Synta Reports Fourth Quarter and Year-End 2013 Financial Results and Provides Corporate Update
Announces GALAXY-2 Clinical Trial Amendment and Updates Timeline
to Data Readout
GALAXY-2 DMC Recommends Continuation
of Study with No Change Following First Planned Safety Analysis
Ganetespib
Now Included in Six Large, Randomized Clinical Trials
“The team at Synta has made important progress with its two lead
programs, ganetespib and the HDC platform,” said
Recent Updates
- GALAXY-2 Clinical Trial Amendment and Updated Timeline to Data Readout. Synta announced today that based on an evolving standard of care and regulatory feedback, it is amending the Company’s pivotal, Phase 3 GALAXY-2 trial of ganetespib and docetaxel vs. docetaxel alone for the 2nd line treatment of patients with NSCLC adenocarcinoma. This trial is being amended to strengthen the provision for testing patients for ALK translocations and EGFR mutations from “strongly encouraged” to “mandatory.” Only those patients whose tumors test negative for both ALK and EGFR status (double-negative) will be enrolled.
To ensure that there are at least 700 patients with ALK, EGFR double-negative status, the trial size has been increased from an anticipated 700 patients to 850 patients. Tumor tissue from patients who were enrolled prior to mandatory testing will be evaluated to establish double negative status and inclusion in the primary analysis population. At this study size, the GALAXY-2 trial has an 87% power to detect a 25% reduction in risk of death (hazard ratio of 0.75) at the time of the final overall survival analysis. Based on the study amendments and current projections, Synta expects the two interim efficacy analyses of GALAXY-2 to be conducted by the independent Data Monitoring Committee (DMC) in the second half of 2015 and the final analysis to be conducted in the first half of 2016.
The Company also announced that the independent DMC for the GALAXY-2 trial, which periodically reviews safety data from the trial, has recommended continuing the trial with no change to study conduct following recent completion of its first such planned safety analysis.
- Ganetespib Selected for I-SPY 2 Breast Cancer Trial. The Company, along with QuantumLeap Healthcare Collaborative, today announced that ganetespib has been selected for study in the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2). I-SPY 2 is a standing Phase 2 randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (Stage 2 or higher) that is designed to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neo-adjuvant setting (prior to surgery). Enrollment in the ganetespib arm of I-SPY 2 is expected to begin in 2014. Ganetespib will initially be available to patients with HER2 negative disease, with the intent to expand its eligibility to all biomarker subtypes after safety testing with trastuzumab is completed.
-
Ganetespib Selected for the AML-LI-1, AML-18 and AML-19 Trials
in AML/MDS. In
January 2014 , the Company announced the initiation of three multicenter, randomized trials, supported by theLeukemia & Lymphoma Research Fund andCancer Research UK , evaluating ganetespib in combination with chemotherapy in first-line treatment of patients with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS). The trials are being conducted under the auspices of theUK National Cancer Research Institute Hematological Oncology Study Group , and under the sponsorship ofCardiff University . Among the studies, the AML-LI (less intensive)-1 trial, which is currently ongoing, evaluates the combination of ganetespib with low dose cytarabine (Ara-C) vs. low dose Ara-C alone in patients who are not eligible for intensive chemotherapy and are traditionally not included in most trials. Up to 50 patients are being enrolled in the ganetespib arm, after which an interim analysis will be conducted to evaluate the potential of proceeding into a potentially registration-enabling extension. This interim analysis is expected to be conducted in mid-2014. -
Ganetespib Selected for the GANNET53 Trial in Ovarian Cancer. In
January 2014 , the Company announced the initiation of GANNET53, a Seventh Framework Programme (FP7) research project funded by theEuropean Commission , which is a pan-European randomized trial designed to evaluate the combination of ganetespib and paclitaxel vs. paclitaxel alone in over 200 patients with metastatic, predominantly p53 mutant, platinum-resistant ovarian cancer. The study’s consortium consists of national clinical trial groups in gynecological oncology and high-volume university centers as well as noted p53 scientists and three innovative small and medium sized companies (SMEs). The safety lead-in Phase 1 portion of GANNET53 is expected to begin enrollment in mid-2014. -
Presented Preclinical Results for Hsp90 Inhibitor Drug
Conjugates (HDC). In February and March of 2014, Synta
reported on progress with lead compounds from its Hsp90-Inhibitor Drug
Conjugate platform at the IASLC 14th Annual Targeted
Therapies of the Treatment of Lung Cancer Meeting and the 12th
International Congress on Targeted Anticancer Therapies . The new compounds, consisting of an Hsp90-inhibitor conjugated with SN-38 (HDC SN-38) and an Hsp90-inhibitor conjugated with docetaxel (HDC docetaxel), demonstrated proof of principle in multiple preclinical cancer models. Notably, complete or near complete regressions of tumors were observed in models of NSCLC, small-cell lung cancer, breast cancer, pancreatic cancer, colon cancer, and skin cancer, including models that are generally resistant or show limited response to treatment with the unconjugated therapies.
Fourth quarter and full year 2013 financial results
There were no revenues recognized in the fourth quarters of 2013 and
2012. There were no revenues recognized for the year ended
Research and development expenses were
General and administrative expenses were
The Company reported a net loss of
As of
More detailed financial information and analysis may be found in the
Company's Annual Report on Form 10-K, which was filed with the
Guidance
Based on our current operating levels the Company expects its cash
resources of approximately
Synta Pharmaceuticals Corp. |
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Condensed Consolidated Statements of Operations |
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(in thousands, except share and per share amounts) |
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(unaudited) |
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Three Months Ended |
Twelve Months Ended |
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2013 | 2012 | 2013 | 2012 | |||||||||||||
Revenues: | ||||||||||||||||
Grant revenues |
$ | — | $ | — | $ | — | $ | 147 | ||||||||
Operating expenses: |
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Research and development | 19,981 | 14,351 | 71,860 | 49,412 | ||||||||||||
General and administrative |
3,463 | 3,352 | 15,699 | 11,676 | ||||||||||||
Total operating expenses |
23,444 | 17,703 | 87,559 | 61,088 | ||||||||||||
Loss from operations | (23,444 | ) | (17,703 | ) | (87,559 | ) | (60,941 | ) | ||||||||
Interest expense, net | (718 | ) | (420 | ) | (2,633 | ) | (1,849 | ) | ||||||||
Net loss | $ | (24,162 | ) | $ | (18,123 | ) | $ | (90,192 | ) | $ | (62,790 | ) | ||||
Basic and diluted net loss per common share | $ | (0.31 | ) | $ | (0.29 | ) | $ | (1.27 | ) | $ | (1.06 | ) | ||||
Basic and diluted weighted average number |
76,769,199 | 62,914,546 | 70,976,705 | 59,411,476 | ||||||||||||
Synta Pharmaceuticals Corp. |
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Condensed Consolidated Balance Sheets Data |
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(in thousands) |
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(unaudited) |
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December 31, |
December 31, |
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Assets | ||||||
Cash, cash equivalents and marketable |
$ | 91,476 | $ | 100,599 | ||
Other current assets | 765 | 786 | ||||
Property, plant and equipment, net | 1,553 | 1,174 | ||||
Other non-current assets | 1,409 | 458 | ||||
Total assets | $ | 95,203 | $ | 103,017 | ||
Liabilities and Equity | ||||||
Current liabilities | $ | 32,207 | $ | 23,486 | ||
Long-term liabilities | 13,905 | 4,465 | ||||
Stockholders’ equity | 49,091 | 75,066 | ||||
Total liabilities and |
$ |
95,203 |
$ |
103,017 |
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Conference call
Synta will host a conference call at
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
The live webcast
can be accessed by visiting the Investor
Relations section of the
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, and 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
About Hsp90-Inhibitor Drug Conjugates (HDCs)
HDCs are small-molecule drugs 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. They exploit the preferential retention of Hsp90 inhibitors in tumors to selectively deliver anti-cancer payloads. HDCs represent a promising new therapeutic class with the potential to enhance the safety and efficacy of a wide range of small molecule anti-cancer drugs.
Synta has established proof of concept for HDC lead candidates in preclinical studies and has developed over 550 compounds, using a broad range of Hsp90 inhibitor moieties, cleavable linkers, and anti-cancer payloads. The latter include cytotoxic chemotherapeutics, kinase inhibitors, hormone therapies, immunomodulators, and epigenetic modifiers, creating the potential for next-generation compounds in each of these categories. Synta has filed worldwide patent applications that include comprehensive claims covering the HDC platform, compositions of matter, methods for identifying therapeutically effective compounds, and methods of use of such compounds against a wide range of diseases and conditions.
About
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Source:
Synta Pharmaceuticals Corp.
Steven Bernitz, 781-541-7250
Senior
Vice President, Corporate Development
[email protected]
or
Argot
Partners
Andrea Rabney, 212-600-1494
[email protected]
or
Media:
Argot
Partners
Eliza Schleifstein, 917-763-8106
[email protected]