Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (June 2013)
31 slides from Cardiff Oncology's investor presentation, Jun 27, 2013
Slide 1: A better clinical pathway for cancer monitoring
A better clinical pathway for cancer monitoring Antonius Schuh, Ph.D. | Chief Executive Officer June 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: Our goal: Towards better treatment for cancer
Our goal: Towards better treatment for cancer INTRODUCTION A better clinical pathway for cancer monitoring Novel clinical utility: non-invasive, near real-time detection of oncogene mutations for any tumor type
Slide 4: Welcome to Trovagene, Inc.
Welcome to Trovagene, Inc. INTRODUCTION INTRODUCTION Addresses a high unmet need in cancer by enabling easier, more frequent monitoring of emergence of oncogene mutation status, disease progression and recurrence Unique IP around cell-free DNA in urine creates a powerful core diagnostic platform for
Slide 5: Team
TEAM Antonius Schuh PhD CEO CEO Sorrento Therapeutics, AviaraDX, Arcturus Biosciences, Sequenom PhD Pharm. Chem Stephen Zaniboni CFO Mark Erlander PhD CSO Keith McCormick VP, Comm. Ops Michael Terry VP, Corp. Devel. Thomas Adams, PhD (Chair) John P. Brancaccio, CPA Gabriele M. Cerrone, MBA CFO, Awar
Slide 6: Understanding cell-free DNA for cancer monitoring
Understanding “cell-free” DNA for cancer monitoring THE CLINICAL UTILITY OF CELL-FREE DNA FROM URINE Cell-free DNA is released by dying cells in the human body Cells in the body die continuously in a process known as “apoptosis” , releasing DNA/RNA into the bloodstream This “cell-free” DNA, detectab
Slide 7: Why not simply use a blood specimen?
Why not simply use a blood specimen? THE CLINICAL UTILITY OF CELL-FREE DNA FROM URINE Blood Draw Sample quantity is limited Sample frequency is limited Inconvenient for patient – requires an appointment Painful and perceived as threatening Requires a medical professional Specimen is a biohazard Requ
Slide 8: Kidneys filter cell-free DNA from blood into the urine
Kidneys filter cell-free DNA from blood into the urine THE CLINICAL UTILITY OF CELL-FREE DNA FROM URINE By isolating cell-free DNA from urine, Trovagene eliminates the need for the cost, complexity and inconvenience of a blood sample Truly non-invasive Patient can self-sample at home or clinic No me
Slide 9: Enabled by a confluence of emerging technologies
Enabled by a confluence of emerging technologies Ability to detect single DNA molecules in a urine sample Trovagene IP Next gen sequencing Digital PCR THE CLINICAL UTILITY OF CELL-FREE DNA FROM URINE BioRad Quantalife up to 100,000 target sequences RainDance Droplet Digital PCR up to 5,000,000 targe
Slide 10: Why Cell-free DNA?
Why Cell-free DNA? Tumors are heterogeneous in their tumor mutational make-up Would need multiple tissue/tumor biopsies to determine heterogeneity and optimal therapy Cell-free DNA from tumors is released into the blood plasma after cell-death Previously established that cell-free DNA increases with
Slide 11: Detecting & monitoring cancer mutations key to effective therapy
Healthy Subject Oncogenic Mutation DRUG A CYCLE 1 CYCLE 2 CYCLE 3 CYCLE 4 SURVIVAL TUMOR MUTATION#1 Selective pressure of targeted drugs enrich tumor tissue with new mutant cells that are drug resistant Match up targeted drugs with mutation profile Treatment SURVIVAL DRUG B DRUG C DRUG D SURVIVAL CE
Slide 12: Opportunity to implement monitoring of tumor dynamics in urine
Opportunity to implement monitoring of tumor dynamics, demonstrated in plasma, in urine High signal consistent with metastatic patient CLINICAL DEVELOPMENT PROGRAM Patient responds to therapy Disease progression Hormonal therapy No response to hormonal RX Circulating Biomarker Epirubicin Letro-zole
Slide 13: Building value through validation
Building value through validation PHASE 1 Initial studies demonstrating concordance with the existence of cancer mutations between tumor, blood and urine. Opportunity for diagnosis when a biopsy is not an option for example. Diagnostic PHASE 2 Tracking cancer mutation trends quantitatively and corre
Slide 14: Trovagene Isolation Method Outperforms Competitors
Trovagene Isolation Method Outperforms Competitors CLINICAL DEVELOPMENT PROGRAM For small target purification. Detection of 50 bp target spiked into identical 10 mL urine samples. Competitor N Competitor Q Travagene First Elution First and Second Elutions Combined Total Number of Copies
Slide 15: Two-Step Assay Design for small footprint assays
STEP ONE Pre-amplification with wild-type suppression DNA template with mutation (“M”; Patient DNA) A B STEP TWO Amplification with A,B primers, digital droplet PCR (Raindance) DNA template with no mutation (Wild Type (“WT”; Patient DNA) WT Blocker of A,B primers M WT A B M M TAQMAN Probe Amplificat
Slide 16: Very high mutation detection sensitivity
0.03% mutant in WT Healthy Control (WT) G12V mutation confirmed MDJ#23 MDJ#9-P1 V600E mutation confirmed MDJ#14 G12D mutation confirmed 0.03% mutant in WT Healthy Control (WT) 0.03% mutant in WT Healthy Control (WT) Template Control 0.03% MDJ#23 #molecules/25ul 44 319 1083 Template Control 0.03% MDJ
Slide 17: Concordance with urinary patient DNA in metastatic cancer patients
ID Mutation Tumor Staging Cancer Type Results DNA mutation fragments 14 G12D IV Colon 489 15 G12D IV Colon 563 16 G12D IV Appendiceal Adenocarcinoma 1231 17 G12D IV Colon 1935 18 G12D IV Colon 2825 19 G12V IV Adenocarcinoma/upper lobe lung 1083 20 G12V IV Colorectal 1168 G12D Healthy Control 234 20
Slide 18: 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 19: Any mutation, any solid tumor: NGS
Any mutation, any solid tumor: NGS 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 COMMERCIALIZATION PATH
Slide 20: Core IP extends into assay detection and development
Core IP extends into assay detection and development Transrenal Nucleic Acid Detection Term to approx. 2029 Allowed US claims to miRNA detection Detection of Diseases and Gene Markers Term to approx. 2032 Allowed US Claims to AML detection with specific NPM1 primers Optical (CMOS) Detection System T
Slide 21: Trovagene's Proprietary HPV Test
Trovagene’s Proprietary HPV Test
Slide 22: HPV in Urine: Market Dynamics
HPV in Urine: Market Dynamics Market Opportunity 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 Advantages Unique primer pair amplifying the E1 region provid
Slide 23: 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 24: 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 25: Validating Analytical Performance of Key Assay
Validating Analytical Performance of Key Assay Europe (UK) Queen Mary University of London PREDICTORS 4 Study - 500 patient cohort - samples currently being processed HPV Brazil Barretos Cancer Hospital – largest cancer hospital in Brazil 350 patient cohort - enrollment underway India Simbiosys Biow
Slide 26: 2012 Achievements
2012 Achievements 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 Liquidity and Acce
Slide 27: 2013 Achievements
2013 Achievements Initiated R&D Partnership with PerkinElmer Collaborate to develop test to determine liver cancer risk Initiated R&D Partnership with Illumina Collaborate to apply NGS for the analysis of transrenal sequence signals Transferred High Risk HPV Carrier Screening Test into CLIA lab Pilo
Slide 28: PerkinElmer R&D agreement
PerkinElmer R&D agreement Research & Development agreement with PerkinElmer to develop a test to determine the risk for developing liver cancer TROV will develop the test TROV and PKI will jointly validate the test The Companies will collaborate on potential automation for TROV’s DNA isolation techn
Slide 29: Illumina Agreement
Illumina Agreement Goal – POC to develop library for NGS (next generation sequencing) from cell-free DNA isolated from urine Strategic imperative to establish TrNAs on NGS NGS will become a platform standard in the industry TROV to gain significant domain knowledge from market leader in NGS Applicat
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: For further information
For further information Please contact: Antonius Schuh, CEO aschuh@trovagene.com Stephen Zaniboni, CFO szaniboni@trovagene.com