Allos Therapeutics Reports Second Quarter 2007 Financial Results



    WESTMINSTER, Colo., Aug. 7 /CNW/ -- 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
    




For further information:

For further information: 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. Web Site: http://www.allos.com

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ALLOS THERAPEUTICS, INC.

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