Exhibit 99.1
Contact:
Carney Duntsch Jonathan M. Nugent
GTx, Inc. Kathy L. Jones, Ph.D
Manager, Communications Burns McClellan, Inc.
901-523-9700 170 212-213-0006
GTX, INC. REPORTS FIRST QUARTER 2004 FINANCIAL RESULTS
MEMPHIS, Tenn - April 19, 2004--GTx, Inc. (Nasdaq: GTXI), a biopharmaceutical
company dedicated to the development and commercialization of therapeutic
products for men's health, today reported financial results for the first
quarter ended March 31, 2004. The total net loss for the quarter was $5.8
million, compared with a net loss of $2.8 million for the same period in 2003.
Research and development expenses increased 105% to $4.3 million for the first
quarter of 2004 from $2.1 million for the first quarter of 2003. This increase
was mainly attributable to planned expenditures related to the pivotal Phase III
clinical trial of ACAPODENE(TM) (Toremifene Citrate) tablets for the treatment
of side effects of androgen deprivation therapy, expenses related to the Phase
IIb clinical trial of ACAPODENE(TM) for reduction of prostate cancer in men with
PIN, continued clinical development of andarine, and continued preclinical
development of other product candidates in the company's Selective Androgen
Receptor Modulator (SARM) program. General and administrative expenses increased
162% during the quarter to $1.6 million from $610,000 for the first quarter of
2003, primarily as a result of increases in personnel and insurance costs, as
well as increased professional fees resulting from reporting obligations
applicable to public companies.
On February 6, 2004, GTx completed an initial public offering (IPO) of 5.4
million shares of common stock at a price of $14.50 per share resulting in net
proceeds of approximately $70 million. Concurrent with the IPO, all outstanding
shares of preferred stock and accrued dividends were converted into 11,521,075
shares of common stock. At March 31, 2004, GTx had outstanding 24,656,923 shares
of common stock.
During the first quarter of 2004, GTx recognized $52,000 of revenue from
amortization of the upfront license fee received from its collaboration and
license agreement with Ortho Biotech Products L. P., a subsidiary of Johnson &
Johnson. At March 31, 2004, GTx had cash and cash equivalents of approximately
$80.6 million.
Corporate Highlights
On March 17, 2004, GTx announced that it had entered into a joint collaboration
and license agreement with Ortho Biotech Products L.P., a subsidiary of Johnson
& Johnson, for andarine, GTx's most advanced SARM compound, and specified backup
SARM compounds. Under the terms of the agreement, GTx received an upfront
licensing fee and will receive reimbursement of expenses in the aggregate of
approximately $6.7 million. Additionally, GTx will receive licensing fees and
milestone payments up to $82 million for andarine and up to $45 million for each
additional specified backup compound achieving specific clinical development
decisions or obtaining regulatory approvals. Johnson & Johnson Pharmaceutical
Research and Development will be responsible for further clinical development
and expenses for collaboration compounds, and Ortho Biotech will be responsible
for all commercialization activities and expenses. We anticipate initiating the
Phase II for andarine in 2004.
Pending FDA approval of andarine, Ortho Biotech will be exclusively responsible
for worldwide marketing. Under the agreement, GTx has the option to co-promote
andarine and other specified backup compounds to urologists in the U.S. for uses
related to men's health. GTx will receive up to double digit royalties on all
sales, as well as additional royalty payments in excess of 20% on all
co-promoted sales to urologists in the U.S.
"This agreement combines GTx's expertise in SARMs and men's health with the
world class research and marketing capabilities of Ortho Biotech. We believe
that andarine could become the first product in this new class of drugs," said
Mitchell Steiner. M.D., F.A.C.S., Vice-Chairman and CEO of GTx.
GTx continues to make progress in other clinical programs including its most
advanced Selective Estrogen Receptor Modulator (SERM) compound, ACAPODENE(TM).
ACAPODENE(TM) is being studied in two indications: (i) the reduction of
incidence of prostate cancer in men with high grade PIN (Prostatic
Intraepithelial Neoplasia) and (ii) the treatment of side effects of androgen
deprivation therapy for those with advanced prostate cancer.
Conference Call
There will be a conference call today at 10:30 a.m. Eastern Time to discuss
GTx's first quarter financial results and to provide a company update. If you
would like to participate in the call, please dial 800-915-4836 from the United
States or Canada or 973-317-5319 from outside North America. A playback of the
call will be available today from approximately 12:00 p.m. Eastern Time through
April 26, 2004 and may be accessed by dialing 800-428-6051 from the United
States or Canada or 973-709-2089 from outside North America. The rebroadcast
code is 349402.
About GTx, Inc.
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 currently has two product candidates that are in human
clinical trials. GTx is currently conducting clinical trials on ACAPODENE(TM),
its most advanced product candidate, for two separate indications: (i) a Phase
IIb clinical trial to assess the effect of toremifene in the reduction in the
incidence of prostate cancer in men with precancerous prostate lesions and (ii)
a pivotal Phase III clinical trial to assess the effect of toremifene in the
treatment of serious side effects of advanced prostate cancer therapy. GTx is
developing its second product candidate, andarine, and other specified backup
compounds, with Ortho Biotech. 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 our current and anticipated clinical trials and
the matters discussed in the "Corporate Highlights" section. 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; neither GTx nor its partner will be able to commercialize GTx's product
candidates if its preclinical studies do not produce successful results or its
clinical trials do not demonstrate safety and efficacy in humans; if third
parties do not manufacture GTx'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 GTx will not have adequate supplies of its product candidates; if
third parties on whom GTx relies do not perform as contractually required or
expected, GTx may not be able to obtain regulatory approval for or commercialize
its product candidates; GTx is currently and expects to continue to be 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 GTx; and if GTx is not able to obtain required regulatory
approvals, GTx will not be able to commercialize its product candidates. 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
MARCH 31,
----------------------------------
2004 2003
------------ ------------
Revenue $ 52 $ --
Operating expenses:
Research and development 4,336 2,113
General and administrative 1,600 610
Depreciation 87 87
------------ ------------
Total operating expenses 6,023 2,810
------------ ------------
Loss from operations (5,971) (2,810)
Interest income 150 29
------------ ------------
Net loss (5,821) (2,781)
Accrued preferred stock dividends (455) (683)
Adjustments to preferred stock redemption value 17,125(1) (73)
------------ ------------
Net income (loss) attributable to common stockholders $ 10,849 $ (3,537)
============ ============
Net income (loss) per share attributable to common stockholders:
Basic $ 0.60 $ (0.46)
============ ============
Diluted $ (0.26)(2) $ (0.46)
============ ============
Weighted average shares used in computing net loss per share
attributable to common stockholders:
Basic 17,962,871(3) 7,734,998
============ ============
Diluted 22,520,659(2) 7,734,998
============ ============
(1) The adjustments to preferred stock redemption value, for the three months
ended March 31, 2004, represents the adjustment of the preferred stock carrying
value to reflect the redemption value (fair value) on the date that all
preferred stock and accrued dividends thereon were converted to common stock
effective upon the closing of the Company's initial public offering on February
6, 2004.
(2) Diluted net loss per share for the quarter ended March 31, 2004 is
calculated as if the conversion of all preferred stock, and accrued dividends
thereon, into shares of common stock occurred on January 1, 2004. As a result,
diluted net loss per share attributable to common stockholders for the quarter
ended March 31, 2004 does not include accrued preferred stock dividends or the
adjustments to preferred stock redemption value discussed in Footnote 1. In
addition, the weighted average shares used in computing diluted net loss per
share for the quarter included an additional 11,456,905 shares to reflect the
assumed conversion of preferred stock, and accrued dividends thereon, into
common stock and 3,263,736 shares to reflect the weighted average effect during
the quarter of 5.4 million shares issued in the IPO.
(3) The weighted average shares used in computing basic net income per share for
the quarter ended March 31, 2004 include 3,263,736 shares, which represent the
weighted average effect during the quarter of the issuance of 5.4 million shares
of common stock in the IPO, and 6,963,287 shares, which represent the weighted
average effect during the quarter of the issuance of 11,521,075 shares for the
conversion of all preferred stock, and accrued dividends thereon, into common
stock at the closing of the IPO. At March 31, 2004, the Company had outstanding
24,656,923 shares of common stock.
GTX, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS)
MARCH 31, DECEMBER 31,
2004 2003
--------- ---------
(UNAUDITED)
ASSETS
Cash and cash equivalents $ 80,620 $ 14,769
Other current assets 7,903 255
--------- ---------
Total current assets 88,523 15,024
Property and equipment, net 799 815
Deferred initial public offering costs -- 1,471
--------- ---------
Total assets $ 89,322 $ 17,310
========= =========
LIABILITIES, CUMULATIVE CONVERTIBLE REDEEMABLE
PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities $ 4,169 $ 2,249
Deferred revenue 5,298 --
Cumulative convertible redeemable preferred stock --(1) 165,292
Total stockholders' equity (deficit) 79,855(1) (150,231)
--------- ---------
Total liabilities and stockholders' equity (deficit) $ 89,322 $ 17,310
========= =========
(1) March 31, 2004 balances reflect the conversion of all outstanding
shares of preferred stock, and accrued dividends thereon, into common
stock and the proceeds on the Company's initial public offering which
closed February 6, 2004.
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