Slide 1: Better Cancer Monitoring with Cell-Free DNA
Better Cancer Monitoring with Cell-Free DNA October 2014
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 Noninvasive Cancer Diagnostics
Our Goal To Improve Treatment Outcomes with Copyright©2014 Trovagene, Inc. 3 Noninvasive Cancer Diagnostics Trovagene’s technology noninvasively detects and quantitates circulating tumor DNA in urine and plasma for improved disease management
Slide 4: Company Overview
Company Overview Copyright©2014 Trovagene, Inc. 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 accredited, hig
Slide 5: Experienced Leadership Team
Experienced Leadership Team Copyright©2014 Trovagene, Inc. 5 Vlada Melnikova MD, PhD VP, Research & Development Transgenomic, ApoCell, MD Anderson Cancer Center MD | PhD Biological Engineering Mark Erlander PhD Chief Science Officer BioTheranostics, AviaraDx, Arcturus, J&J, Scripps Research Institut
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©2014 Trovagene, Inc. 6 Need for Genomic Monitoring Driven by Oncogene mutations and alterations Heterogeneous: In
Slide 7: Limitations of Current Technology for Cancer Monitoring
Limitations of Current Technology for Cancer Monitoring Copyright©2014 Trovagene, Inc. 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 serious complic
Slide 8: Significant Market Opportunity
Significant Market Opportunity Copyright©2014 Trovagene, Inc. 8 $12B In 2010 Insufficient Imaging Tools in Oncology Still Yield Huge Market Prime Opportunity for Trovagene 525K Metastatic cancer patients per year 8-10 Imaging procedures received by cancer patient during first year of treatment $5B P
Slide 9: Circulating Tumor DNA (ctDNA)
Circulating Tumor DNA (ctDNA) Copyright©2014 Trovagene, Inc. 9 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 10: Why Urine?
Why Urine? Copyright©2014 Trovagene, Inc. 10 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 11: 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 12: Trovagene Precision Cancer Monitoring (PCM) Platform
Trovagene Precision Cancer Monitoring (PCM) Platform Copyright©2014 Trovagene, Inc. 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 error rate detec
Slide 13: Patent Portfolio
Patent Portfolio Copyright©2014 Trovagene, Inc. 13 51-110 bp TrNA Family Concentrating Urine Family Patent Term Term to approx. 2035 US provisional app filed Term to approx. 2034 US provisional app filed Term to approx. 2029 US & EU Term 2018 US & EU Small Footprint Family Monitoring Disease Family
Slide 14: Trovagene Performance Advantages
Trovagene Performance Advantages Copyright©2014 Trovagene, Inc. 14 Detection of Rare Genomic Mutations Monitoring Response, Progression & Resistance Robust quantitation to determine number of mutation fragments present Ability to track changes longitudinally Compatible with highly degraded DNA for m
Slide 15: Strategy to Drive Clinical Adoption & Reimbursement
Strategy to Drive Clinical Adoption & Reimbursement Copyright©2014 Trovagene, Inc. 15 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. BRAF, KRAS $100
Slide 16: Clinical Utilities of ctDNA
Clinical Utilities of ctDNA Copyright©2014 Trovagene, Inc. 16 Metastatic Cancers Detection of Mutation Monitoring Mutation Level When tissue biopsy is unavailable Supplement tissue biopsy to get systemic overview of the entire heterogeneity of cancer Tumor load Emergence of resistant mutations Drug
Slide 17: 30+ Collaborations to Validate & Integrate our PCM Platform
30+ Collaborations to Validate & Integrate our PCM Platform Copyright©2014 Trovagene, Inc. 17 Disease Ongoing Pending Protocol Dev/Approval Under Evaluation Lung Cancer (NSCLC) 4 3 — Colorectal Cancer 4 3 — Pancreatic Cancer 3 — 1 Melanoma 2 4 — ECD/LCH 2 — 1 Brain Cancer 1 1 — Prostate Cancer — 1 —
Slide 18: Ongoing Clinical Utility Studies
Ongoing Clinical Utility Studies Copyright©2014 Trovagene, Inc. 18 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 Detection and mo
Slide 19: Increasing Volume of Clinical Study Samples Received by Trovagene
Increasing Volume of Clinical Study Samples Received by Trovagene Copyright©2014 Trovagene, Inc. 19
Slide 20: Clinical Results Presented & Published To Date
Clinical Results Presented & Published To Date Copyright©2014 Trovagene, Inc. 20 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-HPV Manuscript su
Slide 21: High Concordance of KRAS Status in Urine, Plasma & Tissue
High Concordance of KRAS Status in Urine, Plasma & Tissue of Advanced Colorectal Cancer Patients Copyright©2014 Trovagene, Inc. 21 20 Advanced Stage Colorectal Cancer Patients KRAS Mutation in Tissue, Treatment Naïve Matched urine and plasma, archived (3-5 years) Blinded analysis, seven KRAS mutatio
Slide 22: Monitoring ctBRAF V600E and Treatment Response
Monitoring ctBRAF V600E and Treatment Response Copyright©2014 Trovagene, Inc. 22 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 correlate
Slide 23: ctDNA Improves Genotyping Over Tissue Biopsies in Histiocytic Patients
ctDNA Improves Genotyping Over Tissue Biopsies in Histiocytic Patients Copyright©2014 Trovagene, Inc. 23 BRAFV600E burden in urine correlates w/ radiographic response. BRAFV600E Mutant BRAF Wildtype Urinary ctDNA BRAFV600E genotype Tissue BRAFV600E genotype Indeterminate Genotype BRAFV600E Mutant BR
Slide 24: Dynamic Monitoring Captures Early Progression and Response
Dynamic Monitoring Captures Early Progression and Response Copyright©2014 Trovagene, Inc. 24 One week 1 Abdel-Wahab et al., ASCO Poster Highlight 2014 Successful monitoring tumor dynamics independent of drug class used Patient’s tumor progressed within 1 wk of Anakinra withdrawal Demonstration of ne
Slide 25: Ongoing Clinical Studies Continue to Drive Publications
Ongoing Clinical Studies Continue to Drive Publications Copyright©2014 Trovagene, Inc. 25 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 ASCO Submit abstra
Slide 26: Current Development Program for Cancer Monitoring Applications
Current Development Program for Cancer Monitoring Applications Copyright©2014 Trovagene, Inc. 26 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 27: Trovagene Urine-based High Risk HPV Assay
Trovagene Urine-based High Risk HPV Assay Copyright©2014 Trovagene, Inc. 27 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 incidence in U
Slide 28: 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©2014 Trovagene, Inc. 28 Partnering Opportunities Strategic
Slide 29: Reimbursement Value Based on Clinical Utilities of ctDNA
Reimbursement Value Based on Clinical Utilities of ctDNA Copyright©2014 Trovagene, Inc. 29 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/assay Repea
Slide 30: Key Component for Commercialization: Market Development
Key Component for Commercialization: Market Development Copyright©2014 Trovagene, Inc. 30 Market Development (2013-2014) Full Commercialization (2015) Target KOLs/ Early adopters Develop IIS (Investigator Initiated Study) Program Accelerate Adoption within Integrated Healthcare Delivery Networks (ID
Slide 31: Key Components for Full Commercialization in 2015
Key Components for Full Commercialization in 2015 Copyright©2014 Trovagene, Inc. 31 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 sales reps in P
Slide 32: Targeted Segments for Market Development & Commercialization
Targeted Segments for Market Development & Commercialization Copyright©2014 Trovagene, Inc. 32 Data support adoption in clinical academic centers in defined patient populations Pancreatic (Metastatic) Melanoma (Metastatic) Colorectal (Metastatic) Lung (NSCLC) Pancreatic (Stage 2-3) ECD/LCH
Slide 33: Cash Flow Summary 2012 – YTD Jun 2014
Cash Flow Summary 2012 – YTD Jun 2014 Copyright©2014 Trovagene, Inc. 33 ($ in millions) 2012 2013 YTD Jun 2014 Net loss (11.6) (11.8) (4.3) Cash burn Cash used in operating activities (4.9) (7.3) (5.5) Cash used in investing (0.3) (0.6) (0.1) (5.2) (7.9) (5.6) Funding Net cash provided by financing
Slide 34: Funding Details 2012 – YTD Jun 2014
Funding Details 2012 – YTD Jun 2014 Copyright©2014 Trovagene, Inc. 34 ($ in millions) 2012 2013 YTD Jun 2014 Financing activities (net of expenses) Private Placements 6.2 NASDAQ up-listing 9.1 ATM 4.0 Institution Investment 14.8 Exercise of Warrants and options 0.0 3.6 15.3 22.4 - Net borrowing unde
Slide 35: Near Term Catalysts to Drive Valuation
Near Term Catalysts to Drive Valuation Copyright©2014 Trovagene, Inc. 35 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 cancer centers an
Slide 36: For further information
For further information Please contact: Stephen Zaniboni, CFO szaniboni@trovagene.com Antonius Schuh, CEO aschuh@trovagene.com 36