Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (November 2015)
34 slides from Cardiff Oncology's investor presentation, Nov 16, 2015
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
3 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
Slide 3: Company Overview
Copyright ©2015 Trovagene, Inc. Confidential 4 Clinical collaborations with leading cancer centers and pharmaceutical partners CLIA certified, CAP accredited, high complexity lab to offer diagnostic services Trovagene’s noninvasive liquid biopsy assays are used to detect and monitor oncogene mutatio
Slide 4: 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 5: Strong Scientific Advisory Board and Board of Directors
Strong Scientific Advisory Board and Board of Directors Copyright ©2015 Trovagene, Inc. Confidential 6 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 Founde
Slide 6: Significant Market Opportunity
Significant Market Opportunity Physicians lack tools to effectively monitor and react to changes in cancer over time Copyright ©2015 Trovagene, Inc. Confidential 7 Source: 2010 BCC Research Trovagene PCM delivers critical information to detect and measure actionable cancer mutations over time Insuff
Slide 7: 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 ©2015 Trovagene, Inc. Confidential 8 Biopsy Surgery Treatment Treatment Biopsy PROCEDURE IMAGING Every 6-8 weeks Every 6-8 weeks Trovagene platform allows physi
Slide 8: Advantages of Circulating Tumor DNA (ctDNA)
Tumor cells Blood Urine Advantages of Circulating Tumor DNA (ctDNA) 9 Copyright ©2015 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 tim
Slide 9: Trovagene Precision Cancer Monitoring (PCM) Platform
Trovagene Precision Cancer Monitoring (PCM ) Platform 10 SM Copyright ©2015 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 monitorin
Slide 10: Intellectual Property
Intellectual Property Copyright ©2015 Trovagene, Inc. Confidential 11 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 Exchang
Slide 11: Technology Portfolio Evolution
Copyright ©2015 Trovagene, Inc. Confidential 12 Technology Portfolio Evolution 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
Slide 12: Distribution and Service Options
Distribution and Service Options Copyright ©2015 Trovagene, Inc. Confidential 13 CLIA Lab Pharma Services Tech Transfer Cloud Exchange Centralized Democratized
Slide 13: Trovagene Research Institute (TRI)
Trovagene Research Institute (TRI) World Class Team & Technology to Enhance Our Clinical Expertise and Commercial Reach Copyright ©2015 Trovagene, Inc. Confidential 14 Goal: Accelerate adoption of Trovagene's Precision Cancer Monitoring platform in translational research and clinical applications Wo
Slide 14: Strategy to Drive Clinical Adoption and Reimbursement
Strategy to Drive Clinical Adoption and Reimbursement Copyright ©2015 Trovagene, Inc. Confidential 15 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 availab
Slide 15: Histiocytic Disorders: ECD/LCH Monitoring Therapeutic Response
ECD/LCH Tissue Biopsy First Line Treatment Imaging (every 2-3 months) Copyright ©2015 Trovagene, Inc. Confidential 16 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
Slide 16: Urinary ctDNA Outperforms Tissue Biopsies
Urinary ctDNA Outperforms Tissue Biopsies1 1Hyman et al., Cancer Discov. 2015 Jan;5(1):64-71 17 Copyright ©2015 Trovagene, Inc. Confidential Detection Urinary ctDNA BRAF V600E genotype Tissue BRAF V600E genotype Indeterminate Genotype BRAFV600E Mutant BRAF Wildtype n=9 n=6 n=15 BRAFV600E Mutant BRAF
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: Molecular Detection & Response Monitoring: EGFR T790M NSCLC
Molecular Detection & Response Monitoring EGFR T790M Monitoring Emergence of Resistance EGFR T790M NSCLC Standard of Care 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 19 Molecular D
Slide 19: Detection of Resistance Mutations in Lung Cancer Urine
Yu et al Clin Can Res 2013 Copyright©2015 Trovagene, Inc. Confidential 20 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
Slide 20: Urinary Detection of EGFR T790M in Advance of Radiographic Progression
Urinary Detection of EGFR T790M Resistance Mutation in Advance of Radiographic Progression1 21 Copyright ©2015 Trovagene, Inc. Confidential Monitoring for Resistance Lung Cancer Patient 20 Patient 10 Patient 3 PD PD PD T790M detected T790M detected PD T790M detected T790M detected Urine T790M Copies
Slide 21: Urinary ctDNA EGFR Monitoring Predicts Radiographic Response
Monitoring Urinary ctDNA EGFR Mutation Within First 2 Weeks of Targeted Therapy Predicts Subsequent Radiographic Response in Patients 22 Copyright ©2015 Trovagene, Inc. Confidential Quantitate Drug Response Lung Cancer T790M Ex19 del Size on CT scan Sum of Longest Diameters (mm) Week 1 on drug 6 wks
Slide 22: Case Study
Case Study Copyright ©2015 Trovagene, Inc. Confidential 23 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 confirme
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 24 KRAS, NRAS, BRAF Minimal Residual Disease Response Monitoring Molecular Detection KRAS, NRAS, BRAF KRAS, NRAS, BRAF Response Monitoring CRC CLINICAL UTILTY Stage I-III Re
Slide 24: Monitoring ctDNA KRAS for Minimal Residual Disease Post Surgery
Monitoring ctDNA KRAS for Minimum Residual Disease Post Surgery1 1Melnikova et al, AACR 2015 25 Copyright ©2015 Trovagene, Inc. Confidential Minimal Residual Disease (MRD) Colorectal Cancer Curative surgery correlates with undetectable levels of urinary ctDNA KRAS post-surgery in 4 of 5 patients Pal
Slide 25: Pancreatic Cancer
Pancreatic Cancer Standard of Care 26 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 ca
Slide 26: Melanoma
Melanoma Melanoma Standard of Care 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) 27 CLINICAL UTILTY Stage IV Metastatic MELANOMA Monitoring response allows selection or early
Slide 27: 30+ Clinical Studies to Validate & Integrate Our PCM Platform
30+ Clinical Studies to Validate & Integrate Our PCM Platform Copyright ©2015 Trovagene, Inc. Confidential 28 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 42,0
Slide 28: Clinical Studies Continue to Drive Presentations & Publications
Clinical Studies Continue to Drive Presentations & Publications Copyright ©2015 Trovagene, Inc. Confidential 29 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 1
Slide 29: Clinical Studies Continue to Drive Presentations & Publications
Clinical Studies Continue to Drive Presentations & Publications 30 EUROGIN Submit Abstracts ASCO GI KRAS Pancreatic Study Personalized Medicine World Congress Oral Presentation Trovagene Technology and Clinical Evidence Molecular Medicine Tri Conference Oral Presentation Trovagene Technology and Cli
Slide 30: Optimizing the Commercial Model for Scale Up
May - June July – September 2016 Optimizing the Commercial Model for Scale Up CLINICAL INTEREST Copyright ©2015 Trovagene, Inc. Confidential 32 SAMPLE SUBMISSION OPERATIONAL READINESS CLINICAL UTILITY REIMBURSEMENT Significant adoption 500% above goal Multiple applications 100% urine samples 90%+ qu
Slide 31: Reimbursement Value Based on Clinical Utility of ctDNA
Reimbursement Value Based on Clinical Utility of ctDNA Copyright ©2015 Trovagene, Inc. Confidential 33 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 Price
Slide 32: 2015 – 2016 Milestones
2015 – 2016 Milestones Copyright ©2015 Trovagene, Inc. Confidential 34 Clinical Evidence 20+ abstracts in 2015 5 manuscripts Products 6 new menu assays Multiplex panels in 2016 Clinical Studies 30+ clinical studies Top academic centers Strategic Partnerships Geographic expansion Kit manufacturing Ph
Slide 33: For further information
For further information Please contact: Stephen Zaniboni, CFO szaniboni@trovagene.com Antonius Schuh, CEO aschuh@trovagene.com Matt Posard, CCO mposard@trovagene.com
Slide 34: For further information
For further information Please contact: Antonius Schuh, CEO Matt Posard, CCO Stephen Zaniboni, CFO szaniboni@trovagene.com aschuh@trovagene.com _ mposard@trovagene.com