Synta Provides Clinical Updates and Reports First Quarter 2013 Financial Results Business Wire LEXINGTON, Mass. -- April 30, 2013 Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided clinical updates and reported financial results for the first quarter ended March 31, 2013. Clinical Updates Interim results from the randomized GALAXY-1 Phase 2b/3 trial, which compares docetaxel with and without Synta’s investigational Hsp90 inhibitor ganetespib for the second-line treatment of advanced non-small cell lung cancer (NSCLC), will be presented at the American Society for Clinical Oncology (ASCO) in June 2013. Based on current projections, the company expects final progression-free survival and updated overall survival results from GALAXY-1 will be presented in the second half of 2013. As previously announced, the first patients have been enrolled in the confirmatory GALAXY-2 Phase 3 trial in non-small cell lung adenocarcinoma, evaluating the same treatments and regimens as in the GALAXY-1 trial. Based on current projections, the company expects to conduct interim and final analyses for the overall survival primary endpoint of the GALAXY-2 trial in 2014. Data collection continues for the CHIARA and ENCHANT trials, evaluating ganetespib monotherapy in ALK+ NSCLC and metastatic breast cancer, respectively. Results from these trials are expected to be presented in the second half of 2013. Financial Results There were no revenues in the first quarter in 2013, compared to total revenue of $0.1 million for the same period in 2012. Research and development expenses were $16.4 million for the first quarter in 2013, compared to $12.1 million for the same period in 2012. General and administrative expenses were $3.9 million for the first quarter in 2013, compared to $2.6 million for the same period in 2012. The Company reported a net loss of $20.7 million, or $0.30 per basic and diluted share, in the first quarter of 2013, compared to a net loss of $15.1 million, or $0.27 per basic and diluted share, for the same period in 2012. As of March 31, 2013, the Company had $90.4 million in cash, cash equivalents and marketable securities, compared to $100.6 million in cash, cash equivalents and marketable securities as of December 31, 2012. More detailed financial information and analysis may be found in the Company's Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission (SEC) on April 30, 2013. Guidance Based on our current operating levels the Company expects its cash resources of approximately $90.4 million will be sufficient to fund operations into the second quarter of 2014. This estimate assumes no additional funding from new partnership agreements or equity financing events, and that the timing and nature of certain activities contemplated for 2013 and 2014 will be conducted subject to the availability of sufficient financial resources. Conference Call Management will conduct a conference call at 10:00 a.m. (ET) today to discuss the first quarter 2013 financial results and clinical updates. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" section of the Synta Pharmaceuticals website, www.syntapharma.com, prior to the event. The call can also be accessed by dialing (877) 407-8035 or (201) 689-8035 prior to the start of the call. A replay will be available from 2:00 p.m. (ET) this afternoon through midnight (ET) on May 7. To access the replay, dial (877) 660-6853 or (201) 612-7415 and refer to conference ID 412350. The webcast will also be archived on the Company's website. About Ganetespib Ganetespib, an investigational drug candidate, is a selective inhibitor of heat shock protein 90 (Hsp90), a molecular chaperone which controls the folding and activation of a number of client proteins that drive tumor development and progression. Many solid and hematologic tumors are dependent on Hsp90 client proteins including proteins involved in “oncogene addiction” (ALK, HER2, mutant BRAF and EGFR, androgen receptor, estrogen receptor, JAK2); proteins involved in resistance to chemotherapy and radiation therapy (ATR, BCL2, BRCA1/2, CDK1/4, CHK1, survivin, and WEE1); proteins involved in angiogenesis (HIF-1alpha, VEGFR, PDFGR, and VEGF); and proteins involved in metastasis (MET, RAF, AKT, MMPs, HIF-1alpha, and IGF-1R). In preclinical models, inhibition of Hsp90 by ganetespib results in the inactivation, destabilization, and eventual degradation of these cancer-promoting proteins. Ganetespib is being evaluated in over 20 clinical trials including trials in lung, breast, colorectal, and hematologic malignancies. Information on these trials can be found at www.clinicaltrials.gov. About the GALAXY Program The GALAXY (Ganetespib Assessment in Lung cAncer with docetaXel) program consists of two randomized trials comparing the combination of ganetespib and docetaxel versus docetaxel alone in patients with Stage IIIB/IV NSCLC who have received one prior systemic therapy: a 300-patient Phase 2b/3 trial (GALAXY-1) to determine the patient population most likely to derive benefit from ganetespib, and a 500-patient confirmatory Phase 3 trial (GALAXY-2). More information about the GALAXY trials can be found at www.clinicaltrials.gov (NCT01348126 and NCT01798485). About Lung Cancer Lung cancer is the leading cause of cancer-related death in the world, accounting for nearly 1.4 million deaths in 2008, according to the World Health Organization. The five-year survival rate for this disease is approximately 16%; over half of people with lung cancer die within one year of being diagnosed. In the U.S., the American Cancer Society estimates that 228,000 cases of lung cancer will be diagnosed in 2013. Non-small cell adenocarcinoma comprises about 40% of all lung cancer. 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 may contain 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 sufficiency of our cash resources, and the development and progress of our programs, including the timing of interim and final analyses of the GALAXY-2 trial, the timing of final progression-free survival and updated overall survival results from the GALAXY-1 trial, and the timing of results from the CHIARA and ENCHANT trials, 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, including those described in "Risk Factors" of our Form 10-K for the year ended December 31, 2012 as filed with the Securities and Exchange Commission. 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 March 31, 2013 2012 Revenues: Grant revenues $ — $ 147 Operating expenses: Research and development 16,380 12,066 General and administrative 3,878 2,646 Total operating expenses 20,258 14,712 Loss from operations (20,258 ) (14,565 ) Interest expense, net (470 ) (486 ) Net loss $ (20,728 ) $ (15,051 ) Basic and diluted net loss per common share $ (0.30 ) $ (0.27 ) Basic and diluted weighted average number of common shares outstanding 68,991,371 56,366,992 Synta Pharmaceuticals Corp. Condensed Consolidated Balance Sheets Data (in thousands) (unaudited) March 31, December 31, 2013 2012 Assets Cash, cash equivalents and marketable $ 90,394 $ 100,599 securities Other current assets 1,475 786 Property, plant and equipment, net 1,350 1,174 Other non-current assets 481 458 Total assets $ 93,700 $ 103,017 Liabilities and Equity Current liabilities $ 16,551 $ 23,486 Long-term liabilities 20,545 4,465 Stockholders’ equity 56,604 75,066 Total liabilities and $ 93,700 $ 103,017 Stockholders’ equity Contact: Investor Relations Contact: Synta Pharmaceuticals Corp. George Farmer, 781-541-7213 firstname.lastname@example.org
Synta Provides Clinical Updates and Reports First Quarter 2013 Financial Results
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