Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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Allos Therapeutics, Inc. (NASDAQ: ALTH) today reported results for the
third quarter of 2008. For the three months ended September 30, 2008,
the Company reported a net loss of $13.2 million, or ($0.16) per share.
This compares to a net loss of $9.3 million, or ($0.14) per share, for
the third quarter of 2007. For the nine months ended September 30, 2008,
the Company reported a net loss of $37.0 million, or ($0.50) per share,
compared to a net loss of $28.1 million, or ($0.43) per share, for the
same period last year. For the nine months ended September 30, 2008, net
cash used in operating activities was $30.7 million. Cash, cash
equivalents and investments in marketable securities as of September 30,
2008 were $96.4 million.
“During the quarter we continued to make
important progress executing our pralatrexate product development and
commercialization plan in hematologic malignancies and solid tumors,”
said Paul L. Berns, President and Chief Executive Officer of Allos. “We
remain on track to report top line results from PROPEL, our FDA
SPA-approved pivotal Phase 2 trial of pralatrexate in patients with
relapsed or refractory peripheral T-cell lymphoma, in December at the 50th
Annual Meeting of the American Society of Hematology. Following our
review of the trial results, we intend to submit a New Drug Application
for pralatrexate for the treatment of patients with relapsed or
refractory PTCL as expeditiously as possible. We also continue to
advance additional studies evaluating pralatrexate in multiple
indications, notably in non-Hodgkin’s
lymphoma, non-small cell lung cancer and bladder cancer. We look forward
to providing future updates regarding pralatrexate’s
clinical profile and potential commercial opportunities.”
Pipeline Development Update
Pralatrexate (PDX)
Pralatrexate 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 seven ongoing
clinical trials, including the PROPEL trial, evaluating the potential
clinical utility of pralatrexate in hematologic malignancies and solid
tumor indications.
Top Line Results from Pivotal Phase 2 PROPEL Trial to be Presented
at ASH 2008 Annual Meeting
The Company announced that top line results from its pivotal Phase
2 PROPEL trial of pralatrexate in patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL) will be presented at
the 50th American Society of Hematology
(ASH) Annual Meeting and Exposition, taking place December 6-9,
2008 in San Francisco, California. Owen O'Connor, M.D., Ph.D., is
scheduled to report top line results from PROPEL in an oral
presentation titled “PROPEL: A
Multi-center Phase 2 Open-label Study of Pralatrexate (PDX) with
Vitamin B12 and Folic Acid Supplementation in Patients with
Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL).”
Dr. O'Connor is Director of the Lymphoid Development and
Malignancy Program and Chief of the Lymphoma Service at the Irving
Comprehensive Cancer Center at Columbia University Medical Center
and is Principal Investigator of the PROPEL trial. Following
review of the trial results, the Company intends to submit a New
Drug Application (NDA) for pralatrexate for the treatment of
patients with relapsed or refractory PTCL as expeditiously as
possible. The FDA granted orphan drug designation and fast track
designation to pralatrexate for the treatment of patients with
T-cell lymphoma in July 2006 and September 2006, respectively.
Advanced Pralatrexate Hematologic Development Program
The Company advanced patient enrollment in the Phase 1/2a,
open-label, multi-center study of pralatrexate and gemcitabine
with vitamin B12 and folic acid supplementation in patients with
relapsed or refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's
disease. Interim data from this study will be presented at the
December 2008 ASH conference. Steven Horwitz, M.D., will present “A
Phase 1/2a Open-label Study of Pralatrexate and Gemcitabine in
Patients with Relapsed or Refractory Lymphoproliferative
Malignancies.” Dr. Horwitz is Assistant
Attending Physician, Lymphoma Service, Memorial Sloan-Kettering
Cancer Center, and is Principal Investigator of the study.
The Company advanced patient enrollment in the Phase 1,
open-label, multi-center study of pralatrexate with vitamin B12
and folic acid supplementation in patients with relapsed or
refractory cutaneous T-cell lymphoma (CTCL). Interim data from
this study will be presented at the December 2008 ASH conference.
Dr. Horwitz will present “Pralatrexate
(PDX) is Active in Cutaneous T-Cell Lymphoma: Preliminary Results
of a Multi-center Dose-finding Trial.”
Results from a pre-clinical study of a combination of pralatrexate
and Velcade® (bortezomib) will also be
presented at the December 2008 ASH conference. Dr. O’Connor
will present “Pralatrexate (PDX)
Compliments the Activity of the Proteasome Inhibitor Bortezomib
(B) in In Vitro Model of Lymphoid T-Cell Malignancies.”
Advanced Pralatrexate Solid Tumor Development Program
The Company advanced patient enrollment in the Phase 2b,
randomized, multi-center study comparing pralatrexate and Tarceva®
(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. Based on current enrollment rates, the
Company expects to complete patient enrollment in this study in
the second half of 2009.
In July 2008, the Company initiated patient enrollment in a Phase
2, open-label, single-arm, multi-center study of pralatrexate in
patients with advanced or metastatic relapsed transitional cell
carcinoma (TCC) of the urinary bladder. The primary endpoint of
the study is objective response rate (complete and partial
response). Secondary endpoints include duration of response,
clinical benefit rate, progression-free survival, overall survival
and the safety and tolerability of pralatrexate. The study will
seek to enroll approximately 41 patients in up to 20 investigative
sites worldwide.
RH1
RH1 is a novel small molecule chemotherapeutic agent that the Company
believes is bioactivated by the enzyme DT-diaphorase, or DTD, which the
Company believes 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 NHL.
2008 Financial Guidance
The Company reaffirms prior financial guidance that it anticipates net
cash used in operating activities will approximate $45 million to $49
million for the year ending December 31, 2008.
Financial projections entail a high level of uncertainty due to, among
other factors, the variability involved in predicting clinical trial
initiation timelines, enrollment rates and results, and the cost of
commercial preparation activities.
Conference Call
The Company will host a conference call to review its third quarter
results on Wednesday, November 5, 2008, at 4:15 p.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 Wednesday,
November 19, 2008. To access the replay, please dial 800-406-7325
(domestic) or 303-590-3030 (international). The replay pass code is
3927147#.
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, pralatrexate (PDX), is
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 pralatrexate in patients
with non-small cell lung cancer, bladder 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
pralatrexate 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 pralatrexate for the treatment of patients with relapsed
or refractory PTCL, the timing of any potential New Drug Application
filing, the Company’s future financial
performance, 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 pralatrexate 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
pralatrexate 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 share and per share
information)(unaudited)
Three months endedSeptember 30,
Nine months endedSeptember 30,
2008
2007
2008
2007
Operating expenses:
Research and development
$
6,361
$
4,395
$
17,739
$
12,045
Clinical manufacturing
1,728
1,506
4,799
4,038
Marketing, general and administrative
5,326
4,241
15,776
14,503
Total operating expenses
13,415
10,142
38,314
30,586
Loss from operations
(13,415
)
(10,142
)
(38,314
)
(30,586
)
Interest and other income, net
254
844
1,323
2,526
Net loss
$
(13,161
)
$
(9,298
)
$
(36,991
)
$
(28,060
)
Net loss per share: basic and diluted
$
(0.16
)
$
(0.14
)
$
(0.50
)
$
(0.43
)
Weighted average shares outstanding: basic and diluted
80,752,024
66,042,023
73,554,904
64,627,285
ALLOS THERAPEUTICS, INC.CONDENSED BALANCE SHEETS(in
thousands)(unaudited)
September 30,2008
December 31,2007
ASSETS
Cash, cash equivalents and investments in marketable securities
$
96,360
57,756
Other assets
4,307
3,083
Property and equipment, net
847
621
Total assets
$
101,514
$
61,460
LIABILITIES AND STOCKHOLDERS’ EQUITY
Liabilities
$
9,899
$
8,881
Stockholders’ equity
91,615
52,579
Total liabilities and stockholders’ equity
$
101,514
$
61,460