Synta Provides Clinical Updates and Reports Third Quarter 2013 Financial Results

  Synta Provides Clinical Updates and Reports Third Quarter 2013 Financial
  Results

Business Wire

LEXINGTON, Mass. -- November 4, 2013

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided clinical updates and
reported financial results for the third quarter ended September 30, 2013.

Clinical updates

The GALAXY program in lung cancer

At the 2013 World Conference on Lung Cancer (WCLC) last month, investigators
presented one year follow-up results from the ongoing GALAXY-1 trial,
evaluating Synta’s lead oncology drug candidate, ganetespib, in combination
with docetaxel (G+D) vs. docetaxel (D) alone for the second-line treatment of
advanced non-small cell lung cancer (NSCLC). GALAXY-1 was designed to select
the patient population for evaluation in the confirmatory GALAXY-2 Phase 3
trial.

“We are very pleased by the reception at the WCLC meeting to the updated
GALAXY-1 results,” said Dr. Vojo Vukovic, Chief Medical Officer, Synta. “These
results represent the most mature data to date from this program, with over
one-year of follow-up, 65% of survival events, and a strong survival signal
favoring the ganetespib arm. The results have offered a wealth of data and
experience for optimizing the Phase 3 trial.”

Highlights from the recently presented results include:

  *Continued confirmation of clinical activity in the prospectively defined
    chemosensitive patient population selected last year for evaluation in the
    ongoing GALAXY-2 Phase 3 trial.

  *Patients enrolled into the GALAXY-1 trial were prospectively stratified
    into refractory vs. chemosensitive populations based on the rate of their
    disease progression during or following first-line treatment for advanced
    NSCLC (time since diagnosis of advanced disease less than vs. greater than
    six months).
  *In the chemosensitive population (N=178), median overall survival (OS)
    increased from 7.4 to 10.7 months in patients treated with D vs. G+D arms,
    respectively. The Hazard ratio was 0.75 (p=0.065) and 0.72 (p=0.04), in
    the Cox proportional hazards univariate (unadjusted) and multivariate
    (adjusted) models, respectively. Median progression-free survival (PFS)
    improved from 3.4 months to 5.3 months, in the D vs. G+D arms,
    respectively, with Hazard ratios of 0.73 (p=0.031) and 0.72 (p=0.03) in
    the univariate and multivariate models, respectively. All p-values are
    1-sided.
  *In the refractory population (N=75), which progressed rapidly on or
    shortly after first-line chemotherapy, no benefit was observed. These
    results are consistent with results from other clinical trials showing
    little to no benefit from second-line treatment for patients with rapidly
    progressing disease, and from preclinical studies showing that the
    chemosensitizing mechanism of action of ganetespib may be most effective
    in chemosensitive cancers.

  *A favorable safety profile was observed with the G plus D combination in
    adenocarcinoma patients. Transient, mild-to-moderate diarrhea, generally
    manageable with over-the-counter medication,was the most common adverse
    event, consistent with observations from other clinical trials evaluating
    ganetespib. Other adverse events increased relative to control included
    mild to moderate anemia and fatigue, as well as an increase in the number
    of cases of febrile neutropenia.
  *Analysis of data to date revealed that medical profiles from certain
    patients enrolled from two Eastern European countries differed from
    patterns typical of patients enrolled from other countries in this study,
    as well as patients enrolled in other clinical trials for the treatment of
    advanced second-line NSCLC. This observation informed the operational plan
    for the ongoing GALAXY-2 Phase 3 trial, including the decision to limit
    further enrollment from these two countries.

Synta expects final overall survival results from GALAXY-1 by early 2014.

The GALAXY-2 protocol specifies that trial size and statistical assumptions
may be updated based on results from GALAXY-1. Based on the near-final results
from GALAXY-1, Synta intends to review with lead investigators plans for
increasing the GALAXY-2 trial size from 500 patients to 700 patients. This
change is intended to decrease the risk from imbalances or statistical
fluctuations.

Enrollment of GALAXY-2 began in April2013. Assuming an increased trial size
of 700 patients, Synta expects that interim analyses for GALAXY-2 would be
conducted in the second half of 2014, and the final analysis would be
conducted in the first half of 2015.

The ENCHANT program in breast cancer

In July 2013, Synta announced that preliminary results of the ENCHANT-1 Phase
2 trial, evaluating ganetespib monotherapy for treatment of newly diagnosed
HER2-positive or triple-negative metastatic breast cancer, support advancement
into the second stage of the trial. Of the initial five HER2-positive patients
enrolled in the study, two achieved objective tumor response and two achieved
stable disease (SD) within the three cycles of treatment on study (12 weeks).
Of the initial ten triple-negative breast cancer (TNBC) patients enrolled and
evaluable for response, two achieved objective tumor response and three
achieved SD following treatment with ganetespib monotherapy. One of the TNBC
patients enrolled in the study who was diagnosed with inoperable disease at
the time of enrollment achieved a clinical complete response at week 12 and
was restaged to operable disease. This patient recently underwent surgery with
curative intent.

Based on the encouraging results in HER2-positive and triple-negative breast
cancer patients, the trial was expanded to add a third cohort, evaluating
ganetespib monotherapy for the treatment of patients with hormone
receptor-positive disease.

Synta expects initial results from ENCHANT-1 will be presented at the San
Antonio Breast Cancer Symposium in December of this year.

Other clinical trials with ganetespib

A number of investigator and cooperative group-sponsored trials with
ganetespib recently initiated or are expected to initiate by end of this year,
including a trial evaluating ganetespib in combination with pemetrexed and
cisplatin in patients with malignant pleural mesothelioma, being sponsored by
Cancer Research UK; a trial evaluating ganetespib in combination with
paclitaxel in patients with recurrent, platinum-resistant ovarian, fallopian
tube, or primary peritoneal cancer being sponsored at the Fox Chase Cancer
Center; a trial evaluating ganetespib in combination with paclitaxel and
Herceptin in HER2+ breast cancer being conducted at Memorial Sloan-Kettering
Cancer Center (MSKCC) and New York University; and trials designed to evaluate
ganetespib in combination with a variety of different therapeutic modalities
for treatment of head and neck cancer and neuronal tumors. Ongoing
investigator and cooperative group-sponsored trials include a trial in
combination with crizotinib in ALK+ lung cancer; a trial in combination with
fulvestrant in hormone-receptor positive breast cancer; a trial in combination
with chemotherapy and radiotherapy in rectal cancer; a trial in combination
with bortezemib in multiple myeloma; and a trial evaluating the combination of
ganetespib and low dose ara-C chemotherapy in elderly patients with acute
myeloid leukemia (AML). Initiation of additional combination trials with
ganetespib in other cancer indications are planned for 2014.

Other updates

HDC platform

In September 2013, Synta announced the launch of its Hsp90-inhibitor drug
conjugate (HDC) platform technology designed to improve the delivery of
small-molecule anti-cancer therapies to tumors. In October 2013, the Company
announced the publication of the first key patent application covering this
technology, including composition of matter claims covering over 400 HDC
compounds synthesized by Synta to date, methods for identifying
therapeutically effective compounds, and methods of use against a wide range
of diseases and conditions.

HDCs are drug candiates consisting of an Hsp90 inhibitor (targeting moiety)
joined to an anti-cancer agent (payload) via a cleavable chemical linker
optimized for controlled release of payload drug inside cancer cells. Because
HDCs are small molecules, they diffuse into the cell passively, avoiding
reliance on cell surface antigens or transporters, as is required by other
delivery mechanisms such as antibody-drug conjugates (ADCs).

The longer retention of Hsp90 inhibitors in tumors results in higher
concentration and longer duration of active payload drug inside cancer cells
than occurs with standard administration of unconjugated chemotherapy or other
payloads. This enhanced delivery creates the potential for greater cancer cell
killing and reduced side effects.

Synta has developed over 400 HD-Conjugated chemotherapeutics, kinase
inhibitors, hormone therapies, immunomodulators, and epigenetic modifiers,
creating the potential for next-generation compounds in each of these
categories. Examples include HD-Conjugated bendamustine, temozolomide,
doxorubicin, 5-FU, pemetrexed, SN-38, topotecan, vorinostat, panobinostat,
fulvestrant, abiraterone, lenalidomide, pomalidomide, docetaxel, carboplatin,
bortezomib, sunitinib, and sorafenib.

Proof-of-concept has been established in preclinical models of cancer. HDC
improved delivery of SN-38 anti-cancer payload, achieving over thirty times
the concentration of this cytotoxic agent in tumor as compared to the
concentration in plasma and other tissues. Strongly enhanced anti-tumor
activity was seen with the HD-Conjugate as compared to the commonly used SN-38
prodrug, irinotecan, in a broad range of animal models of cancer, including
breast cancer, colon cancer, ovarian cancer, small cell lung cancer, bladder
cancer, and melanoma.

“We are excited by the progress we have made this past quarter both with our
ganetespib program and with our HDC program,” said Dr. Safi Bahcall, CEO,
Synta. “Our top priority is to bring ganetespib to a positive outcome in Phase
3. We are doing this by conducting the GALAXY-2 Phase 3 trial to high
standards of operational excellence, and being data-driven in our approach. I
am proud of our team and collaborators for their work in achieving this,
including the selection of the Phase 3 patient population and identifying
means to reduce the operational risks that often confound large, global
registration programs.”

Financial results

There were no revenues recognized in the third quarters of 2013 and 2012.

Research and development expenses were $17.6 million for the third quarter in
2013, compared to $11.7 million for the same period in 2012. General and
administrative expenses were $4.2 million for the third quarter in 2013,
compared to $2.8 million for the same period in 2012.

The Company reported a net loss of $22.5 million, or $0.33 per basic and
diluted share, in the third quarter of 2013, compared to a net loss of $15.0
million, or $0.25 per basic and diluted share, for the same period in 2012.

As of September 30, 2013, the Company had $53.4 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 November 4, 2013.

Guidance

Based on our current operating levels the Company expects its cash resources
of approximately $53.4 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 the remainder of 2013 and 2014
will be conducted subject to the availability of sufficient financial
resources.

Conference call

Management will host a conference call and webcast at 10:00 a.m. ET today to
discuss the third quarter 2013 financial results and provide clinical updates.

The conference call can be accessed by dialing (877) 407-8035 (U.S.) or (201)
689-8035 (International). For those unable to join the live call, a replay
will be available from 2:00 p.m. ET on November 4 through 11:59 p.m. ET on
November 11. To access the replay, please dial (877) 660-6853 (U.S.) or (201)
612-7415 (International) and refer to conference ID 100513.

The live webcast can be accessed by visiting the Investor Relations section of
the Synta Pharmaceuticals website, www.syntapharma.com. The webcast will also
be archived under Webcasts and Events within the Investor Relations section of
the Company's website.

About Ganetespib

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 trials in lung cancer, breast cancer, and
other tumor types. 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 these trials can be found at
www.clinicaltrials.gov. Ganetespib has received Fast Track designation from
FDA for second-line treatment of non-small cell lung adenocarcinoma in
combination with docetaxel.

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 Phase 2b/3 trial (GALAXY-1) to
determine the patient population most likely to derive benefit from
ganetespib, and a confirmatory Phase 3 trial (GALAXY-2). More information
about the GALAXY trials can be found at www.clinicaltrials.gov (NCT01348126
and NCT01798485).

About the ENCHANT-1 Clinical Trial

ENCHANT-1 is a proof-of-concept trial designed to evaluate single-agent
ganetespib safety and clinical activity in patients with locally advanced or
metastatic breast cancer. The trial will also evaluate the combination of
ganetespib with paclitaxel. More information about this trial can be found at
www.clinicaltrials.gov. (NCT01677455)

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 Breast Cancer

Breast cancer is the most frequent cancer in women, accounting for 458,000
deaths worldwide in 2008, according to the World Health Organization. In the
U.S., the American Cancer Society estimates that about 297,000 cases of breast
cancer will be diagnosed in 2013. Breast cancer is often characterized in the
context of three biomarkers: ER/PR positive, HER2-positive, or negative for
all three (triple-negative). Standard treatment for the first two categories
includes therapies targeting hormonal or HER2 signaling pathways. There are no
established targeted therapies for patients with triple-negative disease,
which accounts for approximately 15% of all breast cancer and is associated
with poor patient prognosis.

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, the developments and progress of our
clinical and preclinical programs, including the timing of the final analysis
of the GALAXY-1 trial, the potential for increasing the GALAXY-2 trial size
from 500 patients to 700 patients, the timing of interim and final analyses of
the GALAXY-2 trial, the timing of results from the ENCHANT-1 trial, and plans
with respect to investigator and cooperative group-sponsored trials with
ganetespib and to initiate additional combination trials with ganetespib in
specific cancer indications in 2013 and 2014, 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)
(unaudited)
                                                                                                                 
                       Three Months Ended                            Nine Months Ended
                       September 30,                                 September 30,
                      2013               2012                   2013               2012
Revenues:
Grant revenues         $ —                    $ —                    $ —                    $ 147
Operating
expenses:
Research and             17,623                 11,743                 51,879                 35,061
development
General and             4,171                2,796                12,236               8,324      
administrative
Total
operating               21,794               14,539               64,115               43,385     
expenses
Loss from                (21,794    )           (14,539    )           (64,115    )           (43,238    )
operations
Interest                (721       )          (457       )          (1,915     )          (1,429     )
expense, net
Net loss               $ (22,515    )         $ (14,996    )         $ (66,030    )         $ (44,667    )
                                                                                                                 
Basic and
diluted net            $ (0.33      )         $ (0.25      )         $ (0.96      )         $ (0.77      )
loss per
common share
Basic and
diluted
weighted
average number
of
common shares            69,047,161             60,661,720             69,024,656             58,235,263
outstanding
                                                                                                                 

                                                                  
Synta Pharmaceuticals Corp.
Condensed Consolidated Balance Sheets Data
(in thousands)
(unaudited)
                                                                             
                                      September 30,         December 31,

                                      2013                  2012
                                                                             
Assets
Cash, cash equivalents and            $    53,384           $   100,599
marketable securities
Other current assets                       1,358                786
Property, plant and                        1,488                1,174
equipment, net
Other non-current assets                  433                 458
Total assets                          $    56,663           $   103,017
                                                                             
Liabilities and Equity
Current liabilities                   $    25,931           $   23,486
Long-term liabilities                      16,120               4,465
Stockholders’ equity                      14,612              75,066
Total liabilities and
Stockholders’ equity                  $    56,663           $   103,017
                                                                             

Contact:

Synta Pharmaceuticals Corp.
George Farmer, 781-541-7213
gfarmer@syntapharma.com
or
Argot Partners
Andrea Rabney, 212-600-1494
andrea@argotpartners.com
 
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