Cardiff Oncology, Inc. · NASDAQ:CRDF

Cardiff Oncology — Trovagene — Investor Presentation (July 2015)

42 slides from Cardiff Oncology's investor presentation, Jul 6, 2015

  1. Slide 1: Better Cancer Monitoring with Cell-Free DNA

    July, 2015 Better Cancer Monitoring with Cell-Free DNA

  2. 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

  3. Slide 3: Our Goal: Improve Treatment Outcomes with Non-invasive Cancer Monitoring

    Our Goal To Improve Treatment Outcomes with 3 Non-invasive Cancer Monitoring Trovagene’s technology non-invasively detects and quantitates circulating tumor DNA in urine and plasma for improved disease management Copyright ©2015 Trovagene, Inc. Confidential

  4. Slide 4: Company Overview

    Company Overview 4 Significant clinical validation program with leading cancer centers Expanding clinical evidence to support broad market adoption Generating health economic data necessary for appropriate reimbursement CLIA certified, CAP accredited, high complexity lab to offer diagnostic services

  5. Slide 5: Experienced Leadership Team

    Experienced Leadership Team 5 Mark Erlander, PhD Chief Scientific Officer BioTheranostics, AviaraDx, Arcturus, J&J, Scripps Research Institute BS, MS Biochem PhD Neuroscience Antonius Schuh, PhD Chief Executive Officer Sorrento Therapeutics, AviaraDx, Arcturus, Sequenom PhD Pharm. Chem Stephen Zanib

  6. 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 6 Driven by Oncogene mutations and alterations Heterogeneous: Inter-tumor (Distal) New Understanding of Cancer Intra-tumor

  7. Slide 7: Significant Market Opportunity

    Significant Market Opportunity 7 $12B In 2010 Insufficient Imaging Tools in Oncology Still Yield Huge Market Initial Opportunity for Trovagene 525K Metastatic cancer patients per year 8-10 Imaging procedures received by cancer patient during first year of treatment $5B Potential market Cancer alread

  8. Slide 8: Circulating Tumor DNA (ctDNA)

    Circulating Tumor DNA (ctDNA) 8 Main Advantages of ctDNA Captures intra- and inter-tumor heterogeneity Systemic overview of cancer Frequent sampling options for monitoring applications Copyright ©2015 Trovagene, Inc. Confidential Tumor cells Blood stream

  9. Slide 9: Why Urine?

    Why Urine? 9 Unlimited Volume Completely Non-invasive Frequency of Testing Convenient Urine ctDNA Plasma ctDNA Copyright ©2015 Trovagene, Inc. Confidential

  10. Slide 10: Trovagene Precision Cancer Monitoring (PCM) Platform

    Trovagene Precision Cancer Monitoring (PCM ) Platform 10 Ultra-Sensitive Detection and Quantitative Monitoring 100-1000 fold enrichment ~300,000 genome equivalents of cfDNA/200 mL of urine Integration with Commercially Available Platforms Single Molecule Detection ctDNA 4.9 ng/ul gDNA 0.04 ng/ul ctD

  11. Slide 11: Trovagene's Competitive Advantage

    Trovagene’s Competitive Advantage Copyright ©2015 Trovagene, Inc. Confidential 11 PCM Platform Has All Of The Required Attributes Above Best In Class Cancer Monitoring Performance SM High input cfDNA Optimized for Degraded cfDNA Enrichment of Mutant Allele Validated Quantitation Max Analytical Sensi

  12. Slide 12: Technology Portfolio Evolution

    Technology Portfolio Evolution Copyright ©2015 Trovagene, Inc. Confidential 12 Single Assays for Monitoring (Ultrasensitive, Quantitative) KRAS (Exons 2,3,4) NRAS (Exons 2,3,4) BRAF (V600E) PIK3CA (H1047R) EGFR (Exon 19 Del) EGFR (Exon 20 T790M) EGFR (Exon 21 L858R) Multiplex Panel KRAS (5 assays) N

  13. Slide 13: Strategy to Drive Clinical Adoption & Reimbursement

    Strategy to Drive Clinical Adoption & Reimbursement Copyright ©2015 Trovagene, Inc. Confidential 13 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

  14. Slide 14: 30+ Clinical Studies to Validate & Integrate our PCM Platform

    30+ Clinical Studies to Validate & Integrate our PCM Platform Copyright ©2015 Trovagene, Inc. Confidential 14 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

  15. Slide 15: Clinical Results Presented & Published To Date

    Clinical Results Presented & Published To Date Copyright ©2015 Trovagene, Inc. Confidential 15 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 Publ

  16. Slide 16: New Standard of Care Enabled by Trovagene Technology

    New Standard of Care Enabled by Trovagene Technology Copyright ©2015 Trovagene, Inc. Confidential 16 Detection Minimal Residual Disease (MRD) Quantitate Drug Response Monitoring Tissue Biopsy Imaging (every 6-8 weeks) Surgery Adjuvant Therapy Therapy Monitoring for Progression and Emergence of Resis

  17. Slide 17: Histiocytic Disorders: ECD/LCH

    ECD/LCH Tissue Biopsy First Line Treatment Imaging (every 2-3 months) Histiocytic Disorders: ECD/LCH Standard of Care Copyright ©2015 Trovagene, Inc. Confidential 17 Monitoring Therapeutic Response BRAF V600E Detection BRAF V600E TROVAGENE ECD/LCH ALL STAGES Molecular diagnosis of BRAF mutation – pa

  18. Slide 18: Urinary ctDNA Outperforms Tissue Biopsies

    Urinary ctDNA Outperforms Tissue Biopsies1 Copyright ©2015 Trovagene, Inc. Confidential 18 1Hyman et al., Cancer Discovery 2015 Jan;5(1):64-71 Urinary ctDNA BRAFV600E genotype Tissue BRAFV600E genotype Indeterminate Genotype BRAFV600E Mutant BRAF Wildtype n=9 n=6 n=15 BRAFV600E Mutant BRAF Wildtype

  19. Slide 19: Dynamic Monitoring Captures Early Progression and Response

    Dynamic Monitoring Captures Early Progression and Response1 One week Successful monitoring tumor dynamics independent of drug class used 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

  20. Slide 20: 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 Primary Biopsi

  21. Slide 21: NSCLC Standard of Care

    NSCLC Standard of Care Copyright ©2015 Trovagene, Inc. Confidential 21 Molecular Detection & Response Monitoring EGFR T790M Monitoring Emergence of Resistance EGFR T790M Molecular Detection EGFR Exon 19 del EGFR L858R KRAS TROVAGENE NSCLC Tissue Biopsy First Line Treatment Second Line Treatment Imag

  22. Slide 22: Replacing Tissue Biopsy in Metastatic NSCLC with ctDNA Monitoring

    Replacing Tissue Biopsy in Metastatic NSCLC with ctDNA Monitoring ctDNA EGFR for Treatment Response and Early Acquisition of EGFR T790M Resistance Mutation 22 30 Metastatic NSCLC Patients, Second Line Therapy 300 Metastatic NSCLC Patients at Diagnosis, EGFR Exons19 and 21 Status in Tissue ctDNA Moni

  23. Slide 23: Urine Identifies More Patients with EGFR T790M Resistance Mutation than Tissue

    Urine Identifies More Patients with EGFR T790M Resistance Mutation than Tissue Copyright ©2015 Trovagene, Inc. Confidential 23 Preliminary Results (Total number of patients examined by urine = 22, number of patients examined by tissue = 13 of 22) 10 Patients 15 Patients Urine Tissue

  24. Slide 24: Urinary Detection of EGFR T790M in Advance of Radiographic Progression

    Patient 20 Patient 10 Patient 3 Copyright ©2015 Trovagene, Inc. Confidential 24 1Husain et al., ELCC 2015 Early T790M Detection (Days to Radiographic Progression) Patient 1 111 Patient 3 52 Patient10 56 Patient 20 29 PD PD PD T790M detected T790M detected PD T790M detected T790M detected Urine T790M

  25. Slide 25: Monitoring Urinary ctDNA EGFR Mutation Predicts Radiographic Response

    Monitoring Urinary ctDNA EGFR Mutation Within First 2 Weeks of Targeted Therapy Predicts Subsequent Radiographic Response in Patients Copyright ©2015 Trovagene, Inc. Confidential 25 1Husain et al., ELCC 2015 Patient 1 Copies/100K GE (95% CI) Time on Drug T790M Exon 19 del Baseline 24 (19-38) 167 (12

  26. Slide 26: Colorectal Cancer Market and Clinical Utility

    TROVAGENE Adjuvant Therapy Imaging (every 6 weeks) Systemic Therapy Imaging (every 6 wks-6 months) Surgery Molecular Detection Molecular Detection ~50,000 stage IV ~50,000 tests MARKET Surgeries ~50,000 patients per year x 4 tests ~200,000 tests Response Monitoring ~80,000 stage I-III colorectal can

  27. Slide 27: Colorectal Cancer Standard of Care

    Colorectal Cancer Standard of Care 27 KRAS, NRAS, BRAF Minimal Residual Disease Response Monitoring TROVAGENE Adjuvant Therapy Imaging (every 6 weeks) Systemic Therapy Imaging (every 6 wks-6 months) Molecular Detection KRAS, NRAS, BRAF Surgery KRAS, NRAS, BRAF Response Monitoring Molecular Detection

  28. Slide 28: Monitoring ctDNA KRAS for Minimum Residual Disease Post Surgery

    Monitoring ctDNA KRAS for Minimum Residual Disease Post Surgery1 28 1Melnikova et al, AACR 2015 Curative surgery correlates with un-detectable levels of urinary ctDNA KRAS post-surgery in 4 of 5 patients Palliative surgery correlates with high levels of urinary ctDNA KRAS post-surgery in 10 of 12 pa

  29. Slide 29: Pancreatic Cancer Standard of Care

    Pancreatic Cancer Standard of Care 30 TROVAGENE Diagnosis Biopsy Adjuvant Therapy Imaging (every 6-12 weeks) Imaging (every 6-12 weeks) Resectable Disease Surgery Non-Resectable Disease Chemotherapy University of Copenhagen University of Copenhagen (50 patients) MDACC (90 patients) University of Cop

  30. Slide 30: Monitoring ctDNA KRAS G12/13 Predicts Overall Survival in Pancreatic Patients

    Baseline KRAS Pre-treatment (cps/100K GE) Week 2 KRAS End of Cycle 1 (cps/100K GE) N Median Overall Survival (after Cycle 1) 95% CI for Median Overall Survival (after Cycle 1) Hazard Ratio of Death (95% CI) 5.5 5.5 28 336 days 235 – 461 days 1.0 5.5 > 5.5 10 252 days >168 days2 1.3 > 5.5 5.5 20 224

  31. Slide 31: Melanoma Standard of Care

    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 MARKET Response Monitoring ~9000 stage IV patients x 60% BRAF+ x 10 tests ~54,000 tests per year – Drug Holidays Imaging (every 6-8 wee

  32. Slide 32: Melanoma Standard of Care and Studies

    Melanoma Standard of Care 33 TROVAGENE First Line Treatment Second Line Treatment Imaging (every 6-8 weeks) Imaging (every 6-8 weeks) STUDIES Response Monitoring BRAF – Drug Holidays Imaging (every 6-8 weeks) Georgetown University (7 patients) UCSF (210 patients) MSKCC (50 patients) DFCI (40 patient

  33. Slide 33: Ongoing Clinical Studies Continue to Drive Publications

    Ongoing Clinical Studies Continue to Drive Publications 34 2015 AACR-NCI-EORTC Submit abstracts ECD Global Alliance. Submit abstracts Q4 Q1 Q2 10/2015 Submit manuscript BRAF and KRAS multiple cancers MD Anderson IPV Conference Abstract Submitted 8/2015 9/2015 NEXTGEN DX SUMMIT Oral presentation Moni

  34. Slide 34: Commercial Organization: Phase I

    Commercial Organization: Phase I Copyright ©2015 Trovagene, Inc. Confidential 35 Chief Commercial Officer SALES Strategic Accounts Field Sales: Northeast Field Sales: MidAtlantic Field Sales: Southeast Field Sales: West MARKETING Product Management Marketing Communications Tradeshows/Conferences COR

  35. Slide 35: External Awareness

    Copyright ©2015 Trovagene, Inc. Confidential 36 External Awareness

  36. Slide 36: Creating Physician Awareness & Demand

    Creating Physician Awareness & Demand Copyright ©2015 Trovagene, Inc. Confidential 37 Allows physicians hands on experience with their patients Assess benefits of: Urine as a sample Quantitation Ultra sensitivity Choice of 3 applications: Diagnostic in lieu of a tissue biopsy result Baseline & monit

  37. Slide 37: Early Adopters

    Early Adopters INSERT PHOTO MONTAGE Copyright ©2015 Trovagene, Inc. Confidential 38

  38. Slide 38: Optimizing the Commercial Model for Scale Up

    Optimizing the Commercial Model for Scale Up Clinical Interest Copyright ©2015 Trovagene, Inc. Confidential 39 Sample Submission Operational Readiness Clinical Utility Reimbursement Significant adoption 500% above goal Multiple applications 100% urine samples 90%+ quality samples Office & Home colle

  39. Slide 39: Reimbursement Value Based on Clinical Utilities of ctDNA

    Reimbursement Value Based on Clinical Utilities of ctDNA Copyright ©2015 Trovagene, Inc. Confidential 40 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 Pri

  40. Slide 40: Lung Cancer Tissue Biopsy: Cost Assumptions

    Lung Cancer Tissue Biopsy: Cost Assumptions1 Copyright ©2015 Trovagene, Inc. Confidential 41 While the median cost for a lung cancer biopsy is ~$3,750, a recent review of 5% of the Medicare population found that complications drove average biopsy cost to $14,634. 1Medicare claims analysis presented

  41. Slide 41: 2015 Catalysts & Milestones to Drive Valuation

    2015 Catalysts & Milestones to Drive Valuation Copyright ©2015 Trovagene, Inc. Confidential 42 Continue to demonstrate clinical utility Expand mutation coverage on PCM platform Initiate new collaborations to establish clinical utility Establish strategic partnerships to grow market reach Drive adopt

  42. Slide 42: For further information

    For further information Please contact: Stephen Zaniboni, CFO szaniboni@trovagene.com Antonius Schuh, CEO aschuh@trovagene.com

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