Synta Provides Clinical Update and Reports Third Quarter 2012 Financial
– GALAXY Phase 2b trial achieves 240-patient enrollment goal, final results
expected 2013 –
– End-of-Phase 2 FDA meeting completed –
– Phase 3 ganetespib lung cancer trial initiating, final results expected 2014
– First patients treated in ENCHANT breast cancer trial and LI-1 randomized
AML trial –
LEXINGTON, Mass. -- November 06, 2012
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today reported financial results
for the third quarter ended September 30, 2012 and provided clinical program
updates regarding its lead oncology drug candidate, ganetespib, a potent and
selective Hsp90 inhibitor.
“Clinical development of ganetespib has progressed exceptionally well this
year, culminating with the recent presentation of positive interim results
from the first stage of our 800-patient Phase 2b/3 randomized GALAXY program
in non-small cell lung cancer,” said Safi Bahcall, Ph.D., President and CEO.
“These encouraging results in combination with docetaxel, together with the
previously reported promising results with ganetespib monotherapy in certain
targeted patient populations, create exciting opportunities for multiple paths
to registration and a unique product profile. We have been pleased with the
strong support for this program in the medical oncology community, reflected
in increasing rates of enrollment across all our trials and a growing number
of third-party supported programs. We are looking forward to upcoming results
from GALAXY and our other programs, and to realizing our goal of creating a
new treatment option for cancer patients.”
Ganetespib is currently being evaluated in over 20 clinical studies. In
addition to the activity observed in the GALAXY combination therapy trial,
objective responses or durable anti-tumor activity have been observed with
ganetespib monotherapy in patients with lung cancer, breast cancer, gastric
cancer, colorectal cancer, renal cancer, and melanoma. The safety profile of
ganetespib has been favorable in over 600 patients treated to date, with
transient, mild or moderate diarrhea as the most common adverse event
Key accomplishments in the third quarter of 2012:
1. At the 2012 Congress of the European Society for Medical Oncology (ESMO),
investigators reported results from the second interim efficacy analysis of
the Phase 2b portion of the GALAXY trial. There were 172 adenocarcinoma
patients in the clinical database at the time of the September 10 cutoff for
a) An increase in overall survival was observed in adenocarcinoma patients
treated with ganetespib plus docetaxel. A median overall survival of 7.4
months was observed in the docetaxel control arm, while median overall
survival had not been reached in the ganetespib arm. Results for docetaxel
were consistent with results from prior second line non-small cell lung cancer
(NSCLC) therapy trials.
b) Objective response rate and progression-free survival in adenocarcinoma
patients were also improved: from 8% to 16%, and from 2.8 months to 4.2
months, in the control arm vs. ganetespib arm, respectively. Overall response
and progression-free survival rates in the control arm were consistent with
results from prior trials with docetaxel in this setting.
c) Results in several GALAXY patient subpopulations, defined by pre-specified
clinical and biomarker characteristics, showed a substantially improved
survival difference between the control arm and ganetespib arm, as compared
with the difference in the all-comer (intent-to-treat) adenocarcinoma patient
population. These findings have been incorporated into the design of the Phase
3 portion of the GALAXY program, with the objective of enriching for patients
likely to derive the greatest benefit from ganetespib treatment.
d) Clinical and preclinical results were presented that suggest potent
ganetespib anti-angiogenic activity. Analyses of tumor samples from patients
treated with ganetespib showed a reduction of levels of hypoxia induced factor
(HIF) and vascular endothelial growth factor (VEGF). In addition, preclinical
experiments demonstrated strong inhibition of tumor vasculature by ganetespib.
These results suggest ganetespib offers a novel way to inhibit angiogenesis:
reducing production of angiogenesis factors, rather than targeting those
signaling factors directly with an antibody (e.g. bevacizumab) or a kinase
e) A favorable safety profile was observed with the ganetespib plus docetaxel
combination in adenocarcinoma patients. Transient, mild-to-moderate diarrhea
was the most common adverse event, consistent with observations from other
clinical trials evaluating ganetespib.
2. Completion of a registered direct common stock offering with net proceeds
of approximately $25.8 million.
GALAXY Phase 2b
The 240 adenocarcinoma patient enrollment target for the Phase 2b portion of
the GALAXY trial was achieved in October. Per protocol, additional
adenocarcinoma patients with elevated baseline levels of lactate dehydrogenase
(LDH) or with tumors exhibiting KRAS mutations, which are pre-specified
patient subpopulations with especially high medical need, may continue to be
enrolled until a specified maximum number of patients with these
characteristics has been achieved. We expect to enroll up to 60 additional
patients in these subpopulations.
Based on our current projections, Synta anticipates final progression free
survival (PFS) and updated overall survival data from the Phase 2b portion of
GALAXY in the first half of 2013, and final overall survival data in the
second half of 2013.
GALAXY Phase 3
Synta recently completed an End-of-Phase 2 (EOP2) meeting with the Food and
Drug Administration (FDA) to review plans for the Phase 3 portion of the
GALAXY program. Synta has incorporated comments from the EOP2 meeting into the
Phase 3 protocol and is currently initiating this trial. Enrollment is
expected to begin early next year.
The Phase 3 trial has the same design as the Phase 2b trial. Adenocarcinoma
patients with advanced NSCLC who have received one prior chemotherapy regimen
will be randomized 1:1 to treatment with either docetaxel plus ganetespib or
docetaxel alone. The same dose and schedule used in the Phase 2b trial will be
used in the Phase 3 trial. Patients on both arms will receive docetaxel
generally for four to six 21-day cycles, as per standard practice at their
treatment center. After completion of docetaxel treatment, patients on the
ganetespib arm are eligible to continue to receive ganetespib monotherapy as
maintenance treatment. The trial will be conducted in many of the 60 centers
across Europe and North America that participated in the Phase 2b trial,
together with up to 60 additional centers.
The Phase 3 trial will enroll approximately 500 adenocarcinoma patients and
overall survival will be the primary endpoint. Based on results from the Phase
2b trial, the Phase 3 trial will exclude patients who experienced rapidly
progressing disease, an estimated 30 to 40% of the total eligible population.
The resulting population, which excludes rapidly progressing patients, showed
a substantially enhanced survival difference between the ganetespib arm and
the control arm in the Phase 2b trial as compared to the survival difference
observed in the total population.
Two event-driven interim analyses for the Phase 3 trial have been specified.
Based on current projections and statistical assumptions, the Company expects
these analyses, together with the final analysis, to occur in 2014. Additional
elements of the Phase 3 trial design will be announced following the start of
Additional clinical updates
*A pre-specified interim analysis of the first 20 patients in the CHIARA
trial, which evaluates ganetespib monotherapy in ALK+ NSCLC patients
previously untreated with a direct ALK inhibitor, is expected to occur in
the first half of 2013.
*An investigator-sponsored trial evaluating the combination of ganetespib
plus crizotinib in patients with ALK+ NSCLC that have not been previously
treated with an ALK inhibitor continues enrolling and treating patients at
Memorial Sloan-Kettering Cancer Center.
*The first patient was treated in the ENCHANT trial, evaluating ganetespib
monotherapy for the treatment of HER2 positive and triple negative
metastatic breast cancer. The Company expects to report preliminary data
from this trial in the first half of 2013.
*The first patient was treated with ganetespib in a randomized Phase 2/3
cooperative group study evaluating ganetespib plus low dose ara-C (LDAC)
vs. LDAC alone for the treatment of elderly patients with acute myeloid
leukemia (AML) who are unable to tolerate intensive chemotherapy. This
“Less Intensive 1” (LI-1) study evaluates a number of treatments in this
randomized setting. Additional information is available at
*A European cooperative group plans to initiate a randomized trial
comparing paclitaxel with and without ganetespib in patients with advanced
ovarian cancer in 2013
There were no revenues in the third quarter of 2012 as compared to $1.7
million dollars of revenues in the same period of 2011 which consisted of
amortization of an upfront payment under the Roche agreement that was
terminated at the end of 2011, and grant revenues.
In the third quarter of 2012 research and development expenses were $11.7
million dollars as compared to $10.8 million dollars for the same period of
2011. Third quarter general and administrative expenses were $2.8 million
dollars as compared to $3.1 million dollars for the comparable period in 2011.
In the third quarter of 2012 the Company’s net loss was $15.0 million dollars
or $0.25 cents per basic and diluted share as compared to a net loss of $12.7
million dollars or $0.26 cents per basic and diluted share in the same period
As of September 30, 2012 the Company had approximately $55.1 million dollars
of cash resources on hand. This includes net proceeds from the registered
direct common stock offering to certain members of the Board of Directors in
The Company expects to end 2012 with $38-$40 million in cash, cash equivalents
and marketable securities. Based on our current operating levels we expect
these cash resources will be sufficient to fund operations into the second
half of 2013. These estimates assume no additional funding from new
partnership agreements or equity financing events, and that the timing and
nature of activities contemplated for 2013 will be conducted subject to the
availability of sufficient financial resources.
Management will conduct a conference call at 10:00 AM (EST) today to discuss
clinical updates and third 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 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 PM (EST)
on November 6 through midnight (EST) on November 13. To access the replay,
dial (877) 660-6853 or (201) 612-7415 and refer to conference ID 401666. The
webcast will also be archived on the Company's website.
Ganetespib is a potent inhibitor of heat shock protein 90 (Hsp90) that is
structurally unrelated to first-generation, ansamycin-related Hsp90
inhibitors. 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. Company-sponsored clinical trials with ganetespib
include 1) the GALAXY Phase 2b/3 trial evaluating ganetespib in combination
with docetaxel as second-line treatment of non-small cell lung cancer (NSCLC),
2) the CHIARA Phase 2 trial evaluating ganetespib monotherapy in ALK positive
NSCLC, and 3) the ENCHANT Phase 2 trial evaluating ganetespib as first-line
treatment for HER2 positive and triple-negative metastatic breast cancer. In
addition, ganetespib is being evaluated in investigator-sponsored trials
including lung, breast, prostate, gastric, pancreatic, and colorectal cancers
as well as ocular melanoma, acute myeloid leukemia and multiple myeloma.
Information on these trials can be found at www.clinicaltrials.gov.
About the GALAXY Trial™
The GALAXY (Ganetespib Assessment in Lung cAncer with docetaXel) trial is a
randomized Phase 2b/3 trial comparing the combination of ganetespib and
docetaxel versus docetaxel alone in patients with Stage IIIB/IV NSCLC who have
received one prior systemic therapy. More information about the GALAXY trial
can be found at www.clinicaltrials.gov (NCT01348126).
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. Many of the “client proteins” of Hsp90 – such
as ALK, AKT, BCR-ABL, BRAF, KIT, MET, EGFR, FLT3, HER2, HIF-1alpha, PDGFRA,
VEGFR are the targets of clinically validated cancer drugs. In preclinical
studies, inhibiting Hsp90 causes the degradation of multiple client proteins
and leads to cancer cell death.
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 contains 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, developments and progress of our GALAXY trial, our clinical
development plans for ganetespib, the expected timing for the release of data
from clinical trials of ganetespib, our expected cash, cash equivalents and
marketable securities as of the end of 2012, the sufficiency of our cash
resources to fund operations into the second half of 2013, and the anticipated
design of the Phase 3 portion of the GALAXY trial, 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. Those
risks and uncertainties include whether the results from the interim analysis
of the Phase 2b portion of the GALAXY trial will be consistent with future
data from the Phase 2b portion and the Phase 3 stage of the trial; whether the
results at the conclusion of the Phase 2b portion of the trial will
demonstrate safety and statistically significant efficacy; challenges with
respect to patient enrollment or other delays in our clinical development
plans; as well as other risks and uncertainties described in the "Risk
Factors" section of our Form 10-K for the year ended December 31, 2011, as
filed with the Securities and Exchange Commission, including those under the
heading “Risks Related to the Development and Regulatory Approval of our Drug
Candidates.” 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 Nine Months Ended
September 30, September 30,
2012 2011 2012 2011
milestone $ — $ 1,143 $ — $ 3,429
collaboration — 1,143 — 3,429
Grant revenues — 521 147 732
Total revenues — 1,664 147 4,161
Research and 11,743 10,751 35,061 30,605
General and 2,796 3,131 8,324 8,749
operating 14,539 13,882 43,385 39,354
Loss from (14,539 ) (12,218 ) (43,238 ) (35,193 )
Interest (457 ) (516 ) (1,429 ) (1,444 )
Net loss $ (14,996 ) $ (12,734 ) $ (44,667 ) $ (36,637 )
diluted net $ (0.25 ) $ (0.26 ) $ (0.77 ) $ (0.79 )
average number 60,661,720 49,403,589 58,235,263 46,446,328
Synta Pharmaceuticals Corp.
Condensed Consolidated Balance Sheets Data
September 30, 2012 December 31, 2011
Cash, cash equivalents and $ 55,139 $ 39,725
Other current assets 803 561
Property, plant and 1,205 1,407
Other non-current assets 466 631
Total assets $ 57,613 $ 42,324
Liabilities and Equity
Current liabilities $ 18,965 $ 15,148
Long-term liabilities 6,458 12,402
Stockholders’ equity 32,190 14,774
Total liabilities and $ 57,613 $ 42,324
Investor Relations Contact:
Synta Pharmaceuticals Corp.
George Farmer, 781-541-7125
Press spacebar to pause and continue. Press esc to stop.