Phase 2 trials initiated for STA-9090 in colon and gastric cancers
LEXINGTON, Mass.--(BUSINESS WIRE)-- Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today reported financial results for the quarter ended March 31, 2010.
“Synta has made significant progress this year in advancing our lead oncology programs, as well as strengthening our financial position,” said Safi R. Bahcall, Ph.D., President and Chief Executive Officer of Synta. “Two investigator-sponsored trials of STA-9090, one in colon cancer and one in gastric cancer, have been recently initiated at leading cancer centers. Results from our two Phase 1 solid tumor studies of STA-9090 were accepted for presentation at the annual meeting of the American Society for Clinical Oncology in June. Our Phase 2 trials in AML, NSCLC, and GIST have been enrolling well. And the public offering of common stock we completed in January has provided us with a cash runway into 2012. Going forward, we remain on track to receive preliminary results from the ongoing Phase 2 trials in the second half of the year, as well as meet our goal of six to ten new trials for STA-9090 initiated in 2010.”
“We are encouraged by the high level of interest in STA-9090 among investigators,” said Vojo Vukovic, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Synta. “We believe this reflects the strong preclinical and encouraging early clinical results with STA-9090, as well as the broad therapeutic potential for a potent Hsp90 inhibitor with a favorable safety profile.”
The Phase 2 colon cancer trial will be conducted at Memorial Sloan-Kettering Cancer Center in New York and will enroll up to 33 patients with metastatic colon cancer or rectal cancer. The Phase 2 gastric cancer trial will be conducted at Massachusetts General Hospital in Boston, MA, and will enroll up to 41 patients with gastric, esophageal, or gastroesophageal cancers. In both trials, patients will be administered STA-9090 on a once-weekly schedule.
In the first quarter, Synta also announced that clinical development of elesclomol is expected to resume in the second half of 2010. Twelve month overall survival (OS) results from the Phase 3 SYMMETRY trial for elesclomol in metastatic melanoma will be presented in a poster at the ASCO meeting. The Company expects to initiate a clinical trial of elesclomol in acute myeloid leukemia later in the year.
Total collaboration revenue was $4.0 million for the first quarter in 2010 compared to net collaboration revenue of $4.5 million for the same period in 2009. The Company reported a net loss of $9.3 million or $0.24 per basic and diluted share for the first quarter in 2010, compared to a net loss of $23.5 million, or $0.69 per basic and diluted share for the same period in 2009.
Research and development expenses were $10.2 million for the first quarter in 2010 compared to $22.6 million for the same period in 2009. General and administrative expenses were $3.1 million for the first quarter in 2010 compared to $4.1 million for the same period in 2009.
In January 2010, the Company raised $26.7 million of net proceeds from the sale of its common stock in an underwritten public offering. As of March 31, 2010, the Company had $57.9 million in cash and cash equivalents compared to $44.2 million in cash and cash equivalents as of December 31, 2009.
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 on May 4, 2010.
Based on our current operating levels, we estimate our cash resources inclusive of proceeds from our January 2010 public offering, together with expected research and development reimbursements and milestone payments in connection with certain preclinical and clinical achievements under our collaborative license agreement with Roche, will be sufficient to fund the Company’s operations into 2012.
Synta continues to target at least one partnership for one or more of its unpartnered assets in 2010.
Management will conduct a conference call at 10:00 a.m. (ET) this morning to review the Company's first-quarter 2010 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. For those unable to join the live conference call, a replay will be available from 2:00 p.m. (ET) today through midnight (ET) on May 11. To access the replay, dial (877) 660-6853 or (201) 612-7415 and refer to both account number 286 and conference ID 348550. The webcast also will be archived on the Company's website.
STA-9090 is a potent, synthetic, small-molecule Hsp90 inhibitor, with a chemical structure unrelated to the first-generation, ansamycin family of Hsp90 inhibitors (e.g., 17-AAG or IPI-504). In preclinical studies, STA-9090 has shown potency up to 100 times greater than the first-generation Hsp90 inhibitors as well as activity against a wider range of kinases. In in vitro and in vivo models, STA-9090 has shown potent activity against a wide range of cancer types, including lung, prostate, colon, breast, gastric, pancreatic, melanoma and certain hematologic cancers - as well as potent activity against cancers resistant to imatinib (Gleevec®), sunitinib (Sutent®), erlotinib (Tarceva®), and dasatinib (Sprycel®).
Hsp90 is a chaperone protein required for the proper folding and activation of other cellular proteins, particularly kinases. Many of these “client proteins” of Hsp90 – such as AKT, BCR-ABL, BRAF, KIT, MET, EGFR, FLT3, HER2, PDGFRA, VEGFR – have been shown to be critical to cancer cell growth, proliferation, and survival and 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. Because mutated kinases which no longer respond to treatment with kinase inhibitors remain dependent on Hsp90 for their activity, inhibiting Hsp90 offers the potential for treating cancers that have become resistant to targeted therapies such as kinase inhibitors.
About Colorectal Cancer
Approximately 106,000 cases of colon cancer and 41,000 cases of rectal cancer were diagnosed in the United States in 2009, and an estimated 50,000 Americans died of the disease, according to the American Cancer Society. Excluding skin cancers, colorectal cancer is the third most common cancer found in men and women in the United States. The five year survival for patients with advanced metastatic disease is less than 11%.
About Esophagogastric Cancer
According to the American Cancer Society, there are close to 40,000 new cases of esophageal or gastric cancer diagnosed in the United States annually, leading to approximately 25,000 deaths. The five-year survival rate for patients with advanced metastatic disease is less than 5%.
Elesclomol induces programmed cell death (apoptosis) in cancer cells by disrupting cancer cell energy production and metabolism. In laboratory studies, elesclomol has been observed to increase the level of reactive oxygen species in cancer cells beyond sustainable levels, triggering the mitochondrial apoptosis pathway. This mechanism of action represents a novel way of selectively targeting and killing cancer cells.
About Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow that can progress quickly if not treated. It is the most common acute leukemia affecting adults. The American Cancer Society estimates that in 2009 approximately 12,810 new cases of AML will be diagnosed in the United States leading to approximately 9,000 deaths.
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 timing, developments and progress of our clinical and preclinical programs, and the sufficiency of our cash reserves, 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, 2009 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 March 31,
|License and milestone revenue||$||1,143||$||4,073|
|Cost sharing reimbursements, net||2,880||437|
|Total collaboration revenues||4,023||4,510|
|Research and development||$||10,195||$||22,639|
|General and administrative||3,086||4,070|
|Total operating expenses||13,281||27,945|
|Loss from operations||(9,258||)||(23,435||)|
|Other (expense) income:|
|Other (expense) income, net||(50||)||(64||)|
|Basic and diluted net loss per common share||$||(0.24||)||$||(0.69||)|
|Basic and diluted weighted average number of common shares outstanding||39,451,592||33,872,016|
Synta Pharmaceuticals Corp.
Condensed Consolidated Balance Sheets Data
March 31, 2010
December 31, 2009
|Cash and cash equivalents||$||57,917||$||44,155|
|Other current assets||1,011||419|
|Property and equipment, net||3,463||3,978|
|Other non-current assets||151||358|
|Liabilities and Stockholders’ Equity|
|Total liabilities and
Synta Pharmaceuticals Corp.
Rob Kloppenburg, 781-541-7125
KEYWORDS: United States North America Massachusetts
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical General Health