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Durata Therapeutics, Inc. Reports Third Quarter 2013 Financial Results

CHICAGO, Nov. 6, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced financial results for the quarter ended September 30, 2013.

Financial results for the quarter ended September 30, 2013

As of September 30, 2013, we had cash and cash equivalents plus short-term investments of $66.6 million, compared to $45.4 million at December 31, 2012. The increase was primarily due to the Company's equity offering in the second quarter of 2013.

Net loss for the three months ended September 30, 2013 (the "2013 Quarter") was $11.9 million, compared to a net loss of $21.8 million for the three months ended September 30, 2012 (the "2012 Quarter").

Research and development expenses for the 2013 Quarter were $5.9 million, compared to $19.0 million for the 2012 Quarter. The $13.1 million decrease from the 2012 Quarter to the 2013 Quarter principally resulted from a decrease of $10.8 million related to clinical related trial costs as a result of our recently completed DISCOVER-1 and DISCOVER-2 clinical trials and a reduction of $3.1 million related to chemistry, manufacturing and control ("CMC") related expenses due to decreased costs related to the manufacture of product in the 2013 Quarter. These reductions were partially offset by an increase of $0.6 million in personnel costs and $0.2 million of consulting costs related to the preparation of our New Drug Application ("NDA") submission.

General and administrative expense for the 2013 Quarter was $4.8 million, compared to $2.6 million for the 2012 Quarter. The $2.2 million increase from the 2012 Quarter to the 2013 Quarter principally resulted from an increase of $1.8 million related to additional headcount and an increase of $0.5 million for marketing and medical affairs spending to support the anticipated commercial launch of dalbavancin.

Q3 2013 Highlights and Recent Events

Recent accomplishments include the following:
  • Submitted our NDA to the U.S. Food and Drug Administration ("FDA") seeking approval for the marketing and sale of dalbavancin for the treatment of patients with acute bacterial skin and skin structure infections ("ABSSSI") caused by susceptible Gram-positive microorganisms, including methicillin resistant Staphylococcus aureus ("MRSA").
  • On October 31, 2013, we and our subsidiaries entered into a credit agreement with PDL BioPharma, Inc. ("PDL"), which provides for up to $70.0 million in debt financing. We used the first funding tranche of $25.0 million to repay amounts owed to Oxford Finance LLC ("Oxford") under our former loan agreement with Oxford, with the remaining funds available for working capital purposes. Upon FDA approval of dalbavancin prior to December 31, 2014, another $15 million will be funded to us within five days of such approval. In addition, we may borrow up to $30.0 million, at our option, for up to nine months following FDA approval.
  • Released and presented results from the DISCOVER-1 and DISCOVER-2 programs, which showed dalbavancin met its primary and secondary endpoints of early response, measured at 48 to 72 hours of therapy, as well as clinical success at the end of treatment in patients with very large skin lesions and high frequencies of fever and systemic inflammatory response syndrome. 

"Durata has accomplished many things in less than a year – from completing two Phase 3 trials that met all its primary and secondary endpoints to our most recent achievement of submitting our NDA for dalbavancin, as well as strengthening our financial position to enhance our commercialization efforts," said Paul Edick, Chief Executive Officer of Durata Therapeutics, Inc. "Hitting these major milestones bring dalbavancin closer to market and, importantly, to patients."  

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