Exhibit 99.1
Contact:
McDavid Stilwell
GTx, Inc.
Manager, Corporate Communications & Financial Analysis
901-523-9700
GTX, INC. REPORTS THIRD QUARTER 2005 FINANCIAL RESULTS
MEMPHIS, TENN. - Nov. 3, 2005--GTx, Inc. (Nasdaq: GTXI), the Men's Health
Biotech Company, today reported financial results for the third quarter of 2005.
The net loss for the third quarter and nine months ended September 30, 2005 was
$9.9 million and $29.0 million, respectively, compared with a net loss of $5.1
million and $15.5 million for the same periods in 2004. At September 30, 2005,
GTx had cash and cash equivalents of $37.8 million. In October 2005, GTx
received net proceeds of approximately $45.8 million from the public offering of
6,325,000 shares of its common stock.
"We have received the SPA for our pivotal Phase III clinical trial of ACAPODENE
for the prevention of prostate cancer in high risk men. The SPA gives our
company regulatory clarity on the trial's design and required endpoints," said
Mitchell Steiner, MD, CEO of GTx. "This now means that both of our pivotal Phase
III clinical programs for ACAPODENE are proceeding under SPAs."
Revenues for the quarter and nine months ended September 30, 2005 were $0.6
million and $3.1 million, respectively, as compared to $0.4 million and $1.5
million for the third quarter and first nine months of 2004, respectively.
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 third quarter and first nine months of
2005 were $8.5 million and $24.4 million, respectively, compared to $4.0 million
and $12.6 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 advancing clinical programs:
- 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 (ADT) for advanced prostate cancer.
- ACAPODENE, toremifene citrate 20 mg dose, in a pivotal Phase III
clinical trial for the prevention of prostate cancer in high risk men.
- Ostarine in Phase I single and multiple ascending dose clinical
trials. Ostarine is being initially developed for acute muscle wasting
associated with burns. GTx has 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 nine months ended
September 30, 2005 were $2.3 million and $7.4 million, respectively, compared to
$1.8 million and $5.0 million for the same periods in 2004. The increases in
both periods primarily resulted from additional personnel and administrative
costs to support the company's growth, higher insurance costs and increased
patent costs and professional fees.
THIRD QUARTER 2005 CORPORATE HIGHLIGHTS
- Reached patient enrollment goal for the pivotal Phase III trial for
the use of ACAPODENE in the treatment of the side effects of ADT on
schedule at the end of the third quarter.
- Received a Special Protocol Assessment for our pivotal Phase III
clinical trial of ACAPODENE for the prevention of prostate cancer in
high risk men. The timing of the analysis of efficacy endpoints for
the trial is event driven. GTx believes it will conduct an efficacy
analysis within 24 months of completion of enrollment. Once GTx has
achieved the efficacy endpoint, it will proceed with a New Drug
Application. Enrollment in the trial is on schedule for completion
during the first quarter of 2006.
- Completed a Phase I multiple ascending dose trial for ostarine in
healthy men and elderly men with truncal obesity. GTx has selected
doses of ostarine to advance into Phase II studies, beginning with a
Phase II clinical trial for acute muscle wasting in burn patients
which the company plans to initiate this quarter.
CONFERENCE CALL
There will be a conference call today at 10 a.m. Eastern Time today to discuss
GTx's third quarter financial results and to provide a company update. To listen
to the conference call, please dial:
- 800-510-9834 from the United States and Canada or
- 617-614-3669 (International)
The access code for the call is 39485009.
A playback of the call will be available from approximately 12:00 p.m., Eastern
Time, on November 3 through November 17, and may be accessed by dialing:
- 888-286-8010 from the United States and Canada or
- 617-801-6888 (International), referencing reservation
number 95133732.
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 for cancer and serious conditions related to
men's health. GTx's lead 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, headquartered in Memphis,
Tenn., currently has four clinical programs. GTx is developing ACAPODENE
(toremifene citrate), a selective estrogen receptor modulator, or
SERM, in two separate clinical programs 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 with the precancerous prostate
lesion called high grade PIN. In its third clinical program, GTx is developing
ostarine for the treatment of acute muscle wasting conditions associated with
burns and plans to initiate a Phase II clinical trial for ostarine for this
indication in the fourth quarter of 2005. GTx is also evaluating clinical
development of ostarine for the treatment of chronic muscle wasting conditions,
such as testosterone deficiency in aging men, or andropause. In its fourth
clinical program, GTx and its collaborator, Ortho Biotech Products, L.P., a
subsidiary of Johnson & Johnson, are developing andarine, another one of GTx's
SARMs, for the treatment of cancer cachexia. GTx is working with Ortho Biotech
to plan a Phase II clinical trial of andarine.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements 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, the risks that (i) GTx will
not be able to commercialize its product candidates if clinical trials do not
demonstrate safety and efficacy in humans; (ii) GTx may not able to obtain
required regulatory approvals to commercialize its product candidates; (iii)
GTx's clinical trials may not be completed on schedule, or at all, or may
otherwise be suspended or terminated; and (iv) GTx could utilize its available
cash resources sooner than its currently expects and may be unable to raise
capital when needed, which would force GTx to delay, reduce or eliminate its
product development programs or commercialization efforts. You should not place
undue reliance on these forward-looking statements, which apply only as of the
date of this press release. GTx's prospectus supplement filed with the U.S.
Securities and Exchange Commission (the "SEC") pursuant to Rule 424(b)(5) on
October 12, 2005, 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.
GTX, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE DATA)
<Table>
<Caption>
SEPTEMBER 30, DECEMBER 31,
2005 2004
------------ -------------
(UNAUDITED)
ASSETS
Current assets:
Cash and cash equivalents $ 37,808 $ 64,528
Inventory 175 448
Prepaid expenses and other current assets 2,497 1,176
------------ -------------
Total current assets 40,480 66,152
Property and equipment, net 1,865 1,537
Purchased intangible assets, net 5,037 4,943
Other assets 312 450
------------ -------------
Total assets $ 47,694 $ 73,082
============ =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,955 $ 900
Accrued expenses 5,585 2,617
Deferred revenue 1,337 1,337
------------ -------------
Total current liabilities 8,877 4,854
Deferred revenue 3,292 4,295
Capital lease obligation 20 24
Stockholders' equity:
Common stock, $0.001 par value: 60,000,000 shares authorized; 24,666,133
shares issued and outstanding at September 30, 2005 and 24,664,716
shares issued and outstanding at December 31, 2004 25 25
Deferred stock compensation (1,884) (2,701)
Additional paid-in capital 223,837 224,015
Accumulated deficit (186,473) (157,430)
------------ -------------
Total stockholders' equity 35,505 63,909
------------ -------------
Total liabilities and stockholders' equity $ 47,694 $ 73,082
============ =============
</Table>
GTX, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
(UNAUDITED)
<Table>
<Caption>
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
----------------------------- ----------------------------
2005 2004 2005 2004
--------- ------------- ----------- ------------
Revenues:
Product sales, net $ 288 $ -- $ 2,133 $ --
Collaboration revenue 334 335 1,003 721
Reimbursement of development costs -- 42 -- 802
--------- ------------- ----------- ------------
Total revenue 622 377 3,136 1,523
Costs and expenses:
Costs of goods sold 185 -- 1,350 --
Research and development expenses 8,454 3,971 24,419 12,606
General and administrative expenses 2,271 1,801 7,433 5,014
--------- ------------- ----------- ------------
Total costs and expenses 10,910 5,772 33,202 17,620
--------- ------------- ----------- ------------
Loss from operations (10,288) (5,395) (30,066) (16,097)
Interest income 345 270 1,023 632
--------- ------------- ----------- ------------
Net loss (9,943) (5,125) (29,043) (15,465)
Accrued preferred stock dividends -- -- -- (455)
Adjustments to preferred stock redemption value -- -- -- 17,125
--------- ------------- ----------- ------------
Net (loss) income attributable to common stockholders $ (9,943) $ (5,125) $ (29,043) $ 1,205
========= ============= =========== ============
Net (loss) income per share attributable to common
stockholders:
Basic $ (0.40) $ (0.21) $ (1.18) $ 0.05
========= ============= =========== ============
Diluted $ (0.40) $ (0.21) $ (1.18) $ (0.65)
========= ============= =========== ============
Weighted average shares used in computing net (loss)
income per share attributable to common stockholders:
Basic 24,664,950 24,656,923 24,664,794 22,433,716
=========== ============== =========== ============
Diluted 24,664,950 24,656,923 24,664,794 23,883,264
=========== ============== =========== ============
</Table>
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