MANCHESTER, NH -- (Marketwired) -- 05/13/14 -- Boston Therapeutics, Inc. (OTCQB: BTHE) ("Boston Therapeutics" or "the Company"), a leading developer of compounds that address diabetes using complex carbohydrate chemistry, reports its financial results for the first quarter ended March 31, 2014.
David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, "In the first quarter, we have continued to work toward fulfilling the milestones we outlined in last quarter's year-end corporate update. Since that time, I am pleased to announce that we have continued to disseminate scientific findings regarding BTI-320, and have initiated steps to prepare for its future development. Specifically, we are pleased to be presenting a poster on the mechanism of action of BTI-320 at the AACE Annual Congress in Las Vegas, and look forward to presenting further results on the properties of this compound in the future. Furthermore, our recently signed agreement with Patheon Inc. to manufacture pharmaceutical-grade tablets of BTI-320 positions us well for our upcoming IND filing later this year, and our planned international Phase III trial for BTI-320 in 2015. All of these efforts will allow us to continue to harness our expertise in complex carbohydrate chemistry to design compounds to better manage blood glucose."
Business and Clinical Highlights for the First Quarter 2014 and Recent Months:
Financial Results for the First Quarter Ended March 31, 2014:
We have incurred recurring operating losses since inception as we have worked to bring our SUGARDOWN® product to market and develop BTI-320 and IPOXYN. IPOXYN is an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. We expect such operating losses will continue until such time that we receive substantial revenues from SUGARDOWN® or we complete the regulatory and clinical development of BTI-320 or IPOXYN. We anticipate that our cash resources will be sufficient to fund our planned operations into the second half of fiscal 2014. We plan to seek additional capital through private placements and public offerings of the Company's common stock. There can be no assurance that the Company will be successful in accomplishing its objectives. Without such additional capital, the Company may be required to curtail or cease operations.
BTI-320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. BTI-320 is a proprietary polysaccharide to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down complex carbohydrates into simple sugars, reducing the availability of glucose for absorption into the bloodstream.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is an innovator in designing compounds using complex carbohydrate chemistry. The company's product pipeline is focused on developing and commercializing therapeutic molecules that address diabetes and inflammatory diseases, including: BTI-320 (formerly PAZ320), a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. The company also produces and sells SUGARDOWN®, a non-systemic complex carbohydrate-based dietary food supplement designed to support healthy blood glucose. More information is available at www.bostonti.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of any of our future drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in any subsequent drug trial could delay obtaining meaningful results from Phase II studies and/or preparing for Phase III studies with the current cash on hand.
Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from our approved products. Plans regarding development, approval and marketing of any of our compounds, including BTI-320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. We have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional risk and other factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2013, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements, and actual results may differ materially from the results anticipated in our forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
Boston Therapeutics, Inc. Statement of Operations (Unaudited) Three Months Ended March 31, -------------------------- 2014 2013 ------------ ------------ Revenue $ 43,827 $ 23,336 Cost of goods sold 54,558 47,937 ------------ ------------ Gross margin (deficit) (10,731) (24,601) Operating expenses: Research and development 269,434 28,661 Sales and marketing 172,735 81,226 General and administrative 1,105,230 528,170 ------------ ------------ Total operating expenses 1,547,399 638,057 Operating loss (1,558,130) (662,658) Interest expense (4,728) (4,764) Other expense (2,940) - Foreign currency loss (625) - ------------ ------------ Net loss $ (1,566,423) $ (667,422) ============ ============ Net loss per share - basic and diluted $ (0.04) $ (0.04) Weighted average shares outstanding basic and diluted 37,451,156 18,880,845 Boston Therapeutics, Inc. Balance Sheet Data March 31, December 31, 2014 2013 ------------- ------------- Cash and cash equivalents $ 2,512,404 $ 3,387,428 Working capital $ 2,384,994 $ 2,859,578 Total assets $ 3,469,725 $ 4,535,032 Total stockholders' equity $ 2,857,279 $ 3,345,270
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