Durata Therapeutics, Inc. Reports Second Quarter 2013 Financial Results

Durata Therapeutics, Inc. Reports Second Quarter 2013 Financial Results

Timing of NDA and MAA Submissions Remain on Track

CHICAGO, Aug. 7, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc.
(Nasdaq:DRTX) today announced financial results for the quarter ended June 30,

Q2 2013 Highlights and Recent Events

Accomplishments include the following:

  *Completed an equity offering in April, resulting in approximately $54.1
    million of net proceeds before deducting costs payable by us
  *Presented new data demonstrating in vitro potency of dalbavancin against
    bacterial pathogens at the 23rd Annual ECCMID Meeting
  *Elected Paul A. Friedman, M.D. to the Board of Directors
  *Concluded pre-New Drug Application ("NDA") clinical and CMC meetings with
    the Food and Drug Administration ("FDA")
  *Confirmed process and timeline for NDA submission with the FDA

"We are pleased to reaffirm the timing of the submission of both the NDA and
the Marketing Authorization Application ("MAA")," said Paul Edick, Chief
Executive Officer of Durata Therapeutics, Inc. "Based on discussions with the
FDA, including pre-NDA meetings in which both clinical and manufacturing data
were discussed, we intend to submit to the FDA our initial NDA submission in
late September. The MAA submission also remains on track to file with the
European Medicines Agency ("EMA") by year-end." Mr. Edick continued, "Our cash
position following our $54 million equity raise remains strong and will enable
us to successfully launch dalbavancin in the U.S. in the second half of 2014."

Financial results for the quarter ended June 30, 2013

As of June 30, 2013, we had cash and cash equivalents plus short-term
investments of $83.5 million, compared to $45.4 million at December 31, 2012.
The increase was primarily due to the Company's equity offering in the second

Net loss for the three months ended June 30, 2013 (the "2013 Quarter") was
$18.8 million, compared to a net loss of $19.2 million for the three months
ended June 30, 2012 (the "2012 Quarter").

Research and development expenses for the 2013 Quarter were $13.2 million,
compared to $16.5 million for the 2012 Quarter. The $3.3 million decrease from
the 2012 Quarter to the 2013 Quarter principally resulted from a decrease of
$7.6 million related to clinical related trial costs as a result of completing
our DISCOVER 1 and DISCOVER 2 clinical trials partially offset by an increase
of $3.6 million related to chemistry, manufacturing and control ("CMC")
related expenses for the production of active pharmaceutical ingredient
("API") for future, potential commercial sale and a $0.5 million increase in
costs related to the preparation of the final study report and NDA submission.

General and administrative expense for the 2013 Quarter was $4.5 million,
compared to $2.4 million for the 2012 Quarter. The $2.1 million increase from
the 2012 Quarter to the 2013 Quarter principally resulted from an increase of
$1.8 million for personnel costs and an increase of $0.3 million for insurance
and other operating expenses to support our pre-launch activities and
increased public company compliance requirements.

Conference Call and Webcast Information

The company will host a conference call today, August 7, 2013 at 8:30 AM EDT.
To access the call, please dial 866-632-4021 for participants in the U.S. or
Canada and 404-991-3968 for international callers (reference Conference ID
12148199). A replay of the call may be accessed through August 21, 2013 by
dialing 800-585-8367 for callers in the U.S. and Canada and 404-537-3406 for
international callers (reference Conference ID12148199). The conference call
will also be webcast live on the Investor Relations section of the Company's
website at www.duratatherapeutics.com.

About Dalbavancin

Dalbavancin is an intravenous antibiotic product candidate under investigation
for once-weekly dosing, which we believe may facilitate the treatment of
patients with ABSSSI in both the in-patient and out-patient settings,
potentially reducing the length of a patient's hospital stay or avoiding
hospital admission altogether, with an impact on the overall cost of care for
these patients.

About Durata Therapeutics

Durata Therapeutics is a pharmaceutical company focused on the development and
commercialization of novel therapeutics for patients with infectious diseases
and acute illnesses. Durata has completed two global Phase 3 clinical trials
with its lead product candidate, dalbavancin, under investigation for the
treatment of patients with acute bacterial skin and skin structure infections
caused by susceptible gram-positive bacteria.

Forward-looking statements

Statements contained in this press release contain forward-looking statements
that involve substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release, including
statements regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and objectives of
management, are forward-looking statements. The words "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and similar
expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.

Forward-looking statements in this press release include statements about the
timing of the filing of a NDA with the FDA and the timing of the filing of a
MAA with the EMA, the potential commercialization of dalbavancin and the
sufficiency of our cash reserves. Actual results may differ materially from
those indicated by these forward-looking statements as a result of various
important factors, including those discussed in the "Risk Factors" section of
our most recent quarterly report on Form 10-Q, which is on file with the SEC
and is also available on our website. In addition, any forward-looking
statements represent our views only as of today and should not be relied upon
as representing our views as of any subsequent date. While we may elect to
update these forward-looking statements at some point in the future, we
specifically disclaim any obligation to do so, even if our views change.
Therefore, you should not rely on these forward-looking statements as
representing our views as of any date subsequent to today.

(A Development Stage Company)
Consolidated Balance Sheet
(in thousands)
Assets                                         June 30,2013 December 31,2012
Current assets:                                             
Cash and cash equivalents                      $ 61,384      $ 32,257
Short-term investments                         22,095        13,094
Prepaid expenses and other current assets      1,857         5,844
Total current assets                           85,336        51,195
Acquired in process research and development   15,292        15,292
Goodwill                                       5,811         5,811
Property and equipment, net                    1,009         981
Restricted cash                                1,145         852
Deferred charge                                11,235        12,417
Other assets                                   576           —
Total assets                                   $ 120,404     $ 86,548
Liabilities and Stockholders' Equity                        
Current liabilities:                                        
Accounts payable                               $ 5,228       $ 8,618
Accrued expenses                               8,597         10,602
Current portion of long-term debt              1,205         —
Income taxes payable                           —             2,281
Total current liabilities                      15,030        21,501
Long-term debt (less unamortized debt discount 17,352        —
of $1,443 at June 30, 2013)
Non-current income tax payable                 1,412         1,117
Contingent consideration                       20,409        19,836
Accrued interest liability                     1,190         —
Other liabilities                              318           222
Total liabilities                              55,711        42,676
Total stockholders' equity                     64,693        43,872
Total liabilities and stockholders' equity     $ 120,404     $ 86,548

(A Development Stage Company)
Consolidated Statement of Operations
(in thousands, except share and per share data)
                                                             Period from
                                                             (November 4,
                Threemonthperiodended Sixmonthperiodended  2009) to
                June 30,                 June 30,                June 30,
                2013         2012        2013        2012        2013
Research and
development      $ 13,179    $ 16,528   $24,271    $23,299    $111,115
General and
administrative   4,514       2,392      8,565      3,613      26,347
related charges, 289         272        573        540        9,117
Operating loss   17,982      19,192     33,409     27,452     146,579
Other (income)                                                
Interest expense 654         --         762        --         762
Interest income  (11)        (4)        (26)       (7)        (85)
Total other      643         (4)        736        (7)        677
(income) expense
Loss before
income tax       18,625      19,188     34,145     27,445     147,256
Income tax
expense          210         --         458        --         (5,353)
Net loss         $(18,835)   $(19,188)  $(34,603)  $(27,445)  $(141,903)
Net loss per
common share –   $(0.75)     $(260.25)  $(1.59)    $ (402.94) 
Basic and
Weighted average
common shares –  25,169,543  73,727     21,787,331 68,113     
Basic and

CONTACT: Investor Relations and Public Affairs Contact
         Allison Wey
         Durata Therapeutics, Inc.
         Vice President, Investor Relations and Public Affairs
         (312) 219-7017

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