Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — TrovaGene — Investor Presentation (January 2012)
29 slides from Cardiff Oncology's investor presentation, Jan 17, 2012
Slide 1: Introduction to TrovaGene, Inc.
Introduction to TrovaGene, Inc. Antonius Schuh, Ph.D. Chief Executive Officer January 2012
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: Contents
Contents INTRODUCTION OUR TEAM VALUE PROPOSITION COMPETITIVE ADVANTAGES ADDRESSABLE MARKET TECHNOLOGY & IP APPLICATION AREAS COMMERCIALIZATION STRATEGY FINANCIALS
Slide 4: Company Overview
Company Overview Molecular diagnostics company Clinical focus in oncology Collaboration opportunities in prenatal diagnostics, infectious disease and transplant medicine IP protects detection of trans-renal nucleic acids in urine (“DNA in urine”) Founded in 1999 $39M invested over a decade Headquart
Slide 5: Trovagene: Cell-free Nucleic Acids in Urine
Trovagene: Cell-free Nucleic Acids in Urine Urine-based detection of molecular signal originating from a localized or systemic condition Oncology: Detection of minimal residual disease Earlier approaches include Circulating cells Immunicon, Veridex... Circulating cell-free nucleic acids Sequenom, Ve
Slide 6: 2012 Recent News
2012 Recent News INTRODUCTION COPYRIGHT © 2011, TROVAGENE, Inc. TrovaGene Acquires CLIA - Certified Laboratory - January 6, 2012 TrovaGene entered into a definitive agreement to acquire MultiGEN Diagnostics, Inc.'s ('MultiGEN') clinical laboratory assets in exchange for the issuance of 750,000 share
Slide 7: Experienced Core Management Team
Experienced Core Management Team OUR TEAM Thomas Adams, PhD Chairman of the Board Corporate VP and CTO, IRIS International, Inc.(2006 to Present) Founder and CEO, Leucadia Technologies (1998-2006) Co-founder and CEO of Genta, Inc. (1989-1997) Co-Founder, Chairman, CEO, Gen-Probe, Inc.(1984-1989) Mem
Slide 8: Board & Scientific Advisory Board
Board & Scientific Advisory Board OUR TEAM Dr. Riccardo Dalla-Favera Director, Institute for Cancer Genetics and Herbert Irving Comprehensive Cancer Center, Columbia University, New York Dr. Brunangelo Falini Director – Institute Hematology, University of Perugia, Italy Dr. Sinuhe Hahn Head of Resea
Slide 9: Clear Advantages Over Competing Technologies
Clear Advantages Over Competing Technologies Ease of sample collection No physician required Self-sampling possible Virtually no sample volume and sampling frequency limitations Ideal for monitoring applications Enrichment of target for better chance to detect rare events Ideal to detect disease ons
Slide 10: Rapid Industry Sector Growth
Rapid Industry Sector Growth Total market $20.1 billion in 2013 CAGR of 13.7% PCR-based diagnostic assays still the largest share $9.5 billion in 2013 CAGR of 11.9%. Lab-on-a-chip (micro-fluidics) is fastest growing segment $2.1 billion in 2013 CAGR of 18.7%. COMPETITIVE ADVANTAGES THE GLOBAL MOLECU
Slide 11: Perfect Timing for Next Generation Urine-based Testing
Perfect Timing for Next Generation Urine-based Testing MARKET TIMING WHY NOW?
Slide 12: >$40BN Addressable Market Space in Oncology Alone
>$40BN Addressable Market Space in Oncology Alone Cancer Patient Monitoring: TAM US > $10B 18 million cancer patients & survivors by 2020 (US only)* 2 monitoring tests per case per year at $300 Early detection of cancer: TAM US > $27B 180 million people > 40 years old by 2020 Bi-annual testing at $3
Slide 13: What are Trans-renal Nucleic Acids (Tr-NAs)
What are Trans-renal Nucleic Acids (Tr-NAs) TECHNOLOGY & IP 100 billion cells die naturally each day Nuclear DNA/RNA is broken into packets of genetic material which are carried away by blood stream Eventually DNA/RNA is filtered through the kidneys and appears in urine as Tr-DNA or Tr-RNA TESTING
Slide 14: Origins of Detectable Tr-DNA/Tr-RNA in Urine
Origins of Detectable Tr-DNA/Tr-RNA in Urine TECHNOLOGY & IP Urine Blood Fetus Transplant Tumor Infections Auto-Immunity
Slide 15: Expanding Range of Morbidity Factors Detectable
TECHNOLOGY & IP GENOME SEQUENCES DETECTED Expanding Range of Morbidity Factors Detectable
Slide 16: Transrenal Nucleic Acid IP Portfolio
Transrenal Nucleic Acid IP Portfolio Issued Prenatal diagnostics Infectious diseases Tumor detection and monitoring Transplantation monitoring European patent for prenatal diagnostics Pending Circulating cell-free nucleic acid isolation from body fluids Methods for detection of “ultra short” DNA seq
Slide 17: Truly Non-invasive Screening of Pre-natal Disorders
Truly Non-invasive Screening of Pre-natal Disorders APPLICATION AREAS: PRE-NATAL The plurality of Y chromosomal sequences clearly demonstrates the presence of transrenal fetal nucleic acids in maternal urine The combination of next gen sequencing with our transrenal nucleic acid platform allows trul
Slide 18: Genome Representation in Urine of Pregnant Women
Genome Representation in Urine of Pregnant Women APPLICATION AREAS: PRE-NATAL Mapping Statistics Input reads processed: 34,850,754 Total reads mapped: 32,476,497 (93.19%) Reads uniquely mapped: 28,272,898 (81.13%) Reads that failed to map: 2,374,257 (6.81%) 10s of 1,000s of sequencing reads from eac
Slide 19: TrovaGene's Non-invasive HPV Assay
TrovaGene’s Non-invasive HPV Assay Unique assay amplifying the E1 region Freedom-To-Operate (FTO) relative to patent landscape targeting L1, E6, and E7 regions is likely E1 region offers novel approach to high risk HPV amplification Simplicity of testing: only 1 PCR reaction identifies all high-risk
Slide 20: TrovaGene's HPV Assay
TrovaGene’s HPV Assay APPLICATION AREAS: HPV ASSAY High Risk vs Low Risk HPV, # patients Urine HPV Test Positive Negative Total Positive 133 7 (false pos.) 140 Negative 10 (false neg.) 170 180 Total 143* 177** 320 Urine Sensitivity: 93.0% Urine Specificity: 96.0% * Sum of concordant positives (102),
Slide 21: Oncology – Minimal Residual Disease
Oncology – Minimal Residual Disease Colorectal Cancer 140,000 new US cases annually 52,000 US deaths annually Pancreatic Cancer 43,000 new US cases annually 37,000 US deaths annually APPLICATION AREAS: ONCOLOGY Urine offers an effective alternative to CTCs, blood-based tests and imaging FEASIBILITY
Slide 22: Detection of K-ras Mutations in Urine
Detection of K-ras Mutations in Urine Mutations occur in 35% - 50% of Colorectal Cancers >90% of pancreatic cancers K-ras mutation detection to Determine completeness of surgery Monitor therapy response Detect onset of disease recurrence Feasibility of urine test demonstrated Comparable blood-based
Slide 23: K-RAS: Favorable Comparison of Urine vs. Blood-based Detection
K-RAS: Favorable Comparison of Urine vs. Blood-based Detection Colorectal Cancer1 PCR assay for K-ras mutation in codon 12 Compare tumor tissue, blood, and urine samples of 20 patients Urine 83% overall concurrence with tissue 5/5 (100%) of K-ras positive CRC cases are K-ras positive in urine Blood
Slide 24: K-RAS: Improved Technologies will Aid Sensitivity, Confidence
K-RAS: Improved Technologies will Aid Sensitivity, Confidence APPLICATION AREAS: ONCOLOGY COMBINED SENSITIVITY Detect at least 1 in 100,000 Sensitive detection plus large sample volumes allow a significant number of events to be counted regardless of number of genome equivalents (GE) per mL. ICE-COL
Slide 25: K-RAS: Informing Pancreatic Cancer Care
K-RAS: Informing Pancreatic Cancer Care APPLICATION AREAS: ONCOLOGY TRACK KRAS: INFORM MEDICAL PRACTICE Determine progression No progression – operate Progression – do not operate Manage radiation, chemotherapy Achieve baseline, stop treatment Mutation levels cycle, continue treatment PANCREATIC CAN
Slide 26: Extending Mutation Tracking to Management of All Cancers
Extending Mutation Tracking to Management of All Cancers APPLICATION AREAS: ONCOLOGY TRACK MUTATION(S): INFORM MEDICAL PRACTICE Determine progression No progression – operate Progression – do not operate Manage radiation, chemotherapy Achieve baseline, stop treatment Mutation levels cycle, continue
Slide 27: Commercialization Through CLIA lab and Out-licensing
Commercialization Through CLIA lab and Out-licensing COMMERCIALIZATION STRATEGY
Slide 28: For More Information
For More Information Antonius Schuh, PhD Chief Executive Officer Mobile: +1 (858) 205-4193 Office: +1 (858) 496-7462 E-mail: aschuh@trovagene.com TrovaGene Inc. 11055 Flintkote Ave, Suite B San Diego, CA 92121 www.trovagene.com PLEASE CONTACT
Slide 29: Thank you
Thank you We will be pleased to answer your questions CONFIDENTIAL