Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (April 2014)
31 slides from Cardiff Oncology's investor presentation, Apr 14, 2014
Slide 1: Better Cancer Monitoring with Cell-Free DNA in Urine
Antonius Schuh, Ph.D. | Chief Executive Officer April 2014 Better Cancer Monitoring with Cell-Free DNA in Urine
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 For Cancer Patients
Our Goal: Improve Treatment Outcomes For Cancer Patients INTRODUCTION Trovagene’s technology detects and quantitates oncogene mutations from cell-free DNA in the urine of cancer patients for improved disease management Our diagnostic platform provides important clinical information beyond the curren
Slide 4: Key Assets
Key Assets Cancer monitoring technology addresses high unmet clinical need Enables more frequent, non-invasive monitoring of oncogene mutation status, disease progression, and recurrence Feasible now that improved PCR and next generation sequencing (NGS) platforms are available at significantly lowe
Slide 5: Experienced Leadership Team
Experienced Leadership Team INTRODUCTION Thomas Adams, PhD (Chair) John P. Brancaccio, CPA Gary S. Jacob, PhD Paul Billings, MD, PhD Charles Cantor, PhD Carlo M. Croce, MD Riccardo Dalla-Favera, MD Antonius Schuh, PhD Stanley Tennant, MD Rodney Markin, MD, PhD Scientific Advisors Antonius Schuh PhD
Slide 6: Large Addressable Market; Est. 45% Rise in U.S. Cancer Incidence by 2030
THE CLINICAL UTILITY OF CELL-FREE DNA FROM URINE Treatment Response and Resistance Monitoring Metastatic cancer patients per year: ~525,000 Price Per Test: $1,000 Tests Per Year: 6 TAM patients: 3.2M TAM $: ~$3.2B Average patient receives 8-10 imaging studies during initial 12 month period post-diag
Slide 7: Clinical Dilemma In Cancer Treatment
Clinical Dilemma In Cancer Treatment Large body of knowledge has been developed around the molecular basis of cancer Paradigm Shift: Cancers are driven by oncogene mutations resulting in the trend toward new targeted therapies Effectiveness requires monitoring Resistance develops Therapies are expen
Slide 8: Cancer Monitoring Using cfDNA Is An Emerging Trend
Cancer Monitoring Using cfDNA Is An Emerging Trend THE CLINICAL UTILITY OF CELL-FREE DNA FROM URINE “Circulating tumor DNA levels showed a greater dynamic range, and greater correlation with changes in tumor burden, than did CA 15-3 or circulating tumor cells. This proof-of-concept analysis showed t
Slide 9: Cell-free DNA Filters Into The Urine
Cell-free DNA Filters Into The Urine THE CLINICAL UTILITY OF CELL-FREE DNA FROM URINE Large volume can be collected High frequency of collection possible Cell-free DNA stable in urine Truly non-invasive Patient can self-sample at home or clinic No medical professional required for specimen No refrig
Slide 10: A Decade of Scientific Work Validates Our Novel Approach
A Decade of Scientific Work Validates Our Novel Approach 15 peer reviewed publications covering all nucleic acid types in urine DNA RNA miRNA Methylation Fields of Study Oncology Prenatal Infectious Disease Transplant TROVAGENE PLATFORM See appendix for details
Slide 11: Genetic Sequencing Advancements Enable TROV Technology
Genetic Sequencing Advancements Enable TROV Technology Detecting rare DNA mutation events in urine made commercially feasible by NGS & ddPCR Trovagene IP Next Gen sequencing Digital Droplet PCR TROVAGENE PLATFORM Decline in cost for gene sequencing outpacing Moore’s Law since 2008; reflects transiti
Slide 12: Trovagene Proprietary Technology Leverages NGS/ddPCR
Trovagene Proprietary Technology Leverages NGS/ddPCR NGS ddPCR TROVAGENE PLATFORM + Resulting in Unparalleled Sensitivity (Analytical Detection to 0.03%) Novel Extraction Process Enrichment of DNA from circulation Enrichment of DNA containing tumor mutations ~100-fold enrichment Select, enrich and a
Slide 13: Short Sequences in Urine & Novel Primers Solidify IP Position
Short Sequences in Urine & Novel Primers Solidify IP Position Determining mutational status of short DNAs limits the DNA sequences available for amplification; therefore enabling IP of surrounding DNA that is difficult to navigate around Use of non-human DNA contiguous with primers used to amplify s
Slide 14: Core IP Extends Into Assay Detection & Development
Core IP Extends Into Assay Detection & Development Original TrNA Patent Family Term to approx. 2018 US & EP Viral and Pathogen TrNA Families Term to approx. 2026 US, EP, JP, China, Australia, Canada, India 20-50 bp TrNA Family Term to approx. 2029 US & EP 51-110 bp TrNA Family Term to approx. 2034 U
Slide 15: Summary of Trovagene Technology
Summary of Trovagene Technology Technology Leverages The Advantages of Cell-Free DNA In Urine Greater chance of “seeing” mutations for detection and monitoring Enabling Advantages of Urine: Specimen Volume & Frequency Oncogene mutations have low abundance in cancer pts (more sample material, bigger
Slide 16: Improved Patient Outcomes Building Value Through Clinical Evidence
Improved Patient Outcomes Building Value Through Clinical Evidence CLINICAL PROGRAM STAGE 1 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’s: BRAF,
Slide 17: Stage 1 & 2: Demonstrating Clinical Utility
Stage 1 & 2: Demonstrating Clinical Utility MD Anderson Cancer Center KRAS and BRAF Mutational Analysis of Cell-free DNA from Urine in Patients with Advanced Cancers Memorial Sloan-Kettering Cancer Center Detecting T790M Resistance Mutations in Lung Cancer USC Norris Cancer Center Monitoring and Eme
Slide 18: Detecting & Monitoring cfDNA Mutations in Urine of Metastatic Cancer Patients
Detecting & Monitoring cfDNA Mutations in the Urine of Metastatic Cancer Patients Title BRAF Mutational Analysis of Cell-free DNA from Urine in Patients with Metastatic Cancers Background Metastatic cancer within a patient has extensive tumor heterogeneity and therefore it is difficult to assess met
Slide 19: Concordance & Longitudinal Detection of BRAF V600E mutations
Concordance & Longitudinal Detection of BRAF V600E mutations1 CLINICAL PROGRAM 1 Janku et al, AACR Annual Meeting, 2014 BRAF V600E mutations were detected in urine irrespective of cancer type with a multitude of different cancers in the study including Glioblastoma (brain cancer) BRAF V600E assay de
Slide 20: Applications to Improve Standard of Care
Applications to Improve Standard of Care Metastatic Cancers Detection of Mutation Monitoring Tumor Load Emergence of Resistant Mutations Clinical Applications Biopsy not available or feasible Ease of collection Large sample volumes Advantages of Urinary cfDNA Better sensitivity vs. imaging Earlier d
Slide 21: Longitudinal Urinary cfDNA BRAF V600E Mutation Correlates with Therapeutic Response
Longitudinal Urinary cfDNA BRAF V600E Mutation Correlates with Therapeutic Response CLINICAL PROGRAM Patient A: Metastatic Non-Small Cell Lung Cancer Patient B: Metastatic Non-Small Cell Lung Cancer Increase in BRAF V600E cfDNA correlates to increase in tumor size
Slide 22: Longitudinal Urinary cfDNA BRAF V600E Mutation Correlates with Therapeutic Response
Patient D: Metastatic Colorectal Cancer Longitudinal Urinary cfDNA BRAF V600E Mutation Correlates with Therapeutic Response CLINICAL PROGRAM Patient C: Metastatic Melanoma Decrease in BRAF V600E cfDNA correlates to decrease in tumor size
Slide 23: Longitudinal Urinary cfDNA BRAF V600E Mutation Correlates with Therapeutic Response
Longitudinal Urinary cfDNA BRAF V600E Mutation Correlates with Therapeutic Response CLINICAL PROGRAM BRAF Inhibitor Patient F: Metastatic Papillary Thyroid Cancer Patient E: Metastatic Temporal Glioblastoma Spike in BRAF V600E may follow cfDNA released by cell lysis as a result of therapy BRAF I
Slide 24: Cumulative # of clinical samples received by Trovagene's CLIA lab
Cumulative # of clinical samples received by Trovagene’s CLIA lab (urine and blood) Increasing volume of samples received, building clinical data CLINICAL PROGRAM
Slide 25: Growing our global network of clinical collaborations
Growing our global network of clinical collaborations CLINICAL PROGRAM
Slide 26: 2014 Development Program For Cancer Monitoring Applications
Completed assays will be transferred to Trovagene’s CLIA laboratory in 2014 2014 Development Program For Cancer Monitoring Applications ASSAY DEVELOPMENT PROGRAM EGFR L858R BRAF Quant HER-2
Slide 27: Obtain Reimbursement Value Commensurate With Clinical Performance
STAGE 3 Obtain Reimbursement Value Commensurate With Clinical Performance Concordance with standard of care (qualitative mutational status) Tier 1 Molecular Diagnostic codes with defined clinical utility and reimbursement values Press for value with payers using appeals process. Early adoption withi
Slide 28: Corporate Development Strategies
Corporate Development Strategies Collaborations with large strategic companies Accelerate our core strategic mission in cancer monitoring Create out-licensing opportunities with potential for incremental revenue streams 2014/14 R&D collaborations include PerkinElmer (NYSE PKI) and Illumina (Nasdaq –
Slide 29: 2013 Achievements
2013 Achievements Validated single oncogene mutation detection assay in CLIA lab Launched BRAF-cf assay Released first prospective data Identified the presence of BRAF, KRAS in multiple cancer types Demonstrated that oncology mutation signal in urine correlates with response to therapy Completed $15
Slide 30: 2014 Goals & Expected Milestones
2014 Goals & Expected Milestones Conduct additional clinical studies at major oncology centers and through collaborations with integrated healthcare networks Present and publish clinical results for studies using Trovagene’s oncogene mutation monitoring platform as they become available Complete CLI
Slide 31: Please contact
Please contact: Stephen Zaniboni, CFO szaniboni@trovagene.com For further information Antonius Schuh, CEO aschuh@trovagene.com