Tengion, Inc. (TNGN)
Q1 2011 Earnings Call Transcript
May 12, 2011 08.30 a.m. ET
Dr. Brian Davis - CFO
Dr. Steven Nichtberger - President and CEO
Dr. Sunita Sheth - Chief Medical Officer
Dr. Tim Bertram - Chief Scientific Officer
Josh Schimmer - Lerink
Ted Tenthoff - Piper Jaffray
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Welcome to the first quarter 2011 Tengion Incorporated Earnings Conference call. My name is Ann, and I will be your coordinator for today’s’ call.
At this time all participants are in a listen-only mode. (Operator Instruction). We will be facilitating a question and answer session following the presentation.
I would now like to turn the presentation over to Mr. Brian Davis, Chief Financial Officer. Please proceed sir.
Welcome everyone and thank you for joining us today on our first quarter earnings call. This morning we issued a press release that provides a business update as well as details of our financial results for the first quarter ended March 31, 2011. The press release is available on our website at www.tengion.com.
I would like to remind that certain statements made in today’s call constitute forward-looking statement within the meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are based on management’s current beliefs and expectations concerning future events and are subject to change. All forward-looking statement involves risks and uncertainties that could cause the company’s actual results to differ materially than currently expected.
You should refer to the risk factors section of the company’s periodic reports filed with the SEC for a discussion of these risks and uncertainties. The risk factors set fort risks regarding our product candidates, clinical trials, financial position, intellectual property and regulatory matters.
With me on today’s call is Dr. Steven Nichtberger, our President and Chief Executive Officer. He will begin by providing a corporate and product development update, and then I will summarize our first quarter financial results. We’ll then wrap up the call by taking your questions.
Dr. Sunita Sheth, our Chief Medical Officer and Dr. Tim Bertram, our Chief Scientific Officer are also on the call to participate in the Q&A session.
With that I will now turn the call over to Steven.
I would like to focus my initial comments on the clinical trial of Neo-Urinary Conduit, a lead clinical product candidate. Tengion is currently conducting an initial clinical trial of its lead product candidate in the Neo-Urinary Conduit. We are using bladder cancer patients requiring urinary diversion following bladder removal or cystectomy.
This trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit, as well as to allow the clinical investigators to optimize the surgical procedure and post-surgical care by incorporating the outcomes observed in each patients in to the surgical technique for subsequent patients as necessary.
To date, three patients have been enrolled and implanted in the trial. Clinical investigators have been surgical modifications in an effort to address conduit patency and vascular supply.
Based on clinical observations and complications to date, including events within the last week, the company is extending its objective of reaching interim data in five patients in to 2012.
The company intends to provide an updated clinical timeline after a full assessment of the clinical data and plans for subsequent patient implants with investigators, the data safety monitoring committee, and the FDA.
Now let me turn to our lead preclinical program, the Neo-Kidney Augment, which is intended to prevent or delay the need for dialysis for kidney transplant by improving kidney function and increasing functional kidney mass in cases with advanced chronic kidney disease.
Patients with end stage renal disease or (ESRD) have chronic kidney disease that has progressed to a point of little to no kidney function. These patients require dialysis or a kidney transplant to survive.
According to the US Renal Data System, the ESRD patients cost Medicare more than $27 billion annually. ESRD is associated with a 20% annual mortality rate.
Tengion scientists have published and presented positive data on the effect of our approach on kidney function in four different preclinical models of CKD. Two of these preclinical models have been conducted for a sufficiently long period of time to demonstrate an impact on survival.
Building on these results, Tengion is actively engaged in the next step in product development, defining product formulation and administration. The data that our scientists have reported from our Neo-Kidney Augment program has attracted the attention of a number of [thought] leaders.
We are pleased during the first quarter to announce the addition of two individuals, Dr. Ben Humphreys and Dr. Giuseppe Remuzzi to our research and development advisory panel.
Dr. Ben Humphreys is an assistant professor of medicine at Harvard Medical School and principal faculty member of the Harvard Stem Cell Institute and Co-Director of the Harvard Stem Cell Institute Kidney program.
Dr. Giuseppe Remuzzi is the Head of Nephrology and Dialysis and Chairman of the Department of Transplantation at Bergamo Hospital and head of the Negri Bergamo Laboratories, which is devoted to the study of renal disease and a center that he has directed since 1984.
As a recognized leader in the field of kidney regeneration, Dr. Remuzzi recently authored a review article in the prestigious medical journal, The Lancet, on the field of kidney regeneration.
Both of these leaders are working with us to advance our Neo-Kidney Augment and in particular as stated by Dr. Remuzzi to help us identify the most rapid and efficient pathways to clinical trials.