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
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Jun 2024 to Jul 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Jul 2023 to Jul 2024