ARIAD Reports Third Quarter 2009 Development Progress and Financial Results

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Thu Nov 5, 2009 7:35am EST

http://www.businesswire.com/news/home/20091105005218/en

~ SUCCEED Trial Full Patient Enrollment On Track for Year-end 2009 

~ Proof-of-Concept Clinical Data of AP24534 to be Presented at ASH 
CAMBRIDGE, Mass.--(Business Wire)--
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today reported financial results for
the third quarter and nine months ended September 30, 2009 and provided an
update on corporate developments. 

SUCCEED Trial Full Enrollment Expected at Year-End

ARIAD reaffirmed that the global, Phase 3 SUCCEED trial of oral ridaforolimus in
patients with metastatic soft tissue and bone sarcomas remains on track for full
enrollment around year-end 2009. 

The independent Data Monitoring Committee (DMC) of the SUCCEED trial completed
the first interim efficacy analysis as specified by the study protocol in
September of this year and recommended that this randomized, placebo-controlled
trial continue to full patient enrollment and completion. The DMC made this
recommendation after reviewing the pre-specified statistical analyses and
available data on the safety and efficacy of oral ridaforolimus. The DMC
indicated that the safety data from the first interim analysis are consistent
with the known safety profile of ridaforolimus, and no modifications to the
study protocol were recommended. 

The report of the second interim efficacy analysis, which will be based on
approximately two-thirds of the total number of progression-free survival (PFS)
events in the trial, is expected around the end of the first quarter of 2010, as
previously announced. The final analysis of all PFS events is expected at
approximately the end of the third quarter of 2010. The complete SUCCEED trial
is 90 percent powered to show a 33 percent improvement in median PFS comparing
the drug-treated and placebo arms of the trial. 

"The recommendation by the DMC to continue the SUCCEED trial to completion was
an important step in the development of oral ridaforolimus as a potential new
treatment option for patients with metastatic sarcomas, and we are very pleased
to be on schedule for full enrollment around the end of the year," stated Harvey
J. Berger, M.D. chairman and chief executive officer of ARIAD. 

AP24534 Clinical Data to be Presented at ASH

Leading cancer investigators will present Phase 1 clinical proof-of-concept data
on ARIAD`s investigational, pan-BCR-ABL inhibitor, AP24534, in patients with
drug-resistant and refractory chronic myeloid leukemia (CML) and other
hematological cancers at the upcoming American Society of Hematology annual
meeting in December. Preliminary trial results on AP24534 that were announced
earlier this quarter provide initial clinical evidence of hematologic,
cytogenetic and molecular responses and anti-cancer activity of AP24534 in
heavily pretreated patients with resistant and refractory CML and
Philadelphia-positive acute lymphoblastic leukemia, including those with the
T315I mutant variant of the target protein, BCR-ABL. 

More than 40 patients have been enrolled in the trial to date at five medical
centers in the United States. All CML patients have been previously treated with
the currently available first- and second-generation targeted therapies for CML
and, in most instances, other investigational agents as well. Pending further
analysis of the results of this trial and discussions with regulatory
authorities, ARIAD believes that it will be able to proceed to a registration
trial of this product candidate in 2010. 

Other Development Progress

In addition to the SUCCEED trial, ARIAD and its ridaforolimus partner, Merck &
Co., Inc., are making steady progress in other clinical trials, including:

* Complete enrollment in the Phase 2 clinical trial of oral ridaforolimus in
combination with trastuzumab (Herceptin®) in patients with Her-2 positive,
resistant and refractory metastatic breast cancer. Preliminary data from this
study were announced earlier this quarter, and updated findings will be
presented at the San Antonio Breast Cancer Symposium in December. 
* Continuing Phase 2 clinical trials of oral ridaforolimus in patients with
advanced endometrial, prostate and non-small cell lung cancers. 
* Continuing enrollment in the Phase 1 study of MK-0646, Merck`s IGF-1R human
monoclonal antibody, in combination with oral ridaforolimus.

Financial Highlights

For the quarter ended September 30, 2009, ARIAD reported a net loss of $20.8
million, or $0.21 per share, compared to a net loss of $20.0 million, or $0.29
per share, for the same period in 2008. For the nine-month period ended
September 30, 2009, ARIAD reported a net loss of $62.0 million, or $0.70 per
share, compared to a net loss of $54.3 million, or $0.78 per share for the
nine-month period ended September 30, 2008. 

These results reflect increases in research and development expenses in 2009
compared to 2008 due to the continued advancement of ARIAD`s development
programs for its lead investigational product candidates, ridaforolimus and
AP24534, as well as non-cash charges related to revaluation of ARIAD`s warrant
liability. These increases and non-cash charges were offset in large part by
decreases in general and administrative expenses in 2009 compared to 2008, due
to reduction in activities and costs related to corporate and commercial
development initiatives and patent litigation. 

On August 7, 2009, ARIAD raised net proceeds of $35.6 million in an underwritten
offering of 21.85 million shares of its common stock. The purchase price in this
offering was $1.75 per share. This offering, along with ARIAD`s offering in
February 2009, has resulted in a total of $58.4 million of funding raised this
year to support its product development progress. 

For the nine-month period ended September 30, 2009, cash used in operations was
$36.0 million, compared to $36.4 million for the same period in 2008. ARIAD
ended the third quarter of 2009 with cash, cash equivalents and marketable
securities of $57.5 million, compared to $39.1 million at December 31, 2008. 

Upcoming Medical Meetings

Clinical data will be presented at the following upcoming medical meetings:

* American Society of Hematology annual meeting in New Orleans, LA, December 7,
2009 - Phase 1 clinical proof-of-concept data on AP24534. 
* San Antonio Breast Cancer Symposium, San Antonio, TX, December 11, 2009 -
Phase 2 clinical data on ridaforolimus in combination with trastuzumab in
patients with Her-2 positive metastatic breast cancer.

Upcoming Investor and Partnering Meetings

ARIAD will make a corporate presentation at the following upcoming investor
conferences:

* Lazard Capital Markets 6th Annual Healthcare Conference, New York, NY,
November 17, 2009. 
* Windhover`s Therapeutic Area Partnerships Conference, Boston, MA, November 18,
2009 
* J.P. Morgan Annual Healthcare Conference, San Francisco, CA, January 11-14,
2010.

Today`s Conference Call Reminder

ARIAD will hold a live webcast of its quarterly conference call today, November
5, at 8:30 a.m. (EST). The live webcast can be accessed by visiting the investor
relations section of the Company`s website at http://www.ariad.com/investor. The
call can be accessed by dialing 866-783-2146 (domestic) or 857-350-1605
(international) five minutes prior to the start time and providing the pass code
97543712. A replay of the call will be available on the ARIAD website
approximately two hours after completion of the call and will be archived for
two weeks. 

About ARIAD

ARIAD`s vision is to transform the lives of cancer patients with breakthrough
medicines. The Company`s mission is to discover, develop and commercialize
small-molecule drugs to treat cancer in patients with the greatest and most
urgent unmet medical need - aggressive cancers where current therapies are
inadequate. ARIAD`s lead product candidate, ridaforolimus, is an investigational
mTOR inhibitor in Phase 3 clinical development in patients with advanced
sarcomas and is being developed in collaboration with Merck & Co., Inc. ARIAD`s
second product candidate, AP24534, is an investigational multi-targeted kinase
inhibitor in Phase 1 clinical development in patients with hematological
cancers. ARIAD has an exclusive license to pioneering technology and patents
related to certain NF-κB cell-signaling activity, which may be useful in
treating certain diseases. For additional information about the Company, please
visit http://www.ariad.com. 

This press release contains "forward-looking statements" including, but not
limited to, statements relating to the enrollment in, and timing of, the interim
analyses of the SUCCEED trial, enrollment in other clinical trials of
ridaforolimus, reporting of clinical proof-of-concept data for AP24534, and
expectations related to the initiation of a registration trial for AP24534.
Forward-looking statements are based on management`s expectations and are
subject to certain factors, risks and uncertainties that may cause actual
results, outcome of events, timing and performance to differ materially from
those expressed or implied by such statements. These risks and uncertainties
include, but are not limited to, preclinical data and early-stage clinical data
that may not be replicated in later-stage clinical studies, the costs associated
with our research, development, manufacturing and other activities, the conduct,
timing and results of pre-clinical and clinical studies of our product
candidates, the adequacy of our capital resources and the availability of
additional funding, the timing, scope, cost and outcome of legal and patent
office proceedings concerning our NF-κB patent portfolio, and other factors
detailed in the Company`s public filings with the U.S. Securities and Exchange
Commission. The information contained in this press release is believed to be
current as of the date of original issue. The Company does not intend to update
any of the forward-looking statements after the date of this document to conform
these statements to actual results or to changes in the Company`s expectations,
except as required by law. 

Herceptin® is a registered trademark of Genentech, Inc., a member of the Roche
Group.

 ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES                                                                                                                
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS                                                                                                             
                                                                                                                                              
 In thousands, except share and per share     Three Months Ended                                     Nine Months Ended                                
 data                                         September 30,                                          September 30,                                    
                                              2009                           2008                2009                          2008           
                                              (Unaudited)                                            (Unaudited)                                      
 License and collaboration revenue         $  2,155                    $     1,536            $  6,148                   $     4,481          
 Operating expenses:                                                                                                                          
 Research and development                     14,384                         13,365              47,939                        36,067         
 General and administrative                   3,472                          8,255               12,412                        23,431         
 Total operating expenses                     17,856                         21,620              60,351                        59,498         
 Other income (expense), net                  (5,108       )                 91                  (7,797      )                 747            
 Net loss                                  $  (20,809      )           $     (19,993     )    $  (62,000     )           $     (54,270     )  
 Net loss per common share                 $  (.21         )           $     (.29        )    $  (.70        )           $     (.78        )  
                                                                                                                                              
 Weighted average number of shares of         100,274,893                    69,429,185          88,119,741                    69,369,602     
 common stock outstanding                                                                                                                     


 CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION                                                             
                                                                                                    
 In thousands                                             September 30,            December 31,     
                                                          2009                     2008             
                                                          (Unaudited)                               
 Cash, cash equivalents and marketable securities      $  57,473                $  39,068           
 Total assets                                          $  85,233                $  68,188           
 Working capital                                       $  37,083                $  14,174           
 Deferred revenue, total                               $  113,616               $  97,264           
 Total liabilities                                     $  157,542               $  137,386          
 Stockholders` deficit                                 $  (72,309        )      $  (69,198       )  


 CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION                                                              
                                                                                                               
 In thousands                                                 Nine Months Ended                                     
                                                              September 30,                                         
                                                              2009                             2008            
                                                              (Unaudited)                      (Unaudited)     
 Net cash used in operating activities                     $  (36,018      )              $    (36,386      )  
 Net cash provided by (used in) investing activities          11,588                           (6,120       )  
 Net cash provided by financing activities                    57,660                           9,776           
                                                                                                               
 Net increase (decrease) in cash and cash equivalents      $  33,230                      $    (32,730      )  


ARIAD Pharmaceuticals, Inc.
Maria E. Cantor, 617-621-2208 



Copyright Business Wire 2009

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