Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Jefferies 2014 Global Healthcare Conference
24 slides from Cardiff Oncology's conference presentation, Jun 2, 2014
Slide 1: Better Cancer Monitoring with Cell-Free DNA in Urine
Stephen Zaniboni | Chief Financial Officer Jefferies 2014 Global Healthcare Conference June 2, 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 / Company Overview
Key Assets Precision cancer monitoring technology addressing a high unmet clinical need Enables more frequent, non-invasive monitoring of oncogene mutation status, disease progression, and recurrence Numerous clinical collaborations with leading cancer centers Expanding clinical evidence to support
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 Paul Billings, MD, PhD Carlo M. Croce, MD Antonius Schuh, PhD Stanley Tennant, MD Rodney Markin, MD, PhD Scientific Advisors Antonius Schuh PhD CEO
Slide 6: The Clinical Utility of Cell-Free DNA from Urine: Large Addressable Market
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 Enabling Benefits Large sample volume Hours of continuous cfDNA collection Cell-free DNA stable in urine High frequency of collection possible Logistics/Convenience Truly non-invasive Patient can self-sample at hom
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: 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 12: Collaborations To Validate & Integrate Our PCM Platform
Collaborations To Validate & Integrate Our PCM Platform CLINICAL PROGRAM
Slide 13: Strategy To Drive Clinical Adoption & Reimbursement
Improved Patient Outcomes Strategy To Drive Clinical Adoption & Reimbursement 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. E
Slide 14: Summary of Ongoing Collaboration Programs
Stage 1 & 2: Summary of Ongoing Collaboration Programs MD Anderson Cancer Center KRAS and BRAF Mutational Analysis of Cell-free DNA from Urine in Patients with Advanced Cancers Multi-institutional Collaboration Includes Memorial Sloan-Kettering Cancer Center Detecting BRAF Mutations in Histiocytic D
Slide 15: Increasing Volume of Clinical Samples Received
Cumulative # of urine and blood samples received by Trovagene to date Increasing Volume of Clinical Samples Received CLINICAL PROGRAM
Slide 16: Clinical Results Presented & Published To Date
Clinical Results Presented & Published To Date Data presentation at AACR 2013/14 MD Anderson “All Comers” study, Mutational status correlates with response to therapy Publication in Journal Oncotarget Monitoring of patients with BRAF V600E malignancy 100% concordance with tissue biopsy Trovagene PCM
Slide 17: Clinical Guidelines Reference Trovagene's PCM Technology
Clinical Guidelines Reference Trovagene’s PCM Technology Guidelines for The Diagnosis & Treatment of Erdheim-Chester Disease (ECD) Published in Blood – May 2014 Mention in clinical guidelines provides early evidence of the utility of Trovagene’s precision cancer monitoring technology ECD serves as a
Slide 18: Longitudinal Urinary cfDNA BRAF V600E Mutation Correlates with 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 19: Data-Driven Commercialization Program To Begin in late 2014
Data-Driven Commercialization Program To Begin in late 2014 Clinical Data Presentations AACR 2013/14 ASCO 2014 Published Peer-Reviewed Manuscripts Oncotarget May 2014 Publication in Second Journal in 2014 Possible Publication in Third Journal in 2014 Expand Sales & Marketing Headcount & Programs Bro
Slide 20: 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 within
Slide 21: 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 22: Corporate Development Strategies
Corporate Development Strategies Collaborations with large strategic diagnostic and life science companies Accelerate our core strategic mission in cancer monitoring Create out-licensing opportunities with potential for incremental revenue streams Current R&D collaboration with Illumina (Nasdaq: ILM
Slide 23: 2014 Goals & Expected Milestones
2014 Goals & Expected Milestones Conduct additional clinical studies at major oncology centers and through collaborations with integrated healthcare networks Develop a health economic model supporting appropriate value and reimbursement levels for Trovagene’s PCM technology Present and publish clini
Slide 24: Please contact
Please contact: Stephen Zaniboni, CFO szaniboni@trovagene.com For further information Antonius Schuh, CEO aschuh@trovagene.com
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