Synta Provides Clinical Update And Reports Third Quarter 2012 Financial Results
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 | |||||||
Select the service that is right for you!
COMPARE ALL SERVICESAction Alerts PLUS
TRY IT FREEJim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
Product Features:
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Dividend Stock Advisor
TRY IT FREENew! $49.95/yr
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
Product Features:
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Stocks Under $10
TRY IT FREEDavid Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.
Product Features:
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts
- Weekly roundups
Real Money
TRY IT FREE24/7 market commentary from Jim Cramer and 20+ veteran Wall Street gurus. Get access to the latest trading ideas on stocks, options, and ETFs as well as a real-time forum to see the pros exchanging their investment ideas.
Product Features:
- Jim Cramer + 20 Wall Street pros
- Intraday commentary & news
- Real-time trading forum
- Actionable trade ideas
Real Money Pro
TRY IT FREEAll of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
Product Features:
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Options Profits
TRY IT FREEOur options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
Product Features:
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV
