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Executives

Michael W. Elliston – Secretary, Treasurer, Chief Accounting Officer, Controller and Chief Financial Officer

Dominick C. Colangelo – President and Chief Executive Officer

David Recker – Chief Medical Officer

Analysts

Steve G. Brozak – WBB Securities LLC

Jason Napodano – Zacks Investment Research

Jason Kolbert – Maxim Group LLC

Aastrom Biosciences, Inc. (ASTM) Q3 2013 Earnings Conference Call November 12, 2013 4:30 PM ET

Operator

Ladies and gentlemen thank you for standing by. Welcome to the Aastrom Biosciences Third Quarter 2013 Conference Call. At this time all participants are in a listen-only mode. I would also like to remind you that this call is being recorded for replay.

I would now like to turn the conference over to Aastrom’s Controller and Corporate Secretary, Michael Elliston. Please go ahead.

Michael W. Elliston

Thank you, operator, and good afternoon everybody. Welcome to the third quarter 2013 conference call to discuss our third quarter 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 date subsequent.

With us on the call today are, Nick Colangelo, Aastorm’s President and Chief Executive Officer; Dan Orlando, Chief Operating Officer; and Dr. David Recker, the Company’s Acting Chief Medical Officer.

I’ll now turn the call over to Nick.

Dominick C. Colangelo

Thank you, Mike and good afternoon everyone. During the third quarter, we’ve made significant progress on a number of fronts. From a financial perspective having successfully broader operations and expenses inline with the goals of our corporate restructuring, we executed several important initiatives to complete our financial restructuring and strengthen our balance sheet to support our development program and broader corporate objectives moving forward.

These initiatives included amending our Series B Preferred Stock agreement with Eastern Capital, which substantially increased our shareholders equity by approximately $43 million. We also completed in offering of common stock in warrants that raised gross proceeds of approximately $9 million to support our preclinical and clinical development programs. Our working capital needs and other general corporate purposes.

These events together with related initiatives completed during the third quarter allowed us to finish the quarter with approximately $5 million in stockholders equity, which positions us from the meet the NASDAQ equity standard listing requirements of $2.5 million of stockholders equity.

In addition, last month we secured shareholder approval authorizing the company to affect the reverse spilt of our common stock and we affected the reverse spilt on October 16th. The reverse spilt was designed to make our stock more attractive to a broader group of investors, improve our capital structure and increase our share price to a level that reflects the underlying value of our technology platform in therapeutic programs.

As a result of this action and as announced at the end of last month, we regain compliance with NASDAQ’s minimum bit prices listing requirements. The completion of these corporate and financial restructuring initiatives and our recent public offering and related financial actions have strengthened our balance sheet and enabled us to continue to advance our research and development programs and pursue promising strategic growth initiatives for the company.

Our goal moving forward is to leverage our existing technology platform and assets and broaden our product portfolio as we continue to advance our research programs in the clinical development of development of our lead product candidate ixmyelocel-T.

Here to provide an update on our ixmyelocel-T clinical development activities is Dr. David Recker, Dave who has served as our Chief Medical Officer for the past year has more than 20 years of experience in drug development. Most recently he advocated a global research and development where he served as Senior Vice President for Clinical Scientists. David added responsibility for planning and executing multiple development programs across a variety of therapeutic areas, many of which are resulted in successful regulatory filings and product approvals.

I’ll now turn the call over Dave.

David Recker

Thank you. Nick. We’re currently focusing the clinical development activities for ixmyelocel-T in three areas. Our lead clinical programs in the primary focus of our internal resources orphan disease program for the treatment of advanced heart failure due the ischemic dilated cardiomyopathy or DCM. The refractory ischemic DCM market clearly represents a significant commercial opportunity for ixmyelocel-T, and we have an opportunity to become the first approved product to market for the treatment of advanced heart failure due to ischemic DCM.

We continue to make good progress in Phase 2b ixCELL-DCM Study. This multi-centre randomized double blind placebo controlled Phase 2b stud is evaluating the efficacy and safety of it in patients with advanced heart failure due to ischemic DCM. With a primary end point being major adverse cardiovascular events defined as the number of all cause deaths in cardiac hospitalizations, and unplanned emergency department visits for treatment of acute worsening of heart failure over its twelve months period.

During the third quarter we submitted a clinical file application to initiate the ongoing Phase 2b excel DCM clinical trail in Canada, and I’m pleased to report that we received approval from Health Canada to proceed with the trail.

We’ve now activated approximately 25 clinical sites and we expect virtually all remaining sites to be activated in the next month or so. We also continue to engage in several important initiatives designed to support rapid execution of the study. Our recent investigator meeting for the study was very well attended and extremely positive, reflecting the strong commitment of the centers that are participating in the study. We also have the enthusiastic support of the study steering committee of internationally renowned cardiovascular and cell therapy clinical investigators with whom we continue work closely on the execution of the study.

We remain focused on the rapid execution of the study and as we have previously stated, we’re targeting a top line efficacy results from the study in mid 2013.

Second area of ongoing clinical investigation of ixmyelocel-T is in the treatment of critical limb ischemia or CLI. The most severe form of peripheral arterial disease. Our Phase 2b restore clinical study results demonstrated that ixmyelocel-T was well tolerated in that efficacious in CLI patients. Continuing to evaluate the safety and efficacy of the 40 or so patients, who enrolled in the revised study and expect to have results from the study, in the second quarter of 2014.

We also continue to evaluate the potential initiation of an investigator sponsor study of Ixmyelocel-T as an adjunct therapy to an endovascular procedure in CLI patients. This is another exciting clinical application for Ixmyelocel-T. It offers the potential to improve the lives of patients again with CLI.

The third area of ongoing clinical activity is cranial facial reconstruction, where we have studies ongoing in partnership with the University of Michigan. These studies are evaluating the use of Ixmyelocel-T treatment for patients with cranial facial defects undergoing reconstructive surgery. Results from the first of these studies were published earlier this year in cell transplantation and demonstrated that Ixmyelocel-T accelerated bone regeneration in patients with cranial facial bone defects.

These findings further highlight the potential of Ixmyelocel-T to play an important role in repairing damaged tissue in a number of clinical studies. Enrollment in the third of these studies Phase I/II trial in patients affected by cleft palate, we all hear with bone defect due to trauma, as expected due completed shortly.

Dominick C. Colangelo

Thanks Dave, as you can see we have multiple clinical initiatives underway and several important clinical milestones look forward to in the months and quarters ahead. Turning to our research programs promising preclinical results are also generating important new information about the therapeutic potential of Ixmyelocel-T.

Earlier this month results from two separate preclinical studies of Ixmyelocel-T were published in the peer-reviewed journal Stem Cell Research & Therapy, results from the first study, which is entitled Ixmyelocel-T and expanded multicellular therapy contains the unique population of M2-Like Macrophages, shows that Ixmyelocel-T contains the macrophage population categorized by the expression of multiple well known M2 macrophage markers decreased secretion of pro-inflammatory cytokines after inflammatory stimuli and efficient removal of apoptotic cells. This population of M2-Like Macrophages in Ixmyelocel-T is believed to play a key role in tissue repair and regeneration.

Results from the second study and titled Potential Beneficial Effects of Ixmyelocel-T in the Treatment of Atherosclerotic Diseases, showed that Ixmyelocel-T macrophages are able to influx modified cholesterol, remain anti-inflammatory in the face of lipid loading and inflammatory challenge, and display enhanced cholesterol efflux capabilities. This study indicates that the unique M2-Like population of macrophages found in Ixmyelocel-T is efficient at maintaining cholesterol homeostasis and represents a potential new modality in the treatment of atherosclerotic disease.

Together these results demonstrate the important role that Ixmyelocel-T may play in a repair and regeneration of damage tissue and other cardiovascular diseases. We look forward to continuing the published results from these important research programs demonstrating the therapeutic potential of Ixmyelocel-T to treat a wide variety of diseases.

As we’ve discussed our innovative technology platform generates multicellular therapies using highly automated GMP manufacturing process. This platform is unique in the industry and it has demonstrated the capability to expand multiple cell populations for therapeutic use including bone marrow mononuclear cells, hematopoietic stem cells from cord blooded bone marrow, dendritic cells and T-cells all of which have the potential to play a critical role in the treatment of serious diseases.

We believe that this platform is an extremely valuable asset that we can leverage to broaden our portfolio and support our long-term growth as such we are exploring opportunities to support the product development efforts of other cell therapy companies to various forms of collaboration and partnership.

Finally, I would like to mention that, we welcome the new Director to Aastrom during the third quarter. Heidi Hagen is a global Chief Operating Officer at Sotio LLC, a biotechnology company developing new therapies for the treatment of cancer and autoimmune diseases using its immunotherapy platform and proprietary cell-based technologies.

Heidi brings to our Board outstanding technical and managerial experience in cellular and regenerative medicine and we are confident that she will play an important role in helping to advance our business strategies and maximize the global commercial opportunities for Aastrom in the years ahead.

That concludes my update on recent activities. I will now turn the call over to Mike to review our third quarter financial results.

Michael W. Elliston

Thanks Nick. As a result of our recent stock offering and reverse split of our common stock, Aastrom now has 6.8 million fully diluted shares outstanding. Please note that our financial results for the third quarter do not reflect the impact of the reverse split of Aastrom’s common stock.

For the third quarter ended September 30, 2013, Aastrom had a net loss of $2.3 million with $0.06 per share versus $6 million or $0.17 per share for the same period in 2012. The decrease in net loss is due to non-cash exchange in the fair value of warrants and decreases in research and development and general administrative expenses.

Our loss from operations for the quarter which excludes the impact of warrants and preferred stock was $3.6 million or $0.06 per share compared to $8.3 million or $0.19 per share a year ago.

Research and development expenses for the quarter ended September 30, 2013, were $2.6 million versus $6.1 million for the same period a year ago. The decrease in R&D expense was primarily attributable to staffing enrollment in the Phase III REVIVE clinical trial, the execution of corporate restructuring that substantially reduce headcount and operating expenses and the reversal of non-cash stock compensation expenses due the forfeiture of stock options.

General and administrative expenses for the quarter ended September 30, 2013, were $1.1 million versus $2.1 million for the same period in 2012. The decrease is primarily attributable to the reduction of operating expenses resulting from the corporate restructuring and the reversal of non-cash stock compensation expense related to the forfeiture stock options.

At the end of the third quarter, Aastrom had $10.8 million in cash and cash equivalents compared to $13.6 million at the end of December 2012. Our cash used for operations of $4.1 million during the quarter was in line with our previous forecast of $4 million to $5 million. We expect our cash expense for the fourth quarter to be in the range of $4 million to $4.5 million.

That concludes my financial review. Now I will turn the call over to Nick.

Dominick C. Colangelo

Thanks Mike. As you can see from our third quarter results, we clearly have brought our expenses in line with the goals of our corporate restructuring. Let me conclude our prepared remarks by stating that we believe that the completion of our corporate and financial restructuring activities has put us in a much stronger position to continue to development of Ixmyelocel-T for the treatment of advanced heart failure due to ischemic DCM, explore other potential indications where Ixmyelocel-T may have meaningful therapeutic benefit and to pursue promising new business opportunities designed to leverage our existing assets and broaden our portfolio.

Now I’d like to ask the operator to open the call for your questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) And our first question is from Steve Brozak of WBB Securities. Your line is open.

Steve G. Brozak – WBB Securities LLC

Good afternoon, gentlemen. Obviously with everything and all the different moving, what people are probably thinking and what I’m thinking and asking is, given the size that you’ve got X number of resources and a whole bottle [ph] of different programs, what would you say your primary focus is going to be? And what would the secondary focus be in terms of partnering? And I’ll have a follow-up after that.

Dominick C. Colangelo

Well, clearly our internal focus, both for our people and our resources is on our ixCELL-DCM clinical program. We are obviously following patients in the REVIVE study and do have an opportunity to let reach external resources through investigator initiated studies for adjunct therapy in CLI patients, as well as in craniofacial reconstruction as well, but again in those cases the latter two were able to leverage external resources while we focus our internal resources on our lead program.

Steve G. Brozak – WBB Securities LLC

Okay. And using and looking at those parameters, what do you look at, what your investors expect in terms of the funding for completion? And I’ll jump back in the queue after that.

Dominick C. Colangelo

Well, as Mike mentioned, we ended the quarter with $10.8 million in cash. That takes us into about the middle of next year. Obviously we’ll raise money to continue development of the programs down the line, but we think we have a pretty healthy run rate ahead of us now and can make some strategic decisions on financing in the months ahead.

Steve G. Brozak – WBB Securities LLC

I’m sorry, but you still obviously have significant backing after the conversion. You still have your same singular investor in there. Is that correct?

Dominick C. Colangelo

Yes. So Eastern Capital, if that’s what you’re referring to, is the holder of our Series B preferred stock. And, yes, and there were an order of common stock in the company as well.

Steve G. Brozak – WBB Securities LLC

Great, okay. Thanks again, gents.

Dominick C. Colangelo

Thanks, Steve.

Operator

Thank you. Our next question is from the line of Jason Napodano of Zacks. Your line is open.

Jason Napodano – Zacks Investment Research

Hey, guys, how are you doing?

Dominick C. Colangelo

Doing great. Thanks. How are you?

Jason Napodano – Zacks Investment Research

Good. Got a little bit of a raspy voice, so I apologize for that. Just trying to get a sense of the investigator-sponsored trial as an adjunct therapy in CLI. Can you talk a little bit about that patient population? I’m I guess a little confused as to where these patients kind of would fall on that scheme of option, no option that you guys have talked about in the past.

Dominick C. Colangelo

Sure. So one of the things that Aastrom found in the original REVIVE trial was that, to surgeons no option rather is a very difficult term. Having the ability to partner with another procedure to have the surgeons perform an atherectomy or a endovascular procedure gives them the opportunity to do what they do the best in addition to benefit the patient by adding ixmyelocel-T on to that where we already know, as I’ve mentioned from RESTORE study the efficacy especially in the wound closure in this population.

Jason Napodano – Zacks Investment Research

Okay. So the patient population is kind of similar to what you were going after. With REVIVE you’ve just allowed – you think there’s going to be an additional endovascular procedure that’s going to be allowed?

Dominick C. Colangelo

Yes. Ixmyelocel-T is now being done as an adjunctive procedure, as you know, in the RESTORE and REVIVE trial to date in the patients that have CLI who have been treated it’s been the only intervention applied. So there is going to be some. It will be probably a Phase I-ish trial, collecting some efficacy data to understand primarily the safety of combining ixmyelocel-T with the endovascular procedure, but of course there will be every attempt to gain understanding of just how the combination of a procedure and ixmyelocel-T could benefit patients.

Jason Napodano – Zacks Investment Research

Got you. And then, just as far as kind of what you guys are hoping to see from those 40 patients that enrolled in REVIVE with data in the second quarter of next quarter. Obviously that’s not enough to get statistical significance, but if you got some good trends there, some trends that kind of matched up with RESTORE-CLI, what would be your next step or what would be your thought process on how to proceed, if that data comes out and it looks as good as maybe the RESTORE data look?

Dominick C. Colangelo

So I can answer. One of the differences, one of the – assuming I’ve got the rest too, we always do. Some of the data that we’re collecting that were not extensively in the REVIVE trial was healing of wounds. So patients, as you know, that are included in this trial have wounds that we are measuring and then we’ll able to demonstrate. So you’re right. There is probably not enough patients they will show statistical significance, certainly not for amputation-free survival.

Depending on how the numbers actually play out, it will be closed. We’re hoping that there will be a strong trend showing reduction in the amputations, improvement and survival and improvement in wound closure. If that’s the case and obviously the data are going to dictate where Aastrom goes, our hope is that we can fully mobilize that into a program that again would be beneficial to patients getting them not only improved survival and there actually maybe amputation, but also healing the wound.

Jason Napodano – Zacks Investment Research

Got you. Let me just add one question about ixCELL-DCM. 108 patients, I think was the goal there. Would you guys provide kind of any guidance as to where we are now or any kind of update as to where we are now in terms of number of patients?

Dominick C. Colangelo

Yes, so as we mentioned before, we choose not to give specific guidance on where the study is with respect to enrollment. For a number of reasons these kinds of trials have a lot of variability to them. That is going extremely well. As I mentioned, got up 25 sites, about 35ish sites have been targeted, 35 nova sites have been targeted for inclusion in the trial, but 25 of those are up right now.

We fully expect most of the rest of those tend to be enrolled by the end of the month. So we are quite pleased with the progress. I also mentioned that in the third quarter we were able to hold a investigator meeting there was majority of the sites – those 36 sites that have attended the meeting and again very positive response from them.

Jason Napodano – Zacks Investment Research

Got you. All right, guys. Thanks for the update.

Dominick C. Colangelo

Thank you.

Operator

(Operator Instructions) Our next question is from Jason Kolbert of Maxim. Your line is open.

Jason Kolbert – Maxim Group LLC

You’re making progress, I really have that same kind of questions that Jason and Jeff asked you which is, if you have 25 of 35 sites open and you’ve just had an investigator meeting, does that imply that you’re actually enrolling in treating patients in DCM now.

Dominick C. Colangelo

Yes.

Jason Kolbert – Maxim Group LLC

And you haven’t given us any kind of timeline in terms of how long it might take to complete this trial, but I’d like to ask that question again, and then I’d like to ask the question once the last patient is treated how long before we might see top line data and then I have really would like that effect what the entry criteria is on DCM patients and what the primary endpoint as of this trail.

Dominick C. Colangelo

Let met take that the enrollment questions, and our timeline and then Dave can answer your questions about entry criteria et cetera. So, as Dave mentioned earlier in the call we do target having top line efficacy data by mid 2015. So we’ve communicated that before, it’s a 12 month study so kind of working your way backwards, that kind of tells you where we expect enrollment to be so without giving specific numbers, our timeline for top line data remain at the same. So Dave – maybe you can ask your enrollment criteria and that point.

David Recker

Sure, and as far as, so as far as enrollment criteria go, I’ve mentioned we’re working very closely with Steering Committee of well recognized cardiovascular individuals who have extensive experience in stem cell therapy and I’ve been working to refine the protocol to allow patients who obviously have ischemic dilated cardiomyopathy so recall from early studies that was much better results seen in the ischemic sub-population of DCM then the non-ischemic. So focusing exclusively on patients with ischemic DCM.

Secondly on patients who are rather more extreme in their [indiscernible] class three then four. And then finally another criteria to again optimize the chance that we’re going to see events, this is remind you an advanced driven trial there are 108 patients that was previously that I mentioned and so in order to show any kind of difference with 108 patients, means they’ll need to have fair number of events.

In order to optimize the chance of seeing that patients can be enrolled if they had one of three additional criteria, either have been hospitalize within the past six months for exacerbation of their congestive heart failure or have a brain natriuretic peptide or proBNP a marker for congestive hear failure exacerbation greater than a pre-specified amount or having limitations in a six minute walk which is a relatively common assessment done in patients with a variety of diseases.

Having a limited six minute walk due to cardiac burden would allow these patients to enroll into the study. So patients with ischemic DCM to our New York three or four who have I forget to mention ejection fraction of less than 35% by echocardiography and who have either been hospitalized with previous six months or exacerbation of the heart failure, have a BNP or proBNP, greater than a pre-specified amount or have a six-minute walk of less than pre-specified distance.

Jason Kolbert – Maxim Group LLC

Thank you. And that’s really helpful. And on the back side, can you just what the end points or your tracking and is there a primary endpoint associated with the trial

David Recker

Yes, so the primary end point is actually a composite, it’s hospitalization for exacerbation of congestive heart failure or its our treatment evaluation and treatment of congestive heart failure. Any one of those three would qualify as an endpoint. In addition there are multiple secondary and even exploratory endpoints being looked at in the trial including improvement in six-minute walk time, improvement in New York heart classifications, improvement in ejection fraction, reduction of BNP, or change in BNP, a number of secondary endpoints that are often being looked at, but should again in totality, give us and more importantly give the cardiovascular community and better idea of exactly what’s happening to these patients.

Jason Kolbert – Maxim Group LLC

Thank you, very much and that help me understand one thing, so I can understand this is an exciting trial. I can understand that it’s a trail that could end up with pretty important informative data towards the pivotal trail, but I am a little bit nervous because even with the reverse stock split, the capital on hand is not really adequate to fund this trial all the way through to completion, Do will know that there is another financing NGR, so it’s the strategic goals that kind of get data good enough and then find a partner and remember that I am asking this in a wake of news such as Dendreon hiring banker to find a partner the autologous model is certainly in the crosshairs these days

So help me understand kind of strategically what the plan is to try to keep the Company alive and that what data will be good enough to attract a partner for set up, and then I guess another financing?

David Recker

Yes, Jason first of all the fact is Dendreon hiring a banker, Dendreon has got its own issues, and I think it’s a rather broad stroke to say that includes its all autologous cell therapy company. As you know we have very different cost of goods structure, et cetera, so that is what it is, but I don’t think its kind of indicative of all autologous therapy platforms, clearly we talked about previously a financing strategy, where we would raise funds during the summer, execute on a few financial restructuring initiatives to with all of our NASDAQ listing issues, and so on and then focused on the financing strategy for the company going forward.

So as I mentioned, we do have capital until the middle of next year, plus other resources at our disposal facilities, et cetera. And so we’ll determine our financing strategy sometime down the road. The data that will support a partnership would come out of the study clearly. These are registration quality endpoints. Clearly the two cardiac hospitalizations and mortality are provided in FDA guidance.

So this is in sort of a surrogate or secondary efficacy end point study, the one that Dave mentioned that will require some discussion with the FDA is the outpatient treatment in emergency rooms as a key decompensating heart failure. But that’s an interesting discussion to have moving forward as payors and government agencies look to limit hospitalization. So these patients may very well be treated in different settings going forward.

But the bottom line answer to your question is we absolutely believe data coming out of this study with support partnering the program, if that’s what we decide to do.

Jason Kolbert – Maxim Group LLC

Okay, thanks Dan. You’re right, it’s not fair to compare Dendreon with such a macro [indiscernible] but it is relevant at some small level. But you point is well taken. Thank you.

Daniel Orlando

Okay, well thanks Jason.

Operator

Thank you. And with that there are no further questions in queue. I’d like to turn it back to Nick Colangelo for final comments.

Dominick C. Colangelo

Well, thanks again everyone for your questions and continued interest in Aastrom and our program. As we talked about, we have several important milestones to look forward to in the months and quarters ahead, including the completion of patient enrolment in the Phase 2b ixCELL-DCM study. Completion of patient follow-up and the revised CLI study. Completion and potential launch of investigator initiated clinical studies with ixmyelocel-T and additional indication and further recording of preclinical findings that may open up new avenues of clinical investigation for our self therapy technology. So we remain excited about the opportunities ahead for the company. And I look forward to reporting on our progress with these initiatives on our next call.

That concludes our call this afternoon.

Operator

Thank you. And once again thank you ladies and gentlemen for joining today’s conference. You may now disconnect. Have a great day.

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