Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Allos Therapeutics Reports 2004 Financial Results
WESTMINSTER, Colo., March 3 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc.
(NASDAQ:ALTH) today reported financial results for the quarter and year ended
December 31, 2004. For the quarter ended December 31, 2004, the Company
reported a net loss of $5.0 million, or $(0.16) per share. This compares to
net income of $791,000, or $0.03 per share, for the fourth quarter of 2003,
which included a one-time gain on settlement claims of $5.1 million.
For the year ended December 31, 2004, the Company reported a net loss of $21.8
million, or $(0.70) per share, compared to a net loss of $23.1 million, or
$(0.87) per share, for 2003.
Cash, cash equivalents and investments in marketable securities as of December
31, 2004 were $23.8 million.
Separately, on March 3, 2005, the Company issued a press release (the
"Financing Release") announcing that it had entered into a definitive
securities purchase agreement with Warburg Pincus Private Equity VIII, L.P., a
Delaware limited partnership ("Warburg Pincus"), for the sale of $50 million of
the Company's exchangeable preferred stock. Please see the Financing Release
for additional information.
Product Portfolio Update:
EFAPROXYN(TM):
* ENRICH, the Company's Phase 3 study of the radiation sensitizer
EFAPROXYN in patients with brain metastases originating from breast
cancer, continues to progress in line with expectations. To date, 80
percent of committed North American trial sites are open for
enrollment, with the remaining centers expected to open by June 2005.
In January, the Company reported expansion of the ENRICH study into
Europe. The Company expects that all planned investigative sites will
initiate by June 2005.
* The Marketing Authorization Application (MAA) for EFAPROXYN, filed in
June 2004, remains under review by the European Medicines Agency. In
October 2004, the Company received the 120-day list of questions
relating to the MAA, to which it must respond by April 2005.
PDX:
* In January 2005, the Company initiated patient enrollment in a Phase 1
dose escalation study of PDX with vitamin B12 and folic acid
supplementation in patients with Stage IIIB-IV non-small cell lung
cancer. This open-label, non-randomized study will seek to enroll one
to six patients per treatment level cohort who have received one prior
chemotherapy regimen and may or may not have received an EGFR Kinase
inhibitor.
RH1:
* In December 2004, the Company in-licensed RH1, a targeted prodrug that
is bioactivated by the enzyme DT-diaphorase, which is over-expressed
in lung, colon, breast and liver tumors. RH1 is currently being
evaluated in an open label Phase 1 dose escalation study at two
medical centers in the UK in patients with advanced solid tumors who
are refractory to other chemotherapy regimens. Recruitment for the
trial began in September 2003 and is expected to complete in the
second half of 2005.
Conference Call
The Company will host a conference call to review its 2004 results and discuss
the Warburg Pincus financing on Thursday, March 3, 2005, at 11 AM ET. The dial
in number for U.S. residents to participate is 877-407-9210. International
callers should dial +1-201-689-8049. Participants should reference the Allos
Therapeutics conference call.
Conference Call Replay
An audio replay of the conference call will be available from 2 PM ET on
Thursday, March 3, 2005, until 11:59 PM ET on Thursday, March 10, 2005. To
access the replay, please dial 877-660-6853 (domestic) or +1-201-612-7415
(international); Replay pass codes (both required for playback): account #:
286, conference ID #: 140780.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing
and commercializing innovative drugs for improving cancer treatments. The
company's lead clinical candidate, EFAPROXYN, is a synthetic small molecule
that has the potential to sensitize hypoxic (oxygen deprived) tumor tissues and
enhance the efficacy of standard radiation therapy. In addition, Allos is
developing PDX (pralatrexate), a novel small molecule cytotoxic injectable
antifolate (DHFR inhibitor) intended to treat non-small cell lung cancer,
mesothelioma and non-Hodgkin's lymphoma, as well as RH1, a targeted cytotoxic
prodrug under investigation in patients with advanced solid tumors. For more
information, please visit the company's web site at: http://www.allos.com/.
Safe Harbor Statement
This press release contains forward-looking statements that are made pursuant
to the safe harbor provisions of the Private Securities Litigation Reform Act
of 1995. Such forward-looking statements include statements concerning our
projected timelines for initiation of investigative sites and completion of
enrollment in our clinical trials, the potential safety and efficacy of
EFAPROXYN, and other statements which are other than statements of historical
facts. In some cases, you can identify forward-looking statements by
terminology such as "may," "will," "should," "expects," "intends," "plans,"
anticipates," "believes," "estimates," "predicts," "projects," "potential,"
"continue," and other similar terminology or the negative of these terms, but
their absence does not mean that a particular statement is not forward-looking.
Such forward-looking statements are not guarantees of future performance and
are subject to risks and uncertainties that may cause actual results to differ
materially from those anticipated by the forward-looking statements. These
risks and uncertainties include, among others: risks that we may experience
delays in our clinical trials; and risks that EFAPROXYN, PDX or RH1 may not
prove to be safe or efficacious. Additional information concerning these and
other factors that may cause actual results to differ materially from those
anticipated in the forward-looking statements is contained in the "Risk
Factors" section of the Company's Annual Report on Form 10-K for the year ended
December 31, 2003, as amended, and in the Company's other periodic reports and
filings with the Securities and Exchange Commission, including its Quarterly
Report on Form 10-Q for the quarter ended September 30, 2004. The Company
cautions investors not to place undue reliance on the forward-looking
statements contained in this press release. All forward-looking statements are
based on information currently available to the Company on the date hereof, and
the Company undertakes no obligation to revise or update these forward-looking
statements to reflect events or circumstances after the date of this
presentation, except as required by law.
ALLOS THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands ~ except share and per share information)
(unaudited)
Three-months ended Year ended
December 31, December 31,
2003 2004 2003 2004
Operating expenses:
Research and development $1,842 $2,521 $11,957 $10,158
Clinical manufacturing 598 390 7,252 2,979
Marketing, general and
administrative 2,039 2,204 9,378 9,194
Restructuring costs -- -- 638 --
Total operating expenses 4,479 5,115 29,225 22,331
Loss from operations (4,479) (5,115) (29,225) (22,331)
Gain on settlement claims 5,110 -- 5,110 --
Interest and other
income, net 160 129 988 494
Net income (loss) $791 $(4,986) $(23,127) $(21,837)
Basic and diluted net
income (loss) per share $0.03 $(0.16) $(0.87) $(0.70)
Weighted average
common shares:
Basic 28,275,497 31,153,731 26,493,861 31,139,192
Weighted average
common shares:
Diluted 28,807,281 31,153,731 26,493,861 31,139,192
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, 2003 December 31, 2004
ASSETS
Cash, cash equivalents and
investments in marketable
securities $45,047 $23,849
Other assets 1,671 1,344
Property, equipment and
leasehold improvements, net 1,456 980
Total assets $48,174 $26,173
Liabilities and Stockholders' Equity
Current liabilities $2,763 $2,310
Stockholders' equity 45,411 23,863
Total liabilities and
stockholders' equity $48,174 $26,173
DATASOURCE: Allos Therapeutics, Inc.
CONTACT: Jennifer Neiman, Corporate Communications Manager of
Allos Therapeutics, Inc., +1-720-540-5227,
Web site: http://www.allos.com/