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 –
“Over the past year, we have made strong progress in the development of
ganetespib, our Hsp90 inhibitor,” said Dr.
“Ganetespib represents a distinct cancer treatment paradigm – targeting
one protein, the chaperone, which simultaneously destabilizes a broad
range of oncogenic pathways,” said Dr.
“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
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
3. Participated in an End-of-Phase 2 (EOP2) meeting with the
4. Presented results at the
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
Ganetespib clinical updates
GALAXY-1
The 240 adenocarcinoma patient enrollment target for GALAXY-1 was
achieved in
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.
GALAXY-2
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
Results from an interim analysis of the GALAXY-1 trial conducted in
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 mid-2013.
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
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 Development.
Fourth quarter and full year 2012 financial results
There were no revenues in the fourth quarter in 2012 compared to total
revenue of
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
Conference call
Management will conduct a conference call at
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
About
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 clinicaltrials.gov.
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 www.clinicaltrials.gov (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 as AKT, ALK, BCR-ABL, BRAF, EGFR, FLT3, HER2, HIF-1alpha, KIT, MET, PDGFRA, 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. | ||||||||||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||||||
(unaudited) | ||||||||||||||||||||
Three Months Ended December 31, |
Twelve Months Ended December 31, |
|||||||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||||||
Revenues: | ||||||||||||||||||||
License and milestone revenue | $ | — | $ | 3,302 | $ | — | $ | 6,731 | ||||||||||||
Grant revenue | — | 121 | 147 | 853 | ||||||||||||||||
Total revenues | — | 3,423 | 147 | 7,584 | ||||||||||||||||
Operating expenses: | ||||||||||||||||||||
Research and development | 14,351 | 10,859 | 49,412 | 41,464 | ||||||||||||||||
General and administrative | 3,352 | 2,803 | 11,676 | 11,552 | ||||||||||||||||
Total operating expenses | 17,703 | 13,662 | 61,088 | 53,016 | ||||||||||||||||
Loss from operations | (17,703 | ) | (10,239 | ) | (60,941 | ) | (45,432 | ) | ||||||||||||
Interest expense, net | (420 | ) | (504 | ) | (1,849 | ) | (1,948 | ) | ||||||||||||
Net loss | $ | (18,123 | ) | $ | (10,743 | ) | $ | (62,790 | ) | $ | (47,380 | ) | ||||||||
Basic and diluted net loss per common share | $ | (0.29 | ) | $ | (0.22 | ) | $ | (1.06 | ) | $ | (1.00 | ) | ||||||||
Basic and diluted weighted average number of |
62,914,546 | 49,426,806 | 59,411,476 | 47,197,572 |
Synta Pharmaceuticals Corp. Condensed Consolidated Balance Sheets Data (in thousands) (unaudited) |
||||||||||
December 31, 2012 | December 31, 2011 | |||||||||
Assets | ||||||||||
Cash, cash equivalents and marketable securities |
$ | 100,599 | $ | 39,725 | ||||||
Other current assets | 786 | 561 | ||||||||
Property, plant and equipment, net | 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
Stockholders’ equity |
$ | 103,017 | $ | 42,324 | ||||||
Source:
Synta Pharmaceuticals Corp.
George Farmer, 781-541-7213