-Company announces plans to proceed into Phase 3 stage of the GALAXY
Trial by year-end-
LEXINGTON, Mass.--(BUSINESS WIRE)--May. 3, 2012--
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided a clinical
program update and reported financial results for the quarter ended
March 31, 2012.
“This year we made significant progress in the clinical development of
ganetespib, our lead Hsp90 inhibitor, for cancer,” said Safi Bahcall,
Ph.D., President and CEO. “We have seen encouraging activity with
ganetespib in two distinct areas – as a single-agent, in patients whose
tumors exhibit certain specific genetic profiles, and in combination
with chemotherapy, in our randomized, second-line lung cancer trial.
These results, together with the favorable safety profile established in
over 500 patients treated to date, support the broad potential of
ganetespib for treating cancer patients.”
“Existing cancer therapies are generally either non-specific or target
one particular signaling protein involved in one or a small number of
cancer signaling pathways,” said Dr. Vojo Vukovic, Chief Medical
Officer. “Chemotherapies are an example of the former while kinase
inhibitors, such as Gleevec® and monoclonal antibodies such as
Herceptin®, are examples of the latter. Ganetespib, on the other hand,
targets one chaperone protein, Hsp90, which is required for proper
functioning of multiple oncoproteins. Consequently, ganetespib inhibits
many different tumor growth and signaling pathways simultaneously. This
characteristic is best demonstrated by the clinical results observed in
a diverse range of tumor types. Ganetespib has demonstrated single-agent
activity in patients with mutated ALK, KRAS, and BRAF non-small cell
lung cancer (NSCLC) as well as HER2+ and triple-negative breast cancer
(TNBC). Ganetespib is the first Hsp90 inhibitor to demonstrate this
broad range of activity with a favorable safety profile.”
The GALAXY trial is a Phase 2b/3 trial designed to compare
standard-of-care docetaxel with or without ganetespib in a second-line
advanced NSCLC treatment setting. The Phase 2b portion of this trial,
targeted to enroll 240 patients, is designed to identify one or more
patient populations, defined by outcomes of biomarker analysis and other
disease characteristics, which are best suited for enrollment in the
Phase 3 portion of the trial. An interim analysis for the first-stage,
Phase 2b portion is currently in progress, with an announcement planned
for later this quarter. Based on encouraging results seen to date, Synta
plans to meet with regulatory agencies and advance to the second-stage
Phase 3 portion of this trial before the end of the year.
Two clinical trials confirming ganetespib activity in crizotinib-naive
ALK+ advanced NSCLC patients are also initiating: a company-sponsored,
100-patient, Phase 2 monotherapy trial and a Phase 1/2 trial in
combination with crizotinib being conducted by Memorial Sloan Kettering
Cancer Center. Preliminary results from the ganetespib monotherapy trial
are expected by year-end.
In addition to NSCLC, ganetespib is also being evaluated as potential
treatment for metastatic breast cancer. Clinical data presented from a
Phase 2 investigator-sponsored trial at the San Antonio Breast Cancer
Symposium in December 2011 provided strong evidence that Hsp90
inhibition may be a promising approach for treating both HER2+ and TNBC.
Based on this encouraging data, investigators at Memorial Sloan
Kettering Cancer Center intend to initiate a Phase 1/2 trial evaluating
ganetespib in combination with paclitaxel and Herceptin® in HER2+ breast
cancer, and ganetespib in combination with paclitaxel in TNBC. In
addition, Synta is designing a global clinical trial also evaluating
ganetespib in these two breast cancer patient populations. Additional
details will be provided as these trials initiate.
Synta expects that a number of third-party sponsored trials evaluating
ganetespib will commence or continue in 2012. These include trials in
combination with radiotherapy, a randomized trial in elderly patients
with acute myelogenous leukemia (AML) in combination with cytarabine,
and a Phase 1/2 trial both as a single agent and in combination with
VELCADE® for the treatment of multiple myeloma. The multiple myeloma
trial is being conducted in collaboration with the Multiple Myeloma
Research Foundation (MMRF). Enrollment in this study began in March
2012. These third-party trials further diversify the ganetespib clinical
trial portfolio and could inform new potential applications for
ganetespib.
Financial Results
Total revenue was $0.1 million for the first quarter in 2012 compared to
total revenue of $1.1 million for the same period in 2011. The Company
reported a net loss of $15.1 million or $0.27 per basic and diluted
share for the first quarter in 2012, compared to a net loss of $11.4
million, or $0.27 per basic and diluted share for the same period in
2011.
Research and development expenses were $12.1 million for the first
quarter in 2012 compared to $9.4 million for the same period in 2011.
General and administrative expenses were $2.7 million for the first
quarter in 2012 compared to $2.7 million for the same period in 2011.
As of March 31, 2012, the Company had $57.4 million in cash, cash
equivalents and marketable securities, including the $33.0 million in
net proceeds raised in the underwritten public offering in January and
February 2012, compared to $39.7 million in cash, cash equivalents and
marketable securities as of December 31, 2011.
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 3, 2012.
Guidance
Based on our current operating levels, the Company expects its cash
resources will be sufficient to fund operations into the first half of
2013. This estimate assumes no additional funding from new partnership
agreements or equity financing events. Certain activities contemplated
for 2012 would be conducted subject to the availability of additional
financial resources.
Conference Call
Management will conduct a conference call at 10:00 a.m. (ET) today to
review the Company's first-quarter 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 call also can be accessed by dialing (877) 407-8035 or (201)
689-8035 prior to the start of the call. For those unable to join the
live conference call, a replay will be available from 2:00 p.m. (ET) on
May 3 through midnight (ET) on May 10. To access the replay, dial (877)
660-6853 or (201) 612-7415 and refer to both account number 286 and
conference ID 392603. The webcast also will be archived on the Company's
website.
About Ganetespib
Ganetespib is a potent, small-molecule inhibitor of heat shock protein
90 (Hsp90). Hsp90 is a molecular chaperone required for the proper
folding and activation of many cancer-promoting proteins, and is
recognized as a key facilitator of cancer cell growth and survival. In
preclinical experiments, ganetespib has shown activity in multiple tumor
models both as a single agent and in combination with certain widely
used cancer agents. Ganetespib is currently being evaluated in a broad
range of cancer clinical trials. In these trials, ganetespib has shown
clinical activity in heavily pretreated patients and has been well
tolerated to date with no evidence of severe liver or common ocular
toxicities seen with other Hsp90 inhibitors. The most common adverse
event seen to date has been transient, mild or moderate diarrhea, which
has been manageable with standard supportive care. Information on
clinical trials with ganetespib can be found at www.clinicaltrials.gov.
About the Phase 2b/3 GALAXY TrialTM in NSCLC
The Phase 2b/3 trial will evaluate treatment with ganetespib and
docetaxel vs. docetaxel alone, with 1:1 randomization, in patients with
Stage IIIB or IV NSCLC who have completed one prior systemic therapy for
advanced disease. The first stage, Phase 2b portion, will assess
efficacy as measured by progression-free survival in approximately 240
patients. Results from this stage will also be used to inform the choice
of patient subpopulation, by biomarker or other disease characteristic
for the second stage, Phase 3 portion. The second stage may enroll up to
600 patients. More information on the trial can be found at www.clinicaltrials.gov.
About Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer-related mortality in the
United States, with over 226,000 new cases and 160,000 deaths estimated
in 2012 according to the American Cancer Society. The five year survival
rate for advanced-staged lung cancer is approximately 4%. Approximately
85% of all lung cancers are classified as non-small cell. Estimates for
the global incidence of ALK+ NSCLC range from 40,000 to 70,000 new cases
per year.
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 timing, development and progress of
our preclinical and clinical programs, including plans to proceed into
Phase 3 stage of the GALAXY Trial by the end of 2012, the expectation
that we will receive preliminary results from the ganetespib monotherapy
trial by year-end, and the expectation that a number of third-party
sponsored trials evaluating ganetespib will commence or continue in
2012; and the sufficiency of our cash resources to fund operations into
the first half of 2013, 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, 2011 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)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
2012
|
|
|
2011
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaboration revenues:
|
|
|
|
|
|
|
|
|
License and milestone revenues
|
|
|
|
$
|
—
|
|
|
|
$
|
1,143
|
|
|
Total collaboration revenues
|
|
|
|
|
—
|
|
|
|
|
1,143
|
|
|
Grant revenues
|
|
|
|
|
147
|
|
|
|
|
—
|
|
|
Total revenues
|
|
|
|
|
147
|
|
|
|
|
1,143
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
12,066
|
|
|
|
|
9,436
|
|
|
General and administrative
|
|
|
|
|
2,646
|
|
|
|
|
2,673
|
|
|
Total operating expenses
|
|
|
|
|
14,712
|
|
|
|
|
12,109
|
|
|
Loss from operations
|
|
|
|
|
(14,565
|
)
|
|
|
|
(10,966
|
)
|
|
Interest expense, net
|
|
|
|
|
(486
|
)
|
|
|
|
(435
|
)
|
|
Net loss
|
|
|
|
$
|
(15,051
|
)
|
|
|
$
|
(11,401
|
)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
|
|
$
|
(0.27
|
)
|
|
|
$
|
(0.27
|
)
|
|
Basic and diluted weighted average number of
|
|
|
|
|
|
|
|
|
common shares outstanding
|
|
|
|
|
56,366,992
|
|
|
|
|
42,008,818
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synta Pharmaceuticals Corp.
|
|
Condensed Consolidated Balance Sheets Data
|
|
(in thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2012
|
|
|
December 31, 2011
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities
|
|
|
|
$
|
57,390
|
|
|
$
|
39,725
|
|
Other current assets
|
|
|
|
|
608
|
|
|
|
561
|
|
Property, plant and equipment, net
|
|
|
|
|
1,324
|
|
|
|
1,407
|
|
Other non-current assets
|
|
|
|
|
519
|
|
|
|
631
|
|
Total assets
|
|
|
|
$
|
59,841
|
|
|
$
|
42,324
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Equity
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
$
|
15,644
|
|
|
$
|
15,148
|
|
Long-term liabilities
|
|
|
|
|
10,427
|
|
|
|
12,402
|
|
Stockholders’ equity
|
|
|
|
|
33,770
|
|
|
|
14,774
|
|
Total liabilities and
|
|
|
|
$
|
59,841
|
|
|
$
|
42,324
|
|
Stockholders’ equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Source: Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp.
George Farmer, 781-541-7125
