LA JOLLA, Calif., Aug. 21 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc. (“Duska”) announced today a clinical review and its financial results for the second quarter of 2008.
A conference call has been scheduled for 2:00 p.m. EDT today. To participate in the conference call, please call toll free: 800-895-0198 and international dial-in: 785-424-1053. A replay of the conference call will be available for 7 days and can be accessed by calling toll free: 800-374-0328 and international dial-in: 402-220-0663.
“We believe we are making remarkable progress in advancing our clinical drug development programs and have broadened our cardiovascular drug portfolio, while remaining on track with our financial goals,” said James S. Kuo, M.D., M.B.A., Chairman and Chief Executive Officer.
Highlights of clinical program accomplishments during the past quarter included:
-- Receipt of comments from the U.S. FDA on the protocol of a Phase 3 clinical trial with the company’s lead drug, ATPace(TM), for the acute treatment of a cardiac arrhythmia called paroxysmal supraventricular tachycardia (PSVT). PSVT, one of the most common cardiac arrhythmias, is a rapid regular heart rate originating in the atria. It has been estimated that there are 89,000 new cases of PSVT annually and approximately 570,000 persons overall with PSVT in the U.S.
Duska is in the process of modifying the proposed design of the Phase 3 clinical trial in accordance with the FDA’s comments and plans to submit a revised protocol to the FDA for Special Protocol Assessment procedure approval. The company intends to initiate a single, prospective, double-blind, placebo-controlled, and randomized trial in patients presenting to the emergency room with PSVT to demonstrate ATPace’s clinical safety and efficacy. Upon successful completion of the trial, Duska intends to file a New Drug Application under section 505(b)(2).
Duska believes that the initial dose of ATPace will be significantly more efficacious in terminating PSVT than the initial labeled dose of adenosine, currently the only FDA approved drug for the acute treatment of this condition.
-- Acquisition of a worldwide license from Duke University and Johns Hopkins University to develop and commercialize a portfolio of novel cardiovascular drugs for the treatment of heart failure. The most advanced drug in the portfolio is expected to enter a Phase 2 clinical trial.
The Phase 2 candidate and all other drugs in the portfolio are designed to improve calcium cycling in the heart by acting on the ryanodine receptor so that heart contractility becomes more efficient. Heart failure, a condition characterized by the inability of the heart to effectively pump blood as well as by fluid accumulation in the lungs and other tissues, is suffered by an estimated five million Americans and is responsible for 300,000 deaths in the U.S. annually, according to the National Heart, Lung and Blood Institute.
Financial highlights of the quarter and six month periods ending June 30, 2008 include:
Duska’s net loss for the second quarter of 2008 was $1,805,007 compared to $268,302 for the second quarter of 2007. For the six months ended June 30, 2008, the net loss was $3,793,038 compared with $798,687 for the same period in 2007. Interest expense related to the convertible note financing in September 2007 accounted for $1,112,318 of the second quarter loss and $2,188,907 of the six months’ loss. Although general and administrative expense decreased from $260,705 for the three months ended June 30, 2007 to $186,551 in the three months ended June 30, 2008, for the six months ended June 30, general and administrative expense increased from 507,795 in 2007 to $925,262 in 2008.
The higher general and administrative expense in the six months of 2008 resulted from a $168,469 increase in salaries incurred by the hiring of two employees in the fourth quarter of 2007 and an increase of $299,423 in stock-based compensation expense (including the fair value of warrants issued to vendors in May, 2008), 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 six months ended June 30, 2008, increased to $678,871, compared with $97,473 for the same period in 2007. Research and development expenses consist mainly of costs directly associated with activities related to the development of ATPace and ATPotent(TM), 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 is due to costs related to the preparation of certain sections of an NDA for ATPace based on section 505(b)(2) of the FDA, and preliminary assessment by our regulatory consultant of the potential marketing approval of ATPotent as a device under section 510(k) of the FDA, and the cost of the license the heart failure technology acquired in May, 2008.
Interest income for the six months ended June 30, 2008, were $33,255, compared with $1,820 for the same period in 2007. This increase was mainly due to fluctuating cash balances. For the six month periods ended June 30, 2008 and 2007, Duska incurred $2,222,162 and $58,842 of interest expense, the majority of which increase was related to the amortization of debt discount and debt issuance costs on the convertible notes issued in the third quarter of 2007.
On June 30, 2008, Duska had cash and cash equivalents of $3,067,677, compared to $4,417,481 on December 31, 2007. Working capital totaled $2,673,034 on June 30, 2008, compared to working capital of $4,123,440 on December 31, 2007. 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 Therapeutics
Duska Therapeutics, Inc. (Duska) is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging new 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 by several pharmaceuticals 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 testing. Duska’s ATPace(TM) is expected to enter a pivotal Phase 3 clinical trial for the treatment of paroxysmal supraventricular tachycardia. Duska’s CDP-1050 is expected to commence a Phase 2 clinical trial for the treatment of heart failure. In addition, Duska has a preclinical program to develop new chemical entities that target a newly discovered pathway in the pathophysiology of chronic obstructive pulmonary disease. For more information, visit http://www.duskatherapeutics.com.
Forward-looking Statements
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 the statements that we believe we are making remarkable progress in advancing and broadening our cardiovascular portfolio while remaining on track with our financial goals, our plan to submit a revised protocol to the FDA, our intention to enter a Phase 3 clinical trial and initiate a single, prospective, double-blind, placebo-controlled, and randomized trial in patients presenting to the emergency room with PSVT to demonstrate ATPace’s clinical safety and efficacy, our intention to file a New Drug Application under section 505(b)(2) upon successful completion of our trial, our belief that the initial dose of ATPace will be significantly more efficacious in terminating PSVT than the initial labeled dose of adenosine and our expectation that the most advanced drug in the portfolio will enter a Phase 2 clinical study later this year. 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(TM) and the Phase 2 clinical trial for our CDP-1050 may not be successful, the licensed portfolio may not lead to the expected results including that our drugs may not improve the efficiency of heart contractility, the NDA may be rejected and we may never successfully commercialize ATPace(TM) or any heart failure compounds. 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-QSB 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.
CONTACT: James S. Kuo, M.D., M.B.A., Chairman and CEO of Duska
Therapeutics, Inc., +1-858-551-5700, fax, +1-858-551-5704,
kuoj@duskascientific.com
Web site: http://www.duskatherapeutics.com/
