WESTMINSTER, Colo., Aug. 8 /PRNewswire-FirstCall/ -- Allos Therapeutics,
Inc. (Nasdaq: ALTH) today reported financial results for the second quarter of
2005. For the three months ended June 30, 2005, the Company reported a net
loss of $5.6 million, or $0.13 per share. This compares to a net loss of $7.2
million, or $0.23 per share, for the second quarter of 2004.
For the six months ended June 30, 2005, the Company reported a net loss of
$10.7 million, or $0.29 per share, compared to a net loss of $12.3 million, or
$0.40 per share, for the same period last year.
Cash, cash equivalents, and investments in marketable securities as of
June 30, 2005 were $62.6 million.
Product Portfolio Update:
EFAPROXYN(TM) (efaproxiral):
* ENRICH, the Company's Phase 3 study of the radiation sensitizer
EFAPROXYN in patients with brain metastases originating from breast
cancer, continues to progress in line with expectations. To date, 100
out of 125 planned investigative sites have opened for enrollment.
The Company expects to complete patient enrollment in this trial
during the second half of 2006 and report preliminary results
approximately six months thereafter.
* In June 2005, the Company entered into a long-term manufacturing
agreement with Hovione for the supply of EFAPROXYN bulk drug
substance, efaproxiral sodium. Under the agreement, Hovione is
committed to manufacture and supply Allos with sufficient quantities
of efaproxiral sodium to support Allos' anticipated requirements for
both the pre-and post-commercialization phases of production.
* Results from the Company's Phase 2 trial of EFAPROXYN in patients with
Stage IIIA/IIIB NSCLC were accepted for publication in the August 20th
edition of the Journal of Clinical Oncology.
* The Marketing Authorization Application (MAA) for EFAPROXYN, filed in
June 2004, remains under review by the European Medicines Agency
(EMEA). In June 2005, the Company received the EMEA's Day 180 List
of Outstanding Issues, to which the Company must respond by
September 14, 2005.
PDX (pralatrexate):
* During the quarter, researchers at Memorial Sloan Kettering completed
enrollment of a Phase 1 trial of PDX in combination with docetaxel in
patients with advanced cancer who failed prior chemotherapy.
RH1:
* Enrollment in a Phase 1 dose escalation study of RH1 in patients with
advanced solid tumors continues to progress in line with expectations.
The Company currently expects to complete enrollment in this trial in
the second half of 2005.
Financial Highlights:
In May 2005, the Company announced stockholder approval of the issuance of
shares of the Company's common stock upon exchange of shares of the Company's
Series A Exchangeable Preferred Stock sold to Warburg Pincus Private Equity
VIII, L.P. (Warburg) and certain other investors in a financing transaction in
March 2005. As a result of such approval, the Company issued a total of
23,524,430 shares of common stock upon exchange of 2,352,443 shares of Series
A Exchangeable Preferred Stock. After giving effect to the share exchange,
the Company now has approximately 55.0 million shares of common stock
outstanding, of which Warburg owns approximately 22.6 million shares, or 41%.
Conference Call
The Company will host a conference call to review its second quarter
results on Monday, August 8, 2005, at 4:30 PM 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 5:30 PM ET
on Monday, August 8, 2005, until 11:59 PM ET on Thursday, August 18, 2005. 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 # 161942.
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. Our 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. Our other product candidates are: PDX (pralatrexate), a
small molecule chemotherapeutic agent (DHFR inhibitor) currently under
investigation as both a single agent and in combination therapy regimens 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 our projected timelines for completion of enrollment and
announcement of the results of our clinical trials, the potential safety and
efficacy of EFAPROXYN, 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 we may
experience difficulties or delays in our clinical trials, whether caused by
adverse events, investigative site initiation rates, patient enrollment rates,
regulatory issues or other factors; and that clinical trials may not
demonstrate the safety and efficacy of our product candidates in their target
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, 2004, 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 Six-months ended
June 30, June 30,
2004 2005 2004 2005
Operating expenses:
Research and
development $3,447 $2,621 $5,435 $4,969
Clinical
manufacturing 1,374 268 2,156 628
Marketing, general
and administrative 2,441 2,615 4,955 4,807
Restructuring costs -- -- -- 380
Total operating
expenses 7,262 5,504 12,546 10,784
Loss from operations (7,262) (5,504) (12,546) (10,784)
Interest and other
income, net 111 507 249 716
Net loss $(7,151) $(4,997) $(12,297) $ (10,068)
Dividend related to
beneficial conversion
feature of preferred
stock -- (623) -- (623)
Net loss attributable
to common
stockholders (7,151) (5,620) (12,297) (10,691)
Basic and diluted
net loss
per share $(0.23) $(0.13) $(0.40) $(0.29)
Weighted average
common shares:
basic
and diluted 31,139,289 42,683,395 31,124,616 36,961,378
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, 2004 June 30, 2005
ASSETS
Cash, cash equivalents and
investments in marketable
securities $23,849 $62,571
Other assets 1,344 1,953
Equipment and leasehold
improvements, net 980 830
Total assets $26,173 $65,354
Liabilities and Stockholders' Equity
Liabilities $2,310 $ 2,061
Stockholders' equity 23,863 63,293
Total liabilities and
stockholders' equity $26,173 $65,354
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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