WESTMINSTER, Colo., Aug. 7 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today reported financial results for the
second quarter of 2006. For the three months ended June 30, 2006, the
Company reported a net loss attributable to common stockholders of $7.0
million, or $0.13 per share. This compares to a net loss attributable to
common stockholders of $5.6 million, or $0.13 per share, for the second
quarter of 2005. For the six months ended June 30, 2006, the Company
reported a net loss attributable to common stockholders of $14.0 million,
or $0.25 per share, compared to a net loss attributable to common
stockholders of $10.7 million, or $0.29 per share, for the same period last
year. Cash, cash equivalents, and investments in marketable securities as
of June 30, 2006 were $43.5 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 we believe will ensure the completion of our
enrollment effort by the end of the third quarter. We also made important
progress in advancing the development of PDX by completing the FDA's SPA
process for our planned Phase 2 study in patients with peripheral T-cell
lymphoma and receiving orphan drug designation for PDX for the treatment of
T-cell lymphoma. We attribute our ability to achieve these milestones to
the diligent efforts of Allos' committed employees. For the balance of the
year, we remain focused on executing our clinical plans for our three
product candidates as we continue to evaluate their broader therapeutic
utility in other potential indications."
Product Portfolio Update:
EFAPROXYN(TM) (efaproxiral):
* Enrollment in ENRICH, the Company's pivotal Phase 3 study of
EFAPROXYN(TM) (efaproxiral) in patients with brain metastases
originating from breast cancer, continues to progress in line with
Company expectations and is projected to complete by the end of the
third quarter. An independent data monitoring committee will conduct a
second planned interim analysis of safety and efficacy data at its
first scheduled meeting 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 mid 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 as expeditiously
as possible to seek marketing approval for EFAPROXYN for the treatment
of patients with brain metastases originating from breast cancer.
* In June 2006, the Company announced the publication of new findings
from its Phase 3 REACH study of EFAPROXYN plus whole brain radiation
therapy in patients with brain metastases from various primary cancers.
Results of the analysis, which were reported in the June 13th edition
of the British Journal of Cancer (volume 94, issue 12), found that
patients who achieved sufficient efaproxiral exposure to realize the
desired pharmacodynamic effect saw clinically meaningful survival and
response rate benefits.
PDX (pralatrexate):
* In August 2006, the Company announced that it reached agreement with
the U.S. Food and Drug Administration (FDA) under the Special Protocol
Assessment process (SPA) on the design of a pivotal Phase 2 trial of
the Company's novel antifolate PDX in patients with relapsed or
refractory peripheral T-cell lymphoma. The SPA process 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 plans to open this non-randomized, open-label study
for accrual in the third quarter of this year and will look to enroll
100 evaluable patients at approximately 35 leading cancer centers in
the U.S., Canada and Europe. The primary endpoint of the trial is
response rate.
* In July 2006, the U.S. Food and Drug Administration awarded orphan drug
designation to PDX 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.
* Investigators at Memorial Sloan Kettering Cancer Center are currently
enrolling patients in two clinical trials with PDX: A Phase 1/2 study
of PDX in patients with relapsed or refractory non-Hodgkin's lymphoma
and Hodgkin's disease and a Phase 1 dose escalation study of PDX in
patients with relapsed or refractory non-small cell lung cancer.
RH1:
* During the quarter, researchers at Cancer Research U.K. completed
enrollment of a Phase 1 dose escalation study of RH1 in patients with
advanced solid tumors. Once the last patient has completed treatment,
the Company will evaluate results from the study to determine future
development plans.
Corporate events:
* In June 2006, the Company appointed James V. Caruso as Executive Vice
President, Chief Commercial Officer. In this newly created role, Mr.
Caruso will oversee the Company's business development, sales and
marketing functions.
Conference Call
The Company will host a conference call to review its second quarter
results on Monday, August 7, 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 Monday, August 7, 2006, until 11:59 PM ET on Thursday, August 17, 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 # 208196.
Webcast
Allos Therapeutics will 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 completion of
enrollment and the conduct of the second interim and final analyses of 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 initiating the Phase 2 trial of PDX in
patients with relapsed or refractory peripheral T-cell lymphoma, 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.
(Tables follow)
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,
2005 2006 2005 2006
Operating expenses:
Research and development $2,621 $3,320 $4,969 $6,760
Clinical manufacturing 268 391 628 952
Marketing, general and
administrative 2,615 3,739 4,807 6,665
Restructuring and
separation costs -- -- 380 646
Total operating expenses 5,504 7,450 10,784 15,023
Loss from operations (5,504) (7,450) (10,784) (15,023)
Interest and other income,
net 507 488 716 992
Net loss $(4,997) $(6,962) $(10,068) $(14,031)
Dividend related to beneficial
conversion feature of
preferred stock (623) -- (623) --
Net loss attributable to
common stockholders $(5,620) $(6,962) $(10,691) $(14,031)
Net loss per share:
basic and diluted $(0.13) $(0.13) $(0.29) $(0.25)
Weighted average shares
outstanding:
basic and diluted 42,683,395 55,102,627 36,961,378 55,090,968
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, 2005 June 30, 2006
ASSETS
Cash, cash equivalents and investments
in marketable securities $55,282 $43,507
Other assets 1,111 1,725
Property and equipment, net 688 668
Total assets $57,081 $45,900
LIABILITIES AND STOCKHOLDERS' EQUITY
Liabilities $3,790 $4,845
Stockholders' equity 53,291 41,055
Total liabilities and stockholders'
equity $57,081 $45,900
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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