Biocept, Inc. · OTC:BIOCQ
Biocept — Investor Presentation (August 2016)
35 slides from Biocept's investor presentation, Aug 3, 2016
Slide 1: Corporate Overview August 2016
NASDAQ: BIOC www.biocept.com Corporate Overview August 2016 Exhibit 99.1
Slide 2: Forward-Looking Statements
This presentation contains, and any accompanying oral presentation would no doubt contain, forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, regarding Biocept, Inc. and our business. Forward-looking statements include all statements that are not
Slide 3: Investment Highlights
Dual platform for liquid biopsy in oncology – unique high-performance CTC and ctDNA assays enable detection and monitoring of actionable NCCN markers Multiple clinical studies, publications and poster presentations support platform Strong ramp of test volume and health plan reimbursement – indicativ
Slide 4: Corporate Profile
Corporate Profile NASDAQ: BIOC, Listed 2014 Market Cap: +/- $15M Shares Out: Approx. 25M ATV: 344K Collaborations and partnerships with renowned institutions Patented technology used for liquid biopsy in cancer Future as IVD kits to be performed in hospitals worldwide Rapidly growing adoption and re
Slide 5: The Executive Team
The Executive Team Michael Nall President & CEO Lyle Arnold, Ph.D. SVP, R&D & CSO 25+ years in healthcare sales, marketing and commercial operations 16 years in cancer diagnostics and genomics Most recently General Manager N. American Sales and Marketing for Clarient—a GE Healthcare Company Senior R
Slide 6: Board of Directors, Clinical & Scientific Advisors
Board of Directors, Clinical & Scientific Advisors David Carbone, MD Director, James Thoracic Center, James Cancer Hospital and Solove Research Institute, Ohio State University David Rimm, MD, PhD Professor of Pathology and Medicine (Oncology) Yale University School of Medicine Clinical Advisory Boa
Slide 7: Molecular Testing: The New Standard of Care in Personalized Cancer Medicine
Molecular Testing: The New Standard of Care in Personalized Cancer Medicine Personalized Molecular Assays Results from molecular analysis for treatment decisions Tissue Biopsy Liquid Biopsy
Slide 8: Liquid Biopsy Addressing Unmet Medical Needs
Liquid Biopsy Addressing Unmet Medical Needs Reduced Healthcare Costs and Patient Complications Target Selector = $1,200 vs. Tissue Biopsy = $5,000-$15,000 Patient Status Limited Tissue Bone Biopsies Intra-tumor Heterogeneity Inter-tumor Discordance
Slide 9: Today – Profiling and Monitoring
925,030 Newly diagnosed cancer cases in the U.S. 13,000,000 worldwide 14,000,000 People living with cancer in the U.S 32,000,000 worldwide Incidence data for 2014 and prevalence data for 2010 of breast, lung, colon, prostate, melanoma, gastric and deaths data provided by National Cancer Institute: h
Slide 10: Large Market Opportunity
Large Market Opportunity Personalized Medicine from a Liquid Biopsy
Slide 11: Premier Commercial Platform in Liquid Biopsy
Premier Commercial Platform in Liquid Biopsy Liquid Biopsy Biocept Strong Growth Driven By Effective Commercial Team Comprehensive High-Performance NCCN Test Offering Increasing Reimbursement 13 Issued Patents Opportunity for Cost Leadership Evolution to IVD Kit Model
Slide 12: Biocept at an Inflection Point
Biocept at an Inflection Point Q/Q Growth Expanding at >30%
Slide 13: CTCs and ctDNA: Important Molecular Information Sources for Treatment Decisions
CTCs and ctDNA: Important Molecular Information Sources for Treatment Decisions Both are essential for comprehensive profiling for treatment purposes as well as for monitoring patients on therapy CTCs are whole cells containing intact genomic material shed from tumors including DNA,RNA and protein (
Slide 14: Biocept: Completing the Answer…
Biocept: Completing the Answer… Company CTCs / Whole Cells ctDNA / DNA Fragments Genomic Health (GHI) X Epic Sciences (private) X Foundation Medicine (FMI) X Guardant Health (private) X Trovagene (TROV) X Biocept (BIOC) X X Biocept advantage Only company commercializing both CTCs and ctDNA from a si
Slide 15: Target Selector Platform Enables both CTC and ctDNA Analysis
Target Selector™ Platform Enables both CTC and ctDNA Analysis Target SelectorTM ctDNA Analysis Actionable Mutations e.g. EGFR, KRAS 1 Target SelectorTM CTC Analysis Protein e.g.PD-L1 ER Gene Rearrangement e.g. ALK, ROS Amplification e.g. HER2
Slide 16: Target Selector CTC Testing for Whole Cell Analysis
Target SelectorTM CTC Testing for Whole Cell Analysis Detection, enumeration and biomarker analysis all within the patented channel ICC for Protein FISH for Genes Industry-leading accuracy >99% specificity and sensitivity Cells captured in patented, clear microfluidic channel Same specimen can be mi
Slide 17: Target Selector ctDNA Testing for Oncogene Mutation Analysis
Target SelectorTM ctDNA Testing for Oncogene Mutation Analysis Superior enrichment of mutant DNA targets vs. wild-type (normal) DNA Complete suppression of wild-type DNA amplification Quantitatively detects cancer-associated mutations present at low levels in plasma Multiple mutations within a singl
Slide 18: Broad IP Coverage – Patents Issued
Broad IP Coverage – 13 Patents Issued Patent pending Target Selector™ Mutation Analysis Patented Microfluidic Channel Patented Blood Transport Tube Patented OncoCEE™ Chemistry: Antibody Cocktails for capture and detection U.S. patent. Additional patents pending. Multiple patents in U.S.(3), EU, Chin
Slide 19: Partners in Establishing Clinical Utility
Partners in Establishing Clinical Utility Collaborations with major cancer centers Participating in medical meetings and symposia Engaging KOL Advisors Building relationships with patient advocacy groups Expanding strategic partnerships with pharma and biotech for personalized diagnostics
Slide 20: Clinical Validation – Published Data
Clinical Validation – Published Data Demonstrated that patients with ER+ metastatic showed correlation of ER status using OncoCEE-BR with metastatic and primary biopsy – in collaboration with Columbia University – published Clinical and Translational Oncology - Feb 2015 Reported 85% of CTC and 72% o
Slide 21: Clinical Validation – Posters and Abstracts
Clinical Validation – Posters and Abstracts 88% of patients in study with metastatic breast cancer showing HER2 - primary tissue biopsy were HER2 - on CTCs as detected with OncoCEE-BR – Dana Farber Cancer Institute, sponsored by Genentech and Komen Foundation. Poster presented at San Antonio Breast
Slide 22: Industry-Leading Assay Performance
Industry-Leading Assay Performance CTC Biomarkers + ctDNA Clinical Validation CTC Biomarkers + ctDNA Clinical Combined Data Size (N) 407 Accuracy 354/407 (87%) Sensitivity 74% Specificity 94.6% Controlled Validation Concordance (standard criteria) – 99.3% CTC Biomarkers + ctDNA Analytical Validation
Slide 23: Real-World Patient Case Example
Real-World Patient Case Example “The results obtained from patients with metastatic lung cancer suggest that the utility of non-invasive Target SelectorTM aids the clinical management of my patients. This was demonstrated in a patient who was correctly identified to have an emerging T790M resistance
Slide 24: Highly Relevant Test Menu: Actionable Biomarkers Found in NCCN Guidelines
Highly Relevant Test Menu: 13 ctionable Biomarkers Found in NCCN Guidelines Cancer Target Selector CTC Target Selector ctDNA Breast HER2*, ER*, FGFR1, AR, PDL1, PR* ESR1 mutations Gastric HER2*, FGFR1 Lung ALK*, ROS1*, MET*, FGFR1, PDL1*, RET EGFR*, KRAS*, BRAF* mutations, ALK mutations Colon EGFR a
Slide 25: The U.S. Oncology Market
The U.S. Oncology Market Approximately 3,000 Oncologists in U.S. 1,500 hospital systems have a cancer center 27 are NCCN designated centers 69 are NCI cancer centers 80% of cancer care is delivered in the community setting
Slide 26: Market Development and Expansion
Market Development and Expansion Salesforce Plan Current 2016 2017 NCCN Center Go-to-market strategy Clinical oncology segment Target regional cancer centers Partner with pharma/biotech Commercial team in place Experienced leadership Regionally based sales team each with >5 years of experience in on
Slide 27: Favorable Health Plan Access
Favorable Health Plan Access Managed Care agreements in place covering >180M lives Dedicated managed care leadership with years of experience from GE, LabCorp and Quest Payors have positive coverage for biomarkers listed in guidelines Aligns with goals of healthcare reform Improved outcomes while re
Slide 28: Reimbursement Gaining Traction
Reimbursement Gaining Traction Bill approved CPT codes for cancer cell detection and biomarker staining (in our microchannel) Payments received from Medicare, UHC, Aetna, and BCBS Average of $1,200 per claim at Medicare rate Billing processes recently refined Cash accounting; plans to move to accrua
Slide 29: Long-Term Growth Strategy
Long-Term Growth Strategy 2017 2019 Today Stage 1 Central Lab Stage 2 Partnership Model Stage 3 IVD Kit Development Distributed IVD Kit Platform
Slide 30: Stage 1: Central Lab
Biocept generates Target Selector test results and send to physicians Stage 1: Central Lab Patient visits cancer center and physician orders Target Selector test Physician utilizes Biocept testing to make a treatment decision Biocept bills patients health plan or responsible party Biocept collects m
Slide 31: Stage 2: Central Lab with Partnership with Hospitals and Pathology
Biocept processes sample and uploads raw data to internet for interpretation and reporting by local pathologist Stage 2: Central Lab with Partnership with Hospitals and Pathology Patient visits cancer center and physician orders Target Selector test Physician utilizes Biocept testing, reported by hi
Slide 32: Stage 3: Distributed IVD Kit Platform
Biocept sells kits to hospital and core labs in U.S. and World Stage 3: Distributed IVD Kit Platform Biocept manufactures Target Selector kits with patented technology Core Lab issues report and bills health plan or responsible party Biocept collects money from core labs
Slide 33: Multi-Purpose Pivotal Clinical Trial
Multi-Purpose Pivotal Clinical Trial 100 patients planned Collaborator: Vector Oncology Sites: 5 - 20 Centers Cost – $1.5 mm (approximate) Endpoint(s): 1. Concordance to tissue when available 2. Response to treatment when tissue not available 3. Cost of liquid biopsy vs tissue biopsy 4. Progression
Slide 34: Anticipated Milestones in 2016
Anticipated Milestones in 2016 Continued Commercial Growth Initiate Pivotal Clinical Study For Kits Enter Into Partnerships – Global and U.S. Present & Publish Clinical Study Results Launch Add’l Oncology Marker Assays Sign New Health Plan Agreements
Slide 35: Biocept Contact
Biocept Contact: David Moskowitz, Vice President Strategy and Corp. Communications Email: [email protected]; Phone: 858-320-8244