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

CONFIDENTIAL

THE NEXT GENERATION OF MOLECULAR DIAGNOSTICS 2019

Company Overv rview

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• Platform offers easily integrated sample

preparation, rapid time to result, and sensitivity over current diagnostic platforms

• 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)

TANGEN BIOSCIENCES HAS DEVELOPED A

RAPID MOLECULAR DIAGNOSTIC PLATFORM CAPABLE OF REVOLUTIONIZING THE

$5B INFECTIOUS DISEASE MARKET

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A Seasoned & Proven Management Team

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

Project Management for analytical and diagnostic instrumentation

• Roche, 454 Life Sciences, Perkin Elmer

Rick Birkmeyer, PhD President & CEO John Davidson, PhD Co-Founder, CSO Richard Carroll, PhD VP BD Noemí Olivo, MSN VP Clinical Affairs Brian Chirico VP Operations

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.

Our Mis ission

Assay Sensitivity Ease

• f Use

Cost

FASTER & MORE ACCURATE DIAGNOSIS

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Sample preparation

Bacterial Culture

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

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The Potential for True Market Dis isruption

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IQumm

SEQUENCING

No existing platform has been able to advance the culture-based infectious disease diagnostics to a rapid solution

COMPETITIVE LANDSCAPE

MICROBES ARE

CONCENTRATED IN SAMPLE TUBE

SAMPLE TUBE IS INSTALLED

FOR AUTOMATIC LYSIS AND DELIVERY TO ASSAY DISK

INSTRUMENT AMPLIFIES AND

DETECTS UP TO 32 TARGETS

& REPORTS RESULTS

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Overv rview of f The Tangen System

QUICK, SENSITIVE AND PORTABLE TESTING

In Intellectual Property

“Apparatus and method for cell, spo spore, , or

• r vi

virus s capture an and disruption”

Sample processing apparatus Application WO 2016/073353 A1 Pending Priority Date: 2014-11-03

USPTO Office of Public Records Document Services Division “Iso Isothermal meth thods for

• r

am ampli lify fying nu nucleic ic aci acid sam sample les”

Two-stage amplification process to improve assay sensitivity and detect SNPs US20170204456A1 Pending Priority Date: 2014-07-16

“Apparatus an and meth thod for

• r extr

xtracting pa pathogens fr from bio biological l sam samples”

Sonic apparatus for cellular disruption US20170274376A1 Priority Date: 2016-03-28

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“A method for suppressing non-specific Am Amplif ific ication pr products s in nu nucle leic aci acid amplification technologies”

Suppression of primer artifacts during isothermal amplification U.S. Application Serial No. 62/792,613 Provisional Patent Filing Date: January 15, 2019

New Tangen Patent

U.S. .S. Applic ication Ser Seria ial No.

• . 62/7

62/792,613 Provisional l Patent Fi Fili ling Da Date: Ja January ry 15, 15, 2019 2019 Title: “A METHOD FOR SUPPRESSING NON- SPE SPECIFIC IC AMPLIFIC ICATION PR PRODUCT CTS IN IN NUC UCLEIC C ACID CID AMPLIFICA CATION TECHNOLOGIES”

50 100 150 200 250 300 350 400 450

Cq

NTFP Suppression Study This method blocks Non-Specific False Positives in Isothermal Nucleic Acid Amplification Reactions

• Is broadly applicable to all Strand

Displacing isothermal Nucleic Acid Amplification Technologies

• Better sensitivity/specificity for our tests
• Significant licensing opportunities

Our Core Technologies

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LVCTM 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)

TangenDxTM Instrument

• Pathogen DNA/RNA extraction
• 1-hour real-time amplification and detection
• Data analysis and reporting into patient EMR

LVC = Large Volume Concentrator

Demonstrated Results: WHO /

/ Tuberculo losis is

1 1

STEP

TANGEN

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

Tuberculosis Study vs. Cepheid GeneXpert

Note: Blinded raw sputum clinical samples from WHO. 24 Patients (5 samples each)

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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%

Rhode Island Hospital Clinical Results

Demonstrated Results: RIH

IH / / Fungal l Panel

Note: 79 Samples tested, spiked whole blood samples

$9.4MM CONTRACT AWARDED TO TANGEN BIOSCIENCES FOR

OR THE DEVELOPMENT OF MOBILE BIOTHREAT ASSAY ON THE TANGENDXTM PLATFORM

• No accessory equipment or

measuring required

• Small portable size (Battery

pack enabled)

• No cold chain for reagents

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Key In Init itiative: Poin int of Care Mole lecular Dia iagnostics

• Best in class sensitivity for

Anthrax testing directly from whole blood

• Rapid testing (<1 hour) for

sample to result with no need for accessory lab equipment

• Testing of up to 30 targets

per sample

• Ability to detect antibiotic

resistance

• Universal Platform with

customizable sample prep kits

SENSITIVE, SIMPLE & FAST REMOTE, HANDHELD USE VERSATILE

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Target # Positive Results # Negative Results Total # Results % Detection Target

pXO1 21 21 100% pXO1 pXO2 20 1 21 95.2% pXO2

• B. anthracis

(pXO1 + pXO2) 20 1 21 95.2%

• B. anthracis

(pXO1 + pXO2)

Independent Lab Results

Demonstrated Results: In

Independent lab lab / / Anthrax

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)

Synergistic Corporate Partnering Opportunity

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MARKET

LEADERSHIP

SYNERGISTIC PARTNER

• Molecular Assay

Development

• GMP Manufacturing
• Market Leader
• Complimentary Products

 Support Drug Development  Point of Care Tests  Companion Diagnostics

DNA/RNA DETECTION

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Technical & Clinical Mil ilestone Tim imeline

M/YY M/YY M/YY M/YY M/YY

Complete Assay Design & analytical testing External Verification with Lab Partner

FDA

Pre-submission Demonstrated Clinically relevant sensitivity Design Lock

H1 H1 H2 H1 H2 H2 H2 H1 H1 H2

2016 2017 2018 2019 2020 2014-15 Fungal Panel Anthrax Corporate Partner

11/18 11/18 8/20 3/16 2/17 11/16 4/18 3/18 2/19

3-5/20 10/20

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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

Executive Summary ry

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PRODUCTS

• Tangen’s products will transform the

bacterial market resulting in improved patient outcomes

PRICE-POINT

• Very low capital cost for adoption will

allow Tangen to quickly capture significant market share

PERFORMANCE

• Tangen’s solution has significant

improvement in assay sensitivity

• Significant advancements in speed &

cost over current competitors

• More rapid diagnosis providing

physician with timely information

PROFESSIONALISM

• Tangen team has significant experience

in developing and commercializing molecular instrumentation

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Appendix & Back-Up

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The Tangen Assay disk contains a central chamber where the amplification reagents are brought to the stringent reaction temperature (66°C) before they are transferred to the outer Detection chambers where the primers are located. No low temp non-specific false positives are produced.

PROBLEM

LAMP reactions suffer from primer-based non- specific amplification Amplicon contamination of work space & equipment Few primer designs work

SOLUTION

This is greatly reduced in the TangenDx instrument primarily by providing a stringent Hot-Start to the reaction The Tangen Assay Disk contains the amplified reactions beneath a self sealing layer of wax to prevent cross contamination Tangen has licensed STEM primers for LAMP – STEM primers provide great flexibility for primer design that the LOOP primer alternative. Stringent Hot-Start enables more primer designs to be useful.

TangenDxTM

TM Im

Improvements To LA LAMP