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
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Senior Manager, Corporate
Communications, +1-720-540-5227, jneiman@allos.com, or Derek Cole
Vice President, Investor Relations, +1-720-540-5367,
dcole@allos.com, both of Allos Therapeutics, Inc.
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