a precision medicines3.amazonaws.com/jujama.usercontent/ae1ed94c-cc67... · annual drug cost...
TRANSCRIPT
Window into the BrainTM
A Precision Medicine Neuro Diagnostic Company
Nondiscretionary Healthcare Spending
Neurodegenerative Diseases Account for
.
The Business Model
No Simple Blood Tests for Brain Diseases
....the unmet need
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
MSDx Initial Focus
Multiple Sclerosis
2.5 M WW
Parkinson’s Diseases
6 M WW
Annual Drug Cost $18,000-$70,000
The Unmet Need in Multiple Sclerosis
An Innovative Biomarker Approach
WINDOW INTO THE BRAINTM
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
MSDx Complex-1
indicating leukocyte
trafficking during disease & repair
Second MSDx Issued Patent
US 8,673,309 B2
MSDx Complex-1
MSDx Complex-1
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-
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
.
MSDx Complex-1 Clinical Data
Composition
Tested in Multiple Brain
Diseases
Tested in
7 of 10
FDA Drugs
Before & After Therapy in 3
Drugs
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
Pathway to Revenue
Institutions & Pharma Companies
Conducting Drug Trials
Neurologist & Patient
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
.
Service Business Model
CLIA Revenue
Product Revenue
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
.
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
.
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
.
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
.
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
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
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
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
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
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
Questions
.
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.
.
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
.
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.