Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (July 2016)
29 slides from Cardiff Oncology's investor presentation, Jul 11, 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: Our mission: harnessing urine to democratize cancer care
our mission Harnessing urine to democratize cancer care Direct to Physician CLIA Trovera Testing Service Tech Transfer & Licensing Clinical Trial Services & Translational Medicine Support
Slide 3: 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 4: Today
today Trovera™ noninvasive urine and blood liquid biopsy tests CLIA certified CAP accredited laboratory Precision Cancer Monitoring® (PCM) proprietary technology Extraction and purification Mutant allele enrichment Quantitation Collaborations validating clinical utility Only company with both urine
Slide 5: Why liquid biopsy: limitations of tissue biopsies
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 6: 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 Diagnostics to Inform Treatment Monitoring Response to Therapy Surveillance for R
Slide 7: Trovagene in the news
Trovagene in the news1 “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 8: Liquid biopsies enable detection and quantitation of ctDNA
Blood Urine Enables understanding of tumor dynamics Captures intra- and inter-tumor heterogeneity Provides timely, clinically actionable data Allows for more frequent testing Providing information before treatment, during treatment and at disease progression Liquid biopsies enable detection & quanti
Slide 9: Trovagene assay technology
Trovagene assay technology Lower limit of detection (LOD) of all assays is <0.01% mutant allele frequency1 Amplifies extremely low levels of mutant DNA in a background of normal DNA Assays show >85% concordance with tissue biopsy1 1Performance from Trovagene CLIA laboratory validation studies Precis
Slide 10: Technology portfolio
Technology portfolio In Development Commercially Available EGFR KRAS BRAF EGFR KRAS BRAF NRAS ALK ROS PIK3CA AKT1 Multi-gene Panel for Detection and Monitoring Solid Tumor Cancers (lung, colorectal, pancreas, melanoma)
Slide 11: Intellectual Property
Intellectual Property 51-110 base pair TrNA Family Concentrating Urine 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 TrNA Families Pat
Slide 12: Trovagene value proposition
Trovagene value proposition Detect the presence or absence of clinically actionable mutations Inform decision making regarding treatment and management of cancer Monitor quantitative changes in mutational status, including response to treatment, minimal residual disease and disease progression Harne
Slide 13: 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 14: Commercial Footprint
Commercial Footprint 1Q 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 p
Slide 15: Data and publication milestones
data and publication milestones 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
Slide 16: 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 17: EGFR T790M detection in NSCLC: matched urine, blood and tissue
Urine (>200 patients) Blood (>200 patients) Blood vs.Tissue Biopsy Concordance for T790M at Baseline Serial monitoring on treatment (n=>600 blood and n=>600 urine samples) 213 Patients with EGFR Activating Mutation Positive Metastatic NSCLC Relapsed on 1st Generation TKI Therapy Enrolled in TIGER-X
Slide 18: 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 19: 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 20: Monitoring early drug response in metastatic NSCLC
> 40 patients with metastatic NSCLC treated with EGFR TKIs Monitoring early Drug response 0 1 2 4 3 5 6 7 days 3 weeks -6 week 6 weeks CT Scan 3rd generation anti-EGFR TKI first administered on day 0 and then continued until progression Serial Urine Collection Urine collected q3-6 weeks on 1st gener
Slide 21: Early assessment of response to 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 22: 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 23: KRAS detection in pancreatic cancer
KRAS detection in pancreatic cancer Prospective study of 239 patients with unresectable, locally advanced or metastatic pancreatic cancer Archived samples from patients undergoing treatment with chemotherapy (Danish BIOPAC study) ctDNA KRAS detection at baseline for association with overall survival
Slide 24: 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 25: 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 26: Earlier detection opportunity
earlier detection opportunity Comprehensive clinical utility from late-stage to earlier stage detection and response to therapy Longitudinal monitoring of response to treatment Minimal Residual Disease (MRD) Improved prognostic and predictive care Test Detection Stage III-IV Pharmaco-dynamics/ Drug
Slide 27: Trovagene Investment Summary
Trovagene Investment Summary Noninvasive liquid biopsy is a large diagnostic opportunity Trovagene is harnessing urine to democratize cancer care Scalable model: CLIA lab services Global technology platform – transfer and licensing Translational pharma clinical trial support 2016 goals to establish
Slide 28: Thank you
Thank you for more information, please email ir@trovagene.com
Slide 29: Thank you
THANK YOU trovagene | trévera for more information, please email