Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (January 2014)
28 slides from Cardiff Oncology's investor presentation, Jan 13, 2014
Slide 1: Better Cancer Monitoring with Cell-Free DNA in Urine
Better Cancer Monitoring with Cell-Free DNA in Urine Antonius Schuh, Ph.D. | Chief Executive Officer January 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 For Cancer Patients
Our Goal: Improve Treatment Outcomes For Cancer Patients INTRODUCTION Trovagene’s technology is designed to detect and quantitatively monitor DNA mutations in the urine of cancer patients to improve disease management Our diagnostic platform provides important clinical information beyond the current
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 Carlo M. Croce, MD Riccardo Dalla-Favera, MD Brunangelo Falini, MD Kunwar Shailubhai, PhD Antonius Schuh, PhD Stanley Tennant, MD Chris McGuigan, PhD Scientific Adviso
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
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 Truly non-invasive Patient can self-sample at home or clinic No medical professional required for specimen No refrigeration required No infection
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 Because highly degra
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 Techology 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 patients (bigger sample, bigger dyn
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 USC Norris Cancer Center Monitoring and Emergence of KRAS Resistant Mutations in Colorectal Cancer US Oncology Detecting and Monitorin
Slide 18: Concordance of Urine-Based Oncogene Mutation Testing vs. Tumor Biopsy
Concordance of Urine-Based Oncogene Mutation Testing vs. Tumor Biopsy Title: KRAS and BRAF Mutational Analysis of Cell-free DNA from Urine in Patients with Advanced Cancers Principal Investigator: Filip Janku MD PhD; Investigational Cancer Therapeutics (Phase I Clinical Trials Program) MD Anderson C
Slide 19: Concordance of BRAF V600E mutations
Concordance of BRAF V600E mutations1 CLINICAL PROGRAM 1 Janku et al, AACR-NCI-EROTC International Conference, 2013 BRAF V600E mutations were detected in urine irrespective of cancer type with a multitude of different cancer types including Glioblastoma (brain cancer) BRAF V600E assay demonstrated 95
Slide 20: Longitudinal Urinary cf-DNA BRAF V600E Mutation Correlates with Therapy Response
Longitudinal Urinary cf-DNA BRAF V600E Mutation Correlates with Therapy Response CLINICAL PROGRAM Patient 5: Melanoma Progressive Disease Vemurafenib only Urinary cfDNA BRAF V600E mutuation (%) 40 35 30 25 20 15 10 5 0 BRAF V600E cfDNA 10/1/2012 11/1/2012 12/1/2012 1/1/2013 2/1/2013 3/1/2013 4/1/201
Slide 21: Longitudinal Urinary cf-DNA BRAF V600E Mutation Correlates with Therapy Response
Progressing on Chemotherapy Patient 16 Colorectal Cancer Patient 44 Appendiceal Cancer Progressing on chemotherapy Longitudinal Urinary cf-DNA BRAF V600E Mutation Correlates with Therapy Response CLINICAL PROGRAM 10/1/2013 11/1/2013 12/1/2013 1/1/2013 2/1/2013 3/1/2013 4/1/2013 5/1/2013 6/1/2013 7/1
Slide 22: 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 KRAS KRAS QUANT BRAF Quant EFGR T790M EFGR Ex19Del EFGR L858R c-met amp HER-2 NRAS PIK3CA 1047 KRAS Q61H Melanoma CRC Lung, Bre
Slide 23: 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 24: 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 25: Collaborations With Leading MDx/Life Science Companies
Collaborations With Leading MDx/Life Science Companies PerkinElmer R&D collaboration TROV to develop a urine-based assay for the liver cancer market - PKI option for commercialization Companies will collaborate on automation of TROV’s urine-based DNA isolation method Financial terms not disclosed; p
Slide 26: 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 27: 2014 Goals & Expected Milestones
2014 Goals & Expected Milestones Conduct additional clinical studies with our diagnostic technology at major oncology centers Enter into additional clinical collaborations with pharmaceutical companies Expand and enter into new partnerships with Life Science/MDx technology companies Publish clinical
Slide 28: For further information
For further information Please contact: Antonius Schuh, CEO aschuh@trovagene.com Stephen Zaniboni, CFO szaniboni@trovagene.com