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
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Manager, Corporate
Communications, Allos Therapeutics, Inc., +1-720-540-5227,
jneiman@allos.com
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