WESTMINSTER, Colo., Nov. 3 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today reported financial results
for the third quarter of 2006. For the three months ended September
30, 2006, the Company reported a net loss attributable to common
stockholders of $8.1 million, or $0.15 per share. This compares to
a net loss attributable to common stockholders of $4.8 million, or
$0.09 per share, for the third quarter of 2005. For the nine months
ended September 30, 2006, the Company reported a net loss
attributable to common stockholders of $22.1 million, or $0.40 per
share, compared to a net loss attributable to common stockholders
of $15.5 million, or $0.36 per share, for the same period last
year. Cash, cash equivalents, and investments in marketable
securities as of September 30, 2006 were $37.8 million. Paul L.
Berns, President and Chief Executive Officer, stated: "During the
quarter we continued to make important progress in the development
of our lead product candidates. Notably, we completed patient
enrollment in our pivotal Phase 3 ENRICH trial of EFAPROXYN in
women with brain metastases originating from breast cancer, and
reached agreement with the FDA under the Special Protocol
Assessment process on the design of our pivotal Phase 2 PROPEL
trial of PDX in patients with peripheral T-cell lymphoma, which we
also initiated during the quarter. We would like to acknowledge our
investigators, patients and employees for their contributions
toward the attainment of these important milestones." Product
Portfolio Update: EFAPROXYN(TM) (efaproxiral): * In August 2006,
the Company announced the completion of patient enrollment in its
pivotal Phase 3 ENRICH trial of EFAPROXYN(TM) (efaproxiral) plus
whole brain radiation therapy in women with brain metastases
originating from breast cancer. A total of 368 patients were
enrolled at 78 medical centers in the United States, Canada, Europe
and South America. * In October 2006, the Company announced that an
independent data monitoring committee completed a second planned
interim analysis of data from the ENRICH trial and recommended that
the trial continue to the final efficacy analysis. The interim
analysis was triggered by the occurrence of 188 patient deaths and
was based upon an evaluation of patients randomized through July
31, 2006. The Company will conduct the final analysis of safety and
efficacy data following the occurrence of 282 patient deaths, which
is currently expected to occur in mid 2007. If the trial results
are positive at the final analysis, the Company intends to submit
an amendment to its previously filed new drug application to the
U.S. Food and Drug Administration (FDA) to seek marketing approval
for EFAPROXYN for use as an adjunct to radiation therapy for the
treatment of patients with brain metastases originating from breast
cancer. * In October 2006, the Company announced that data
evaluating EFAPROXYN was accepted for presentation at the 2006
American Society for Therapeutic Radiology and Oncology Annual
Meeting. Hak Choy, M.D., Chairman, Department of Radiation
Oncology, University of Texas Southwestern Medical Center, is
scheduled to present an updated survival analysis of a Phase 2
trial of EFAPROXYN in patients with locally advanced (Stage IIIA/B)
non-small cell lung cancer in an oral presentation titled
"Comparison of 5-Year Survival Between RTOG-94-10 and a Phase 2
Study of Induction Chemotherapy Followed by Efaproxiral +
Radiotherapy in Patients with Locally Advanced NSCLC" on Monday,
November 6. In addition, Huagang Hou, M.D., Research Assistant
Professor of Radiology, Dartmouth Medical School, is scheduled to
present findings from a pre-clinical study of EFAPROXYN in a poster
titled "Effects of repeated EFAPROXYN (TM) (efaproxiral) dosing, an
allosteric hemoglobin modifier, on oxygenation and enhancement of
radiotherapy in subcutaneous RIF-1 tumors, in mice" on Tuesday,
November 7. PDX (pralatrexate): * In July 2006, the FDA awarded
orphan drug designation to PDX (pralatrexate) for the treatment of
patients with T-cell lymphoma. Orphan drug designation provides for
U.S. marketing exclusivity for seven years following marketing
approval by the FDA. * In August 2006, the Company initiated
patient enrollment in PROPEL (Pralatrexate in Patients with
Relapsed Or Refractory PEripheral T-cell Lymphoma), a pivotal Phase
2 study of PDX with concurrent vitamin B12 and folic acid
supplementation in patients with relapsed or refractory peripheral
T-cell lymphoma (PTCL). This Phase 2, international, multi-center,
open-label, single-arm study will seek to enroll 100 evaluable
patients with relapsed or refractory PTCL who have progressed after
at least one prior treatment. Patients will receive 30 mg/m2 of PDX
once every week for six weeks followed by one week of rest per
cycle of treatment. The primary endpoint of the study is objective
response rate (complete and partial response). Secondary endpoints
include duration of response, progression-free survival and overall
survival. The protocol for the study was reviewed by the FDA under
its special protocol assessment process, which allows for FDA
evaluation of a clinical trial protocol intended to form the
primary basis of an efficacy claim in support of a new drug
application, and provides a binding agreement that the study
design, including trial size, clinical endpoints and/or data
analyses are acceptable to the FDA. The Company currently
anticipates that patient enrollment at approximately 35 centers in
the U.S., Canada and Europe will be completed by the third quarter
of 2008. * In October 2006, the FDA granted fast track designation
to PDX for the treatment of patients with T-cell lymphoma. The fast
track program is designed to facilitate the development and
expedite the review of new drugs that are intended to treat serious
or life-threatening conditions and that demonstrate the potential
to address unmet medical needs. * In October 2006, the Company
announced that data evaluating PDX in patients with relapsed or
refractory non-Hodgkin's lymphoma and Hodgkin's disease was
accepted for presentation at the 2006 EORTC-NCI-AACR Annual
Meeting. Owen O'Connor, M.D., Ph.D., Head of the Laboratory of
Experimental Therapeutics for Lymphoproliferative Malignancies,
Lymphoma and Development Chemotherapy Services, Memorial
Sloan-Kettering Cancer Center, is scheduled to present an updated
assessment of patient response in a poster titled "Clinical
Experience with Pralatrexate (10-Propargyl-10-deazaaminopterin
(PDX)), a Novel Antifolate with High Affinity for the Reduced
Folate Carrier, in Patients with Chemotherapy Refractory
Lymphoproliferative Malignancies" on Friday, November 10.
Conference Call The Company will host a conference call to review
its third quarter results on Friday, November 3, 2006, at 11 AM ET.
The dial in number for U.S. residents to participate is
877-407-8031. International callers should dial 201-689-8031.
Participants should reference the Allos Therapeutics conference
call. Conference Call Replay An audio replay of the conference call
will be available from 5 PM ET on Friday, November 3, 2006, until
11:59 PM ET on Friday, November 10, 2006. To access the replay,
please dial 877-660-6853 (domestic) or 201-612-7415
(international); Replay pass codes (both required for playback):
account # 286; conference ID # 218565. Webcast Allos Therapeutics
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 http://www.allos.com/ and will be
archived for 30 days. About Allos Therapeutics, Inc. Allos
Therapeutics, Inc. (ALTH) is a biopharmaceutical company focused on
the development and commercialization of small molecule
therapeutics for the treatment of cancer. The Company has two
product candidates in late-stage clinical development: EFAPROXYN
(efaproxiral), a radiation sensitizer currently under evaluation in
a pivotal Phase 3 trial in women with brain metastases originating
from breast cancer, and PDX (pralatrexate), a novel, next
generation antifolate currently under evaluation in a pivotal Phase
2 trial in patients with relapsed or refractory peripheral T-cell
lymphoma. The Company is also evaluating RH1, a targeted
chemotherapeutic agent, in a Phase 1 trial in patients with
advanced solid tumors. For additional information, please visit the
Company's website at http://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 concerning the Company's projected
timeline for conducting the final analysis of safety and efficacy
data from the ENRICH trial, the potential safety and efficacy of
EFAPROXYN for the treatment of patients with brain metastases
originating from breast cancer, the Company's intent to file an
amendment to its previously filed new drug application in the event
the ENRICH trial results are positive, the Company's projected
timeline for completing patient enrollment in the PROPEL trial, the
Company's intent to continue evaluating the therapeutic utility of
its product candidates in other potential 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, whether caused by competition, adverse events,
investigative site initiation rates, patient enrollment rates,
regulatory issues or other factors; and that the Company's clinical
trials may not demonstrate the safety and efficacy of the Company's
product candidates in their target indications. Even if clinical
trials demonstrate the safety and efficacy of the Company's product
candidates, regulatory authorities may not approve such product
candidates, the Company may not be able to successfully market such
product candidates, or the Company may face post-approval problems
that require the withdrawal of its product candidates from the
market. In addition, the Company may lack the financial resources
and access to capital to fund planned or future clinical trials of
its product candidates, or to continue evaluating their therapeutic
utility in other potential indications. 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, 2005, 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 share and
per share information) (unaudited) Three-months ended Nine-months
ended September 30, September 30, 2005 2006 2005 2006 Operating
expenses: Research and development $3,001 $4,210 $7,970 $10,970
Clinical manufacturing 307 486 934 1,438 Marketing, general and
administrative 2,005 3,895 6,813 10,560 Restructuring and
separation costs -- -- 380 646 Total operating expenses 5,313 8,591
16,097 23,614 Loss from operations (5,313) (8,591) (16,097)
(23,614) Interest and other income, net 522 480 1,238 1,471 Net
loss $(4,791) $(8,111) $(14,859) $(22,143) Dividend related to
beneficial conversion feature of preferred stock -- -- (624) -- Net
loss attributable to common stockholders $(4,791) $(8,111)
$(15,483) $(22,143) Basic and diluted net loss per share $(0.09)
$(0.15) $(0.36) $(0.40) Weighted average shares outstanding: basic
and diluted 55,015,757 55,196,369 43,045,637 55,126,488 ALLOS
THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands)
(unaudited) December 31, September 30, 2005 2006 ASSETS Cash, cash
equivalents and investments in marketable securities $55,282
$37,830 Other assets 1,111 1,686 Property and equipment, net 688
658 Total assets $57,081 $40,174 LIABILITIES AND STOCKHOLDERS'
EQUITY Liabilities $3,790 $6,172 Stockholders' equity 53,291 34,002
Total liabilities and stockholders' equity $57,081 $40,174
DATASOURCE: Allos Therapeutics, Inc. CONTACT: Jennifer Neiman ,
Manager, Corporate Communications of Allos Therapeutics, Inc.,
+1-720-540-5227, Web site: http://www.allos.com/
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