WESTMINSTER, Colo., Nov. 9 /PRNewswire-FirstCall/ -- Allos Therapeutics,
Inc. (Nasdaq: ALTH) today reported financial results for the third quarter of
2005. For the three months ended September 30, 2005, the Company reported a
net loss of $4.8 million, or $0.09 per share. This compares to a net loss of
$4.6 million, or $0.15 per share, for the three months ended September 30,
2004.
For the nine months ended September 30, 2005, the Company reported a net
loss of $15.5 million, or $0.36 per share, compared to a net loss of
$16.9 million, or $0.54 per share, for the same period last year.
Cash, cash equivalents, and investments in marketable securities as of
September 30, 2005 amounted to $59.4 million.
Product Portfolio Update:
EFAPROXYN(TM) (efaproxiral):
* 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 Company expectations. The
Company expects to complete patient enrollment in this trial during the
second half of 2006 and report preliminary results approximately
six months thereafter.
* In September 2005, the Company announced the publication of results
from its Phase 2 multi-center study of EFAPROXYN in patients with
unresectable non-small cell lung cancer (NSCLC) receiving sequential
chemoradiotherapy (S-CRT). Results from the study, which were reported
in the September 1st edition of the Journal of Clinical Oncology,
suggest that the addition of EFAPROXYN to S-CRT may improve survival
over S-CRT alone without increasing radiation toxicity rates.
* In October 2005, the Company withdrew its European Marketing
Authorization Application (MAA) for its investigational radiation
sensitizer REVAPROXYN(TM) (efaproxiral, EFAPROXYN(TM) in the United
States) for use as an adjunct to whole brain radiation therapy for the
treatment of patients with brain metastases originating from breast
cancer. The Company believes that the ongoing ENRICH trial, if
positive, together with other supporting data, should provide the
additional data necessary to support the filing of a new MAA and the
future approval of EFAPROXYN for the treatment of brain metastases
originating from breast cancer in Europe.
* Charles Scott, Ph.D., CBS Squared, is scheduled to present a quality
adjusted survival analysis of the Phase 3 REACH study of EFAPROXYN in
patients with brain metastases in a poster presentation titled
"Improved survival, quality of life and quality-adjusted survival in
breast cancer patients treated with efaproxiral + whole brain radiation
therapy for brain metastases" at the San Antonio Breast Cancer
Symposium on December 10, 2005.
PDX (pralatrexate):
* Enrollment in a Phase 1/2 study of PDX in patients with relapsed or
refractory aggressive lymphoproliferative malignancies continues to
progress in line with Company expectations. The Company expects to
complete patient enrollment in the Phase 1 portion of this trial in
the fourth quarter of 2005.
* In January 2005, the Company initiated a Phase 1 dose escalation study
of PDX with vitamin B12 and folic acid supplementation in patients with
previously treated advanced NSCLC. The Company currently expects to
complete patient enrollment in this trial in 2006.
RH1:
* Enrollment in a Phase 1 dose escalation study of RH1 in patients with
advanced solid tumors continues to progress in line with Company
expectations. The Company currently expects to complete enrollment in
this trial in the fourth quarter of 2005. Sarah Danson, M.D.,
Department of Medical Oncology, Christie Hospital, is scheduled to
report updated clinical and PK/PD data from an on-going Phase 1 study
of RH1 in patients with advanced solid tumors in a poster presentation
titled "Phase 1 Pharmacokinetic (PD) trial of the bioreductive drug
RH1" at the AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics on November 17, 2005.
Corporate Highlights:
* In October 2005, the only remaining securities class action lawsuit
that had been brought against the Company and one of its officers in
May 2004 was dismissed with prejudice. In an opinion dated October 20,
2005, the United States District Court for the District of Colorado
concluded that the plaintiff's complaint failed to meet the legal
pleading requirements applicable to its alleged claims. The plaintiff
has until November 19, 2005 to determine whether it will appeal the
decision to the U.S. Court of Appeals for the Tenth Circuit.
* In July 2005, a shareholder of the Company commenced a stockholder's
derivative action in the United States District Court for the District
of Colorado against several current and former directors of the
Company, naming the Company as a nominal defendant. The factual
allegations in the derivative action were substantially the same as the
factual allegations in the purported securities class action lawsuit
filed in May 2004. On November 2, 2005, the court granted the parties
joint motion for voluntary dismissal and dismissed the case without
prejudice.
Conference Call
The Company will host a conference call to review its third quarter
results on Wednesday, November 9, 2005, 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 Wednesday, November 9, 2005, until 11:59 PM ET on Wednesday, November 16,
2005. 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 # 175174.
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 our projected timelines for completion of enrollment and
announcement of the results of our clinical trials, the potential safety and
efficacy of EFAPROXYN for the treatment of patients with NSCLC receiving S-CRT
or any other type of cancer, 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 Nine-months ended
September 30, September 30,
2004 2005 2004 2005
Operating expenses:
Research and
development $2,203 $3,001 $7,638 $7,970
Clinical
manufacturing 432 307 2,589 934
Marketing, general
and administrative 2,035 2,005 6,989 6,813
Restructuring costs -- -- -- 380
Total operating
expenses 4,670 5,313 17,216 16,097
Loss from operations (4,670) (5,313) (17,216) (16,097)
Interest and other
income, net 116 522 365 1,238
Net loss (4,554) (4,791) (16,851) (14,859)
Dividend related to
beneficial conversion
feature of preferred
stock -- -- -- (624)
Net loss attributable
to common stockholders $(4,554) $(4,791) $(16,851) $(15,483)
Basic and diluted net
loss per share $(0.15) $(0.09) $(0.54) $(0.36)
Weighted average
common shares:
basic and diluted 31,153,489 55,015,757 31,134,311 43,045,637
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, September 30,
2004 2005
ASSETS
Cash, cash equivalents and investments
in marketable securities $23,849 $59,426
Other assets 1,344 1,512
Equipment and leasehold improvements, net 980 748
Total assets $26,173 $61,686
Liabilities and Stockholders' Equity
Liabilities $2,310 $3,212
Stockholders' equity 23,863 58,474
Total liabilities and stockholders' equity $26,173 $61,686
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, Inc., +1-720-540-5227,
jneiman@allos.com
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