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
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman , Manager, Corporate
Communications of Allos Therapeutics, Inc., +1-720-540-5227,
jneiman@allos.com
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