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Window into the Brain TM A Precision Medicine Neuro Diagnostic Company

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Page 1: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis

Window into the BrainTM

A Precision Medicine Neuro Diagnostic Company

Page 2: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis
Page 3: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis

Nondiscretionary Healthcare Spending

Neurodegenerative Diseases Account for

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The Business Model

No Simple Blood Tests for Brain Diseases

....the unmet need

Page 5: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis

The MSDx Opportunity

Attractive Life Science Deal Active Segment with Viable Exits

Personalized Medicine Solution for Brain Diseases Large Market with Strong Growth

Innovative Technology- Window into the BrainTM Robust Platform for Neurodegeneration

Robust Business Model- Clinical & Pharma CLIA Service, Product, & License

Page 6: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis

MSDx Initial Focus

Multiple Sclerosis

2.5 M WW

Parkinson’s Diseases

6 M WW

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Annual Drug Cost $18,000-$70,000

The Unmet Need in Multiple Sclerosis

Page 8: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis
Page 9: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis
Page 10: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis

An Innovative Biomarker Approach

WINDOW INTO THE BRAINTM

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WINDOW INTO THE BRAINTM Neuromelanin

Tau Hippocalcin 1

UCHL-1 MBP

First MSDx Issued Patent US 8,506,933 B2

This Debris is

Information Rich

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MSDx Complex-1

indicating leukocyte

trafficking during disease & repair

Second MSDx Issued Patent

US 8,673,309 B2

MSDx Complex-1

MSDx Complex-1

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A Blood Sample is Drawn and Analyzed for the MSDx Biomarkers

MSDx Complex‐1

PBMC – WINDOW INTO THE BRAIN ™ Myelin Basic Protein

Tau Hippocalcin 1 like 1

Neuromelanin UCHL1-

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771 Subjects,

1129 Samples

17 Studies

1175 Samples

815 Subjects

MS Human (755)

MS Animal

(80)

Parkinson Human

(20)

Parkinson Animal (117)

Alzheimer

Human

(7)

Other CNS and Controls

(195)

BARROW Neurological

Institute

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MSDx Complex-1 Clinical Data

Composition

Tested in Multiple Brain

Diseases

Tested in

7 of 10

FDA Drugs

Before & After Therapy in 3

Drugs

Page 16: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis

MSDx Intellectual Property Progress First Two US Patent Issued

European Notification of Intention to Grant

Provisional Filings

Non-Provisional

Filings

International Filings

Office Actions Issued Patent USPTO

European Notification of

Intention to Grant

MSDx Complex 1

US

8,506,933

Window Into

The Brain

US

8,673,309

XX

Algorithm

Page 17: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis

Pathway to Revenue

Institutions & Pharma Companies

Conducting Drug Trials

Neurologist & Patient

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Clinical Drug Development

Biomarkers Provide:

Tools for monitoring therapeutic effect, progression, early detection,

and differential diagnosis

Tools for pharmaco-dynamic monitoring of drug therapy.

MSD Business Model

Offer MSDx Panel from a CLIA Lab and sell FDA Product Kits

Offer MSDx Biomarkers for use in Pre-Clinical & Clinical Studies

Target: Neurologist, Trauma, Motor Disorder Reference Labs US, Canada, Europe

R & D Scientists, Pharmaceutical Companies, and

Clinical Researchers.

Pathway to Revenue

Clinical & Drug Development

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Service Business Model

CLIA Revenue

Product Revenue

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Launch of the MSDx Blood Test

Converting the MSDx Research Use Only (RUO) Assays to A Laboratory Developed Test (LDT)

Launch the MSDx Blood Test Utilizing a CLIA Certified

Laboratory

License MSDx Technology to Diagnostics Equipment Manufacturer

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MSDx Team

Marie Wesselhoft – President (Co-Founder) Humana, Baxter, Cardinal Health, Misys, Arizona Center for Innovation

University of Wisconsin, University of Chicago, University of Arizona

Ramesh Nayak, PhD.– Director of Research Queens Square London, Harvard Medical School,

Tufts College of Medicine, Joslin Diabetes Center, University of Arizona

Melita Ball – Director of Regulatory & Quality Third Wave Technologies, Ventana Medical Systems, ALARIS

George Washington University, Bridgewater College

Betty Weaver, CPA – Controller The Bourne Group, Tubac Real Estate

Vanessa White – Research Associate Univ. of Wisconsin, Electrical Engineering, Astronautics Co., Dedicated Computing

Univ. of Arizona, Professional Science Masters

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MSDx Board of Directors

Conrad Plimpton-Chairman Inolex Chemical,

McKinsey

Mike Sember- Vice Chairman

Élan Corporation,

Acorda

David McCaleb CV Therapeutics,

Amgen, Merck

Marie Wesselhoft Humana, Baxter,

Cardinal Health

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MSDx Advisors and Partners

Dan Martens, CEO MISIX, Data-Driven Marketing

Larry Hecker, Esq. Hecker & Muehlebach P.L.L.C.

Timothy L Vollmer, MD University of Colorado Denver

David Stumpf, MD. PhD Past Chairman of Neurology,

Northwestern, Informaticist

Grant Senner, MD Sentinel Reimbursement

Consulting Group

Uwe Muller, PhD Assay Development, Banyon

Nanosphere, Corning, Vysis

Quan L. Nguyen, Esq., Nguyen & Tarbet Intellectual Property Law

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MSDx Clinical & Technical Timeline

MJ Fox Parkinson’s Round 2 Animal

MS Study UC Denver

MS Progressive - Innate Immuno Inc. Treatment Study

2nd Generation Assay Development

Validated LDT Assay Development CLIA

MS ACP Opt-up 5 Years

TBI Feasibility Study

Human Alzheimer's Study

2015 Q3

2015 Q4

2016 Q1

2016 Q2

2016 Q3

2016 Q4

2017 Q1

2017 Q2

Commercial Launch

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MSDx A-3 Current Offering

Convertible Preferred Stock

$750,000 Round

– Offering A-3 Convertible Preferred Stock

– Pre-Money Value today $3.7 million

– Share Price of $0.67

– Milestone: Laboratory Developed Test (LDT)

– Investors- Desert Angels, Mergelane, & Pipeline

Invested Committed Remaining

$480,000 $20,000 $250,000

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MSDx Capital Requirements

and Milestones

2016 2017 2018 2019

SERIES A3

$750,000

CLINICAL STUDIES

US LAUNCH

FDA 510k filing

CANADA, EUROPE

PRODUCT

LICENSE

COMMERCIALIZATION ROUND

$3-4 MILLION

FINALIZE NEXT GENERATION

BLOOD TEST

2020

GROWTH ROUND

$4 MILLION

Page 27: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis

MSDx Target Exits

Multiples of 5-13 times Revenue

Drug Companies

Roche

Novartis

Reference Labs

Quest

LCA

ARUP

Diagnostic Companies

Abbott

Roche

GE

Myriad

Active Exit Market

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MSDx: At a Glance

Investors Collaborators

Funding Clinical Studies

Founder & Individual

Angels (AZ, IL)

Multiple Sclerosis

Relapse & MRI

Multiple Sclerosis

Progressive Therapy

Multiple Sclerosis

Opt-Up

Alzheimer’s

Human 2a

Traumatic Brain Injury

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Why MSDx?

• Significant Unmet Market need

• Personalized Medicine -Healthcare quality and cost

• Innovative Platform Technology for Expansion

• Proven Business Model

• Team with Healthcare Expertise that delivers

• Strong Intellectual Property

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Questions

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MSDx Inc. Highlights

• Precision Medicine Solution in Brain Diseases including Multiple Sclerosis, Parkinson’s, and other neurodegenerative diseases

• Innovative MSDx blood-based biomarker platform leverages across multiple diseases.

• These products provide the neurologists with critical data that can be useful in diagnosis, monitoring, and assessing therapeutic response.

• Initially the company will target pharmaceutical companies working on drug discovery and clinical trials in this CNS market.

• We call our patented blood test panel WINDOW INTO THE BRAINTM.

• Strong IP portfolio with first two US patents issued.

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MSDx Inc. -Milestones

• The company conducted 17 Multiple Sclerosis, Parkinson’s and Alzheimer’s studies testing 1175+ samples in over 800 human and animal subjects.

• Data from cross-sectional studies demonstrates that the biomarkers are elevated in multiple neurological diseases and can detect a treatment effect in MS patients.

• Ongoing clinical studies with University of Colorado, Innate Immunotherapeutics, University of Arizona , Accelerated Cure Project.

• Business model includes revenues from CLIA products, product kits, as well as licensing to leading IVD equipment manufacturers

• Market potential in excess of $900 M. • Exit Strategy- Acquisition

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MSDx Inc. Investment Opportunity

• Total Capital to date- $2.4 M.

• Current Investor include Desert Angels (Tucson) , Pipeline Angels

(San Diego), Mergelane (Boulder), and private individuals

• Non-Dilutive funding includes MJ Fox, Flinn Foundation, Arizona

Commerce.

• Completing A3 Convertible Preferred $750,000 Angel round

• Syndication opportunity

• Beginning Commercial Round of $3-4 M.

Page 34: A Precision Medicines3.amazonaws.com/JuJaMa.UserContent/ae1ed94c-cc67... · Annual Drug Cost $18,000-$70,000 The Unmet Need in Multiple Sclerosis

www.msdx.co Marie Wesselhoft

President & Co-Founder [email protected]

1-520-907-3267