Exhibit 99.1
Contact:
McDavid Stilwell
GTx, Inc.
Manager, Corporate Communications & Financial Analysis
901-523-9700
GTX, INC. REPORTS FIRST QUARTER 2006 FINANCIAL RESULTS
MEMPHIS, TENN. -- April 27, 2006--GTx, Inc. (Nasdaq: GTXI), the Men's Health
Biotech Company, today reported financial results for the first quarter of 2006.
The net loss for the quarter ended March 31, 2006 was $9.9 million, compared
with a net loss of $9.1 million for the same period in 2005. At March 31, 2006,
GTx had cash and cash equivalents of $65.3 million.
"In the first quarter, GTx continued to make substantial progress in our
clinical programs," said Mitchell S. Steiner, M.D., CEO of GTx. "GTx is pushing
ahead with plans for the commercialization of ACAPODENE(R) in the US and in the
rest of the world. We are excited that ostarine, our lead SARM, will enter a
Phase II proof of concept trial next month. The trial will lay the groundwork
for us to position this drug candidate for an array of acute and chronic
indications related to bone and muscle loss."
Revenue for the first quarter was $1.2 million, compared to $0.7 million for the
same period in 2005. Revenues included net sales of FARESTON(R) (toremifene
citrate 60 mg), marketed for the treatment of metastatic breast cancer in
postmenopausal women, and collaboration revenue for andarine from our partner,
Ortho Biotech Products, LP, a subsidiary of Johnson & Johnson.
Research and development expenses for the quarter were $8.4 million, compared to
$7.3 million for the same period in 2005. The increase in research and
development expenses was primarily the result of the company's continued
investment in its clinical programs.
General and administrative expenses for the quarter were $3.0 million, compared
to $2.5 million for the same period in 2005.
EVENTS SUBSEQUENT TO THE FIRST QUARTER
GTx expects to announce within one week that it has attained its enrollment goal
of 1,260 men in its pivotal Phase III clinical trial evaluating ACAPODENE
(toremifene citrate) in a 20 mg dose for the prevention of prostate cancer in
men with high grade prostatic intraepithelial neoplasia, or PIN. Enrollment of
the trial began in the first quarter of 2005. The trial is being conducted under
a Special Protocol Assessment with the United States Food & Drug Administration.
The trial is designed as a 36 month study but provides for an interim efficacy
analysis after a sufficient number of cancer events have occurred. GTx believes
this interim analysis will occur in the fourth quarter of 2007 or the first
quarter of 2008. If the efficacy endpoint is statistically achieved, we plan to
file a new drug application with the FDA during 2008.
"Within the next few days we will reach the enrollment goal of our pivotal Phase
III high grade PIN trial," said Steiner. "We believe the rapid enrollment of
this large clinical trial is an indication that both doctors and their patients
recognize the significant risks of this disease."
FIRST QUARTER 2006 CORPORATE HIGHLIGHTS
* An independent drug safety monitoring board (DSMB) conducted a per protocol
interim review of safety data of more than 2,000 patients enrolled in two
pivotal Phase III clinical trials of ACAPODENE and recommended that GTx continue
the two clinical development programs as planned. In addition to the trial
evaluating ACAPODENE for prevention of prostate cancer in men with high grade
PIN, GTx is evaluating ACAPODENE in an 80 mg dose for the treatment of multiple
side effects of androgen deprivation therapy for advanced prostate cancer.
* MacroArray Technologies, LLC, one of five diagnostic companies collaborating
with GTx on the development of a diagnostic test for high grade PIN, announced
at the 2006 annual meeting of the American Association for Cancer Research that
it has identified the ABCA5 protein as a selective molecular marker for high
grade PIN. Identification of this protein may lead to the development of a
commercial non-invasive diagnostic test.
* In January, GTx signed an exploratory research collaboration agreement with
Gen-Probe, Inc., to evaluate the ability of Gen-Probe's research-stage PCA3
Assay to detect
high grade PIN. Under terms of the agreement, GTx is providing Gen-Probe with
urine samples from patients enrolled in GTx's clinical trials testing ACAPODENE
for the prevention of prostate cancer in men with high grade PIN. Gen-Probe will
evaluate the samples from this special patient cohort with its research-stage
test for PCA3 gene expression.
In addition to MacroArray Technologies and Gen-Probe, GTx is continuing to work
with three other diagnostic companies, diaDexus, Inc., Hybritech, Inc., and
Tessera, Inc., in developing a non-invasive diagnostic test for high grade PIN.
* With respect to ostarine, GTx's first-in-class selective androgen receptor
modulator, or SARM, GTx plans to initiate in the second quarter a proof of
concept Phase II clinical trial in 60 elderly men and 60 postmenopausal women.
The trial is designed to provide extensive proof of concept data demonstrating
ostarine's effects on building muscle and promoting bone and to evaluate dose
and safety in both men and women. Endpoints of the trial will include
measurements of bone, fat, muscle mass and function, and performance. GTx
anticipates receiving data from the trial in the second half of 2006.
CONFERENCE CALL
There will be a conference call today at 9 a.m. Eastern Time today to discuss
GTx's first quarter financial results and to provide a company update. To listen
to the conference call, please dial:
- 800-688-0836 from the United States and Canada or
- 617-614-4072 (International)
The access code for the call is 44385455.
A playback of the call will be available beginning today at 11:00 a.m., Eastern
Time through May 11, and may be accessed by dialing:
- 888-286-8010 from the United States and Canada or
- 617-801-6888 (International)
The reservation number for the replay is 72588019.
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, headquartered in Memphis, Tenn., 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
is developing ACAPODENE(R) (toremifene citrate), a selective estrogen receptor
modulator, or SERM, in two separate clinical programs in men: first, a pivotal
Phase III clinical trial for the treatment of serious side effects of androgen
deprivation therapy for advanced prostate cancer, and second, a pivotal Phase
III clinical trial for the prevention of prostate cancer in high risk men with
high grade PIN. GTx also is developing ostarine, a selective androgen receptor
modulator, or SARM, for a variety of indications including muscle wasting and
bone loss in frail elderly patients, osteoporosis, muscle wasting in end stage
renal disease patients, and severe burn wounds and associated muscle wasting.
GTx has licensed to Ortho Biotech Products, L.P., a subsidiary of Johnson &
Johnson, another of its SARMs, andarine, under a joint collaboration and license
agreement.
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 it 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 annual report on form 10-K filed with the U.S.
Securities and Exchange Commission on March 2, 2006, contains 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)
MARCH 31, DECEMBER 31,
2006 2005
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(UNAUDITED)
ASSETS
Current assets:
Cash and cash equivalents $ 65,277 $ 74,014
Accounts receivable 68 153
Inventory 171 135
Prepaid expenses and other current assets 2,430 1,702
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Total current assets 67,946 76,004
Property and equipment, net 1,790 1,746
Purchased intangible assets, net 4,921 4,978
Other assets 55 83
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Total assets $ 74,712 $ 82,811
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,967 $ 1,407
Accrued expenses 4,391 3,230
Deferred revenue -- current portion 1,337 1,337
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Total current liabilities 7,695 5,974
Deferred revenue, less current portion 2,624 2,958
Other long term liability 371 280
Capital lease obligation 18 20
Stockholders' equity:
Common stock, $0.001 par value: 60,000,000 shares authorized; 30,998,217
shares issued and outstanding at March 31, 2006 and 30,993,967 shares
issued and outstanding at December 31, 2005 31 31
Deferred stock compensation - (1,725)
Additional paid-in capital 268,166 269,542
Accumulated deficit (204,193) (194,269)
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Total stockholders' equity 64,004 73,579
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Total liabilities and stockholders' equity $ 74,712 $ 82,811
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GTx, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
(UNAUDITED)
THREE MONTHS ENDED
MARCH 31,
------------------------
2006 2005
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Revenues:
Product sales, net $ 876 $ 353
Collaboration revenue 334 334
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Total revenues 1,210 687
Costs and expenses:
Costs of product sales 467 245
Research and development expenses 8,441 7,326
General and administrative expenses 2,950 2,520
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Total costs and expenses 11,858 10,091
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Loss from operations (10,648) (9,404)
Interest income 724 324
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Net loss $ (9,924) $ (9,080)
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Net loss per share:
Basic $ (0.32) $ (0.37)
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$
Diluted $ (0.32) ( 0.37)
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Weighted average shares used in computing net loss per share:
Basic 30,995,714 24,664,716
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Diluted 30,995,714 24,664,716
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