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 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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Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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