Corporate Presentation. February 2, 2018

Transcription

1 Corporate Presentation February 2, 2018

2 Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our transactions with biopharmaceutical companies, possible companion diagnostic products, revenue estimates, potential addressable markets, our timeline strategy, planned product development and our product and technology roadmap, expected regulatory submissions and filings, anticipated reimbursement, prospects, and plans and objectives are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, will, would, could, should, continue, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in forward-looking statements, including due to risks involved in the development and commercialization of products, replacement of existing technologies and the outcome of relationships with third parties. The forward-looking statements contained in this presentation reflect our views with respect to future events as of the date set forth on the first page of this presentation, and we assume no obligation to update any forward-looking statements as a result of new information, future events or otherwise as of such date. This presentation also contains estimates, projections and other information concerning our industry, our business, and the markets for our products, product candidates and services, as well as data regarding market research, estimates and forecasts prepared by our management. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. These statements are based upon information available to us as of the date of the presentation, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements. 2

3 Global Cancer Profiling Market Expected CAGR of 19% ( ) 2017 ~$30B Market 2017 ~40% Genomics Fastest Growing Growth Drivers: Aging population Rising utility of biomarkers Increasing demand for next generation sequencing P&S Market Research MarketsandMarkets 3

4 The Current Issues The Patient I have cancer! Why does testing take so long to get answers. I want to know what to do as soon as possible. The Physicians Lead-time to results is way too long. I need an integrated patient report from the lab. My patient is extremely anxious. The Lab I can t keep up with all the new test offerings. We have so many platforms and workflows to maintain. There is seldom enough sample to do all the testing needed. Many tests are only available as send-outs. 4

5 HTG Molecular Diagnostics, Inc. (HTG) A molecular platform technology, the HTG EdgeSeq system enables fast and easy use of next-generation sequencing (NGS) instruments for molecular profiling/genomic testing at the local level. Based in Tucson, AZ IPO 2015 Commercial stage ~ 100 Employees Direct sales US and EU 5

6 HTG Investment Highlights Why HTG, why now HTG EdgeSeq Technology Proprietary NGS-based technology with broad applications Product Pipeline Driven by Pharma collaborations and new NGS-based test workflows Leadership Deep Dx experience Attractive Markets Pharma CDx Immuno-Oncology Reimbursement Expected to work within existing codes Industry Partnerships Illumina ThermoFisher QIAGEN 6

7 Strategy Pure and Simple Continual innovation of our HTG EdgeSeq platform enabling cost effective, highly multiplexed, low sample input and targeted sequencing based profiling from liquid and solid samples Expand compelling medical menu via deep collaborations with late stage Pharma drug programs and replacement of single analyte based testing methods 7

8 HTG Management Timothy (TJ) B. Johnson President and Chief Executive Officer Hill-Rom Shaun D. McMeans SVP and Chief Financial Officer The Long Companies John L. Lubniewski SVP and Chief Business Officer Patrick (Pat) C. Roche, Ph.D. SVP, Scientific and Medical Affairs Debra (Deb) A. Gordon, Ph.D., JD SVP, Chief Legal Counsel Sam M. Rua, Jr. SVP, of Regulatory Affairs and Quality Systems 8

9 Our Customers Current Molecular Profiling Products Developing Molecular Diagnostic Kits Pharma Drug Development Supporting biomarker strategies and development of new diagnostic tests Academic Medical Centers Molecular Diagnostic Labs Simple, cost effective, multiplexed NGS-based clinical workflows 9

10 How We Work With Our Customers Accelerating adoption Molecular Profiling Panels Customer Adoption Options 10

11 HTG and Immuno-oncology Profiling Planned Product Roadmap T cell load Effector activation Generic inflammation Cytokine profiling Tumor inflammation Immunophenotyping (M1/M2) Checkpoint resistance Tumor biology / subtyping I/O Version 1 Inflammation signatures Tumor classifiers Novel Content (MDx apps) Immune health monitoring Immune health prescreening Hyper-progression Combination response Collaborations I/O Version 1 (549 genes) I/O Version 2 (~1150 genes) I/O Version 3 (expanded apps) On Market In Development Future 11

12 Diagnostic Menu through PHARMA Partnerships Immuno oncology Research collaboration Master CDx agreement + Immuno oncology NGS based GEP clinical assays Biomarker Research Agreement PHARMA 3 Clinical development of NGS based GEP assay Master Precision Medicine development, manufacturing and commercialization agreement 12

13 Building a clinical diagnostic company EU collaborations / HTG EdgeSeq ALKPlus Assay EU Paris, France Hunninque, France NSCLC Other trials Valencia Spain Lyon, France Rheumatoid arthritis Autoimmune disease Breast cancer risk recurrence score ALK Immuno oncology Tumor subtyping 13

14 HTG 2017 Building momentum 14

15 HTG and Liquid Biopsies Circulating component Molecule Sample type Cell free RNA mirna Plasma / serum Circulating lymphocytes mirna PAXGene Circulating lymphocytes mrna PAXGene Exosomes mirna Isolated exosomes FACS sorted / CTC s mirna Sorted cells 15

16 Business Model Research / Collaborations / Diagnostics Leverage VERI/O laboratory services for quicker technology adoption Clinical & CDx assay development Sell instruments and kits (razor / razor blade Dx model) * Diagnostic Development Agreements * ** $10K - $300K $5M - $15M $25M - $100M IUO / IVD assay development Dx clinical trial & regulatory submission Market access and commercialize * potential per project/program aggregate revenue ** potential annual CDx test revenue 16

17 HTG EdgeSeq System Winning in the molecular lab Low sample input No RNA/DNA extraction Fast and simple data Multi plexing 1000 s of genes Three day workflow 17

18 Empowering Precision Medicine at the Local Level 18