Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (January 2016)
35 slides from Cardiff Oncology's investor presentation, Jan 11, 2016
Slide 1: 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 2: Our Goal: Improve Treatment Outcomes with Noninvasive Cancer Monitoring
Our Goal Improve Treatment Outcomes with Noninvasive Cancer Monitoring Trovagene’s technology noninvasively detects and quantitates circulating tumor DNA in urine and plasma for improved disease management 3
Slide 3: Company Overview
NASDAQ: TROV Company Overview Founded in 1999 NASDAQ listing in 2012 Technology feasibility established 2013 Clinical feasibility established 2014 Marketing launch initiated 2015 Cash: $74M as of Sept 30, 2015 Proprietary methods of extracting, purifying, detecting and quantifying oncogene mutations
Slide 4: Experienced Leadership Team
Experienced Leadership Team Antonius Schuh, PhD Chief Executive Officer Stephen Zaniboni Chief Financial Officer Mark Erlander, PhD Chief Scientific Officer Sorrento Therapeutics, AviaraDx, Arcturus, Sequenom PhD Pharmaceutical Chemistry, University of Bonn Awarepoint, XIFIN, Sorrento Therapeutics,
Slide 5: Strong Scientific Advisory Board and Board of Directors
Strong Scientific Scientific Advisors Advisory Board and Board Board of Directors of Directors Thomas Adams, PhD Chairman Paul R. Billings, MD, PhD Director, Member Executive Compensation and Nominating Committees Gary Jacob, PhD Director, Member Executive Compensation Committee Rodney S. Markin, MD
Slide 6: Significant Market Opportunity
Significant Market Opportunity Physicians lack tools to effectively monitor and react to changes in cancer over time Trovagene PCM delivers critical information to detect and measure actionable cancer mutations over time Liquid Biopsy Market – $13.6B $15B 2015 est. Cancer already in advanced state N
Slide 7: New Standard of Care Enabled by Trovagene Technology
New Standard of Care Enabled by Trovagene Technology therapy weeks in 8 Copyright ©2015 Trovagene, Inc. | Confidential PCM CLINICAL UTILITY IMAGING PROCEDURE Minimal Residual Disease (MRD) Detection Quantitate Drug Response Monitoring BiopsySurgeryTreatmentBiopsyTreatment Every 6-8 weeksEvery 6-8 we
Slide 8: Advantages of Circulating Tumor DNA (ctDNA)
Advantages of Circulating Tumor DNA (ctDNA) ctDNA enters blood stream and kidneys Tumor cells Apoptosis or necrosis occurs, ctDNA is released Blood Urine during treatment and at disease progression 9 Copyright ©2015 Trovagene, Inc. | Confidential Captures intra-and inter-tumor heterogeneity Delivers
Slide 9: Trovagene Precision Cancer Monitoring (PCM) Platform
Trovagene Precision Cancer Monitoring (PCMSM ) Platform Quantification 10 Copyright ©2015 Trovagene, Inc. | Confidential Integrates with NGS and digital PCR platforms LDT and CLIA compliant Compatible for tech transfer agreements Enables monitoring over time ~300,000 genome equivalents of cfDNA/200
Slide 10: Intellectual Property
Intellectual Property Patent Families Patent Term US provisional app filed US provisional app filed US, EU, Canada US, EU, JP, China, Australia, Canada, India 11 Copyright ©2015 Trovagene, Inc. | Confidential Concentrating Urine Family 2035 51-110 bp TrNA Family 2034 Small Footprint Family 2034 US p
Slide 11: Technology Portfolio Evolution
Technology Portfolio Evolution 12 Copyright ©2015 Trovagene, Inc. | Confidential Feasibility Analysis In Development Commercially Available Single Assays for MonitoringKRAS (Exon 2) (Ultrasensitive, Quantitative) BRAF (V600E) EGFR (Exon 19 Del) EGFR (Exon 20 T790M) EGFR (Exon 21 L858R) Multi-gene Pa
Slide 12: Distribution and Service Options
Distribution and Service Options CLIA Lab Pharma Services Cloud Exchange Tech Transfer 13 Copyright ©2015 Trovagene, Inc. | Confidential Democratized Centralized
Slide 13: Trovagene Research Institute (TRI)
Trovagene Research Institute (TRI) World Class Team & Technology to Enhance Our Clinical Expertise and Commercial Reach University of Torino Technology and intellectual property transferred to TRI Leverage relationships with key opinion leaders and pharmaceutical companies Conduct clinical and trans
Slide 14: Strategy to Drive Clinical Adoption and Reimbursement
Strategy to Drive Clinical Adoption and Reimbursement STANDARD OF CARE QUALITATIVE QUANTITATIVE Stage 2 Tumor Dynamics Stage 3 Improve Patient Outcomes Stage 1 Tumor Status • Demonstrate concordance of oncogene mutation status between ctDNA and tumor tissue • Expand mutational coverage of the PCM pl
Slide 15: Histiocytic Disorders: ECD/LCH Standard of Care
Histiocytic Disorders: ECD/LCH Standard of Care ECD/LCH First Line Treatment Tissue Biopsy Imaging (every 2-3 months) 16 Copyright ©2015 Trovagene, Inc. | Confidential STUDIES TROVAGENE CLINICAL YTILITY MSKCC, MDACC, NIH (30 patients) Detection BRAF V600E Monitoring Therapeutic Response BRAF V600E E
Slide 16: Detection: Urinary ctDNA Outperforms Tissue Biopsies
Detection Urinary ctDNA Outperforms Tissue Biopsies1 100% concordance between tissue, urine and plasma in treatment naive patients. 1Hyman et al., Cancer Discov. 2015 Jan;5(1):64-71 17 Copyright ©2015 Trovagene, Inc. | Confidential Tissue Biopsies 70% BRAF mutational status obtained n=15Mutant Tissu
Slide 17: Drug Response | Histiocytic Disorders
Drug Response | Histiocytic Disorders Early Progression and Response1 Dynamic Monitoring Captures 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 mon
Slide 18: NSCLC Standard of Care
NSCLC Standard of Care Tissue Biopsy Surgery Adjuvant Therapy First Line Treatment Imaging (every 6-8 weeks) Tissue Biopsy Second Line Treatment Imaging (every 6-8 weeks) NSCLC Response Monitoring KRAS G12/13 19 Copyright ©2015 Trovagene, Inc. | Confidential TROVAGENE CLINICAL UTILTY Minimal Residua
Slide 19: Detection | Lung Cancer
Detection | Lung Cancer Circulating Free DNA Detection in the Urine of Patients with Activating EGFR and T790M Resistance Mutations HER2 + T790M 4% MET amplification 3% HER2 8% Small cell + MET 1% Unknown 18% Small cell 1% Small cell + T790M 2% T790M 60% MET+ T790M 3% Yu et al Clin Can Res 2013 20 C
Slide 20: Monitoring for Resistance | Lung Cancer
Monitoring for Resistance | Lung Cancer Urinary Detection of EGFR T790M Radiographic Progression1 Resistance Mutation in Advance of 10 1Husain et al., ELCC 2015 21 Copyright ©2015 Trovagene, Inc. | Confidential Urine T790M Copies/100K GE 4/11/14 5/21/14 6/30/14 8/9/14 9/18/14 Urine T790M Copies/100K
Slide 21: Quantitate Drug Response | Lung Cancer
Quantitate Drug Response | Lung Cancer Monitoring Urinary ctDNA EGFR Mutation Within First 2 Weeks of Targeted Therapy Predicts Subsequent Radiographic Response in Patients Patient 1 60 8 (6-13) 117 (88-187) < LOD 1Husain et al., ELCC 2015 22 Copyright ©2015 Trovagene, Inc. | Confidential Urine EGFR
Slide 22: Case Study: Non-Small Cell Lung Cancer
71 year old female September 2013 December 2013 March 2014 May 2014 August 2014 November 2014 January 2015 February 2015 Needle tissue biopsy performed, confirming NSCLC Scan confirmed decrease in tumor and metastases Scan confirmed stable disease Scan confirmed new lesion Tissue biopsy performed Im
Slide 23: Colorectal Cancer Standard of Care
Colorectal Cancer Standard of Care diagnosis of RAS: selection of correct therapy within days of BRAF or Chemotherapy?) CRC Imaging (every 6 weeks) Surgery Adjuvant Therapy Systemic Therapy Imaging (every 6 wks-6 months) Molecular Detection 24 Copyright ©2015 Trovagene, Inc. | Confidential TROVAGENE
Slide 24: Minimal Residual Disease (MRD) | Colorectal Cancer
Minimal Residual Disease (MRD) | Colorectal Cancer Monitoring ctDNA KRAS for Minimum Residual Disease Post Surgery1 Curative surgery correlates with undetectable levels of urinary ctDNA KRAS post-surgery in 4 of 5 patients Palliative surgery correlates with high levels of urinary ctDNA KRAS post-sur
Slide 25: Pancreatic Cancer Standard of Care
Pancreatic Cancer Standard of Care Pancreatic Cancer Diagnosis Biopsy Resectable Disease Surgery Adjuvant Therapy Imaging (every 6-12 weeks) Non-Resectable Disease Chemotherapy Imaging (every 6-12 weeks) Response Monitoring Response Monitoring 26 Copyright ©2015 Trovagene, Inc. | Confidential TROVAG
Slide 26: Melanoma Standard of Care
Melanoma Standard of Care Melanoma First Line Treatment Imaging (every 6-8 weeks) Second Line Treatment Imaging (every 6-8 weeks) Drug Holidays Imaging (every 6-8 weeks) — 27 Copyright ©2015 Trovagene, Inc. | Confidential TROVAGENE CLINICAL UTILTY Response Monitoring BRAF STAGE IV METASTATIC MELANOM
Slide 27: 30+ Clinical Studies to Validate & Integrate Our PCM Platform
30+ Clinical Studies to Validate & Integrate Our PCM Platform Size U.S. 28 Copyright ©2015 Trovagene, Inc. | Confidential Disease Ongoing Pending Protocol in Dev/Approval Under Evaluation Market (# of pts) Lung Cancer (NSCLC) 7 0 — 399,000 Colorectal Cancer 3 3 — 1,154,000 Pancreatic Cancer 4 — 1 42
Slide 28: Clinical Studies Continue to Drive Presentations & Publications
Clinical Studies Continue to Drive Presentations & Publications 4/2015 ELCC Meeting Oral Presentation EGFR T790M 1/2015 Personalized Medicine 8/2015 NEXTGEN DX 7/2014 Publication 4/2015 AACR Posters Pancreatic & colon cancers 1/2015 2 ASCO GI Posters KRAS Urine sample has >10x 9/2015 ESMO Abstracts
Slide 29: Clinical Studies Continue to Drive Presentations & Publications
Clinical Studies Continue to Drive Presentations & Publications 1/2016 ASCO GI KRAS Pancreatic Study 4/ Personalized Medicine World Congress Oral Presentation Trovagene Technology and Clinical Evidence 1/2016 Molecular Medicine Tri Conference Oral Presentation Trovagene Technology and Clinical Evide
Slide 30: Creating Physician Awareness & Demand
Creating Physician Awareness & Demand The Trovagene Clinical Experience Program (CEP) offers physicians hands-on experience with their patients biopsy result 31 Copyright ©2015 Trovagene, Inc. | Confidential Physician Access Benefits Choice of 3 Applications Urine as a sample Diagnostic in lieu of a
Slide 31: Optimizing the Commercial Model for Scale Up
Optimizing the Commercial Model for Scale Up • • • Utilize small sales force to target early adopter clinicians Clinical Experience Program (CEP) establishes early evangelists and reference sites Foundational adoption and evidence to demonstrate clinical utility CLINICAL INTEREST Significant adoptio
Slide 32: Reimbursement Value Based on Clinical Utility of ctDNA
Reimbursement Value Based on Clinical Utility of ctDNA Detection of Mutation Monitoring Tumor Size Supplement tissue biopsy to get systemic overview of the entire heterogeneity of cancer Emergence of resistant mutations When tissue biopsy is unavailable Tumor load Drug holidays Once Clinical Data Es
Slide 33: 2015 – 2016 Milestones
2015 – 2016 Milestones 34 Copyright ©2015 Trovagene, Inc. | Confidential Marketing & Adoption Real world case studies High clinical interest and strong service levels Reimbursement and sales & marketing scale up in 2016 Strategic Partnerships Geographic expansion Kit manufacturing Pharma collaborati
Slide 34: For further information
For further information Please contact: Stephen Zaniboni, CFO szaniboni@trovagene.com
Slide 35: For further information
For further information Please contact: Stephen Zaniboni, CFO szaniboni@trovagene.com