CONFIDENTIAL

THE NEXT GENERATION OF MOLECULAR DIAGNOSTICS

2019

Company Overview

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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, PhDPresident & CEO

John Davidson, PhDCo-Founder, CSO

Richard Carroll, PhDVP BD

Noemí Olivo, MSNVP Clinical Affairs

Brian ChiricoVP 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 Mission

Assay Sensitivity

Ease of Use

CostFASTER & 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 Disruption

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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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Overview of The Tangen System

QUICK, SENSITIVE AND PORTABLE TESTING

Intellectual Property

“Apparatus and method for cell, spore, or virus capture and

disruption”

Sample processing apparatus

Application WO 2016/073353 A1Pending

Priority Date: 2014-11-03 USPTOOffice of Public Records

Document Services Division

“Isothermal methods for amplifying nucleic acid samples”

Two-stage amplification process to improve assay sensitivity and detect SNPs

US20170204456A1Pending

Priority Date: 2014-07-16

“Apparatus and method for extracting pathogens from biological samples”

Sonic apparatus for cellular disruption

US20170274376A1Priority Date: 2016-03-28

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“A method for suppressing non-specific Amplification products in nucleic acid

amplification technologies”

Suppression of primer artifacts during isothermal amplification

U.S. Application Serial No. 62/792,613Provisional Patent Filing Date: January 15, 2019

New Tangen Patent

U.S. Application Serial No. 62/792,613Provisional Patent Filing Date: January 15, 2019

Title: “A METHOD FOR SUPPRESSING NON-SPECIFIC AMPLIFICATION PRODUCTS IN NUCLEIC ACID AMPLIFICATION TECHNOLOGIES”

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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 / Tuberculosis

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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 / Fungal Panel

Note: 79 Samples tested, spiked whole blood samples

$9.4MM CONTRACT AWARDED TO TANGEN BIOSCIENCES FOR 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 Initiative: Point of Care Molecular Diagnostics

• 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

USEVERSATILE

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Target# Positive

Results# Negative

ResultsTotal # Results

% Detection Target

pXO1 21 0 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: Independent 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 Milestone Timeline

M/YY M/YY M/YY M/YYM/YY

Complete Assay Design & analytical testing

External Verification with Lab Partner

FDAPre-submission

Demonstrated Clinically relevant sensitivity

Design Lock

H1 H1 H2 H1 H2 H2H2 H1H1 H2

2016 2017 2018 2019 20202014-15

FungalPanel

Anthrax

CorporatePartner

11/18

11/18

8/20

3/16 2/1711/16 4/18

3/18

2/19

3-5/20

10/20

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Milestones

• 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

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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 TangenDxinstrument 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 Improvements To LAMP