Synta Reports Second Quarter 2015 Financial Results
- Phase 3 GALAXY-2 Trial on Track for Interim Analysis by Year End 2015 -
- Webcast and Conference Call Today,
“The ganetespib development program is approaching its first key
milestone, with the Phase 3 GALAXY-2 trial in non-small cell lung cancer
nearing its first interim analysis, which is anticipated by year end,
followed by the second interim and final analyses expected in 2016,”
said
Second Quarter Accomplishments and Recent Updates
- Pivotal, Phase 3 GALAXY-2 Clinical Trial Remains on Track for Interim Analysis of Overall Survival in 2015. The Company’s pivotal GALAXY-2 trial, a Phase 3 global, randomized, multi-center study comparing the combination of ganetespib and docetaxel to docetaxel alone for the second-line treatment of advanced non-small cell lung adenocarcinoma, remains on track to meet previously provided data readout timelines. Ganetespib, the Company’s lead program, is a novel, potent small molecule inhibitor of heat shock protein 90 (Hsp90). Based on current projections and statistical assumptions, the Company expects that the first interim overall survival (OS) analysis of GALAXY-2 will be conducted by the end 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 for NSCLC in 2016.
-
Results from the Phase 2 GALAXY-1 trial published in Annals
of Oncology. Results from the Company’s Phase 2 GALAXY-1
trial were published in the
May 21 , online first issue of the journal Annals of Oncology. GALAXY-1 was a global, randomized, multi-center study designed to identify the patients with advanced NSCLC most likely to benefit from second-line treatment with ganetespib in combination with docetaxel versus docetaxel alone. The results from this trial demonstrated that patients diagnosed with advanced non-small cell lung adenocarcinoma more than six months prior to study entry derived the most benefit from combination treatment, leading to the selection of this population for the ongoing Phase 3 GALAXY-2 trial. -
First patient enrolled in Phase 2 Portion of GANNET53 Study of
ganetespib in ovarian cancer. In June, Synta announced
commencement of patient enrollment in the Phase 2 portion of the
GANNET53 study, a randomized, pan-European study evaluating ganetespib
in combination with paclitaxel vs. paclitaxel alone in over 200
patients with metastatic, predominantly p53 mutant, platinum-resistant
ovarian cancer. Enrollment in the Phase 2 portion of GANNET53 follows
the successful completion of the Phase 1 portion, the results of which
were recently presented at the 2015
American Society of Clinical Oncology (ASCO ) Annual Meeting inChicago . The Phase 1 data demonstrated that the combination of ganetespib 150 mg/m² with paclitaxel 80 mg/m² once weekly for 3 out of 4 weeks was generally well tolerated, with no dose limiting toxicities, and was therefore chosen for the randomized phase 2 trial. GANNET53 is sponsored byInnsbruck Medical University inAustria and funded by theEuropean Commission . -
Results from three investigator-sponsored trials of ganetespib
and preclinical results of STA-12-8666 presented at
ASCO . Promising results from three studies evaluating ganetespib combination therapy in ALK-positive lung cancer, platinum-resistant ovarian cancer, and rectal cancer were presented at the 2015 ASCO Annual Meeting. In addition, preclinical results for the Company’s lead HDC candidate, STA-12-8666, in pediatric sarcoma were also presented at this year’s ASCO Annual Meeting. STA-12-8666 is a conjugate of an Hsp90 inhibitor and SN-38, the active metabolite of the widely used drug irinotecan. The Company remains on track for an IND submission by the first quarter of 2016 to begin clinical studies of STA-12-8666.
Second Quarter 2015 Financial Results
There were no revenues recognized in the second quarters of 2015 and 2014.
Research and development expenses were
The Company reported a net loss of
As of
More detailed financial information and analysis may be found in the
Company's Quarterly Report on Form 10-Q, which was filed with the
Guidance
The Company expects its cash, cash equivalents and marketable securities
of approximately
Conference call
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The conference call can also 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
About Synta Pharmaceuticals
Safe Harbor Statement
This media release may contain forward-looking statements about
Synta Pharmaceuticals Corp. | |||||||||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||||||||||
(unaudited) | |||||||||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||||||
Revenues: | |||||||||||||||||||||
Total revenues | |||||||||||||||||||||
Operating expenses: | $ | — | $ | — | $ | — | $ | — | |||||||||||||
Research and development | 16,377 | 18,761 | 32,559 | 36,344 | |||||||||||||||||
General and administrative | 3,127 | 2,940 | 7,277 | 8,264 | |||||||||||||||||
Total operating expenses | 19,504 | 21,701 | 39,836 | 44,608 | |||||||||||||||||
Loss from operations |
(19,504 |
) |
(21,701 | ) | (39,836 | ) | (44,608 | ) | |||||||||||||
Interest expense, net | (296 | ) | (585 | ) | (671 | ) | (1,235 | ) | |||||||||||||
Net loss | $ | (19,800 | ) | $ | (22,286 | ) | $ | (40,507 | ) | $ | (45,843 | ) | |||||||||
Basic and diluted net loss per common share | $ | (0.15 | ) | $ | (0.24 | ) | $ | (0.34 | ) | $ | (0.51 | ) | |||||||||
Basic and diluted weighted average number of common shares outstanding | 132,295,909 | 94,046,278 | 120,402,163 | 89,765,982 |
Synta Pharmaceuticals Corp. | |||||||||
Condensed Consolidated Balance Sheets | |||||||||
(in thousands) | |||||||||
(unaudited) | |||||||||
June 30,
2015 |
December 31,
2014 |
||||||||
Assets | |||||||||
Cash, cash equivalents and marketable securities | $ | 98,334 | $ | 97,690 | |||||
Other current assets | 2,213 | 1,656 | |||||||
Property, plant and equipment, net | 714 | 1,024 | |||||||
Other non-current assets | 278 | 305 | |||||||
Total assets | $ | 101,539 | $ | 100,675 | |||||
Liabilities and Equity | |||||||||
Current liabilities | $ | 32,525 | $ | 30,889 | |||||
Long-term liabilities | 32 | 4,650 | |||||||
Stockholders’ equity | 68,982 | 65,136 | |||||||
Total liabilities and | |||||||||
Stockholders’ equity | $ | 101,539 | $ | 100,675 | |||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20150806005616/en/
Source:
Investors:
Synta Pharmaceuticals Corp.
Daniel Cole,
781-541-7250
[email protected]
or
Argot
Partners
Andrea Rabney, 212-600-1494
[email protected]
or
Media:
Argot
Partners
Eliza Schleifstein, 917-763-8106
[email protected]