Exhibit 99.1
Contact:
Marc S. Hanover
GTx, Inc.
President and Chief Operating Officer
901-523-9700
GTX, INC. REPORTS SECOND QUARTER 2005 FINANCIAL RESULTS
MEMPHIS, TENN. - July 28, 2005 -- GTx, Inc. (Nasdaq: GTXI), a biopharmaceutical
company dedicated to the discovery, development and commercialization of
therapeutics for cancer and other serious men's health conditions, today
reported financial results for the second quarter of 2005. The net loss for the
second quarter and six months ended June 30, 2005 was $10.0 million and $19.1
million, respectively, compared with a net loss of $4.5 million and $10.3
million for the same periods in 2004. At June 30, 2005, GTx had cash and cash
equivalents of $48.1 million.
"We continue to achieve our objectives for 2005," said Mitchell Steiner, M.D.,
CEO of GTx. "Both Phase III clinical trials of ACAPODENE for two separate
indications are enrolling on schedule. Our ostarine clinical trials are
advancing as planned. Ostarine is a SARM to which GTx holds exclusive rights and
is the second SARM developed by GTx to enter clinical trials. Next month we will
complete the Phase I multiple ascending dose clinical trial for ostarine and
will present scientific conclusions from this trial shortly thereafter.
Preparations for the ostarine Phase II trials are underway."
Revenues for the quarter and six months ended June 30, 2005 were $1.8 million
and $2.5 million, respectively, as compared to $1.1 million for the second
quarter and first six months of 2004. Revenues for 2005 included net sales of
FARESTON(R) (toremifene citrate 60 mg), marketed for the treatment of metastatic
breast cancer, and collaboration revenue from our partner, Ortho Biotech
Products, L.P., a subsidiary of Johnson & Johnson, for andarine, one of our
proprietary selective androgen receptor modulator (SARM) compounds. Revenues for
2004 consisted of collaboration revenue and reimbursement of development costs
from Ortho Biotech Products, L.P.
Research and development expenses for the second quarter and first six months of
2005 were $8.6 million and $16.0 million, respectively, compared to $4.2 million
and $8.6 million for the
same periods of 2004. The increase in research and development expenses was
primarily the result of the Company's continued investment in the following
clinical programs:
o ACAPODENE(R) (toremifene citrate 20 mg) in a pivotal Phase III clinical
trial for the prevention of prostate cancer in high risk men.
o ACAPODENE(R) (toremifene citrate) 80 mg dose in a pivotal Phase III
clinical trial for the treatment of serious side effects of androgen
deprivation therapy for advanced prostate cancer.
o Ostarine in Phase I single and multiple ascending dose clinical trials.
Ostarine is being developed for andropause and other chronic wasting
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 and six months ended June
30, 2005 were $2.6 million and $5.2 million, respectively, compared to $1.6
million and $3.2 million for the same periods in 2004. The increases in both
periods primarily resulted from increased personnel costs to support the
Company's growth, higher insurance costs and increased patent costs and
professional fees.
SECOND QUARTER 2005 CORPORATE HIGHLIGHTS
o The patient enrollment in both pivotal Phase III clinical trials of
ACAPODENE for two separate indications is on schedule.
o Presented the ACAPODENE Phase IIb clinical results for the prevention of
prostate cancer in high risk men at the annual meeting of the American
Society of Clinical Oncology and to the American Urological
Association.
o Initiated a second Phase I clinical trial evaluating multiple ascending
doses of ostarine in healthy and elderly men.
o Appointed Robert Karr, M.D. to the Board of Directors. Dr. Karr served as
Senior Vice President, Strategic Management at Pfizer, Inc. and brings
to GTx additional senior executive pharmaceutical industry knowledge
and strategic experience in research and development.
CONFERENCE CALL
There will be a conference call today at 10 a.m. Eastern Time today to discuss
GTx's second quarter financial results and to provide a company update. To
listen to the conference call, please dial:
o 800-322-5044 from the United States and Canada or
o 617-614-4927 (International)
The access code for the call is 83170819.
A playback of the call will be available from approximately 12:00 p.m., Eastern
Time, on July 28 through August 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 27915479.
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 cancer
and other 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, two essential classes of hormones.
GTx has four clinical programs. The company is developing ACAPODENE(R)
(toremifene citrate 80 mg and 20 mg) for two separate indications in men: (1) a
pivotal Phase III clinical trial for the treatment of serious side effects of
androgen deprivation therapy for advanced prostate cancer, and (2) a pivotal
Phase III clinical trial for the prevention of prostate cancer in high risk men.
In its third clinical program, GTx and its partner, Ortho Biotech Products,
L.P., a subsidiary of Johnson & Johnson, are developing andarine, a SARM, for
cancer cachexia. In its fourth clinical program, GTx is developing its second
SARM, ostarine, for andropause and other chronic wasting conditions related to
aging, including frailty and sarcopenia. GTx maintains exclusive rights to
ostarine. GTx also has a marketed product, FARESTON(R) (toremifene citrate 60mg)
tablets, utilizing the same active pharmaceutical ingredient as ACAPODENE(R),
for the treatment
of metastatic breast cancer. 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 candidate, for hormone refractory prostate
cancer. Additional information can be found at the company's web site,
www.gtxinc.com.
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 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 BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE DATA)
JUNE 30, DECEMBER 31,
2005 2004
------------ ------------
(UNAUDITED)
ASSETS
Current assets:
Cash and cash equivalents $ 48,082 $ 64,528
Inventory 241 448
Prepaid expenses and other current assets 1,577 1,176
--------- ---------
Total current assets 49,900 66,152
Property and equipment, net 1,843 1,537
Purchased intangible assets, net 5,027 4,943
Other assets 956 450
--------- ---------
Total assets $ 57,726 $ 73,082
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 2,875 $ 900
Accrued expenses 4,595 2,617
Deferred revenue 1,337 1,337
--------- ---------
Total current liabilities 8,807 4,854
Deferred revenue 3,626 4,295
Capital lease obligation 21 24
Stockholders' equity:
Common stock, $0.001 par value: 60,000,000 shares authorized; 24,664,716
shares issued and outstanding at June 30, 2005 and December 31, 2004 25 25
Deferred stock compensation (2,286) (2,701)
Additional paid-in capital 224,063 224,015
Accumulated deficit (176,530) (157,430)
--------- ---------
Total stockholders' equity 45,272 63,909
--------- ---------
Total liabilities and stockholders' equity $ 57,726 $ 73,082
========= =========
GTX, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
(UNAUDITED)
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
--------------------------- ----------------------------
2005 2004 2005 2004
------------ ------------ ------------- ------------
Revenues:
Product sales, net $ 1,492 $ -- $ 1,845 $ --
Collaboration revenue 335 334 669 386
Reimbursement of development costs -- 760 -- 760
------------ ------------ ------------ ------------
Total revenue 1,827 1,094 2,514 1,146
Costs and expenses:
Costs of goods sold 920 -- 1,165 --
Research and development expenses 8,639 4,224 15,965 8,635
General and administrative expenses 2,642 1,601 5,162 3,213
------------ ------------ ------------ ------------
Total costs and expenses 12,201 5,825 22,292 11,848
------------ ------------ ------------ ------------
Loss from operations (10,374) (4,731) (19,778) (10,702)
Interest income 354 212 678 362
------------ ------------ ------------ ------------
Net loss (10,020) (4,519) (19,100) (10,340)
Accrued preferred stock dividends -- -- -- (455)
Adjustments to preferred stock redemption value -- -- -- 17,125
------------ ------------ ------------ ------------
Net (loss) income attributable to common stockholders $ (10,020) $ (4,519) $ (19,100) $ 6,330
============ ============ ============ ============
Net (loss) income per share attributable to common
stockholders:
Basic $ (0.41) $ (0.18) $ (0.77) $ 0.30
============ ============ ============ ============
Diluted $ (0.41) $ (0.18) $ (0.77) $ (0.44)
============ ============ ============ ============
Weighted average shares used in computing net (loss)
income per share attributable to common stockholders:
Basic 24,664,716 24,656,923 24,664,716 21,309,897
============ ============ ============ ============
Diluted 24,664,716 24,656,923 24,664,716 23,524,621
============ ============ ============ ============
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