Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (August 2012)
52 slides from Cardiff Oncology's investor presentation, Aug 29, 2012
Slide 1: Introduction to Trovagene, Inc.
Introduction to Trovagene, Inc. Antonius Schuh, PhD Chief Executive Officer August 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 Clinical 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 over a decade Headquart
Slide 4: Experienced Core Management Team
Experienced Core Management Team OUR TEAM Charlie Rodi, PhD Chief Technology Officer Vice President Research & Development/Collaborations, Sorrento Therapeutics, Inc. (SRNE.OB) (2009 – 2011) Senior Fellow, ICx BioSystems, (2007 – 2009) Founder, CEO, Rodi Pharma, Inc. (2002 – 2006) Executive Vice Pre
Slide 5: Board & Scientific Advisory Board
Board & Scientific Advisory Board OUR TEAM Scientific Advisory Board Carlo M. Croce, MD John W. Wolfe Chair, Human Cancer Genetics, and Chairman, Department of Molecular Virology, Immunology and Medical Genetics, and Director of the Human Cancer Genetics Program and the Genetics Institute at Ohio St
Slide 6: Trovagene: Cell-free Nucleic Acids in Urine
Trovagene: Cell-free Nucleic Acids in Urine Urine-based detection of systemic molecular markers Oncology Detection of oncogene mutations Infectious Disease Transplantation Prenatal Diagnostics INTRODUCTION Our Value Proposition
Slide 7: Perfect Timing for Next Generation Urine-based Testing
Perfect Timing for Next Generation Urine-based Testing MARKET TIMING Why Now?
Slide 8: Clear Advantages Over Competing Technologies
Clear Advantages Over Competing Technologies Ease of sample collection No physician required Self-sampling possible Virtually no sample volume and sampling frequency limitations Ideal for monitoring applications Enrichment of target for better chance to detect rare events Ideal to detect disease ons
Slide 9: What are Transrenal Nucleic Acids (TrNAs)
What are Transrenal Nucleic Acids (TrNAs) TECHNOLOGY & IP 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 10: Origins of Detectable TrDNA/TrRNA in Urine
Origins of Detectable TrDNA/TrRNA in Urine TECHNOLOGY & IP Urine Fetus Tumor Auto-Immunity Transplant Infections
Slide 11: Broad Clinical Utility
Transplant markers In recipient urine for acute allograft rejection Fetal DNA markers In maternal urine for aneuploidy screening Pathogens Viruses: HPV, HIV, EBV, JC Bacteria: Mycobacterium tuberculosis, Helicobacter pylori, Bacillus anthracis Parasites: Leishmania, Plasmodium Tumor markers KRAS: Co
Slide 12: Molecular Cancer Diagnostics
Molecular Cancer Diagnostics Oncogene mutations, miRNAs
Slide 13: >$40B Addressable US Oncology Market
>$40B Addressable US Oncology Market Cancer Patient Monitoring: TAM US > $10B 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 trend
Slide 14: KRAS Mutations in Cancer
KRAS Mutations in Cancer 38%/45% (female/male) lifetime risk of cancer with a 20%/23% mortality risk* KRAS mutations present in 22% of all cancer tissue samples examined by the Sanger Center** Prevalence of KRAS mutations in pancreatic cancer More sensitive detection methods suggest 100% contain KRA
Slide 15: Detection of KRAS Mutations in Urine
Detection of KRAS Mutations in Urine KRAS mutation detection to Determine completeness of surgery Monitor therapy response Detect onset of disease recurrence Feasibility of urine test demonstrated* Comparable blood-based test requires minimum 50mL blood sample** * Serdyuk OI, Botezatu IV, Shelepov V
Slide 16: KRAS: Comparison of Urine vs. Blood-based Detection
KRAS: Comparison of Urine vs. Blood-based Detection ONCOLOGY: TUMOR MUTATION MONITORING Source: Su et al., Cancer Biomarkers 1 (2005), 177 - 182 More Sensitive Detection of KRAS Mutations in Urine vs. Plasma Tissue and KRAS Result Urine Sample Plasma Sample Colorectal Cancer, KRAS + 5/5 (100%) 2/5 (
Slide 17: KRAS: Informing Pancreatic Cancer Care
KRAS: Informing Pancreatic Cancer Care ONCOLOGY: TUMOR MUTATION MONITORING Track KRAS: Inform Medical Practice Determine progression No progression – operate Progression – do not operate Manage radiation, chemotherapy Achieve baseline: stop treatment Mutation levels cycle: continue treatment Mutatio
Slide 18: 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 19: Required Components
Required Components ONCOLOGY: TUMOR MUTATION MONITORING Clinical samples: matched biopsy and urine samples Robust sample preparation of TrNAs Small footprint mutation assays CLIA laboratory
Slide 20: Clinical Sample Sets
Clinical Sample Sets ONCOLOGY: REQUIREMENTS: CLINICAL SAMPLES
Slide 21: Trovagene Purification Outperforms Competitors
Trovagene Purification 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 22: 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 23: Molecular Cancer Diagnostics Commercial Market Assessments
Molecular Cancer Diagnostics Commercial Market Assessments June, 2012
Slide 24: KRAS Mutations in Cancer
KRAS Mutations in Cancer 38%/45% (female/male) lifetime risk of cancer with a 20%/23% mortality risk* KRAS mutations present in 22% of all cancer tissue samples examined by the Sanger Center** Prevalence of KRAS mutations in pancreatic cancer More sensitive detection methods suggest 100% contain KRA
Slide 25: KRAS Mutations – Potential US Market
KRAS Mutations – Potential US Market COMMERCIALIZATION STRATEGY Therapies affected by KRAS mutations include Erbitux (cetuximab), Vectibix (panitumumab) and TKI inhibitors Based on http://seer.cancer.gov/csr/1975_2009_pops09 based on November 2011 SEER data submission, multiplied by prevalence of mu
Slide 26: BRAF Mutations – Potential US Market
BRAF Mutations – Potential US Market COMMERCIALIZATION STRATEGY BRAF therapies include Zelboraf (vemurafenib), dabrafinib (GSK2118436)(pending approval), both for metastatic melanoma. Zelboraf (vemurafenib) is currently in a Phase II trial for thyroid cancer. Based on http://seer.cancer.gov/csr/1975
Slide 27: PIK3CA Mutations – Potential US Market
PIK3CA Mutations – Potential US Market COMMERCIALIZATION STRATEGY Treatments in development include perifosine (Ph III), MK-2206, CAL101, PX-866 (all Ph I-II). PIK3CA known to influence effectiveness of MTOR therapies - Toresil (temsirolimus), Afinitor (everolimus) Based on http://seer.cancer.gov/cs
Slide 28: Potential Revenue: 1st Three Mutation Markers
Potential Revenue : 1st Three Mutation Markers COMMERCIALIZATION STRATEGY Assumes validation data available for use in monitoring treatment response and recurrence Assumes 2 tests / year per patient at $400 per test
Slide 29: Launch KRAS Mutation Test
Launch KRAS Mutation Test COMMERCIALIZATION STRATEGY Initial study in pancreatic cancer patients with MDACC Validate feasibility of urine as a sample Broadly promote results across pancreatic cancer centers Develop opinion leader support within cancer centers Promote data through publications and sc
Slide 30: Building Advocacy – Key Opinion Leaders (KOLs)
Building Advocacy – Key Opinion Leaders (KOLs) COMMERCIALIZATION STRATEGY Clinical Trials Clinical Experience KOLs Advisory Boards & Society Meetings Literature & Medical Affairs Outreach
Slide 31: 2012 Key Milestones
2012 Key Milestones COMMERCIALIZATION STRATEGY Q1 Establish KRAS assay using digital PCR platform Recruit clinical study sites for KRAS mutation monitoring in pancreatic cancer patients Q2 Analytical validation of KRAS wild type and mutant assays Q3 Establish concordance of tissue- and urine-based m
Slide 32: Recent News & Events
Recent News & Events INTRODUCTION Strengthened Patent Portfolio Received Notification of Issuance of U.S. Patent for NPM Mutants to Diagnose and Monitor Acute Myeloid Leukemia on July 18, 2012 Received Notification of Issuance of European Patent for Detection of Pathogenic Infections on May 10, 2012
Slide 33: Commercialization Through CLIA Lab and Out-licensing
Commercialization Through CLIA Lab and Out-licensing COMMERCIALIZATION STRATEGY
Slide 34: Financials and Capitalization
Financials and Capitalization Through June 30, 2012
Slide 35: 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)
Slide 36: Capitalization Table
Capitalization Table June 30, 2012 (000’s) 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
Slide 37: Consolidated Profit and Loss
Consolidated Profit and Loss Statement of Operations (in thousands, except per share data) 3 months ended June 30, 2011 3 months ended June 30, 2012 6 months ended June 30, 2011 6 months ended June 30, 2012 Total Revenue 41 80 75 168 Total Operating Expenses 1,287 727 2,452 1,536 Net Loss from Opera
Slide 38: Appendix
Appendix
Slide 39: Broad Clinical Utility
Transplant markers In recipient urine for acute allograft rejection Fetal DNA markers In maternal urine for aneuploidy screening Pathogens Viruses: HPV, HIV, EBV, JC Bacteria: Mycobacterium tuberculosis, Helicobacter pylori, Bacillus anthracis Parasites: Leishmania, Plasmodium Tumor markers KRAS: Co
Slide 40: Trovagene Non-invasive HPV Assay
Trovagene Non-invasive HPV Assay Unique assay amplifying the E1 region Freedom-To-Operate (FTO) relative to patent landscape targeting L1, E6, and E7 regions is likely E1 region offers novel approach to high risk HPV amplification Simplicity of testing: only 1 PCR reaction identifies all high-risk H
Slide 41: Initial Urine-HPV Test Results
Initial Urine-HPV Test Results COLLABORATION OPPORTUNITY: NON-INVASIVE HPV TEST High Risk vs Low Risk HPV, # patients QIAGEN hc2 Results High Risk QIAGEN hc2 Results Low Risk Total Trovagene Urine-HPV Results – High Risk 102 38 140 Trovagene Urine-HPV Results – Low Risk 34 146 180 Total 136 184 320
Slide 42: HPV Discordant Samples Resolved by DNA Sequencing
HPV Discordant Samples Resolved by DNA Sequencing COLLABORATION OPPORTUNITY: NON-INVASIVE HPV TEST Discordants Previous Results High Risk HPV by Sequencing High Risk Low Risk 38 Urine+ / hc2 - 31 7 34 Urine- / hc2+ 10 24 Trovagene True Positives 31 hc2 True Positives 10 Trovagene True Negatives 24 h
Slide 43: Trovagene Test Feasibility – Final Results
Trovagene Test Feasibility – Final Results COLLABORATION OPPORTUNITY: NON-INVASIVE HPV TEST Urine HPV Test Final Results* Number of Patients Total High Risk Low Risk High Risk 102 + 31 = 133 7 140 Low Risk 10 146 + 24 = 170 180 Total 143* 177* 320 Trovagene QIAGEN Sensitivity: 93.0% 78.3% Specificit
Slide 44: Broad Clinical Utility
Transplant markers In recipient urine for acute allograft rejection Fetal DNA markers In maternal urine for aneuploidy screening Pathogens Viruses: HPV, HIV, EBV, JC Bacteria: Mycobacterium tuberculosis, Helicobacter pylori, Bacillus anthracis Parasites: Leishmania, Plasmodium TECHNOLOGY & IP Broad
Slide 45: Truly Non-invasive Screening of Pre-natal Disorders
Truly Non-invasive Screening of Pre-natal Disorders COLLABORATION OPPORTUNITY: NON-INVASIVE PRENATAL DIAGNOSIS The plurality of Y chromosomal sequences clearly demonstrates the presence of transrenal fetal nucleic acids in maternal urine The combination of next gen sequencing with our transrenal nuc
Slide 46: Genome Representation in Urine of Pregnant Women
Genome Representation in Urine of Pregnant Women COLLABORATION OPPORTUNITY: NON-INVASIVE PRENATAL DIAGNOSIS Mapping Statistics Input reads processed: 34,850,754 Total reads mapped: 32,476,497 (93.19%) Reads uniquely mapped: 28,272,898 (81.13%) Reads that failed to map: 2,374,257 (6.81%) Tens of thou
Slide 47: Broad Clinical Utility
Transplant markers In recipient urine for acute allograft rejection Fetal DNA markers In maternal urine for aneuploidy screening Pathogens Viruses: HPV, HIV, EBV, JC Bacteria: Mycobacterium tuberculosis, Helicobacter pylori, Bacillus anthracis Parasites: Leishmania, Plasmodium TECHNOLOGY & IP Broad
Slide 48: Transplantation Diagnostics
Transplantation Diagnostics ONCOLOGY: EARLY DETECTION OF DISEASE From “Noninvasive diagnosis of acute rejection of renal allografts.” Hartono C, Muthukumar T, Suthanthiran M. Curr Opin Organ Transplant. 2010 Feb;15(1):35-41. Review. Test Platform Examples of Potential Biomarkers Gene Transcripts Sin
Slide 49: TrNAs in Transplantation Diagnostics
TrNAs in Transplantation Diagnostics EARLY DETECTION OF DISEASE, PATIENT STATUS Urinary miR-210 as a mediator of acute T-cell mediated rejection in renal allograft recipients Lorenzen JM, Volkmann I, Fiedler J, Schmidt M, Scheffner I, Haller H, Gwinner W, Thum T. Am J Transplant. 2011 Oct;11(10):222
Slide 50: HPV-HR in Urine: Broad Market Applicability
HPV-HR in Urine: Broad Market Applicability COMMERCIALIZATION STRATEGY Estimated 25M HPV tests run annually (US) 1 Represents only about 35-40% 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
Slide 51: HPV in Urine: Value Proposition
HPV in Urine: Value Proposition COMMERCIALIZATION STRATEGY TrovaCheckSM HPV-PLUS assay: Convenient, urine-based carrier screening for women and potentially men Screens for all known high risk HPV types Specific testing and typing for low-risk types 6 and 11 (which cause 90% of genital warts) Specifi
Slide 52: For further information contact
For further information contact: Antonius Schuh, CEO aschuh@trovagene.com Stephen Zaniboni, CFO szaniboni@trovagene.com