of TAILORx trial•  Professor of Clinical Pathology and Laboratory Medicine, Weill Cornell Medical College•  Attending Pathologist, New York Presbyterian Hospital•  Professor and Chair, Department of Epidemiology and Population Health, AECOM•  Member of the Board of Scientific Counselors of the National Cancer InstituteJohn S. Condeelis,Ph.D.Frank B. Gertler, Ph.D.Joseph Sparano, M.D.Joan Jones, M.D.Thomas E. Rohan,M.D. ,Ph.D.Experienced Senior Management & Advisors•  Healthcare executive with >20 years start-up and biotechnology experience•  Former founder of AdventRx Pharmaceuticals (ANX) and Opexa Therapeutics (OPXA)
  19. 19. www.metastat.com19Significant unmet clinical need•  Systemic metastasis is responsible for 90% of cancer deaths•  Currently no diagnostic, prognostic or therapeutic specific to systemic metastasis on the market•  Patient misclasifications result in over-treatment for some and under-treatment for othersNovel proprietary technoloogy that allowed us to understand and characterize the behavior,mechanics and genetics of highly metastatic cancer cells•  15+ years and $50M of development and collaboration from 4 scientific/academic institutionsProducts addressing billion dollar markets•  4 largest cancer indications with over 840,000 new cases per year in U.S. alone•  $2.4B+ total annual U.S. diagnostic market opportunityNear-term product opportunity – MetaSite Breast•  No FDA approval required (CLIA GLP certification)•  500 patient Large Population Validation Study results expected in early 2013•  Anticipate initial pilot marketing beginning by end of 2013Broadly applicable diagnostic platform – MenaCalc•  Up to 80% of solid epithelal cancers with encouraging data in breast, lung and prostate cancersDeveloping therapeutic platform to prevent or eliminate metastasis – MenaBloc•  Positive preclinical data published in Breast Cancer Research (2010)Intellectual property in place to protect proprietary innovations around the worldInvestment Highlights
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