Lineage Cell Therapeutics, Inc. · AMEX:LCTX
Lineage Cell Therapeutics — Biotime — Investor Presentation (September 2014)
33 slides from Lineage Cell Therapeutics's investor presentation, Sep 25, 2014
Slide 1: Joseph Wagner, Ph.D. Chief Executive Officer
Joseph Wagner, Ph.D. Chief Executive OfficerSeptember 25, 2014
Slide 2: OncoCyte Corporation
OncoCyte Corporation * Our mission is to develop novel products for the diagnosis and treatment of cancer in order to improve both the quality and length of life of cancer patients Internally developed cancer gene discovery platformPlatform based on extensive microarray datasetMarker discovery princ
Slide 3: OncoCyte Investment Opportunity
OncoCyte Investment Opportunity * Multiple clinical studies reporting by year-end 2014, coupled with very large market potential of products may yield large, near-term valuation increases Initial clinical validation studies on three diagnostic products reporting by year-end 2014Novel molecular cance
Slide 4: OncoCyte Presentation Highlights
OncoCyte Presentation Highlights * Our mission is to develop novel products for the diagnosis and treatment of cancer in order to improve both the quality and length of life of cancer patients Technology OverviewBusiness StrategyProduct Development & Marketing PathProduct ProgramsBreast Cancer Diagn
Slide 5: OncoCyte Technology
OncoCyte Technology * Many of the same genes that drive embryonic development drive tumor formation and growth A substantial proportion of the mammalian genome is exclusively activated during embryonic developmentThese embryo-exclusive genes regulate:Cell proliferationCell signalingOrgan formationAn
Slide 6: OncoCyte's Product Development Path
OncoCyte’s Product Development Path * Translating proprietary cancer marker platform into near-term revenue opportunities in oncology markets Cancer Marker Discovery (2011-):Assembled >700 sample microarray dataset Bioinformatics generated >3000 candidate markersProtection of Intellectual Property (
Slide 7: OncoCyte Publications
OncoCyte Publications * Validation of cancer marker biology through peer-review process Many more to come…
Slide 8: Example 1: COL10A1
Example 1: COL10A1 * COL10A1 is normally only expressed during embryonic development and regulates long bone mineralization Tumors Tumor Cell Lines Normal Cells Normal Tissues Data from Illumina microarray shows high levels of COL10A1 expression in a majority of tumor samples tested with little expr
Slide 9: Example 2: FSIP1
Example 2: FSIP1 * FSIP1 is a protein normally only expressed in the tail of mature male sperm cells Data from Illumina microarray shows high levels of FSIP1 expression in a majority of breast cancer samples tested with no expression elsewhereFSIP1 represents a novel breast cancer-specific biomarker
Slide 10: Multiplex Breast Cancer Biomarker Panel
Multiplex Breast Cancer Biomarker Panel * Normal Donors Breast Cancer Patients Preliminary data compilation shows discrimination between breast cancer patient serum and normal donor serum. Individual biomarker expression in patient samples validates microarray dataCombining individual markers demons
Slide 11: OncoCyte's Business Formula
OncoCyte’s Business Formula * Designed to translate proprietary cancer marker platform into near-term revenue opportunities “Listen to Your Technology”“Listen to Your Customers”Create Scalable Business ModelEarly Revenues Fund Larger Trials
Slide 12: "Listen to Your Technology"
“Listen to Your Technology” * Technology platform defines product opportunities in subsectors of cancer diagnostics Potential products based on dataset structure:Screening diagnosticsRecurrence diagnosticsPotential products based on markers:Breast cancerColorectal/GI cancersBladder/urothelial cancer
Slide 13: "Listen to Your Customer"
“Listen to Your Customer” * Physician adoption is the key barrier to entry for cancer screening diagnostics User Will Adopt Tests That:Key Opinion Leaders supportResolve diagnostic dilemmasJustify the need for proceduresEliminate unnecessary proceduresHave reasonable cost/reimbursementUser Will Not
Slide 14: OncoCyte Products: Business Strategy
OncoCyte Products: Business Strategy * How does OncoCyte identify and prioritize its products? Strategically develop diagnostic products that will be rapidly adopted and have short- and long-term revenue potentialFocus on developing products that:Fit with proprietary technologyAre simple to perform
Slide 15: Product Development & Marketing Strategy
Product Development & Marketing Strategy * Create a scalable business model beginning with an immediate market with early adopters, successively expanding into larger opportunities $15M Initial Initial Use & Market:Early adopters with immediate needsCan be addressed rapidly with relatively low costE
Slide 16: Key Driver: Limitations of Current Tests
Key Driver: Limitations of Current Tests * Initial users/use will be to clarify diagnostic dilemmas due to uncertainties in imaging and other traditional tests Current Tests With Significant Limitations Include:Mammography for breast cancerUrine cytology for bladder cancer recurrence surveillanceLow
Slide 17: Current Product Programs
Current Product Programs * Simple, low cost cancer screens that address current unmet user needs in large patient markets ONC-BR-001:Blood-based breast cancer screenMeasures sera proteins via ELISAONC-BL-002:Urine-based bladder cancer screenMeasures RNA levels via PCRONC-LN-003:Blood-based lung canc
Slide 18: ONC-LN-003: Lung Cancer Product
* Initial test use late in diagnostic tree with progressive data driving test use earlier and earlier ONC-LN-003: Lung Cancer Product
Slide 19: ONC-LN-003: Lung Cancer Product
* Initial test use late in diagnostic tree with progressive data driving test use earlier and earlier ONC-LN-003: Lung Cancer Product
Slide 20: ONC-LN-003: Lung Cancer Product
ONC-LN-003: Lung Cancer Product * Blood-based lung cancer screen for high-risk population Initial Use & Market:Radiologists/thoracic surgeons: Management of imaging positive patients350K tests/year in USExpanded Use & Market:Radiologists/thoracic surgeons: Management of all LDCT+ patients1.75M tests
Slide 21: ONC-LN-003: Lung Cancer Clinical Study
ONC-LN-003: Lung Cancer Clinical Study * Ongoing study in target population initiated by collaborators at the Wistar Institute Subjects:N = 600All high-risk, includes cancer-free, benign nodules, confirmed cancer patientsEndpoints:Primary: Correlation with diagnosisSecondary: Correlation with tumor
Slide 22: ONC-BL-002: Bladder Cancer Product
* Initial test use late in diagnostic tree with progressive data driving test use earlier and earlier ONC-BL-002: Bladder Cancer Product
Slide 23: ONC-BL-002: Bladder Cancer Product
* Initial test use late in diagnostic tree with progressive data driving test use earlier and earlier ONC-BL-002: Bladder Cancer Product
Slide 24: ONC-BL-002: Bladder Cancer Diagnostic
ONC-BL-002: Bladder Cancer Diagnostic * Urine-based multiplex PCR recurrence diagnostic test $15M $15M Initial Use & Market:Pathologist: Resolution of indeterminate cytology during recurrence surveillance500K tests/year in USExpanded Use & Market:Oncologist: All recurrence surveillance1.5M test/year
Slide 25: ONC-BL-002: Bladder Cancer Clinical Studies
ONC-BL-002: Bladder Cancer Clinical Studies * Multisite clinical studies in setting of surveillance cytology testing or cystoscopy Subjects:N = 100/1200At time of surveillance cytology/cystoscopyEndpoints:Correlation of markers to cytology/cystoscopy resultsSites:Cytopathology: Johns HopkinsCystosco
Slide 26: ONC-BR-001: Breast Cancer Product
* Initial test use late in diagnostic tree with progressive data driving test use earlier and earlier ONC-BR-001: Breast Cancer Product
Slide 27: ONC-BR-001: Breast Cancer Product
* ONC-BR-001: Breast Cancer Product Initial test use late in diagnostic tree with progressive data driving test use earlier and earlier
Slide 28: ONC-BR-001: Breast Cancer Product
ONC-BR-001: Breast Cancer Product * Blood-based screening diagnostic measures sera protein biomarkers using ELISA $15M $25M Initial Use & Market:Radiologist: Management of BIRADS 3-4 patients350K tests/year in USExpanded Use & Market:Radiologist: In conjunction with all diagnostic mammographyOncolog
Slide 29: ONC-BR-001: Breast Cancer Clinical Study
ONC-BR-001: Breast Cancer Clinical Study * Prospective, multisite study in diagnostic mammography patients Subjects:N = 600At time of diagnostic mammographyEndpoints:Primary: Correlation with BIRADS scoreSecondary: Correlation of biomarker with pathologySites:Up to 6 totalCurrently enrolling: Ron Ko
Slide 30: Adoption Strategy
Adoption Strategy * Superior product at lower cost to drive rapid adoption in initial markets, followed by widespread adoption KOL endorsementsDrive adoption within KOLs’ own practices as well as among other physiciansCan lead to medical society recommendationsStrong Clinical Trial DataSupports posi
Slide 31: Reimbursement Strategy
Reimbursement Strategy * Favorable reimbursement potential for multiplex molecular tests despite recent CMS changes Anticipated Reimbursement for Our Tests:Each test would receive new 815XX codeApril 2014 Medicare patch exempts molecular tests from pricing cutsPotential for value-based pricing is re
Slide 32: Upcoming Development Milestones
Upcoming Development Milestones * Positive clinical trial results will drive commercialization efforts with first test launch in 2015 Q4 2014: Completion of breast, bladder and lung clinical trial enrollment and data analysisPublication of lung trial results; submission of clinical study data for pr
Slide 33: OncoCyte: Investment Highlights
OncoCyte: Investment Highlights * Beginning with an immediate market with early adopters, expanding into large opportunities Broad platform of cancer markersLow-cost tests using standard methodsPotential for rapid initial adoption and broad eventual adoptionScalable business model:Significant revenu