2. OTCQB:BTHE
Safe Harbor
2
This presentation contains "forward-looking statements" within the meaning of the
“safe-harbor” provisions of the private securities litigation reform act of 1995.
Such statements involve known and unknown risks, uncertainties and other
factors that could cause the actual results of the Company to differ materially from
the results expressed or implied by such statements, including changes from
anticipated levels of revenues, future national or regional economic and
competitive conditions, difficulties in developing the Company’s technology
platforms, retaining and expanding the Company’s customer base, fluctuations in
consumer spending on the Company’s products and other factors. Accordingly,
although the Company believes that the expectations reflected in such forward-
looking statements are reasonable, there can be no assurance that such
expectations will prove to be correct. The Company has no obligation to update
the forward-looking information contained in this presentation.
3. OTCQB:BTHE
Boston Therapeutics is an innovative
developer of novel compounds based on
complex carbohydrate chemistry for the
treatment of diabetes and inflammatory
disease.
3
4. OTCQB:BTHE
Key Investment Highlights
4
• Raised $5.8 million in 2013 to support product near-term drug portfolio
• BTI-320 (formerly PAZ-320) non-systemic diabetes drug
– Addressable diabetes drug market $35 billion
– Phase IIa clinical trial completed and published: 45% reduction in 40% of patients
– Conducting two Phase llb clinical trials in U.S. & France
– Preparing IND submission to the FDA to conduct Phase III clinical trial
• IPOXYN anti-necrosis, anti-hypoxia drug
– $30 billion market: No current approved therapies for major unmet medical need
• OXYFEX veterinary oxygen: $200 million U.S. market
• Strong IP portfolio for injectable and oral drug agents
• Team with expertise in clinical development and regulatory affairs
5. OTCQB:BTHE
Complex Carbohydrate Chemistry Platform
• Growing interest in carbohydrates in drug design
– Plays fundamental role in normal cell functions
– Participates in cell-cell interactions
• David Platt, Ph.D. is an expert and pioneer in
the use of galactomannan in drug design
– Holder of more than ten patents
• Co-editor of Carbohydrate Drug Design
– Influential volume in the design of drugs using complex carbohydrates
• Founder & CEO of three publicly traded companies:
– International Gene Group / SafeScience (Nasdaq:SAFS) - Cancer
– Pro-Pharmaceuticals now Galectin Therapeutics (Nasdaq: GALT) - Liver /cancer
– Boston Therapeutics (OTCQB: BTHE) - Diabetes
5
6. OTCQB:BTHE
Team Background
David Platt,
Ph.D.
Chairman & CEO,
Founder
• Expert in carbohydrate chemistry
• Led development of two drug candidates from concept through phase II clinical trials
• Founder, former CEO & Chairman of Pro-Pharmaceuticals (AMEX: PRW); Safe Science
(Nasdaq: SAFS); International Gene Group (Nasdaq: IGGI)
• Developed or co-developed core technology of three publicly traded companies: Galectin
Therapeutics (Nasdaq: GALT), LaJolla Pharmaceuticals (OTC: LJPC) & BTHE
Benjamin Rivnay,
Ph.D.
Chief Scientist
• Director of R&D at Formatech; Managed 50+ projects on formulation development
• Vice President, R&D and Lab Director at Repromedix: Introduced over 50 new test products
• Senior Investigator and Program Leader at Procept: Initiated and led R&D programs
• Senior Scientist at Neurex Corporation
• Associate Professor of Biochemistry
• Ph.D., Biochemistry, Weizmann Institute of Science; B.Sc., Biology, Tel Aviv University
Anthony Squeglia,
MBA
Chief Financial Officer
• Former CFO for Pro-Pharmaceuticals and Galectin Therapeutics; VP Investor Relations
• Senior management positions at AT&T, ITT, Unisys, and Colonial Penn
• BBA, The Wharton School; MBA, Pepperdine
Tomasz Zastawny,
Ph.D., DSc., MSc.
Clinical Consultant
• President/CEO ECRC/MTZ U.S. Clinical Research
• Director Clinical Operation, Infinity Pharmaceuticals
• Clinical Trials Director, Pro-Pharmaceuticals
• Director Clinical Operations, PRA International
• Ph.D., Medical Sciences, University of Medical Sciences, Poland
Management Team
6
7. OTCQB:BTHE
Board of Directors
7
Team Background
Dale H. Conaway,
DVM
Director since 2009
• Chief Veterinary Medical Officer for the Office of Research Oversight
• Served as Manager of the Equine Drug Testing and Animal Disease Surveillance Labs for the Michigan
Department of Agriculture; Former Regulatory Affairs Mgr for the Michigan Department of Public Health
• Former director of Pro-Pharmaceuticals
Rom E. Eliaz,
Ph.D., MBA
Director since 2009
• VP, Innovative Project Leadership, Branded Products and Global R&D at Teva Pharmaceuticals
• President and CEO of JJ Pharma Inc., CEO and Managing Director of Elrom Ventures
• Former Sr. Director of Development at Intradigm & Director of Development at Pfizer (Rinat Neuroscience).
• Held management positions at Alza; managed its portfolio companies, led to market blockbuster drugs
• (Co)author of more than 40 publications mostly in the field of drug targeting & delivery and gene therapy
Henry J. Esber,
Ph.D.
Director since 2011
• Principal in Esber D&D consulting; Former Sr. Consultant, Business Development at Charles River Labs
• Former Senior Vice President and Chief Business Officer for Bio-Quant
• Former director of Apricus Biosciences and Pro-Pharmaceuticals
• Serves on the SAB of several biotech companies and is the author of more than 130 technical publications
S. Colin Neill
Director since 2013
• Former President and CFO of Pharmos Corporation
• Served as CFO, Treasurer and Secretary of Axonyx
• Former Senior Vice President, CFO, Secretary and Treasurer of ClinTrials Research
• Served on the boards of Pro-Pharmaceuticals, Galectin Therapeutics and OXIS International
Conroy Chi-Heng
Cheng
Director since 2013
• Director of Advance Pharmaceutical Company, in Hong Kong, the Asian licensee of sugardown®
• Executive Director of the Board of Directors of New World Development, Hong Kong
• Executive Director of Chow Tai Fook Jewelry Group; non-executive director of China Huishan Dairy
• Director of Chow Tai Fook (Holdings) Limited and Chow Ti Fook Enterprises Limited.
Jan Brinkman,
M.D., Ph.D.
Director since 2014
• Served as a member of the Biotechnology Business Strategies Committee with ABN-Amro Bank N.V. in
London, New York and Hong Kong, reconciling global regulatory affairs.
• Focused his financial expertise in biotech, becoming ABM-Amro’s liaison to Motorola Biochip, Harvard
Medical, Merck, Serono, Teva, Bayer, Philips, Siemens, M.I.T. and the Mayo Foundation.
Alan M. Hoberman,
Ph.D.
Director since 2014
• President and CEO of Argus International, Inc., overseeing a staff of scientists and other professionals who
provide consulting services in the U.S. and internationally
• Held a series of positions at Charles River Laboratories Preclinical Services most recently as Executive
Director of Site Operations and Toxicology. He currently works with that organization to design, supervise
and evaluate reproductive and developmental toxicity, neurotoxicity, inhalation and photobiology studies
8. OTCQB:BTHE
Medical & Scientific Advisory Board
8
Team Background
Larry K. Ellingson, B.Sc.,
Pharmacy
Chairman of MAB
• Former Chairman, American Diabetes Association
• Former Executive Director, Diabetes Care at Eli Lilly for 30 years
• Former chair of the board of Protemix Ltd.,
• B.Sc., Pharmacy, North Dakota State University, M.B.A., Babson College
Meng Hee Tan, M.D.
Medical Director
(Consulting) & MAB
• Professor of Internal Medicine at the University of Michigan
• Member of the American Diabetes Association & American College of Endocrinology
• Author/ coauthor of 110 peer-reviewed pubs in diabetes and carbohydrate metabolism
• M.D. degree, Dalhousie University
Philip Raskin, M.D.
MAB
• Clifton and Betsy Chair in Biomedical Research and Professor of Medicine, University of Texas
• Director of University Diabetes Treatment Center at Parkland Memorial Hospital
• Editor of the Journal of Diabetes and Its Complications
• M.D. degree, University of Pittsburgh
Charles M. Clark, M.D.
MAB
• Professor Emeritus of medicine at Indiana University Medical Center
• Past President of the American Diabetes Association; Former Editor, Diabetes Care
• M.D. degree, Indiana University School of Medicine
Jaime A. Davidson, M.D.,
MAB
• Clinical Professor of Internal Medicine in the Division of Endocrinology, Touchstone Diabetes Center,
University of Texas Southwestern Medical Center
• President, WorldWIDE, non-profit diabetes foundation; Editorial Board, The Journal of Diabetes
• M.D. degree, Universidad Nacional Autonoma de Mexico
Zbigniew J. Witczak,
Ph.D., M.S., SAB
• Professor & Chair, Department of Pharmaceutical Sciences, Wilkes University, Wilkes-Barre, PA
• Member, American Chemical Society; 2011 ACS Fellow of the American Chemical Society
• Author or coauthor of more than 75 research articles in the area of carbohydrate chemistry
• Ph.D. & M.S. degrees in organic chemistry from Medical University, Lodz, Poland
David S.H. Bell, MB,
FACP, FACE, MAB
• Adjunct clinical professor of medicine at the University of Alabama at Birmingham
• Fellow of the American College of Physicians; Royal College of Physicians of Edinburgh, and the Royal
College of Physicians and Surgeons of Canada; Author or coauthor of more than 320 publications
• Member of the ADA; Editorial Boards of Diabetes Obesity and Metabolism and Endocrine Today
• MB, BCh & BAO degrees from Belfast Royal Academy and Queens University School
Hana Chen-Walden, M.D.,
MAB
• Specialized in regulatory affairs in the pharmaceutical industry in the U.S and Europe
• Thirty years of regulatory experience with EMEA and individual European countries
• Practiced medicine in France & Germany; consulted for European Clinical and Regulatory
• M.D. degree University of Tel Aviv, Israel
9. OTCQB:BTHE
Diabetes Trend: A Growing Epidemic
9
US Population with Diagnosed Diabetes Diabetes Facts (US)
• 25.8 million people with diabetes (8.3% of U.S.
population)
– 460% increase since 1980
• 79 million people considered pre-diabetic
• 1 of 3 US adults will have diabetes by 2050 if
current trends continue
• Leading cause of:
– kidney failure
– non-traumatic lower-limb amputations
– new cases of blindness
• Major cause of heart disease and stroke
• $245 Billion in Direct and Indirect Cost to US
Economy
Source: CDC Division of Diabetes Translation. National Diabetes Surveillance System and 2011 CDC Diabetes Fact Sheet
0.00
5.00
10.00
15.00
20.00
25.00
30.00
1980
1983
1986
1989
1992
1995
1998
2001
2004
2007
2010
People with
Diabetes
(millions)
% with
Diabetes
10. OTCQB:BTHE
Diabetes Growth Projections 2012-2030
10
Source: Standard & Poor’s and International Diabetes Federation Diabetes Atlas 5th Edition: 2012 Update
38.4
51.2
33%
26.4
40.0
51%
55.0
64.2
17%
34.2
59.7
75%
14.9
28.0
88%
70.3
120.9
72%
132.2
187.9
42%
2012 : 371M
2030 : 552M
Increase 49%
World
Diabetes worldwide drug market size $35 billion
Expected to grow to $58 billion by 2018
11. OTCQB:BTHE
Drug Product Pipeline
11
Product Description Indication Preclinical Phase l Phase ll Phase lll
Chewable tablet
taken prior to
meals to manage
post-meal glucose
excursion
Type 2
Diabetes
Injectable
anti-necrosis
drug
Lower-limb
ischemia in
diabetic patients
BTI-320
IPOXYN
• BTI-320 works non-systemically in the gastrointestinal tract by
inhibiting carbohydrate enzymes, reducing available sugar
• IPOXYN is an injectable anti-necrosis drug intended to treat
hypoxia, which is the lack of oxygen to living cells
12. OTCQB:BTHE
Diabetes Complications
12
Eyes
(retinopathy)
Kidney
(nephropathy)
Brain and cerebral circulation
(cerebro-vascular disease)
Heart and coronary circulation
(coronary heart disease)
Peripheral nervous system
(neuropathy)
Diabetic foot
(ulceration and amputation)
Lower limbs
(peripheral vascular
disease)
Diabetes Atlas, 3rd edition.
International Diabetes Federation
13. OTCQB:BTHE
Post-meal Glucose in Diabetes
13
•A growing body of evidence suggests that reducing post-meal plasma
glucose excursions is as important, or perhaps more important for
achieving HbA1c goals.
•The relationship between hyperglycemia and cardiovascular disease is
complex with evidence suggesting that an acute increase of glycemia,
particularly after a meal, may have a direct detrimental effect on
cardiovascular disease.
•Targeting both post-meal plasma glucose and fasting plasma
glucose is an important strategy for achieving optimal glycemic control
International Diabetes Federation
2011 Guideline for Management of Post-Meal Glucose in Diabetes
15. OTCQB:BTHE
BTI-320 (formerly PAZ320)
• Reduces post-meal plasma glucose
excursions in clinical studies
• Complex carbohydrate chemical structure
• Chewable drug taken before meals intended
for improved glycemic control in Type 2
diabetes
• Novel, non-systemic approach to blood
sugar management
• Strong safety profile
– No serious adverse events (SAE)
• Expected to be an adjunct therapy to widely
prescribed Metformin
15
Typical mechanisms
involve interaction
with liver, kidney,
pancreas and cells
Most Diabetes Drugs
Systemic
Works in the
gastrointestinal tract
BTI320
Non-Systemic
BTI-320
16. OTCQB:BTHE
BTI-320: Mechanism of Action
16
Enzymes break down complex
carbohydrates into simple sugars
Without BTI-320
Inhibits enzymes that release glucose
from complex carbohydrates
Carbohydrate-hydrolyzing Enzyme Inhibitor (CHEI)
With BTI-320
Enzymes Enzymes
Complex Carbohydrates
from Food
Complex Carbohydrates
from Food
•Fast Glucose Release from
Carbohydrate Foods
•Unhealthy Glucose Spike
•Less Glucose Released from
Carbohydrate Foods
•Reduced Glucose Elevation
BTI-320 (CHEI)
Consume
Carbohydrate
Foods
Function: Reduction of Postmeal Glucose Excursion
17. OTCQB:BTHE 17
Enzymes break down complex
carbohydrates into simple sugars
Inhibits enzymes that release glucose
from complex carbohydrates
Carbohydrate-hydrolyzing Enzyme Inhibitor (CHEI)
Enzymes Enzymes
Complex Carbohydrates
from Food
Complex Carbohydrates
from Food
Increased POST-MEAL
Glucose Spike
Decreased POST-MEAL
Glucose Spike
BTI-320 (CHEI)
Consume
Carbohydrate
Foods
Without BTI-320 With BTI-320
BTI-320: Mechanism of Action
18. OTCQB:BTHE
BTI-320 Phase IIa Trial Results
Published in AACE journal Endocrine
Practice July-August 2013 edition
• 45% patient response: 40% reduction in
postprandial glucose excursion
• No serious adverse events
• Sense of fullness was observed
• Works regardless of duration of diabetes
• Works regardless of other medications
• No significant hypoglycemia
• Mild GI effects
18
4000
8000
Control Meal 4 tablets
Responder Summary
Average Area Under the Curve
(p-value: ANOVA Friedman 0.012)
Average AUC
Trial conducted at Dartmouth Medical Center
19. OTCQB:BTHE
BTI-320: Current and Planned Trials
19
Trial Type Status Patient Population Goals
Phase II Study
Dartmouth-Hitchcock
Medical Center, US
Completed
Data published in
Endocrine
Practice Q3 2013
• 21 people with Type 2
diabetes
• Currently using oral
agents or insulin
• Efficacy and safety
• In combination with oral anti-
diabetic medications and insulin
Phase IIb
Lisieux, France
Phase IIb (2)
U.S.
Enrolling
Initiating
• 24 people with Type 2
diabetes currently using
metformin
• 24 people with Type 2
diabetes w/ metformin
• Efficacy and safety
Phase ll
US, Europe, Hong
Kong, Korea and China
On-Going
Collaboration with
US diabetes clinic
• 300+ patients • Evaluation of the effects of BTI-
320 on glucose HbA1c , AUC in
patients currently taking
metformin
Mechanism of Action
Validation
University of Minnesota
Initiated • To study and validate BTI-320
mechanism of inhibition of
carbohydrate hydrolyzing
enzymes
21. OTCQB:BTHE
IPOXYN
21
• Carbohydrate-based intravenous solution that may
potentially prevent necrosis, or cell death
• Treats ischemia, or lack of oxygen supply to living cells
• New chemical entity, not a biologic agent therefore strong
regulatory position compared to biologic competitors
• Prevent amputation associated with lower limb ischemia or
diabetic foot
• Contains oxygen rechargeable iron which
picks up oxygen in the lungs
• 5,000 times smaller than red blood cell (RBC)
• Requires no blood type matching IPOXYN
RBC
Necrosis: localized death of
living tissue.
Ischemia: deficient supply of
blood to a body part, leading to
necrosis
22. OTCQB:BTHE
IPOXYN: Market Opportunity
22
Facts and Figures
Global Addressable Market: $30 billion*
Indications in which necrosis occurs:
• Stroke is a leading cause of death in the US
• Over 800,000 people die in the US each year
from cardiovascular disease and strokes
Competitive Advantage
• No current drug available to treat
or prevent necrosis
• Ischemia currently treated by high
pressure (hyperbaric) chamber
• All oxygen therapeutic drugs have
failed in FDA trials
• IPOXYN is stable and does not
scavenge Nitric Oxide
• Stable at room temperature
• Stroke
• Heart Disease
• Trauma
• Anemia
• Kidney Failure
• Diabetic Foot
• Surgery
Source: Center for Disease Control and Prevention; *bcc Research
23. OTCQB:BTHE
Milestones
BTI-320 Phase IIa clinical trial results show significant 40% reduction in the post-meal blood
sugar excursion in 45% study population with no serious adverse effects (SAE) in patients taking
various oral and injectable diabetes drugs
Initiated/enrolling Phase IIb trial
Dartmouth Study: Principal investigators published BTI-320 Phase IIa clinical trial results in
Endocrine Practice, peer-reviewed journal
Submit IND questions to FDA
.
23
2013 2014 2015 2016/17
BTI-320 ● Publish Phase IIa data
Endocrine Practice
●
●
File IND
Initiate/Conduct 3
Phase IIb trials in U.S.
and France
●Interim data analysis
Phase II study
(International)
●New Drug Application
(NDA)
●Phase IIb trial
enrollment
(France)
● Initiate pivotal Phase II
study
(International)
IPOXYN ● Initiate preclinical
experiments
●IND Application ●First in Human Study
indication
● Pre-IND meeting with
FDA
24. OTCQB:BTHE
Key Investment Highlights
24
• Raised $5.8 million in 2013 to support product near-term drug portfolio
• BTI-320 (formerly PAZ-320) non-systemic diabetes drug
– Addressable diabetes drug market $35 billion
– Phase IIa clinical trial completed and published: 45% reduction in 40% of patients
– Conducting two Phase llb clinical trials in U.S. & France
– Preparing IND submission to the FDA to conduct Phase III clinical trial
• IPOXYN anti-necrosis, anti-hypoxia drug
– $30 billion market: No current approved therapies for major unmet medical need
• OXYFEX veterinary oxygen: $200 million U.S. market
• Strong IP portfolio for injectable and oral drug agents
• Team with expertise in clinical development and regulatory affairs
Our management team is highlighted by our CEO and Chairman, Dr. David Platt. David has a 30 year history in developing new technologies and building companies, has many patents and co-edited two scientific volumes called Galectins and Carbohydrate Drug Design.
Our management team is highlighted by our CEO and Chairman, Dr. David Platt. David has a 30 year history in developing new technologies and building companies, has many patents and co-edited two scientific volumes called Galectins and Carbohydrate Drug Design.
Diabetes occurs when the body fails to produce the hormone insulin which allows sugar into the body’s cells, (that’s type 1 diabetes) or when the cells in the body lose their ability to receive sugar, or type 2 diabetes. The diabetic population is split 9 to 1, with 90% being Type 2.
There are 26 million Americans living with diabetes and 79 MM considered prediabetic, or who are at risk of developing the disease. Our oral drug candidate PAZ320 addresses both the pre-D and D population. The problem is epidemic, and the market is huge. When left unmanaged cause other problems in the body. D is a major cause of heart attack and stroke, and the leading cause of kidney failure and non-traumatic amputation. The NYC Health Dept reported in 2011, that nearly 650,000 adult New Yorkers reported having.
Diabetes is not only an American problem. The U.S. has an average 8.5% prevalence of diabetes with some minority demographics at about 14%. Some middle east countries are at 25%, and China has 92 million people living with diabetes according the IDF. These numbers are expected to grow 49% by the year 2030
Poor management of D can lead to serious complications including blindness, kidney failure and heart disease. About 10% of people with diabetes will develop lesions on their lower limbs potentially leading to necrosis and amputation. Our two drug candidates PAZ320 and IPOXYN have potentially huge implications in the prevention and treatment of these complications.