Allos Therapeutics Reports First Quarter 2008 Financial Results
07 Mai 2008 - 1:30PM
Business Wire
Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported results for
the first quarter of 2008. For the three months ended March 31,
2008, the Company reported a net loss of $12.0 million, or $(0.18)
per share. This compares to a net loss of $8.4 million, or $(0.14)
per share, for the first quarter of 2007. For the three months
ended March 31, 2008, net cash used in operating activities was
$9.3 million. Cash, cash equivalents and investments in marketable
securities as of March 31, 2008 totaled $50.5 million. "During the
quarter, we continued to drive our PDX product development program
in hematologic malignancies and solid tumors,� said Paul L. Berns,
President and Chief Executive Officer of Allos. �In April, we
completed patient enrollment in PROPEL, our SPA-approved pivotal
Phase 2 trial of PDX in patients with relapsed or refractory
peripheral T-cell lymphoma, and we expect to report top line
results of the trial by the end of 2008. Following our review of
the trial results, we intend to submit a New Drug Application for
PDX for the treatment of patients with relapsed or refractory PTCL
as expeditiously as possible.� Pipeline Development 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. The Company currently has six ongoing
clinical trials, including the PROPEL trial, evaluating the
potential clinical utility of PDX in hematologic malignancies and
solid tumor indications. -- Completed patient enrollment in the
pivotal Phase 2 PROPEL trial in April -- Advanced PDX development
program -- Advanced patient enrollment in the Phase 2b, randomized,
multi-center study comparing PDX and Tarceva(R)(erlotinib) in
patients with Stage IIIB/IV non-small cell lung cancer (NSCLC) who
are, or have been, cigarette smokers who have failed treatment with
at least one prior platinum-based chemotherapy regimen. -- Advanced
patient enrollment in the Phase 1/2a, open-label, multi-center
study of PDX and gemcitabine with vitamin B12 and folic acid
supplementation in patients with relapsed or refractory
non-Hodgkin's lymphoma (NHL) or Hodgkin's disease. -- Advanced
patient enrollment in the Phase 1, open-label, multi-center study
of PDX with vitamin B12 and folic acid supplementation in patients
with relapsed or refractory cutaneous T-cell lymphoma (CTCL). --
Advanced patient enrollment in the Phase 1/2 open-label,
single-center study of PDX in patients with relapsed or refractory
B-cell NHL and Hodgkin's disease. 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,
including lung, colon, breast and liver tumors. The Company is
currently evaluating RH1 in a Phase 1, open-label, multi-center
dose escalation study in patients with advanced solid tumors or
non-Hodgkin's lymphoma, which was initiated in November 2007.
Conference Call The Company will host a conference call to review
its first quarter results on Wednesday, May 7, 2008, at 8:30 a.m.
ET. The dial in number for U.S. residents to participate is
800-762-8779. International callers should dial 480-248-5081.
Participants should reference the Allos Therapeutics conference
call. 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
www.allos.com and will be archived for 30 days. Conference Call
Replay An audio replay of the conference call will be available
from approximately two hours after completion of the call through
Friday, May 23, 2008. To access the replay, please dial
800-406-7325 (domestic) or 303-590-3030 (international). The replay
pass code is 3865346#. About Allos Therapeutics, Inc. Allos
Therapeutics is a biopharmaceutical company focused on developing
and commercializing small molecule therapeutics for the treatment
of cancer.�The Company's lead product candidate, PDX
(pralatrexate), is a novel antifolate currently under evaluation in
a pivotal Phase 2 (PROPEL) trial in patients with relapsed or
refractory peripheral T-cell lymphoma. The PROPEL trial is being
conducted under an agreement reached with the U.S. Food and Drug
Administration under its special protocol assessment, or SPA
process. The Company is also investigating PDX in patients with
non-small cell lung cancer and a range of lymphoma subtypes. The
Company's other product candidate�is RH1, a targeted
chemotherapeutic agent currently being evaluated in a Phase 1 trial
in patients with advanced solid tumors or non-Hodgkin�s Lymphoma
(NHL). Allos currently retains exclusive worldwide rights to PDX
and RH1 for all indications. For additional information, please
visit the Company�s website at 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 relating to the Company�s projected
timeline for reporting top line results of the PROPEL trial, the
Company�s intent to submit a New Drug Application for PDX for the
treatment of patients with relapsed or refractory PTCL, the timing
of any potential New Drug Application filing, the Company�s
projected timelines and intent to initiate additional trials to
evaluate PDX�s potential clinical utility in other hematologic
malignancies and solid tumor 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,
including the PROPEL trial, whether caused by competition, adverse
events, investigative site initiation rates, patient enrollment
rates, regulatory issues or other factors; that clinical trials may
not demonstrate that PDX is both safe and effective for the
treatment of patients with PTCL or any other type of cancer; that
the safety and/or efficacy results of the PROPEL trial may not
support an application for marketing approval in the United States
or any other country; that an application for marketing approval
may not be accepted for priority review or at all by the FDA or any
other regulatory authority; and that the Company may lack the
financial resources and access to capital to fund future clinical
trials for PDX or any of its other product candidates. 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, 2007, 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 per
share information) (unaudited) � Three Months EndedMarch 31, 2008 �
2007 � Operating expenses: Research and development $ 5,974 $ 3,289
Clinical manufacturing 1,587 1,147 Marketing, general and
administrative 5,011 � 4,748 � Total operating expenses 12,572
9,184 Loss from operations (12,572 ) (9,184 ) Interest and other
income, net 565 � 773 � Net loss (12,007 ) (8,411 ) Net loss per
share: basic and diluted $ (0.18 ) $ (0.14 ) Weighted average
shares outstanding: basic and diluted 67,267 � 62,151 � ALLOS
THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands)
(unaudited) � � March 31, December 31, 2008 2007 ASSETS � � � �
Cash, cash equivalents and investments in marketable securities $
50,514 $ 57,756 Other assets 3,421 3,083 Property and equipment,
net 605 621 Total assets $ 54,540 $ 61,460 LIABILITIES AND
STOCKHOLDERS� EQUITY Current liabilities $ 9,572 $ 8,881
Stockholders� equity 44,968 � 52,579 Total liabilities and
stockholders� equity $ 54,540 $ 61,460
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