Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (September 2016)
32 slides from Cardiff Oncology's investor presentation, Sep 26, 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 constitute “forward-looking statements” for purposes of the safe harbor provisions of the Private S
Slide 2: Experienced Leadership Team
Experienced Leadership Team Bill Welch Chief Executive Officer Mark Erlander, PhD Chief Scientific Officer Karsten Schmidt, PhD Chief Technology Officer Elizabeth Anderson, CPA VP, Finance & Administration Rob Kelley VP, Marketing Vlada Melnikova, MD, PhD VP, Clinical & Translational Affairs Nick Ne
Slide 3: Harnessing urine to democratize cancer care
technology company Harnessing urine to democratize cancer care CLIA Lab Testing Services Trovera Tests Tech Transfer & Licensing Collaborations Academic and Pharmaceutical
Slide 4: Trovagene advantages
Trovagene advantages Industry leading clinical sensitivity Detecting, extracting and analyzing ctDNA Identifies actionable markers at industry leading sensitivities of <0.01% Consumer friendly collection Noninvasive Easily accessible Broadly available Proprietary Reagent Kits, Instruments and intell
Slide 5: 2016 goals
2016 goals Establish market presence with physicians through clinical collaborations, increased patient testing and favorable reimbursement Grow billable sample volume, quarter over quarter Sign insurance agreements for >100M covered lives Submit up to 9 manuscripts demonstrating clinical utility in
Slide 6: Why liquid biopsy
Why liquid biopsy insufficient DNA tumor heterogeneity inconclusive results inadvisable due to tumor location and/or patient health status results can take up to 30 days significant cost over course of treatment Inherent limitations with tissue biopsies Meric-Bernstrom, JCO, 2015. Gerlinger, NEJM, 2
Slide 7: Noninvasive tumor profiling
Blood Urine Noninvasive tumor profiling Circulating tumor DNA (ctDNA) Bardelli and Diaz. JCO. 2014 1Tumor growth causes an increase in tumor cell turnover Tumor cells Turnover of tumor cells: apoptosis or necrosis – tumor DNA (ctDNA) is released1 ctDNA enters blood stream, then excreted in urine via
Slide 8: Liquid biopsy Market Opportunity
liquid biopsy Market Opportunity $20B market spanning from late-stage disease to early cancer detection $2B $5B 2020E – JP Morgan – Life Sciences Deep Dive Series: Liquid Biopsies; May 2015 ~$4-7B ~$9B Stage I Stage IV Detect Actionable Mutations Monitor Response to Treatment Surveillance for Recurr
Slide 9: Urine DNA Preservation kit
urine dna Preservation kit Enables applications for genomic and genetic testing Patent pending locking and preservative delivery and automation-friendly design Consumer Friendly Completely noninvasive biopsy Patient-collected Cost effective Goal: Research Use Only (RUO) early 2017 and CE mark and FD
Slide 10: Proprietary and enabling
proprietary and enabling Wide-mouth opening Proprietary preservative Graduation (0 – 250 mL) Skirt supporting firm stand Concealed piercing tips Perfect fit for bench-top centrifuge adapter
Slide 11: Urine DNA markets
Urine DNA markets First of its kind urine collection and DNA preservation kit Comprehensive analysis of cell-free and cellular DNA Opening distribution for low cost DNA collection Domestic and International distribution Infectious Disease Transplant Urology Genetics Oncology
Slide 12: Hot spot approach
Hot spot approach DNA Extraction from urine Proprietary reagents, technology and methodology Proprietary primers designed for 20 – 110 base pair analysis High sensitivity Work in DNA from urine or blood Hot spot probes for targeted applications Allele-enrichment technology Separates mutants from wil
Slide 13: Competitive advantage
competitive advantage Traditional Liquid Biopsy Trovagene Difference Clinical Relevance Cost Portability Broad markers – relatively few clinically actionable and limited sensitivity Designed for clinically actionable biomarkers with industry leading sensitivity Global distribution and transferable t
Slide 14: Intellectual Property
Intellectual Property 51-110 base pair TrNA Family Urine Collection and Concentration Family Patent Term 2035 US app filed 2034 US app filed 2029 US & EU 2018 US & EU Small Footprint Family Monitoring Disease Family 20-50 Base Pair TrNA Family Anion Exchange Purification Family Viral and Pathogen Tr
Slide 15: Technology portfolio
Technology portfolio In Development Commercially Available EGFR KRAS BRAF EGFR KRAS BRAF NRAS ALK ROS PIK3CA AKT1 Others Multi-gene Panels for Detection and Monitoring Solid Tumor Cancers (lung, colorectal, pancreas, melanoma)
Slide 16: Multigene panel
Multigene panel MEK ERK KRAS NRAS Design Features Guideline-driven actionable oncogene panel for use in urine and blood Includes: 7 actionable oncogenes > 200 mutation, insertion and deletion variants Quantitative Sensitivity <0.01% Lung, Colorectal, Melanoma, Pancreas, Gastric Cancers Goal: Analyti
Slide 17: Clinical evidence
Clinical evidence Clinical Evidence Detection and Monitoring Lung EGFR Colorectal BRAF KRAS Histiocytic BRAF Pancreatic KRAS
Slide 18: Data and publications
data and publications Test Detection Stage III-IV Pharmaco-dynamics/ Drug MOA Monitoring Response/ Progression Detection Stage I-II Minimal Residual Disease Screening Suspicious Lesions EGFR KRAS ongoing BRAF ongoing Multiplex Panel ongoing ongoing ongoing Advanced and Metastatic Stage III-IV Early
Slide 19: ASCO 2016 Lung cancer
ASCO 2016 Lung cancer1 “The hope is that we will have plasma and urine testing available for patients so that we can avoid invasive biopsies for most patients in the future.” Heather Wakelee, MD 1June 2016, ASCO Oral Presentation Demonstrates Trovagene's Liquid Biopsy Urine Test Detects EGFR T790M M
Slide 20: Patient Care Testing opportunity
Patient Care Testing opportunity Resistance Detection Tumor Load Monitoring Drug Response Tumor Load Monitoring Treatment Treatment Biopsy then PROCEDURE Scan every 6-8 weeks Scan every 6-8 weeks Biopsy then Detection Cancer Specific Mutation Panel Driver Mutation Detection Driver Mutation One week
Slide 21: Detection Across sample types
Detection Across sample types Trovagene Urine (N = 213) Qiagen Tissue (N =482) Sysmex Blood (N = 482) Percentage Identified as T790M Positive* 79.3% 79.4% 77.6% Trovagene Urine Qiagen Tissue Sysmex Blood 19 5 8 18 4 104 16 Trovagene urine identified a similar proportion of T790M+ patients as tissue
Slide 22: Response to targeted therapy
response to targeted therapy 1 0 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Months 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 Probability Plasma Tissue Urine + Censored Median (Months) 95% CI Range Plasma 7.2 5.9–9.0 1.2, 21.4 Tissue‡ 8.7 7.1–9.3 1.2, 21.4 Urine 8.7 6.9–12.6 1.4, 21.0 0 0
Slide 23: Monitoring for T790M in advance of Radiographic Progression
Monitoring for T790M in advance of Radiographic Progression Patient 20 Patient 10 Patient 3 PD* PD* PD* T790M detected T790M detected PD* T790M detected T790M detected Urine T790M Copies/100K GE Patient 1 Urine T790M Copies/100K GE Urine T790M Copies/100K GE Urine T790M Copies/100K GE Early T790M De
Slide 24: Early Assessment of Response to targeted 3rd generation TKI therapy
Early Assessment of Response to targeted 3rd generation TKI therapy Within 1st week on therapy with a 3rd generation TKI, spikes in ctDNA represent tumor cell death Spikes gradually decrease, further indicating response to therapy Response to therapy confirmed with radiographic imaging Husain et al,
Slide 25: EGFR T790M Study conclusions
EGFR T790M Study conclusions Urine identified a similar proportion of T790M+ patients as tissue or blood Inadequate biopsy or tumor heterogeneity likely explain discordant results, and urine identified mutations that tissue missed EGFR mutation detection from urine demonstrated very strong clinical
Slide 26: ctDNA KRAS as an improved diagnostic tool
analysis demonstrating ctDNA KRAS as an improved diagnostic tool Baseline KRAS ctDNA is Highly Predictive of Overall Survival Variable Hazard Ratio (95% CI) p-value Baseline KRAS > 5.5 vs < 5.5 copies/105 GEq 2.4 (1.6 – 3.4) <0.0001 CA19-9* > 315 vs <315 U/mL 1.6 (1.2 – 2.3) 0.005 Gender (male vs fe
Slide 27: KRAS Study conclusions
Kras Study conclusions 92.9% of 210 patients with unresectable pancreatic cancer were positive for ctDNA KRAS using Trovagene’s liquid biopsy assay This detection rate closely matches the published prevalence of KRAS in pancreatic cancer (90%), and out-performs previous studies Studies using other l
Slide 28: Trovagene: A DNA technology company with broad applications
trovagene A DNA technology company with broad applications Only Molecular Dx in urine and blood Focused on clinically actionable, reimbursable biomarkers Global distribution model and tech transfer
Slide 29: Commercial Footprint
Commercial Footprint 1H’ 2016, Phase 1 field force Sales specialists, medical affairs and national accounts Early adopter focus – research institutions, key opinion and community leaders for lung, colorectal and pancreas >160 million covered lives today and growing Reimbursement goals, supported by
Slide 30: Near-term catalysts
Near-term catalysts Universal urine preservation kit for broad distribution Development of multigene panel(s) Urine and blood 7 actionable oncogenes > 200 mutation, insertion and deletion variants Corporate Development Collaborations and technology transfers Clinical Evidence 9 manuscripts submitted
Slide 31: Thank you
Thank you for more information, please email ir@trovagene.com
Slide 32: Thank you
THANK YOU trovagene | trévera for more information, please email