Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (November 2012)
33 slides from Cardiff Oncology's investor presentation, Nov 6, 2012
Slide 1: Introduction to Trovagene, Inc.
Introduction to Trovagene, Inc. Antonius Schuh, PhD Chief Executive Officer November 2012
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, $40M invested in R&D and IP Hired ne
Slide 4: Experienced Management Team
Experienced Management Team CEO - Antonius Schuh, PhD Sorrento Therapeutics, AviaraDx, Arcturus Biosciences, Sequenom CFO - Stephen Zaniboni, MBA, CPA Awarepoint, Xifin, AviaraDx, Sequenom, Arthur Anderson CTO - Charlie Rodi, PhD Sorrento Therapeutics, Icx BioSystems, Sequenom, Monsanto/G.D. Searle
Slide 5: Corporate Board and Scientific Advisory Board
New Website – www.trovagene.com INTRODUCTION Corporate Board Thomas Adams, PhD - Chairman John P. Brancaccio, CPA Gabriele M. Cerrone, MBA Gary S. Jacob, PhD Antonius Schuh, PhD Stanley Tennant, MD Scientific Advisory Board Carlo M. Croce, MD Riccardo Dalla-Favera, MD Mark Erlander, PhD Brunangelo F
Slide 6: What are Transrenal Nucleic Acids (TrNAs)
What are Transrenal Nucleic Acids (TrNAs) 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 Transrena
Slide 7: Perfect Timing for Next Generation Urine-based Testing
Perfect Timing for Next Generation Urine-based Testing IINTRODUCTION
Slide 8: 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 9: 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 10: Clear Advantages Over Other Specimens
Clear Advantages Over Other Specimens VALUE PROPOSITION
Slide 11: Oncogene Mutation Detection
Oncogene Mutation Detection
Slide 12: Market Entry: Oncology
Market Entry: Oncology Very large market opportunity Demonstration of clinical utility is straight-forward Urine as a sample has enabling features for this market Role of oncogene mutation detection is already established Patients are concentrated at large oncology centers ADDRESSABLE MARKET
Slide 13: > $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 at $400 Early detection of cancer: TAM US > $27B 180 million people > 40 years old by 2020 Testing every other year Price tren
Slide 14: Oncogene Mutation Test Rollout
Oncogene Mutation Test Rollout Q4 12 Q1 13 Q2 13 Test Release Cancer Site Involvement ( > 10% Mutation Prevalence) ADDRESSABLE MARKET
Slide 15: 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 16: 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 17: 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 18: 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 19: 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 20: KRAS: Improved Assays
KRAS: Improved Assays ONCOLOGY: REQUIREMENTS: MUTATION ASSAYS Effect of Amplicon Size on Digital Detection Sample # 80 bp Positives as % of 110 bp Positives 1 180% 2 217% 3 222% 4 185% 5 215% Average Improvement 204% Expected Percent of Molecules Detected Target size (bp) 146 Amplicon size (bp) 110
Slide 21: KRAS (55 bp) Assays
KRAS (55 bp) Assays ONCOLOGY: REQUIREMENTS: MUTATION ASSAYS Digital quantification Excellent separation of signal from noise Excellent specificity
Slide 22: 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 23: 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 24: Clinical Sample Sets
Clinical Sample Sets ONCOLOGY: REQUIREMENTS: CLINICAL SAMPLES
Slide 25: Extending Mutation Tracking to All Cancers
Extending Mutation Tracking to All Cancers ONCOLOGY: TUMOR MUTATION MONITORING Track Mutation(s): Inform Medical Practice Determine progression Monitor minimal residual disease (MRD) Manage treatment (radiation, chemotherapy) Monitor for recurrence Configure Mutation Assays Count individual wild typ
Slide 26: 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 27: Summary and Financials Through June 30, 2012
Summary and Financials Through June 30, 2012
Slide 28: Strategy Summary
Strategy Summary Defined a unique multi-billion dollar market opportunity Oncogene mutations are prevalent across a broad range of cancers Mutation assays can be compiled into personalized panels Monitor progression, re-occurrence/residual disease and therapy response Requires repeat testing and cre
Slide 29: Commercialization Through CLIA Lab and Out-licensing
Commercialization Through CLIA Lab and Out-licensing COMMERCIALIZATION STRATEGY
Slide 30: Balance Sheet
Balance Sheet (In Thousands) June 30, 2012 December 31, 2011 Cash & Cash Equivalents 9,304 700 Other Assets 648 339 Total Liabilities 4,463 5,270 Total Shareholder’s Equity (Deficiency) 5,489 (4,231) Financials and Capitalization
Slide 31: Capitalization Table
Capitalization Table (000’s) June 30, 2012 Common Stock Outstanding 14,175 Series A Convertible Preferred Stock 96 Outstanding Options Exercise price ($3.00 - $15.00) 3,062 Outstanding Warrants Exercise price ($3.00 - $10.80) 5,730 Total Fully Diluted Shares Outstanding 23,062 Financials and Capital
Slide 32: For further information contact
For further information contact: Antonius Schuh, CEO aschuh@trovagene.com Stephen Zaniboni, CFO szaniboni@trovagene.com
Slide 33: Strategy
Strategy Define a unique market space which represents a multi-billion opportunity Dominate market space by offering products that are highly differentiated and defended by IP Elements of Trovagene’s strategy to accomplish this: Target oncogene mutations that are prevalent across a broad range of ca