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Aastrom Biosciences (ASTM)

Q2 2013 Earnings Call

August 15, 2013 4:30 pm ET


Brian D. Gibson - Principal Financial Officer, Chief Accounting Officer, Vice President of Finance, Corporate Secretary and Treasurer

Dominick C. Colangelo - Chief Executive Officer, President and Director



Good day, ladies and gentlemen, and thank you for standing by, and welcome to the Aastrom Biosciences Second Quarter 2013 Conference Call. [Operator Instructions] I would also like to remind you that today's call is being recorded for replay. I would now like to turn the call over to -- the floor over to Brian Gibson, Aastrom's Vice President of Finance. Sir, the floor is yours.

Brian D. Gibson

Great, thank you, Huey, and good afternoon, everyone. Welcome to our Second Quarter 2013 Conference Call to discuss our most recent financial results and the progress of our development programs.

Before we begin, let me remind you that on today’s call, we will be making forward-looking statements covered under the Private Securities Litigation Reform Act of 1995, and all our projections and forward-looking statements represent our judgment as of today. These statements may involve risks and uncertainties that are described more fully in our filings with the SEC, which are also available on our website. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

With us on today's call is Aastrom's President and Chief Executive Officer, Nick Colangelo; and because we're in the midst of finalizing our public offering, which closes tomorrow, we will not be holding a question-and-answer session on today's call.

I will now turn the call over to Nick.

Dominick C. Colangelo

Thank you, Brian, and good afternoon, everyone. I'd like to begin today by providing some perspectives on Aastrom's technology platform and the current development strategy for our lead product candidate, ixmyelocel-T, to highlight our progress with some of the important changes that we've instituted in recent months.

At Aastrom, we're working everyday to help people with severe chronic cardiovascular diseases realize the promise of cellular therapy. We've developed an innovative technology platform that generates patient-specific multicellular therapies using a highly automated GMP manufacturing process. This platform is unique in the industry and has demonstrated the capability to expand multiple cell populations for therapeutic use, including bone marrow mononuclear cells, hematopoietic stem cells from cord blood or bone marrow, dendritic cells and T cells, all of which have the potential to play a critical role in the treatment of serious diseases. Our lead product candidate, ixmyelocel-T, is a highly differentiated multicellular therapy. It's the only cell therapy that contains expanded populations in both mesenchymal stromal cells and alternative reactivated M2 like macrophages, 2 cell populations that are known to play a key role, both individually and collectively, in promoting tissue repair and regeneration. In our preclinical and clinical research, we've generated consistent positive data in multiple preclinical models and across a number of clinical indications, demonstrating that ixmyelocel-T is well tolerated and efficacious in treating cardiovascular and other diseases. Aastrom's technology in therapeutic platforms also are covered by a comprehensive patent estate comprised of multiple U.S. and international patents, including a composition of matter patent that protects ixmyelocel-T through 2029.

Our clinical development focus is on the treatment of severe chronic cardiovascular diseases, and we have several clinical development activities under way and expect to have a number of clinical milestones to announce over the next year. Our current clinical development programs fall into 3 areas. The first, is our orphan disease program for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy, or DCM. Earlier this year, we refocused our internal resources on this very important and promising program because it represents an area of significant unmet medical need and a highly compelling commercial opportunity for the company. We also have a potentially streamlined path to regulatory approval and commercialization of ixmyelocel-T for this orphaned indication.

DCM is a leading cause of heart failure and heart transplantation in the world today, with more than 0.25 million advanced heart failure patients in the U.S. refractory to further medical therapy, and with approximately 60% of these cases being of ischemic origin, due to atherosclerotic cardiovascular disease, the refractory ischemic DCM market clearly represents a significant commercial opportunity for ixmyelocel-T. As we've previously stated, with this clinical development program well underway, we have an opportunity to become the first approved product to market for the treatment of ischemic DCM, and we have a strong pharmacoeconomic rationale to support premium pricing based on the limited availability and high treatment cost of -- or high cost of alternative treatments, such as left ventricular assist devices and heart transplantation for these patients.

During the second quarter, we initiated enrollment and treatment of patients in the Phase IIb ixCELL-DCM study. This study is a multicenter randomized double-blind, placebo-controlled Phase IIb study to evaluate the efficacy and safety of ixmyelocel-T in patients with advanced heart failure due to ischemic DCM. The study is designed to enroll 108 patients with advanced heart failure at approximately 30 clinical sites in the U.S. and Canada, with the primary end point being major adverse cardiovascular events, also known as MACE events, which are defined as the number of all caused deaths and hospitalizations and unplanned emergency department visits for treatment of acute worsening heart failure over 12 months. We'll also be evaluating several secondary clinical, functional and symptomatic efficacy measures at 3, 6 and 12 months.

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