WINSTON-SALEM, N.C., March 26, 2012/PRNewswire/ -- Tengion, Inc. (NASDAQ: TNGN), a leader in regenerative medicine, today reported its financial results for the year ended December 31, 2011 and provided a business and clinical update detailed in a separate press release issued today, in which the Company reported that it has made significant advances in its two lead programs.
"We have made significant progress advancing our Neo-Urinary Conduit and Neo-Kidney Augment programs and I believe we have created strong momentum to build upon as we continue to execute on our aggressive development goals in 2012," stated John L. Miclot, President and Chief Executive Officer of Tengion. "A fourth patient has now been enrolled and implanted in our Neo-Urinary Conduit clinical trial and we have submitted a pre-Investigational New Drug filing to FDA for our Neo-Kidney Augment one quarter ahead of schedule."
Financial Update
For the year ended December 31, 2011, the Company reported an adjusted net loss of $24.4 million, or $1.13 per basic and diluted common share, compared with an adjusted net loss of $25.8 million, or $2.80 per basic and diluted common share, for the same period in 2010.
The decreased adjusted net loss for the 2011 period was primarily due to a decrease in interest expense of $1.2 million resulting from lower average debt balances outstanding in 2011, and a decrease in depreciation expense of $1.7 million resulting from both a change in the estimated useful life of leasehold improvements at the Company's leased facility in Winston-Salem, North Carolina and the impairment of the Company's leased facility in East Norriton, Pennsylvania. These decreases were offset in part by increased general and administrative expense of $1.2 million related to restructuring charges incurred during 2011 and an increase in research and development expense of $0.4 million primarily due to increased preclinical study costs associated with the Company's Neo-Kidney Augment program. The adjusted net loss per basic and diluted common share for the year ended December 31, 2011 was significantly affected by the issuance of common stock in connection with equity financings completed in April 2010 and March 2011.
For the quarter ended December 31, 2011, the Company reported an adjusted net loss of $6.2 million, or $0.26 per basic and diluted common share, compared with an adjusted net loss of $5.9 million, or $0.48 per basic and diluted common share, for the same period in 2010.
The increased adjusted net loss for the 2011 period was primarily due to an increase in research and development expense of $1.0 million related to preclinical studies associated with the Company's Neo-Kidney Augment program. In addition, general and administrative expense also increased $0.3 million primarily due to a restructuring charge. These increases were offset in part by a decrease in depreciation expense of $1.0 million related to a change in the estimated useful life of leasehold improvements at the Company's leased facility in Winston-Salem, North Carolina and the impairment of the property and equipment at the Company's leased facility in East Norriton, Pennsylvania. The adjusted net loss per basic and diluted common share for the fourth quarter ended December 31, 2011 was significantly affected by the issuance of common stock in connection with the equity financing completed in March 2011.
As of December 31, 2011, the Company held $15.3 million in cash, cash equivalents, and short-term investments. Based upon the Company's currently expected level of operating expenditures and debt repayments, the Company expects to be able to fund its operations to September 2012.
Recent Clinical Advancements
In a separate release issued today, the Company reported that it has made significant clinical advances in its two lead programs, as follows:
- Neo-Urinary Conduit. Tengion enrolled a fourth patient in its ongoing initial clinical trial of its lead product candidate, the Neo-Urinary Conduit, which is being evaluated in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). The Company plans to discuss with the Data Safety Monitoring Board a reduction in the timelines between future patient implants. If granted and assuming appropriate safety data, the Company anticipates that it will complete implantation of up to 10 patients by the end of 2012.
- Neo-Kidney Augment. The Company submitted a pre-IND filing to the U.S. Food and Drug Administration (FDA) for its lead preclinical program, the Neo-Kidney Augment, which is intended to prevent or delay the need for dialysis or kidney transplant in patients with advanced chronic kidney disease (CKD). Following the submission, Tengion's Board of Directors has authorized the Company to aggressively pursue the development of its Neo-Kidney Augment program. Tengion has scheduled a meeting with the FDA to discuss the Company's proposed GLP animal study program to support an IND filing. The Company expects to provide an update on its expectations for the clinical trial program in its first quarter 2012 financial results announcement in May.
Conference Call and Webcast
John L. Miclot, President and Chief Executive Officer, Brian Davis, Chief Financial Officer and Vice President of Finance, and Dr. Tim Bertram, Chief Scientific Officer and President of Research and Development, will host a conference call today, March 26, 2012, at 5:00 p.m. EDT to provide a business update and discuss the Company's full year 2011 financial results.
The call can be accessed by dialing 1-800-638-4930 (domestic) or 1-617-614-3944 (international) five minutes prior to the start time and providing the access code 34844557. The conference call can be accessed from the Investors section of the Company's website or directly at http://edge.media-server.com/m/p/o4v89uyi/lan/en. The webcast will also be archived on the website.
About Tengion
Tengion, a clinical-stage regenerative medicine company, is focused on discovering, developing, manufacturing and commercializing a range of neo-organs, or products composed of living cells, with or without synthetic or natural materials, implanted or injected into the body to engraft into, regenerate, or replace a damaged tissue or organ. Using its Organ Regeneration Platform, the Company creates neo-organs using a patient's own cells, or autologous cells. Tengion's proprietary product candidates harness the intrinsic regenerative pathways of the body to regenerate a range of native-like organs and tissues. The Company's product candidates are intended to delay or eliminate the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications. An initial clinical trial is ongoing for the Company's lead product candidate, the Neo-Urinary Conduit, an autologous implant that is intended to catalyze regeneration of native-like bladder tissue for bladder cancer patients requiring a urinary diversion following bladder removal. The Company's lead preclinical candidate is the Neo-Kidney Augment, which is designed to prevent or delay dialysis by increasing renal function in patients with advanced chronic kidney disease. Tengion has worldwide rights to its product candidates.
