Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (April 2013)
35 slides from Cardiff Oncology's investor presentation, Apr 22, 2013
Slide 1: Introduction to Trovagene, Inc.
Introduction to Trovagene, Inc. Antonius Schuh, Ph.D. Chief Executive Officer April 2013
Slide 2: Forward-Looking Statements
Forward-Looking Statements DISCLAIMER Statements in this presentation about the Company's expectations, applications of its technology, markets, launch of tests and other statements that are not historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act
Slide 3: Company Overview
Company Overview Molecular diagnostics company Internal focus in oncology Collaboration opportunities in prenatal diagnostics, infectious diseases and transplant medicine IP protects detection of transrenal nucleic acids in urine (“DNA in urine”) Founded in 1999, $55M invested in R&D and IP NASDAQ l
Slide 4: Experienced Team
Experienced Team INTRODUCTION Executive Management Team Antonius Schuh, PhD, CEO Stephen Zaniboni, CFO Mark Erlander, PhD, CSO Charlie Rodi, PhD, VP and CTO Keith McCormick, VP Comm. Ops Michael Terry, VP Corp. Devel. Scientific Advisory Board Paul Billings, MD, PhD Carlo M. Croce, MD Riccardo Dalla
Slide 5: Cell-free Nucleic Acids: from Blood to Urine
Cell-free Nucleic Acids: from Blood to Urine INTRODUCTION Billions of cells die naturally each day, releasing DNA/RNA Nucleic acids are broken into packets of genetic material which are carried away by the blood stream DNA/RNA fragments are filtered through the kidneys and appears in urine as Transr
Slide 6: Perfect Timing for Next Generation Urine-based Testing
Perfect Timing for Next Generation Urine-based Testing Enables Unique Opportunity Next generation sequencing technologies Next generation digital PCR platforms Breadth of novel molecular diagnostic markers Urine-based Molecular Tests Broad range of clinical applications Replace complex and less robu
Slide 7: Broad Clinical Utility
Transplantation In recipient urine for acute allograft rejection Prenatal Diagnostics In maternal urine for aneuploidy screening Infectious Disease Viruses: HPV, HIV, EBV, JC Bacteria: Mycobacterium tuberculosis, Helicobacter pylori, Bacillus anthracis Parasites: Leishmania, Plasmodium Oncology KRAS
Slide 8: Transrenal Nucleic Acid IP Portfolio
Transrenal Nucleic Acid IP Portfolio Issued Tumor detection and monitoring Infectious diseases Transplantation monitoring Prenatal diagnostics Pending Circulating cell-free nucleic acid isolation from body fluids Diagnostic applications of miRNA from urine and other bodily fluids Methods for detecti
Slide 9: Clear Advantages Over Other Specimens
Clear Advantages Over Other Specimens VALUE PROPOSITION Feature Urine Blood Biopsy Ease of Sample Collection Truly non-invasive No physician or healthcare provider needed Sample Stability and Safety Ships at ambient temperatures Ideal for centralized testing facilities Specimen is not considered a b
Slide 10: Commercialization Through CLIA Lab and Out-licensing
Commercialization Through CLIA Lab and Out-licensing Q1 2013: HPV carrier test Q2 2013: KRAS Q3 2013: BRAF Q4 2013: PIK3CA, HBV, p53 (Hepatocellular Carcinoma) Commercialize urine based diagnostic tests through CLIA lab Transplant medicine Prenatal medicine Infectious disease Export markets Portfoli
Slide 11: Trovagene's Proprietary HPV Test
Trovagene’s Proprietary HPV Test
Slide 12: HPV in Urine: US Market Dynamics
HPV in Urine: US Market Dynamics Estimated 11-12M HPV tests run annually (US) 1 Represents only about 35% market penetration 8.7 – 14.2% of cases come back as positive2 Repeat HPV testing often performed at 6 and 12 months No convenient test for male partner to check for carrier status Potentially >
Slide 13: Advantages of Urine-Based HPV DNA Assay
Advantages of Urine-Based HPV DNA Assay High Specificity High Sensitivity Non-invasive procedure – No Pap Smear or other tissue sample required Home-based collection possible (Cost effective, enhances patient privacy & convenience) Reduces cultural barriers inhibiting use of cervical based tests, im
Slide 14: HPV-HR Assay CLIA Lab Test Results
HPV–HR Assay CLIA Lab Test Results HPV NCI SUCCEED samples Patient 2961 - negative Patient 2972 - negative Patient 2858 - positive Patient 2972 - positive Assay conditions: PCR template = 5ul DNA solution in 25ul reaction Capillary Electrophoresis = 0.5ul undiluted reaction; Signal also acceptable w
Slide 15: HPV-HR Test Feasibility Results
HPV-HR Test Feasibility Results HPV Urine HPV Test Number of Patients Total High Risk Low Risk High Risk 133 7 140 Low Risk 10 170 180 Total 143 177 320 Trovagene QIAGEN Sensitivity: 93.0% 78.3% Specificity: 96.0% 86.4% Clinical Study Results
Slide 16: International Validation Collaborators
International Validation Collaborators India Simbiosys Bioware / Metropolis 320 patient cohort complete Strand Life Science Study ongoing Brazil Barretos Cancer Hospital – largest cancer hospital in Brazil 350 patient cohort - enrollment underway Europe (UK) Queen Mary University of London PREDICTOR
Slide 17: Potential Revenue: HPV Addressable Market
Potential Revenue : HPV ADDRESSABLE MARKET *Based on average number of positive HPV tests (range 8-14%) resulting from 12M women tested annually HPV-Patient HPV-Partner Totals Total Patients 1.54M* 1.54M 3.08M Assay Price $150 $150 NA 1% Penetration $2.3M $2.3M $4.6M 3% Penetration $6.9M $6.9M $13.8
Slide 18: Trovagene's Oncogene Mutation Detection
Trovagene’s Oncogene Mutation Detection
Slide 19: > $40B Addressable US Oncology Market
> $40B Addressable US Oncology Market Market for Cancer Testing / Monitoring Cancer Patient Monitoring: TAM US > $14B 18 million cancer patients & survivors by 2020 (US only)* 2 monitoring tests per case per year Early detection of cancer: TAM US > $27B 180 million people > 40 years old by 2020 Test
Slide 20: Potential Utility of Assays
Potential Utility of Assays UTILITY OF TROVAGENE ASSAYS Monitoring Therapy Resection Recurrence Near Real-time Results Assess Treatment Outcomes Response Rate Stable Disease Progressing Disease Progression-free Survival Overall Survival No Mutation Detected Successful Surgery Mutation Detected Incom
Slide 21: Oncology Clinical Development
Oncology Clinical Development POINT OF DIAGNOSTIC ENTRY Patient diagnosed with metastatic cancer CT/PET scans Standard of Care Expensive $3000/scan Radiation exposure Patient hassle Not real-time evaluation of response Receives chemotherapy and/or molecularly targeted therapy DIAGNOSIS THERAPY MONIT
Slide 22: TrNA Scientific Publications
TrNA Scientific Publications Numerous scientific publications DNA mutation detection Viral mutants KRAS p53 miRNA Cancer Transplants Kidney Disease Prenatal Diagnostics PUBLICATIONS
Slide 23: Quantitatively Measure Patient Response to Therapy
Quantitatively Measure Patient Response to Therapy Conclusion of Study The management of metastatic breast cancer requires monitoring of the tumor burden to determine response to treatment Improved biomarkers to measure this are greatly needed Measurement of circulating tumor DNA (ct DNA) was superi
Slide 24: Technology Leadership
Technology Leadership Isolation of short nucleic acid fragments from urine Yields are significantly higher than from competitors kits Higher yields mean more molecules to detect Development of ultra-short amplicon assays Optimizes detection of the short nucleic acids that pass through the kidney Sho
Slide 25: Trovagene Isolation Method Outperforms Competitors
Trovagene Isolation Method Outperforms Competitors ONCOLOGY: REQUIREMENTS: SAMPLE PREPARATION For small target purification. Detection of 50 bp target spiked into identical 10 mL urine samples. First Elution First and Second Elutions Combined Total Number of Copies
Slide 26: KRAS G12D Mutation Detection in Clinical Samples
KRAS G12D Mutation Detection in Clinical Samples ONCOLOGY: KRAS DETECTION TROV-02 G12D G12R G12V TROV-01 G12D G12R G12V TROV-03 G12D G12R G12V Results for 2 DG8 wells plotted = 90ng DNA
Slide 27: Clinical Sample Sets
Clinical Sample Sets Mutation Cancer Type Total Mutation Positive Patients (U.S.) Principal Investigator Institution Status Start Date KRAS Pancreatic 26,049 Katz MD Anderson Accrual in Progress August KRAS Colorectal 399,056 TBD BRAF Melanoma, Thyroid, Colorectal, Ovary 729,370 Janku MD Anderson Ac
Slide 28: Mutation Tracking for Management of Any Cancer
Mutation Tracking for Management of Any Cancer ONCOLOGY: PERSONALIZED TUMOR MUTATION MONITORING Configure TROV-MUT Assay(s) Count individual wild type and mutant molecules Any Cancer For any patient, determine mutation profile Determine Mutation Profile Directed NexGen Sequencing of Oncogenes
Slide 29: Potential Revenue: First Set of Mutation Markers
Potential Revenue : First Set of Mutation Markers ADDRESSABLE MARKET Assumes 2 tests/year per patient Mutation KRAS BRAF PIK3CA Totals Total Patients 625,000 729,000 989,000 2,343,000 Assay Price $400 $400 $400 NA 1% Penetration $5.0M $5.8M $7.9M $18.7M 3% Penetration $14.9M $17.5M $23.7M $56.2M 5%
Slide 30: 2013 Milestones
2013 Milestones Oncology Mutation Detection Tests Launch KRAS 2Q 2013 Launch BRAF 3Q 2013 Launch PIK3CA 4Q 2013 Launch HCC – HBV and p53 4Q 2013 Expand Clinical Collaboration Program Add Clinical Trial Collaborators 4Q 2013 Execute Commercial Sales and Marketing Plan Initiate HPV Pilot Launch 1Q 201
Slide 31: Summary
Summary
Slide 32: 2012 Achievements
2012 Achievements CONCLUSION Acquired CLIA Laboratory CAP certified, high complexity molecular diagnostic lab Strengthened Patent Portfolio Issued U.S. Patent for NPM Mutants to Diagnose and Monitor Acute Myeloid Leukemia Issued European Patent for Detection of Pathogenic Infections Improved Liquidi
Slide 33: 2013 Achievements
2013 Achievements Launched High Risk HPV Carrier Screening Test Initiated launch in Southern California in Q1 2013 Extended Oncogene Mutation Detection Development Program Began Second Study at MD Anderson Cancer Center focusing on BRAF and KRAS Mutations in 2013 Initiated HCC development program Ex
Slide 34: Capitalization Table
Capitalization Table FINANCIALS AND CAPITALIZATION (000’s) December 31, 2012 Common Stock Outstanding 15,478 Series A Convertible Preferred Stock 99 Outstanding Options Exercise price ($3.00 - $15.00) 3,711 Outstanding Warrants Exercise price ($3.00 - $10.80) 6,985 Total Fully Diluted Shares Outstan
Slide 35: Please contact
Please contact: For further information Antonius Schuh, CEO aschuh@trovagene.com Stephen Zaniboni, CFO szaniboni@trovagene.com