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Aastrom Biosciences, Inc. (ASTM)

Q2 2008 Earnings Call

February 8, 2008 9:00 am ET


Ms. Kris Maly - Director of Investor Relations

George Dunbar - Chief Executive Officer

Gerald Brennan - Chief Financial Officer

Elmar Burchardt - Vice President of Medical Affairs


Ren Benjamin - Rodman and Renshaw

Jose Horeska - Merrill Lynch

Amy Stevens - Susquehanna Financial Advisors

Aaron Lindberg - William Smith & Company

Scott Smith



Greetings ladies and gentlemen, and welcome to the Aastrom Biosciences Second Quarter Fiscal Year 2008 Investor Conference Call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instruction). As a remainder this conference is being recorded. It is now my pleasure to introduce your moderator Ms. Kris Maly, Director of Investor Relations at Aastrom. Thank you Kris Maly you may begin.

Ms. Kris Maly - Director of Investor Relations

Thank you, Avert. Good morning and welcome to our conference call. Before we continue it’s important that you review our Safe Harbor statement. This conference call and webcast contain forward-looking statements including without limitation statements concerning clinical trails, plans and expectations, clinical activity timing, intended product development and commercialization objective, adequacy of existing capitals of core operations reflect by time, future capital needs and potential advantages and applications of tissue repair cell technology all of which involves certain risks and uncertainties.

These and other significant factors are discussed in greater detail in Aastrom's annual report on Form 10-K and other filings with the SEC. Actual results may differ significantly from the expectations contained in these forward-looking statements.

Now it is my pleasure to turn our call over to our CEO, George Dunbar.

George Dunbar �� Chief Executive Officer

Good morning everyone and thanks Kris. Thank you very much for participating on our call today. This morning we will briefly highlight Aastrom's clinical progress since our last quarterly call and we'll review our second quarter financial highlights. Then we'll open the call up to questions from the audience.

First let me make a comment about the fact that Aastrom's stock has been trending below $1 a share for the last several months. I'm personally frustrated and I'm sure some of you are as well feel strongly that our stock price doesn't reflect our achievements during the last year and half.

We have successfully met all of our clinical milestones in a timely fashion, demonstrated safety and shown promising signs of efficacy in our vascular and bone indications and we intend to continue meeting our milestones during 2008.

With regard to our clinical milestones for cardiac regeneration, we recently reported the first patient treatment using cardiac repair cells, what we call CRC manufactured using our TRC technology. The patient who was treated with compassionate use in Europe suffered from dilated cardiomyopathy, a severe chronic heart disease. This represents a significant clinical milestone for Aastrom.

The compassionate use of CRC is ongoing and we expect to report clinical data from these cases during 2008. Dr. Burchardt will provide more information on the cardiac regeneration program and the rest of our programs during the clinical update section of the call.

In addition to beginning our cardiac regeneration program, we also continue to recruit patients in our US Restore-CLI Phase II B clinical trial to treat critical limb ischemia or CLI. We currently have 15 clinical sites initiated and we'll update our website as sites open up for patient enrollment.

If you are interested in learning more, we invite you to visit the clinical trials website at This website has been developed to provide more information on CLI, the most severe form of peripheral vascular disease and how Aastrom's vascular repair cells are being clinically evaluated in the treatment of these patients.

Likewise our US ON-CORE Phase III clinical trial to treat osteonecrosis of the femoral head is actively recruiting patients. Currently five clinical sites have been initiated and we'll update our website as sites open for patient enrollment.

If you would like more information on osteonecrosis and Aastrom's clinical evaluation of BRC, bone repair cells in the treatment of osteonecrosis, please visit the clinical trial site at

I'll now turn the call over to Gerry Brennan, our CFO for review of the second quarter financial highlights.

Gerald Brennan – Chief Financial Officer

Thank you, George. We ended our second quarter on December 31st, 2007 with approximately $31.2 million in cash, cash equivalents and short-term investments compared to 28.3 million at June 30th 2007. This increase is due in part to a registered direct offering of our common shares for net cash proceeds of 12.5 million which was completed in October 2007.

Our projected average cash utilization is $1.8 million per month for fiscal year 2008. These projections are consistent with our current clinical plans and announced clinical milestones.

Total revenues for the quarter ended December 31st, 2007 consisting of brand funding and limited profit sales were $84,000 compared to $158,000 for the same period in 2007. As a result of the continued expansion of research and development activities to support regulatory submissions and ongoing plant tissue regeneration, clinical trials, and activities in the US and EU.

Research and development expenses for the quarter ended December 31st, 2007, increased to 3.9 million from 2.6 million for the same period in fiscal year 2007. We also reported that this increase was in part offset by a decrease in our Selling, General and Administrative expenses for the quarter ended December 31, 2007 to 1.7 million from 2.3 million for the same period in fiscal year 2007.

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