NEWTON, MA -- (Marketwired) -- 11/20/15 -- Boston Therapeutics, Inc. (OTCQB: BTHE), a leading developer of novel compounds based on complex carbohydrate chemistry for the treatment of metabolic disease and inflammatory disease states, today reported its financial results for the third quarter and nine months ended September 30, 2015 and provided a corporate update.
David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, "We have progressed the development of our lead therapeutic candidate, BTI-320, through our alliance partners. The process of initiating a clinical trial with Joslin Diabetes Clinic as the lead site with others is tied to the timing of a capital raise to fund this effort. Our strategic partner, Advance Pharmaceutical Company, Ltd., (APC), based in Hong Kong, has recently completed enrollment in a clinical trial for BTI-320 with Chinese University Hong Kong as a proof of concept for drug effect and clinical benefit. In addition as a precursor to seeking approval with the Chinese FDA our alliance partner has continued the enrollment and filing process for the medical/health position for product registration targeted for 2016. To date, BTI-320, in clinical trials, appears to be safe and may be used as preventative medicine for people who are pre-diabetic and need to manage their diets (blood sugar, caloric and weight gain) as well as for people with type 2 diabetes. We believe we have a unique development of a clinically proven safe, non-toxic compound to manage blood sugar non-systemically," said Dr. Platt.
Business and Clinical Highlights for the Third Quarter 2015 and Subsequent Developments:
- APC completed enrollment of a clinical trial at the Chinese University Hong Kong for the proof of concept and to evaluate BTI-320 in subjects that are pre-diabetic. The clinical trial has enrolled 60 patients (Clinical trials.gov). The analyses are currently underway and the clinical results will be announced soon. The clinical trial was conducted with good clinical compliance and a requirement for some adjustment to the CGM (continuous glucose monitoring) to better capture the food variability effect on Post Prandial Glucose (PPG) as blinded and placebo controlled. This important developmental trial is supportive for contributing to the parallel China study for the BTI-320 registration in mainland China in 2016.
- BTI-320 in clinical trial significantly reduces both glucose and fructose levels in blood. Interim clinical results of BTI-320 were demonstrated on post-prandial hyperglycemia in high-risk Chinese subjects with pre-diabetes. BTI-320 actually does not reduce blood sugar, however, it inhibits an increase in sugar levels after a meal through a unique non-systemic mechanism of action.
- Paid off convertible promissory notes totaling approximately $753,000 with funds invested into BTI by a director and major shareholder of $1,050,000 through a convertible promissory note issued during September and October of 2015.
- Boston Therapeutics believes its cash resources will be sufficient to fund planned operations into December 2015. The Company is seeking additional capital through private placements, public offerings and private debt or equity financings; however, 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.
Financial Results for the Third Quarter Ended September 30, 2015:
- Revenue for the three months ended September 30, 2015 was $4,601, a decrease of $116,891 as compared to revenue of $121,493 for the three months ended September 30, 2014. The decrease is primarily related to shipments of approximately $120,000 to Advance Pharmaceutical during the three months ended September 30, 2014, as compared to $0 shipments to Advance Pharmaceutical during the three months ended September 30, 2015.
- The Company generated a gross margin deficit for the three months ended September 30, 2015 of $45,467 as compared to a gross margin of $39,432 for the three months ended September 30, 2014. The decrease is primarily related to the lower sales volume during the three months ended September 30, 2015 which did not cover fixed overhead as well as management's analysis of inventory's carrying value and determination that certain raw material required a valuation adjustment of $45,000 during the three months ended September 30, 2015.
- Research and development expense for the three months ended September 30, 2015 was $46,751, a decrease of $471,882 as compared to $518,633 for the three months ended September 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 September 30, 2014 that concluded in September 2014. In addition, the Company scaled back its research and development activities including staffing due to a lack of funding during the three months ended September 30, 2015.
- Sales and marketing expense for the three months ended September 30, 2015 was $1,076, a decrease of $29,010 as compared to $30,086 for the three months ended September 30, 2014. The decrease is attributed to the Company significantly reducing its operations, including employees, due to its lack of funding during the three months ended September 30, 2015.
- General and administrative expense for the three months ended September 30, 2015 was $369,928, a decrease of $274,041 as compared to $643,969 for the three months ended September 30, 2014. Payroll and payroll related expense decreased approximately $48,000 primarily due to headcount reductions caused by the lack of funding in the three months ended September 30, 2015, resulting in the Company furloughing its employees. Legal professional fees decreased approximately $50,000 due to the Company reducing its operations. Outside consulting fees dropped by approximately $31,000 due to the Company's reduced spending and operation. Non-cash stock-based compensation expense decreased approximately $55,000 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 third quarter ended September 30, 2015 was $533,882 or $0.01 per share, compared with a net loss of $1,159,926 or $0.03 per share in the prior year's second quarter. As of September 30, 2015, there were 39.1 million weighted average shares outstanding, compared with 38.4 million weighted average shares outstanding as of September 30, 2014.
About Boston Therapeutics, Inc.
Boston Therapeutics, Inc., headquartered in Newton, MA, (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||Nine Months Ended|
|September 30,||September 30,|
|Cost of goods sold||50,069||82,061||148,957||158,605|
|Gross margin (deficit)||(45,467||)||39,432||(54,175||)||28,106|
|Research and development||46,751||518,633||349,162||1,200,321|
|Sales and marketing||1,076||30,086||35,970||287,642|
|General and administrative||369,928||643,969||1,270,025||2,457,636|
|Total operating expenses||417,755||1,192,688||1,655,157||3,945,599|
|Other income (expense)||(181||)||(1,360||)||77,394||(4,973||)|
|Change in fair value of warrant liability||-||-||19,600||-|
|Loss on extinguishment of debt||(219,993||)||-||(219,993||)||-|
|Change in fair value of derivative liabilities||252,014||-||274,331||-|
|Net loss per share - basic and diluted||$||(0.01||)||$||(0.03||)||$||(0.05||)||$||(0.10||)|
|Weighted average shares outstanding basic and diluted||39,120,555||38,435,195||38,777,113||38,094,498|
|Boston Therapeutics, Inc.|
|Balance Sheet Data|
|September 30,||December 31,|
|Cash and cash equivalents||$||58,239||$||157,278|
|Total stockholders' (deficit) equity||$||(682,054||)||$||74,663|
Source: Boston Therapeutics