Neogenomics, Inc. · NASDAQ:NEO
Neogenomics — Investor Day (May 2017)
121 slides from Neogenomics's investor day presentation, May 30, 2017
Slide 1: Annual Meeting and Investor Day May 25, 2017
Annual Meeting and Investor Day May 25, 2017 Exhibit 99.1
Slide 2: Meeting Agenda – May 25th
Meeting Agenda – May 25th 8:00 – 8:30am Annual Shareholders Meeting Analyst/Investor Day Presentations 8:30 – 9:15am CEO Review 9:15 – 10:00am Pathologist Perspective 10:00 – 10:15am Break 10:15 – 11:00am Pharma Services 11:00 – 12:00am R&D and New Test Development Noon - 1:00pmLunch/Review of Gover
Slide 3: Annual Shareholder Meeting May 25, 2017
Annual Shareholder Meeting May 25, 2017
Slide 4: Investor/Analyst Day Presentations May 25, 2017
Investor/Analyst Day Presentations May 25, 2017
Slide 5: Meeting Agenda – May 25th
Meeting Agenda – May 25th 8:00 – 8:30am Annual Shareholders Meeting Analyst/Investor Day Presentations 8:30 – 9:15am CEO Review 9:15 – 10:00am Pathologist Perspective 10:00 – 10:15am Break 10:15 – 11:00am Pharma Services 11:00 – 12:00am R&D and New Test Development Noon - 1:00pmLunch/Review of Gover
Slide 6: Forward-looking Statements
Forward-looking Statements This presentation contains statements which constitute forward-looking statements within the meaning of Section 27A of the Securities Act, as amended; Section 21E of the Securities Exchange Act of 1934; and the Private Securities Litigation Reform Act of 1995. The words “m
Slide 7: CEO Summary
CEO Summary Douglas VanOort Chairman & CEO
Slide 8: NeoGenomics Vision
NeoGenomics Vision By providing uncompromising quality, exceptional service and innovative solutions, we will be the World’s leading cancer testing and information company.
Slide 9: NeoGenomics - Facts
NeoGenomics - Facts # 1 or 2 largest somatic cancer testing Lab in America Approximately 650,000 tests will be performed in 2017 Approx. 160,000 SF of space, 1,000 employees, 50 Physicians and PhDs Most advanced and comprehensive cancer testing menu in America Outstanding franchise with Hospitals/Pa
Slide 10: Drive for Growth
Drive for Growth Clinical Genetic Testing Annual Revenue Clinical Genetic Tests Performed ($, 000s) * Base NEO represents organic revenue and test volume growth from legacy business and excludes the impacts from the PathLogic and Clarient acquisitions. Base NEO* CAGR Through 2015 = 59% Base NEO* CAG
Slide 11: Impact of Clarient Acquisition
Impact of Clarient Acquisition Key Benefits Outstanding Customer Mix Similar Product Lines (1) Synergy potential of $20mm-$30mm within 3 years East Coast/West Coast Labs w/similar instrumentation Combine Irvine Lab into 78,000 sq. ft. Aliso Viejo Lab Strategic leadership in Heme cancers and Solid tu
Slide 12: Post Acquisition – Focus on Client Retention
Post Acquisition – Focus on Client Retention Revenue up 29% over 6 quarters pre-acquisition Revenue flat during Integration
Slide 13: Integration Complete
Integration Complete After 15 months, as of March 31, 2017, Integration is 100% complete. Sales force completely integrated after 2 months All “back - office” systems and processes integrated after 6 months LIS reprogrammed to incorporate Best Practices after 8 months Corporate culture and incentive
Slide 14: New NeoGenomics
New NeoGenomics Same historically successful attributes : Growth orientation Leadership in Innovation Entrepreneurialism Exceptional Quality/Service Deep/comprehensive test menu Low-cost testing processes Strong culture Scale from doubling our volume Improved Profitability
Slide 15: Pursuit of Growth - Again
Pursuit of Growth - Again Growth Goals: Mid-teens organic clinical volume growth 20%+ organic Pharma revenue growth 25-35% incremental Adjusted EBITDA on revenue growth Driven by: Market share gains Demographics and medical advances Innovation in test development Increased efficiencies
Slide 16: U.S. Cancer Testing Market
U.S. Cancer Testing Market Based on CMS Data, the Cancer Market was $5.1B in 2014 Assuming modest growth, the Cancer Market is about $6B in 2017 NeoGenomics 2017 Revenue estimate of $260M --- about 5% of the market Industry is highly fragmented – and is expected to consolidate further over time
Slide 17: Cancer Testing Industry
Cancer Testing Industry Large Reference Labs Approximately $2 Billion in Oncology Testing LabCorp Quest Diagnostics About 20 M&A and Strategic Initiatives over past 12 months BioReference/OPKO Myriad Genetics Eurofins Pure-Play Comprehensive Oncology Labs Approximately $500 million in Oncology Testi
Slide 18: Market Demand
Market Demand Source: National Institutes of Health (NIH) Aging Population – incidence increases with age Increased Prevalence – better treatments lead to more survivors and monitoring Scientific advances – driving targeted therapeutics Increased cost of drugs – more careful triage
Slide 19: Demographic Tailwinds
Demographic Tailwinds Shifting Demographics Incidence of Cancer by Age Source: United States Census Bureau Source: National Cancer Institute
Slide 20: Scientific Advances
Scientific Advances Therapeutic Area Drug Examples Example Companion or Complimentary Tests Immuno-Oncology Keytruda, Opdivo, and many in development PD-L1, MSI, MMR, Tumor Mutation Burden (TMB) NSCLC Anti-EGFR, ALK inhibitors, etc. EGFR, ALK, ROS1, BRAF V600E, MET, RET, NTRAK, etc. Ovarian and Pros
Slide 21: Innovation in Test Development
Innovation in Test Development 70 new/revised tests: NeoLABTM Liquid Biopsies MDS/CMML Profile AML Profile FLT3 Mutation Analysis NPM1 Mutation Analysis PML-RARA Translocation RUNX1-RNX1T1Transloc INV16 Translocation c-kit Mutation Analysis IDH1 Mutation Analysis IDH2 Mutation Analysis NRAS Mutation
Slide 22: Opportunities by Customer Type
Opportunities by Customer Type Pathologists & Hospitals (about 80% of Revenue) Large Market with 5,600 Hospitals in U.S., and 18,000 active Pathologists Enable Pathologists to practice using sophisticated tools/tests and “tech-only” services Unique ability to be “One-stop shop” with comprehensive on
Slide 23: Cross Selling to Pathologists & Hospitals
Cross Selling to Pathologists & Hospitals “Old Clarient Clients” Great reputation – Solid Tumors FISH – great solid tumor FISH franchise, good capacity Flow Cytometry – excellent program, expandable capacity Cytogenetics – good product and service Digital Imaging and IHC – outstanding and unique pro
Slide 24: Cost Synergies and Opportunities
Cost Synergies and Opportunities 2015 Adjusted EBITDA NeoGenomics $ 9.7 MM Clarient Pro Forma $ 9.2 MM Pro Forma Combined $18.9 MM 2016 “New Neo” EBITDA$ 34.7 MM Clearly, “synergies” showed up in 2016 --- and there are more to be realized in 2017- 18 2017 – 2018 Opportunities: Laboratory facilities
Slide 25: Reducing Cost per Test
Reducing Cost per Test Cost per Test - Total Clinical $250 $236 $230 $210 $190 $170 $150 Qis 2581S aS 16 = 26 = 816 = ate = Qt 17 ™ Clinical Cost of Goods Sold per Test - Total
Slide 26: Improving Productivity
Improving Productivity * To facilitate comparison, all data is for Clinical Genetic Testing and excludes the impact from the PathLogic acquisition and Pharma Services. Productivity calculated as the average number of lab tests completed per month per laboratory FTE.
Slide 27: Growing Pharma Services
Growing Pharma Services $41.6mm Backlog as of 3/31/17 - Approx. 400 active projects from 100+ Clients 50% of projects in pre-clinical space – possible lead to more lucrative Phase I, II, and III work Major PD-L1 testing site for Keytruda (Merck) and Opdivo (BMS) – positioned in immuno-oncology Medic
Slide 28: Acquisition Strategy
Acquisition Strategy NEO Focus – Upper right hand quadrant Synergistic Deals High High Low Market Growth Technologies NextGen Seq Digital Companion Dx Pathology Oncology FISH Clinical Trials Flow Cytogenetics Traditional Anatomic Path. BioInformatics Requirements Synergy Scale Added Capability
Slide 29: NEO Stock Price
NEO Stock Price May 2012$1.67
Slide 30: 2020 Goals
2020 Goals By providing uncompromising quality, exceptional service & innovative solutions, we will be the world’s leading cancer testing and information company! 15%+ Clinical Volume CAGR 20%+ Pharma Services Revenue CAGR 20-25% Adjusted EBITDA Margins
Slide 31: Key Takeaways
Key Takeaways þUnique and leading pure-play Oncology Company þ History of strong performance þ Significant opportunities for growth þ Realization of cost synergies expected to accelerate þ Strategic opportunities highly likely over the next 36 mos þ Well positioned for continued Industry Leadership
Slide 32: Questions and Answers
QNEO Questions and Answers
Slide 33: Review of NEO Testing Platforms
Review of NEO Testing Platforms Lawrence M. Weiss, MD Medical Director, Aliso Viejo
Slide 34: Lawrence Weiss, M.D. Medical Director, Aliso Viejo
Lawrence Weiss, M.D. Medical Director, Aliso Viejo Dr. Weiss currently serves as NeoGenomics’ Medical Director, Aliso Viejo and served as the Medical Director at Clarient Diagnostic Services, Inc. prior to the NeoGenomics acquisition in 2015. Dr. Weiss received his BS summa cum laude and MD summa cu
Slide 35: Testing Modalities Offered by NeoGenomics
Testing Modalities Offered by NeoGenomics Morphologic interpretation/consultation Immunohistochemistry Diagnostic Prognostic Flow cytometry Cytogenetics FISH Molecular studies Single gene Large NGS profiles
Slide 36: Reactive follicular hyperplasia in a lymph node: CD20
Reactive follicular hyperplasia in a lymph node: CD20
Slide 37: Flow Cytometry
Flow Cytometry [Lymphocyte Gate 69.00% Lymphocyte and Activation Related Antigens [T-CellsINK B.Cells Others Coexpression % CDI9ICD5 0.00 ‘CDISICD10 0.00 [Kappa Oe El Lambda [Loo | n [co10 cl (cots [0 _¥ [cote TI] (co20 JLo JN [cose | [CDAICDBRATIO= 96.00 increased (cD45 100] 8 | NA Low or no B cell
Slide 38: Cytogenetics
Cytogenetics
Slide 39: Fluorescent in-Situ Hybridization (FISH)
Normal Abnormal Fluorescent in-Situ Hybridization (FISH) Chromosome 9 Chromosome 22
Slide 40: Why Pathologists Choose NeoGenomics?
Why Pathologists Choose NeoGenomics? Full service lab with most comprehensive menu. Highly experienced technical staff able to perform complex studies with high accuracy Flexible business models allows clients to perform professional interpretations Expert medical staff able to interpret any studies
Slide 41: PD-L1 Testing
PD-L1 Testing Lawrence M. Weiss, MD Medical Director, Aliso Viejo
Slide 42: Dual Role of Immune System in Cancer
Dual Role of Immune System in Cancer Suppress neoplastic growth by recognizing cells with neoantigens and eliminating them Promote neoplastic growth by inadvertently selecting for cancer clones that evade immune surveillance
Slide 43: Interaction Between Immune Cell and Cancer
Interaction Between Immune Cell and Cancer (IASLC Atlas of PD-L1 Immunohistochemistry Testing in Lung Cancer Lung)
Slide 44: Anti-PD-L1 Therapy
Anti‒PD-L1 Therapy PD-L1 Expressing Carcinoma Cell PD1 Expressing Active Cytotoxic T-Cell Anti PD1 Therapy
Slide 45: Nivolumab vs. Docetaxel in Advanced NSCLC
Nivolumab (PD-1 Inhibitor) vs. Docetaxel in Advanced Non-Squamous Non-Small Cell Lung Cancer (N Engl J Med 2015;373:1627-1639) Imunno-Oncology vs. Targeted Therapy
Slide 46: Treatment Results in NSCLC Clinical Trials Applying PD-L1 IHC 22C3
Treatment Results in NSCLC Clinical Trials Applying PD-L1 IHC 22C3 (IASLC Atlas of PD-L1 Immunohistochemistry Testing in Lung Cancer) Trial Name Rx Line 2 Drug PD-L1 TPS No. of Patients ORR, % OS (median), months PFS (median), months PD-L1 Predict Trmt Resp? Reference KEYNOTE 010 Treated Pembrolizum
Slide 47: Companion vs. Complementary Testing
Companion vs. Complementary Testing Companion diagnostic test Typically linked to a specific drug within its approved label Identifies patient who have a significant benefit from the drug Complementary diagnostic test Not required for use of drug May provide additional information for physicians reg
Slide 48: PD-L1 Testing
PD-L1 Testing Companies develop an IHC kit to be used as a companion or complementary diagnostic test for each drug Different kits, with different antibodies and different scoring systems Different manufacturers (DAKO vs. Ventana) Different machine platforms Count tumor cells, inflammatory cells, or
Slide 49: Different PD-L1 Antibodies
Different PD-L1 Antibodies PD-L1 Diagnostic Antibody Clone PD-L1 Binding Domain Platform 28-8 (rabbit) Extracellular Link 48 Autostainer 22C3 (mouse) Extracellular Link 48 Autostainer SP142 (rabbit) Cytoplasmic BenchMark ULTRA SP263 (rabbit) Extracellular BenchMark
Slide 50: PD-1/PD-L1/CTLA-4 Treatment
PD-1/PD-L1/CTLA-4 Treatment Name Target FDA-Companion PD-L1 FDA-Complimentary Approved Indications lpilimumab (Yervoy®) CTLA-4 None None Inoperable or Metastatic Melanoma None None Adjuvant Treatment of Stage Illa Melanoma Nivolumab (Opdivo®) PD-1 ≥1% (28-8) Inoperable or Metastatic Melanoma ≥1% (28
Slide 51: Pulmonary Adenocarcinoma
Pulmonary Adenocarcinoma
Slide 52: Pulmonary adenocarcinoma/PD-L1: 1.5% staining seen
Pulmonary adenocarcinoma/PD-L1: 1.5% staining seen
Slide 53: Bladder carcinoma
Bladder carcinoma
Slide 54: PD-L1 Testing is a Part of Overall Testing Strategy
PD-L1 Testing is a Part of Overall Testing Strategy (IASLC Atlas of PD-L1 Immunohistochemistry Testing in Lung Cancer)
Slide 55: Role of PD-L1 In Treatment Plan for Lung Cancer
Role of PD-L1 In Treatment Plan for Lung Cancer (IASLC Atlas of PD-L1 IHC Testing in Lung Cancer Lung)
Slide 56: PD-1 Therapy Companion Testing: Rapidly Changing Landscape
PD-1 Therapy Companion Testing: Rapidly Changing Landscape Keytruda approved on May 23, 2017 for use in unresectable or metastatic solid tumors that have been identified as having microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) We already do routine testing for MSI/MMR in
Slide 57: Key Takeaways
Key Takeaways þ Full-service Lab with complete range of testing in all major testing modalities - “one-stop” shop þ High level of technical and professional expertise in all cancer testing areas þ PD-L1 and related testing is an important new area and will continue to grow in the foreseeable future
Slide 58: Questions and Answers
QNEO Questions and Answers
Slide 59: Minute Break
15 Minute Break The Webcast will resume at approximately 10:15 AM PST
Slide 60: Pharma Services Overview
Pharma Services Overview Gina Wallar, PhD, MPH Division Vice President, Pharma Services Sales
Slide 61: Gina Wallar, PhD, MPH
Gina Wallar, PhD, MPH Division Vice President, Pharma Services Sales Gina Wallar currently serves as Division Vice President for Pharma Services Sales at NeoGenomics, a leading provider of specialty testing services and solutions for clinical trials. NeoGenomics Pharma Services provides customized b
Slide 62: Highlights
Highlights Large and rapidly growing market opportunity Early successes and gaining momentum Immuno-oncology is a major driver of growth potential Investing for growth Unique and proprietary capabilities Expanding internationally
Slide 63: Oncology Drug Market IO Therapies
Oncology Drug Market IO Therapies
Slide 64: Clinical Trial Landscape
Clinical Trial Landscape In 2016: 14,239 trials began world wide (27% oncology) 5,223 trials began by US companies (33% oncology) 4,047 trials began by EU companies (24% oncology) Global market size for central lab testing services for trials: $2.4 - $3.5 BN LEK Analysis 2014 226 # of U.S. Trials: P
Slide 65: Companion Diagnostics
Companion Diagnostics Kantar Health projects that 30% of cancer patients will have a predictive biomarker by 2018. Biomarkers and companion diagnostics expand drug potential. Suzanne Shelley, | August 28, 2013
Slide 66: Neo Pharma Services Growth Drivers
Neo Pharma Services Growth Drivers Companion and Complementary Diagnostics Immuno-Oncology MultiOmyx Molecular High Quality Sales Personnel International expansion
Slide 67: Services Offered
Services Offered Number of Marker Output qPCR Flow IHC FISH NGS Relative Sensitivity Discovery MultiOmyx/Image Analysis Neo Sanger Sanger Clinical Trials Protein DNA/RNA Key High Sensitivity Low Sensitivity NanoString 1 10^5
Slide 68: Sales Team
Sales Team Bus Dev Reps Years in Industry Time with Neo 1 19 2 years 2 16 2 years 3 25 1 year 4 30 1 year 5 13 10 months 6 11 9 months
Slide 69: New Bookings Summary
New Bookings Summary Backlog of $41.6 MM as of 3/31 Additional $9 MM booked in last 8 weeks Double from PY Momentum with full team in Q3 2016 Over 40 new clients in the last 12 months ($, MMs)
Slide 70: Pharma Services Billed Revenue & Backlog
Pharma Services Billed Revenue & Backlog ($, MMs)
Slide 71: Recent Companion Diagnostic Success
Recent Companion Diagnostic Success Selected by Merck due to IHC expertise Participated in Early Validation Program for Keytruda One of only three labs to offer PD-L1 testing on Day 1 Now, leading provider of clinical PD-L1 testing
Slide 72: Immuno-Oncology
Immuno-Oncology Unique approach to fighting cancer by activating the body’s immune system Paradigm shift: Assessing the environment versus the tumor itself As number of immunotherapies and their combinations increase, so does the demand for predictive tests Sid P. Kerkar and Nicholas P. Restifo. Cel
Slide 73: Immuno-Oncology Market Potential
Immuno-Oncology Market Potential 2016: 1000+ combination IO trials 20% of total oncology therapeutics market
Slide 74: Pharma Activity in Immuno-Oncology
Pharma Activity in Immuno-Oncology Company Name IO Therapy IO Pipeline 2016 Oncology Sales ($, MMs) F. Hoffmann-La Roche Ltd Tecentriq >20 compounds $27,106 Celgene Corp > 8 Programs 10,011 Novartis AG 6 compounds 8,651 AstraZeneca Plc Imfinzi 27 trials 3,279 Bristol-Myers Squibb Opdivo; Yervoy > 10
Slide 75: Biomarkers of Interest in Immuno-Oncology
Biomarkers of Interest in Immuno-Oncology PDL1/PD1 – MRK, BMS, Roche, AZN CD4/CD8 FOXP3 ICOS – Celgene Mismatch Repair (MMR) Tumor Mutation Burden – BMS Microsatellite Instability (MSI) Mutation profiling NeoAntigen discovery Gene Expression – Merck Protein DNA RNA
Slide 76: Immuno-Oncology Companion & Complementary Tests
Immuno-Oncology Pharma Drug Clone Indication Merck Keytruda® (pembrolizumab) 22C-3 NSCLC BMS Opdivo® (nivolumab) 28-8 NSCLC Genentech Tecentriq® (atezolizumab) SP142 Urothelial Carcinoma AZ Durvalimab SP263 Urothelial Carcinoma Companion & Complementary Tests
Slide 77: Introduction to MultiOmyx
Introduction to MultiOmyx ™ Dye Inactivation >50 Proteins PD-L1 PanCK Hyperplexed IHC: stain, image, erase and repeat
Slide 78: Benefits of MultiOmyx for Immunotherapy tests
Benefits of MultiOmyx™ for Immunotherapy tests Co-localization of markers can determine the exact phenotype of the cell The only platform that can systematically assess the area around the tumor Quantify beyond the “by eye” ability which can only “bucket” Can systematically look at distance as well
Slide 79: MultiOmyx vs. Traditional IHC
MultiOmyx One target per slide Semi-quantitative Additional slides for: Other biomarkers FISH DNA analysis ~ 50 targets Quantitative NGS compatible Analytical software tools Traditional IHC MultiOmyx Proprietary technology that accommodates small specimen sizes
Slide 80: MultiOmyx illuminates the tumor and its environment
PanCK CD3 CD4 CD8 FoxP3 PD-L1 CD68 The only technology that illuminates the tumor and its environment! Tumor/PanCK+ CD3+CD4+ T helper CD3+CD4+FoxP3+ T regulatory PD-L1+CD68+ CD3+CD8+ T cytotoxic Tumor Margin PD-L1 expressing macrophages MultiOmyx
Slide 81: MultiOmyx Spatial Analytics
CD4 CD8 CD68 PD-L1 pan-CK * pan-CK * CD68 PD-L1 Expression CD68/pan-CK Expression Distance from Tumor (µm) Distance from Tumor (µm) Probability Density Probability Density PD-L1 CD68 CD8 CD4 CD4 CD8 CD68 PD-L1 pan-CK * pan-CK * CD68 PD-L1 Expression CD68/pan-CK Expression PD-L1 CD68 CD8 CD4 A. B. Mu
Slide 82: NeoGenomics Europe, S.A.
NeoGenomics Europe, S.A. Route de l’Etraz A1, Rolle Scheduled opening: September 2017 New 740 square meter laboratory Situated midway between Geneva & Lausanne, in the Canton of Vaud Initial on-site capabilities: Flow Cytometry, FISH and IHC based on current Sponsor needs Additional capabilities wil
Slide 83: Key Takeaways
Key Takeaways þRapidly growing market þWell-positioned in terms of expertise, technology, and growth þInvesting to support growth þImmuno-Oncology has changed the oncology market þMultiOmyx is a key differentiator in the immuno-oncology space
Slide 84: Questions and Answers
QNEO Questions and Answers
Slide 85: R&D and New Test Development
R&D and New Test Development Maher Albitar, MD Senior Vice President, Chief Medical Officer and Director of R&D
Slide 86: Maher Albitar, M.D.
Maher Albitar, M.D. Senior Vice President, Chief Medical Officer and Director of R&D Dr. Albitar has served as Chief Medical Officer and Director of Research and Development since January 2012. Prior to that Dr. Albitar served as the Medical Director of Hematopathology and Oncology and Chief of R&D
Slide 87: Key Drivers of our Leadership in Oncology Testing
Key Drivers of our Leadership in Oncology Testing Expanding Molecular Testing: integrating molecular in Anatomic pathology, Flow cytometry, FISH and cytogenetics Unique molecular capabilities: Proprietary high sensitivity NGS, RNA Sequencing and Quantitative Profiling Leadership in Liquid biopsy (He
Slide 88: Sample molecular test report
Patient DOB / Sex ™ ‘Specimen Type: Paraffin Tissue ‘Specimen ID. Received Date: 03/02/2017 04:02:00 AM EST Report Date: 02/03/2017 10:47:33 AM EST IND INN] | Pes re UINUIU Diagnosis: IDOMINAL WALL TUMOR (SGS17-2251-86)- : IBROSARCOMA, FAVORING “INFAN" [ARIANT|(MOLECULAR STUDIES PENDING) {Clinical D
Slide 89: Improving Sensitivity of NGS
Improving Sensitivity of NGS Read Alignment and assembly Fragmenting DNA Indexing Sequencing Amplification/Selection X X X X X
Slide 90: Developing High Sensitivity NGS
Developing High Sensitivity NGS Positive Selection No Selection 6% 98% Variant
Slide 91: Patent Pending on High Sensitivity NGS
Patent Pending on High Sensitivity NGS
Slide 92: NeoLAB Liquid Biopsy Heme Profiles
NeoLAB™ Liquid Biopsy Heme Profiles 4 multiplex profiles and 10 single-gene analyses AML Profile (28 genes via NGS) BTK Inhibitor Acquired Resistance Profile (2 genes) MDS/CMML Profile (31 genes via NGS) Myeloid Disorders Profile (54 genes via NGS) Single gene NeoLABs FLT3 Mutation AnalysisKRAS Muta
Slide 93: NeoLAB Solid Tumor Liquid Biopsy Profiles
NeoLAB™ Solid Tumor Liquid Biopsy Profiles NeoLAB Solid Tumor Monitor Plasma based test that uses cfDNA (48 genes via NGS) Useful for monitoring response to therapy, monitoring heterogeneity, and predicting early relapse. NeoLAB EGFR T790M Plasma based test that uses cfDNA for detecting resistance t
Slide 94: Emerging Leader in Liquid Biopsies
Hematologic Neoplasms Solid Tumors Emerging Leader in Liquid Biopsies
Slide 95: Emerging Leader in Liquid Biopsies
Emerging Leader in Liquid Biopsies NeoLAB™ Liquid Biopsies Circulating Tumor Cells (CTC) Cell-free DNA/RNA (and protein) Solid Tumors Hematologic Neoplasms Solid Tumors Apoptosis Paraptosis Autophagy Necrosis Exosome Microvessels
Slide 96: FISH Testing
FISH Testing Translocations: ALK, RET, ROS, MYC, PDGFRA, BRAF Copy Number Variation (CNV): PTEN, MET, HER2 IHC PD-L1 TMB ABL1 C11orf30 (EMSY) DDR2 FGFR4 IL7R MET PIK3CA SDHD TSHR ABL2 CARD11 DICER1 FH INHBA MITF PIK3CB SETD2 U2AF1 ACVR1B CBFB DNMT3A FLCN INPP4B MLH1 PIK3CG SF3B1 VEGFA AKT1 CBL DOT1L
Slide 97: Extensive Menu of NeoTYPE Cancer Specific Profiles
Extensive Menu of NeoTYPE Cancer Specific Profiles Brain (22 MolDx, 5 FISH, PD-L1) Liver/Billiary (24 MolDx, 2 FISH, PD-L1) Breast (22 MolDx, 3 FISH, PD-L1) Liposarcoma (5 MolDx, 1 FISH) Cervical (22 MolDx, 2 FISH, PD-L1) Lung (21 MolDx, 6 FISH, PD-L1) Colorectal (24 MolDx, 2 FISH, PD-L1) Melanoma (
Slide 98: Extensive Menu of NeoTYPE Cancer Specific Profiles
Extensive Menu of NeoTYPE Cancer Specific Profiles AITL Peripheral T-Cell Lymph (5 MolDx) AML Favorable Risk (2 MolDx) AML Prognostic (27 MolDx) CLL Prognostic (5 MolDx, 5 FISH) JMML (16 MolDx) Lymphoma (8 MolDx) MDS/CMML (32 MolDx) MPN (25 MolDx) 8 NeoTYPE Hematologic Neoplasm Profiles
Slide 99: Immunoprofiling: PD-L1, MSI and TMB
Immunoprofiling: PD-L1, Microsatellite instability and Tumor Mutation Burden (TMB)
Slide 100: Integrating Molecular Testing with Cytogenetic and FISH Analysis
Integrating Molecular Testing with Cytogenetic and FISH Analysis
Slide 101: Genome-Wide Copy Number Variation Detection by NGS
Genome-Wide Copy Number Variation Detection by NGS
Slide 102: Genomic Changes not Detected by FISH or Cytogenetics
Genomic Changes not Detected by FISH or Cytogenetics: Copy Number Neutral Mosiac 11q LOH in CLL
Slide 103: Complimenting FISH Testing Using NGS
Complimenting FISH Testing Using NGS: ALK Exon20/ELM4 Exon13 Fusion
Slide 104: Using RNA in NGS Testing: Fusion/Expression Panel
Using RNA in NGS Testing: Fusion/Expression (1385 gene) Panel ABCC3 BAP1 CCND3 COX6C EDIL3 FCRL4 GOT1 IDH1 LAMA5 MET NOTCH1 PLCB4 RAD50 SGK1 SUV39H2 TRPS1 ABI1 BARD1 CCNE1 CPNE1 EDNRB FEN1 GPC3 IDH2 LAMP2 METTL18 NOTCH2 PLCG1 RAD51 SGPP2 SUZ12 TSC1 ABL1 BAX CCNG1 CPS1 EED FEV GPHN IFNG LASP1 METTL7B
Slide 105: RNA Quantification by NGS is very Reliable
RNA Quantification by NGS is very Reliable for Cancer Profiling
Slide 106: Using NGS RNA Expression for Differential Diagnosis
Using NGS RNA Expression for Differential Diagnosis and Immunoprofiling Gene Location Sarcoma1 UHR KTP-4 KTP-8 KTP-33 ALL Sarcoma2 BCL10 chr1:85731459-85743771 0.31673734803505799 0.83298121160716587 1.2485902279795409 0.95631120363944799 1.3917032924666513 0.89958362248438606 1.2472254350116945 BCL
Slide 107: Advances in Artificial Intelligence
Advances in Artificial Intelligence Pattern recognition (70s and 80s) Machine Learning (90s): choose an algorithm, and wait for the computations to finish Deep Learning (Today): Convolutional Neural Nets (CNN)
Slide 108: Utilizing Deep Learning/Artificial Intelligence
Utilizing Deep Learning/Artificial Intelligence (AI) Reducing subjectivity in: Diagnosis Predicting response Predicting prognosis Predicting relapse and MRD Laboratory Processes and procedures
Slide 109: Quantifying and Capturing Image Data As Numerical Values
Example - Quantifying and Capturing Image Data As Numerical Values
Slide 110: Recent NeoGenomics Filed Patents
Recent NeoGenomics Filed Patents Date 10/02/14Methods for early detection of esophageal cancer 03/13/14Automated fish reader using learning machines 11/13/14Compositions and methods for detecting and determining a prognosis for prostate cancer 05/12/16Deep sequencing of peripheral blood plasma DNA a
Slide 111: Prostate Cancer Is the Most Common Cancer in Men
CA: A Cancer Journal for Clinicians Volume 67, Issue 1, pages 7-30, 5 JAN 2017 DOI: 10.3322/caac.21387 http://onlinelibrary.wiley.com/doi/10.3322/caac.21387/full#caac21387-fig-0001 Prostate Cancer Is the Most Common Cancer in Men
Slide 112: Over Diagnosis Of Prostate Cancer
CA: A Cancer Journal for Clinicians Volume 67, Issue 1, pages 7-30, 5 JAN 2017 DOI: 10.3322/caac.21387 http://onlinelibrary.wiley.com/doi/10.3322/caac.21387/full#caac21387-fig-0003 Over Diagnosis Of Prostate Cancer and the Effects US Preventive Task Force
Slide 113: Currently Unmet Needs in Prostate Cancer Screening
Currently Unmet Needs in Prostate Cancer Screening and Management Better Screening approach Reducing unnecessary biopsies Reducing overtreatment Better selection of patients for active Surveillance better monitoring
Slide 114: Urine/Plasma Assay for Predicting Gleason ≥3+4
Urine/Plasma Assay (NeoLAB Liquid Biopsy) for predicting Gleason ≥3+4 using cell-free RNA (cfRNA) levels of UAP1, PDLIM5, IMPDH2, HSPD1, PCA3, PSA, TMPRSS2, ERG, AR, PTEN, and ERG Clinical Parameters: sPSA, age, race, history of prior Bx, DRE Multi-Center Prospective Study of 489 Patients Combined U
Slide 115: Predicting Prostatectomy Findings
Predicting Prostatectomy Findings Objective: Clinical validation of the Urine/Plasma test using Prostatectomy data Variable Descriptive Statistics (CUSP data,8,16) Valid N Mean Median Minimum Maximum Std.Dev. Age (Median, Min-Max) 61 (36-77) Age (Median, Min-Max) 61 (36-77) Family Hx DRE results 266
Slide 116: NeoLAB Liquid Biopsy Test More Accurate Than Biopsy
NeoLAB Liquid Biopsy Test is More Accurate Than Biopsy in Predicting Prostatectomy Results Sensitivity and Specificity of Prostate Biopsy in Predicting Prostatectomy Findings Urine/Plasma Test in Predicting Biopsy Findings Urine/Plasma Test in Predicting Prostatectomy Findings Discrepancy Between Bi
Slide 117: NeoLAB Prostate Test Indications
NeoLAB Prostate Test Indications Prior to performing biopsy When Biopsy findings are questionable To determine if patients patient should be put on active surveillance To monitor patients on Active Surveillance
Slide 118: Independent Validation of NeoLAB Prostate Testing
Pre-Bx samples (41 patients) Post-Bx samples (41 patients) Independent Validation of NeoLAB Prostate Testing Performed in Odense University, Denmark High Standard Low Pre/High sensitivity Pre/standard and low Post/high and standard Post/Low Condition Totals Condition Totals Condition Totals Conditio
Slide 119: Key Takeaways
Key Takeaways þ Rapid and continuous innovation to improve patient care þ Utilization of cutting edge science and technologies. þ Multiple proprietary technologies þ Extensive menu of multi-modality tumor profiles þ Leading provider of Liquid Biopsies
Slide 120: Questions and Answers
QNEO Questions and Answers
Slide 121: This Concludes our Investor Day Presentations
This Concludes our Investor Day Presentations. Thank you for joining us. Should you have any questions on any of these materials, please contact: Steven Jones Executive Vice President & Director of Investor Relations (239) 325-2001 steven.jones@NeoGenomics.com Thank you for joining us.