Exhibit 99.1
GTX, INC. REPORTS FOURTH QUARTER AND YEAR-END 2003 FINANCIAL RESULTS
Memphis, Tennessee. (March 3, 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
fourth quarter and year ended December 31, 2003.
For the fourth quarter ended December 31, 2003, GTx reported a net loss of $4.5
million compared with a net loss of $3.5 million for the fourth quarter of 2002.
For the year ended December 31, 2003, the Company reported a net loss of $14.2
million compared with a net loss of $11.9 million for the year ended December
31, 2002. At December 31, 2003, the Company had cash and cash equivalents of
$14.8 million compared to $8.9 million at December 31, 2002. As previously
reported, on February 6, 2004, the Company completed an initial public offering
of 5.4 million shares of common stock at a public offering price of $14.50 per
share, resulting in net proceeds of approximately $70 million. After the IPO,
the Company has outstanding 24,656,923 shares of common stock.
Mitchell Steiner, M.D., F.A.C.S., CEO of GTx, Inc., stated, "2003 was a highly
successful year for GTx. We received positive clinical data for our lead product
candidate, Acapodene(TM), in two separate indications targeting large markets.
We also advanced our second product candidate by completing several Phase I
clinical trials for our lead Selective Androgen Receptor Modulator (SARM)
compound, Andarine. We believe Andarine represents the first SARM to enter human
clinical trials."
2003 ACHIEVEMENTS
o Completed enrollment and an interim analysis in accordance
with the protocol of our Phase IIb clinical trial for
Acapodene for the reduction in the incidence of prostate
cancer in men with high grade Prostatic Intraepithelial
Neoplasia (PIN)
o Completed two Phase II clinical trials using Acapodene for the
treatment of side effects of androgen deprivation therapy for
prostate cancer
o Initiated a pivotal Phase III clinical trial of Acapodene for
the treatment of side effects of androgen deprivation therapy
for prostate cancer
o Completed Phase Ia, Ib and Ic clinical trials for the
Company's lead SARM compound, Andarine, for the treatment of
muscle wasting weight loss, or cachexia, which occurs from
various types of cancer
o Selected several SARM product candidates for clinical testing
o Completed a $20 million Series E private equity financing
2003 FOURTH QUARTER AND FULL YEAR HIGHLIGHTS
Research and development expenses represented 73% of total operating expenses
for the quarter and year ended December 31, 2003. General and administrative
expenses represented 25% and 24% of total operating expenses for the quarter and
year ended December 31, 2003, respectively. Depreciation expense accounted for
the remaining operating expenses.
For the fourth quarter ended December 31, 2003, research and development
expenses increased 16.3% to $3.3 million from $2.9 million for the fourth
quarter of 2002. For the year ended December 31, 2003, research and development
expenses increased 12.7% to $10.5 million from $9.3 million for the year ended
December 31, 2002. Stock-based compensation expenses accounted for $413,000 and
$472,000 of research and development expenses for the quarter and year ended
December 31, 2003, respectively. Research and development expenses for the
fourth quarter and the year included increased expenditures related to the
preparation for and initiation of a pivotal Phase III clinical trial of
Acapodene for the treatment of side effects of androgen deprivation therapy for
prostate cancer. In addition, research and development expenses included the
continued development of Andarine and other product candidates in the Company's
SARM program.
For the fourth quarter ended December 31, 2003, general and administrative
expenses increased 104% to $1.2 million from $575,000 for the fourth quarter of
2002. For the year ended December 31, 2003, general and administrative expenses
increased 46% to $3.5 million from $2.4 million for the year ended December 31,
2002. Stock-based compensation expenses accounted for $54,000 and $78,000 of
general and administrative expenses for the quarter and year ended December 31,
2003, respectively. The increase in general and administrative expenses for the
fourth quarter and the year is due primarily to the Company's expanding
operational capabilities.
ANTICIPATED 2004 MILESTONES
The Company plans to achieve the following milestones during 2004:
o Complete a Phase IIb clinical trial of, and announce results
for, Acapodene for the reduction in the incidence of prostate
cancer in men with high grade PIN
o Initiate a pivotal Phase III clinical trial of Acapodene for
the reduction in incidence of prostate cancer in men with high
grade PIN
o Initiate a Phase II clinical trial of Andarine for cancer
cachexia
2004 FINANCIAL GUIDANCE
o For the year ended December 31, 2004, the Company anticipates
total operating expenses of approximately $35 million to $40
million.
CONFERENCE CALL
There will be a conference call today at 10:00 a.m. EST to discuss GTx's fourth
quarter and full-year 2003 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 this call will be available today from approximately 12:00 p.m. EST through
March 10, 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
access code is 340140.
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 currently has two product candidates that are in human
clinical trials. The company is developing Acapodene, its most advanced product
candidate, through clinical trials for two separate indications: (1) a Phase IIb
clinical trial for the reduction in the incidence of prostate cancer in men with
precancerous prostate lesions and (2) a pivotal Phase III clinical trial for the
treatment of serious side effects of advanced prostate cancer therapy. GTx is
initially developing its second product candidate, Andarine, for the treatment
of muscle wasting weight loss, or cachexia, which occurs from various types of
cancer.
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 "Anticipated 2004 Milestones" and "2004 Financial
Guidance" sections. 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 commercialize its 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 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 expects 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 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. The final prospectus filed with the U.S. Securities and
Exchange Commission on February 3, 2004 contains under the heading "Risk
Factors" 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.
CONTACT: Carney Duntsch, Manager Corporate Communications GTx, Inc. -
901-523-9700 ext.170 or cduntsch@gtxinc.com
---Financial Statements Attached---
GTX, INC.
SUMMARY FINANCIAL INFORMATION
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
THREE MONTHS ENDED FOR THE YEARS ENDED
DECEMBER 31, DECEMBER 31,
------------------------------ ------------------------------
2003 2002 2003 2002 (1)
------------ ------------ ------------ ------------
(UNAUDITED) (UNAUDITED) (UNAUDITED)
Operating expenses:
Research and development $ 3,345 $ 2,877 $ 10,468 $ 9,285
General and administrative 1,173 575 3,512 2,405
Depreciation 93 92 357 332
------------ ------------ ------------ ------------
Total operating expenses 4,611 3,544 14,337 12,022
Other income:
Interest income 64 51 143 156
------------ ------------ ------------ ------------
Total other income 64 51 143 156
------------ ------------ ------------ ------------
Net loss (4,547) (3,493) (14,194) (11,866)
Accrued preferred stock dividends (1,136) (681) (3,436) (2,147)
Adjustments to preferred stock redemption value(2) (1,178) (73) (77,844) (7,220)
------------ ------------ ------------ ------------
Net loss attributable to common stockholders $ (6,861) $ (4,247) $ (95,474) $ (21,233)
============ ============ ============ ============
Net loss per share attributable to common stockholders,
basic and diluted $ (0.89) $ (0.55) $ (12.34) $ (2.75)
============ ============ ============ ============
Weighted average shares used in computing net loss
per share attributable to common stockholders,
basic and diluted 7,735,502 7,735,000 7,735,125 7,735,000
============ ============ ============ ============
Pro forma net loss per share attributable to common
stockholders, basic and diluted (unaudited) (3) $ (0.24) $ (0.83)
============ ============
Shares used in computing pro forma net loss per share
attributable to common stockholders, basic and
diluted (unaudited) 19,032,281 17,018,655
============ ============
(1) Derived from the audited financial statements included in the Company's
registration statement on Form S-1 for the year ended December 31, 2002.
(2) The adjustments to preferred stock redemption value represents the
adjustment to the preferred stock carrying value to reflect the redemption value
(fair value) at the end of each reporting period.
(3) Pro forma net loss per share for the three months ended December 31, 2003
and the year ended December 31, 2003 is computed using the weighted average
number of shares of common stock outstanding, including the pro forma effects of
the automatic conversion of the Company's preferred stock and accrued dividends
thereon into shares of common stock effective upon the closing of the initial
public offering as if such conversion occurred on October 1, 2003 and January 1,
2003 or at the date of the original issuance, if later. The resulting pro forma
adjustments include an increase in the weighted average shares used to compute
basic and diluted net loss per share attributable to common stockholders of
11,296,779 and 9,283,530 shares for the three months ended December 31, 2003 and
the year ended December 31, 2003. The calculation of pro forma net loss per
share attributable to common stockholders excludes incremental common stock
issuable upon exercise of options, as their effects would be antidilutive.
GTX, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS)
PRO FORMA
DECEMBER 31, DECEMBER 31, DECEMBER 31,
2003 2002(1) 2003(2)
------------ ------------ ------------
(UNAUDITED) (UNAUDITED)
ASSETS
Cash and cash equivalents $ 14,769 $ 8,925 $ 14,769
Other current assets 255 41 255
--------- --------- ---------
Total current assets 15,024 8,966 15,024
Property and equipment, net 815 1,064 815
Deferred initial public offering costs 1,471 1,471
--------- --------- ---------
Total assets $ 17,310 $ 10,030 $ 17,310
========= ========= =========
LIABILITIES, CUMULATIVE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS'
(DEFICIT) EQUITY
Current liabilities $ 2,249 $ 1,312 $ 2,249
Cumulative redeemable convertible preferred stock 165,292 64,026
Total stockholders' (deficit) equity (150,231) (55,308) 15,061
--------- --------- ---------
Total liabilities and stockholders' (deficit) equity $ 17,310 $ 10,030 $ 17,310
========= ========= =========
(1) Derived from the audited financial statements included in the Company's
registration statement on Form S-1 for the year ended December 31, 2002.
(2) The pro forma balance sheet at December 31, 2003 includes the pro forma
effects of the automatic conversion of the Company's preferred stock and accrued
dividends thereon, into shares of common stock effective upon the closing of the
initial public offering as if such conversion occurred on December 31, 2003.