Exhibit 99.1
Contact:
McDavid Stilwell
GTx, Inc.
Manager, Corporate Communications & Financial Analysis
901-523-9700
GTX REPORTS FOURTH QUARTER AND YEAR END 2005 RESULTS
MEMPHIS, Tenn - February 16, 2006 -- GTx, Inc. (Nasdaq: GTXI), the Men's Health
Biotech Company, today reported financial results for the fourth quarter and
year ended December 31, 2005. The net loss for the respective periods was $7.8
million and $36.8 million compared with a net loss of $6.9 million and $22.3
million for the same periods in 2004. At December 31, 2005, GTx had cash and
cash equivalents of $74.0 million.
"In 2005, GTx met or exceeded each milestone for ACAPODENE that management
established at the beginning of the year," said Mitchell Steiner, MD, chief
executive officer of GTx. "2006 will be the defining year for SARMs. We should
have proof of concept Phase II data for our first-in-class compound, ostarine,
in late summer."
GTx has four clinical development programs: First, ACAPODENE(R), toremifene
citrate 80 mg dose, is in a pivotal Phase III trial for the treatment of
multiple serious side effects of androgen deprivation therapy (ADT) in men with
advanced prostate cancer; second, ACAPODENE, toremifene citrate 20 mg dose, is
in a pivotal Phase III trial for the prevention of prostate cancer in high risk
men who have high grade prostatic intraepithelial neoplasia (PIN); third,
ostarine, a first-in-class selective androgen receptor modulator (SARM), will be
entering a Phase II clinical trial for the treatment of muscle wasting and bone
loss; and fourth, andarine, another GTx SARM, is being developed with our
partner Ortho Biotech Products LP (Ortho Biotech), a subsidiary of Johnson &
Johnson, for the treatment of cancer cachexia.
2005 CORPORATE HIGHLIGHTS
ACAPODENE for treatment of side effects of ADT:
- Completed enrollment of approximately 1,400 patients in the pivotal
Phase III ADT trial.
- Completed an interim analysis of bone mineral density (BMD), a
secondary endpoint of the ADT trial, that demonstrated efficacy with
highly statistically significant positive changes among men treated
with ACAPODENE compared to placebo.
ACAPODENE for prevention of prostate cancer in men with high grade PIN:
- Presented the ACAPODENE Phase IIb clinical results for the
prevention of prostate cancer in men with high grade PIN at the 2005
annual meetings of the American Society of Clinical Oncology (ASCO)
and the American Urological Association. The study abstract was
selected by peer review for inclusion in Best of ASCO.
- Received a Special Protocol Assessment (SPA) with the United States
Food and Drug Administration (FDA) for the pivotal Phase III trial,
providing regulatory clarity for this important indication.
- Started patient enrollment for the pivotal Phase III trial in the
first quarter of 2005. Enrollment continues in approximately 150
centers in the United States, Canada, Mexico and Argentina.
- Formed a collaboration with a fourth diagnostic company, MacroArray
Technologies, Inc., to develop a urine based diagnostic test for
high grade PIN.
Ostarine, our lead SARM:
- Advanced ostarine through two Phase I trials. Results of the Phase I
multiple ascending dose trial in 72 subjects showed that ostarine is
a selective anabolic agent.
Andarine:
- Continued preclinical and clinical development of andarine, another
GTx SARM, with our partner Ortho Biotech.
Corporate:
- Completed a follow-on public offering of common stock, resulting in
net proceeds of approximately $46 million.
- Appointed to GTx's Board of Directors Robert W. Karr, MD, former
Senior Vice President of Strategic Management at Pfizer Global
Research and Development and current President of Idera
Pharmaceuticals, Inc.
FINANCIAL HIGHLIGHTS FOR THE YEAR AND QUARTER ENDED DECEMBER 31, 2005
Revenue for the quarter and year ended December 31, 2005, was $0.6 million and
$3.8 million compared to $0.3 million and $1.9 million for the same periods in
2004. 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, for andarine.
Research and development expenses for the quarter and year ended December 31,
2005, were $6.5 million and $30.9 million, compared to $5.3 million and $18.0
million for the same periods in 2004. 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 and year ended December 31,
2005, were $2.4 million and $9.8 million, compared to the $2.2 million and $7.2
million for the same periods of 2004.
ANNUAL PRODUCT PORTFOLIO UPDATE
ACAPODENE for treatment of side effects of ADT:
GTx enrolled nearly 1,400 men in its pivotal Phase III ADT trial at
approximately 150 sites in the United States and Mexico. A December
2005 interim analysis of BMD in the first 200 men to complete a full
year of treatment resulted in highly statistically significant
positive changes in BMD in the treatment arm compared to placebo:
+2.3% in lumbar spine (p<0.001), +2.0% in hip (p=0.001), and +1.5%
in the femoral neck (p=0.009). The magnitude of these positive
changes in BMD provides more confidence that ACAPODENE will show
efficacy in the trial's primary endpoint, a 40% reduction in
vertebral fractures at two years. Secondary endpoints include
improvements in BMD, hot flashes, gynecomastia, and lipid profiles.
The trial is being conducted under a SPA with the FDA. GTx
anticipates receiving data from this trial in the second half of
2007, and if the data demonstrates significant fracture benefit,
filing a new drug application in 2008.
ACAPODENE for prevention of prostate cancer in men with high grade PIN:
By the end of the current quarter, GTx anticipates attaining its
total enrollment goal of 1,260 patients in the pivotal Phase III
trial, which is being conducted under a SPA with the FDA. The
primary endpoint of the trial is a reduction in prostate cancer
incidence. By the first quarter of 2008, GTx anticipates conducting
an interim efficacy analysis, with the timing of the analysis driven
by the rate of prostate cancer detected. If successful, GTx will
file a new drug application.
Ostarine:
GTx plans to initiate in the second quarter a proof of concept Phase
II trial of ostarine in approximately 120 elderly men and
postmenopausal women. The study will evaluate the effects of
ostarine on muscle and bone over three months. GTx expects to report
data from the trial in late summer 2006. The data from this study is
expected to give GTx confidence that ostarine will be a safe and
effective treatment for a variety of indications
including frailty, osteoporosis, muscle wasting in end stage renal
disease patients, and treatment of severe burn wounds and associated
wasting.
Although GTx has received FDA clearance to commence a Phase II trial
of ostarine in burn patients, GTx has decided it can better evaluate
ostarine in a larger patient population over the same time period
required for the burn study and receive a broader array of relevant
data.
Andarine:
GTx is developing a second SARM, andarine, for the treatment of
cancer cachexia with its partner, Ortho Biotech. A Phase II trial is
being planned.
2006 CORPORATE MILESTONES
- GTx anticipates in the current quarter attaining its enrollment goal
of its pivotal Phase III high grade PIN trial.
- GTx intends to secure a partnership for ACAPODENE for treatment of
side effects of ADT and ACAPODENE for prevention of prostate cancer
in men with high grade PIN.
- Early results of a urine based high grade PIN diagnostic test
developed by MacroArray Technologies in collaboration with GTx will
be presented at the American Association of Cancer Research's 2006
annual meeting in April.
- The company expects to receive data from its proof of concept Phase
II trial of ostarine by the end of the summer of 2006.
2006 FINANCIAL GUIDANCE
By the end of the year, the Company anticipates having two fully enrolled
pivotal Phase III clinical trials of ACAPODENE, a completed proof of concept
Phase II clinical trial for ostarine, and participating with our partner Ortho
Biotech in a Phase II trial for andarine. As a result of these programs, the
Company anticipates a net loss for 2006 of $37 million to $47 million.
CONFERENCE CALL
There will be a conference call today at 9:00 a.m. Eastern Time to discuss GTx's
fourth quarter and full year financial results and to provide a company update.
To listen to the conference call, please dial 866-277-1184 from the United
States or Canada or 617-597-5360 from outside North America. The access code for
the call is 54502054. A playback of the call will be available from
approximately 11:00 a.m., Eastern Time today through March 2, 2006 and may be
accessed by dialing 888-286-8010 from the United States or Canada or
617-801-6888 from outside North America, and referencing reservation number
64277344. 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.
GTX, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
(UNAUDITED)
THREE MONTHS ENDED YEAR ENDED
DECEMBER 31, DECEMBER 31,
----------------------------- ----------------------------
2005 2004 2005 2004
------------ ------------- ------------- ------------
Revenues:
Product sales, net $ 312 $ -- $ 2,445 $ --
Collaboration revenue 334 334 1,337 1,055
Reimbursement of development costs -- 10 -- 812
------------ ------------ ------------- ------------
Total revenues 646 344 3,782 1,867
Costs and expenses:
Cost of product sales 223 -- 1,573 --
Research and development expenses 6,504 5,344 30,923 17,950
General and administrative expenses 2,412 2,197 9,845 7,211
------------ ------------ ------------- ------------
Total costs and expenses 9,139 7,541 42,341 25,161
------------ ------------- ------------- ------------
Loss from operations (8,493) (7,197) (38,559) (23,294)
Interest income 697 314 1,720 946
------------ ------------ ------------- ------------
Net loss (7,796) (6,883) (36,839) (22,348)
Accrued preferred stock dividends -- -- -- (455)
Adjustments to preferred stock redemption value -- -- -- 17,125
------------ ------------ ------------- ------------
Net loss attributable to common stockholders $ (7,796) $ (6,883) $ (36,839) $ (5,678)
============ ============ ============= ============
Net loss per share attributable to common stockholders:
Basic $ (0.26) $ (0.28) $ (1.42) $ (0.25)
============ ============ ============ ============
Diluted $ (0.26) $ (0.28) $ (1.42) $ (0.93)
============ ============ ============ ============
Weighted average shares used in computing net loss
per share attributable to common stockholders:
Basic 29,892,565 24,659,564 25,982,478 22,993,221
============ ============ ============ ============
Diluted 29,892,565 24,659,564 25,982,478 24,062,271
============ ============ ============ ============
GTX, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS)
DECEMBER 31, DECEMBER 31,
2005 2004
------------ -----------
(unaudited) (1)
ASSETS
Cash and cash equivalents $74,014 $64,528
Other current assets 1,990 1,624
------- -------
Total current assets 76,004 66,152
Property and equipment, net 1,746 1,537
Purchased intangible assets, net 4,978 4,943
Other assets 83 450
------- -------
Total assets $82,811 $73,082
======= =======
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 4,637 $ 3,517
Deferred revenue, current 1,337 1,337
------- -------
Total current liabilities 5,974 4,854
Deferred revenue 2,958 4,295
Other long term liability 280 --
Capital lease obligation 20 24
Total stockholders' equity 73,579 63,909
------- -------
Total liabilities and stockholders' equity $82,811 $73,082
======= =======
(1) Derived from the audited financial statements included in the Company's
annual report on form 10-K for the year ended December 31, 2004.
# # #
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 high grade PIN. In its third
clinical program, GTx is evaluating ostarine for a variety of indications
including frailty, osteoporosis, muscle wasting in end stage renal disease
patients, and treatment of severe burn wounds and associated wasting. In its
fourth clinical program, GTx and its partner, Ortho Biotech Products, L.P., a
subsidiary of Johnson & Johnson, are developing andarine, another 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 be 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 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.