Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (February 2013)
33 slides from Cardiff Oncology's investor presentation, Feb 12, 2013
Slide 1: Introduction to Trovagene, Inc.
Introduction to Trovagene, Inc. Antonius Schuh, PhD Chief Executive Officer 13 February 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: Trovagene's Mission
Trovagene’s Mission Trovagene is committed to developing urine-based molecular diagnostics as an enabling technology that can transform the way physicians diagnose, monitor and treat disease. By analyzing genomic markers in urine rather than in blood, Trovagene introduces a systemic liquid biopsy fo
Slide 4: Experienced Management Team
Experienced Management Team INTRODUCTION Executive Management Team Antonius Schuh, PhD, CEO Stephen Zaniboni, CFO 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-Favera, MD M
Slide 5: Urine-based Detection of Molecular Markers
Urine-based Detection of Molecular Markers VALUE PROPOSITION 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 Tra
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 High Risk HPV Test
Trovagene’s Proprietary High Risk HPV Test
Slide 12: Trovagene HPV DNA Test Value Proposition
Trovagene HPV DNA Test Value Proposition No Pap Smear or other tissue sample required Unique primer pair amplifying the E1 region provides Freedom-To-Operate (FTO) for molecular HPV testing E1 region offers novel, proprietary approach to high risk HPV identification Trovagene’s patented method for D
Slide 13: HPV in Urine: US Market Dynamics
HPV in Urine: US Market Dynamics Estimated 12-15M 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 14: Advantages of Urine-Based HPV DNA Assay
Advantages of Urine-Based HPV DNA Assay High Specificity High Sensitivity Non-invasive procedure – no cervical scraping needed Home-based collection possible (Cost effective, enhances patient privacy & convenience) Reduces cultural barriers inhibiting use of cervical based tests, improving complianc
Slide 15: Transfer to Trovagene CLIA Lab is in Progress
Transfer to Trovagene CLIA Lab is in Progress 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 accep
Slide 16: Trovagene Test Feasibility
Trovagene Test Feasibility 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 17: 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 18: HPV: US Launch March 2013
HPV: US Launch March 2013 Southern California Pilot Launch Target 600 Ob-Gyns in Orange, Riverside and San Diego Counties Use of direct mail to promote awareness and trial Three waves of direct mail planned Web-based promotion and awareness building Internal Client Services to follow up on lead gene
Slide 19: Oncogene Mutation Detection
Oncogene Mutation Detection
Slide 20: > $40B Addressable US Oncology Market
> $40B Addressable US Oncology Market 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 Testing every other year First three planne
Slide 21: 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 22: Detection of KRAS Mutations in Both Urine and Blood
Detection of KRAS Mutations in Both Urine and Blood ONCOLOGY: TUMOR MUTATION MONITORING Blood Lecomte T, et al. 2010. Circulating free tumor DNA and colorectal cancer. Gastroenterol Clin Biol. 34(12):662-81. Diehl F, et al. 2008. Circulating mutant DNA to assess tumor dynamics. Nat Med. 14(9):985-90
Slide 23: 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 24: 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 25: 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 26: Mutation Detection – Comparison to Published Data
Mutation Detection – Comparison to Published Data ONCOLOGY: KRAS DETECTION Stage Ave. # of Fragments Analyzed Ave. # of Mutant Fragments Adenoma 8,000 2 A 5,374 2 B 3,359 30 D 4,999 359 Results for all DG8 wells; 8 wells (360 ng DNA) for TROV-01 and TROV-03; 6 wells (270 ng DNA) for TROV-02. Stage S
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: Summary and Financials
Summary and Financials
Slide 30: 2012/2013 Achievements
2012/2013 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 Li
Slide 31: Potential Revenue: First Set of Mutation Markers
Potential Revenue : First Set of Mutation Markers ADDRESSABLE MARKET Assumes 2 tests/year per patient
Slide 32: Capitalization Table
Capitalization Table FINANCIALS AND CAPITALIZATION (000’s) December 31, 2012 Common Stock Outstanding 15,428 Series A Convertible Preferred Stock 96 Outstanding Options Exercise price ($3.00 - $15.00) 3,585 Outstanding Warrants Exercise price ($3.00 - $10.80) 6,978 Total Fully Diluted Shares Outstan
Slide 33: Please contact
Please contact: For further information Antonius Schuh, CEO aschuh@trovagene.com Stephen Zaniboni, CFO szaniboni@trovagene.com