WESTMINSTER, Colo., Nov. 5 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (Nasdaq: ALTH) today reported financial results for the
third quarter of 2007. For the three months ended September 30, 2007, the
Company reported a net loss of $9.3 million, or ($0.14) per share. This
compares to a net loss of $8.1 million, or ($0.15) per share, for the third
quarter of 2006. For the nine months ended September 30, 2007, the Company
reported a net loss of $28.1 million, or ($0.43) per share, compared to a
net loss of $22.1 million, or ($0.40) per share for the same period last
year. For the nine months ended September 30, 2007, net cash used in
operating activities was $22.5 million. Cash, cash equivalents and
investments in marketable securities as of September 30, 2007 were $63.4
million.
"With five PDX trials ongoing and two additional studies scheduled to
begin in the near term, we continue to make important progress advancing
the development of PDX in hematologic malignancies and solid tumors,"
stated Paul L. Berns, President and Chief Executive Officer of Allos.
"PROPEL, our pivotal Phase 2 trial of PDX in patients with relapsed or
refractory peripheral T-cell lymphoma, is ahead of schedule with completion
of patient enrollment expected in the second quarter of 2008. We look
forward to providing future updates regarding PDX's clinical profile and
potential commercial opportunities."
Pipeline Development 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 an investigational drug currently under evaluation in patients with
lymphoma and non-small cell lung cancer (NSCLC).
PROPEL
In September 2007, the Company announced the completion of pre-planned
interim analyses of patient response and safety data from the Company's
pivotal Phase 2 PROPEL trial of PDX in patients with relapsed or refractory
peripheral T-cell lymphoma (PTCL). Results of the interim analysis of
patient response data exceeded the pre-specified threshold for continuation
of the trial, which required a minimum of four responses (complete or
partial) out of the first 35 evaluable patients, as determined by
independent oncology review. In addition, an independent Data Monitoring
Committee (DMC) completed an interim analysis of the safety data from the
first 35 evaluable patients and recommended that the trial continue per the
protocol. In accordance with the trial protocol, the DMC will conduct
another interim analysis of safety data from the first 65 evaluable
patients. The Company expects to report the outcome of the 65-patient
safety analysis by the end of 2007 and complete enrollment in the trial in
the second quarter of 2008.
PDX in CTCL
In August 2007, the Company announced the initiation of patient
enrollment in a Phase 1, open-label, multi-center study of PDX with vitamin
B12 and folic acid supplementation in patients with relapsed or refractory
cutaneous T-cell lymphoma (CTCL). Up to 56 evaluable patients will be
enrolled in the study with the objective of determining the optimal dose
and safety profile of PDX in this population. A total of 20 of these
patients will be enrolled at the determined optimal dose and schedule.
PDX in NSCLC (Phase 1)
In October 2007, data from the Company's Phase 1 dose ranging study of
PDX with vitamin B12 and folic acid supplementation in patients with
previously treated advanced NSCLC were presented at the 2007 AACR-NCI-EORTC
conference. In this study, a total of 22 patients with relapsed or
refractory NSCLC were treated at doses of 150 to 325 mg/m2 of PDX. The
maximum tolerated dose (MTD) was determined to be 270 mg/m2, which is
nearly twice that observed in a previous Phase 1 study in which PDX was
administered without vitamin supplementation. Clinically significant
radiologic responses were observed. Greater than 50% of patients (13/22)
received 2 or more prior treatment regimens. Based on PDX clinical
experience to date, the Company plans to initiate a randomized Phase 2
study of PDX in patients with NSCLC.
PDX in NHL (Phase 1/2)
In October 2007, additional interim data from the Company's on-going
Phase 1/2 study of PDX in patients with non-Hodgkin's lymphoma (NHL) and
Hodgkin's disease were presented at the 2007 AACR-NCI-EORTC conference.
Responses were observed in 14 of 26 (54%) evaluable patients with T-cell
lymphoma, with the duration of response typically exceeding the previously
administered line of chemotherapy. No major safety concerns were identified
in this heavily pre-treated population. These results are consistent with
the interim data presented at the 2006 American Society of Hematology (ASH)
meeting.
PDX In Vivo and In Vitro
In October 2007, results from a Company-sponsored pre-clinical study
that investigated the mechanism of action of PDX and its differences from
other antifolates, and compared the in vivo activity of PDX, methotrexate
(MTX) and Alimta(R) against two NSCLC models were presented at the 2007
AACR-NCI-EORTC conference. The results suggest that PDX is mechanistically
different from MTX and Alimta and that these differences may be due to
enhanced uptake of PDX into the tumor cell and/or greater intracellular
accumulation and polyglutamylation, resulting in greater inhibition of
dihydrofolate reductase (DHFR). In addition, PDX induced greater tumor
regression compared to MTX or Alimta in two human NSCLC xenograft models,
including the highly aggressive H460 model.
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 fourth quarter of 2007.
Conference Call
The Company will host a conference call to review its third quarter
results on Monday, November 5, 2007, at 8:30 AM ET. The dial in number for
U.S. residents to participate is 888-339-9446. International callers should
dial 480-629-9562. 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, November 16, 2007. To access the replay, please dial
800-406-7325 (domestic) or 303-590-3030 (international). The access code is
3789950.
Webcast
The Company will also hold a live webcast of the conference call. The
webcast will be available from the homepage and the investors/media section
of the Company's website 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 (PROPEL) trial in patients with relapsed or refractory
peripheral T-cell lymphoma. The PROPEL trial is being conducted under an
agreement reached with the U.S. Food and Drug Administration under its
special protocol assessment, or SPA process. 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 fourth
quarter 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 65
patient safety assessment and completion of enrollment of the PROPEL trial,
the Company's intent to initiate a Phase 2 study of PDX in patients with
NSCLC, 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.
ALLOS THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands ~ except share and per share information)
(unaudited)
Three-months ended Nine-months ended
September 30, September 30,
2006 2007 2006 2007
Operating expenses:
Research and development $4,210 $4,395 $10,970 $12,045
Clinical manufacturing 486 1,506 1,438 4,038
Marketing, general and
administrative 3,895 4,241 10,560 14,503
Restructuring and
separation costs - - 646 -
Total operating
expenses 8,591 10,142 23,614 30,586
Loss from operations (8,591) (10,142) (23,614) (30,586)
Interest and other income,
net 480 844 1,471 2,526
Net loss $(8,111) $(9,298) $(22,143) $(28,060)
Net loss per share: basic and
diluted $(0.15) $(0.14) $(0.40) $(0.43)
Weighted average shares
outstanding:
basic and diluted 55,196,369 66,042,023 55,126,488 64,627,285
ALLOS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, September 30,
2006 2007
ASSETS
Cash, cash equivalents and
investments in marketable
securities $32,796 $63,370
Other assets 2,982 3,525
Property and equipment, net 604 543
Total assets $36,382 $67,438
LIABILITIES AND STOCKHOLDERS' EQUITY
Liabilities $6,832 $8,170
Stockholders' equity 29,550 59,268
Total liabilities and
stockholders' equity $36,382 $67,438
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Derek Cole, Vice President, Investor
Relations of Allos Therapeutics, Inc., +1-720-540-5367,
dcole@allos.com
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