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 THIRD QUARTER 2004 FINANCIAL RESULTS
MEMPHIS, Tenn - November 11, 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 three and nine-month periods ended September
30, 2004. The net loss for the three and nine-month periods was $5.1 million and
$15.5 million, respectively, compared with a net loss of $3.4 million and $9.6
million for the same periods in 2003. At September 30, 2004, GTx had cash and
cash equivalents of $76.1 million.
"We have made significant progress during this quarter for both indications of
our lead product candidate, ACAPODENE(TM), through carefully designed clinical
plans and dedication to fiscal responsibility." said Mitchell Steiner, M.D., CEO
of GTx. "We expect to continue to meet our milestones with the advancement of
the Phase III clinical trial for ACAPODENE(TM) for the treatment of serious side
effects of androgen deprivation therapy for advanced prostate cancer as well as
initiating the pivotal Phase III clinical trial for ACAPODENE(TM) to prevent
prostate cancer in high risk men. In addition, we continue to focus on our SARM
program, first through our partnership with Johnson and Johnson for andarine,
and second by strategically moving other compounds, including ostarine, into
Phase I clinical trials."
Revenue for the three and nine-month periods ended September 30, 2004 was $0.4
million and $1.5 million, respectively, and resulted from 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 for the three and nine-month periods ended
September 30, 2004 were $3.9 million and $12.3 million, respectively, compared
to $2.4 million and $7.1 million during the same periods of 2003. The increase
in expenses for both periods was primarily the result of GTx's growing
investment in its lead clinical program for ACAPODENE(TM) (toremifene citrate)
in an ongoing pivotal Phase III clinical trial for the treatment of serious side
effects of androgen deprivation therapy for advanced prostate cancer. The
increases in research and development expenses also included (1) continuing
development of GTx's second clinical program, andarine, (2) preclinical
development of its other selective androgen receptor modulator (SARM) compounds,
including ostarine and (3) preclinical development of other product candidates
including andromustine.
General and administrative expenses for the three and nine-month periods ended
September 30, 2004 were $1.8 million and $5.0 million, respectively, compared to
the $0.9 million and $2.3 million for the same periods in 2003. The increase in
both periods 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.
Diluted net loss per share attributable to common stockholders for the three and
nine-month periods ended September 30, 2004 was $0.21 and $0.65, respectively,
compared to $11.08 and $11.46 for the same periods in 2003.
Based on our results through the third quarter and our forecasted spending for
the fourth quarter, the Company has revised its 2004 financial guidance to
reduce its anticipated net loss of $28 to $33 million to $21 to $25 million.
This revision is primarily related to the timing of expenditures for the
Company's clinical trials, the cost of which the Company anticipates incurring
in the first half of 2005. The Company remains on track for completing its
clinical trials within the previously announced time frames.
Third Quarter 2004 Corporate Highlights
GTx entered into a collaboration agreement with Tessera, Inc., a diagnostic lab.
GTx will provide clinical samples to Tessera, from its completed Phase IIb
ACAPODENE(TM) clinical trial for the prevention of prostate cancer in high risk
men. This is the third collaboration that GTx has forged with diagnostic
companies that have expertise in prostate cancer. The other two companies are
Hybritech, a subsidiary of Beckman Coulter, in San Diego and diaDexus in South
San Francisco. These collaborations are intended to develop a commercial blood
or urine test which could detect high grade prostatic intraepithelial neoplasia
(PIN) in the 9.4 million men in the US who unknowingly harbor these precancerous
lesions of the prostate and are at high risk for developing prostate cancer.
GTx appointed Timothy R. G. Sear as a new independent board member. Mr. Sear
currently serves as Chairman of the board of directors of Alcon, Inc. and
recently served as its President and CEO.
Conference Call
There will be a conference call today at 10:00 a.m. Eastern Time to discuss
GTx's third quarter financial results and to provide a company update. If you
would like to participate in the call, please dial 800-819-9193 from the United
States or Canada or 913-981-4911 from outside North America. A playback of the
call will be available today from approximately 1:00 p.m. Eastern Time through
November 18, 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 923532. 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 for 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. The company is
developing ACAPODENE(TM), its most advanced product candidate, through clinical
trials for two separate indications: (1) a planned pivotal Phase III clinical
trial for the reduction in the incidence 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. GTx is developing
its second product candidate, andarine, and other specified backup compounds,
with its partner, Ortho Biotech Products, L.P., a subsidiary of
Johnson & Johnson. It is currently anticipated that andarine will be entering a
Phase II clinical trial in 2005. GTx is developing another one of its SARMs,
ostarine, for andropause. GTx has a deep pipeline generated from its own
discovery program which includes specific product candidates prostarine, a SARM
for benign prostatic hyperplasia or 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 potential future licensing fees and milestone
and royalty payments and GTx's current and anticipated clinical trials and
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 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 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 SHARE AND PER SHARE DATA)
(UNAUDITED)
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
------------- -------------
2004 2003 2004 2003
---- ---- ---- ----
Collaboration revenue:
License fees $ 335 $ -- $ 721 $ --
Reimbursement of development costs 42 -- 802 --
------------ ------------ ------------ ------------
Total collaboration revenue 377 -- 1,523 --
Operating expenses:
Research and development 3,859 2,420 12,334 7,123
General and administrative 1,781 928 4,966 2,339
Depreciation 132 89 320 264
------------ ------------ ------------ ------------
Total operating expenses 5,772 3,437 17,620 9,726
------------ ------------ ------------ ------------
Loss from operations (5,395) (3,437) (16,097) (9,726)
Interest income 270 36 632 79
------------ ------------ ------------ ------------
Net loss (5,125) (3,401) (15,465) (9,647)
Accrued preferred stock dividends -- (934) (455) (2,300)
Adjustments to preferred stock redemption value -- (81,402) 17,125 (76,666)
------------ ------------ ------------ ------------
Net income (loss) attributable to common stockholders $ (5,125) $ (85,737) $ 1,205 $ (88,613)
============ ============ ============ ============
Net income (loss) per share attributable to common
stockholders:
Basic $ (0.21) $ (11.08) $ 0.05 $ (11.46)
============ ============ ============ ============
Diluted $ (0.21) $ (11.08) $ (0.65) $ (11.46)
============ ============ ============ ============
Weighted average shares used in computing net income
(loss) per share attributable to common stockholders:
Basic 24,656,923 7,734,998 22,433,716 7,734,998
============ ============ ============ ============
Diluted 24,656,923 7,734,998 23,883,264 7,734,998
============ ============ ============ ============
GTX, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS)
SEPTEMBER 30, DECEMBER 31,
2004 2003
---- ----
(UNAUDITED)
ASSETS
Cash and cash equivalents $ 76,095 $ 14,769
Other current assets 1,189 255
--------- ---------
Total current assets 77,284 15,024
Property and equipment, net 1,523 815
Other assets 348 --
Deferred initial public offering costs -- 1,471
--------- ---------
Total assets $ 79,155 $ 17,310
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LIABILITIES, CUMULATIVE REDEEMABLE CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS' EQUITY (DEFICIT)
Accounts payable and accrued expenses $ 2,610 $ 2,249
Deferred revenue, current 1,338 --
--------- ---------
Total current liabilities 3,948 2,249
Deferred revenue 4,628 --
Cumulative redeemable convertible preferred stock -- 165,292
Total stockholders' equity (deficit) 70,579 (150,231)
--------- ---------
Total liabilities and stockholders' equity (deficit) $ 79,155 $ 17,310
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