WESTMINSTER, Colo., Aug. 7 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today reported financial results for the
second quarter of 2007. For the three months ended June 30, 2007, the
Company reported a net loss of $10.4 million, or ($0.16) per share. This
compares to a net loss of $7.0 million, or ($0.13) per share, for the
second quarter of 2006. For the six months ended June 30, 2007, the Company
reported a net loss of $18.8 million, or ($0.29) per share, compared to a
net loss of $14.0 million, or ($0.25) per share for the same period last
year. For the six months ended June 30, 2007, net cash used in operating
activities was $15.5 million. Cash, cash equivalents, and investments in
marketable securities as of June 30, 2007 were $68.7 million.
"During the quarter, we continued to make important progress with our
PDX development program," stated Paul L. Berns, President and Chief
Executive Officer of Allos. "Thanks to support from leading oncologists and
patient advocacy groups, PROPEL, our pivotal Phase 2 trial of PDX in
patients with peripheral T-cell lymphoma, continues to enroll well. Twelve
months ago, we had just reached agreement with the FDA on the Special
Protocol Assessment for PROPEL. Today, with four Allos-sponsored PDX
studies underway and another two scheduled to begin in the near-term, we
believe we have established a solid foundation to accelerate PDX
development and evaluate its therapeutic potential across multiple
indications. For the balance of the year, we remain focused on advancing
these targeted drug development programs and charting the development path
for PDX and RH1 in solid tumors."
Product Portfolio Update:
PDX (pralatrexate):
PDX is a novel, small molecule chemotherapeutic agent that inhibits
dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzyme
involved in the building of nucleic acid, or DNA, and other processes. PDX
is currently under evaluation in patients with lymphoma and non-small cell
lung cancer.
-- PROPEL, the Company's pivotal Phase 2 study of PDX in patients with
relapsed or refractory peripheral T-cell lymphoma, continues to
progress in line with Company expectations and is projected to
complete accrual by the third quarter of 2008. The Company plans to
conduct an interim analysis of patient response data after 35
evaluable patients have completed at least one cycle of treatment with
PDX. The Company currently expects to announce the outcome of the
interim analysis prior to the end of October of this year. An
independent data monitoring committee will also assess patient safety
as part of the 35 patient interim analysis and again after 65
evaluable patients have completed at least one cycle of treatment with
PDX.
-- In April 2007, the Commission of the European Communities, with a
favorable opinion from the Committee for Orphan Medicinal Products of
the European Medicines Agency (EMEA) granted orphan medicinal product
designation to PDX for the treatment of patients with peripheral
T-cell lymphoma.
-- In May 2007, the Company initiated patient enrollment in a Phase 1/2a
open-label, multi-center study of sequential PDX and gemcitabine with
vitamin B12 and folic acid supplementation in patients with relapsed
or refractory non-Hodgkin's lymphoma or Hodgkin's disease. Up to 84
evaluable patients will be enrolled in the study with the objective of
determining the maximum tolerated dose, safety, tolerability,
pharmacokinetic profile and preliminary signs of efficacy of
sequential administration of PDX and gemcitabine.
RH1:
RH1 is a novel small molecule chemotherapeutic agent that is
bioactivated by the enzyme DT-diaphorase, or DTD, which is over-expressed
in many tumors, including lung, colon, breast and liver tumors. The Company
expects to initiate a Phase 1 study of RH1 in patients with advanced solid
tumors in the second half of 2007.
EFAPROXYN:
In June 2007, the Company announced top line results from ENRICH, a
pivotal Phase 3 study of EFAPROXYN (efaproxiral) plus whole brain radiation
therapy (WBRT) in women with brain metastases originating from breast
cancer. The study failed to achieve its primary endpoint of demonstrating a
statistically significant improvement in overall survival in patients
receiving EFAPROXYN plus WBRT, compared to patients receiving WBRT alone.
Based on these results, the Company discontinued the EFAPROXYN development
program during the second quarter of 2007.
Corporate Events:
In April 2007, the Company appointed Jeffrey R. Latts, former Executive
Vice President and Chief Medical Officer of Exelixis, Inc., to its Board of
Directors.
In June 2007, the Company was selected to join the broad-market Russell
3000(R) Index. Annual reconstitution of Russell's U.S. indexes captures the
3,000 largest U.S. stocks as of the end of May, ranking them by total
market capitalization.
Conference Call
The Company will host a conference call to review its second quarter
results on Tuesday, August 7, 2007, at 8:30 AM ET. The dial in number for
U.S. residents to participate is 866-225-8729. International callers should
dial 480-629-9564. Participants should reference the Allos Therapeutics
conference call.
Conference Call Replay
An audio replay of the conference call will be available until 11:59 PM
ET on Friday, August 24, 2007. To access the replay, please dial
303-406-7325 (domestic) or 800-590-3030 (international). The access code is
3761474.
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. (ALTH) is a biopharmaceutical company focused
on the development and commercialization of small molecule therapeutics for
the treatment of cancer. The Company's lead product candidate, PDX
(pralatrexate), is a novel antifolate currently under evaluation in a
pivotal Phase 2 trial in patients with relapsed or refractory peripheral
T-cell lymphoma. The Company is also investigating PDX in patients with non
small cell lung cancer and a range of other lymphoma sub-types. The
Company's other product candidate is RH1, a targeted chemotherapeutic agent
for which the Company expects to initiate a Phase 1 study in patients with
advanced solid tumors in the second half of 2007. For additional
information, please visit the Company's website 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 for the performance of the 35
patient response assessment and completion of enrollment of the PROPEL
trial, 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,
2006, 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,
2006 2007 2006 2007
Operating expenses:
Research and development $3,320 $4,360 $6,760 $7,650
Clinical manufacturing 391 1,385 952 2,532
Marketing, general and
administrative 3,739 5,515 6,665 10,263
Restructuring and
separation costs - - 646 -
Total operating
expenses 7,450 11,260 15,023 20,445
Loss from operations (7,450) (11,260) (15,023) (20,445)
Interest and other income,
net 488 909 992 1,683
Net loss $(6,962) $(10,351) $(14,031) $(18,762)
Net loss per share: basic
and diluted $(0.13) $(0.16) $(0.25) $(0.29)
Weighted average shares
outstanding: basic and 55,102,627 65,645,678 55,090,968 63,908,192
diluted
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, June 30,
2006 2007
ASSETS
Cash, cash equivalents and
investments in marketable
securities $32,796 $68,720
Other assets 2,982 3,562
Property and equipment, net 604 567
Total assets $36,382 $72,849
LIABILITIES AND STOCKHOLDERS'
EQUITY
Liabilities $6,832 $7,803
Stockholders' equity 29,550 65,046
Total liabilities
and stockholders' equity $36,382 $72,849
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Derek Cole, Vice President, Investor
Relations, +1-720-540- 5367, dcole@allos.com, or Jennifer Neiman,
Senior Manager, Corporate Communications, +1-720-540-5227,
jneiman@allos.com, both Allos Therapeutics, Inc.
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