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Duska Therapeutics Provides Clinical Program Review and Reports Second Quarter 2008 Financial Results

2008-08-21 08:00:00

    LA JOLLA, Calif., Aug. 21 /EMWNews/ -- Duska Therapeutics,

Inc. (OTC Bulletin Board: DSKA) ("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.





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