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Tengion Reports Fourth Quarter and Full Year 2013 Financial Results

WINSTON-SALEM, NC, March 26, 2014
-- Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today reported its financial results for the fourth quarter and full year ended December 31, 2013 and provided a business update.

“We made important progress on our two lead clinical programs over the last year. We now have two Phase 1 clinical trials ongoing for the Neo-Kidney Augment, one in Sweden and the other recently initiated in the U.S. to implant up to 12 patients. We have already successfully implanted five patients in the Sweden trial, and recently received regulatory approval to enroll 10 additional patients in that trial. We believe that the momentum in clinical development of the Neo-Kidney Augment is a testament to the tremendous need for this product candidate for patients suffering from chronic kidney disease,” commented John L. Miclot, President and Chief Executive Officer of Tengion. “We are also pleased to announce the completion of enrollment in the ongoing Phase 1 clinical trial for the Neo-Urinary Conduit. We believe that the Neo-Urinary Conduit offers significant improvements over the current standard of care for bladder cancer patients undergoing cystectomy, and we look forward to engaging key opinion leaders and the FDA for guidance on our plans for further development of this product candidate during this year.”

Neo-Kidney Augment™ Program Update

Tengion is currently conducting Phase 1 clinical trials for the Neo-Kidney Augment in Sweden and the U.S. The Neo-Kidney Augment is being developed to prevent or delay the need for dialysis by increasing renal function in patients with advanced chronic kidney disease (CKD). The Neo-Kidney Augment is based on the Company’s proprietary technology, which uses tubular epithelial cells procured by a cortical biopsy of the patient’s kidney, to create an injectable product candidate that can catalyze the regeneration of functional kidney tissue.

Both trials are designed to evaluate the safety and implantation of the Neo-Kidney Augment and involve delivery of an active regenerative dose of Neo-Kidney Augment in patients with CKD who will be followed for up to two years.

The Phase 1 clinical trial at the Karolinska Institute in Stockholm, Sweden commenced in May 2013, and five patients with CKD were implanted in 2013. To date, the Neo-Kidney Augment has been safe and well tolerated in these five patients. In March 2014, the Company received regulatory approval from the Medical Products Agency (MPA) to expand enrollment in this trial to a total of 15 patients.

In January 2014, Tengion announced the initiation of a Phase 1 clinical trial in the U.S. The Company expects to enroll up to 12 patients and anticipates that it will complete patient enrollment during 2014.


The following information was filed by Tengion Inc (TNGNQ) on Thursday, March 27, 2014 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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