BOSTON THERAPEUTICS, INC. (BTHE) SPO
|Company Name||BOSTON THERAPEUTICS, INC.|
|Company Address||33 SOUTH COMMERCIAL STREET
MANCHESTER, NH 03101
|Employees (as of 11/14/2012)||2|
|State of Inc||DE|
|Fiscal Year End||12/31|
|Shares Over Alloted||0|
|Shareholder Shares Offered||--|
|Lockup Period (days)||180|
|Quiet Period Expiration||12/24/2012|
Our offering is being made in a direct public offering, without any involvement of underwriters or broker-dealers on a no minimum, 20,000,000 share maximum offering basis. Selling all of the shares in the offering could result in $10,000,000 gross proceeds. We intend to use the proceeds from this offering for the further development, testing and approval of SUGARDOWN®, PAZ320 and IPOXYN TM. More specifically, and consistent with FDA requirements, we intend to use the proceeds from this offering to (1) initiate a Phase IV clinical trial of SUGARDOWN® and Metformin, (2) initiate a Phase lll clinical trial of PAZ320 and Metformin (3) and initiate pre-clinical studies of IPOXYN TM. We also intend to use the proceeds from this offering to further develop and market SUGARDOWN®, build a management team and for general corporate purposes and working capital. We could receive up to an additional $10,000,000 in gross proceeds if the warrants being offered were subsequently fully exercised. We intend to use those proceeds, if received, for general corporate purposes, including some of the purposes described in the preceding sentences.
Competitive Products: SUGARDOWN® Nutritional Supplements Products in the non-prescription, dietary supplements category which may be useful to prediabetics and diabetics, and could be potential competitors with SUGARDOWN® include a variety of tablets, capsules and powders and include Cinnamon, Chromium, Vanadium, Banaba Leaf, Alpha Lipoic Acid, Fenugreek, Glucomannan, and Gymnema Sylvestra. Secretagogues Secretagogues, which include Sulfonylureas and Meglitinides , help enhance insulin secretion. Sulfonylureas were the first widely used oral hypoglycemic medications. They are insulin secretagogues , triggering insulin release by direct action on the K ATP channel of the pancreatic beta cells . Glipizide (Glucotrol®) falls into this category with side effects including GI discomfort, diarrhea and hypoglycemia. Meglitinides help the pancreas produce insulin and are often called "short-acting secretagogues." Their mode of action is original, affecting potassium channels By closing the potassium channels of the pancreatic beta cells, they open the calcium channels, hence enhancing insulin secretion. They are taken with or shortly before meals to boost the insulin response to each meal. If a meal is skipped, the medication is also skipped. Repaglinide (Prandin®) falls into this category with side effects including hypoglycemia and hyperglycemia. Sensitizers Insulin sensitizers address the core problem in type 2 diabetes—insulin resistance—and include Biguanides and Thiazolidinediones . Among oral hypoglycemic agents, insulin sensitizers are the largest category. Biguanides reduce hepatic glucose output and increase uptake of glucose by the periphery, including skeletal muscle. Although it must be used with caution in patients with impaired liver or kidney function, metformin, a biguanide, has become the most commonly used agent for type 2 diabetes in children and teenagers. Amongst common diabetic drugs, metformin is the only widely used oral drug that does not cause weight gain. Metformin is the most prescribed drug in this category whose side effects may be hypoglycemia and lactic acidosis. Thiazolidinediones (TZDs), also known as "glitazones," bind to PPARã, a type of nuclear regulatory protein involved in tr anscription of genes regulating glucose and fat metabolism. Rosiglitazone (Avandia®) and Pioglitazone (Actos®) fall into this category of anti-diabetic agent. --- The biotechnology and pharmaceutical industries are intensely competitive. We face direct competition from U.S. and foreign companies focusing on pharmaceutical products, which are rapidly evolving. Our competitors include major multinational pharmaceutical and chemical companies, specialized biotechnology firms and universities and other research institutions. Many of these competitors have greater financial and other resources, larger research and development staffs and more effective marketing and manufacturing organizations, than we do. In addition, academic and government institutions are increasingly likely to enter into exclusive licensing agreements with commercial enterprises, including our competitors, to market commercial products based on technology developed at such institutions. Our competitors may succeed in developing or licensing technologies and products that are more effective or less costly than ours, or succeed in obtaining FDA or other regulatory approvals for product candidates before we do. Acquisitions of, or investments in, competing pharmaceutical or biotechnology companies by large corporations could increase such competitors’ financial, marketing, manufacturing and other resources.
We were organized as a Delaware corporation on August 24, 2009 under the name “Avanyx Therapeutics, Inc.” On November 10, 2010, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Boston Therapeutics, Inc., a New Hampshire corporation (“BTI”) providing for the
merger of BTI into the Company with the Company being the surviving entity (the “Merger”), the issuance by the Company of 4,000,000 shares of common stock to the stockholders of BTI in exchange for 100% of the outstanding common stock of BTI, and the change of the Company’s name to Boston Therapeutics, Inc. David Platt, the Company’s Chief Executive Officer and Chief Financial Officer, is a founder of BTI and was a director and minority stockholder of BTI at the time of the Merger. Dr. Platt received 400,000 shares of our common stock in connection with the Merger. Kenneth A. Tassey, Jr., who became our President shortly after the Merger, was the Chief Executive Officer, President and principal stockholder of BTI at the time of the Merger. Mr. Tassey received 3,200,000 shares of our common stock in connection with the Merger. At the time of the merger, BTI was in the business of developing and commercializing, among other things, dietary supplements including its initial product, SUGARDOWN®, a complex carbohydrate based dietary supplement based on BTI’s proprietary processes and technology. SUGARDOWN® is currently in the initial stage of market introduction. We believe that SUGARDOWN® has significant revenue and positive cash flow potential. We are a development stage company with limited operating history, which makes it difficult to evaluate our current business and future prospects, and may increase the risk of your investment. Our primary business is the development, manufacture and commercialization of therapeutic drugs and dietary supplements based on complex carbohydrate chemistry to initially treat diabetes and inflammatory diseases. We are currently focusing on two products: SUGARDOWN®, a non-systemic, chewable tablet dietary supplement designed to moderate post-meal blood glucose levels that we are currently marketing and PAZ320, a chewable table designed to lower after meal blood glucose levels. PAZ320 recently completed a Phase ll clinical trial at Dartmouth Hitchcock Medical Center. We intend to develop and manufacture IPOXYN TM, a glyco-protein-based therapeutic agent that incorporates our proprietary processes and patented technology. Our IPOXYN TM anti-hypoxia drug consists of a stabilized glycoprotein composition containing oxygen-rechargeable iron, targeting both human and animal tissues and organ systems deprived of oxygen and in need of metabolic support. IPOXYN TM is based on novel unproven technologies. We may be unsuccessful in developing these technologies into drugs which the United States Food and Drug Administration (FDA) ultimately will approve. We have completed development of SUGARDOWN® and are marketing it as a dietary supplement. We are not required to attain FDA approval in order to offer SUGARDOWN® in this manner. We are required to either comply with certain FDA guidelines with respect to certain marketing claims for SUGARDOWN®, or to file those claims with the FDA. We believe that we comply with those guidelines. We have voluntarily filed thirty structural and functional claims with the FDA with respect to SUGARDOWN® which describe the proposed mechanism of action of SUGARDOWN® in reducing post-meal elevation of glucose in the blood. If we choose to offer SUGARDOWN® as a drug, it will be subject to a drug approval process with the FDA. ----------- BOSTON THERAPEUTICS, INC. 1750 Elm Street, Suite 103 Manchester, NH 03104 Telephone number : 603-935-9799 Website: www.bostonti.com.
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