Exhibit 99.1
Contact:
Marc S. Hanover
GTx, Inc.
President and Chief Operating Officer
901-523-9700
GTX, INC. REPORTS FIRST QUARTER 2005 FINANCIAL RESULTS
MEMPHIS, TENN. - April 28, 2005--GTx, Inc. (Nasdaq: GTXI), a biopharmaceutical
company dedicated to the discovery, development and commercialization of
therapeutics for serious men's health conditions and oncology, today reported
financial results for the first quarter of 2005. The net loss for the first
quarter ended March 31, 2005 was $9.1 million compared with a net loss of $5.8
million for the same period in 2004. At March 31, 2005, GTx had cash and cash
equivalents of $55.6 million.
"We continue to meet our Company's stated goals, and we are particularly pleased
to have the opportunity to showcase our latest clinical results for our lead
drug, ACAPODENE(R) (toremifene citrate), at the upcoming annual meeting of the
American Society of Clinical Oncology," said Mitchell Steiner, M.D., CEO of GTx.
"Our team, along with our physician investigators, has done an excellent job
advancing our four clinical programs and consistently achieving our medical and
commercial objectives."
Revenues for the quarter ended March 31, 2005 were $687,000 as compared to
$52,000 for the first quarter of 2004. The first quarter revenues for 2005 were
comprised of net sales of FARESTON(R) (toremifene citrate 60 mg), marketed for
the treatment of metastatic breast cancer, and collaboration income from our
partner, Ortho Biotech, L.P., a subsidiary of Johnson & Johnson, for andarine,
one of our proprietary selective androgen receptor modulator (SARM) compounds.
FARESTON net sales were $353,000 and cost of goods sold was $245,000 while the
collaboration income from Ortho Biotech, L.P. was $334,000.
Research and development expenses for the first quarter of 2005 were $7.3
million, compared to $4.4 million for the same period of 2004. The $2.9 million
increase in research and development expenses was primarily the result of the
Company's continued investment in the following clinical programs:
o ACAPODENE (toremifene citrate 20 mg) in a pivotal Phase III
clinical trial for the prevention of prostate cancer in high
risk men.
o ACAPODENE (toremifene citrate 80 mg) in a pivotal Phase III
clinical trial for the treatment of serious side effects of
androgen deprivation.
o Ostarine in a recently completed Phase I single ascending dose
clinical trial in 96 volunteers, which is being developed for
andropause and other chronic conditions related to aging. GTx
retains the exclusive rights to ostarine, which is the second
SARM that GTx has developed from discovery into clinical
trials.
General and administrative expenses for the quarter ended March 31, 2005 were
$2.5 million, compared to $1.6 million for the same period in 2004. The
difference primarily resulted from increased personnel costs to support the
Company's growth, higher insurance costs and increased patent costs and
professional fees.
FIRST QUARTER 2005 CORPORATE HIGHLIGHTS
o Initiated a pivotal Phase III clinical trial of ACAPODENE for
the prevention of prostate cancer in high risk men.
o Completed a Phase I single ascending dose clinical trial for
ostarine, GTx's second SARM compound to enter clinical trials.
CONFERENCE CALL
There will be a conference call today at 10 a.m. Eastern Time today to discuss
GTx's first quarter financial results and to provide a company update. To listen
to the conference call, please dial:
o 800-638-5495 from the United States and Canada or
o 617-614-3946 (International)
The access code for the call is 66040231.
A playback of the call will be available from approximately 12:00 p.m., Eastern
Time, on April 28 through May 5, 2005 and may be accessed by dialing:
o 888-286-8010 from the United States and Canada or
o 617-801-6888 (International),
referencing reservation number 76732232.
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 is a biopharmaceutical company dedicated to the discovery, development and
commercialization of therapeutics primarily related to the treatment of serious
men's health conditions and oncology. GTx's drug discovery and development
programs are focused on small molecules that selectively modulate the effects of
estrogens and androgens, two essential classes of hormones. GTx has a marketed
product and four clinical programs. The marketed product is FARESTON (toremifene
citrate 60mg) tablets for the treatment of metastatic breast cancer. The company
is developing the same active compound, toremifene citrate, as ACAPODENE in two
of its clinical programs for men: (1) a pivotal Phase III clinical trial for the
prevention of prostate cancer in high risk men and (2) a pivotal Phase III
clinical trial for the treatment of serious side effects of androgen deprivation
therapy for advanced prostate cancer. In its third clinical program, GTx and its
partner, Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson, are
developing andarine, a SARM, which they are working to progress to a Phase II
clinical trial in the second half of 2005. In its fourth clinical program, GTx
is developing its second SARM, ostarine, for andropause and other chronic
conditions related to aging, including sarcopenia. In addition, GTx has an
extensive preclinical pipeline generated from its own discovery program which
includes the specific product candidates, prostarine, a SARM for benign
prostatic hyperplasia (BPH), and andromustine, an anticancer drug, for hormone
refractory prostate cancer.
FORWARD-LOOKING INFORMATION IS SUBJECT TO RISK AND UNCERTAINTY
This press release contains forward-looking statements, including, without
limitation, statements related to GTx's current and anticipated clinical trials
and its other research and development programs. These forward-looking
statements are based upon GTx's current expectations. Forward-looking statements
involve risks and uncertainties. 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, risks that GTx will need substantial additional funding and may be
unable to raise capital when needed; GTx will not be able to achieve its
milestones within the time period indicated or at all; neither GTx nor its
partner will be able to commercialize its product candidates if preclinical
studies do not produce successful results or clinical trials do not demonstrate
safety and efficacy in humans; if third parties do not manufacture the Company's
product candidates in sufficient quantities and at an acceptable cost, clinical
development and commercialization of its product candidates would be delayed;
use of third-party manufacturers may increase the risk that the Company will not
have adequate supplies of its product candidates; if third parties on whom the
Company relies do not perform as contractually required or expected, the Company
may not be able to obtain regulatory approval for or commercialize its product
candidates; the Company is dependent upon collaborative arrangements to complete
the development and commercialization of some of its product candidates, and
these collaborative arrangements may place the development of its product
candidates outside its control, may require it to relinquish important rights or
may otherwise be on terms unfavorable to the Company; and if the Company is not
able to obtain required regulatory approvals, the Company will not be able to
commercialize its product candidates. You should not place undue reliance on
these forward-looking statements, which apply only as of the date of this press
release. The annual report filed on Form 10-K with the U.S. Securities and
Exchange Commission (the "SEC") on March 24, 2005 contains under the heading
"Additional Factors That Might Affect Future Results," 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.
GTX, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
(UNAUDITED)
THREE MONTHS ENDED
MARCH 31,
----------------------------
2005 2004
---------- ----------
Revenues:
Product sales, net $ 353 $ --
Collaboration revenue 334 52
---------- ----------
Total revenues 687 52
Costs and expenses:
Cost of goods sold 245 --
Research and development expenses 7,326 4,411
General and administrative expenses 2,520 1,612
---------- ----------
Total costs and expenses 10,091 6,023
---------- ----------
Loss from operations (9,404) (5,971)
Interest income 324 150
---------- ----------
Net loss (9,080) (5,821)
Accrued preferred stock dividends -- (455)
Adjustments to preferred stock redemption value -- 17,125
---------- ----------
Net (loss) income attributable to common stockholders $ (9,080) $ 10,849
========== ==========
Net (loss) income per share attributable to common stockholders:
Basic $ (0.37) $ 0.60
========== ==========
Diluted $ (0.37) $ (0.26)
========== ==========
Weighted average shares used in computing net (loss) income
per share attributable to common stockholders:
Basic 24,664,716 17,962,871
========== ==========
Diluted 24,664,716 22,456,489
========== ==========
GTX, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS)
MARCH 31, DECEMBER 31,
2005 2004
--------- ------------
(UNAUDITED)
ASSETS
Cash and cash equivalents $55,578 $64,528
Other current assets 2,908 1,624
------- -------
Total current assets 58,486 66,152
Property and equipment, net 1,612 1,537
Purchased intangible assets, net 4,901 4,943
Other assets 672 450
------- -------
Total assets $65,671 $73,082
======= =======
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 5,249 $ 3,517
Deferred revenue 1,337 1,337
------- -------
Total current liabilities 6,586 4,854
Deferred revenue 3,961 4,295
Capital lease obligation 23 24
Total stockholders' equity 55,101 63,909
------- -------
Total liabilities and stockholders' equity $65,671 $73,082
======= =======
# # #