Investor Presentation

History and Partner Product Strategy
Premier Biomedical stock is traded on the OTCQB under the symbol “BIEI”
Visit us at www.premierbiomedical.com
PBI Timeline
2009 - PBI incorporated in Nevada
May 2010 –
Company formed
August 2012 –
July 2013 –
August 2014–
• Mutual Non-Disclosure
Agreement signed with
UTEP, PBI, and US Army
Clinical Investigation
Regulatory Office
(CIRO).
Cooperative Research
and Development
Agreement (CRADA)
signed with the
Department of Defense
(CIRO)
October 2014 –
University of Texas El
Paso (UTEP) begins
laboratory production
of custom monoclonal
cancer antibodies.
Feldetrex U.S.
Patent granted
2009
Dr. Felder
develops the
theories that
make the Felder
Doctrine.
Patents written
and submitted
May 2012 –
June 2013 –
PBI and University of
Texas El Paso (UTEP)
sign Collaborative
Agreement
Successful initial mouse
testing of PBI/UTEP
breast cancer treatment
© 2012-2015, Premier Biomedical Inc.
April 2014–
• Initial Mouse study
results presented to
AACR Conf.
• Duplication mouse
study initiated
May 2015–
Unique breast Cancer
antibody Provisional
Patent Filed
Premier Biomedical Co-Founders Biographies and Contact Information
William A. Hartman phone: (724) 372-5242
email: [email protected]
President and Chief Executive Officer and a member of our Board of Directors. Previously,
Mr. Hartman was the COO of NanoLogix, piloting PBI from the earliest start up stages to a
publicly listed company. Mr. Hartman has led PBI from its initial inception (2-man company)
to the fully reporting public company, with the current dedicated Board of Directors. Prior
to his time at NanoLogix, Mr. Hartman launched Greenfield automotive supplier
manufacturing facilities in Europe, Mexico, and the US with revenue in excess of $1B annual
sales. Academic credentials include a BSME degree from Youngstown State University and a
MSIA degree (Industrial Administration/Management) from the University of Michigan. Mr.
Hartman is also acting vice-president of the PBI cancer division.
Dr. Mitchell S. Felder
phone: (724) 301-1216
email: [email protected]
Chairman of the Board of Directors, Chairman of the Scientific Advisory Board. Dr.
Felder is a Board Certified Neurologist on staff at the William Beaumont Army
Medical Center (WBAMC) in El Paso, TX. Previously he founded the company
Infectech, which eventually became NanoLogix. Dr. Felder is a prolific inventor who
authored or co-authored six publications, three studies and has currently 21 issued
patents and oover 20 provisional patent applications in the area of novel
approaches to curing today’s most insidious diseases. Dr. Felder served as the
Acting Chief of the Department of Neurology at the William Beaumont Army Medical
Center in 2011.
©2013-15 Premier Biomedical, Inc.
The Felder Doctrine
TM
Physical removal of the
pathophysiologic basis
of the disease.
7/26/2013
© 2013, Premier Biomedical, Inc.
4
Additive vs. Subtractive
According to the World Health Organization (WHO) chronic diseases,
such as heart disease, stroke, cancer, chronic respiratory diseases
and diabetes, are by far the leading cause of mortality in the world,
representing 63% of all deaths out of the 36 million people who died
in 2008.
To date there is still no cure using
the “Additive” medicine method!
Premier’s approach is “Subtractive”.
© 2013-15, Premier Biomedical, Inc.
5
Sequential Dialysis
Sequential-Dialysis Technique is a methodology for the removal of molecules which are
harmful and responsible for causing diseases.
– Extracorporeal (outside the body) process to prevent the severe side effects
which are normally encountered with other treatments
– The methodology can be used for:
• The treatment of cancer and prevention of metastasis
• Reducing the effects of Traumatic Brain Injuries
• Eliminating the neuropathological changes created by Alzheimer's Disease.
• Preventing the death of anterior motor neurons in ALS
• Eradicating the causations of Infectious Diseases ,e.g., Ebola
The methodology involved in this technique is largely unexplored and has the
opportunity to create a huge market share within a $2 trillion industry.
© 2013-15, Premier Biomedical, Inc.
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Sequential Dialysis Model
Patented method for the
removal of specific and
unique molecules utilizing
antibody antigens as a
target attraction
Smart
Sensor
Pressure
Monitor
Filtered Blood/CSF
returned to the
patient
Dialysis Unit
Patient
Smart Sensor
Mixing Chamber
PBI drug therapy
introduction canisters
Pump
Smart
Sensor
(Disease
Intensity)
Outgoing
Blood/Cerebral
Spinal Fluid
For neurological conditions (diseases or concussions) cerebrospinal brain
fluid is removed from the body and sequentially dialyzed.
© 2012-2015, Premier Biomedical Inc.
Feldetrex®
• A patented drug; PBI has exclusive license
• A unique combination of FDA approved drug
components
• Consists of low dose naltrexone, cyclobenzaprine,
cyanocobalamin (Vitamin B12), Pyridoxine
(Vitamin B6) and Coenzyme Q10 (Co Q10)
• Intended for the treatment of neuropathic pain
(fibromyalgia, neuropathy) and the symptoms of
Multiple Sclerosis.
©2012 confidential and proprietary. All
rights reserved
Feldetrex®
•
•
•
•
•
•
Naltrexone and its active metabolite 6-β-naltrexol are competitive antagonists
at μ- and κ-opioid receptors, and to a lesser extent at δ-opioid receptors.
Naltrexone reduces inflammatory auto-immune reaction.
Regular doses of low-dose naltrexone can be used to increase a patient's
endorphin and enkephalin levels.
The interaction of naltrexone with microglia cells within the central nervous
system is believed to be how the drug exerts its beneficial effects in individuals
who suffer from fibromyalgia; this interaction on microglial cells results in a
reduction of proinflammatory cytokines as well as neurotoxic superoxides.
Naltrexone has an antagonistic effect on Toll-like receptor 4 (TLR4), which are
found on microglia, which can modulate the body's response to inflammation.
Naltrexone was approved by the U.S. Food and Drug Administration (FDA) for
the treatment of opioid addiction in 1984 and for alcohol dependence in 1994.
©2012 confidential and proprietary. All
rights reserved
Feldetrex®
• Cyclobenzaprine is a muscle relaxer medication that
blocks pain sensations sent to the brain.
• Cyclobenzaprine is FDA-approved to treat muscle
spasms associated with acute, painful
musculoskeletal conditions.
©2012 confidential and proprietary. All
rights reserved
Feldetrex®
• Cyanocobalamin (B12)- frequently prescribed people suffering
from chronic fatigue syndrome and fibromyalgia. This
particular use has long been thought by many researchers to
aid in several nerve-related disorders, including multiple
sclerosis and Alzheimer’s disease.
• Pyridoxine (B6) is required for the human body to bioconvert
energy obtained from foods, the production of red blood
cells, and proper nerve function.
• Coenzyme Q10 (CoQ10) is a mitochondrial energy coupling, and
an essential part of the cellular machinery used to produce
adenosine triphosphate (ATP) to assist necessary functioning
of muscle contraction and other vital cellular functions.
©2012 confidential and proprietary. All
rights reserved
The PBI R&D Model
PBI
The tripod approach
Academia *
DOD **
Coordinate our IP with the lab services of a large research
based university (University of Texas El Paso (UTEP) $45
million lab)
Add the remarkable services of the Department of Defense
(DOD) with their large, unequalled power of advanced
model creation and clinical testing
* Collaborative Agreement signed April, 2012 with University of Texas at El Paso
** Cooperative Research and Development Agreement (CRADA) signed with the Department of Defense (DOD) July, 2013
© 2012-2015, Premier Biomedical Inc.
Currently Available Drugs/Treatments
Feldetrex® - Fibromyalgia
Description:
Market & Competition:
• Medication for treatment of
diseases with symptoms which
include nerve pain,
demylenation, muscle aches
and spasms (i.e., fibromyalgia,
MS, auto-immune, depression,
etc.)
• Lyrica ® by Pfizer
Status:
Plans/Actions:
• U.S. Patent issued 4Q14
• Initial submission to FDA 1Q15
• Guidance provided by FDA
• Conduct Clinical Trials outside
of US under ICH6 guidelines
(reciprocity)
• FDA filings for additional
treatment uses
13
– $4.7B annual sales in U.S.
– Patent expires in 2016
• Cymbalta® by Eli Lilly
– U.S. Patent expired end of 2013
– $3.9 B annual U.S. sales in 2013
• Savella® by Actavis (Forrest Labs)
© 2015, Premier Biomedical, Inc.
Currently Available Drugs/Treatments
Multiple Sclerosis (MS)
Description:
Market & Competition:
• Medication for treatment of
diseases with symptoms which
include nerve pain,
demylenation, muscle aches
and spasms (i.e., fibromyalgia,
MS, auto-immune, depression,
etc.)
• Affects 400,000 people in the
U.S.
• No cure; only symptom mgmt.
• Numerous symptom treatments
• $20B annual drug treatment
expenditures in U.S. (2014 est.)
Status:
Plans/Actions:
• Potential extension of
Feldetrex® applications under
development
• U.S. Patent issued 4Q14
• Submission to FDA in 2015 for
treatment of MS
• Clinical trials to be conducted
outside of US.
14
© 2015, Premier Biomedical, Inc.
Drugs/Treatments Under Development
Ebola Sequential Antigen Therapy (ESAT)
Description:
Market & Competition:
• Device/Treatment for removal
of Ebola Hemorrhagic Fever
target antigens from
patient’s blood.
• No FDA approved vaccine or
medicine
• Experimental drugs used to
treat latest outbreak
– ZMapp (Mapp Biopharmaceuticals)
– TKM-Ebola (Tekmira Pharm. Corp.)
Status:
Plans/Actions:
•
•
•
•
• Conduct FDA required tests
• Refine ESAT design
• File foreign patent applications
15
Provisional Patent filed 4Q14
FDA submission 4Q14
FDA testing roadmap defined
ESAT Device Prototyped
© 2015, Premier Biomedical, Inc.
Drugs/Treatments Under Development
Duchenne Muscular Dystrophy (DMD)
Description:
Market & Competition:
• Device/Treatment for removal
of target disease antigens
from patient’s blood.
• No known cure
• Treatment costs exceed $23B
Status:
Plans/Actions:
• Rare Disease designation
received from FDA
• U.S. Patent Application
submitted 3Q14
• Prove Safety
• Refine ESAT design
• File foreign patent applications
16
– 1M cases worldwide
– Less than 4,000 new cases per
year in U.S.
© 2015, Premier Biomedical, Inc.
Drugs/Treatments Under Development
Neurofibromatosis (NF)
Description:
Market & Competition:
• Device/Treatment for removal
of disease target antigens
from patient’s blood.
• No treatments to stop tumor
growth
• Affects 100,000 in the U.S.
Status:
Plans/Actions:
• U.S. Patent Application
submitted 3Q14
• Awaiting Rare Disease
designation from FDA
• Prove Safety
• Refine ESAT design
• File foreign patent applications
17
© 2015, Premier Biomedical, Inc.
Drugs/Treatments Under Development
Multiple Cancer Types
Description:
Market & Competition:
• Metronomic anti-CTLA-4
treatment in conjunction
with sequential dialysis
therapy
• ~$20B annual treatment costs
• Kadcyla®; Roche
– Full treatment course - $94,000
• Herceptin®; Roche
– $6B in annual sales
• Numerous other drugs to
prolong life.
Status:
Plans/Actions:
• Duplicated mouse testing
success presented to AACR
Conference, April, 2014
• U.S. Provisional Patent Apps
filed 2Q14 and May-15
• Improved anti-CTLA-4/PD-1/
BTLA drug under development
• FDA Application in 2015
18
© 2015, Premier Biomedical, Inc.
Drugs/Treatments Under Development
Atherosclerosis
Description:
Market & Competition:
• Target antigen antibodies in
conjunction with sequential
dialysis therapy
• Currently no cure
• Leading cause of death in U.S.
– 4.6M people in U.S. actively
treating disease
– Est. 50% (est.) of population
affected
• Most prescribed drug treatments
– Crestor® (AZ); $5.6B sales (WW)
– Merck products - $4.6B sales
– Lipitor®, Plavix® et.al off-patent
Status:
Plans/Actions:
• Filed for U.S. Patent 2Q14
• File Supplemental FDA
submission after ESAT
approval.
19
© 2015, Premier Biomedical, Inc.
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© 2015, Premier Biomedical, Inc.
Table of Contents
1. EXECUTIVE SUMMARY
3. THE PREFESEABILITY STUDY
1.1 Brazil Core Views
1.2 Brazil Political Analysis
1.3 Long Term Political Outlook
1.4 Local Opportunities & Key Risks
1.5 Local Opportunities For PBI
1.6 Economic Brazil Healthcare SWOT Analysis
1.7 Exchange Rates Perspectives
1.8 Fiscal Policy And Federal Incentive
Programs
1.9 Customs: How To Import Into Brazil
1.10 Brazil Regulatory Health Agencies:
1.11 Brazil Healthcare Market Overview
3.1 PBI Startup In Brazil And South America
Countries
3.2 Pbi Brazil/Latam Work Plan
3.3 Key Success Factors For PBI Start Up
3.4 Priorities And South America Pipeline To
Ramp Up Sales
4. MARKETING STRATEGY
5. PRICING STRATEGY
6. COMPETITION ANALYSIS
7. CONSIDERATION OF M&A AND
PARTNERSHIP OPPORTUNITES
2. MARKET ASSESSMENT
2.1 PBI Products & Treatments – Opportunities
In Brazil
2.2 Doing Business In Brazil – Fiscal & Market
Model
2.3 Technical Assumptions From PBI Global
Strategy Info
21
© 2015, Premier Biomedical, Inc.
Some Key Advantages for Brazil
• Brazil - seventh largest economy in the world (GDP); fifth by
population.
• Since 2003, some 36 million people have risen out of poverty
and joined the ranks of middle class.
• Demographic trends appear favorable; median age 30.7 years.
• Brazil’s unemployment rate below 5% (2014), an historical low.
• Diverse economy with a wide range of natural resources.
• Education a top priority; literacy rate is above 90%.
• 406,000 physicians in Brazil + 16,000 new/year
• 5,565 cities & >7,000 hospitals & 1,100 HMOs
• 5% of GDP invested at Public Health Sector
• 16 million over 60 years will be 30 millions in 2025
• Demographic Bonus on the next 20 years
22
© 2015, Premier Biomedical, Inc.
Some Key Risks for Brazil
• Inflation rate that was under control in the last 20 years appears
like the big challenger at the new economic scenario for 2015 &
2016
• The new international scenario linked to USA economic
momentum are pushing dollar rate over R$ 3,00 per dollar and
the expectation is close 2015 around R$ 3,5 per dollar.
• To manage the public budget deficit the Federal Government is
announcing cuts at federal programs that could affect the social
area like healthcare at public sector
• Patents protection related to pharmaceutical products could be
a issued In Brazil considering the historical approach to push
compulsory licenses to reduce drugs cost and several discussion
at public sector regarding public interest priority.
23
© 2015, Premier Biomedical, Inc.
Local Opportunities for PBI
Orphan Drugs
• Incidence rate of < 65 patients / 100,000
• Congressional Bill being examined by Brazil
Economic Affairs Committee
• Legislation would
– Allow importation of Orphan Drugs without
ANVISA pre-approval
– Streamline ANVISA approval process
24
© 2015, Premier Biomedical, Inc.
Brazil Market Assessment
• Alzheimer’s Disease
– 1.2 M Affected in Brazil
– Increasing to over 2.5 M by 2025 and 4 M by 2050
• Amyotrophic Lateral Sclerosis (ALS)
– 12,000 patients in 2015 (est.)
• Blood Sepsis and Viremia
– High potential for treatments supported by Public
Health Campaigns
25
© 2015, Premier Biomedical, Inc.
Brazil Market Assessment
• Cancer
– Breast Cancer is most common
– 115,000 new cases in Latin America each year
– 50,000 of these in Brazil
• Fibromyalgia
– 6 M Fibromyalgia patients in Brazil
– 25 M patients affected with chronic pain (12% of
population
26
© 2015, Premier Biomedical, Inc.
Brazil Market Assessment
• Multiple Sclerosis (MS)
– Approx. 36,000 patients in Brazil
• Traumatic Brain Injury
– Will surpass many diseases by 2020
– Affects 150 – 170 per 100,000 people
– 300,000 in Brazil
27
© 2015, Premier Biomedical, Inc.
Brazilian Work Plan
28
© 2015, Premier Biomedical, Inc.
Key Success Factors
29
© 2015, Premier Biomedical, Inc.
Priorities & Ramp Up
30
© 2015, Premier Biomedical, Inc.
Business Plan Strategy
• Manufacture and Market Feldetrex®
• Build patentable Sequential Dialysis machines.
• Build patentable antigen-dispersing canisters into
the Sequential DialysisTM Machine.
• Lease Machines at cost to Hospitals and
Treatment Centers to reduce entry barrier.
• Train technicians (for 2-days) at cost.
• Manufacture antigen cartridges and ship
overnight to Hospitals and Treatment Centers.
©2015 Premier Biomedical, Inc.
Brazil Market Introduction
2015
2016
2017
32
• Feldetrex® - Fibromyalgia & MS
• Sequential Antigen Therapy – Duchenne
Muscular Dystrophy; Neurofibromatosis
• Proprietary Breast Cancer Antibody
• Amyotrophic Lateral Sclerosis (ALS)
• Atherosclerosis, Blood Sepsis, et. al.
© 2015, Premier Biomedical, Inc.
Product Launch & Revenue Projections
Country
HUD
+Cancer
+Feldetrex
+Sequential
Dialysis
Full
Portfolio
Private
Market
Full
Portfolio
Private &
Public
Market
2015
2016
2017
2018
2019
2020
Brazil
$ 100 K
$3M
$ 25 M
$ 75 M
$ 125 M
$ 250 M
S. America
Countries
$ 100 K
$3M
$ 25 M
$ 50 M
$ 75 M
$ 150 M
Total
South
America
$ 200 K
$6M
$ 50 M
$ 125 M
$ 200 M
$ 400 M
33
© 2015, Premier Biomedical, Inc.
Market Expansion Plan
2015
Brazil
South America
Central America
Asia
Europe
North America
34
© 2015, Premier Biomedical, Inc.
A World Leader in New Biomedical
Technology Research & Development
William A. Hartman
President & CEO
Phone: (01)-814-786-8849
Visit us at www.premierbiomedical.com
35
© 2015, Premier Biomedical, Inc.