WESTMINSTER, Colo., May 5 /PRNewswire-FirstCall/ -- Allos Therapeutics,
Inc. (Nasdaq: ALTH) today reported financial results for the first quarter of
2005. For the three months ended March 31, 2005, the Company reported a net
loss of $5.1 million, or $(0.16) per share. This compares to a net loss of
$5.1 million, or $(0.17) per share, for the first quarter of 2004.
Cash, cash equivalents, and investments in marketable securities as of
March 31, 2005 were $67.8 million.
Product Portfolio Update:
EFAPROXYN(TM) (efaproxiral):
* The Company continues to initiate investigative sites and enroll
patients in its pivotal Phase 3 trial of EFAPROXYN for the treatment of
patients with brain metastases from breast cancer. To date, more than
70 of 125 planned investigative sites have opened for enrollment in
North America, Europe and South America. In addition, patient
enrollment commenced during the first quarter in Europe and South
America, thus expanding the trial into all three geographic regions.
The Company currently expects to complete enrollment in this trial in
the second half of 2006.
* The Marketing Authorization Application (MAA) for EFAPROXYN, filed in
June 2004, remains under review by the European Medicines Agency
(EMEA). In April 2005, the Company responded to the Agency's 120-day
list of questions generated during review of the MAA.
PDX (pralatrexate):
* In January 2005, the Company announced the initiation of patient
enrollment in a Phase 1 dose escalation study of PDX with vitamin B12
and folic acid supplementation in patients with Stage IIIB-IV non-small
cell lung cancer. The Company currently expects to complete enrollment
in this trial in the second half of 2005.
* A Phase 1 study of PDX in combination with a taxane is currently
underway at Memorial Sloan-Kettering Cancer Center. This open-label
study is designed to determine the optimal dose and toxicity profile of
PDX when combined with a taxane. The Company currently expects to
complete patient accrual in this trial in the first half of 2005.
RH1:
* In December 2004, the Company reported the status of a Phase 1 dose
escalation study of RH1 in patients with advanced solid tumors in
conjunction with news of the product's in-licensing. The Company
currently expects to complete enrollment in this trial in the second
half of 2005.
Financial Highlights:
* In March 2005, the Company issued and sold an aggregate of 2,352,443
shares of Series A Exchangeable Preferred Stock to Warburg Pincus
Private Equity VIII, L.P. and certain other investors at a purchase
price of $22.10 per share, for total net proceeds of $48.9 million. In
conjunction with this financing, Stewart Hen and Jonathan Leff, both
managing directors of Warburg Pincus, joined the Company's Board of
Directors.
Conference Call
The Company will host a conference call to review its first quarter
results on Thursday, May 5, 2005, 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 Thursday, May 5, 2005, until 11:59 PM ET on Thursday, May 12, 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 #: 150227.
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 initiation of investigative sites and
completion of enrollment in 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
March 31,
2004 2005
Operating expenses:
Research and development $1,988 $2,348
Clinical manufacturing 783 360
Marketing, general and administrative 2,513 2,193
Restructuring costs -- 380
Total operating expenses 5,284 5,281
Loss from operations (5,284) (5,281)
Interest and other income, net 138 209
Net loss $(5,146) $(5,072)
Net loss per share: basic and diluted $(0.17) $(0.16)
Weighted average common shares:
Basic and diluted 31,109,944 31,175,783
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, 2004 March 31, 2005
ASSETS
Cash, cash equivalents and
investments in marketable
securities $23,848 $67,834
Other assets 1,345 2,664
Property, equipment and
leasehold improvements, net 980 905
Total assets $26,173 $71,403
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $2,310 $3,713
Series A Exchangeable Preferred Stock -- 48,914
Stockholders' equity 23,863 18,776
Total liabilities and
stockholders' equity $26,173 $71,403
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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