Synta Provides Company Updates and Reports Fourth Quarter and Year-End 2012 Financial Results

  Synta Provides Company Updates and Reports Fourth Quarter and Year-End 2012
  Financial Results

   -- Expects mid-year overall survival results from the GALAXY-1 trial for
            ganetespib in second-line non-small cell lung cancer –

 -- Expects enrollment of the pivotal GALAXY-2 Phase 3 trial to commence this
                                   month --

           -- Announces key addition to executive management team –

Business Wire

LEXINGTON, Mass. -- March 14, 2013

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided an update on recent
progress with its clinical programs and reported financial results for the
fourth quarter and year ended December 31, 2012.

“Over the past year, we have made strong progress in the development of
ganetespib, our Hsp90 inhibitor,” said Dr. Safi Bahcall, President and CEO of
Synta. “Interim results presented last year from our GALAXY-1 trial evaluating
ganetespib as second-line treatment of non-small cell lung cancer showed
encouraging clinical activity. We look forward to presenting more mature
results from the 240-patient target population of this trial mid-year, and
enrolling the first patient in our GALAXY-2 Phase 3 trial before the end of
this month.”

“Ganetespib represents a distinct cancer treatment paradigm – targeting one
protein, the chaperone, which simultaneously destabilizes a broad range of
oncogenic pathways,” said Dr. Sumant Ramachandra, President of Research and
Development. “This approach is differentiated: existing cancer therapies are
generally either non-specific, for example anti-mitotic chemotherapies, or
target one particular signaling protein involved in a limited number of cancer
signaling pathways, for example tyrosine kinase inhibitors.”

“The clinical evidence to date, together with the preclinical results that
show treatment with ganetespib changes the broader biology of cancer cells,
reducing tumor aggressiveness, are encouraging,” continued Dr. Ramachandra.
“Results expected later this year will be important in confirming the clinical
activity and establishing the potential for ganetespib beyond lung cancer.”

The safety profile of ganetespib has been favorable in over 700 patients
treated to date in more than 20 clinical trials. Transient, mild or moderate
diarrhea has been the most commonly reported adverse event.

Key accomplishments in 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 GALAXY-1 trial. There were 172 adenocarcinoma patients in the clinical
database at the time of the September 10 cutoff for this analysis.

Highlights included:

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 yet 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. Objective response rate and progression-free survival
were also improved in the ganetespib arm.

b. 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
GALAXY-2 trial, with the objective of enriching for patients likely to derive
the greatest benefit from ganetespib treatment.

c. Clinical and preclinical results were presented that suggest ganetespib
reduces or disrupts new blood vessel formation (angiogenesis) and the
emergence of new lesions (metastases). Analyses of tumor samples from patients
treated with ganetespib showed a reduction of levels of vascular endothelial
growth factor (VEGF) and hypoxia induced factor-1alpha (HIF-1alpha), key
drivers of angiogenesis and metastasis.

d. 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. Completed enrollment of the 240 adenocarcinoma patient target population of
GALAXY-1 in October 2012.

3. Participated in an End-of-Phase 2 (EOP2) meeting with the Food and Drug
Administration (FDA) to review plans for the GALAXY-2 Phase 3 trial. Synta has
incorporated comments from the EOP2 meeting into the Phase 3 protocol and is
initiating this trial.

4. Presented results at the American Society of Clinical Oncology (ASCO)
meeting in June 2012 showing that common ocular toxicities seen with some
Hsp90 inhibitors, but not observed in clinical trials with ganetespib or with
17-AAG, are associated with physicochemical properties that affect drug
distribution to the eye.

5. Synta collaborators enrolled the first patients in investigator-sponsored
trials evaluating ganetespib in combination regimens for treatment of ALK+
NSCLC, hormone receptor-positive metastatic breast cancer, multiple myeloma,
acute myeloid leukemia, and rectal cancer.

6. Completed equity financings resulting in approximately $119 million of net
proceeds to the company.

Ganetespib clinical updates


The 240 adenocarcinoma patient enrollment target for GALAXY-1 was achieved in
October 2012. Twelve additional patients in screening at that time were also
enrolled, yielding a total of 252 adenocarcinoma patients, with the last
patient randomized in November 2012. An overall survival analysis of the
all-comers (intent-to-treat; ITT) adenocarcinoma population was specified for
six months from last patient enrolled. Based on current projections, Synta
plans to conduct this analysis in mid-2013.

The GALAXY-1 protocol specified that enrollment of patients with either of two
pre-specified biomarkers may continue, following completion of the targeted
number of all-comers adenocarcinoma patients, in order to ensure a sufficient
number of patients in each of these biomarker-defined subpopulations. We
expect that approximately 60 additional such patients will be enrolled. Based
on our current projections, we expect that the final PFS analyses for these
GALAXY-1 biomarker-defined subpopulations will be conducted in the second half
of 2013.


The GALAXY-2 Phase 3 trial has the same design as the GALAXY-1 trial.
Approximately 500 patients with advanced adenocarcinoma NSCLC will be
randomized 1:1 to treatment with docetaxel plus ganetespib or docetaxel alone.
The same dose and schedule used in the GALAXY-1 trial will be used in the
GALAXY-2 trial. Patients on both arms will receive docetaxel generally for
four to six 21-day cycles, according to standard practice at their treatment
center. After completion of docetaxel treatment, patients on the ganetespib
arm are eligible to continue to receive ganetespib as monotherapy treatment
until disease progression. The trial will be conducted in many of the 60
centers across Europe and North America that participated in the GALAXY-1
trial, together with up to 60 additional centers.

Results from an interim analysis of the GALAXY-1 trial conducted in September
2012 were used in selecting the eligibility criteria for the GALAXY-2 trial,
in order to enrich for the patients most likely to derive the greatest benefit
from ganetespib treatment. GALAXY-2 will enroll patients who have progressed
following treatment with one prior platinum-containing regimen of chemotherapy
and who were diagnosed with metastatic disease at least six months prior to
study entry. This represents approximately 65% of the GALAXY-1 patient

Overall survival is the primary endpoint for GALAXY-2. Two event-driven
interim analyses have been specified. Based on current projections and
statistical assumptions, Synta expects these analyses, together with the final
analysis, to occur in 2014.

Additional clinical updates

1. Results from an initial phase of the CHIARA trial, evaluating ganetespib
monotherapy for treatment of ALK+ NSCLC naïve to ALK inhibitor therapy, will
inform the decision as to whether to continue additional enrollment in this
trial. Synta plans to provide additional updates regarding this program

2. Synta also plans to provide updates mid-year from the ongoing ENCHANT
trial, designed to evaluate ganetespib monotherapy as first-line treatment of
HER2+ and triple negative metastatic breast cancer.

3. New investigator-sponsored and cooperative group studies are being planned
to evaluate ganetespib in combination with standard-of-care chemotherapies for
the treatment of metastatic breast and ovarian cancers.

Elesclomol clinical update

In March 2011, the Gynecological Oncology Group (GOG) initiated a Phase 2
clinical trial of elesclomol, an oxidative stress inducer, in combination with
paclitaxel for the treatment of persistent or recurrent ovarian, fallopian
tube or primary peritoneal cancer for patients with total baseline serum
lactate dehydrogenase (LDH) level less than 0.8 times the upper limit of
normal (ULN). Synta has recently been informed that this trial has met the
pre-specified efficacy requirement to advance to stage 2, indicating potential
activity in this difficult-to-treat patient population that has limited
treatment options.

Executive management team addition

In a separate release, the Company announced yesterday that Sumant
Ramachandra, M.D., Ph.D., has joined Synta as President, Research and

Fourth quarter and full year 2012 financial results

There were no revenues in the fourth quarter in 2012 compared to total revenue
of $3.4 million for the same period in 2011. Total revenue was $0.1 million
for the year ended December 31, 2012 compared to $7.6 million for the same
period in 2011.

Research and development expenses were $14.4 million for the fourth quarter in
2012 compared to $10.9 million for the same period in 2011. Research and
development expenses were $49.4 million for the year ended December 31, 2012
compared to $41.5 million for the same period in 2011.

General and administrative expenses were $3.4 million for the fourth quarter
in 2012 compared to $2.8 million for the same period in 2011. General and
administrative expenses were $11.7 million for year ended December 31, 2012
compared to $11.6 million for the same period in 2011.

The Company reported a net loss of $18.1 million or $0.29 per basic and
diluted share in the fourth quarter of 2012, compared to a net loss of $10.7
million or $0.22 per basic and diluted share for the same period in 2011. For
the year ended December 31, 2012, the Company reported a net loss of $62.8
million or $1.06 per basic and diluted share, compared to a net loss of $47.4
million or $1.00 per basic and diluted share for the same period in 2011.

As of December 31, 2012, the Company had $100.6 million in cash, cash
equivalents and marketable securities, including $59.8 million of net proceeds
from the registered direct offering of our common stock in December 2012,
compared to $39.7 million as of December 31, 2011.

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 March 14, 2013.


Based on our current operating levels the Company expects its cash resources
of approximately $100.6 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 activities contemplated for 2013 will be conducted subject to the
availability of sufficient financial resources.

Conference call

Management will conduct a conference call at 10:00 AM (EST) today to discuss
clinical updates and fourth quarter and year-end 2012 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,, 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 (ET)
this afternoon through midnight (ET) on March 21. To access the replay, dial
(877) 660-6853 or (201) 612-7415 and refer to conference ID 407525. The
webcast will also be archived on the Company's website.

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

About Ganetespib

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 studies with ganetespib
include 1) the randomized GALAXY-1 and GALAXY-2 trials 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+ NSCLC, and 3) the ENCHANT Phase 2 trial evaluating ganetespib as
first-line treatment for HER2+ and triple-negative metastatic breast cancer.
In addition, ganetespib is being evaluated in investigator-sponsored trials
for treatment of a number of solid tumor and hematologic cancer indications.
Information on these trials can be found at

The safety profile of ganetespib has been favorable in over 700 patients
treated to date in more than 20 clinical trials. Transient, mild or moderate
diarrhea has been the most commonly reported adverse event.

About the GALAXY Trials

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
(NCT01348126 and NCT01798485).

About 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. Many of the “client proteins” of Hsp90 – such
and 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.

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 timing, developments and
progress of our clinical and preclinical programs, including, the timing of
the presentation of additional results from the GALAXY-1 trial, the timing of
enrollment of the first patient in the GALAXY-2 trial, the timing of interim
analyses and the final analysis of the GALAXY-2 trial, and the timing of
updates and results for the ENCHANT and CHIARA 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                    Twelve Months Ended
                   December 31,                          December 31,
                    2012             2011             2012             2011       
License and
milestone          $ —                $ 3,302            $ —                $ 6,731
Grant revenue       —                121              147              853        
Total revenues      —                3,423            147              7,584      
Research and         14,351             10,859             49,412             41,464
General and         3,352            2,803            11,676           11,552     
operating           17,703           13,662           61,088           53,016     
Loss from            (17,703    )       (10,239    )       (60,941    )       (45,432    )
Interest            (420       )      (504       )      (1,849     )      (1,948     )
expense, net
Net loss           $ (18,123    )     $ (10,743    )     $ (62,790    )     $ (47,380    )
Basic and
diluted net        $ (0.29      )     $ (0.22      )     $ (1.06      )     $ (1.00      )
loss per
common share
Basic and
average number       62,914,546         49,426,806         59,411,476         47,197,572

Synta Pharmaceuticals Corp.

Condensed Consolidated Balance Sheets Data

(in thousands)


                                   December 31, 2012   December 31, 2011
Cash, cash equivalents and
                                       $     100,599         $      39,725
marketable securities
Other current assets                         786                    561
Property, plant and equipment,               1,174                  1,407
Other non-current assets                    458                   631
Total assets                           $     103,017         $      42,324
Liabilities and Equity
Current liabilities                    $     23,486          $      15,148
Long-term liabilities                        4,465                  12,402
Stockholders’ equity                        75,066                14,774
Total liabilities and
                                       $     103,017         $      42,324
Stockholders’ equity


Synta Pharmaceuticals Corp.
George Farmer, 781-541-7213
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