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 GALAXY-1 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. 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 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 population.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 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 additionIn 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 $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.Guidance 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, www.syntapharma.com, 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 www.syntapharma.com. 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. 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 December 31,||Twelve Months Ended December 31,|
|License and milestone revenue||$||—||$||3,302||$||—||$||6,731|
|Research and development||14,351||10,859||49,412||41,464|
|General and administrative||3,352||2,803||11,676||11,552|
|Total operating expenses||17,703||13,662||61,088||53,016|
|Loss from operations||(17,703||)||(10,239||)||(60,941||)||(45,432||)|
|Interest expense, net||(420||)||(504||)||(1,849||)||(1,948||)|
|Basic and diluted net loss per common share||$||(0.29||)||$||(0.22||)||$||(1.06||)||$||(1.00||)|
|Basic and diluted weighted average number of common shares outstanding||62,914,546||49,426,806||59,411,476||47,197,572|
|Synta Pharmaceuticals Corp. Condensed Consolidated Balance Sheets Data (in thousands) (unaudited)|
|December 31, 2012||December 31, 2011|
|Cash, cash equivalents and marketable securities||$||100,599||$||39,725|
|Other current assets||786||561|
|Property, plant and equipment, net||1,174||1,407|
|Other non-current assets||458||631|
|Liabilities and Equity|
|Total liabilities and Stockholders’ equity||$||103,017||$||42,324|