Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (February 2015)
39 slides from Cardiff Oncology's investor presentation, Feb 5, 2015
Slide 1: Better Cancer Monitoring with Cell-Free DNA
Better Cancer Monitoring with Cell-Free DNA February, 2015
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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 of 1933 an
Slide 3: Our Goal: Improve Treatment Outcomes with Non-invasive Cancer Monitoring
Our Goal To Improve Treatment Outcomes with Copyright©2015 Trovagene, Inc. | Confidential 3 Non-invasive Cancer Monitoring Trovagene’s technology non-invasively detects and quantitates circulating tumor DNA in urine and plasma for improved disease management
Slide 4: Company Overview
Company Overview Copyright©2015 Trovagene, Inc. | Confidential 4 Numerous clinical collaborations with leading cancer centers 30+ clinical studies Expanding clinical evidence to support broad market adoption Generating health economic data necessary for appropriate reimbursement CLIA certified, CAP
Slide 5: Experienced Leadership Team
Experienced Leadership Team Copyright©2015 Trovagene, Inc. | Confidential 5 Vlada Melnikova MD, PhD VP, Research & Development Transgenomic, ApoCell, MD Anderson Cancer Center MD | PhD Biological Engineering Mark Erlander PhD Chief Scientific Officer BioTheranostics, AviaraDx, Arcturus, J&J, Scripps
Slide 6: Targeted Therapies for Cancer
Targeted Therapies for Cancer Therapies are expensive and have side effects Specific for particular biomarkers Response monitoring required Resistance develops Clinical Problem Copyright©2015 Trovagene, Inc. | Confidential 6 Need for Genomic Monitoring Driven by Oncogene mutations and alterations He
Slide 7: Limitations of Current Technology for Cancer Monitoring
Limitations of Current Technology for Cancer Monitoring Copyright©2015 Trovagene, Inc. | Confidential 7 Imaging Tissue biopsy Circulating tumor cells Rough indication of tumor size No molecular information Radiation concerns for younger patients Invasive procedures, often not possible Potential for
Slide 8: Significant Market Opportunity
Significant Market Opportunity Copyright©2015 Trovagene, Inc. | Confidential 8 $12B In 2010 Insufficient Imaging Tools in Oncology Still Yield Huge Market Initial Opportunity for Trovagene 525K Metastatic cancer patients per year 8-10 Imaging procedures received by cancer patient during first year o
Slide 9: ctDNA Emerging as Preferred Analyte to Monitor Cancer
“The statistically significant correlation between mutational status and treatment response suggests oncogene mutation monitoring using urinary cell-free DNA can help clinicians rapidly determine responders from non-responders, [to] improve patient outcomes.” Dr. Frances Collins, National Institutes
Slide 10: Circulating Tumor DNA (ctDNA)
Circulating Tumor DNA (ctDNA) Copyright©2015 Trovagene, Inc. | Confidential 10 Tumor cells Main Advantages of ctDNA Captures intratumor heterogeneity Systemic overview of cancer Frequent sampling options for monitoring applications Different analyte options depending on clinical context
Slide 11: Why Urine?
Why Urine? Copyright ©2015 Trovagene, Inc. | Confidential 11 Unlimited Volume Urine ctDNA Plasma ctDNA 3,000 – 15,000 genome equivalent 15,000 – 150,000 genome equivalent Frequency of Testing Completely Non-invasive Convenient
Slide 12: Trovagene Precision Cancer Monitoring (PCM) Platform
Trovagene Precision Cancer Monitoring (PCM ) Platform Copyright ©2015 Trovagene, Inc. | Confidential 12 Ultra-Sensitive Detection and Quantitative Monitoring 100-1000 fold enrichment ~0.5µg ctDNA/ 100 mL of urine Integration with Commercially Available Platforms Single Molecule Detection Proprietary
Slide 13: Patent Portfolio
Patent Portfolio Copyright©2015 Trovagene, Inc. | Confidential 13 51-110 bp TrNA Family Concentrating Urine Family Patent Term Term to approx. 2035 US provisional app filed Term to approx. 2034 PCT filed Term to approx. 2029 US & EU Term 2018 US & EU Small Footprint Family Monitoring Disease Family
Slide 14: Strategy to Drive Clinical Adoption & Reimbursement
Strategy to Drive Clinical Adoption & Reimbursement Copyright©2015 Trovagene, Inc. | Confidential 14 Demonstrate concordance of oncogene mutation status between urine and tumor tissue Clinical Utility: Determine mutational status of actionable biomarkers in urine when a biopsy is not an option. Ex.
Slide 15: 30+ Collaborations to Validate & Integrate our PCM Platform
30+ Collaborations to Validate & Integrate our PCM Platform Copyright©2015 Trovagene, Inc. | Confidential 15 Disease Ongoing Pending Protocol in Dev/Approval Under Evaluation Market Size U.S. (# of pts) Lung Cancer (NSCLC) 8 1 — 399,000 Colorectal Cancer 4 3 – 1,154,000 Pancreatic Cancer 3 – 1 42,00
Slide 16: Increasing Volume of Clinical Study Samples Received
Increasing Volume of Clinical Study Samples Received Copyright©2015 Trovagene, Inc. | Confidential 16
Slide 17: Clinical Results Presented & Published To Date
Clinical Results Presented & Published To Date Copyright©2015 Trovagene, Inc. | Confidential 17 2014 2 ASCO Presentations Histiocytic BRAF MSKCC/MD Anderson Longitudinal BRAF MD Anderson AACR Poster Concordant BRAF NEXTGEN DX SUMMIT Oral Presentation, Technology IPV Meeting Poster Presentation HR-HP
Slide 18: Prospective Blinded Study of BRAF V600E in Histiocytic Disorders
Prospective Blinded Study of BRAF V600E Mutation Detection in Cell-Free DNA of Patients with Systemic Histiocytic Disorders1 18 Histiocytic Patients N=30 Urine cfDNA BRAF V600E V600E Positive V600E Negative Evaluate Tissue Biopsy BRAF V600E Concordance Evaluate Plasma BRAF V600E Concordance Evaluate
Slide 19: ctDNA Improves Genotyping Over Tissue Biopsies in Histiocytic Patients
ctDNA Improves Genotyping Over Tissue Biopsies in Histiocytic Patients1 19 Urinary ctDNA N=30 Initial Tissue Results Plasma ctDNA N=19 Initial Tissue Results Trovagene Assay Results Trovagene Assay Results Urinary ctDNA BRAFV600E genotype Tissue BRAFV600E genotype Indeterminate Genotype BRAFV600E Mu
Slide 20: Correlation between Longitudinal ctDNA and Radiographic Response
Correlation between Longitudinal ctDNA and Radiographic Response1 20 BRAFV600E burden in urine correlates w/ radiographic response. BRAFV600E allele burden in urine changes dynamically with therapy. 1Hyman et al., Cancer Discov. 2015 Jan;5(1):64-71 Copyright©2015 Trovagene, Inc. | Confidential
Slide 21: Dynamic Monitoring Captures Early Progression and Response
Dynamic Monitoring Captures Early Progression and Response1 Copyright©2015 Trovagene, Inc. | Confidential 21 One week Successful monitoring tumor dynamics independent of drug class used Patient’s tumor progressed within 1 wk of Anakinra withdrawal Demonstration of need for higher frequency urine-bas
Slide 22: Minimal Residual Disease in Colorectal Cancer with Liver Metastases
Detection and Monitoring Minimal Residual Disease in Surgical Colorectal Cancer Patients with Liver Metastases1 Urine (20 Patients) Plasma (20 Patients) Plasma vs. Tissue Biopsy Concordant KRAS mutation at baseline 19/20 evaluable Urine vs. Plasma Concordant KRAS mutation at baseline 12/12 matched U
Slide 23: High Concordance between Urine & Plasma ctDNA KRAS in Advanced CRC
High Concordance btw Urine & Plasma ctDNA KRAS in Advanced CRC: Monitoring During & Post Surgery1 Curative surgery correlates with un-detectable levels of ctDNA KRAS post-surgery Palliative surgery correlates with high levels of ctDNA KRAS post-surgery 1Poole et al, ASCO GI 2015 23 Copyright©2015 Tr
Slide 24: Monitoring Treatment Response in Advanced Pancreatic Cancer by ctDNA KRAS
Monitoring Treatment Response in Resectable and Non-Resectable Advanced Pancreatic Cancer Patients by ctDNA KRAS1 24 182 Patients with Non-Resectable Pancreatic Cancer Chemotherapy Plasma, archived < 6 years 50 Patients with Resectable Pancreatic Cancer Surgery, Chemotherapy Plasma, archived < 6 yea
Slide 25: Monitoring ctBRAF V600E and Treatment Response
Monitoring ctBRAF V600E and Treatment Response1 25 17 metastatic cancer patients 15 evaluable patients for ctDNA BRAF V600E >4 weeks Evaluate time to progression % tumor change per RECIST 1.1 Urine ctDNA BRAF decrease Urine ctDNA BRAF increase Urine BRAF ctDNA correlates to BRAF/MEK targeted therapy
Slide 26: Longitudinal ctDNA BRAF V600E Status Correlates with Therapy Response
Patient 5: Metastatic Melanoma Patient 36: Metastatic Non-Small Cell Lung Cancer Longitudinal ctDNA BRAF V600E Mutation Status Correlates with Therapy Response1 26 Patient 8: Metastatic Non-Small Cell Lung Cancer Patient 16: Metastatic Colorectal Cancer Urine BRAF V600E ctDNA monitoring has clinical
Slide 27: NSCLC Standard of Care Monitoring
NSCLC Standard of Care 27 Monitoring Emergency of Resistance EGFR T790M Monitoring Tumor Burden EGFR T790M Monitoring Tumor Burden EGFR Exon 19 Deletion EGFR L858R Detection EGFR Exon 19 Deletion EGFR L858R TROVAGENE Copyright©2015 Trovagene, Inc. | Confidential
Slide 28: NSCLC Initial Biopsy: Cost Assumptions
28 Biopsy with AE ~20% Claims Biopsy without AE ~80% Claims Average Biopsy Cost While the median cost for a lung cancer biopsy is ~$3,750, a recent review of 5% of the Medicare population found that complications drove average biopsy cost to $14,634. 1Medicare claims analysis presented by Lokhandwal
Slide 29: Replacing Tissue Biopsy in Metastatic NSCLC with ctDNA Monitoring
Replacing Tissue Biopsy in Metastatic NSCLC with ctDNA Monitoring ctDNA EGFR for Treatment Response and Early Acquisition of EGFR T790M 30 Metastatic NSCLC Patients, Exploratory 3rd Generation TKIs 300 Metastatic NSCLC Patients at Diagnosis, EGFR Exons19 and 21 Status in Tissue ctDNA Monitoring for
Slide 30: Current Development Program for Cancer Monitoring Applications
Current Development Program for Cancer Monitoring Applications Copyright©2015 Trovagene, Inc. | Confidential 30 KRAS Exon 2 BRAF V600E KRAS Exon 2,3,4 NRAS Exon 2,3,4 BRAF V600E PIK3CA H1047R EGFR Exon 20 T790M EGFR Exon 19 Del EGFR Exon 21 L858R ALK Rearrangements NRAS Exon 2
Slide 31: Ongoing Clinical Utility Studies
Ongoing Clinical Utility Studies Copyright©2015 Trovagene, Inc. | Confidential 31 Detection of Mutation Monitoring Tumor Load Emergence of Resistant Mutations Pancreatic/MDACC Brain/UCSD Lung/MSKCC KRAS BRAF EGFR Minimal residual disease detection post surgery Detect ctDNA in brain cancer patients D
Slide 32: Ongoing Clinical Studies Continue to Drive Publications
Ongoing Clinical Studies Continue to Drive Publications Copyright©2015 Trovagene, Inc. | Confidential 32 2014 EORTC-NCI-AACR Submit abstracts HISTIOCYTIC SOC. Submit abstracts Q4 Q1 Q2 Q3 3/2015 10/2015 Submit manuscript Longitudinal and pharmacodynamic BRAF and KRAS multiple cancers MD Anderson ASC
Slide 33: Market Development Activities for Commercialization Program
Market Development Activities for Commercialization Program Copyright©2015 Trovagene, Inc. | Confidential 33 Market Development (2013-2014) Full Commercialization (2015) Target KOLs/ Early adopters Develop IIS (Investigator Initiated Study) Program Accelerate Adoption within Integrated Healthcare De
Slide 34: Key Components for Full Commercialization in 2015
Key Components for Full Commercialization in 2015 Copyright©2015 Trovagene, Inc. | Confidential 34 Full Commercialization (2015) Drive Adoption of Expanded Menu Conversion of Research Collaborators to Clinical Adopters Expand New Market Segments New Market for Genomic Monitoring Direct sales team 6
Slide 35: Reimbursement Value Based on Clinical Utilities of ctDNA
Reimbursement Value Based on Clinical Utilities of ctDNA Copyright©2015 Trovagene, Inc. | Confidential 35 Detection of Mutation Monitoring Tumor Size When tissue biopsy is unavailable Tumor load Emergence of resistant mutations Drug holidays Tier 1 MDx Codes Concordance with SOC Established codes Pr
Slide 36: Trovagene Urine-based High Risk HPV Assay
Trovagene Urine-based High Risk HPV Assay Copyright©2015 Trovagene, Inc. | Confidential 36 Urine-based High Risk HPV Assay established in Trovagene’s CLIA lab since 2013 265K Deaths in 2012 Market in 2013 $9B Market in 2020 HPV Testing Market Globally Screening is a viable solution: 75% reduction in
Slide 37: Developing Trovagene's HPV Franchise
Developing Trovagene’s HPV Franchise Internal Development Clinical studies in general screening population Strand Life Sciences (3,000 patients, enrollment underway) Planning stages for pivotal studies Obtain regulatory compliance Copyright©2015 Trovagene, Inc. | Confidential 37 Partnering Opportuni
Slide 38: Catalysts & Milestones to Drive Valuation
Catalysts & Milestones to Drive Valuation Copyright©2015 Trovagene, Inc. | Confidential 38 Demonstrate clinical utility Expand mutation coverage on PCM platform Initiate new collaborations to establish clinical utility Establish strategic partnerships to grow market reach Drive early adoption in top
Slide 39: For further information
For further information Please contact: Stephen Zaniboni, CFO szaniboni@trovagene.com Antonius Schuh, CEO aschuh@trovagene.com