Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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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