Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported results
for the first quarter of 2009. For the three months ended March 31,
2009, the Company reported a net loss of $15.2 million, or $(0.19)
per share. This compares to a net loss of $12.0 million, or $(0.18)
per share, for the first quarter of 2008. For the three months
ended March 31, 2009, net cash used in operating activities was
$11.9 million. Cash, cash equivalents and investments in marketable
securities as of March 31, 2009 totaled $72.5 million.
Additionally, subsequent to March 31, 2009, the Company received
net proceeds of approximately $46.8 million from an underwritten
public offering of its common stock.
�We made significant progress during the quarter, including the
submission of an NDA to the FDA for pralatrexate for the treatment
of patients with relapsed or refractory peripheral T-cell lymphoma,
as well as advancing our preparations for the potential commercial
launch of pralatrexate,� said Paul L. Berns, president and chief
executive officer of Allos Therapeutics. �If approved by the FDA,
pralatrexate would be the first agent indicated for the treatment
of patients with relapsed or refractory PTCL. Based on promising
data from the PROPEL trial, we believe pralatrexate has the
potential to be a meaningful treatment option for patients with
this devastating disease.�
Recent Highlights
- Submitted a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) for the use of
pralatrexate for the treatment of patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL) in March. The Company
has requested a priority review of the application, which, if
granted, would give the FDA six months from receipt of the
submission to take action on the NDA. There are currently no
FDA-approved agents for patients with PTCL, either in the
first-line or relapsed or refractory setting.
- Reported final results from the
Company�s pivotal Phase 2 PROPEL trial of pralatrexate in patients
with relapsed or refractory PTCL in February. The results of the
trial demonstrated that 29 of 109 evaluable patients, or 27%,
achieved a response as assessed by central independent oncology
review, which is the primary endpoint of the trial. The
Kaplan-Meier estimate for the median duration of response was 287
days, or 9.4 months. The most common grade 3/4 adverse events were
thrombocytopenia, mucosal inflammation, neutropenia and anemia.
Patients in the PROPEL trial were heavily pre-treated, having
received a median of three prior systemic treatment regimens.
Pralatrexate has orphan drug designation and fast track designation
in the U.S. for the treatment of patients with T-cell lymphoma and
orphan medicinal product designation in Europe for the treatment of
PTCL.
- Advanced the Company�s Phase 2b
study comparing pralatrexate and 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. The Company remains on track
to complete patient enrollment in this study in the third quarter
of 2009.
- Announced preclinical data
demonstrating the anticancer activity of pralatrexate in colon,
ovarian, lung, prostate, and head and neck cancer cell lines at the
2009 American Association for Cancer Research (AACR) Annual Meeting
in April. The research showed that the antiproliferative effects
against these cancer lines were achieved at drug concentrations
that are attainable in humans. Further analysis of the data
demonstrated a potential correlation between the sensitivity to
pralatrexate and the expression level of folyl-polyglutamate
synthetase (FPGS), an enzyme that catalyzes the addition of
polyglutamate tails to natural folate and antifolates such as
pralatrexate.
- Strengthened the Company's
balance sheet with an underwritten public offering of 7,750,000
shares of newly issued common stock in April, resulting in net
proceeds of approximately $46.8 million, after deducting
underwriting commissions and estimated offering expenses.
2009 Financial Guidance Update
For the year ending December 31, 2009, the Company currently
anticipates that net cash use in operating activities will
approximate $55 million to $60 million, an increase from prior
guidance of $50 million to $54 million. This increase primarily
relates to additional investments associated with commercial
preparations for the potential launch of pralatrexate, including
scale-up of manufacturing. The financial guidance for 2009 includes
the phase-in of certain key investments related to the potential
commercialization of pralatrexate, as well as $1.5 million and $5.3
million of potential milestone payments under the Company�s license
agreement for pralatrexate payable upon FDA acceptance and approval
of the Company�s NDA, respectively.
Conference Call Information
The Company will host a conference call to review its first
quarter results on Tuesday, May 5, 2009 at 4:30 p.m. ET.
Participants can access the call at 877-941-1465 (U.S. and Canada)
or +480-629-9677 (international).�To access the live audio webcast
or the subsequent archived recording, visit the �Investors and
Media � Calendar of Events� section of the Allos website at
www.allos.com. Webcast and telephone replays of the conference call
will be available approximately two hours after the completion of
the call.�Callers can access the replay by dialing 800-406-7325
(domestic) or 303-590-3030 (international). The passcode is
4060691#. The webcast will be recorded and available for replay on
the Company's website until May 15, 2009.
About Pralatrexate
Pralatrexate is a targeted antifolate designed to accumulate
preferentially in cancer cells. Based on preclinical studies, the
Company believes that pralatrexate selectively enters cells
expressing RFC-1, a protein that is over expressed on certain
cancer cells compared to normal cells. Once inside cancer cells,
pralatrexate is efficiently polyglutamylated, which leads to high
intracellular drug retention. Polyglutamylated pralatrexate
essentially becomes �trapped� inside cancer cells, making it less
susceptible to efflux-based drug resistance. Acting on the folate
pathway, pralatrexate interferes with DNA synthesis and triggers
cancer cell death. The Company believes pralatrexate has the
potential to be delivered as a single agent or in combination
therapy regimens.
About Peripheral T-cell Lymphoma
PTCL comprises a biologically diverse group of blood cancers
that account for approximately 10 to 15 percent of all newly
diagnosed cases of non-Hodgkin's lymphoma (NHL) in the U.S. The
American Cancer Society estimates that approximately 66,000 new
cases of NHL were diagnosed in the U.S. in 2008. The Company
estimates the current annual prevalence of PTCL in the U.S. to be
approximately 9,500 patients. There are currently no pharmaceutical
agents approved for use in the treatment of either first-line or
relapsed or refractory PTCL. In addition to those PTCL patients who
do not respond to first-line treatment, a significant number of
first-line multi-agent chemotherapy responders relapse or become
refractory after treatment. According to the clinical literature,
patients with aggressive PTCL have an overall five-year survival
rate of approximately 25% after first-line therapy.
About Allos Therapeutics, Inc.
Allos Therapeutics is a biopharmaceutical company focused on
developing and commercializing innovative small molecule drugs for
the treatment of cancer. The Company�s lead product candidate,
pralatrexate, is a targeted antifolate designed to accumulate
preferentially in cancer cells. In February 2009, the Company
announced the final results from PROPEL, the Company�s pivotal
Phase 2 trial of pralatrexate in patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL). The PROPEL trial was
conducted under an agreement reached with the U.S. Food and Drug
Administration under its special protocol assessment (SPA) process.
Based on the results of the PROPEL trial, the Company submitted a
New Drug Application to the U.S. Food and Drug Administration for
pralatrexate for the treatment of relapsed or refractory PTCL in
March 2009. The Company is also investigating pralatrexate in
patients with non-small cell lung cancer, bladder cancer and a
range of lymphoma sub-types.�The Company currently retains
exclusive worldwide rights to pralatrexate for all indications. For
additional information, please visit 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 regarding the potential for
pralatrexate to provide a meaningful treatment option for patients
with relapsed or refractory PTCL; the Company�s projected timeline
for completing enrollment in the Company�s Phase 2b trial comparing
pralatrexate and erlotinib in patients with advanced non-small cell
lung cancer; the Company�s projected net cash use in operating
activities for fiscal year 2009; and other statements that 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 design of
or data collected from the PROPEL trial may not be adequate to
demonstrate the safety and efficacy of pralatrexate for the
treatment of patients with relapsed or refractory PTCL, or
otherwise be sufficient to support FDA approval; that the Company�s
New Drug Application may not be accepted for priority review or at
all by the FDA; that the FDA may disagree with the Company�s
interpretations of data from preclinical studies and clinical
trials involving pralatrexate, including the PROPEL trial, or
otherwise determine such data are not sufficient to support
approval; 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 may lack the financial
resources and access to capital to support its future operations,
including the potential commercialization of pralatrexate if
approved for marketing. 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, 2008 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.
ALLOS THERAPEUTICS,
INC.CONDENSED STATEMENTS OF OPERATIONS(in thousands,
except per share information)(unaudited)
� �
Three Months EndedMarch
31,
2009 2008 � Operating expenses: Research and
development $ 5,705 $ 5,974 Clinical manufacturing 2,655 1,587
Marketing, general and administrative � 6,963 � � 5,011 � Total
operating expenses � 15,323 � � 12,572 � Loss from operations
(15,323 ) (12,572 ) Interest and other income, net � 173 � � 565 �
Net loss � (15,150 ) � (12,007 ) Net loss per share: basic and
diluted $ (0.19 ) $ (0.18 ) Weighted average shares: basic and
diluted � 81,096 � � 67,267 � �
ALLOS THERAPEUTICS,
INC.CONDENSED BALANCE SHEETS(in
thousands)(unaudited)
� �
March 31, December 31, 2009 2008
ASSETS Cash, cash equivalents and investments in marketable
securities $ 72,539 $ 83,966 Other assets 2,528 4,067 Property and
equipment, net � 1,422 � 1,307 Total assets $ 76,489 $ 89,340
LIABILITIES AND STOCKHOLDERS� EQUITY Current liabilities $
8,607 $ 9,875 Stockholders� equity � 67,882 � 79,465 Total
liabilities and stockholders� equity $ 76,489 $ 89,340 �
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