Revolutionary Monitoring Technology for Vascular Healthlexingtonbiosciences.com/.../02/Lexington-Roadshow-Presentation-2.… · This presentation was prepared to assist interested

Revolutionary Monitoring Technology for Vascular Health

SIMPLE | NON-INVASIVE | EFFECTIVE | LOW COST

CSE: LNB │ OTCQB: LXGTF

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Information contained in this presentation is the property of Lexington BioSciences (“Lexington” or the“Company”). This presentation does not constitute, or form part of, any offer or invitation to sell orissue, or any solicitation of any offer to subscribe for or purchase any securities in the Company, nor shallit, or the fact of its communication, form the basis of, or be relied upon in connection with, or act as anyinducement to enter into, any contract or commitment whatsoever with respect to such securities. Thecommunication of this presentation in or to persons in certain jurisdictions may be restricted by law andpersons who may receive communication of this presentation should inform themselves about, andobserve, any such restrictions in advance of communication to them of this presentation. No securitiesexchange or affiliated service provider has reviewed or accepts responsibility for the adequacy oraccuracy of the content of this presentation.

The material contained in this presentation is provided solely for your general knowledge and is notintended to be a comprehensive review of all matters and developments concerning Lexington or itsaffiliates. Lexington has taken all reasonable care in producing the information contained in thispresentation. This information may contain technical or other inaccuracies, omissions, or typographicalerrors, for which Lexington assumes no responsibility. Lexington makes no representation or warrantyregarding, and assumes no responsibility for, the use, validity, accuracy, completeness, reliability orcurrency of any claims, statements or information in this presentation.

To the extent permitted by law, Lexington BioSciences Inc. and its employees, agents, affiliates andconsultants exclude all liability for any loss or damage arising from the use of, or reliance on, any suchinformation, whether or not caused by any negligent act or omission. Statements in this presentationother than purely historical information, including statements relating to Lexington’s future plans,objectives or expected results, constitute forward-looking statements within the meaning of the U.S.federal and Canadian securities laws. Forward-looking statements are based on numerous assumptionsand are subject to the risks and uncertainties inherent in Lexington’s business, including risks inherent inearly stage start up ventures and development. As a result, actual results may vary materially from thosedescribed in the forward-looking statements. Lexington disclaims any obligation to update any forward-looking statements.

This presentation was prepared to assist interested parties in making their own assessment of Lexingtonand its business plans and does not purport to contain all of the information that a prospective investormay desire. In all cases, interested parties should conduct their own investigation and analysis of theCompany, its assets and the information provided in this presentation. Any and all statements, forecasts,projections and estimates contained in this presentation are based on management’s current knowledgeand no representation or warranty is made as to their accuracy and/or reliability.

LEGAL


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Cardiovascular Disease is Highly Prevalent and Poorly Diagnosed

• 1 in 3 deaths annually are caused by heart disease and stroke.

• 1.5 million people suffer heart attacks annually in the U.S.

• Nearly 1/3 of the deaths could be preventedthrough proactive changes in clinical

management or lifestyle

• Often the FIRST SYMPTOM of coronary artery disease is a heart attack.

1 World Health Organization (WHO)2 Center for Disease Control (CDC), Atlanta


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• Current front line cardiovascular health

diagnostics are insensitive at measuring

heart disease development and

progression

• Specialized cardiovascular diagnostics

are highly invasive and expensive and

generally only catch cardiovascular

disease AFTER it’s developed

...we need a simple way to proactively measure and monitor

cardiovascular system health

BEFORE the development of heart disease

The First Sign of Heart Disease is Often a Heart Attack


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Knowing the core health of the cardiovascular system is critical to preventing future heart attacks and strokes

• Monitoring cardiovascular health changes over time is key to prevention via lifestyle modification, physician care and ongoing monitoring.

• Traditional measures of blood pressure and cholesterol measurements are only partial indicators of cardiovascular health.

Early Heart Disease Detection Is Critical


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Endothelial function measurement predicts when arteries are vulnerable to developing atherosclerosis

• Endothelium: a single layer of cells that line the heart, blood and lymphatic vessels.

• Function: Acts as a shield, preventing plaque from forming inside the artery wall, and produce substances that stop blood clots from developing in the vessel.

Endothelial Health Predicts Onset of Disease

• Monitoring endothelial function over time predicts the onset of heart disease

long before symptoms begin.


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Current Endothelial Function Measurement Tools are Complicated and Expensive

• Gold standard - ULTRASOUND

• Measurement directly views arterial diameter changes

• Only at specialized diagnostic centers

• Requires trained ultrasonographer

• Expensive capital equipment needed

• Alternative method - ENDOPAT

• Measurement uses a fingertip blood oxygen sensor and laptop computer.

• Only at specialized diagnostic centers

• Requires trained technician

Currently only used in specialized research centers by highly trained staff


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Lexington Has a Simple and Elegant Solution

An easy-to-use product designed to easily and accurately measure endothelial

function

HeartSentry stimulates a patient’s endothelium and then accurately measures

the arterial response.

In healthy patients, arterial volume changes after endothelial stimulation are

much greater than baseline levels, typically by more than 80%.

HeartSentry is compact and inexpensive enough for use in the professional

clinic market as well as the home market.


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Technology Comparison

ULTRASOUND ENDOPAT HEARTSENTRY

Cost ~$50k-$200k / unit

Varying hospital costs

~$27k / unit

$40 per procedure

Inexpensive

Minimal operating costs

Training Ultrasonographer Specialized technician No specialized training

Location Clinic based Clinic Based Portable: Designed for clinic or

home use

Time 1hr+ ~15 min 5 min

Method Imaging of large arteries in

arm

Measures capillaries in

fingertip

Directly measures endothelial

function in large arteries in arm

IT data

integration

None None Bluetooth results upload easily to

cloud hosted database


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Compelling HeartSentry Research and Test Data

Early Clinical Research:

• Initial results with 50 patients demonstrated a strong correlation to standard ultrasound measurements

HeartSentry Testing:

• 500% improved sensitivity over ultrasound•A consistently higher accuracy with lower variability than ultrasound• Faster and easier to use

HeartSentry First Prototype

HeartSentry Commercial Product Concept

HeartSentry Gen 1Clinical Study Product


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HeartSentry Technology Origin

Invented and developed over a fifteen year period by Thomas F. Budinger, M.D. Ph.D, and

Jonathan S. Maltz, Ph.D, joint-winners of an international award in 2006 for their instrument to

assess endothelial function.

Licensed to Lexington by Lawrence Berkeley National Laboratory in the field of cardiovascular

vascular health diagnosis and monitoring.

The Lawrence Berkeley National Laboratory (Berkeley Lab) is synonymous with “excellence.”

• Thirteen Nobel Prizes are associated with Berkeley Lab

• Seventy lab scientists are members of the National Academy of Sciences (NAS)

• Thirteen lab scientists have won the National Medal of Science

• Eighteen lab engineers have been elected to the National Academy of Engineering

• Three scientists have been elected into the Institute of Medicine (IOM)


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HeartSentry U.S. Market Approval is Fast Tracked

HEARTSENTRY is an FDA regulated product that uses the expedited 510(k) premarket approval process

HeartSentry FDA Classification:• Class: II• Panel: Cardiovascular

Likely HeartSentry Predicates

• Itamar Medical EndoPat 2000

• iHealth Wireless Blood Pressure Monitor

International market approvals are also being pursued.

The 510(k) process demonstrates to the FDA that the device to be marketed is as safe and effective, and is substantially equivalent (SE) to an existing legally marketed predicate device


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• Blood pressure monitor market forecast to exceed $2.6 billion by 2020

• Historical CAGR of 6.53% from 2012 to 2016

• Increasing prevalence of high and low blood pressure issues in patients

• Market is fragmented and commoditized

• Acquirers seeking high value differentiated features for premium product offerings

Robust Market Scope and Dynamics

Stats: Global Industry Analysts, Inc.

• HeartSentry initially targeted at the

clinic based professional market, with

the intention to market direct to

consumer pending FDA approval

• Endothelial function monitoring will

increase the demand for high value

connected cardiovascular monitoring

devices

• HeartSentry is marketable both as a

capital investment as well as a pay per

use model

• Potential reimbursement offers revenue

sharing opportunities with clinics


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Healthcare Industry is Rapidly Evolving into Personal Health Management

Nokia/Withings, Apple, FitBit, Google: All are creating

integrated and exclusive health platforms and devices

Tens of millions of personal health devices sold annually:

Multi billion dollar growing market

Endothelial function measurement for cardiovascular

disease prediction is a vital missing portfolio component


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Connected Biosensing is the Future of Medicine

iRhythm Technologies (NASDAQ:IRTC)

Founded in 2005 by physicians and

engineers to remotely measure and

diagnose cardiac arrhythmias

Cloud connected wearable biosensing

technology is both device and service

Initially targeted at the professional

marketplace

IPO in Oct 2016

Current Market Cap (1/18): US$1.4B


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Lexington Has a Broad Spectrum of Potential Partners

Traditional Medtech Information Technology


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Eric Willis, Chief Executive Officer

Mr. Willis is an entrepreneurial healthcare technology executive with a track record of success inbringing products from initial concept to market. He is the past President and Chief OperatingOfficer of ParaPatch (2013–2015), where he was responsible for the development and launch of anover-the-counter women’s health product for the treatment of urinary incontinence. Prior to this,he served as President and CEO of InSite Medical Technologies (2008–2013) a venture backedstart-up medical device company that developed a new method for performing epiduralanesthesia. From 1994–2008 he served in a variety of executive and operational roles forcardiovascular medical device companies.

Nick Furber, Chief Financial Officer

Nick Furber is a Chartered Accountant (US) and Chartered Financial Analyst who is currently theprincipal of NJF Consulting offering financial services growing public companies. Previously Nickhas over 10 years experience as Chief Financial Officer of a producing gold corporation listed onthe TSX and prior to which over 10 years accounting, Mergers & Acquisitions, valuation and duediligence experience gained in a variety of industries working for PricewaterhouseCoopers.

Nancy Lince, Regulatory and Clinical Advisor

Nancy has over 25 years of experience in regulatory, clinical and quality affairs for medicalproducts. Nancy has written or overseen over 200 submissions, has conducted extensivenegotiations with FDA and International regulatory agencies, and developed regulatory strategiesresulting in significant cost savings and decreased time to market.

Scott Bluni - General Counsel, Intellectual Property

Scott Bluni is a Senior Principal with the firm Kacvinsky Daisak Bluni. His practice includes patentportfolio management and strategic counseling, licensing, product clearance, prosecution, dealdiligence and litigation. Previously, Scott was vice president and cardiovascular chief patentcounsel at Boston Scientific Corporation, a major global medical device company. Scott began hislegal career as a patent examiner with the United States Patent and Trademark Office whileattending evening law school, after which he was an associate at Kenyon & Kenyon, anintellectual property boutique, in Washington, D.C.

Executive Leadership


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Jonathan Maltz, Ph.D., Chief Scientific Advisor

Dr. Maltz, received his PhD degree in Electrical Engineering from the University of California atBerkeley, and has over 16 years of experience designing new devices for assessing vascularfunction and evaluating these on human subjects. Dr Maltz is author of over 25 peer-reviewedpublications, and holds 18 granted US patents.

Jeffrey Olgin, M.D., Medical Advisor

Dr. Jeffrey Olgin, a cardiologist and electrophysiologist, is co-director of the UCSF Heart and

Vascular Center and chief of Cardiology. A specialist in the treatment of arrhythmias, he has

developed treatment techniques for irregular heartbeats and founded the UCSF Atrial Arrhythmia

Clinic that provides comprehensive patient care and studies genetic links in atrial fibrillation.

Greg Robertson, M.D., Medical Advisor

Dr. Greg Robertson is chief of the Emory Heart and Vascular Clinic at Johns Creek. At the Emory

Johns Creek Hospital he is chief of cardiology and the medical director of the cardiac

catheterization laboratory and interventional program. He is board certified in Vascular Medicine,

Endovascular Medicine, Interventional Cardiology and Cardiovascular Medicine. He is an associate

professor of medicine at Emory University. Dr. Robertson’s clinical expertise has focused on

preventative care and using minimally-invasive vascular and cardiac treatment.

James Wall, M.D., Medical Advisor

Dr. James Wall is a practicing Pediatric Surgeon at Stanford University. He is an alumnus of theStanford Biodesign program and holds a Master's degree in Bioengineering. His current researchinterest is in the design, development and analysis of health technology as well as the emergingfield of surgical endoscopy. James currently leads the surgical endoscopy program at LucilePackard Children’s Hospital and is the Assistant Director of the Biodesign Innovation Fellowshipfor Stanford Biodesign.

Scientific Advisors


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Doug Janzen, Chairman

Mr. Janzen has 20 years of experience in life sciences with leadership experience in corporatefinance, business development, and operational management of life sciences companies. Mr.Janzen is currently Co-Founder and Managing Director of Northview Ventures. He serves asChairman and CEO of Aequus Pharmaceuticals (AQS-TSXV), a company that was founded withinNorthview. Prior to Northview Ventures, he was President and CEO of Cardiome Pharma (NASDAQ:CRME) During this time he raised over $300 million from investors, completed over $1 billion inlicensing deals, and led a partnership with Merck to bring Cardiome’s lead product, Brinavess,through to clinical approval and marketing in Europe.

Rocco Rossi, Director

A successful entrepreneur and business executive, champion fundraiser, and dedicated publicservant, Rocco Rossi is currently President and CEO of Prostate Cancer Canada. His unique blendof experience intersects general management, philanthropy, public policy, politics, businessstrategy, and new media. As CEO of the Heart and Stroke Foundation – one of Canada’s largestnon-profit organizations – from 2004 to 2009, Rossi oversaw four consecutive years of recordfundraising raising over $500 million in total and launching many new, life-saving initiatives.

Bryan Disher, Director, Audit Committee Chair

Mr. Disher (CPA, CA) spent 38 years with PricewaterhouseCoopers in Canada, Australia andUkraine. He was admitted to partnership in PwC Canada in 1991 and from 2011 until hisretirement in June 2015 was a partner with PwC Central and Eastern Europe, where he served asboth Managing Partner of its 400+ person Ukrainian practice and leader of its Ukrainian audit andassurance group.

Donald A. McInnes, Board Advisor

Mr. McInnes is a co-founder and principal at Oxygen Capital Corporation, where he applies hisover twenty years’ experience building companies from the ground up. He serves as Chairman ofthe Clean Energy Association of British Columbia and is a director of Prostate Cancer Canada, theDuke of Edinburgh’s Award-British Columbia and Yukon Division and is a Governor of the BritishColumbia Business Council.

Board of Directors


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Capitalization

Issuer: Lexington Biosciences Inc.

Security: Common Shares

Symbol(s): CSE: LNB│OTCQB: LXGTF

Issued & Outstanding: 37,853,401

Reserved for Issuance: 3,227,400

Options: 1,800,000

Warrants: 1,427,400

Financial Snapshot

End Q3 17 Cash on hand: CDN$480,000

Warrant exercises Q4 2017 CDN$1.65M

Lexington Capitalization and Financials


Milestones and Operating Plan2017

2018

2019

a. Develop 1st generation

product for

distribution into

clinical studies.

b. Define regulatory &

clinical data strategy

for market approval.

c. Establish Scientific

Advisory Board.

d. Create 1st gen. clinical

data demonstrating

correlation to results

obtained by competing

technologies.

e. Create clinical data to

support product FDA

approval.

f. Begin initiatives to

support insurance

reimbursement.

f. Obtain full US

market approval

for HeartSentry

measurement.

g. Product

development

advances toward

industrial design,

consumer and

commercial

strategies.

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HeartSentry Enables Core Cardiovascular Health Monitoring

• HeartSentry is a simple non-invasive

way to measure a patient’s core

cardiovascular system health.

• A large market already exists for

cardiovascular monitoring products.

• Fast growing demand for personalized

health measurement.

• Generated data integrates into broader

“big data” health IT initiatives for

clinicians and insurers.

Proposed design

Similar in look to a typical

blood pressure cuff,

HEARTSENTRY represents

a major leap forward in

cardiac health monitoring


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• Lexington BioSciences (CSE: LNB) (OTCQB: LXGTF) has developed the HeartSentry.

• HeartSentry measures the health of the endothelium – the critical inner lining of a person’s cardiovascular system which protects arteries from disease.

• The core research and IP portfolio has been exclusively licensed to the company.

• Lexington is beginning clinical studies for FDA approval.

• The cardiovascular diagnostic market is growing fast and evolving into personalized medicine.

• Our goal is to make HeartSentry the standard of care for cardiologists, general practitioners, and ultimately patients first line evaluation of cardiovascular health.

• We seek the participation of dedicated stakeholders and committed partners who share our vision of the future of cardiovascular personalized medicine.

Company Summary

http://thecse.com/en/listings/life-sciences/lexington-biosciences-inchttps://www.otcmarkets.com/stock/LXGTF/quotehttps://lexingtonbiosciences.com/our-solution/technology/https://lexingtonbiosciences.com/the-need/endothelial-function/

Lexington BioSciences, Inc.

Contact

+1 (800) 320-2640

[email protected]

CSE: LNB│OTCQB: LXGTF
mailto:[email protected]

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Revolutionary Monitoring Technology for Vascular Healthlexingtonbiosciences.com/.../02/Lexington-Roadshow-Presentation-2.… · This presentation was prepared to assist interested