bthe 201507
TRANSCRIPT
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Safe Harbor
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.
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Boston Therapeutics is an innovative developer of novel compounds based on complex carbohydrate chemistry for the treatment of diabetes and inflammatory
disease.
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Key Investment Highlights
• 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
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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
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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,MBAChief 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
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Board of DirectorsTeam Background
Dale H. Conaway,DVMDirector 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., MBADirector 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 NeillDirector 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 ChengDirector 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
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Medical & Scientific Advisory BoardTeam Background
Larry K. Ellingson, B.Sc., PharmacyChairman 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
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Diabetes Trend: A Growing Epidemic
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
19801984
19881992
19962000
20042008
0.00
5.00
10.00
15.00
20.00
25.00
30.00
People with Diabetes (millions)% with Diabetes
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Diabetes Growth Projections 2012-2030
Source: Standard & Poor’s and International Diabetes Federation Diabetes Atlas 5th Edition: 2012 Update
38.451.233%
26.440.051%
55.064.217%
34.259.775%
14.928.088%
70.3120.972%
132.2187.942%
2012 : 371M2030 : 552MIncrease 49%
World
Diabetes worldwide drug market size $35 billionExpected to grow to $58 billion by 2018
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Drug Product Pipeline
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
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Diabetes Complications
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
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Post-meal Glucose in Diabetes
•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
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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
Typical mechanisms involve interaction with liver, kidney,
pancreas and cells
Most Diabetes Drugs
Systemic
Works in the gastrointestinal
tract
BTI320
Non-Systemic
BTI-320
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BTI-320: Mechanism of Action
Enzymes break down complex carbohydrates into simple sugars
Without BTI-320Inhibits enzymes that release glucose
from complex carbohydrates
Carbohydrate-hydrolyzing Enzyme Inhibitor (CHEI)
With BTI-320
Enzymes Enzymes
Complex Carbohydratesfrom Food
Complex Carbohydratesfrom 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
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Enzymes break down complex carbohydrates into simple sugars
Inhibits enzymes that release glucose from complex carbohydrates
Carbohydrate-hydrolyzing Enzyme Inhibitor (CHEI)
Enzymes Enzymes
Complex Carbohydratesfrom Food
Complex Carbohydratesfrom 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
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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
Control Meal 4 tablets4000
8000
Responder Summary Average Area Under the
Curve(p-value: ANOVA Friedman
0.012)Average AUC
Trial conducted at Dartmouth Medical Center
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BTI-320: Current and Planned Trials
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
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IPOXYN
• 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
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IPOXYN: Market Opportunity
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
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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 2016/17BTI-320 ● Publish Phase IIa data
Endocrine Practice●●
File INDInitiate/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
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Key Investment Highlights
• 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
Diabetes
Boston Therapeutics, Inc. Anthony Squeglia, Chief Financial Officer
Phone: 603-935-9799Email: [email protected]