MANCHESTER, NH -- (Marketwired) -- 08/13/15 -- Boston Therapeutics, Inc. (OTCQB: BTHE), a leading developer of novel compounds based on complex carbohydrate chemistry for the treatment of diabetes and inflammatory disease, today reported its financial results for the second quarter and six months ended June 30, 2015 and provided a corporate update.
David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, "We are making progress in the development of our lead therapeutic candidate, BTI-320. We are in the process of initiating a clinical trial with Joslin Diabetes Clinic as the lead site of which timing will be dependent upon securing financing. Also our strategic partner, Advance Pharmaceutical Company, Ltd., (APC), based in Hong Kong, has initiated a clinical trial for BTI-320 with China University in Hong Kong as a precursor to seeking approval with the Chinese FDA. BTI-320 is designed as preventative medicine for people who are pre-diabetic and need to manage their blood sugar as well as for people with type 2 diabetes. We believe we are the only company to develop a safe, non-toxic compound to manage blood sugar non-systemically," said Dr. Platt.
Business and Clinical Highlights for the Second Quarter 2015 and Subsequent Developments:
- APC initiated a clinical trial at the Chinese University of Hong Kong to evaluate BTI-320 in subjects that are pre-diabetic. The clinical trial has enrolled 30 of the planned 60 patients. Also, the interim analysis in the proof of concept trial is due to be reported shortly. This key developmental trial is pivotal for concluding the BTI-320 registration in mainland China.
- Kevin H. Mayo, Ph.D., a professor in the Department of Biochemistry, Molecular Biology and Biophysics at the University of Minnesota, presented data on BTI-320, as a poster presentation at the 75th Annual Meeting of the American Diabetes Association.
- The marketing agreement between the Company and Benchworks SD, LLC expired by its terms in May but the parties had continued to operate under the terms of the agreement on an "at will" basis following the expiration. Benchworks SD, LLC notified the Company in July that it was terminating the agreement.
- Nominated Philip Getter, President and CEO of KIDSRx International, to our Board of Directors.
Financial Results for the Second Quarter Ended June 30, 2015:
- Revenue for the second quarter ended June 30, 2015 was $38,851 compared to revenue of $21,391 for the second quarter ended June 30, 2014. The increase is primarily related to larger shipments to Advance Pharmaceutical as compared to the three months ended June 30, 2014.
- A gross margin deficit for the second quarter ended June 30, 2015 was $27,927 compared to a gross margin deficit of $595 for the second quarter ended June 30, 2014. The decrease is primarily related to management's analysis of inventory's carrying value and determination that certain raw material required a valuation adjustment of approximately $26,000 during the three months ended June 30, 2015.
- Research and development expense for the second quarter ended June 30, 2015 was $96,992 compared to $412,255 for the second quarter ended June 30, 2014. The decrease is primarily related to clinical trial and consulting expenses associated with the Phase IIb clinical trial for BTI-320 conducted in the U.S. during the three months ended June 30, 2014 that concluded in September 2014.
- Sales and marketing expense for the second quarter ended June 30, 2015 was $2,143 compared to $84,821 for the second quarter ended June 30, 2014. Payroll and payroll related expenses decreased approximately $34,000 due to the reduction of two employees. The personnel reduction also contributed to a decrease in non-cash, stock-based compensation expense of approximately $19,000. Additionally, trade show and associated travel expenses decreased approximately $27,000 due to the Company's cost reduction initiatives during the three months ended June 30, 2015.
- General and administrative expense for the second quarter ended June 30, 2015 was $384,175 compared to $708,436 for the second quarter ended June 30, 2014. Payroll and payroll related expense decreased approximately $155,000 primarily due to the resignation of the Company's former President in June 2014 that incurred severance costs of approximately $68,000 combined with payroll reductions for employees in the three months ended June 30, 2015. Accounting, financial and legal professional fees decreased approximately $96,000 primarily related to the Company's legal services. During the three months ended June 30, 2014, the Company incurred approximately $33,000 of legal costs associated with the indemnification of Dr. Platt's legal expenses. In addition, general legal expense decreased approximately $64,000 due to reduced legal services during the three months ended June 30, 2015. The Company's cost reduction initiatives resulted in an approximate decrease of $20,000 for travel and entertainment expenses. Non-cash stock-based compensation expense decreased approximately $35,000 primarily due to stock options granted to the board of director members during the first quarter of 2014 at a higher market price than those granted to the board of director members in the first quarter of 2015.
- Net loss for the second quarter ended June 30, 2015 was $686,238 or $0.02 per share, compared with a net loss of $1,211,095 or $0.03 per share in the prior year's second quarter. As of June 30, 2015, there were 38.6 million weighted average shares outstanding, compared with 38.4 million weighted average shares outstanding as of June 30, 2014.
Boston Therapeutics believes its cash resources will be sufficient to fund planned operations into September 2015. The Company is seeking additional capital through private placements, public offerings, private debt or equity financings but there can be no assurance that the Company will be able to raise necessary funding. Without such additional capital, the Company may be required to curtail or cease operations.
About Boston Therapeutics, Inc.
Boston Therapeutics, Inc., 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, a non-systemic 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. 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, 2014, 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.|
|Condensed Statements of Operations (Unaudited)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Cost of goods sold||66,778||21,986||98,888||76,544|
|Gross margin (deficit)||(27,927||)||(595||)||(8,708||)||(11,326||)|
|Research and development||96,992||412,255||302,411||681,689|
|Sales and marketing||2,143||84,821||34,894||257,556|
|General and administrative||384,175||708,436||900,097||1,813,666|
|Total operating expenses||483,310||1,205,512||1,237,402||2,752,911|
|Other income (expense)||(71||)||(48||)||77,575||(4,334||)|
|Change in fair value of warrant liability||9,800||-||19,600||-|
|Change in fair value of derivative liabilities||33,689||-||22,317||-|
|Net loss per share - basic and diluted||$||(0.02||)||$||(0.03||)||$||(0.04||)||$||(0.07||)|
|Weighted average shares outstanding basic and diluted||38,645,870||38,397,142||38,605,392||37,924,149|
|Boston Therapeutics, Inc.|
|Balance Sheet Data|
|June 30,||December 31,|
|Cash and cash equivalents||$||207,849||$||157,278|
|Total stockholders' (deficit) equity||$||(1,010,756||)||$||74,663|
Source: Boston Therapeutics