WESTMINSTER, Colo., March 6 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today reported financial results
for the quarter and year ended December 31, 2005. For the three
months ended December 31, 2005, the Company reported a net loss of
$5.3 million, or $0.10 per share. This compares to a net loss of
$5.0 million, or $0.16 per share, for the fourth quarter of 2004.
For the year ended December 31, 2005, the Company reported a net
loss attributable to common stockholders of $20.8 million, or $0.45
per share, compared to a net loss of $21.8 million, or $0.70 per
share, for 2004. Cash, cash equivalents, and investments in
marketable securities as of December 31, 2005 totaled $55.3
million. Product Portfolio Update: EFAPROXYN(TM) (efaproxiral): *
ENRICH, the Company's pivotal Phase 3 study of EFAPROXYN in
patients with brain metastases originating from breast cancer,
continues to progress in line with Company expectations. An
independent Data Monitoring Committee will conduct the first
planned interim analysis of the study's primary endpoint (survival)
at its first planned meeting following the occurrence of 94 patient
deaths, which the Company anticipates will occur in the first
quarter of 2006. The Company expects to complete patient enrollment
in this trial during the second half of 2006 and report preliminary
results in the first half of 2007. * In January 2006, the Company
announced the publication of results from its Phase 3 REACH study
of EFAPROXYN in patients with brain metastases. Results of the
study, which were reported in the January 1st edition of the
Journal of Clinical Oncology, suggest that the addition of
EFAPROXYN to whole brain radiation therapy may improve survival and
response rates in patients with brain metastases, particularly
those from breast cancer. * In December 2005, the Company announced
the presentation of a quality adjusted survival analysis of data
from the Company's Phase 3 REACH study. Results of the analysis,
which were presented at the 28th Annual San Antonio Breast Cancer
Symposium, indicated that the addition of EFAPROXYN to whole brain
radiation therapy led to a statistically significant increase in
survival for EFAPROXYN-arm patients with brain metastases
originating from breast cancer, which was accompanied by a
statistically significant improvement in both quality of life and
quality adjusted survival. PDX (pralatrexate): * In December 2005,
the Company announced the presentation of interim results from a
Phase 1/2 single-agent study of PDX in patients with relapsed or
refractory non-Hodgkin's lymphoma and Hodgkin's disease, currently
being conducted at Memorial Sloan-Kettering Cancer Center. The
interim findings, which were presented at the 2005 American Society
of Hematology Annual Meeting demonstrated preliminary evidence of
activity in patients with various subtypes of T-cell lymphoma.
Notably, four of seven evaluable patients with T-cell lymphoma who
were treated with PDX achieved a complete response within the first
cycle, despite having failed multiple prior therapies. Moreover,
the addition of vitamins successfully mitigated the previously
established dose limiting toxicity of stomatitis. Little
hematological toxicity was observed. In January 2006, a dosing
schedule of 30 mg/m2 weekly for six weeks in a seven week cycle was
established as optimal for future development in this setting. The
Phase 2 portion of this study commenced following the establishment
of the maximum tolerated dose and will look to determine the
efficacy of PDX across a variety of patients with relapsed or
refractory non-Hodgkin's lymphoma and Hodgkin's disease. * In
February 2006, the Company announced its intent to initiate a Phase
2, open-label, multi-center study of PDX in patients with relapsed
or refractory peripheral T-cell lymphoma, which the Company's
believes has the potential to support marketing approval in this
indication. * In February 2006, the Company announced the
publication of results from a pre-clinical study designed to
compare the activity of a pralatrexate/gemcitabine combination
relative to a commonly used combination of methotrexate/cytarabine
(ara-C) in treating lymphoma. Results of the study, which were
reported in the February 1st edition of Clinical Cancer Research,
indicated that the combination of pralatrexate followed by
gemcitabine was superior to the combination of methotrexate/ara-C
in in vitro and in in vivo models of lymphoma, and was more potent
in inducing apoptosis in certain lymphoma cell lines. RH1: * In
December 2005, the Company announced the presentation of interim
results from a Phase 1 dose escalation study of RH1 in patients
with advanced solid tumors at the 17th Annual AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics. Corporate Events: * In November 2005, the Company
announced that Timothy P. Lynch was elected to its Board of
Directors, expanding the Board to eight members. * In January 2006,
the Company announced that Michael E. Hart, the Company's
President, Chief Executive Officer and Chief Financial Officer,
notified the Company's Board of Directors of his intent to resign
his positions once a successor CEO is named. Effective March 3,
2006, the Company entered into a Separation Agreement with Mr.
Hart, pursuant to which he will continue to serve as a member of
the Board of Directors and will remain in his current capacity
while the Board conducts a search for a successor. A form 8-K
reporting additional information regarding the Separation Agreement
will be filed with the SEC on or before March 9, 2006. Conference
Call The Company will host a conference call to review its fourth
quarter results on Monday, March 6, 2006, at 11 AM ET. The dial in
number for U.S. residents to participate is 877-407-8031.
International callers should dial 201-689-8031. Participants should
reference the Allos Therapeutics conference call. Conference Call
Replay An audio replay of the conference call will be available
from 5:30 PM ET on Monday, March 6, 2006, until 11:59 PM ET on
Friday, March 17, 2006. To access the replay, please dial
877-660-6853 (domestic) or 201-612-7415 (international); Replay
pass codes (both required for playback): account # 286; conference
ID # 193926. Webcast Allos Therapeutics will hold a live webcast of
the conference call. The webcast will be available from the
homepage and the investors/media section of the Company's web site
at http://www.allos.com/ and will be archived for 30 days. About
Allos Therapeutics, Inc. Allos Therapeutics, Inc. (NASDAQ:ALTH) is
a biopharmaceutical company focused on developing and
commercializing innovative small molecule therapeutics for the
treatment of cancer. The Company's lead product candidate,
EFAPROXYN(TM) (efaproxiral), is a synthetic small molecule designed
to sensitize hypoxic, or oxygen-deprived, tumor tissue during
radiation therapy. EFAPROXYN is currently being evaluated as an
adjunct to whole brain radiation therapy in a pivotal Phase 3 trial
in women with brain metastases originating from breast cancer. The
Company's other product candidates are: PDX (pralatrexate), a small
molecule chemotherapeutic agent (DHFR inhibitor) currently under
investigation as both a single agent and in combination therapy
regimens in patients with non-small cell lung cancer and
Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic
agent bioactivated by the enzyme DT-diaphorase currently under
evaluation 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 the Company's projected timelines for the first planned
interim analysis, completion of enrollment and announcement of the
results of the ENRICH trial, the Company's intent to initiate a
Phase 2 study of PDX in patients with relapsed of refractory T-cell
lymphoma and the potential for such study to support marketing
approval in this indication, 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: that we may
experience difficulties or delays in our clinical trials, whether
caused by adverse events, investigative site initiation rates,
patient enrollment rates, regulatory issues or other factors; and
that clinical trials may not demonstrate the safety and efficacy of
our product candidates in their target indications. 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, 2004, and in the Company's other periodic
reports and filings with the Securities and Exchange Commission.
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, 2004 2005 2004 2005 Operating
expenses: Research and development $2,521 $3,245 $10,158 $11,215
Clinical manufacturing 390 332 2,979 1,266 Marketing, general and
administrative 2,204 2,231 9,194 9,044 Restructuring costs -- -- --
380 Total operating expenses 5,115 5,808 22,331 21,905 Loss from
operations (5,115) (5,808) (22,331) (21,905) Interest and other
income, net 129 530 494 1,768 Net loss (4,986) (5,278) (21,837)
(20,137) Dividend related to beneficial conversion feature of
preferred stock -- -- -- (623) Net loss attributable to common
stockholders $(4,986) $(5,278) $(21,837) $(20,760) Net loss per
share: basic and diluted $(0.16) $(0.10) $(0.70) $(0.45) Weighted
average shares: basic and diluted 31,153,731 55,047,189 31,139,192
46,070,686 ALLOS THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in
thousands) (unaudited) December 31, 2004 December 31, 2005 ASSETS
Cash, cash equivalents and investments in marketable securities
$23,848 $55,282 Other assets 1,345 1,111 Property and equipment,
net 980 688 Total assets $26,173 $57,081 Liabilities and
Stockholders' Equity Current liabilities $2,310 $ 3,790
Stockholders' equity 23,863 53,291 Total liabilities and
stockholders' equity $26,173 $57,081 DATASOURCE: Allos
Therapeutics, Inc. CONTACT: Jennifer Neiman, Manager, Corporate
Communications, Allos Therapeutics, Inc., +1-720-540-5227, Web
site: http://www.allos.com/
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Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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