ASTM

Aastrom Biosciences, Inc. (ASTM)

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Aastrom Biosciences (ASTM)

Q4 2012 Earnings Call

March 18, 2013 4:30 pm ET

Executives

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

Dominick C. Colangelo - Chief Executive Officer and President

Dan Orlando - Chief Commercial Officer

Analysts

Jason Kolbert - Maxim Group LLC, Research Division

Boris Peaker - Oppenheimer & Co. Inc., Research Division

Megan McCloskey - MLV & Co LLC, Research Division

Stephen G. Brozak - WBB Securities, LLC, Research Division

Chad J. Messer - Needham & Company, LLC, Research Division

Jason N. Butler - JMP Securities LLC, Research Division

Jason Napodano - Zacks Investment Research Inc.

Presentation

Operator

Ladies and gentlemen, thank you for standing by. Welcome to Aastrom Biosciences Fourth Quarter 2012 Conference Call. [Operator Instructions] I would also like to remind you that today's call is being recorded for replay. I will now turn the conference call over to Brian Gibson, Aastrom's Vice President of Finance.

Brian D. Gibson

Thank you, Jonathan, and good afternoon, everyone. Welcome to our Fourth Quarter 2012 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 of 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 are Aastrom's President and Chief Executive Officer, Nick Colangelo; and our Chief Commercial Officer, Dan Orlando. Following our prepared remarks, we will open the call to your questions.

And I would now turn the call over to Nick.

Dominick C. Colangelo

Thank you, Brian, and good afternoon, everyone. Given that this is my first conference call as Aastrom's President and CEO, I'd like to begin with a few comments regarding the exceptional opportunities that I see for Aastrom, the current challenges we face and my near-term priorities.

As you might imagine, I did a significant amount of due diligence on Aastrom before joining the company. It quickly became apparent to me that Aastrom's multicell therapy, ixmyelocel-T, is a highly differentiated product with unique biological activities that promote tissue repair and enormous therapeutic potential to treat severe ischemic cardiovascular diseases. It also is evident that ixmyelocel-T has potential therapeutic application in additional disease indications, which is a very exciting prospect. Aastrom has developed world-class manufacturing technology, which is highly scalable to meet future product demand and can be utilized to develop additional cell therapy products.

Finally, Aastrom is working with many of the world's leading cardiologists who are extremely enthusiastic about the clinical potential of ixmyelocel-T. It was clear to me that there is a substantial unmet medical need in commercial opportunity for Aastrom's products and that Aastrom's patient-specific cell therapy business model is a robust one.

These attributes are a testament to the vision and hard work of my predecessors and new colleagues who have created a very powerful therapeutic platform, a highly promising clinical pipeline and an extremely exciting company. My goals are to build on their achievements by accelerating the clinical development and commercialization of ixmyelocel-T, and ultimately, to broaden Aastrom's product portfolio by applying our technology platform to new areas of unmet medical need. All of these goals are achievable but they will take some time to accomplish.

My near-term priorities are to enhance the execution of our current clinical studies and to address the capital needs of the company. As you know, we're currently evaluating ixmyelocel-T in 2 severe cardiovascular diseases, critical limb ischemia and ischemic dilated cardiomyopathy. The patients in these clinical trials are in urgent need of new treatment alternatives. I'm pleased to announce that we are scheduled to enroll our first patients in the ixCELL-DCM trial within the next couple of weeks.

As Dan will describe, we've expanded the target number of clinical sites in the study, momentum is picking up nicely, and we expect to complete enrollment of this study within a year. With respect to the REVIVE-CLI study, one of my immediate priorities is to enhance the enrollment trajectory of this study. The initial startup in enrollment phase has been slower than anticipated, and we've not yet hit an inflection point in study enrollment. However, as Dan will describe in a moment, we're in the process of implementing new strategies and initiatives to drive enrollment. Over the coming weeks, I'll be thoroughly evaluating study enrollment to date, working closely with our clinical team insights to assess the impact of new enrollment initiatives and working to identify and implement additional initiatives to improve the pace of enrollment. Upon completion of this assessment, we will then be in a position to provide an update on the overall study timelines.

While we're not satisfied with the pace of our clinical activity to date, I'm confident that the studies are well designed, that they're being conducted to the highest industry standards and that the recently implemented initiatives will improve enrollment rates going forward. Importantly, these clinical trials have the potential to change the standard of care in severe ischemic cardiovascular diseases, which ultimately will drive value for patients, the medical community and our investors.

My second year term priority is to address the capital needs of the company. I've already spoken with many of you about our need to raise additional capital in the near future through financing and/or partnering activities. Of course, our financing and partnering strategies are interrelated. While I cannot provide specifics on the possible timing of either of these efforts at this time, I can assure you that we're actively engaged in several initiatives and focused on financing the company in a manner that serves the best interest of our shareholders and the company. In the meantime, we'll continue to manage our resources carefully and execute our programs as efficiently as possible.

Read the rest of this transcript for free on seekingalpha.com