WESTMINSTER, Colo., May 8 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today reported financial results
for the first quarter of 2007. For the three months ended March 31,
2007, the Company reported a net loss of $8.4 million, or ($0.14)
per share. This compares to a net loss of $7.1 million, or ($0.13)
per share, for the first quarter of 2006. Cash, cash equivalents,
and investments in marketable securities as of March 31, 2007 were
$75.5 million. Paul L. Berns, President and Chief Executive
Officer, stated: "During the quarter we continued to make important
progress in advancing our product development programs, notably
through the successful completion of the first interim safety
assessment for our pivotal Phase 2 PROPEL trial of PDX. We also
strengthened our leadership team through the appointment of
seasoned industry executives to our senior management team and
Board of Directors and improved our financial position through the
completion of our underwritten offering of common stock in
February. We believe these clinical development and organizational
advances position Allos for continued progress through the balance
of the year." Product Portfolio Update: PDX (pralatrexate): PDX is
a novel, small molecule chemotherapeutic agent that inhibits
dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent
enzyme involved in the building of nucleic acid, or DNA, and other
processes. PDX is currently under evaluation in patients with
lymphoma and non-small cell lung cancer. * In January 2007, an
independent Data Monitoring Committee (DMC) completed a planned
interim analysis of safety data from the Company's pivotal Phase 2
PROPEL trial of PDX in patients with relapsed or refractory
peripheral T-cell lymphoma, and recommended that the trial continue
per the protocol. The interim assessment was based upon an
evaluation of the first ten patients enrolled in the study who
completed at least one cycle of treatment with PDX. No major
patient safety concerns were identified by the DMC. In accordance
with the study's design, an interim analysis of efficacy data will
be conducted after 35 patients have completed at least one cycle of
treatment with PDX, which is currently expected to occur in the
second half of 2007. The DMC will assess patient safety as part of
the 35 patient response assessment and again after 65 patients have
completed at least one cycle of treatment. The Company currently
anticipates that study enrollment at up to 35 centers in the United
States, Canada and Europe will be completed by the third quarter of
2008. * In April 2007, the Commission of the European Communities,
with a favorable opinion of the Committee for Orphan Medicinal
Products of the European Medicines Agency (EMEA) granted orphan
medicinal product designation to PDX for the treatment of patients
with peripheral T-cell lymphoma (PTCL). EFAPROXYN(TM)
(efaproxiral): EFAPROXYN is the first synthetic small molecule
designed to sensitize hypoxic, or oxygen-deprived, areas of tumors
during radiation therapy by facilitating the release of oxygen from
hemoglobin, the oxygen-carrying protein contained within red blood
cells, and increasing the level of oxygen in tumors. EFAPROXYN is
currently under evaluation in patients with brain metastases
originating from breast cancer, and in patients with primary
non-small cell lung cancer and cervical cancer. * Patient
enrollment in ENRICH, the Company's pivotal Phase 3 study of
EFAPROXYN plus whole brain radiation therapy in women with brain
metastases originating from breast cancer was completed in
September 2006. Patients were randomized 1:1 to receive standard
whole brain radiation therapy, 3 Gy fractions for 10 days plus
supplemental oxygen, with or without EFAPROXYN. At the time of
randomization patients were stratified by KPS and known liver
metastases. The primary endpoint of the trial is survival, which
will be compared between treatment arms using the stratified log
rank test. The Company plans to conduct the final analysis of
safety and efficacy data from this trial following the occurrence
of 282 eligible patient deaths, which is expected to occur in
mid-2007. If the results are positive, the Company intends to
submit an amendment to its previously filed new drug application to
the FDA as expeditiously as possible. RH1: RH1 is a novel small
molecule chemotherapeutic agent that is bioactivated by the enzyme
DT-diaphorase, or DTD, which is over-expressed in many tumors
relative to normal tissue, including lung, colon, breast and liver
tumors. RH1 was recently the subject of a Phase 1 study in patients
with various solid tumors. * Sarah Danson, Ph.D., of Christie
Hospital and the Paterson Institute for Cancer Research,
Manchester, UK is scheduled to present a poster presentation titled
"Final results of a phase I clinical trial of the bioreductive drug
RH1" at the American Society of Clinical Oncology Annual Meeting on
June 4, 2007. Corporate events: * In April 2007, the Company
appointed Jeffrey R. Latts, former Executive Vice President and
Chief Medical Officer of Exelixis, Inc., to its Board of Directors.
* In March 2007, the Company appointed Pablo J. Cagnoni, M.D. as
Senior Vice President, Chief Medical Officer. * In February 2007,
the Company closed an underwritten offering of 9,000,000 shares of
its common stock, resulting in aggregate net proceeds to the
Company of approximately $50.3 million. * In January 2007, the
Company appointed William R. Ringo, former President and CEO of
Abgenix Inc., to its Board of Directors. Conference Call The
Company will host a conference call to review its first quarter
results on Tuesday, May 8, 2007, at 8:30 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 2:00 PM ET on
Tuesday, May 8, 2007, until 11:59 PM ET on Friday, May 18, 2007. 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 # 239702. Webcast The
Company will also hold a live web cast 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. (ALTH) is a biopharmaceutical company focused on
the development and commercialization of small molecule
therapeutics for the treatment of cancer. The Company has two
product candidates in late-stage clinical development: EFAPROXYN
(efaproxiral), a radiation sensitizer currently under evaluation in
a pivotal Phase 3 trial in women with brain metastases originating
from breast cancer, and PDX (pralatrexate), a novel antifolate
currently under evaluation in a pivotal Phase 2 trial in patients
with relapsed or refractory peripheral T-cell lymphoma. The Company
is also evaluating RH1, a targeted chemotherapeutic agent, in a
Phase 1 trial in patients with advanced solid tumors. For
additional information, please visit the Company's website 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. These forward-looking statements include, but are not
limited to, statements concerning the Company's projected timelines
for the completion of enrollment, performance of interim and final
analyses and announcement of results from the Company's ongoing
clinical trials, statements concerning the Company's future product
development and regulatory strategies, including the Company's
intent to develop or seek regulatory approval for its product
candidates in specific indications, 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 the Company may
experience difficulties or delays in the initiation, progress or
completion of its clinical trials; whether caused by competition,
adverse events, investigative site initiation rates, patient
enrollment rates, regulatory issues or other factors; and that the
Company's clinical trials may not demonstrate the safety and
efficacy of the Company's product candidates in their target
indications. Even if clinical trials demonstrate the safety and
efficacy of the Company's product candidates, regulatory
authorities may not approve such product candidates, the Company
may not be able to successfully market such product candidates, or
the Company may face post-approval problems that require the
withdrawal of its product candidates from the market. In addition,
the Company may lack the financial resources and access to capital
to fund planned or future clinical trials of its product
candidates, or to continue evaluating their therapeutic utility in
other potential 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, 2006, 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 press release, except as
required by law. (Tables follow) ALLOS THERAPEUTICS, INC. CONDENSED
STATEMENTS OF OPERATIONS (in thousands ~ except share and per share
information) (unaudited) Three Months Ended March 31, 2006 2007
Operating expenses: Research and development $3,440 $3,289 Clinical
manufacturing 561 1,147 Marketing, general and administrative 2,926
4,748 Restructuring and separation costs 646 -- Total operating
expenses 7,573 9,184 Loss from operations (7,573) (9,184) Interest
and other income, net 504 773 Net loss $(7,069) $(8,411) Net loss
per share: basic and diluted $(0.13) $(0.14) Weighted average
shares outstanding: Basic and diluted 55,079,180 62,151,400 ALLOS
THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands)
(unaudited) December 31, 2006 March 31, 2007 ASSETS Cash, cash
equivalents and investments in marketable securities $32,796
$75,519 Other assets 2,982 2,917 Property and equipment, net 604
602 Total assets $36,382 $79,038 LIABILITIES AND STOCKHOLDERS'
EQUITY Current liabilities $6,832 $6,038 Stockholders' equity
29,550 73,000 Total liabilities and stockholders' equity $36,382
$79,038 DATASOURCE: Allos Therapeutics, Inc. CONTACT: Jennifer
Neiman, Senior Manager, Corporate Communications, +1-720-540-5227,
, or Derek Cole Vice President, Investor Relations,
+1-720-540-5367, , both of Allos Therapeutics, Inc. Web site:
http://www.allos.com/
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