elemental breath

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Leading the way to the earliest possible diagnosis of Lung Cancer with new technology for breath analysis. C O N F I D E N T I A L

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Page 1: Elemental Breath

Leading the way to the earliest possible diagnosis of Lung Cancer with new technology for breath analysis.

C O N F I D E N T I A L

Page 2: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

LUNG CANCER: THE BIGGEST KILLER

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160,000Mortalities every year in US / 1.6M Worldwide

63 millionAt risk in US

318 Million US ADULTS

63M Regular Smokers

20%smokers

Sources: American Lung Association and CDC

2011 data

Page 3: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

EXPENSIVE AND DANGEROUS SCREENING

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Lung Cancer typically has no symptoms until later stages of the disease.

The most common preliminary screening is a low dose CT scan every 3 or 6 months. It is a flawed test that is expensive and introduces radiation. AVERAGE COST: $1500

CT scan is the only currently FDA approved screening test.

Page 4: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

TRAGEDY: 85% NOT CAUGHT UNTIL IT’S TOO LATE

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Stage 1 5 Year Survival70%

Stage 4 5 Year Survival5%

85% OF LUNG CANCER IS DETECTED AT ABOUT STAGE 4 95% DIE WITHIN A YEAR OF DIAGNOSIS

Page 5: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

VOC ANALYSIS IS PROVEN BUT NOT SCALEABLE

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• Microanalysis of breath using mass spectroscopy invented in 1970s and is now a predictably repeatable and accurate science.

• Results take more than 10 hours

• Expensive: Require high vacuums, radioactive sources and pure gases

• Not scaleable, requires lab work with expensive equipment

Studies show breath test to be as accurate as chest CT for predicting lung cancer. Possibly better

REFERENCES: Nature (2015), Analytical Chemistry (2014), Cancer Medicine (2013),

Cancer Cell (2012), American Chemical Society (2012), Nanomedicine (2012), Bristish Jounal of Medicine (2010), British Journal of Cancer (2010), BioMed Central

(2009), Clinica Chimica Acta (2009), American Cancer Society (2007), Journal of

Chromatography (2005)

Page 6: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

PROPRIETARY TECHNOLOGIES

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• 3 International PCT Patents filed• Unique hyper-stable liquid concentrator technology• Already measuring lung cancer targets• Highly accurate tests can detect 100s of targets• Concentrator allows for volume information (critical data) • Ambient / environmental sampling reduces false positives

VOC Activator

VOC Concentrator

VOCSorter

DataAnalytics

We have technology that identifies the broadest range of key markers more reliably, rapidly and cost-effectively than any other methodology.

Page 7: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

DEFINING LEADERSHIP IN BREATH ANALYSIS TECHNOLOGY

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Elemental(Mass(

Spectroscopy( Colorimetry(Ion(Mobility((Spectroscopy(

Carbon((Nanotube( Metal(Nanopar7cle(

Company(Elemental(Sensor(CA(

Menssana((NJ(

Metabolomx((CA(

Zenosense(((Spain)(Owlstone(((UK)(

AlphaSzenszor(((Boston)(

Technion(University((Israel)(and(University(of(Denver(Cancer(Center(

Stage( Development( Clinical(Studies( Development(Clinical(Studies( Development( Clinical(Studies(

Ease(of(Use( ✓( 𐄂(( ✓( ✓( ✓( ✓(Instant(results( ✓( 𐄂(( ✓( ✓( ✓( ✓(Detect(specific((VOCs( ✓( ✓( ✓( ✓( 𐄂(( 𐄂((Can(target(all(VOCs( ✓( ✓( ✓( 𐄂(( 𐄂(( 𐄂((Measure(VOC(levels( ✓( ✓( 𐄂(( ✓( 𐄂(( 𐄂((Accuracy( ✓( ✓( 𐄂(( ✓( 𐄂(( 𐄂((

Standardized collection and handling of breath samples is key.This is a core technology unique to Elemental Breath

Page 8: Elemental Breath

Series A late 2016 / 2017 Series B 2018

1. Working Model

We are already capturing, concentrating and measuring lung cancer targets.

R&D- Complete prototype concentrator- File additional patents- Complete testing LC molecules- Pilot study at El Camino Hospital

Business Development- Develop medical protocol- Establish pilot study protocol- Locate pilot study partner- Start conversation with FDA

R&D- Develop pre-production prototype- Design clinical trials- Develop data warehouse

Business Development- File PMA request with FDA- CPT- Conduct pilot study- Refine medical protocol- License technology vs.

manufacture product- Possible strategic capital

CAPITAL REQUIREMENTS: $1M (20% discount / 7% Int.)

Seed 2016

2. Adjunct Test Applications

3. Clinical Trials / FDA 4. Diagnostic Test

R&D- First pilot builds- Refinement of software

Business Development- Sales team in place- Get doctors excited- Insurance coverage supported- Build supply chain- Device manufacturing- Techs and trainers setup- Establish CLIA certified lab- Development of ISFET chip- Possible strategic capital / exit

TIMELINE MILESTONES

CAPITAL REQUIREMENTS: $3-5 M Institutional

CAPITAL REQUIREMENTS: $ 5+ M Institutional

Page 9: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

TEAM

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Oliver King-Smith, PhDFounder and CEO

Greg JamesCo-founder Business Development

Eric Hoobler, PhDChief Chemist

Bernard SmitVP, Engineering

Murat YukselProject Manager

David LaoneLead Software Developer

Page 10: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

John BarrettMedical and FDA regulatoryCEO CoAlign(Acquired by Stryker)Abbott, Baxter

ADVISORS

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Surendra AroraVice PresidentInFocus

David Cummings Ph.D. Glasgow University and Leader Microsystem Technology Group

Michael Hurlston Executive Vice President, Worldwide Sales, Broadcom

Scott Oliver Ph.D. Professor of Chemistry UCSC,Thin film and surface chemistry

David ShantzEarly Stage New Product MarketingMultiple medical, consumer and tech ventures 15+ exits

Jeannie Chen, MD, MBAActing Chief Medical Officer

Page 11: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

EXPERIENCE

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Management team has a long track record togetherdesigning and launching medical devices

Ventilator Home Health Monitor Glucometer Portable Assay

FlowCytometry

Intravascular Imaging

Portable Ultrasound

VisionTesting

Page 12: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

$4.5B US MARKET / 13B WORLDWIDE

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PHASE ONE: ADJUNCT TESTPrimarily 9,000 Radiologists and Pulmonologists$500 testSimpler 510k FDA regulatory

PHASE TWO: GENERAL SCREENING TEST200k Primary Care Physicians$100 testPart of annual checkup for smokers and over 50

20M at RiskPossible test candidates

9MHigh Risk

65M at General Risksmokers etc.

102Mover 50 years age

Page 13: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

FUTURE VERTICAL MARKETS / APPLICATIONS

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Breast CancerParkinson’s Disease

Pulmonary TuberculosisHeart Disease

Small Intestine Bacterial OvergrowthNecrotizing Enterocolitis

There are a broad range of possibilities for the use of the technologies. Elemental can lead the medical testing market with this minimally invasive testing methodology. Breath can function to give doctors cost-effective and

actionable information that could prove as valuable as genetic or blood testing.

Page 14: Elemental Breath

Elemental Breath CONFIDENTIAL All Rights Reserved

FINANCIAL PROJECTIONS

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