WESTMINSTER, Colo., Aug. 7 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today reported financial results
for the second quarter of 2006. For the three months ended June 30,
2006, the Company reported a net loss attributable to common
stockholders of $7.0 million, or $0.13 per share. This compares to
a net loss attributable to common stockholders of $5.6 million, or
$0.13 per share, for the second quarter of 2005. For the six months
ended June 30, 2006, the Company reported a net loss attributable
to common stockholders of $14.0 million, or $0.25 per share,
compared to a net loss attributable to common stockholders of $10.7
million, or $0.29 per share, for the same period last year. Cash,
cash equivalents, and investments in marketable securities as of
June 30, 2006 were $43.5 million. Paul L. Berns, President and
Chief Executive Officer, stated: "During the quarter we continued
to meet patient recruitment goals for our pivotal Phase 3 ENRICH
trial, which we believe will ensure the completion of our
enrollment effort by the end of the third quarter. We also made
important progress in advancing the development of PDX by
completing the FDA's SPA process for our planned Phase 2 study in
patients with peripheral T-cell lymphoma and receiving orphan drug
designation for PDX for the treatment of T-cell lymphoma. We
attribute our ability to achieve these milestones to the diligent
efforts of Allos' committed employees. For the balance of the year,
we remain focused on executing our clinical plans for our three
product candidates as we continue to evaluate their broader
therapeutic utility in other potential indications." Product
Portfolio Update: EFAPROXYN(TM) (efaproxiral): * Enrollment in
ENRICH, the Company's pivotal Phase 3 study of EFAPROXYN(TM)
(efaproxiral) in patients with brain metastases originating from
breast cancer, continues to progress in line with Company
expectations and is projected to complete by the end of the third
quarter. An independent data monitoring committee will conduct a
second planned interim analysis of safety and efficacy data at its
first scheduled meeting following the occurrence of 188 patient
deaths, which is currently expected to occur in the second half of
2006. The Company will conduct the final analysis of safety and
efficacy data following the occurrence of 282 patient deaths, which
is currently expected to occur mid 2007. If the trial results are
positive at either the second interim or final analysis, the
Company will submit an amendment to its previously filed new drug
application as expeditiously as possible to seek marketing approval
for EFAPROXYN for the treatment of patients with brain metastases
originating from breast cancer. * 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 efaproxiral exposure to realize
the desired pharmacodynamic effect saw clinically meaningful
survival and response rate benefits. PDX (pralatrexate): * In
August 2006, the Company announced that it reached agreement with
the U.S. Food and Drug Administration (FDA) under the Special
Protocol Assessment process (SPA) on the design of a pivotal Phase
2 trial of the Company's novel antifolate PDX in patients with
relapsed or refractory peripheral T-cell lymphoma. The SPA process
allows for FDA evaluation of a clinical trial protocol intended to
form the primary basis of an efficacy claim in support of a new
drug application, and provides a binding agreement that the study
design, including trial size, clinical endpoints and/or data
analyses are acceptable to the FDA. The Company plans to open this
non-randomized, open-label study for accrual in the third quarter
of this year and will look to enroll 100 evaluable patients at
approximately 35 leading cancer centers in the U.S., Canada and
Europe. The primary endpoint of the trial is response rate. * In
July 2006, the U.S. Food and Drug Administration awarded orphan
drug designation to PDX for the treatment of patients with T-cell
lymphoma. Orphan drug designation provides for U.S. marketing
exclusivity for seven years following marketing approval by the
FDA. * Investigators at Memorial Sloan Kettering Cancer Center are
currently enrolling patients in two clinical trials with PDX: A
Phase 1/2 study of PDX in patients with relapsed or refractory
non-Hodgkin's lymphoma and Hodgkin's disease and a Phase 1 dose
escalation study of PDX in patients with relapsed or refractory
non-small cell lung cancer. RH1: * During the quarter, researchers
at Cancer Research U.K. completed enrollment of a Phase 1 dose
escalation study of RH1 in patients with advanced solid tumors.
Once the last patient has completed treatment, the Company will
evaluate results from the study to determine future development
plans. Corporate events: * In June 2006, the Company appointed
James V. Caruso as Executive Vice President, Chief Commercial
Officer. In this newly created role, Mr. Caruso will oversee the
Company's business development, sales and marketing functions.
Conference Call The Company will host a conference call to review
its second quarter results on Monday, August 7, 2006, 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 PM ET on Monday, August 7, 2006, until
11:59 PM ET on Thursday, August 17, 2006. 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 # 208196. Webcast Allos Therapeutics
will 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. (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 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 the Company's projected timelines relating to
the completion of enrollment and the conduct of the second interim
and final analyses of the ENRICH trial, the potential safety and
efficacy of EFAPROXYN for the treatment of patients with brain
metastases originating from breast cancer, the Company's intent to
file an amendment to its previously filed new drug application in
the event the ENRICH trial results are positive, the Company's
projected timeline for initiating the Phase 2 trial of PDX in
patients with relapsed or refractory peripheral T-cell lymphoma,
the Company's intent to continue evaluating the therapeutic utility
of its product candidates in other potential 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
presentation, 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 Six-months ended June 30, June 30, 2005 2006 2005 2006
Operating expenses: Research and development $2,621 $3,320 $4,969
$6,760 Clinical manufacturing 268 391 628 952 Marketing, general
and administrative 2,615 3,739 4,807 6,665 Restructuring and
separation costs -- -- 380 646 Total operating expenses 5,504 7,450
10,784 15,023 Loss from operations (5,504) (7,450) (10,784)
(15,023) Interest and other income, net 507 488 716 992 Net loss
$(4,997) $(6,962) $(10,068) $(14,031) Dividend related to
beneficial conversion feature of preferred stock (623) -- (623) --
Net loss attributable to common stockholders $(5,620) $(6,962)
$(10,691) $(14,031) Net loss per share: basic and diluted $(0.13)
$(0.13) $(0.29) $(0.25) Weighted average shares outstanding: basic
and diluted 42,683,395 55,102,627 36,961,378 55,090,968 ALLOS
THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands)
(unaudited) December 31, 2005 June 30, 2006 ASSETS Cash, cash
equivalents and investments in marketable securities $55,282
$43,507 Other assets 1,111 1,725 Property and equipment, net 688
668 Total assets $57,081 $45,900 LIABILITIES AND STOCKHOLDERS'
EQUITY Liabilities $3,790 $4,845 Stockholders' equity 53,291 41,055
Total liabilities and stockholders' equity $57,081 $45,900
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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