WESTMINSTER, Colo., May 9 /PRNewswire-FirstCall/ -- Allos Therapeutics,
Inc. (Nasdaq: ALTH) today reported financial results for the first quarter
of 2006. For the three months ended March 31, 2006, the Company reported a
net loss of $7.1 million, or ($0.13) per share. This compares to a net loss
of $5.1 million, or ($0.16) per share, for the first quarter of 2005. Cash,
cash equivalents, and investments in marketable securities as of March 31,
2006 were $50.3 million.
Paul L. Berns, President and Chief Executive Officer, stated: "During
the quarter we continued to meet patient recruitment goals for our pivotal
Phase 3 ENRICH trial, which positions us to reach target enrollment for the
study by year end. We also continued to build upon our clinical experience
with PDX in patients with non-Hodgkin's lymphoma and Hodgkin's disease and
anticipate initiating a Phase 2 multi-center study of PDX in patients with
peripheral T-cell lymphoma in the third quarter of this year. The progress
made during the quarter in advancing our product development programs
reflects the outstanding efforts of our employees and clinical
collaborators and their commitment to patients."
Product Portfolio Update:
EFAPROXYN(TM) (efaproxiral):
* Enrollment in ENRICH, the Company's Phase 3 study of EFAPROXYN(TM)
(efaproxiral) in patients with brain metastases originating from breast
cancer, continues to progress in line with Company expectations. In
April, the Company announced that an independent data monitoring
committee (DMC) completed a planned interim analysis of the study's
primary endpoint (survival), found no major patient safety concerns and
recommended that the trial continue per the protocol. The DMC will
conduct a second planned interim analysis of safety and efficacy data
following the occurrence of 188 patient deaths, which is currently
expected to occur in the second half of 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 the
first half of 2007. If the trial results are positive at either the
second interim or final analysis the Company will submit an amendment
to its previously filed new drug application to seek marketing approval
for EFAPROXYN for use as an adjunct to radiation therapy for the
treatment of brain metastases originating from breast cancer.
* The Company is currently enrolling patients in two other clinical
trials with EFAPROXYN: a Phase 1 study of patients with locally
advanced non-small cell lung cancer receiving concurrent
chemoradiotherapy in combination with EFAPROXYN and a Phase 1b/2
clinical trial of EFAPROXYN in patients with locally advanced cancer of
the cervix receiving concurrent chemoradiotherapy.
* Brian D. Kavanagh, M.D., Vice-Chair, Associate Professor, Department of
Radiation Oncology, University of Colorado Health Sciences Center is
scheduled to present a poster presentation titled "The influence of
efaproxiral on breast cancer xenograft hypoxia and HIF-1-alpha
expression" at the American Society of Clinical Oncology Annual Meeting
on June 5, 2006.
PDX (pralatrexate):
* The Phase 2 portion of the Company's Phase 1/2 single-agent study of
PDX in patients with relapsed or refractory non-Hodgkin's lymphoma and
Hodgkin's disease is currently on-going at Memorial Sloan-Kettering
Cancer Center. Based on interim results from the Phase 1 portion of
this study, the Company plans to initiate a Phase 2, open-label,
multi-center study of PDX in patients with relapsed or refractory
peripheral T-cell lymphoma in the third quarter of this year.
* A Phase 1 dose escalation study of PDX in patients with relapsed or
refractory non-small cell lung cancer is currently on-going at Memorial
Sloan-Kettering Cancer Center.
RH1:
* A Phase 1 dose escalation study in patients with advanced solid tumors
is currently on-going at two cancer centers in the U.K.
Corporate events:
* In March 2006, the Company announced the appointment of Paul L. Berns
as the Company's President, Chief Executive Officer and a member of the
Board of Directors. With Mr. Berns' appointment, David C. Clark, the
Company's Corporate Controller and Treasurer, was appointed to serve as
the Company's Principal Financial Officer.
Conference Call
The Company will host a conference call to review its first quarter
results on Tuesday, May 9, 2006, at 11:00 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 2:00 PM
ET on Tuesday, May 9, 2006, until 11:59 PM ET on Friday, May 19, 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 # 199888.
Webcast
The Company will also hold a live web cast 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. (Nasdaq: ALTH) is a biopharmaceutical company
focused on developing and commercializing innovative small molecule
therapeutics for the treatment of cancer. The Company's lead product
candidate, EFAPROXYN(TM) (efaproxiral), is a synthetic small molecule
designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during
radiation therapy. EFAPROXYN is currently being evaluated as an adjunct to
whole brain radiation therapy in a pivotal Phase 3 trial in women with
brain metastases originating from breast cancer. The Company's other
product candidates are: PDX (pralatrexate), a small molecule
chemotherapeutic agent (DHFR inhibitor) currently under investigation in
patients with non-small cell lung cancer and non-Hodgkin's lymphoma; and
RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme
DT-diaphorase currently under evaluation in patients with advanced solid
tumors. For more information, please visit the Company's web site 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 timelines relating to 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 projected timeline for initiating the Phase 2 trial of PDX in
patients with relapsed or refractory peripheral T-cell lympoma 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 ENRICH trial, 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, including the ENRICH trial, may not demonstrate
the safety and efficacy of the Company's product candidates in their target
indications. Even if the ENRICH trial demonstrates the safety and efficacy
of EFAPROXYN, regulatory authorities may not approve EFAPROXYN for the
treatment of brain metastases originating from breast cancer, the Company
may not be able to successfully market EFAPROXYN, or the Company may face
post-approval problems that require the withdrawal of EFAPROXYN from the
market. 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
March 31,
2005 2006
Operating expenses:
Research and development $2,348 $3,440
Clinical manufacturing 360 561
Marketing, general and administrative 2,193 2,926
Restructuring and separation costs 380 646
Total operating expenses 5,281 7,573
Loss from operations (5,281) (7,573)
Interest and other income, net 209 504
Net loss $(5,072) $(7,069)
Net loss per share: basic and diluted $(0.16) $(0.13)
Weighted average common shares:
Basic and diluted 31,175,783 55,079,180
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, March 31,
2005 2006
ASSETS
Cash, cash equivalents and investments in
marketable securities $55,282 $50,262
Other assets 1,111 1,164
Property and equipment, net 688 679
Total assets $57,081 $52,105
Liabilities and Stockholders' Equity
Current liabilities $3,790 $5,400
Stockholders' equity 53,291 46,705
Total liabilities and
stockholders' equity $57,081 $52,105
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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