Tengion Provides Business Update and Reports Year-End 2010 Financial Results
Clinical Trial of Tengion Neo-Urinary Conduit™ On-Track for Implantation of Five Patients by the End of 3Q11 with Initial Follow-Up by Year-End
Neo-Kidney Augment™ Program Progressing as Expected Towards FDA Interaction by Year-End 2011
Year-End 2010 Adjusted Net Loss Reduced to $25.8 Million, or $2.80 Per Common Share, from 2009 Adjusted Net Loss of $31.7 million, or $4.99 Per Common Share
Company Forecasts that Cash on Hand Will Fund Operations through May 2012
East Norriton, PA, March 25, 2011 – Tengion, Inc. (Nasdaq: TNGN) today provided a business update and reported its financial results for the year ended December 31, 2010.
“Our Neo-Urinary Conduit clinical trial in patients with bladder cancer is advancing as expected and investigators are continuing to gather valuable insights to optimize the surgical procedure,” stated Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion. “In parallel, we continue to make great strides with our Neo-Kidney Augment program. Recent publications and presentations by our scientists have demonstrated positive and promising early preclinical data showing that the Neo-Kidney Augment stabilizes and preserves kidney function in a wide variety of animal models of kidney failure, including in diabetic animals and in large animals. Based on these findings, we are now focused on formulation and related work to support a request to meet with FDA by the end of this year regarding the path to clinical trials with this product candidate.”
Neo-Urinary Conduit Bladder Cancer Trial – Clinical Update
Tengion continues to advance the ongoing initial clinical trial of its lead product candidate, the Neo-Urinary Conduit, in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). To date, three patients have been enrolled and implanted in the ongoing clinical trial, which is on track to complete three-month clinical assessments in five patients by the end of this year.
The study is designed to provide data on the safety profile of the Neo-Urinary Conduit as an alternative to the current standard treatment, which requires the use of a patient’s own bowel tissue and can cause significant complications. The study is also intended to provide investigators with data to optimize the surgical technique and post-surgical patient care during the trial. Patients have been enrolled and implanted at both the University of Chicago Medical Center and The Johns Hopkins Hospital. The Company plans to provide its next enrollment update on this trial with its next quarterly financial report.
The following information was filed by Tengion Inc (TNGNQ) on Friday, March 25, 2011 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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Ticker: TNGNQ CIK: 1296391 Form Type:10-K Annual Report Accession Number: 0000950159-11-000222 Submitted to the SEC: Wed Mar 30 2011 4:06:33 PM EST Accepted by the SEC: Wed Mar 30 2011 Period: Friday, December 31, 2010 Industry: Biological Products No Disgnostic Substances