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MEMPHIS, Tenn., Nov. 11-- 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 & 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 $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 http://www.gtxinc.com.
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 December
30, 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
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
About
GTx Forward Looking Statement
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