Exhibit 99.1
Contact:
Carney Duntsch Jonathan M. Nugent
GTx, Inc. Kathy Nugent, Ph.D
Investor and Media Relations Burns McClellan, Inc.
901-523-9700 212-213-0006
GTX, INC. REPORTS SECOND QUARTER 2004 FINANCIAL RESULTS
MEMPHIS, Tenn - July 29, 2004--GTx, Inc. (Nasdaq: GTXI), a biopharmaceutical
company dedicated to the discovery, development and commercialization of
therapeutics for serious men's health conditions, today reported financial
results for the second quarter and six months ended June 30, 2004. The net loss
for the quarter and six-month period was $4.5 million and $10.3 million,
respectively, compared with a net loss of $3.5 million and $6.2 million for the
same periods in 2003.
"We are very pleased to report another positive quarter at GTx with significant
progress of our lead clinical program, ACAPODENE," said Mitchell Steiner, M.D.,
CEO of GTx. "We are focused on continuing the momentum in our clinical trials
for both ACAPODENE for prevention of prostate cancer and ACAPODENE for
supportive care of patients being treated for advanced prostate cancer. In
addition, our SARM program continues to progress successfully."
Revenue for both the second quarter and six months ended June 30, 2004 was $1.1
million, and resulted from the reimbursement of development costs and the
amortization of upfront fees. The revenue was associated with the Company's
collaboration and license agreement with Ortho Biotech Products L.P., a
subsidiary of Johnson & Johnson, for GTx's lead SARM compound, andarine.
Research and development expenses increased to $4.1 million for the second
quarter of 2004 from $2.6 million for the second quarter of 2003 and increased
to $8.5 million from $4.7 million for the first six months of 2004 as compared
to the same period in 2003. These increases reflect GTx's growing investment in
its lead clinical program for ACAPODENE(TM) (toremifene citrate) which includes
an ongoing pivotal Phase III clinical trial for the treatment of side effects of
androgen deprivation therapy (ADT) and a recently completed Phase IIb clinical
trial for the prevention of prostate cancer in high risk men with high grade
prostatic intraepithelial neoplasia (PIN). Increases in research and development
expenses also reflect continuing development of GTx's second clinical program,
andarine, and preclinical development of its other selective androgen receptor
modulator (SARM) compounds, including ostarine and andromustine.
General and administrative expenses increased during the quarter to $1.6 million
from $0.8 million for the second quarter of 2003 and increased to $3.2 million
for the first six months of 2004 from $1.4 million for the same period in 2003.
The increase primarily resulted from the addition of key personnel, increased
insurance costs and professional fees to support GTx's growth and its reporting
obligations as a public company.
At June 30, 2004, GTx had 24,656,923 shares of common stock outstanding, and
cash and cash equivalents of approximately $81.4 million.
Corporate Highlights
o On June 4, 2004, GTx announced positive Phase IIb clinical
trial results for its lead program ACAPODENE(TM). This is the
largest prospective study to determine the natural history of
patients with high grade PIN and the findings suggest that
ACAPODENE(TM) may be an effective agent in preventing prostate
cancer. Specifically, the trial demonstrated that
ACAPODENE(TM) 20mg can produce a clinically significant
reduction of prostate cancer cumulative risk over one year.
Patients treated with ACAPODENE(TM) 20mg had a lower incidence
of prostate cancer compared to placebo, 24.4% vs. 31.2%
respectively. The study also revealed that patients who were
treated with ACAPODENE(TM) for the entire 12 months had a 48%
reduction in prostate cancer incidence. Following discussions
with the Food and Drug Administration (FDA), GTx plans to
initiate a pivotal Phase III clinical trial to confirm these
positive findings.
o GTx entered into collaboration agreements with diagnostic labs
Hybritech, Inc., a wholly owned subsidiary of Beckman Coulter,
Inc. and diaDexus, Inc. GTx will provide clinical samples to
these diagnostic labs from its now completed Phase IIb
ACAPODENE(TM) trial. These collaborations are intended to
develop a commercial blood or urine test which could detect
high grade PIN in the millions of men who unknowingly harbor
this precancerous lesion of the prostate or who may develop
prostate cancer.
o At the 40th Annual Meeting of the American Society of Clinical
Oncology (ASCO), results were presented describing data from
GTx's Phase II clinical trial for the treatment of side
effects associated with ADT and data from a preclinical study
designed to demonstrate ACAPODENE's(TM) ability to prevent
bone loss as a result of ADT in rats. In addition,
presentations on GTx's SARM program were made at the Endocrine
Society Meeting and the National Chemistry Symposium.
o GTx announced the Urology Resident Research Fellowship
program, in partnership with the Department of Urology at the
University of Tennessee College of Medicine. This program will
allow urology residents from the University of Tennessee to
spend a research rotation at the GTx research laboratories.
This program underscores GTx's commitment to the continued
development of drugs to treat serious men's health conditions.
By exposing these residents to our scientists and clinicians,
we are helping to develop well-rounded urologists who will not
only contribute to cutting-edge research during their time in
the GTx labs, but will also be better able to treat their
patients as they enter their own practices.
Conference Call
There will be a conference call today at 10:00 a.m. Eastern Time to discuss
GTx's second quarter financial results and to provide a company update. If you
would like to participate in the call, please dial 877-847-5346 from the United
States or Canada or 719-867-0720 from outside North America. A playback of the
call will be available on July 29, 2004 from approximately 1:00 p.m. Eastern
Time through August 5, 2004 and may be accessed by dialing 888-203-1112 from the
United States or Canada or 719-457-0820 from outside North America, and
referencing reservation number 280922. To access the archived recording, visit
the GTx website at 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. GTx's drug discovery and development programs are
focused on small molecules that selectively modulate the effects of estrogens
and androgens. GTx has two clinical programs: In the first clinical program, GTx
is developing ACAPODENE(TM), its most advanced product candidate for two
separate indications: (1) a pivotal Phase III clinical trial for the treatment
of serious side effects of advanced prostate cancer therapy and (2) its
completed Phase IIb clinical trial for the reduction in the incidence of
prostate cancer in high risk men with precancerous prostate lesions. In the
second clinical program, GTx is developing andarine, and other specified backup
compounds, with its partner, Ortho Biotech Products, L.P., a subsidiary of
Johnson & Johnson. Andarine will be entering a planned Phase II clinical trial
this year. GTx retains all rights to the discovery, development, and
commercialization of the rest of its SARM program including its other specific
product candidates ostarine, prostarine and andromustine.
Forward Looking Statements
This press release contains forward-looking statements, including, without
limitation, statements related to GTx's current and anticipated clinical trials
of ACAPODENE(TM) 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 neither GTx nor its collaboration
partners will not 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 the press
release. The annual report filed on Form 10-K with the U.S. Securities and
Exchange Commission on March 26, 2004 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 PER SHARE AMOUNTS)
(UNAUDITED)
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
----------------------------- -----------------------------
2004 2003 2004 2003
------------ ------------ ------------ ------------
Collaboration revenue:
License fees $ 334 $ -- $ 386 $ --
Reimbursement of development costs 760 -- 760 --
------------ ------------ ------------ ------------
Total collaboration revenue 1,094 -- 1,146 --
Operating expenses:
Research and development 4,139 2,590 8,475 4,703
General and administrative 1,585 801 3,185 1,411
Depreciation 101 88 188 175
------------ ------------ ------------ ------------
Total operating expenses 5,825 3,479 11,848 6,289
------------ ------------ ------------ ------------
Loss from operations (4,731) (3,479) (10,702) (6,289)
Interest income 212 14 362 43
------------ ------------ ------------ ------------
Net loss (4,519) (3,465) (10,340) (6,246)
Accrued preferred stock dividends -- (683) (455) (1,366)
Adjustments to preferred stock redemption value -- 4,809 17,125 4,736
------------ ------------ ------------ ------------
Net income (loss) attributable to common stockholders $ (4,519) $ 661 $ 6,330 $ (2,876)
============ ============ ============ ============
Net income (loss) per share attributable to common
stockholders:
Basic $ (0.18) $ 0.09 $ 0.30 $ (0.37)
============ ============ ============ ============
Diluted $ (0.18) $ (0.22) $ (0.44) $ (0.39)
============ ============ ============ ============
Weighted average shares used in computing net loss
per share attributable to common stockholders:
Basic 24,656,923 7,734,998 21,309,897 7,734,998
============ ============ ============ ============
Diluted 24,656,923 15,982,982 23,524,621 15,886,677
============ ============ ============ ============
GTX, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS)
JUNE 30, DECEMBER 31,
2004 2003
------- ------------
(UNAUDITED)
ASSETS
Cash and cash equivalents $81,444 $ 14,769
Other current assets 1,928 255
------- ---------
Total current assets 83,372 15,024
Property and equipment, net 1,439 815
Other assets 231 --
Deferred initial public offering costs -- 1,471
------- ---------
Total assets $85,042 $ 17,310
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LIABILITIES, CUMULATIVE CONVERTIBLE REDEEMABLE PREFERRED STOCK AND
STOCKHOLDERS' EQUITY (DEFICIT)
Accounts payable and accrued expenses $ 3,221 $ 2,249
Deferred revenue, current 1,338 --
------- ---------
Total current liabilities 4,559 2,249
Deferred revenue 4,963 --
Cumulative redeemable convertible preferred stock -- 165,292
Total stockholders' equity (deficit) 75,520 (150,231)
------- ---------
Total liabilities and stockholders' equity (deficit) $85,042 $ 17,310
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