Synta Provides Clinical Updates and Reports First Quarter 2013 Financial
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.
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.
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.
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.
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.
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)
Three Months Ended
Grant revenues $ — $ 147
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
March 31, December 31,
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
Investor Relations Contact:
Synta Pharmaceuticals Corp.
George Farmer, 781-541-7213
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