Re: Farmas USA
Synta Provides Clinical Updates and Reports Second Quarter 2013 Financial Results
LEXINGTON, Mass.--(BUSINESS WIRE)-- Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided clinical updates and reported financial results for the second quarter ended June 30, 2013.
Clinical Updates
Our lead clinical candidate is ganetespib, a selective inhibitor of the Hsp90 chaperone protein, which is being evaluated in over 25 clinical trials that have enrolled over a thousand patients to date, including our GALAXY program in lung cancer and our ENCHANT program in breast cancer.
The GALAXY program in lung cancer
At the 2013 meeting of the American Society of Clinical Oncology (ASCO), investigators presented results from an interim analysis evaluating 252 adenocarcinoma patients treated in our ongoing GALAXY-1 Phase 2b/3 trial evaluating ganetespib in combination with docetaxel vs. docetaxel alone for the second-line treatment of advanced non-small cell lung adenocarcinoma. Results included:
In the all-adenocarcinoma population (N=252), the ganetespib combination arm showed improved overall survival, progression-free survival, and response rate compared to the docetaxel arm.
A statistical interaction test showed that one of the four prospectively-defined stratification factors was strongly predictive of ganetespib activity (p=0.006). Patients with "chemo-sensitive" disease (N=176; 70%) derived substantially greater benefit from ganetespib than patients with "chemo-refractory" disease (N=76; 30%).
In the chemo-sensitive population, defined as time since diagnosis of advanced disease greater than six months, median overall survival increased from 6.4 to 10.7 months, and the Hazard ratio was 0.61 (1-sided p=0.009), corresponding to a 39% reduction in the risk of death.
The rate of new lesion formation decreased by 50% in patients treated with ganetespib (Hazard ratio 0.50, p=0.005). This observation is consistent with preclinical and clinical results suggesting ganetespib inhibits the biological pathways that drive angiogenesis (new blood vessel formation) and metastasis (the spread of tumors) in cancer cells.
Transient, mild-to-moderate diarrhea, manageable with OTC medication, was the most common adverse event observed with ganetespib, consistent with observations from other clinical trials. Other adverse events increased relative to control included mild to moderate anemia and fatigue, as well as an increase in the number of cases of febrile neutropenia.
Based on our current event rate projections, Synta expects the final analysis of the GALAXY-1 trial to be conducted in the fourth quarter of 2013.
The GALAXY-2 trial evaluates the same dose, schedule, and regimen as the GALAXY-1 trial, but in a larger population (N=500), with overall survival as the primary endpoint, and in chemo-sensitive patients. Trial enrollment began in the second quarter of 2013. Based on our current projections, Synta expects the first interim analysis of the GALAXY-2 trial to be conducted in the first half of 2014, and the second interim and final analyses to be conducted in the second half of 2014.
The ENCHANT program in breast cancer
Some of the strongest evidence for the role of Hsp90 in fueling cancer growth is from breast cancer: reduced expression of tumor Hsp90 is associated with significantly longer patient survival [1].
Based on the supportive scientific findings, evidence of single-agent clinical activity for ganetespib in triple-negative breast cancer, the widespread use of taxanes in this disease, and the positive results for ganetespib in combination with docetaxel in lung cancer, Synta has developed two registration programs focusing on triple-negative breast cancer. The first is in the metastatic setting, and the second is in the neo-adjuvant setting. Synta expects those programs to initiate in 2014, pending completion of certain ongoing partnership discussions.
Recently announced clinical results from the ENCHANT-1 trial have confirmed prior signals of single-agent clinical activity. Synta expects results from ENCHANT-1 will be presented at a medical conference later this year.
Other trials with ganetespib
A number of investigator and cooperative group-sponsored trials are ongoing, including trials in breast cancer in combination with fulvestrant, in multiple myeloma with bortezomib, in ALK+ NSCLC with crizotinib, in rectal cancer with chemoradiotherapy, and in AML with low-dose Ara-C. Additional trials are expected to initiate later this year or early next year including in mesothelioma with pemetrexed and cisplatin, in HER2+ breast cancer with trastuzumab and paclitaxel, in ovarian cancer with paclitaxel and carboplatin, in pancreatic cancer in combination with nab-paclitaxel and gemcitabine, and in prostate cancer with radiotherapy.
“We have made strong progress this quarter in advancing ganetespib development in both lung cancer and breast cancer,” said Safi Bahcall, President and CEO of Synta. “We are encouraged both by the promising clinical results and the growing medical community interest in working with ganetespib. We look forward to completing our GALAXY-2 Phase 3 trial in lung cancer, entering the next stage of development in breast cancer, and bringing ganetespib to patients as quickly as possible.”
Financial results
There were no revenues recognized in the second quarters of 2013 and 2012.
Research and development expenses were $17.9 million for the second quarter in 2013, compared to $11.3 million for the same period in 2012. General and administrative expenses were $4.2 million for the second quarter in 2013, compared to $2.9 million for the same period in 2012.
The Company reported a net loss of $22.8 million, or $0.33 per basic and diluted share, in the second quarter of 2013, compared to a net loss of $14.6 million, or $0.25 per basic and diluted share, for the same period in 2012.
As of June 30, 2013, the Company had $70.2 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 August 1, 2013.
Guidance
Based on our current operating levels the Company expects its cash resources of approximately $70.2 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.
SNTA
