GLEN ALLEN, Va., Nov. 12, 2013 /PRNewswire/ -- Star Scientific, Inc., (NASDAQ: STSI) today filed with the Securities and Exchange Commission its Form 10-Q for the quarter ended September 30, 2013. The Company reported net sales totaling $2.3 million for the three months ending September 30, 2013, compared with net sales of $1.7 million for the same period in 2012. Net sales for the nine months ending September 30, 2013, totaled $7.3 million, compared with $4.2 million for the same period in 2012. The net loss for the third quarter of 2013 was ($3.4) million compared with a net profit of $0.4 million for the same period in 2012. The net loss for the nine months ending September 30, 2013, totaled ($20.3) million compared with a net loss of ($12.8) million for the same period in 2012. The gain for third quarter 2012 and lower net loss for the 2012 nine month period reflected the payments received by the Company in 2012 as part of the R J Reynolds patent litigation settlement.
General and administrative expenses were approximately $2.8 million for the three months ending September 30, 2013, a decrease of approximately $0.9 million, or 24.0%, from approximately $3.7 million for the same period in 2012. Research and development costs in the three months ending September 30, 2013, were approximately $0.4 million, a decrease of approximately $1.1 million from $1.5 million in third quarter 2012. This decrease in research costs reflects the fact that the Company had completed several clinical trials prior to the third quarter 2013 and completed the double-blind and open-ended portions of its Anatabloc® Facial Creme study in August 2013. Collection and analysis of data from that study currently are underway. The Company also reported, in an October 31 press release, publication of the results of the Company's Thyroid Health Study. The peer-reviewed article was published on-line in The Journal of Clinical Endocrinology & Metabolism as an "early release" titled, "Anatabine supplementation decreases thyroglobulin antibodies in patients with chronic lymphocytic autoimmune (Hashimoto's) thyroiditis: A randomized controlled clinical trial". The "Early Release" manuscript is currently available and may be obtained by clicking the following link: http://jcem.endojournals.org/content/early/2013/10/31/jc.2013-2951.abstract
The Company has developed a time-release version of its Anatabloc® dietary supplement that will undergo pharmacokinetic (PK) and related pre-market testing. Once testing is complete, the new version of Anatabloc® is expected to better enable users to take significantly fewer tablets per day. Previous Internet and web studies undertaken by Rock Creek Pharmaceuticals, the Company's wholly owned subsidiary, revealed consumer preference for a reduction in the number of tablets recommended for daily usage. The Company believes that the time-release version of Anatabloc® will enhance customer satisfaction with its flagship product.
In September 2013, the Company announced that it had entered into an agreement with Hall of Fame golfer Nancy Lopez under which she became the first female Brand Ambassador for Anatabloc®. Ms. Lopez joins PGA professional Fred Couples and ATP professional John Isner as the Company's brand ambassadors. On October 15, 2013 the United States Patent and Trademark Office issued Patent No. 8,557,999 to Rock Creek Pharmaceuticals. The patent covers anatabine citrate, the active ingredient in the Company's Anatabloc® and CigRx® products.
On November 7, 2013, the Company filed a preliminary proxy statement in preparation for its 2013 annual shareholder meeting that proposed significant changes in the Company's Board of Directors and senior management. As the Company's November 7 press release reported, Michael J. Mullan MBBS (MD), PhD, would assume the role of the Company's Chairman of the Board and CEO following his election to the board at the annual meeting. Christopher C. Chapman, MD, currently an independent director, would serve as President, and would be a management member of the board. The Company believes that Dr. Chapman's prior experience, including his role as the Medical Director of Quintiles Transnational makes him uniquely qualified to oversee the development of the Company's novel anatabine compound as a pharmaceutical product.
Dr. Mullan, as CEO of the Roskamp Institute, has directed extensive research into the Company's anatabine compound. This week, Dr. Mullan and colleagues from the Roskamp Institute are highlighting anatabine research in two presentations at this year's Annual Society for Neuroscience convention in San Diego, California. This annual convention is the largest meeting of neuroscientists in the world, with an annual average of over 30,000 attendees.
On Sunday, November 10, Dr. Scott Ferguson of the Roskamp Institute presented data on anatabine as a potential treatment for traumatic brain injury (TBI). The study, which was funded by the Department of Defense and the Roskamp Foundation, used a published preclinical laboratory model of mild repetitive TBI, developed by the Roskamp team, which demonstrates cognitive impairment and neuropathological changes consistent with human TBI patients. Dr. Ferguson showed that chronic treatment with anatabine significantly improved cognitive performance in the TBI group, and significantly reduced TBI-induced inflammatory responses in the brain. The significance of repetitive mild brain injury, and its negative long term consequences on health, has become increasingly evident over the past few years both from military statistics on TBI in troops, and the data from athletes such as NFL players who have suffered multiple concussions. These data from the Roskamp Institute TBI program support investigation of anatabine as a potential treatment for TBI.
On Wednesday, November 13, Dr. Daniel Paris and his colleagues will present continuing data from their examination of the effects of anatabine in transgenic mouse models of Alzheimer's disease, and normal control mice. The data show that anatabine reduces anxiety in normal mice, both immediately after treatment, and after long term chronic administration. In the "Alzheimer" mice, chronic administration of anatabine, even after Alzheimer pathology has begun, improved social interaction and social memory. Overall, these data show that anatabine improves cognition in the Alzheimer mouse model, and reduces anxiety in normal mice. Studies are ongoing to investigate the impact of chronic use of anatabine on the Alzheimer pathology in these mice.
Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as "believes," "expects," "anticipates," "estimates," "intends," "plans," "targets," "projects" and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and market acceptance of our nutraceutical dietary supplements products, the effect of any competitive products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices and the outcome of the ongoing investigations as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2012 and our quarterly reports on Form 10-Q for the quarters ended March 31, 2013 and June 30, 2013. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.
About Star Scientific
Star Scientific, Inc. is a technology-oriented company with a mission to promote maintenance of a healthy metabolism and lifestyle. Through its wholly owned subsidiary, Rock Creek Pharmaceuticals, Star Scientific has been engaged in the manufacturing, sale, and marketing of two nutraceutical dietary supplements, cosmetic products, and the development of other nutraceuticals and pharmaceuticals. The company also continues to pursue the licensing of the technology behind its proprietary StarCured® curing process and its related products. Rock Creek Pharmaceuticals has scientific and research offices in Gloucester, MA, and a regulatory office in Washington, DC. Star Scientific has a Corporate and Sales Office in Glen Allen, VA, and an Executive, Scientific & Regulatory Affairs office in Washington, DC.
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
|SOURCE Star Scientific, Inc.|
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