Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided an
update on recent progress with its clinical programs and reported
financial results for the quarter and year ended December 31,
2011.
“This past year Synta made substantial progress in developing
ganetespib – including demonstrating clinical activity in certain
types of lung and breast cancer; reinforcing the differentiated,
favorable safety profile; and initiating a comprehensive
development plan that allows for multiple paths to registration
with important data readouts in 2012,” said Safi Bahcall, Ph.D.,
President and CEO. “The clinical activity together with the
favorable safety profile have established ganetespib as the leading
Hsp90 inhibitor in the industry and have helped generate the broad
support for our company-sponsored trials in lung and breast cancer
– as well as for the over 15 investigator- or third-party-sponsored
trials in lung, breast, and other cancers.”
Over 500 patients have been treated to date in clinical trials
with ganetespib. The most common adverse event seen with ganetespib
has been mild to moderate diarrhea, which has been transient and
manageable with standard supportive care. There has been no
evidence of the common ocular toxicities and serious liver
toxicities reported with some other Hsp90 inhibitors; or the
neurotoxicity, bone marrow toxicities, or alopecia characteristic
of many chemotherapies.
“We are particularly excited that ganetespib has the potential
to be the first compound to realize the therapeutic potential of
chaperone inhibition,” continued Dr. Bahcall. “This is an entirely
distinct approach to interrupting cancer cell signaling than either
directly inhibiting a kinase with a small molecule, or directly
binding a growth factor with a monoclonal antibody. We are hopeful
that ganetespib can provide a new approach to treating cancer,
which is different than, and potentially complementary to kinase
inhibitors, monoclonal antibodies, and chemotherapy.”
Synta is currently initiating a global clinical trial in
patients with advanced non-small cell lung cancer whose tumors show
an ALK gene rearrangement (ALK+ NSCLC), and a global clinical trial
in patients with breast cancer whose tumors show either a HER2+ or
triple-negative genetic profile. The GALAXY trial – a Phase 2b/3
trial evaluating ganetespib in combination with docetaxel vs.
docetaxel alone in patients with advanced lung cancer who have
progressed following one prior treatment – was initiated in 2011
and is currently enrolling patients in the U.S. and Europe.
Ganetespib is a potent inhibitor of heat shock protein 90
(Hsp90) that is structurally unrelated to first-generation,
ansamycin-family Hsp90 inhibitors such as 17-AAG, 17-DMAG and
IPI-504.
Ganetespib Clinical Update
Highlights of Recent Ganetespib Results
and 2011 Achievements
- Activity in ALK+ NSCLC
- Results presented at ASCO in 2011
showed a 50% (4/8) objective response rate and 88% (7/8) disease
control rate following treatment with ganetespib monotherapy
(single-agent) in patients with advanced ALK+ NSCLC. These patients
had previously failed to respond to, or progressed following
treatment with, multiple prior treatments for advanced NSCLC,
including combination chemotherapy. Responses were durable, with
patients remaining on treatment an average of approximately one
year.
- Preclinical results demonstrated that
ganetespib activity is complementary to direct ALK inhibition (e.g.
crizotinib) – suggesting promising potential for combination
treatment in ALK+ NSCLC patients.
- Activity in breast cancer
- Ganetespib is the first Hsp90 inhibitor
to show single-agent activity in breast cancer. Results presented
at the San Antonio Breast Cancer Symposium in 2011 showed
encouraging anti-tumor activity in both HER2+ and triple-negative
breast cancer.
- Favorable safety
- Over 500 patients have been treated to
date in trials with ganetespib. Results from ongoing safety reviews
are consistent with previously reported findings: absence of the
common ocular toxicities and serious liver toxicities seen with
other Hsp90 inhibitors; and an absence of the neurotoxicity, bone
marrow toxicities, or alopecia characteristic of chemotherapy. The
most common adverse event seen with ganetespib has been transient,
mild to moderate diarrhea, which has been manageable with standard
supportive care.
- Physicochemical properties
- Synta scientists published preclinical
results of physicochemical properties of ganetespib believed to
contribute to the improved safety and activity profile seen
relative to other Hsp90 inhibitors. These include smaller molecular
weight, greater potency, greater lipophilicity, ability of
ganetespib to enter the ATP binding pocket of Hsp90 in either the
open- or closed-pocket lid conformation, ability of ganetespib to
penetrate deep into tumor tissues, absence of the benzoquinone
moiety in ganetespib’s molecular structure, and reduced
accumulation in the retina.
- Synergy with other anti-cancer agents
- Hsp90 is believed to be critical for
cancer cells’ abilities to recover or resist a range of stresses –
including those induced by certain chemotherapeutic and targeted
agents. Synta scientists and collaborators published preclinical
results showing synergistic activity of ganetespib with paclitaxel,
docetaxel, cisplatin, carboplatin, PI3K/mTOR inhibitors, MEK
inhibitors, HER2 inhibitors, and other widely used agents.
- Parallel paths to registration
- Designed and initiated a comprehensive
clinical plan that can potentially lead to seven or more separate
paths to registration, with meaningful data readouts expected in
2012.
- The GALAXY trial de-risks the path to
registration in second-line lung cancer through a two-stage Phase
2b/3 design – using the biomarker and subpopulation results, as
well as operational experience, gained in the first-stage,
240-patient Phase 2b portion, to de-risk the second-stage, Phase 3
portion.
- Identified targeted patient
populations, such as ALK+ NSCLC, HER2+ breast cancer, and
triple-negative breast cancer with encouraging single-agent
activity.
- Designed and initiated a development
plan in these targeted patient populations that offers
complementary paths to registration to the populations being
evaluated in the GALAXY trial.
- Built third-party support for
additional proof-of-concept trials in lung cancer, breast cancer,
colon cancer, prostate cancer, melanoma, AML, and multiple myeloma
already initiated, or expected to initiate in 2012.
- Scientific and medical community
awareness
- Over 15 investigator-sponsored,
foundation-sponsored, or cooperative-group sponsored trials already
initiated or expected to initiate in 2012.
Expected 2012 Ganetespib
Milestones
- GALAXY trial: Phase 2b/3 trial
evaluating ganetespib in combination with docetaxel vs. docetaxel
alone in patients with advanced NSCLC who have progressed following
one prior treatment for metastatic disease
- Complete enrollment of 240-patient,
first-stage Phase 2b portion in Q2
- Interim Phase 2b results in Q2
- Final PFS data and preliminary OS data
from Phase 2b portion in 2H
- Initiate Phase 3 portion in 2H, based
on results from Phase 2b
- ALK+ trial: monotherapy ganetespib
treatment in advanced NSCLC patients previously untreated with ALK
inhibitor
- Preliminary results by year-end
- Breast cancer trial: HER2+ and
triple-negative breast cancer patients
- Preliminary results by year-end
- Investigator, foundation, or
cooperative group trials initiating in 2012:
- Trial in combination with crizotinib in
ALK+ NSCLC
- Trial in combination with paclitaxel
and Herceptin® in HER2+ breast cancer, and in combination with
paclitaxel in triple-negative breast cancer
- Trial in combination with Velcade® in
multiple myeloma
- Trial in combination with radiotherapy
in rectal cancer
- Randomized trial in elderly patients
with acute myeloid leukemia in combination with the chemotherapy
drug ara-C
“We have worked closely with investigators over the past year to
develop a diversified, risk-mitigated registration plan,” said Dr.
Vojo Vukovic, Chief Medical Officer. “The results to date with
ganetespib in lung cancer, breast cancer, and certain other tumors
– together with the very strong preclinical results and supportive
results seen with other Hsp90 inhibitors – form a very compelling
picture. The results in ALK+ NSCLC position this program on the
cutting edge of available treatment options, and we have seen this
resonate strongly with leading investigators in U.S., Europe, and
Asia.”
Additional Programs at Synta
In addition to progress with our ganetespib program in 2011, we
also made significant progress with our elesclomol and CRAC
programs. For our elesclomol program we published preclinical
results demonstrating that elesclomol triggers cancer cell
apoptosis by disrupting mitochondrial energy metabolism,
potentially establishing elesclomol as a leading compound in the
emerging field of anti-cancer therapies targeting cancer cell
metabolism. We also continued development of elesclomol in patients
with advanced ovarian cancer, in a trial being conducted by the
Gynecologic Oncology Group and supported by the National Cancer
Institute; and in acute myeloid leukemia, working closely with a
leading cancer center in Canada. For our CRAC program, our
scientists developed a number of distinct families of preclinical
stage compounds that exhibited a favorable safety and activity
profile in inflammatory disease models.
Additional Updates
Please go to www.syntapharma.com for additional details.
Fourth Quarter and Full Year 2011 Financial Results
In the fourth quarter of 2011, Synta recognized total revenue of
$3.4 million compared to $4.0 million for the same period in 2010.
Total revenue was $7.6 million for the year ended December 31, 2011
compared to $14.8 million for the same period in 2010.
Research and development expenses were $10.9 million for the
fourth quarter in 2011 compared to $9.3 million for the same period
in 2010. Research and development expenses were $41.5 million for
the year ended December 31, 2011 compared to $40.3 million for the
same period in 2010.
General and administrative expenses were $2.8 million for the
fourth quarter in 2011 compared to $3.1 million for the same period
in 2010. General and administrative expenses were $11.5 million for
year ended December 31, 2011 compared to $11.4 million for the same
period in 2010.
The Company reported a net loss of $10.7 million or $0.22 per
basic and diluted share in the fourth quarter of 2011, compared to
a net loss of $8.8 million or $0.21 per basic and diluted share for
the same period in 2010. For the year ended December 31, 2011, the
Company reported a net loss of $47.4 million or $1.00 per basic and
diluted share, compared to a net loss of $37.5 million or $0.93 per
basic and diluted share for the same period in 2010.
As of December 31, 2011, the Company had $39.7 million in cash,
cash equivalents and marketable securities compared to $51.0
million as of December 31, 2010.
In January and February 2012, the Company raised approximately
$33.0 million in net proceeds from the sale of an aggregate of
8,050,000 shares of its common stock in a public offering at a
public offering price of $4.40 per share, including 7,000,000
shares in the initial closing in January 2012 and 1,050,000 shares
in a second closing in February 2012 following the full exercise of
the over-allotment option granted to the underwriters.
More detailed financial information and analysis may be found in
the Company's Annual Report on Form 10-K, which was filed with the
Securities and Exchange Commission on February 22, 2012.
Guidance
Based on our current operating levels, the Company expects its
cash resources, including the $33.0 million in net proceeds raised
in the January and February 2012 public offering, will be
sufficient to fund operations into the first half of 2013. This
estimate assumes no additional funds 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)
this morning to review the Company's fourth-quarter and year-end
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 February 22 through midnight (ET) on February 29. To access
the replay, dial (877) 660-6853 or (201) 612-7415 and refer to both
account number 286 and conference ID 388181. The webcast also will
be archived on the Company's website.
About Ganetespib
Ganetespib (formerly STA-9090) is a potent, synthetic,
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 histology or
biomarker, or other disease characteristic for the second stage,
Phase 3 portion. The second stage will enroll between 400 and 600
patients. Interim results from the first-stage portion of the trial
are expected in Q2 2012. 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 clinical and preclinical
programs, including the generation of significant data readouts in
2012 for ganetespib; the information set forth above under the
heading “Expected 2012 Ganetespib Milestones”; 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 EndedDecember
31,
Twelve Months EndedDecember
31,
2011 2010
2011 2010 Collaboration
revenues: License and milestone revenue $ 3,302 $ 1,143 $ 6,731 $
4,572 Cost sharing reimbursements, net — 1,916
—
9,253
Total collaboration revenues 3,302 3,059 6,731 13,825 Grant revenue
121 978 853 978
Total revenues 3,423 4,037 7,584 14,803 Operating expenses:
Research and development 10,859 9,347 41,464 40,252 General and
administrative
2,803
3,055 11,552 11,449 Total
operating expenses 13,662 12,402
53,016 51,701 Loss from operations (10,239 ) (8,365 )
(45,432 ) (36,898 ) Interest expense, net (504 ) (458
) (1,948 ) (569 ) Net loss $ (10,743 ) $ (8,823 ) $
(47,380 ) $ (37,467 ) Basic and diluted net loss per common
share $ (0.22 ) $ (0.21 ) $ (1.00 ) $ (0.93 ) Basic and diluted
weighted average number of common shares outstanding 49,426,806
41,263,628 47,197,572 40,365,215
Synta Pharmaceuticals
Corp.Condensed Consolidated Balance Sheets Data(in
thousands)(unaudited)
December 31, 2011
December 31, 2010 Assets
Cash, cash equivalents andmarketable
securities
$ 39,725 $ 50,973 Other current assets 561
547 Property and equipment, net 1,407
2,181 Other non-current assets
631
366
Total assets
$
42,324
$
54,067
Liabilities and Equity
Current liabilities $ 15,148 $ 16,736
Long-term liabilities 12,402 13,852
Stockholders’ equity
14,774
23,479
Total liabilities andStockholders’
equity
$
42,324
$
54,067
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