Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (May 2015)
45 slides from Cardiff Oncology's investor presentation, May 19, 2015
Slide 1: Better Cancer Monitoring with Cell-Free DNA
May, 2015 Better Cancer Monitoring with Cell-Free DNA
Slide 2: 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 3: 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 ac
Slide 4: Experienced Leadership Team
Experienced Leadership Team Copyright©2015 Trovagene, Inc. Confidential 5 Mark Erlander, PhD Chief Scientific Officer BioTheranostics, AviaraDx, Arcturus, J&J, Scripps Research Institute BS, MS Biochem PhD Neuroscience Antonius Schuh, PhD Chief Executive Officer Sorrento Therapeutics, AviaraDx, Arct
Slide 5: 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 Driven by Oncogene mutations and alterations Heterogeneous: Inter-tumor (Dist
Slide 6: 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 Not representative of tumor heterogeneity Not informati
Slide 7: 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 of
Slide 8: Circulating Tumor DNA (ctDNA)
Circulating Tumor DNA (ctDNA) Copyright©2015 Trovagene, Inc. Confidential 9 Main Advantages of ctDNA Captures intra- and inter-tumor heterogeneity Systemic overview of cancer Frequent sampling options for monitoring applications Different analyte options depending on clinical context Tumor cells Blo
Slide 9: Why Urine?
Why Urine? Copyright©2015 Trovagene, Inc. 10 Unlimited Volume Completely Non-invasive Frequency of Testing Convenient Urine ctDNA Plasma ctDNA
Slide 10: Trovagene Precision Cancer Monitoring (PCM) Platform
Trovagene Precision Cancer Monitoring (PCM ) Platform Copyright©2015 Trovagene, Inc. Confidential 11 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 ctDNA 4.9 ng/u
Slide 11: Available Tests and Tests in Development
Available Tests and Tests in Development Copyright ©2015 Trovagene, Inc. Confidential 12 CRC LUNG MELANOMA PANCREATIC KRAS Exon 2 BRAF V600E KRAS Exon 2 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 2,3 KRAS Exon 3,4 ROS
Slide 12: Strategy to Drive Clinical Adoption & Reimbursement
Strategy to Drive Clinical Adoption & Reimbursement Copyright©2015 Trovagene, Inc. Confidential 13 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. BR
Slide 13: 30+ Collaborations to Validate & Integrate our PCM Platform
30+ Collaborations to Validate & Integrate our PCM Platform Copyright©2015 Trovagene, Inc. Confidential 14 Disease Ongoing Pending Protocol in Dev/Approval Under Evaluation Market Size U.S. (# of pts) Lung Cancer (NSCLC) 7 0 – 399,000 Colorectal Cancer 3 3 – 1,154,000 Pancreatic Cancer 4 – 1 42,000
Slide 14: ECD/LCH Standard of Care
ECD/LCH Tissue Biopsy First Line Treatment Imaging (every 2-3 months) Histiocytic Disorders: ECD/LCH Standard of Care Copyright©2014 Trovagene, Inc. Confidential Monitoring Therapeutic Response BRAF V600E Detection BRAF V600E TROVAGENE ECD/LCH ALL STAGES Molecular diagnosis of BRAF mutation – patien
Slide 15: 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 17 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 16: Urinary ctDNA Outperforms Tissue Biopsies
Urinary ctDNA Outperforms Tissue Biopsies1 Copyright©2015 Trovagene, Inc. Confidential 18 1Hyman et al., Cancer Discovery 2015 Jan;5(1):64-71 Urinary ctDNA N=30 Initial Tissue Results Plasma ctDNA N=19 Initial Tissue Results Trovagene Assay Results Trovagene Assay Results Wildtype Mutant Unknown On
Slide 17: Correlation between Longitudinal ctDNA and Radiographic Response
Correlation between Longitudinal ctDNA and Radiographic Response1 19 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 19
Slide 18: Dynamic Monitoring Captures Early Progression and Response
Dynamic Monitoring Captures Early Progression and Response1 Copyright©2014 Trovagene, Inc. Confidential 20 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-based
Slide 19: NSCLC Standard of Care
NSCLC Standard of Care Copyright©2014 Trovagene, Inc. Confidential 21 Molecular Detection & Response Monitoring EGFR T790M Monitoring Emergence of Resistance EGFR T790M Molecular Detection EGFR Exon 19 del EGFR L858R KRAS TROVAGENE NSCLC Tissue Biopsy First Line Treatment Tissue Biopsy Second Line T
Slide 20: NSCLC Standard of Care: Studies
NSCLC Standard of Care Copyright©2014 Trovagene, Inc. Confidential 22 Molecular Detection & Response Monitoring EGFR T790M Monitoring Emergence of Resistance EGFR T790M Molecular Detection EGFR Exon 19 del EGFR L858R KRAS TROVAGENE NSCLC Tissue Biopsy First Line Treatment Tissue Biopsy Second Line T
Slide 21: 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 Resistance Mutation 30 Metastatic NSCLC Patients, Second Line Therapy 300 Metastatic NSCLC Patients at Diagnosis, EGFR Exons19 and 21 Status in Tissue ctDNA Monitor
Slide 22: Urine Identifies More Patients with EGFR T790M Mutation than Tissue
Urine Identifies More Patients with EGFR T790M Mutation than Tissue Copyright©2014 Trovagene, Inc. Confidential 24 15 Patients Tissue Urine 10 Patients Preliminary Results (Total number of patients examined by urine = 22, number of patients examined by tissue = 13 of 22) 24
Slide 23: Monitoring Urinary ctDNA EGFR Mutation Predicts Radiographic Response
Monitoring Urinary ctDNA EGFR Mutation Within First 2 Weeks of Targeted Therapy Predicts Subsequent Radiographic Response in Patients Copyright©2015 Trovagene, Inc. Confidential 25 1Husain et al., ELCC 2015 Quantitate Drug Response: Lung Cancer Patient 1 Copies/100K GE (95% CI) Time on Drug T790M Ex
Slide 24: Monitoring for Resistance: Lung Cancer Early T790M Detection
Patient 20 Patient 10 Patient 3 Copyright©2015 Trovagene, Inc. Confidential 26 1Husain et al., ELCC 2015 Monitoring for Resistance: Lung Cancer Early T790M Detection (Days to Radiographic Progression) Patient 1 111 Patient 3 52 Patient10 56 Patient 20 29 PD PD PD T790M detected T790M detected PD T79
Slide 25: Colorectal Cancer Standard of Care
Colorectal Cancer Standard of Care Copyright©2014 Trovagene, Inc. Confidential 27 KRAS, NRAS, BRAF Minimal Residual Disease Response Monitoring TROVAGENE Adjuvant Therapy Imaging (every 6 weeks) Systemic Therapy Imaging (every 6 wks-6 months) Molecular Detection KRAS, NRAS, BRAF Surgery KRAS, NRAS,
Slide 26: Colorectal Cancer Standard of Care: Studies
Colorectal Cancer Standard of Care Copyright©2014 Trovagene, Inc. Confidential 28 KRAS, NRAS, BRAF Minimal Residual Disease Response Monitoring TROVAGENE Adjuvant Therapy Imaging (every 6 weeks) Systemic Therapy Imaging (every 6 wks-6 months) Molecular Detection KRAS, NRAS, BRAF Surgery KRAS, NRAS,
Slide 27: Minimal Residual Disease in Surgical 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 28: Monitoring ctDNA KRAS for Minimum Residual Disease Post Surgery
Monitoring ctDNA KRAS for Minimum Residual Disease Post Surgery1 Copyright©2015 Trovagene, Inc. Confidential 30 1Melnikova et al, AACR 2015 Curative surgery correlates with un-detectable levels of urinary ctDNA KRAS post-surgery in 4 of 5 patients Palliative surgery correlates with high levels of ur
Slide 29: Pancreatic Cancer Standard of Care
Pancreatic Cancer Standard of Care Copyright©2014 Trovagene, Inc. Confidential 31 TROVAGENE Pancreatic Cancer Diagnosis Biopsy Adjuvant Therapy Imaging (every 6-12 weeks) Imaging (every 6-12 weeks) Resectable Disease Surgery Non-Resectable Disease Chemotherapy Prognostic for Survival KRAS G12/13 + C
Slide 30: Pancreatic Cancer Standard of Care: Studies
Pancreatic Cancer Standard of Care Copyright©2014 Trovagene, Inc. Confidential 32 TROVAGENE Pancreatic Cancer Diagnosis Biopsy Adjuvant Therapy Imaging (every 6-12 weeks) Imaging (every 6-12 weeks) Resectable Disease Surgery Non-Resectable Disease Chemotherapy CLINICAL UTILTY University of Copenhage
Slide 31: Monitoring ctDNA KRAS Predicts Overall Survival in Pancreatic Patients
Baseline KRAS Pre-treatment (cps/100K GE) Week 2 KRAS End of Cycle 1 (cps/100K GE) N Median Overall Survival (after Cycle 1) 95% CI for Median Overall Survival (after Cycle 1) Hazard Ratio of Death (95% CI) 5.5 5.5 28 336 days 235 – 461 days 1.0 5.5 > 5.5 10 252 days >168 days2 1.3 > 5.5 5.5 20 224
Slide 32: Melanoma Standard of Care
Melanoma Standard of Care Copyright©2014 Trovagene, Inc. Confidential 34 TROVAGENE MELANOMA First Line Treatment Second Line Treatment Imaging (every 6-8 weeks) Imaging (every 6-8 weeks) CLINICAL UTILTY Response Monitoring BRAF MARKET Response Monitoring ~9000 stage IV patients x 60% BRAF+ x 10 test
Slide 33: Melanoma Standard of Care: Studies
Melanoma Standard of Care Copyright©2014 Trovagene, Inc. Confidential 35 TROVAGENE MELANOMA First Line Treatment Second Line Treatment Imaging (every 6-8 weeks) Imaging (every 6-8 weeks) CLINICAL UTILTY STUDIES Response Monitoring BRAF – Drug Holidays Imaging (every 6-8 weeks) Georgetown University
Slide 34: Monitoring ctBRAF V600E and Treatment Response
Monitoring ctBRAF V600E and Treatment Response1 36 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 35: 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 37 Patient 8: Metastatic Non-Small Cell Lung Cancer Patient 16: Metastatic Colorectal Cancer Urine BRAF V600E ctDNA monitoring has clinical
Slide 36: Ongoing Clinical Studies Continue to Drive Publications
Ongoing Clinical Studies Continue to Drive Publications Copyright©2015 Trovagene, Inc. Confidential 38 2015 AACR-NCI-EORTC Submit abstracts HISTIOCYTIC SOC. Submit abstracts Q3 Q4 Q1 10/2015 10/2015 Submit manuscript BRAF and KRAS multiple cancers MD Anderson AACR Presentations 1. Pancreatic 2. Colo
Slide 37: Market Development Activities for Commercialization Program
Market Development Activities for Commercialization Program Copyright©2015 Trovagene, Inc. Confidential 39 Target KOLs/ Early adopters Market Development (2013-2014) Full Commercialization (2015) Develop IIS (Investigator Initiated Study) Program Accelerate Adoption within Integrated Healthcare Deli
Slide 38: Key Components for Full Commercialization in 2015
Key Components for Full Commercialization in 2015 Copyright©2015 Trovagene, Inc. Confidential 40 Full Commercialization (2015) Drive Adoption of Expanded Menu Conversion of Research Collaborators to Clinical Adopters Expand New Market Segments New Market for Genomic Monitoring Commercial operations
Slide 39: Transforming the Standard of Cancer Care
Transforming the Standard of Cancer Care Copyright©2015 Trovagene, Inc. Confidential 41 Treatment Starts Diagnosis Scan at 3 Months Baseline Determined by Whole Body Molecular Information Daily Noninvasive Monitoring for Therapy Response Trovagene PCM Week 1-2
Slide 40: From Diagnostic Tool to Screening Tool
From Diagnostic Tool to Screening Tool Copyright©2015 Trovagene, Inc. Confidential 42 Stage IV High ctDNA concentration enables detection in both urine and blood EGFR Today Stage III Tomorrow Stage II Stage I NSCLC Diagnostic Tomorrow Screening EGFR EGFR EGFR
Slide 41: The Trovagene Vision – A High Resolution Molecular Microscope
Copyright©2015 Trovagene, Inc. Confidential 43 The Trovagene Vision – A High Resolution Molecular Microscope Future Today Building Evidence for Clinical Utilities and early commercial applications Correlation to Tissue Superior Detection Sensitivity to Plasma Response to Therapy and tracking Tumor B
Slide 42: Reimbursement Value Based on Clinical Utilities of ctDNA
Reimbursement Value Based on Clinical Utilities of ctDNA Copyright©2015 Trovagene, Inc. Confidential 44 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 Pric
Slide 43: Lung Cancer Tissue Biopsy: Cost Assumptions
Lung Cancer Tissue Biopsy: Cost Assumptions1 Copyright©2015 Trovagene, Inc. Confidential 45 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 b
Slide 44: Catalysts & Milestones to Drive Valuation
Catalysts & Milestones to Drive Valuation Copyright©2015 Trovagene, Inc. Confidential 46 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 c
Slide 45: For further information, please contact
For further information Please contact: Stephen Zaniboni, CFO szaniboni@trovagene.com Antonius Schuh, CEO aschuh@trovagene.com