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 DATASOURCE: Allos
Therapeutics, Inc. CONTACT: Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, Inc., +1-720-540-5227, Web
site: http://www.allos.com/
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