Company Overv rview Platform offers easily integrated sample T - PowerPoint PPT Presentation

T HE N EXT G ENERATION OF M OLECULAR D IAGNOSTICS 2019 C ONFIDENTIAL

Company Overv rview • Platform offers easily integrated sample T ANGEN B IOSCIENCES HAS DEVELOPED A preparation, rapid time to result, and RAPID MOLECULAR DIAGNOSTIC PLATFORM sensitivity over current diagnostic CAPABLE OF REVOLUTIONIZING THE platforms $5B INFECTIOUS DISEASE MARKET • A fungal assay 510(k) pre-submission has been reviewed by the FDA with positive feedback and is planned for commercialization in 2019 • $ 9.4 million BARDA grant (2017-21) 2

A Seasoned & Proven Management Team • Seasoned executive with over 30 years of diagnostics experience • Former CEO, CD Diagnostics; Founder/CEO, Strategic Diagnostics- NASDAQ (SDIX) Rick Birkmeyer, PhD • Implemented successful corporate partnerships & strategic acquisitions President & CEO • BS, Biology, SUNY Plattsburgh; PhD, Biochemistry/Immunology, SUNY Binghamton • 14 yrs. developing DNA technologies: Mutation detection in cancer, Gene synthesis John Davidson, PhD • Senior Director for Research and Development at Ion Torrent/Life Technologies • Commercialized multiple DNA seq. & highly automated sample prep platforms Co-Founder, CSO • Harvard biochemistry PhD 2000 • 40 years of FDA diagnostic product experience Richard Carroll, PhD • 7 FDA cleared Dx products; 5 patents & numerous pubs in HIV & blood separation • Cleared first ever FDA gene sequencing technology in 2002, TruGene VP BD • VP for Clinical Research at HistoRx (2009), President ViveBio (2013) • Epidemiology, CCRP, VP Clinical Affairs Noemí Olivo, MSN • Amida Care, Director Research and Grants Management • HistoRx, Senior Director Clinical Research, GCP VP Clinical Affairs • ViveBio, Senior Director of Quality Management • 30 years of experience in Operations, Service, Customer Support, Quality, and Brian Chirico Project Management for analytical and diagnostic instrumentation VP Operations • Roche, 454 Life Sciences, Perkin Elmer 3

Our Mis ission To launch an innovative molecular diagnostic platform that transforms the standard of care for critical infections by providing low cost, portable, and rapid diagnostics for patients. F ASTER & M ORE Cost Sample A CCURATE Assay Ease preparation Sensitivity of Use D IAGNOSIS 4

Bacterial Culture Only 50% of infected samples grow Requires 24-120 hours for results Identification requires additional time 5

The Potential for True Market Dis isruption C OMPETITIVE No existing platform has been able to advance the L ANDSCAPE culture-based infectious disease diagnostics to a rapid solution IQumm S EQUENCING 6

Overv rview of f The Tangen System M ICROBES ARE S AMPLE T UBE IS INSTALLED I NSTRUMENT AMPLIFIES AND DETECTS UP TO 32 TARGETS CONCENTRATED FOR AUTOMATIC LYSIS AND IN S AMPLE T UBE & REPORTS RESULTS DELIVERY TO ASSAY DISK Q UICK , S ENSITIVE AND P ORTABLE T ESTING 7

In Intellectual Property “Apparatus and method for cell, “ Iso Isothermal meth thods for or spore, spo , or or vi virus s capture an and ampli am lify fying nu nucleic ic aci acid sam sample les ” disruption” Two-stage amplification process to Sample processing apparatus improve assay sensitivity and detect SNPs Application WO 2016/073353 A1 US20170204456A1 Pending Pending Priority Date: 2014-11-03 USPTO Priority Date: 2014-07-16 Office of Public Records Document Services Division “A method for suppressing non -specific “ Apparatus an and meth thod for or extr xtracting Amplif Am ific ication pr products s in nu nucle leic aci acid pathogens fr pa from bio biological l sam samples ” amplification technologies” Sonic apparatus for cellular disruption Suppression of primer artifacts during isothermal amplification US20170274376A1 Priority Date: 2016-03-28 U.S. Application Serial No. 62/792,613 Provisional Patent Filing Date: January 15, 2019 8

New Tangen Patent U.S. .S. Applic ication Ser Seria ial No. o. 62/7 62/792,613 NTFP Suppression Study Provisional l Patent Fi Fili ling Da Date: Ja January ry 15, 15, 450 2019 2019 400 Title: “A METHOD FOR SUPPRESSING NON - SPE SPECIFIC IC AMPLIFIC ICATION PR PRODUCT CTS IN IN 350 NUC UCLEIC C ACID CID AMPLIFICA CATION 300 TECHNOLOGIES” 250 Cq This method blocks Non-Specific False 200 Positives in Isothermal Nucleic Acid 150 Amplification Reactions 100 • Is broadly applicable to all Strand 50 Displacing isothermal Nucleic Acid 0 Amplification Technologies • Better sensitivity/specificity for our tests • Significant licensing opportunities

Our Core Technologies LVC TM Sample processing system • Multiple sample types and volumes • High Sensitivity • Rapid-less than minutes RAMP amplification and detection disk • Demonstrated ability to detect 1 CFU/mL blood • Robust single-enzyme isothermal system • 35-channels (controls + up to 33 targets) TangenDx TM Instrument • Pathogen DNA/RNA extraction • 1-hour real-time amplification and detection • Data analysis and reporting into patient EMR LVC = Large Volume Concentrator 1 0

Demonstrated Results: WHO / / Tuberculo losis is Tuberculosis Study vs. Cepheid GeneXpert STEP T ANGEN Cepheid GeneXpert Sampling of liquefied sputum >95% 33% Capture of cells >95% 40% Cell Lysis 90% 50% Delivery of lysate to amplification chambers 75% 30% Total DNA delivery eff 61% 2% Amplification sensitivity @95% confidence 13 copies 5.5 copies Input Genome sensitivity (Tangen using all channels) 21 genomes 275 genomes CFU sensitivity 10.5 cfu 126 cfu Note: Blinded raw sputum clinical samples from WHO. 24 Patients (5 samples each) 1 1

Demonstrated Results: RIH IH / / Fungal l Panel Rhode Island Hospital Clinical Results Target Species CFU/ml Input # Spiked Sensitivity Specificity Accuracy C albicans 1.5 15 100% 100% 100% C glabrata 1.5 14 100% 100% 100% C krusei 1.5 10 100% 98% 98% C parapsilosis 1.5 21 90% 95% 93% C tropicalis 3.0 19 100% 98% 98% Note: 79 Samples tested, spiked whole blood samples 1 2

Key In Init itiative: Poin int of Care Mole lecular Dia iagnostics $9.4MM CONTRACT AWARDED TO T ANGEN B IOSCIENCES FOR OR THE DEVELOPMENT OF MOBILE BIOTHREAT ASSAY ON THE T ANGEN D X TM PLATFORM S ENSITIVE , S IMPLE R EMOTE , H ANDHELD V ERSATILE & F AST U SE • Testing of up to 30 targets • Best in class sensitivity for • No accessory equipment or Anthrax testing directly measuring required per sample from whole blood • Small portable size (Battery • Ability to detect antibiotic • Rapid testing (<1 hour) for pack enabled) resistance sample to result with no • No cold chain for reagents • Universal Platform with need for accessory lab customizable sample prep kits equipment 13

Demonstrated Results: In Independent lab lab / / Anthrax Independent Lab Results # Positive # Negative Total # Target % Detection Target Results Results Results pXO1 21 0 21 100% pXO1 pXO2 20 1 21 95.2% pXO2 B. anthracis B. anthracis 20 1 21 95.2% (pXO1 + pXO2) (pXO1 + pXO2) Notes: • 21 runs with spiked whole blood at 5.7CFU/ml input • Protocol is as expected for clinical users, except BSL-3 precautions taken for safety working with a BSL-2 organism (instrument run in BSL-3 hood) 1 4

Synergistic Corporate Partnering Opportunity DNA/RNA D ETECTION  Support Drug Development M ARKET  Point of Care Tests  Companion Diagnostics L EADERSHIP S YNERGISTIC P ARTNER • Molecular Assay • Market Leader • Complimentary Products Development • GMP Manufacturing 15

Technical & Clinical Mil ilestone Tim imeline M/YY M/YY M/YY M/YY M/YY Complete Assay Design External Verification FDA Demonstrated Clinically Design & analytical testing with Lab Partner relevant sensitivity Lock Pre-submission 2014-15 2016 2017 2018 2019 2020 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 Fungal 3/16 11/16 2/17 11/18 4/18 Panel 10/20 Anthrax 3/18 11/18 3-5/20 Corporate 2/19 8/20 Partner 16

Mil ilestones • Completion of pivotal clinical trial for Rapid Candida Panel (12/19) • FDA (510k) submission and clearance of Rapid Candida Panel (3/20) • Build-out of commercial infrastructure • R&D for Rapid Bacterial Panel completed • Pilot testing for Rapid Bacterial panel underway 17

Executive Summary ry P RODUCTS P RICE -P OINT • • Tangen’s products will transform the Very low capital cost for adoption will bacterial market resulting in improved allow Tangen to quickly capture patient outcomes significant market share P ERFORMANCE P ROFESSIONALISM • • Tangen’s solution has significant Tangen team has significant experience improvement in assay sensitivity in developing and commercializing molecular instrumentation • Significant advancements in speed & cost over current competitors • More rapid diagnosis providing physician with timely information 18

Appendix & Back-Up 19