Htg Molecular Diagnostics, Inc. · OTC:HTGMQ
Htg Molecular Diagnostics — Investor Presentation (January 2016)
22 slides from Htg Molecular Diagnostics's investor presentation, Jan 11, 2016
Slide 1: HTG
HTG HTG
Slide 2: Forward-looking statements
HTG 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 timeline strategy, future operations, future product development,
Slide 3: Investment highlights
HTG investment highlights HTG Disruptive technology positioned to replace & consolidate existing tests in $2B+ markets. ( FISH, Flo Cytometry, IHC) Growing pipeline of late stage BioPharma collaborations with potential to lead to high valued companion diagnostic tests Well positioned for continued e
Slide 4: Clinical molecular testing transformed: HTG's solution for the future
Clinical molecular testing transformed HTG’s solution for the future HTG Today Centralized, remote testing labs Slow, 2-4 week turnaround time for results Samples are limited And often insufficient for multiple tests and platforms Poor integration of data Creates confusion among doctors and frustrat
Slide 5: HTG corporate timeline/strategy 2016-2020
HTG HTG corporate timeline/strategy 2016 - 2020 Clinical Sequencing Product Company Next Gen Workflow Pharma Companion Dx Partner Lung PMA Democratizing NGS molecular testing - Approved Diagnostics - Global expansion $3.5B targeted market 2011 - 2015 RUO Menu/Expansion IPO HTG EdgeSeq Products Launc
Slide 6: Targeting late stage drug programs for companion diagnostics
Targeting late stage drug programs for companion diagnostics (Lymphoma, RNA biomarker, Immuno Oncology) HTG Biopharma Drug Development $2.5 billion Transparency Market Research Report Immuno Oncology panel launch 27 14 2013 2014 2015 HTG Biomarker & CDx Projects 8 January 2016 © HTG Molecular Diagno
Slide 7: BioPharma A: The Case of the Assay Failure
BioPharma A The Case of the Assay Failure HTG Problem Statement – in a 300 case phase II study, over 50% of the samples failed to yield a diagnostic result by RNASeq because of lack of sample or poor sample quality causing clinical development of the compound to be stopped HTG Solution – A subset of
Slide 8: Targeting translational research centers for diagnostic development
Targeting translational research centers for diagnostic development HTG Translational Medicine Science Translational Medicine $7.7 billion Wells Fargo Genomic Tools Report Stanford MEDICINE Freidenrich Center for Translational Research THE UNIVERSITY OF TEXAS MD Anderson Cancer Center Making Cancer
Slide 9: Developing clinical menu for NGS based diagnostics
HTG Developing clinical menu for NGS based diagnostics Molecular Diagnostics $10.6 billion Genome Web Report, company est. HTG Product Fusions & CNVs IHC / Flow Replacement Mutations Market Size * $250M $1,900M TBD Reimbursement 81450 ($647) 81450 ($647) 81445 ($597) * Company estimates Lung ALK PMA
Slide 10: HTG EdgeSeq technology provides the solution
HTG EdgeSeq technology Provides the Solution HTG Multiplexing Allows analysis of thousands of molecular targets Extremely Small Samples Produce robust data and profiles No DNA/RNA Extraction Proprietary patented chemistry Automated Platform With minimal labor, simple user interfaces, and turnkey ana
Slide 11: HTG EdgeSeq sample requirements
HTG EdgeSeq sample requirements Setting a new standard for molecular testing HTG Traditional Methods XD-10927 XD-10927 XD-10927 XD-10927 XD-10927 XD-10927 XD-10927 XD-10927 HTG EdgeSeq system XD-10927 8 January 2016 © HTG Molecular Diagnostics, Inc. 11
Slide 12: Improving molecular testing workflow
Improving molecular testing workflow Traditional versus HTG EdgeSeq system HTG Traditional Targeted RNA Seq Workflow Estimated ~52 hours time to completion; 9 hours hands-on time Crude sample processing RNA extraction and fragmentation cDNA synthesis & ligation Target enrichment Library amplificatio
Slide 13: HTG platform innovation
HTG platform innovation Continuous product evolution HTG Edge system 2013 96 samples 47 genes Reader Next Generation Sequencing HTG EdgeSeq system 2014 8-96 samples 1000s genes Reader and NGS Next Generation Sequencing HTG EdgeSeq system (HTG IVD system*) 2015 8-96 samples 1,000s genes NGS only HTGE
Slide 14: JANUS - Continuing the innovation toward sample to answer workflow
JANUS - Continuing the innovation toward sample to answer workflow (intended to expand the addressable market) HTG Modular design concept 1 2 3 4 5 Lane 1. 2.5 uL PCR product Lane 2. 5 uL PCR product Lane 3. 10 uLPCR product Lane 4. 15 uLPCR product Lane 5. 20 uLPCR product Crude sample processing T
Slide 15: HTG forms IVD test development agreement with Illumina
HTG forms IVD test development agreement with Illumina October 30, 2014 HTG HTG EdgeSeq HTG Molecular Sample Plate Lot 0000 Part 00000000 Store at 15-30°C Expires 12.31.25 illumina® 8 January 2016 © HTG Molecular Diagnostics, Inc. 15
Slide 16: Creating diagnostic menu
Creating diagnostic menu HTG Profiling Panels ImmunoOncology Micro RNA mRNA Biomarker Biopharma Drug Development $2.5 billion Transparency Market Research Report 13 Biopharma Clients 27 Active Programs Translational Medicine Science Translational Medicine $7.7 billion Wells Fargo Genomic Tools Repor
Slide 17: Reimbursement (Diagnostic addressable market increasing)
Reimbursement (Diagnostic addressable market increasing) $3.5B + HTG January 2013 – Code Stacking Eliminated January 2015 – Tier 2 GSP Procedures Added February 2015 – RNA language adopted by AMA CPT Panel August 2015 – Congressional Letter to CMS on RNA September 2015 – CMS pricing on two GSP’s Oct
Slide 18: HTG's reimbursement summary – POSITIVE
HTG’s reimbursement summary – POSITIVE HTG HTG customers will now be able to access the molecular pathology codes for reimbursement. (>100 codes) HTG’s initial clinical menu is expected to utilize the GSP’s (General Sequencing Procedure Codes) with pricing from CMS of $597 and $647 Expect potential
Slide 19: Reimbursement economics
Reimbursement economics CMS genomic sequencing procedure codes HTG 81445 Solid Organ 5 – 50 genes 81450 Hematolymphoid 5 – 50 genes 81455 Solid or Hematolymphoid 51+ genes CMS Pricing $597 - $1,000 - HTG Panels $300 - $500 Potential Lab Margin $300 - $500 (approx.) Company Estimates 8 January 2016 ©
Slide 20: 2016-2020 Menu: Disruption of existing markets
2016-2020 Menu Disruption of existing markets HTG Liquid Tumors Solid Tumors #1 FISH #2 IHC / Flow #6 Sequencing #3 FISH #5 Classifiers #4 IHC Market Disrupted HTG Product Fusions & CNVs IHC / Flow Replacement Mutations Fusions Classifiers IHC / Flow Replacement Market Size $250M $1,900M TBD $55M $2
Slide 21: 2016-2020 Product Plan
2016-2020 Product Plan targeted market grows from estimated $350m to $3.5b HTG 2016 2017 2018 Clinical Lung PMA Heme CNVs OPTIONS: RUO Heme Fusions Solid Fusions Mutations Breast Classifier RUO IHC / Flow Updates to IHC / Flow or Low Complexity Tools Assays T Cell Diversity Sample Apps – Urine, FACS
Slide 22: Empowering precision medicine at the local level
Empowering precision medicine at the local level HTG HTGEdgeSeq 8 January 2016 © HTG Molecular Diagnostics, Inc. 22
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