MEMPHIS, Tenn.--(BUSINESS WIRE)--Aug. 8, 2012--
GTx, Inc. (Nasdaq: GTXI) today provided a Company update and reported
financial results for the second quarter of 2012.
“We continue to make progress on our late stage clinical programs. We
are enrolling our two pivotal Phase III clinical trials evaluating
enobosarm for the prevention and treatment of muscle wasting in
non-small cell lung cancer patients,” said Mitchell S. Steiner, MD, CEO
of GTx. “We expect to receive topline data from these studies during the
second quarter of 2013. In addition, we will begin screening patients
this month for our Phase II clinical study of Capesaris® as
secondary hormonal therapy in men with metastatic castration resistant
prostate cancer.”
Clinical updates
Enobosarm (Ostarine®,
GTx-024), an oral selective androgen receptor modulator, for the
prevention and treatment of muscle wasting in patients with advanced
non-small cell lung cancer: GTx is currently enrolling subjects
with advanced non-small cell lung cancer in two pivotal Phase III
clinical trials, POWER 1 and POWER 2. These international Phase III
studies are being conducted in clinical sites in the United States,
Europe, and South America. In each of the placebo-controlled,
double-blind clinical trials, 300 patients with Stage III or IV
non-small cell lung cancer are being randomized to oral daily doses of
placebo or enobosarm 3 mg at the time they begin first line standard
chemotherapy. The studies are evaluating as co-primary endpoints at
three months of treatment the response rates of enobosarm versus placebo
on maintaining or improving total lean body mass (muscle) assessed by
dual x-ray absorptiometry and improving physical function assessed by
the Stair Climb Test. Durability of the drug effect is being evaluated
as a secondary endpoint after five months of treatment. Enrollment for
both studies is expected to be completed in the fourth quarter of this
year, and topline results should be released during the second quarter
of 2013.
Capesaris® (GTx-758), an
oral selective estrogen receptor alpha agonist, for secondary hormonal
therapy of advanced prostate cancer: GTx is initiating this
quarter an open-label clinical study of 75 men with metastatic
castration resistant prostate cancer to test three lower doses of
Capesaris (125 mg, 250 mg and 500 mg) sequentially in cohorts of 25
patients each. The Phase II 712 clinical trial is designed to assess the
effect of Capesaris on serum prostate specific antigen response and
prostate cancer progression. The study is expected to provide
confirmation of the mechanism of drug action for Capesaris on lowering
serum free testosterone levels by increasing serum SHBG in castrated men
who failed primary androgen deprivation therapy. The safety and
tolerability of lower doses of Capesaris will also be evaluated in these
subjects, including the incidence of venous thromboembolic events.
Financial highlights for the quarter ended June 30, 2012
The net loss for the quarter ended June 30, 2012 was $10.4 million
compared to a net loss of $10.7 million for the same period in 2011.
Revenue for both the second quarter of 2012 and 2011 was $1.6 million
and consisted of net sales of FARESTON® (toremifene citrate)
60 mg, approved for the treatment of metastatic breast cancer in
postmenopausal women.
Research and development expenses for the quarter ended June 30, 2012
were $9.2 million compared to $7.6 million for the same period in 2011.
General and administrative expenses for the quarter ended June 30, 2012
were $2.6 million compared to $4.5 million for the same period in 2011.
At June 30, 2012, GTx had cash and short-term investments of $55.9
million.
Conference call
There will be a conference call today at 9:00 a.m. Eastern Time. To
listen to the conference call, please dial 866-356-4281 from the United
States or Canada or 617-597-5395 from other international locations. The
access code for the call is 90153804. A playback of the call will be
available from approximately 11:00 a.m. Eastern Time today through
August 22, 2012 and may be accessed by dialing 888-286-8010 from the
United States or Canada or 617-801-6888 from other international
locations and referencing reservation number 54291257. Additionally, you
may access the live and subsequently archived webcast of the conference
call from the Investor Relations section of the Company’s website at http://www.gtxinc.com.
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical
company dedicated to the discovery, development, and commercialization
of small molecules for the treatment of cancer, cancer supportive care,
and other serious medical conditions.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon
GTx's current expectations. Forward-looking statements involve risks and
uncertainties, and include, but are not limited to, statements relating
to GTx's clinical trials for enobosarm (also known as Ostarine®
or GTx-024) and its planned clinical trial of Capesaris®
(GTx-758). GTx's actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as
a result of these risks and uncertainties, which include, without
limitation, the risks (i) that GTx will not be able to commercialize its
product candidates if clinical trials do not demonstrate safety and
efficacy in humans; (ii) that GTx may not be able to obtain required
regulatory approvals to commercialize its product candidates in a timely
manner or at all; (iii) that clinical trials being conducted by GTx may
not be completed on schedule, or at all, or may otherwise be suspended
or terminated; or (iv) that GTx could utilize its available cash
resources sooner than it currently expects and may be unable to raise
capital when needed, which would force GTx to delay, reduce or eliminate
its product candidate development programs or commercialization efforts.
You should not place undue reliance on these forward-looking statements,
which apply only as of the date of this press release. GTx’s quarterly
report on Form 10-Q filed with the Securities and Exchange Commission on
May 10, 2012 contains under the heading, "Risk Factors", a more
comprehensive description of these and other risks to which GTx is
subject. GTx expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in its expectations
with regard thereto or any change in events, conditions or circumstances
on which any such statements are based.
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GTx, Inc.
Condensed Balance Sheets
(in thousands, except share data)
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June 30,
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December 31,
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2012
|
|
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2011
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|
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(unaudited)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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47,319
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$
|
63,745
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Short-term investments
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8,610
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10,695
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Accounts receivable, net
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908
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981
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Inventory
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|
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105
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161
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Prepaid expenses and other current assets
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1,223
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|
|
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1,266
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Total current assets
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58,165
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76,848
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Property and equipment, net
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779
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1,096
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Intangible and other assets, net
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201
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|
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240
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Total assets
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$
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59,145
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$
|
78,184
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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Current liabilities:
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Accounts payable
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$
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1,462
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$
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1,219
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Accrued expenses and other current liabilities
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5,732
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|
4,857
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Total current liabilities
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7,194
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|
|
|
6,076
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Other long-term liabilities
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|
|
262
|
|
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|
234
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Commitments and contingencies
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Stockholders’ equity:
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Common stock, $0.001 par value: 120,000,000 shares authorized at
both June 30, 2012 and December 31, 2011; 62,809,673 and 62,790,223
shares issued and outstanding at June 30, 2012 and December 31,
2011, respectively
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63
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|
63
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Additional paid-in capital
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459,261
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457,985
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Accumulated deficit
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(407,635
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)
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|
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(386,174
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)
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Total stockholders’ equity
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|
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51,689
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|
|
|
71,874
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|
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Total liabilities and stockholders’ equity
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|
$
|
59,145
|
|
|
$
|
78,184
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GTx, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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2012
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2011
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2012
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2011
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Revenues:
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Product sales, net
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$
|
1,639
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|
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$
|
1,645
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$
|
3,468
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|
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$
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2,874
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Collaboration revenue
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|
|
-
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|
|
|
-
|
|
|
|
-
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|
|
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8,066
|
|
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Total revenues
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|
|
1,639
|
|
|
|
1,645
|
|
|
|
3,468
|
|
|
|
10,940
|
|
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Costs and expenses:
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|
|
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|
|
|
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Cost of product sales
|
|
|
245
|
|
|
|
264
|
|
|
|
519
|
|
|
|
469
|
|
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Research and development expenses
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|
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9,237
|
|
|
|
7,591
|
|
|
|
19,072
|
|
|
|
14,894
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|
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General and administrative expenses
|
|
|
2,591
|
|
|
|
4,470
|
|
|
|
5,399
|
|
|
|
9,154
|
|
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Total costs and expenses
|
|
|
12,073
|
|
|
|
12,325
|
|
|
|
24,990
|
|
|
|
24,517
|
|
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Loss from operations
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|
|
(10,434
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)
|
|
|
(10,680
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)
|
|
|
(21,522
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)
|
|
|
(13,577
|
)
|
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Other income, net
|
|
|
53
|
|
|
|
7
|
|
|
|
61
|
|
|
|
309
|
|
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Net loss
|
|
$
|
(10,381
|
)
|
|
$
|
(10,673
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)
|
|
$
|
(21,461
|
)
|
|
$
|
(13,268
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)
|
|
|
|
|
|
|
|
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Net loss per share:
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.17
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.26
|
)
|
|
|
|
|
|
|
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Weighted average shares used in computing net loss per share:
|
|
|
|
|
|
|
|
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Basic and diluted
|
|
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62,805,662
|
|
|
|
51,968,667
|
|
|
|
62,801,835
|
|
|
|
51,844,616
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Source: GTx, Inc.
GTx, Inc.
Marc Hanover, President, 901-523-9700
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