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Synta Provides Clinical Update And Reports Third Quarter 2012 Financial Results

Stocks in this article: SNTA

About Ganetespib

Ganetespib is a potent inhibitor of heat shock protein 90 (Hsp90) that is structurally unrelated to first-generation, ansamycin-related Hsp90 inhibitors. In preclinical experiments, ganetespib has shown activity in multiple tumor models both as a single agent and in combination with certain widely used cancer agents. Company-sponsored clinical trials with ganetespib include 1) the GALAXY Phase 2b/3 trial evaluating ganetespib in combination with docetaxel as second-line treatment of non-small cell lung cancer (NSCLC), 2) the CHIARA Phase 2 trial evaluating ganetespib monotherapy in ALK positive NSCLC, and 3) the ENCHANT Phase 2 trial evaluating ganetespib as first-line treatment for HER2 positive and triple-negative metastatic breast cancer. In addition, ganetespib is being evaluated in investigator-sponsored trials including lung, breast, prostate, gastric, pancreatic, and colorectal cancers as well as ocular melanoma, acute myeloid leukemia and multiple myeloma. Information on these trials can be found at www.clinicaltrials.gov.

About the GALAXY Trial™

The GALAXY ( Ganetespib Assessment in Lung c Ancer with doceta Xel) trial is a randomized Phase 2b/3 trial comparing the combination of ganetespib and docetaxel versus docetaxel alone in patients with Stage IIIB/IV NSCLC who have received one prior systemic therapy. More information about the GALAXY trial can be found at www.clinicaltrials.gov (NCT01348126).

About Hsp90

Hsp90 is a molecular chaperone required for the proper folding and activation of many cancer-promoting proteins, and is recognized as a key facilitator of cancer cell growth and survival. Many of the “client proteins” of Hsp90 – such as ALK, AKT, BCR-ABL, BRAF, KIT, MET, EGFR, FLT3, HER2, HIF-1alpha, PDGFRA, VEGFR are the targets of clinically validated cancer drugs. In preclinical studies, inhibiting Hsp90 causes the degradation of multiple client proteins and leads to cancer cell death.

About Synta Pharmaceuticals

Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases. Synta has a unique chemical compound library, an integrated discovery engine, and a diverse pipeline of clinical- and preclinical-stage drug candidates with distinct mechanisms of action and novel chemical structures. All Synta drug candidates were invented by Synta scientists using our compound library and discovery capabilities. For more information, please visit www.syntapharma.com.

Safe Harbor Statement

This media release contains forward-looking statements about Synta Pharmaceuticals Corp. Such forward-looking statements can be identified by the use of forward-looking terminology such as "will", "would", "should", "expects", "anticipates", "intends", "plans", "believes", "may", "estimates", "predicts", "projects", or similar expressions intended to identify forward-looking statements. Such statements, including statements relating to the timing, developments and progress of our GALAXY trial, our clinical development plans for ganetespib, the expected timing for the release of data from clinical trials of ganetespib, our expected cash, cash equivalents and marketable securities as of the end of 2012, the sufficiency of our cash resources to fund operations into the second half of 2013, and the anticipated design of the Phase 3 portion of the GALAXY trial, reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include whether the results from the interim analysis of the Phase 2b portion of the GALAXY trial will be consistent with future data from the Phase 2b portion and the Phase 3 stage of the trial; whether the results at the conclusion of the Phase 2b portion of the trial will demonstrate safety and statistically significant efficacy; challenges with respect to patient enrollment or other delays in our clinical development plans; as well as other risks and uncertainties described in the "Risk Factors" section of our Form 10-K for the year ended December 31, 2011, as filed with the Securities and Exchange Commission, including those under the heading “Risks Related to the Development and Regulatory Approval of our Drug Candidates.” Synta undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.

Synta Pharmaceuticals Corp.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
           
 

Three Months Ended September 30,

Nine Months Ended September 30,

2012 2011 2012 2011
Revenues:
Collaboration revenues:
License and milestone revenue $   $ 1,143   $   $ 3,429  
Total collaboration revenues 1,143 3,429
Grant revenues       521     147     732  
Total revenues       1,664     147     4,161  
Operating expenses:
Research and development 11,743 10,751 35,061 30,605
General and administrative   2,796     3,131     8,324     8,749  
Total operating expenses   14,539     13,882     43,385     39,354  
Loss from operations (14,539 ) (12,218 ) (43,238 ) (35,193 )
Interest expense, net   (457 )   (516 )   (1,429 )   (1,444 )
Net loss $ (14,996 ) $ (12,734 ) $ (44,667 ) $ (36,637 )
 

Basic and diluted net loss per common share

$ (0.25 ) $ (0.26 ) $ (0.77 ) $ (0.79 )

Basic and diluted weighted average number of common  shares outstanding

60,661,720 49,403,589 58,235,263 46,446,328
 
 
Synta Pharmaceuticals Corp.
Condensed Consolidated Balance Sheets Data
(in thousands)
(unaudited)
             
 
      September 30, 2012           December 31, 2011
                   
Assets                  
Cash, cash equivalents and marketable securities     $ 55,139           $ 39,725
Other current assets       803             561
Property, plant and equipment, net       1,205             1,407
Other non-current assets       466             631
Total assets     $ 57,613           $ 42,324
                   
Liabilities and Equity                  
Current liabilities     $ 18,965           $ 15,148
Long-term liabilities       6,458             12,402
Stockholders’ equity       32,190             14,774

Total liabilities andStockholders’ equity

    $ 57,613           $ 42,324




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