LEXINGTON, Mass.--(BUSINESS WIRE)--Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today reported financial results for the first quarter ended March 31, 2015 and provided an operational update.
“We remain encouraged by the progress of our ganetespib clinical program including enrollment in our pivotal, Phase 3 GALAXY-2 trial in non-small cell lung adenocarcinoma, and the broad investigator-led trial effort, which includes large, ongoing randomized trials in acute myeloid leukemia and ovarian and breast cancers,” said Chen Schor, President and Chief Executive Officer of Synta. “We are also excited by the emerging profile of STA-12-8666, the lead therapeutic candidate emerging from our novel Hsp90 drug conjugate platform, which has demonstrated anti-tumor activity in resistant tumor models through studies conducted by leading research institutions, such as the Fox Chase Cancer Center in Philadelphia. Synta remains on course to reach several critical milestones throughout the rest of this year and 2016, including the first interim analysis of GALAXY-2 in the second half of this year and progression of STA-12-8666 toward IND in the first quarter of 2016.”
First Quarter Accomplishments and Recent Updates
- Appointed Chen Schor as President, Chief Executive Officer and Director. In April 2015, the Company announced that Chen Schor, Executive Vice President, Chief Operating Officer, was named President, Chief Executive Officer and a Director of the Company, replacing Anne Whitaker. Ms. Whitaker stepped down from her roles at Synta to pursue a professional opportunity at a large multinational pharmaceutical company.
- Pivotal, Phase 3 GALAXY-2 Clinical Trial Remains on Track for Interim Analysis of Overall Survival in 2015. To date, over 500 patients have been enrolled in the GALAXY-2 trial, a Phase 3 global, randomized, multi-center study comparing the combination of ganetespib, the Company’s lead program and a novel, potent small molecule inhibitor of heat shock protein 90 (Hsp90), and docetaxel to docetaxel alone for the second-line treatment of advanced non-small cell lung adenocarcinoma. The Company expects, based on current projections and statistical assumptions, that the first interim overall survival (OS) analysis of GALAXY-2 will be conducted in the second half of 2015, and the second interim and final OS analysis will be conducted in 2016. Assuming positive interim results from the ongoing GALAXY-2 trial of ganetespib, and pending regulatory feedback, the Company plans to seek regulatory approval of ganetespib in North America and Europe for NSCLC in 2016.
- Presented Preclinical Data from Ganetespib and STA-12-8666. In April 2015, the Company announced that poster presentations related to studies with ganetespib and STA-12-8666, the Company’s leading candidate from its proprietary Hsp90 inhibitor Drug Conjugate (HDC) Program, were presented at the 2015 Annual Meeting of the American Association of Cancer Research (AACR) in Philadelphia, Pennsylvania. The data provide further support for the Company’s broad clinical strategy with ganetespib and demonstrated encouraging preclinical proof of concept data for STA-12-8666 in several animal models, including resistant pancreatic cancer and small cell lung cancer patient derived xenografts. The Company remains on track for an IND submission by the first quarter of 2016 to begin clinical studies of STA-12-8666.
- Closed Underwritten Public Offering. In April 2015, the Company announced the closing of an underwritten public offering of common stock for net proceeds to Synta of approximately $41.8 million.
- New Corporate Strategy Strengthened Organization. In February 2015, Synta outlined a new strategy for transforming the Company into a leading oncology biopharmaceuticals company. The strategy highlighted divestiture of non-core programs, a more focused research program, and the reallocation of resources with an emphasis on value creating milestones in 2015 and 2016 with ganetespib and its HDC product candidates.
First Quarter 2015 Financial Results
There were no revenues recognized in the first quarters of 2015 and 2014.
Research and development expenses were $16.2 million for the first quarter in 2015, compared to $17.6 million for the same period in 2014. General and administrative expenses were $4.2 million for the first quarter in 2015, compared to $5.3 million for the same period in 2014.
The Company reported a net loss of $20.7 million, or $0.19 per basic and diluted share, in the first quarter of 2015, compared to a net loss of $23.6 million, or $0.28 per basic and diluted share, for the same period in 2014.
As of March 31, 2015, the Company had $76.6 million in cash, cash equivalents and marketable securities, compared to $97.7 million in cash, cash equivalents and marketable securities as of December 31, 2014.
In April 2015, the Company raised approximately $41.8 million in net proceeds from the sale of an aggregate of 25,300,000 shares of its common stock in an underwritten public offering at a public offering price of $1.75 per share.
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 May 7, 2015.
The Company expects its cash resources of approximately $76.6 million as of March 31, 2015, together with the $41.8 million in net cash proceeds raised in the public offering in April 2015, will be sufficient to fund operations at least through the first half of 2016. This estimate assumes no additional funding from new partnership agreements, equity financings or further sales under its ATM facility. The timing and nature of certain activities contemplated for the remainder of 2015 and 2016 will be conducted subject to the availability of sufficient financial resources.
Synta will host a conference call at 10:00 AM ET today to discuss clinical updates first quarter 2015 financial results. 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 conference call can be accessed by dialing (877) 407-8035 (U.S.) or (201) 689-8035 (International). For those unable to join the live call, a replay will be available from 2:00 p.m. ET on May 7 through 11:59 p.m. ET on May 14. To access the replay, please dial (877) 660-6853 (U.S.) or (201) 612-7415 (International) and refer to conference ID 13607924.
The live webcast can be accessed by visiting the Investor Relations section of the Synta Pharmaceuticals website, www.syntapharma.com. The webcast will also be archived under Webcasts and Events within the Investor Relations section of the Company's website.
About Synta Pharmaceuticals
Synta Pharmaceuticals Corp. is an innovative, agile biopharmaceutical company focused on research, development and commercialization of novel oncology medicines that have the potential to change the lives of cancer patients. Synta’s lead oncology drug candidate, ganetespib, a novel heat shock protein 90 (Hsp90) inhibitor, is currently being evaluated in several clinical trials including the pivotal GALAXY-2 Phase 3 trial in non-small cell lung cancer. Building on its extensive expertise in the science of Hsp90, Synta also has a novel proprietary Hsp90 inhibitor Drug Conjugate (HDC) small molecule drug development program. IND enabling studies have commenced for the first clinical candidate from the HDC program, STA-12-8666, and preclinical evaluation of additional HDC candidates is ongoing. 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 anticipated timing for the interim and final analyses from the GALAXY-2 trial, the timing around seeking regulatory approval of ganetespib, the timing of an IND submission for STA-12-8666, as well as the expectation that Synta’s existing cash resources will be sufficient to fund operations at least through the first half of 2016, reflect Synta’s 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, 2014 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)|
Three Months Ended
|Research and development||16,182||17,583|
|General and administrative||4,150||5,324|
|Total operating expenses||20,332||22,907|
|Loss from operations||(20,332||)||(22,907||)|
|Interest expense, net||(375||)||(650||)|
|Basic and diluted net loss per common share||$||(0.19||)||$||(0.28||)|
|Basic and diluted weighted average number of common shares outstanding||108,376,264||85,438,127|
|Synta Pharmaceuticals Corp.|
|Condensed Consolidated Balance Sheets Data|
|Cash, cash equivalents and marketable securities||$||76,606||$||97,690|
|Other current assets||1,367||1,656|
|Property, plant and equipment, net||855||1,024|
|Other non-current assets||564||305|
|Liabilities and Equity|
|Total liabilities and|