Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (January 2016)
37 slides from Cardiff Oncology's investor presentation, Jan 13, 2016
Slide 1: 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 2: Our Goal: Improve Treatment Outcomes with Noninvasive Cancer Monitoring
Our Goal Improve Treatment Outcomes with Noninvasive Cancer Monitoring Trovagene’s technology noninvasively detects and quantitates circulating tumor DNA in urine and plasma for improved disease management Copyright ©2016 Trovagene, Inc. Confidential
Slide 3: Experienced Leadership Team
Matt Posard Chief Commercial Officer Karsten Schmidt, PhD Senior VP, Technology Operations Illumina Inc., Biosite Dx, Gen-Probe BA Quantitative Economics and Decision Sciences, UCSD Sequenom, Inc., Sanofi-Aventis Deutschland GmbH (formerly: Rhône-Poulenc Rorer), Fisons plc PhD The University of Bonn
Slide 4: Strong Scientific Advisory Board and Board of Directors
Strong Scientific Advisory Board and Board of Directors Copyright ©2016 Trovagene, Inc. Confidential Alberto Bardelli, PhD Department of Oncology, Torino Medical School, Institute for Cancer Research Paul Billings, MD, PhD Chief Medical Officer, Omica Scientific Advisors Charles Cantor, PhD Founder
Slide 5: Significant Market Opportunity
Significant Market Opportunity Physicians lack tools to effectively monitor and react to changes in cancer over time Copyright ©2016 Trovagene, Inc. Confidential Source: 2010 BCC Research Trovagene Precision Cancer Monitoring (PCM) delivers critical information to detect and measure actionable cance
Slide 6: New Standard of Care Enabled by Trovagene Technology
Detection Minimal Residual Disease (MRD) Quantitate Drug Response Monitoring New Standard of Care Enabled by Trovagene Technology Copyright ©2016 Trovagene, Inc. Confidential Biopsy Surgery Treatment Treatment Biopsy PROCEDURE IMAGING Every 6-8 weeks Every 6-8 weeks Trovagene platform allows physici
Slide 7: Advantages of Circulating Tumor DNA (ctDNA)
Tumor cells Blood Urine Advantages of Circulating Tumor DNA (ctDNA) Copyright ©2016 Trovagene, Inc. Confidential Apoptosis or necrosis occurs, ctDNA is released ctDNA enters blood stream and kidneys High-depth systemic understanding of tumor dynamics Delivers clinically actionable data in real time
Slide 8: Trovagene Precision Cancer Monitoring (PCM) Platform
Trovagene Precision Cancer Monitoring (PCM) Platform Copyright ©2016 Trovagene, Inc. Confidential 100-1000 fold enrichment ~300,000 genome equivalents of cfDNA/200 mL of urine Collection, Extraction and Isolation of ctDNA Mutant Allele Enrichment Detection and Quantification Enables monitoring over
Slide 9: Intellectual Property
Intellectual Property Copyright ©2016 Trovagene, Inc. Confidential 51-110 bp TrNA Family Concentrating Urine Family Patent Term 2035 US provisional app filed 2034 US provisional app filed 2029 US & EU 2018 US & EU Small Footprint Family Monitoring Disease Family 20-50 bp TrNA Family Anion Exchange P
Slide 10: Technology Portfolio Evolution
Technology Portfolio Evolution Copyright ©2016 Trovagene, Inc. Confidential Feasibility Analysis In Development Commercially Available KRAS (Exon 2) BRAF (V600E) EGFR (Exon 19 Del) EGFR (Exon 20 T790M) EGFR (Exon 21 L858R) KRAS (5 assays) NRAS (5 assays) EGFR (6 assays) BRAF (1 assays) PIK3CA (2 ass
Slide 11: Commercial Revenue Opportunities
Commercial Revenue Opportunities Copyright ©2016 Trovagene, Inc. Confidential 13 CLIA Clinical Testing Services Tech Transfer & TrovaCloud Exchange Clinical Trial Services & Translational Medicine Support Core Technologies
Slide 12: Pharma Clinical Trial Services Program
Pharma Clinical Trial Services Program Copyright ©2016 Trovagene, Inc. Confidential 14 Establish Clinical Trial Services Establish Clinical Trial Services (CTS) through translational research collaborations with pharma Collect samples to demonstrate utility of urine in translational research; “early
Slide 13: Trovagene Research Institute (TRI)
Trovagene Research Institute (TRI) World Class Team & Technology to Enhance Our Clinical Expertise and Commercial Reach Copyright ©2016 Trovagene, Inc. Confidential Goal: Accelerate adoption of Trovagene's Precision Cancer Monitoring platform in translational research and clinical applications World
Slide 14: Strategy to Drive Clinical Adoption and Reimbursement
Strategy to Drive Clinical Adoption and Reimbursement Copyright ©2016 Trovagene, Inc. Confidential Demonstrate concordance of oncogene mutation status between ctDNA and tumor tissue Clinical Utility: Determine mutational status of actionable biomarkers in ctDNA when a tissue biopsy is not available
Slide 15: Histiocytic Disorders: ECD/LCH Standard of Care
ECD/LCH Tissue Biopsy First Line Treatment Imaging (every 2-3 months) Copyright ©2016 Trovagene, Inc. Confidential Monitoring Therapeutic Response BRAF V600E Detection BRAF V600E TROVAGENE ECD/LCH ALL STAGES Molecular diagnosis of BRAF mutation – patients are placed on targeted therapy Re-staging of
Slide 16: Urinary ctDNA Outperforms Tissue Biopsies
Urinary ctDNA Outperforms Tissue Biopsies1 1Hyman et al., Cancer Discov. 2015 Jan;5(1):64-71 Copyright ©2016 Trovagene, Inc. Confidential Histiocytic Disorders: ECD/LCH Detection Urinary ctDNA BRAF V600E genotype Tissue BRAF V600E genotype Indeterminate Genotype BRAFV600E Mutant BRAF Wildtype n=9 n=
Slide 17: Dynamic Monitoring Captures Early Progression and Response
Dynamic Monitoring Captures Early Progression and Response1 Successful monitoring tumor dynamics independent of drug class used One week Patient’s tumor progressed within 1 week of Anakinra withdrawal Demonstration of need for higher frequency urine-based testing to monitor Patient responded to Vemu
Slide 18: Lung Cancer: Standard of Care
Molecular Detection & Response Monitoring EGFR T790M Monitoring Emergence of Resistance EGFR T790M TROVAGENE NSCLC Tissue Biopsy First Line Treatment Tissue Biopsy Second Line Treatment Imaging (every 6-8 weeks) Surgery Imaging (every 6-8 weeks) Adjuvant Therapy Molecular Detection EGFR Exon 19 del
Slide 19: Lung Cancer: Detection of Resistance Mutations in Urine
Yu et al Clin Can Res 2013 Copyright ©2016 Trovagene, Inc. Confidential Circulating Free DNA Detection in the Urine of Patients with Activating EGFR and T790M Resistance Mutations T790M 60% Her2 Amplification NFkB Upregulation MET Amplification AXL Upregulation Histologic Transformation Mechanisms o
Slide 20: Urinary Detection of EGFR T790M in Advance of Radiographic Progression
Urinary Detection of EGFR T790M Resistance Mutation in Advance of Radiographic Progression1 Copyright ©2016 Trovagene, Inc. Confidential Lung Cancer: Monitoring for Resistance Patient 20 Patient 10 Patient 3 PD PD PD T790M detected T790M detected PD T790M detected T790M detected Urine T790M Copies/1
Slide 21: Lung Cancer: Quantitate Drug Response
Monitoring Urinary ctDNA EGFR Mutation Within First 2 Weeks of Targeted Therapy Predicts Subsequent Radiographic Response in Patients Copyright ©2016 Trovagene, Inc. Confidential Lung Cancer: Quantitate Drug Response T790M Ex19 del Size on CT scan Sum of Longest Diameters (mm) Week 1 on drug 6 wks C
Slide 22: NSCLC: Case Study
NSCLC: Case Study Copyright ©2016 Trovagene, Inc. Confidential September 2013 December 2013 March 2014 May 2014 August 2014 November 2014 January 2015 February 2015 Needle tissue biopsy performed, confirming NSCLC Patient started on erlotinib Scan confirmed decrease in tumor and metastases Scan conf
Slide 23: Colorectal Cancer: Standard of Care
TROVAGENE Adjuvant Therapy Imaging (every 6 weeks) Systemic Therapy Imaging (every 6 wks-6 months) Surgery Molecular Detection KRAS, NRAS, BRAF Minimal Residual Disease Response Monitoring Molecular Detection KRAS, NRAS, BRAF KRAS, NRAS, BRAF Response Monitoring CRC CLINICAL UTILTY Stage I-III Resec
Slide 24: Monitoring ctDNA KRAS for Minimum Residual Disease Post Surgery
Monitoring ctDNA KRAS for Minimum Residual Disease Post Surgery1 1Melnikova et al, AACR 2015 Copyright ©2016 Trovagene, Inc. Confidential Colorectal Cancer: Minimal Residual Disease (MRD) Curative surgery correlates with undetectable levels of urinary ctDNA KRAS post-surgery in 4 of 5 patients Palli
Slide 25: Pancreatic Cancer: Standard of Care
TROVAGENE Diagnosis Biopsy Adjuvant Therapy Imaging (every 6-12 weeks) Imaging (every 6-12 weeks) Resectable Disease Surgery Non-Resectable Disease Chemotherapy CLINICAL UTILTY Diagnosis Screening for cancer RESECTABLE DISEASE Success of surgery Re-staging of cancer Chemo or not? Advanced and Metast
Slide 26: Melanoma: Standard of Care
Melanoma TROVAGENE First Line Treatment Second Line Treatment Imaging (every 6-8 weeks) Imaging (every 6-8 weeks) Response Monitoring BRAF - Drug Holidays Imaging (every 6-8 weeks) CLINICAL UTILTY Stage IV Metastatic MELANOMA Monitoring response allows selection or early switch to optimal therapy: B
Slide 27: 25+ Clinical Studies to Validate & Integrate Our PCM Platform
25+ Clinical Studies to Validate & Integrate Our PCM Platform Copyright ©2016 Trovagene, Inc. Confidential 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 28: Clinical Studies Continue to Drive Presentations & Publications
Clinical Studies Continue to Drive Presentations & Publications Copyright ©2016 Trovagene, Inc. Confidential NEXTGEN DX SUMMIT Oral Presentation, Technology IPV Meeting Poster Presentation HR-HPV Publication Cancer Discovery Histiocytic BRAF 3Q’14 Publication Blood ECD Clinical Guidelines 4Q’14 1Q’1
Slide 29: Clinical Studies Continue to Drive Presentations & Publications
Clinical Studies Continue to Drive Presentations & Publications Copyright ©2016 Trovagene, Inc. Confidential EUROGIN Submit Abstracts ASCO GI KRAS Pancreatic Study Personalized Medicine World Congress Oral Presentation Trovagene Technology and Clinical Evidence Molecular Medicine Tri Conference Oral
Slide 30: Optimizing the Commercial Model for Scale Up
May - June July – September 2016 Optimizing the Commercial Model for Scale Up Copyright ©2016 Trovagene, Inc. Confidential SAMPLE SUBMISSION OPERATIONAL READINESS CLINICAL UTILITY REIMBURSEMENT Significant adoption 500% above goal Multiple applications 100% urine samples 90%+ quality samples Office
Slide 31: Reimbursement Value Based on Clinical Utility of ctDNA
Reimbursement Value Based on Clinical Utility of ctDNA Copyright ©2016 Trovagene, Inc. Confidential Detection of Mutation Monitoring Tumor Dynamics Increase targeted therapy eligibility when tissue is inadequate for MolDx Evaluate response to therapy in advance of CT scans Identify resistance mutati
Slide 32: Reimbursement Value Drivers
Reimbursement Value Drivers Copyright ©2016 Trovagene, Inc. Confidential 35 % impact to final cash Appeals Strategy Secure Contracts Early Health Economics Value Proposition Multi-test Clinical Utility 0% 100% 2016 2017
Slide 33: Reimbursement Strategy
Reimbursement Strategy Copyright ©2016 Trovagene, Inc. Confidential 36 Where has the MolDx Industry Missed? Trovagene Difference Expected Outcome Reimbursement of only select content of clinically actionable biomarkers within a large panel Tests are designed to focus only on clinically relevant biom
Slide 34: Revenue Cycle Roadmap
Phase II Phase III Revenue Cycle Roadmap Copyright ©2015 Trovagene, Inc. Confidential 37 Payor Enrollment Initiate Contract Negotiation Secure Z-Codes Appeal Strategy Developed Finalize Coding Method Create Health-Economic Study Plan Establish CMS/Noridian Billing ESTABLISH BEST PRACTICES Phase II E
Slide 35: 2016 Milestones
2016 Milestones Copyright ©2016 Trovagene, Inc. Confidential Clinical Evidence 15+ abstracts in 2016 6 manuscripts Products 5 single assays 6 multi-gene panels Clinical Studies 25+ clinical studies Top academic centers Strategic Partnerships Clinical Trial Services Translational Research collaborati
Slide 36: For further information
For further information Please contact: Stephen Zaniboni, CFO szaniboni@trovagene.com
Slide 37: For further information
For further information Please contact Stephen Zaniboni, CFO szaniboni@trovagene.com