WESTMINSTER, Colo., March 5 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today outlined its key objectives
for 2007, summarized its 2006 and recent corporate highlights, and
reported its financial results for the fourth quarter and year
ended December 31, 2006. "We believe the corporate and clinical
development progress we achieved this past year sets the stage for
continued growth in 2007," said Paul L. Berns, President and Chief
Executive Officer. "With the completion of our recent fundraising,
we are focused on optimizing the development of PDX in patients
with peripheral T-cell lymphoma, and plan to initiate several new
trials to further explore PDX's potential clinical utility. We also
look forward to completing the final analysis of efficacy data from
our pivotal Phase 3 ENRICH trial of EFAPROXYN in patients with
brain metastases originating from breast cancer. These key product
development programs reflect our commitment to pursuing clinical
success and underscore the important contributions of our
employees, clinical collaborators and patients toward the continued
advancement of our product candidates." 2007 Key Objectives: *
Drive PDX product development and commercialization program -- The
company intends to make significant progress in advancing PROPEL,
its pivotal Phase 2 trial of PDX in patients with peripheral T-cell
lymphoma, and plans to initiate several new trials to further
evaluate PDX's potential clinical utility in hematologic and
oncologic indications. * Advance EFAPROXYN launch and lifecycle
plans -- If the company's pivotal Phase 3 ENRICH trial of EFAPROXYN
in patients with brain metastases originating from breast cancer is
positive, the company plans to submit an amendment to its
previously filed new drug application to the U.S. Food and Drug
Administration, or FDA, to seek marketing approval of
EFAPROPXYN(TM) for this indication. In addition, the company would
seek to initiate several new trials with the objective of
broadening EFAPROXYN's clinical utility and future market
potential. * Establish RH1 targeted clinical development program --
The company plans to initiate a Phase 1 trial to determine the
safety, tolerability, pharmacokinetics and maximum tolerated dose
of RH1 in patients with various solid tumors. 2006 and Recent
Corporate Highlights: PDX (pralatrexate) * Initiated pivotal Phase
2 PROPEL trial of PDX in patients with peripheral T-cell lymphoma.
In August 2006, the company initiated patient enrollment in PROPEL,
a pivotal Phase 2 multi-center, single-arm trial of PDX with
vitamin B12 and folic acid supplementation in patients with
relapsed or refractory peripheral T-cell lymphoma. Earlier in
August, the company reached agreement with the FDA under its
special protocol assessment, or SPA, process on the design of this
pivotal trial. * Demonstrated activity of PDX in heavily
pre-treated peripheral T-cell lymphoma patients. In December 2006,
the company announced the presentation of interim results from its
on-going Phase 1/2 trial of PDX in patients with relapsed or
refractory non-Hodgkin's Lymphoma and Hodgkin's disease at the 48th
Annual Meeting of the American Society of Hematology. The results
demonstrated a high overall response rate in patients with various
sub-types of T-cell lymphoma. Notably, responses were observed in
10 of 22 (45%) evaluable patients with T-cell lymphoma, including
nine complete responses. * Completed a planned interim assessment
of safety data from the PROPEL trial. In January 2007, an
independent Data Monitoring Committee completed a planned interim
analysis of safety data from the PROPEL trial and recommended that
the trial continue per the protocol. No major patient safety
concerns were identified by the DMC. * Received FDA Orphan Drug and
Fast Track Designation for PDX for the treatment of patients with
T-cell lymphoma. In August 2006, the FDA awarded orphan drug
designation to PDX for the treatment of patients with T-cell
lymphoma. Orphan drug designation provides for marketing
exclusivity in the United States for seven years following
marketing approval by the FDA. In October 2006, the FDA granted
fast track designation to PDX for the treatment of patients with
T-cell lymphoma. The fast track program is designed to facilitate
the development and expedite the review of new drugs that are
intended to treat serious or life-threatening conditions and that
demonstrate the potential to address unmet medical needs.
EFAPROXYN(TM) (efaproxiral) * Completed patient enrollment in
pivotal Phase 3 ENRICH trial of EFAPROXYN in patients with brain
metastases originating from breast cancer. In August 2006, the
company completed patient enrollment in ENRICH, its pivotal Phase 3
trial of EFAPROXYN plus whole brain radiation therapy in women with
brain metastases originating from breast cancer. A total of 368
patients were enrolled at 78 medical centers in the United States,
Canada, Europe and South America. * Completed planned interim
analyses of data from Phase 3 ENRICH trial. In April and October
2006, an independent data monitoring committee (DMC) completed the
first and second planned interim analyses of data from the Phase 3
ENRICH trial. In both cases, the DMC identified no major patient
safety concerns and recommended that the trial continue to
completion. * Reported new findings from Phase 3 REACH trial. In
June 2006, the company announced the publication of new findings
from its Phase 3 REACH study of EFAPROXYN plus whole brain
radiation therapy in patients with brain metastases from various
primary cancers. Results of the analysis, which were reported in
the June 13th edition of the British Journal of Cancer (volume 94,
issue 12), found that patients who achieved sufficient EFAPROXYN
exposure to realize the desired pharmacodynamic effect saw
clinically meaningful survival and response rate benefits.
Corporate Highlights * Strengthened the company's balance sheet. 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 $50.5 million. *
Strengthened the company's leadership. In March 2006, the company
appointed Paul L. Berns as President, Chief Executive Officer and a
member of the Board of Directors. In June 2006, the company
appointed James V. Caruso as Executive Vice President, Chief
Commercial Officer. In January 2007, the company appointed William
R. Ringo, former President and CEO of Abgenix Inc., to its Board of
Directors. * Added to NASDAQ Biotech Index. In November 2006, the
company was selected for inclusion in the NASDAQ Biotechnology
Index (NBI), which includes biotechnology and pharmaceutical
companies listed on the NASDAQ National Market that meet minimum
requirements for market value, average daily share volume and
seasoning as a public company. Financial Results For the three
months ended December 31, 2006, the company reported a net loss of
$8.1 million, or $0.14 per share. This compares to a net loss of
$5.3 million, or $0.10 per share, for the fourth quarter of 2005.
For the year ended December 31, 2006, the company reported a net
loss attributable to common stockholders of $30.2 million, or $0.55
per share, compared to a net loss attributable to common
stockholders of $20.8 million, or $0.45 per share, for 2005. Cash,
cash equivalents, and investments in marketable securities as of
December 31, 2006 totaled $32.8 million. Conference Call The
company will host a conference call to review its 2006 results on
Monday, March 5, 2007, 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 5:00 PM ET on
Monday, March 5, 2007, until 11:59 PM ET on Thursday, March 15,
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 # 231653. Webcast The
company 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. (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, next
generation 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. Such forward-looking
statements include 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, 2005, 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. 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, 2005 2006 2005 2006 Operating expenses:
Research and development $3,245 $3,352 $11,215 $14,322 Clinical
manufacturing 332 845 1,266 2,284 Marketing, general and
administrative 2,231 4,317 9,044 14,876 Restructuring and
separation costs -- -- 380 646 Total operating expenses 5,808 8,514
21,905 32,128 Loss from operations (5,808) (8,514) (21,905)
(32,128) Interest and other income, net 530 444 1,768 1,916 Net
loss (5,278) (8,070) (20,137) (30,212) Dividend related to
beneficial conversion feature of preferred stock -- -- (623) -- Net
loss attributable to common stockholders $(5,278) $(8,070)
$(20,760) $(30,212) Net loss per share: basic and diluted $(0.10)
$(0.14) $(0.45) $(0.55) Weighted average common shares: basic and
diluted 55,047,189 55,813,346 46,070,686 55,299,614 ALLOS
THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands)
(unaudited) December 31, 2005 December 31, 2006 ASSETS Cash, cash
equivalents and investments in marketable securities $55,282
$32,796 Other assets 1,111 2,982 Property and equipment, net 688
604 Total assets $57,081 $36,382 Liabilities and Stockholders'
Equity Current liabilities $3,790 $ 6,832 Stockholders' equity
53,291 29,550 Total liabilities and stockholders' equity $57,081
$36,382 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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