Corporate Presentation. September 6th, 2018

Transcription

1 Corporate Presentation September 6th, 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 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/testing in any lab. Based in Tucson, AZ IPO 2015 Proprietary Technology ~ 110 Employees Direct sales US and EU 3

4 HTG Highlights 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 Molecular Profiling Industry Partnerships Illumina ThermoFisher QIAGEN 4

5 Strategic Roadmap Our building blocks 1) Capture category leadership in RNA based profiling 2) Expand into multi-modal capabilities as market matures Molecular classifiers, mutation load, genomic instability, inflammation. 3) Build Dx menu via BioPharma and KOL collaborations High value, capital efficient 4) Win in the MDx market with superior workflow, cost Category leader in NGS targeted panel workflow 5

6 RNA, Gaining Importance as a Biomarker DNA predicts what could happen but doesn t tell you much about what is happening Protein tells you what is happening but it is really difficult to measure accurately, quantitatively and in high plex RNA tells you what will happen and measurements are accurate, quantitative, and facilitates high gene plex The clinical rationale for RNA The simple, one gene, medical questions have already been answered (HER2, EGFR) The questions of today s clinical research (IO response, patient prognosis) require accurate measurement of the activity (not possibility) of many genes 6

7 HTG Leadership Timothy (TJ) B. Johnson Chief Executive Officer Hill-Rom Shaun D. McMeans SVP and Chief Financial Officer John L. Lubniewski President and Chief Operating Officer Michael C. Hrubiak SVP, Profiling BU Byron T. Lawson SVP, Biopharma Partnerships BU Sam M. Rua, Jr. SVP, of Regulatory Affairs and Quality Systems 7

8 HTG EdgeSeq System Solving clinical sequencing issues Low sample input No RNA/DNA extraction Fast and simple data Multi plexing 1000 s of genes Three day workflow 8

9 Customer Validation Peer reviewed posters, abstracts, publications increasing 9 Company internal Reporting

10 Revenue Growth Existing and planned revenue streams 2015 RUO Profiling Products 2017 CDx Collaboration Revenue 2019 Molecular Dx Products (MDx) $25.0m MDx Products (planned) $21.0m $8.1m $8.1m $4.0m $5.1m $6.6m Guidance 10

11 Molecular Profiling - RUO H 2018 $4.0m $5.1m $6.8m $3.7m 11

12 RUO Profiling Development Pipeline Driving growth in translational research and BioPharma Q Q planned HTG EdgeSeq Precision IO (launched) HTG EdgeSeq mirna Mouse (in development) HTG EdgeSeq mrna Mouse (in development) HTG EdgeSeq RNA Tumor Mutation Burden (TMB) HTG EdgeSeq Tumor Inflammation Liquid Biopsy Applications Exosomes Platelets Vesicles 12 Company planned timeframes

13 HTG EdgeSeq Precision IO Panel Just Released for Shipments Tumor inflammation T cell load Effector activation Generic inflammation Cytokine profiling HTG EdgeSeq Immuno-Oncology Assay (549 genes) Immunophenotyping (M1/M2) Checkpoint resistance Tumor biology / subtyping I/O Version 1 HTG EdgeSeq Precision Immuno-Oncology Panel (~1400 genes) Most complete IO specific GEP panel Content driven by scientific advisory board Supports comprehensive applications for IO based precision diagnostics On Market On Market 13

14 Working with BioPharma Building a CDx pipeline via RUO biomarker projects Right patient with right drug, drug combination Immuno Oncology panel launch 50* Merck KGaA research agreement 14 BMS IO research agreement 2014 * Pharma Profiling Projects *Company tracking estimates

15 Companion Diagnostics Building high value test menu via BioPharma collaborations 2016 Signed Merck KGaA Darmstadt Master CDx Agreement Signed QIAGEN master Precision Diagnostics Partnership (PDP) agreement 2017 Signed SOW 1 associated with CDx development, PDP program 1 Signed SOW 2 associated with CDx development, PDP program Signed SOW 3 associated with CDx development, PDP program 3 Signed SOW 2 extension amendment for broad use of CTA SOW 1 and PDP program 1 terminated, not CDx assay related PDP Collaboration Revenue Q Q Q Q Q $311k $2.1m $5.5m $2.4m $2.9m 15

16 CMS National Coverage Determination (NCD) Reimbursement for Companion Diagnostics (CDx) in Oncology HTG planned assays are CDx tests in Oncology 16

17 HTG s Diagnostic Strategy for IO One highly multiplexed panel, multiple applications/algorithms Multi-modal Guideline driven Kitted Precision Cancer Profiling

18 EU Diagnostic Collaborations Lymphoma subtyping Leeds UK Paris, France Berlin Germany Hunninque, France Triple negative breast cancer NSCLC Other trials Valencia Spain Lyon, France Rheumatoid arthritis Autoimmune disease Breast cancer risk recurrence score ALK Immuno oncology Tumor subtyping 18

19 Molecular Diagnostic Pipeline BioPharma Collaborations 50+ early phase trials 2 PDP agreements Companion Dx 1, 2 (expected) EU Dx Collaborations Rheumatoid Arthritis (announced) HTG Development on market HTG ALKPlus CE/IVD HTG Total Lung HTG Breast in development in development 19

20 Molecular Diagnostic Products HTG EdgeSeq AlkPlus EU CE/IVD - Company estimated available market EU ($75m) (300,000 cases X $250 per test) 20

21 HTG and Liquid Biopsies Leading the way with our mirna WT Panel 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 21

22 Financials / Revenues $ 14.8M $ 9.1M (6 months) $ 4.0M $ 5.1M H May 6, 2015 IPO Q2 Cash $40.7m 22

23 Empowering Precision Medicine at the Local Level 23