Synta Provides Clinical Updates and Reports First Quarter 2013 Financial Results
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
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
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
Based on our current operating levels the Company expects its cash
resources of approximately
Conference Call
Management will conduct a conference call at
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
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
About
Safe Harbor Statement
This media release may contain forward-looking statements about
Synta Pharmaceuticals Corp. |
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Condensed Consolidated Statements of Operations |
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(in thousands, except share and per share amounts) |
||||||||
(unaudited) |
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Three Months Ended |
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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. |
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Condensed Consolidated Balance Sheets Data |
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(in thousands) |
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(unaudited) |
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|
March 31,
2013 |
December 31,
2012 |
||||||||||
Assets | ||||||||||||
Cash, cash equivalents and marketable |
$ | 90,394 | $ | 100,599 | ||||||||
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 |
Source:
Investor Relations Contact:
Synta Pharmaceuticals Corp.
George
Farmer, 781-541-7213
[email protected]