Allos Therapeutics, Inc. (NASDAQ: ALTH) today reported results for
the second quarter of 2008. For the three months ended June 30,
2008, the Company reported a net loss of $11.8 million, or ($0.16)
per share. This compares to a net loss of $10.4 million, or ($0.16)
per share, for the second quarter of 2007. For the six months ended
June 30, 2008, the Company reported a net loss of $23.8 million, or
($0.34) per share, compared to a net loss of $18.8 million, or
($0.29) per share for the same period last year. For the six months
ended June 30, 2008, net cash used in operating activities was
$19.5 million. Cash, cash equivalents and investments in marketable
securities as of June 30, 2008 were $106.5 million. "During the
quarter, we continued to make important progress advancing the
development of PDX in both hematologic malignancies and solid
tumors," said Paul L. Berns, President and Chief Executive Officer
of Allos. "In May, we announced interim data from the first 65
evaluable patients in PROPEL, our SPA-approved pivotal Phase 2
trial of PDX in patients with relapsed or refractory peripheral
T-cell lymphoma. We expect to report top line results of the trial
by the end of 2008 and, following our review of the trial results,
to submit a New Drug Application for PDX for the treatment of
patients with relapsed or refractory PTCL as expeditiously as
possible. In June, we reported encouraging interim data from our
Phase 1 study of PDX in patients with relapsed or refractory
cutaneous T-cell lymphoma and, in July, we expanded our PDX solid
tumor development program into bladder cancer. During the quarter,
we also strengthened our balance sheet through an underwritten
public offering of common stock, which resulted in net proceeds of
approximately $65.2 million for the continued execution of our PDX
product development and commercialization plan." 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 seven ongoing clinical trials, including the
PROPEL trial, evaluating the potential clinical utility of PDX in
hematologic malignancies and solid tumor indications. -- Reported
Interim Response and Safety Data from Pivotal Phase 2 PROPEL Trial
-- In May 2008, the Company reported interim response and safety
data from the PROPEL trial of PDX in patients with relapsed or
refractory peripheral T-cell lymphoma. Twenty-nine percent (n=19)
of the first 65 evaluable patients enrolled in the trial
experienced either a complete or partial response, as assessed by
central independent oncology review. Forty-five percent (n=29) of
the first 65 evaluable patients experienced either a complete or
partial response, as assessed by the PROPEL investigators. The
median duration of response for these patients could not be
estimated due to the current length of follow up. The most common
drug related grade 3/4 adverse events were mucositis and
thrombocytopenia, which were observed in 14% and 23% of patients,
respectively. Patients received a median of three prior treatment
regimens. -- Reported Interim Response and Safety Data from Phase 1
CTCL Trial -- In June 2008, the Company announced the presentation
of interim data from its Phase 1 open-label, multi-center study of
PDX in patients with relapsed or refractory cutaneous T-cell
lymphoma (CTCL). Data were presented on 17 patients, including 14
evaluable patients who completed at least one cycle of treatment
with PDX at doses ranging from 15 - 30 mg/m2 as part of a weekly
schedule for two or three weeks followed by one week of rest.
Patients received a median of three prior systemic therapies.
Investigator-assessed responses were observed in seven of 14
evaluable patients (50%), including two complete responses and five
partial responses. Responses were observed in all four treatment
cohorts. The most common adverse event was mucositis, with Grade 2
mucositis observed in six of 17 patients and Grade 3 mucositis
observed in two of 17 patients. There were no Grade 4 toxicities
and no thrombocytopenia above Grade 1. -- Advanced PDX solid tumor
development program -- In July 2008, the Company initiated patient
enrollment in a Phase 2, open-label, single-arm, multi-center study
of PDX 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 (PFS),
overall survival and the safety and tolerability of PDX. The study
will seek to enroll approximately 41 patients in up to 20
investigative sites worldwide. -- The Company 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. Based on current enrollment
rates, the Company expects to complete patient enrollment in this
study in the second half of 2009. RH1 RH1 is a novel small molecule
chemotherapeutic agent that we believe is bioactivated by the
enzyme DT-diaphorase, or DTD, which we believe 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. Corporate Highlights -- Strengthened the Company's
balance sheet -- In May 2008, the Company closed an underwritten
public offering of 12,420,000 shares of common stock at a public
offering price of $5.64 per share, resulting in net proceeds of
approximately $65.2 million. 2008 Financial Guidance Update For the
year ending December 31, 2008, the Company anticipates that net
cash used in operating activities will approximate $45 million to
$49 million, an increase from our prior guidance of $42 million to
$46 million. This increase is expected to primarily relate to
additional investments associated with our clinical and preclinical
development program, pre-commercial scale-up of manufacturing, and
preparations for the potential commercial launch of PDX, in the
event we obtain regulatory approval. 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 second quarter results on Tuesday,
August 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 Friday, August 15, 2008. To access the replay, please dial
800-406-7325 (domestic) or 303-590-3030 (international). The replay
pass code is 3900919#. 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, 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 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 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 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. -0- *T ALLOS THERAPEUTICS, INC. CONDENSED
STATEMENTS OF OPERATIONS (in thousands - except share and per share
information) (unaudited) Three-months ended Six-months ended June
30, June 30, ----------------------- ----------------------- 2008
2007 2008 2007 ----------- ----------- ----------- -----------
Operating expenses: Research and development $5,404 $4,360 $11,378
$7,650 Clinical manufacturing 1,485 1,385 3,071 2,532 Marketing,
general and administrative 5,439 5,515 10,450 10,263 -----------
----------- ----------- ----------- Total operating expenses 12,328
11,260 24,899 20,445 Loss from operations (12,328) (11,260)
(24,899) (20,445) Interest and other income, net 504 909 1,069
1,683 ----------- ----------- ----------- ----------- Net loss
$(11,824) $(10,351) $(23,830) $(18,762) ----------- -----------
----------- ----------- Net loss per share: basic and diluted
$(0.16) $(0.16) $(0.34) $(0.29) =========== =========== ===========
=========== Weighted average shares outstanding: basic and diluted
72,382,487 65,645,678 69,916,800 63,908,192 =========== ===========
=========== =========== *T -0- *T ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS (in thousands) (unaudited) June 30, 2008
December 31, 2007 ------------- ----------------- ASSETS Cash, cash
equivalents and investments in marketable securities $106,466
$57,756 Other assets 3,749 3,083 Property and equipment, net 650
621 ------------- ----------------- Total assets $110,865 $61,460
============= ================= LIABILITIES AND STOCKHOLDERS'
EQUITY Liabilities $ 9,642 $ 8,881 Stockholders' equity 101,223
52,579 ------------- ----------------- Total liabilities and
stockholders' equity $110,865 $61,460 =============
================= *T Allos Therapeutics, Inc. (NASDAQ: ALTH) today
reported results for the second quarter of 2008. For the three
months ended June 30, 2008, the Company reported a net loss of
$11.8 million, or ($0.16) per share. This compares to a net loss of
$10.4 million, or ($0.16) per share, for the second quarter of
2007. For the six months ended June 30, 2008, the Company reported
a net loss of $23.8 million, or ($0.34) per share, compared to a
net loss of $18.8 million, or ($0.29) per share for the same period
last year. For the six months ended June 30, 2008, net cash used in
operating activities was $19.5 million. Cash, cash equivalents and
investments in marketable securities as of June 30, 2008 were
$106.5 million. �During the quarter, we continued to make important
progress advancing the development of PDX in both hematologic
malignancies and solid tumors,� said Paul L. Berns, President and
Chief Executive Officer of Allos. �In May, we announced interim
data from the first 65 evaluable patients in PROPEL, our
SPA-approved pivotal Phase 2 trial of PDX in patients with relapsed
or refractory peripheral T-cell lymphoma. We expect to report top
line results of the trial by the end of 2008 and, following our
review of the trial results, to submit a New Drug Application for
PDX for the treatment of patients with relapsed or refractory PTCL
as expeditiously as possible. In June, we reported encouraging
interim data from our Phase 1 study of PDX in patients with
relapsed or refractory cutaneous T-cell lymphoma and, in July, we
expanded our PDX solid tumor development program into bladder
cancer. During the quarter, we also strengthened our balance sheet
through an underwritten public offering of common stock, which
resulted in net proceeds of approximately $65.2 million for the
continued execution of our PDX product development and
commercialization plan.� 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 seven
ongoing clinical trials, including the PROPEL trial, evaluating the
potential clinical utility of PDX in hematologic malignancies and
solid tumor indications. Reported Interim Response and Safety Data
from Pivotal Phase 2 PROPEL Trial In May 2008, the Company reported
interim response and safety data from the PROPEL trial of PDX in
patients with relapsed or refractory peripheral T-cell lymphoma.
Twenty-nine percent (n=19) of the first 65 evaluable patients
enrolled in the trial experienced either a complete or partial
response, as assessed by central independent oncology review.
Forty-five percent (n=29) of the first 65 evaluable patients
experienced either a complete or partial response, as assessed by
the PROPEL investigators. The median duration of response for these
patients could not be estimated due to the current length of follow
up. The most common drug related grade 3/4 adverse events were
mucositis and thrombocytopenia, which were observed in 14% and 23%
of patients, respectively. Patients received a median of three
prior treatment regimens. Reported Interim Response and Safety Data
from Phase 1 CTCL Trial In June 2008, the Company announced the
presentation of interim data from its Phase 1 open-label,
multi-center study of PDX in patients with relapsed or refractory
cutaneous T-cell lymphoma (CTCL). Data were presented on 17
patients, including 14 evaluable patients who completed at least
one cycle of treatment with PDX at doses ranging from 15 - 30 mg/m2
as part of a weekly schedule for two or three weeks followed by one
week of rest. Patients received a median of three prior systemic
therapies. Investigator-assessed responses were observed in seven
of 14 evaluable patients (50%), including two complete responses
and five partial responses. Responses were observed in all four
treatment cohorts. The most common adverse event was mucositis,
with Grade 2 mucositis observed in six of 17 patients and Grade 3
mucositis observed in two of 17 patients. There were no Grade 4
toxicities and no thrombocytopenia above Grade 1. Advanced PDX
solid tumor development program In July 2008, the Company initiated
patient enrollment in a Phase 2, open-label, single-arm,
multi-center study of PDX 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 (PFS), overall survival and the safety and tolerability of
PDX. The study will seek to enroll approximately 41 patients in up
to 20 investigative sites worldwide. The Company advanced patient
enrollment in the Phase 2b, randomized, multi-center study
comparing PDX 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. RH1 RH1 is a novel small molecule
chemotherapeutic agent that we believe is bioactivated by the
enzyme DT-diaphorase, or DTD, which we believe 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. Corporate Highlights Strengthened the Company's
balance sheet In May 2008, the Company closed an underwritten
public offering of 12,420,000 shares of common stock at a public
offering price of $5.64 per share, resulting in net proceeds of
approximately $65.2 million. 2008 Financial Guidance Update For the
year ending December 31, 2008, the Company anticipates that net
cash used in operating activities will approximate $45 million to
$49 million, an increase from our prior guidance of $42 million to
$46 million. This increase is expected to primarily relate to
additional investments associated with our clinical and preclinical
development program, pre-commercial scale-up of manufacturing, and
preparations for the potential commercial launch of PDX, in the
event we obtain regulatory approval. 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 second quarter results on Tuesday,
August 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 Friday, August 15, 2008. To access the replay, please dial
800-406-7325 (domestic) or 303-590-3030 (international). The replay
pass code is 3900919#. 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, 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 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 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 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 share and per share information)
(unaudited) � � Three-months ended June 30, � Six-months ended June
30, 2008 � � 2007 � 2008 � � 2007 � � Operating expenses: Research
and development $ 5,404 $ 4,360 $ 11,378 $ 7,650 Clinical
manufacturing 1,485 1,385 3,071 2,532 Marketing, general and
administrative 5,439 � 5,515 � 10,450 � 10,263 � � Total operating
expenses 12,328 11,260 24,899 20,445 � Loss from operations (12,328
) (11,260 ) (24,899 ) (20,445 ) Interest and other income, net 504
� 909 � 1,069 � 1,683 � � Net loss $ (11,824 ) $ (10,351 ) $
(23,830 ) $ (18,762 ) � Net loss per share: basic and diluted $
(0.16 ) $ (0.16 ) $ (0.34 ) $ (0.29 ) Weighted average shares
outstanding: basic and diluted 72,382,487 � 65,645,678 � 69,916,800
� 63,908,192 � ALLOS THERAPEUTICS, INC. CONDENSED BALANCE SHEETS
(in thousands) (unaudited) � June 30, 2008 December 31, 2007 �
ASSETS Cash, cash equivalents and investments inmarketable
securities $ 106,466 $ 57,756 Other assets 3,749 3,083 Property and
equipment, net 650 621 � � Total assets $ 110,865 $ 61,460 �
LIABILITIES AND STOCKHOLDERS� EQUITY Liabilities $ 9,642 $ 8,881
Stockholders� equity � 101,223 � 52,579 Total liabilities and
stockholders� equity $ 110,865 $ 61,460
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