LA JOLLA, Calif., Nov. 20 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) will host a teleconference call today at 2:30 p.m. EST to review its drug development programs and financial results for the third quarter of 2008. Duska's chief executive officer, James S. Kuo, MD, MBA, will host the call and there will be a question-and-answer session immediately afterward.
To participate in the teleconference, please call toll-free 800.895.0198 (direct dial 785.424.1053) five minutes prior to the scheduled starting time in order to register for the call. A replay of the call will be available after its completion for ten days at 800.283.8217 (direct dial 402.220.0868).
"We have made remarkable progress in our two lead drug development programs this past quarter as we prepare for a Phase 2 trial for one compound and a Phase 3 trial for the other early next year," said Dr. Kuo. "In addition, we strengthened the intellectual property position around our ATPotent program through licenses with several inventors."
Highlights of accomplishments included: -- Submission of a pivotal Phase 3 ATPace clinical trial protocol for review under a Special Protocol Assessment (SPA) procedure with the U.S. Food and Drug Administration (FDA). Subject to securing an agreement with the FDA, Duska intends to initiate a single, prospective, double-blind, placebo-controlled and randomized Phase 3 clinical trial with ATPace, its lead product. The trial will be aimed at demonstrating clinical safety and efficacy of ATPace in treating emergency room patients presenting with paroxysmal supraventricular tachycardia (PSVT). PSVT is a condition characterized by a rapid, regular heart rate originating in the atria, which affects approximately 570,000 patients in the United States alone; in addition, 89,000 new cases per year of PSVT are diagnosed. Upon successful completion of the trial, Duska intends to file a New Drug Application under section 505(b)(2). The SPA is a process that provides for an official FDA evaluation of Phase 3 clinical study protocols. Once the SPA is agreed to by both the FDA and the trial sponsor, the SPA provides trial sponsors with a binding written agreement that the design and analysis of the studies are adequate to support a license application submission if the study is performed according to the SPA and if the results are successful. The SPA agreement may only be changed by the sponsor company or the FDA by a written agreement, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. -- The entry into a preliminary agreement with DSM Pharmaceuticals, Inc., to collaborate on the manufacturing of commercial batches of ATPace for Duska's pivotal Phase 3 clinical trial in patients with PSVT. ATPace will be produced at DSM's commercial facilities in Greenville, NC. ATPace, a stable liquid formulation of adenosine 5'-triphosphate (ATP) for intravenous injection, is an investigational drug for the acute termination of PSVT. The bradycardic (slowing heart rate) effect of ATP, in particular its blockade of atrio-ventricular (AV) nodal conduction, has been shown in numerous published clinical studies to safely and effectively terminate re-entrant PSVT involving the AV node. The Company expects to commence the pivotal Phase 3 trial in Q1 2009. -- Jonathan S. Stamler, MD, joined Duska as a consultant to advise on the scientific and clinical development of CDP-1050 for the treatment of heart failure. Dr. Stamler is the George Barth Geller Professor of Research in Cardiovascular Diseases and Professor of Medicine and Biochemistry at Duke University. He is considered to be a thought leader in the area of nitric oxide (NO), and has conducted scientific studies that establish a critical regulatory role of NO signal transduction. Dr. Stamler's research supports the hypothesis that dysregulated NO signaling contributes to human diseases including heart failure, arrhythmia, respiratory diseases, and cancer. CDP-1050 is an investigational drug candidate for the treatment of heart failure. The drug is designed to correct NO and redox imbalance in the failing heart and the cardiovascular system. CDP-1050 has a dual mechanism of action; it inhibits the creation of excessive reactive oxygen radicals, and it restores physiologic levels of NO. The principal therapeutic target is the ryanodine receptor, the main ion channel in the heart that supplies the calcium necessary for the heart to contract. CDP-1050 is expected to enter a Phase 2 clinical trial early next year. -- Acquisition of exclusive worldwide rights for ATPotent, a novel adenosine 5'-triphosphate (ATP)-based sperm-processing medium designed to enhance sperm motility and reduce the failure rates of in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures. A series of agreements were completed with several inventors to develop and commercialize technologies relating to the use of ATP for improving human and animal sperm motility. Male factor infertility is implicated in about half of the 6 million infertile couples in the U.S. Asthenozoospermia, or lack of or low sperm motility, is a common cause of human male infertility. It has been reported in medical literature that the prevalence of asthenozoospermia in infertile men is approximately 82 percent. Currently, there is no FDA-approved product that enhances sperm motility.
Financial highlights of the quarter and nine-month period ended September 30, 2008 are as follows:
Duska's net loss for the third quarter of 2008 was $1,766,392 compared to $972,618 for the third quarter of 2007. For the nine months ended September 30, 2008, the net loss was $5,559,430 compared with $1,771,305 for the same period in 2007. Interest expense related to the convertible note financing in September 2007 accounted for $1,145,620 of the third quarter loss and $3,363,782 of the nine months' loss. Although general and administrative expense decreased from $816,280 for the three months ended September 30, 2007 to $405,486 in the three months ended September 30, 2008, it increased for the nine-month period ended September 30, from $1,324,074 in 2007 to $1,330,748 in 2008.
The higher general and administrative expense in the first nine months of 2008 resulted from a $244,843 increase in salaries incurred by the hiring of two employees in the fourth quarter of 2007, and an increase of $318,384 in stock-based compensation expense (including the fair value of warrants issued to vendors in May, 2008) which was offset in part by a decrease in legal fees and insurance costs. In addition, Duska recorded registration rights penalties of $79,616 in the six months ended June 30, 2008.
Research and development expenses for the nine months ended September 30, 2008 increased to $901,151, compared with $171,769 for the same period in 2007. Research and development expenses consisted mainly of costs directly associated with activities related to the development of ATPace and ATPotent, and the acquisition of a license for a new class of drugs for the treatment of heart failure. The increase in research and development expenses from 2007 to 2008 was due to costs related to the preparation of certain sections of an NDA for ATPace based on section 505(b)(2) of the FDA, for preliminary assessment by our regulatory consultant of the potential marketing approval of ATPotent as a device under section 510(k) of the FDA, and for the license cost for the heart failure technology acquired in May 2008.
Interest income for the nine months ended September 30, 2008, were $40,251, compared with $3,306 for the same period in 2007. This increase was mainly due to fluctuating cash balances. For the nine-month periods ended September 30, 2008 and 2007, Duska incurred $3,367,782 and $142,371 of interest expense respectively, with the majority of the increase relating to the amortization of debt discount and debt issuance costs on the convertible notes issued in the third quarter of 2007.
On September 30, 2008, Duska had cash and cash equivalents of $2,302,980, compared to $4,417,481 on December 31, 2007. Working capital totaled a negative $753,425 on September 30, 2008, compared to working capital of $4,123,440 on December 31, 2007 as a result of reclassification of the convertible notes to a current liability since they mature in less than 12 months. To date, Duska has funded its operations, including research and development activities, through funds derived from several private placements totaling approximately $12.3 million of equity securities and convertible debt issues.
About Duska (www.duskatherapeutics.com):
Duska is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging pharmacology of adenosine triphosphate (ATP) and nitric oxide (NO). These two molecules play critical roles in cellular metabolism and signal transduction, the manipulation of which constitute novel therapeutic modalities for the treatment of major cardiovascular disorders. Duska is developing a portfolio of investigational medicines, two of which are in late stages of clinical trials. Duska's ATPace is expected to enter a pivotal Phase 3 clinical trial for the treatment of paroxysmal supraventricular tachycardia in Q1 2009. Duska's CDP-1050 is expected to commence a Phase 2 clinical trial for the treatment of heart failure early in 2009. In addition, Duska has a preclinical program to develop new chemical entities that target a recently discovered pathway in the pathophysiology of chronic obstructive pulmonary disease.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. The forward-looking statements are based on current expectations, estimates and projections made by management. Duska intends for the forward-looking statements to be covered by the safe harbor provisions for forward-looking statements. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," or variations of such words are intended to identify such forward-looking statements. All statements in this release regarding the future outlook related to Duska are forward-looking statements, including, but not limited to, the statements that Duska's ATPace is expected to enter a pivotal Phase 3 clinical trial for the treatment of paroxysmal supraventricular tachycardia and the anticipated results of the trial, Duska's CDP-1050 is expected to commence a Phase 2 clinical trial for the treatment of heart failure and the anticipated filing of a New Drug Application under section 505(b)(2). The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Such risks include the risk that the clinical trial for approval of ATPace and the Phase 2 clinical trial for our CDP-1050 may not be successful, that our preclinical program to develop new chemical entities that target a newly discovered pathway in the pathophysiology of chronic obstructive pulmonary disease may not be successful, that we may not reach agreement with the FDA, that the FDA evaluation may not be favorable or adequate to support a license application submission, that we may not file a New Drug Application when anticipated if at all, the ability of DSM to meet our specifications and timeline as well as the FDA requirements of a commercial drug manufacturer, the involvement of Dr. Stamler may not lead to expected results, that ATPotent will not enhance sperm mobility as anticipated and that our technology may not lead to expected results including the development or the successful commercialization of technologies relating to the use of ATP or nitric oxide. Additional uncertainties and risks are described in Duska's most recently filed SEC documents, such as its most recent annual report on Form 10-KSB, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-KSB. Copies of these filings are available through the SEC website at http://www.sec.gov. All forward-looking statements are based upon information available to Duska on the date hereof. Duska undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law.
|SOURCE Duska Therapeutics, Inc.|
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