Durata Therapeutics, Inc. (NASDAQ: DRTX) today announced
financial and corporate results for the quarter ended September 30,
2012.
“With the completion of patient enrollment in our two ongoing
global Phase 3 clinical trials of dalbavancin, we remain on track
to file a New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA) in the first half of 2013, pending results
from these trials,” said Paul Edick, Chief Executive Officer of
Durata Therapeutics, Inc. “Our financial results reflect our
increase in spending as the studies draw to a close.”
Recent Accomplishments
Our significant recent accomplishments include the
following:
- Completed target enrollment for both of
our global Phase 3 clinical trials of dalbavancin.
- Received Qualified Infectious Disease
Product (QIDP) designation for dalbavancin from the FDA, which
provides Durata priority review by the FDA, eligibility for
fast-track status, and extension of statutory exclusivity periods
for an additional five years upon FDA approval of the product for
the treatment of acute bacterial skin and skin structure infections
(ABSSSI).
- Completed QT study of dalbavancin,
which indicated that dalbavancin had no clinically significant
impact on cardiac conduction.
- Released in vitro study data that could
help support a clinical development program to investigate
dalbavancin for the treatment of pneumonia.
Financial results for the quarter ended September 30,
2012
As of September 30, 2012, we had cash and cash equivalents of
$60.8 million, compared to $11.5 million at December 31, 2011. In
July 2012, we raised $73.9 million in net proceeds from our initial
public offering.
Net loss for the three months ended September 30, 2012 (the
“2012 Quarter”) was $21.8 million, compared to net loss of $9.4
million for the three months ended September 30, 2011 (the “2011
Quarter”).
Research and development expense for the 2012 Quarter was $19.0
million, compared to $8.3 million for the 2011 Quarter. The $10.7
million increase from the 2011 Quarter to the 2012 Quarter
principally resulted from an increase of $7.6 million in contract
research organization and other clinical trial expenses, including
consulting, an increase of $0.5 million for personnel costs to
support our studies and an increase of $2.6 million related to
chemistry, manufacturing and control related expenses due to the
production of active product ingredient to support registration
batches.
General and administrative expense for the 2012 Quarter was $2.6
million, compared to $1.0 million for the 2011 Quarter. The $1.6
million increase from the 2011 Quarter to the 2012 Quarter
principally resulted from an increase of $0.7 million for personnel
costs, an increase of $0.4 million in legal and consulting fees and
an increase of $0.5 million for insurance and other operating
expenses to support our pre-launch activities and increased
compliance requirements.
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 acute bacterial skin and
skin structure infections, or 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 enrollment in two global Phase 3 clinical trials with its
lead product candidate, dalbavancin, for the treatment of patients
with ABSSSI.
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 filing of a New Drug Application with the U.S. Food and Drug
Administration. 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.
DURATA THERAPEUTICS, INC. AND SUBSIDIARY (A
Development Stage Company) Condensed Consolidated Balance
Sheet Unaudited (in thousands)
December 31, September 30,
Assets 2011 2012 Current assets: Cash and cash
equivalents $ 11,485 $ 60,790 Prepaid expenses and other current
assets 997 1,351 Total current assets 12,482 62,141 Acquired in
process research and development 15,292 15,292 Goodwill 5,811 5,811
Property and equipment, net — 507 Restricted cash — 850 Deferred
charge — 10,991 Other assets 40 — Total assets $ 33,625 $ 95,592
Liabilities, Redeemable Preferred Stock and Stockholders’
Equity Current liabilities: Accounts payable $ 1,957 $ 6,659
Accrued expenses 1,369 8,579 Income taxes payable — 2,841 Total
current liabilities 3,326 18,079 Non-current income tax payable —
1,000 Contingent consideration 18,739 19,556 Other liabilities — 89
Total liabilities 22,065 38,724 Redeemable portion - Series A
Convertible Preferred Stock 6,000 — Total stockholders’ equity
5,560 56,868 Total liabilities, redeemable preferred stock
and stockholders' equity $ 33,625 $ 95,592
DURATA
THERAPEUTICS, INC. AND SUBSIDIARY (A Development Stage
Company) Consolidated Statement of Operations
(Unaudited) (in thousands, except share and per share
data) Period from
inception (November 4, 2009) to Three Month
Period Ended September 30, Nine Month Period Ended September
30, September 30, 2011 2012 2011
2012 2012 Operating expenses: Research and
development expenses $ 8,325 $ 18,956 $ 21,094 $ 42,255 $ 77,404
General and administrative expenses 1,009 2,553 3,313 6,166 14,160
Acquisition related charges, net 760 277 357
817 8,264 Operating loss 10,094 21,786 24,764 49,238
99,828 Interest income (2 ) (12 ) (11 ) (19 ) (36 ) Loss before
income tax benefit 10,092 21,774 24,753 49,219 99,792 Income tax
benefit (706 ) - (1,489 ) - (5,811 ) Net loss $
(9,386 ) $ (21,774 ) $ (23,264 ) $ (49,219 ) $ (93,981 ) Net loss
attributable to common stockholders $ (9,386 ) $ (21,774 ) $
(23,264 ) $ (49,219 ) $ (93,981 ) Net income attributable to Series
A preferred stockholders - - - - -
Net loss $ (9,386 ) $ (21,774 ) $ (23,264 ) $ (49,219 ) $
(93,981 ) Net loss per common share – Basic and Diluted $
(150.18 ) $ (1.47 ) $ (394.12 ) $ (9.83 ) Weighted-average common
shares – Basic and Diluted 62,500 14,781,419 59,028 5,008,367
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