Athersys Inc (ATHX) 2011 Q2 法說會逐字稿

Good afternoon. My name is Melissa, and I will be your conference operator today. At this time I would like to welcome everyone to the Athersys Second Quarter 2011 Financial Results Call. (Operator Instructions) Ms. Lisa Wilson, you may begin your conference.

Thank you, and good afternoon, everyone. I am Lisa Wilson of In-Site Communications and Investor Relations for Athersys. Thank you for joining today's call. You should have a copy of the press release issued at the close of market. If you have not received it, the release is available on the Athersys website at athersys.com, or you may call Libby Abelt at 212-759-5665, and it will be sent to you immediately.

Gil Van Bokkelen, Chairman and Chief Executive Officer, and B.J. Lehmann, President and Chief Operating Officer of Athersys, will host today's call. The call is expected to last approximately 45 minutes and may also be accessed through the Company's website at athersys.com. A replay will be available two hours after the call's completion, and access information is in today's press release.

Any remarks that Athersys may make about future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Company's Form 10-Q, 10-K, and other public SEC filings.

Athersys anticipates that subsequent events and developments may cause its outlook to change. And while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

For the benefit of those who may be listening to the replay, this call was held and recorded on August 10, 2011. Since then, Athersys may have made announcements related to the topics discussed, so please reference the Company's most recent press releases and SEC filings. With that, I would like to turn the call over to B.J. Lehmann. B.J.?

Thanks, Lisa. Good afternoon, and welcome to the Athersys second-quarter 2011 earnings call. I am B.J. Lehmann, President and Chief Operating Officer at Athersys. I will briefly review our financial results for the second quarter ended June 30, 2011, and then I will turn the call over to Gil Van Bokkelen, Chairman and CEO, for a corporate update.

In the second quarter of 2011, we recorded revenues of approximately $2.4 million compared to $1.9 million for the same period in 2010. Our revenues consist of contract revenue related to the provision of services to and the amortization of license fees and other payments from our business collaborators, and grant revenue from public and private entities which fund certain of our research and development projects.

Contract revenue increased $621,000 for this period, which largely reflects the impact of our collaboration with RTI Biologics to develop an orthopedic allograft product. This increase was partially offset by a decrease in grant revenue of $57,000 during the period.

Our research and development expenses for the second quarter increased to $4.4 million compared to $3.4 million for the same period last year. The increase reflects a $637,000 increase in clinical and preclinical development costs, and increases in personnel cost, sponsor research, other research and development expenses, and patent legal fees, which were partially offset by a decrease in stock-based compensation expense.

The increase in clinical and preclinical development costs for this period related primarily to increased manufacturing and process development costs related to ongoing and planned MultiStem clinical trials.

Our clinical development costs are reflected net of the $175,000 cost-share amount from our collaboration to develop MultiStem for acute myocardial infarction. We expect our research and development expenses to increase for the remainder of the year due to increased MultiStem clinical trial and clinical manufacturing activities.

General and administrative expenses for the second quarter of 2011 decreased to $1.4 million compared to $1.5 million in the second quarter of 2010. We expect our general and administrative expenses to continue at similar levels for the remainder of 2011.

Our net loss was $3.2 million, or $0.14 per share in the second quarter of 2011, compared to $3.1 million, or $0.16 per share in the second quarter of 2010.

For the six months ended June 30, 2011, we used $6.1 million in cash, and ended the period with $20.9 million in cash, cash equivalents and available for sale securities at June 30, 2011. With that, I'd like to turn it over to Gil for a corporate update. Gil?

Thanks, B.J. Good afternoon, everyone, and thank you for joining our call today. In the second quarter of 2011, we continued to make solid progress in the development of MultiStem, our patented and proprietary stem cell product candidate. We are exploring its therapeutic potential in three primary areas -- cardiovascular disease, specific neurological conditions, and certain inflammatory and immune disorders.

We have established multiple programs in each of these therapeutic areas, several of which are in clinical development. Some of these programs are partnered, and we are currently developing others independently.

Our strategy is to advance key opportunities into and through clinical development while we continue to evaluate and advance additional applications both internally and through collaborations.

Currently, our most advanced clinical program involves administration of MultiStem for the treatment of inflammatory bowel disease, or IBD, which affects approximately 2.4 million individuals in the US, Europe and Japan. In December 2009, we established a global collaboration with Pfizer around this program, and Pfizer is now conducting a randomized, double-blind, placebo-controlled, multicenter Phase II clinical study designed to evaluate the safety and efficacy of MultiStem for the treatment of ulcerative colitis in approximately 126 patients.

While there are multiple therapies currently available to treat IBD, many patients either do not respond to these therapies or they experience only temporary benefit. We believe this is because most therapies are designed to intervene at one specific point in the disease process, which typically involves a cascade of events. This inflammatory cascade destroys healthy tissue, resulting in significant pain and discomfort for the patient, and erodes quality of life.

A hallmark feature of MultiStem is that it is capable of reducing disease-inducing inflammation and modifying immune system function in multiple ways. Enrollment in participating US sites was successfully initiated in the first quarter, and this process continued in the second quarter. In addition, progress was made in anticipation of initiating clinical sites in both Canada and Europe.

While initial clinical enrollment has been somewhat slower than originally hoped for, Pfizer has made revisions to the study design that should simplify and streamline things, and keep the study on a path to meet the objective of completing enrollment in the second half of 2012 with top-line results obtained around the end of next year.

Given that MultiStem can reduce inflammation and restore balance to the immune system in multiple ways, we believe that it may have broad relevance in treating multiple different types of inflammatory disease and immune system dysfunction, and maybe more effective than alternative approaches leading to better and more durable responses.

Progress from our other research in the area is encouraging as evidenced by the recent results from the Phase I clinical study of MultiStem for transplantation and oncology treatment support. The patients who are participating in this study have leukemia or related conditions, and have been treated with radiation or chemotherapy and a donor-derived hematopoietic stem cell transplant.

These patients are typically at significant risk for graft-versus-host disease, or GvHD, a condition in which immune cells from the transplanted tissue, such as marrow or peripheral blood, recognize the transplant recipient as foreign and mounts an immunological attack. The effects of such an attack can be debilitating or even fatal.

Additional complications may include tissue damage from the radiation and chemotherapy treatments that are conducted prior to the transplant, lack of effective engraftment, or poor regeneration of certain cell types, such as neutrophils or platelets.

Our open-label, multicenter, Phase I study is designed to evaluate the safety and maximum tolerated dose of MultiStem in single dose and repeated dose treatment arms. The primary endpoint of this study is maximum tolerated dose, evaluating dose-limiting toxicities over 30 days. The study is also evaluating other safety and clinical parameters over 100 days, including engraftment, incidents in severity of GvHD, infections, and relapse-free survival.

The clinical trial is being conducted at transplant centers in the United States and Europe. We completed the single-dose administration arm in December 2010. In this arm, patients received a low dose of MultiStem -- a single dose of MultiStem administered intravenously at either a low, medium or high dose level two days after a peripheral blood or bone marrow hematopoietic stem cell transplant.

The single dose arm included patients in three dose groups based on cells-per-kilogram body weight, and dosing escalation was determined by an independent data safety monitoring board using a continual reassessment methodology that was established in consultation with the FDA prior to the initiation of the study.

This arm enrolled 10 male and 8 female subjects ranging in age from 31 to 61 years old. There are several factors that can influence the risk profile for patients to experience GvHD. One important parameter is the nature of the donor. Transplants from unrelated donors are typically associated with a higher risk of GvHD.

In this arm of the study, 11 of the 18 patients received hematopoietic stem cell transplants from matched unrelated donors, including one donor with a slight degree of mismatch. 7 patients received a transplant from matched related donors. These patients were spread across the three dose groups.

Another important risk factor is the tissue source used to obtain cells for the transplant, which may be bone marrow-derived cells, or peripheral blood stem cells. Published clinical studies show that transplants obtained from peripheral blood are associated with a meaningfully higher risk of GvHD. In this arm of the study, 16 grafts were obtained from peripheral blood and 2 were obtained from bone marrow. So, overall, the patients enrolled in this arm of the study were in a higher risk category.

In May we reported results for this arm of the clinical trial. The data demonstrated that MultiStem was well tolerated at all dose levels and also suggests that the product may reduce the incidence of severe GvHD as compared to historical clinical experience.

Highlights from the single dose administration arm include the following. There were no observations of infusional or product-related toxicities over 30 days following treatment, and no product-related serious adverse events over 100 days following treatment. Successful engraftment occurred in all 18 subjects, averaging 15 days for matched unrelated donor transplants, and 14 days for matched related donor transplants.

There were no primary or secondary hematopoietic stem cell transplant graft failures through day 100, and engraftment rates of specific clinically relevant cell populations such as neutrophils and platelets appeared to improve relative to historical experience.

Overall, there was a low cumulative incidence of acute GvHD over the 100-day observation period for all subjects enrolled, approximately half of what might be expected for this type of high risk patient group based on historical experience. In the high-dose group, there were no cases of severe GvHD, and only one case of moderate GvHD which was subsequently resolved with treatment.

Other clinical parameters, such as relapse-free survival and infections were meaningfully better or in line with expectations for this patient population based on historical data. For example, relapse-free survival at 100 days was 88% for MultiStem-treated patients, which compares favorably with the historical clinical experience of approximately 70% in similar patients.

These clinical results suggested a single dose of MultiStem can have a significant and durable effect on immune system function. The results also add to the growing foundation of safety data for MultiStem. We believe the data also suggests the potential for using MultiStem to treat other immunological disorders, including complications associated with solid organ transplantation and other conditions that remain areas of significant clinical need. Each of these represents substantial commercial opportunities.

Looking ahead, enrollment in the repeated dose administration portion of this study is well underway, and we continue to expect enrollment in this arm will be complete in 2011. Patients in this arm receive additional doses at weekly intervals for up to one month following the transplant, and as with the single dose arm, there is further assessment of patients up to 100 days. We anticipate completing enrollment of the study sometime in the third quarter and having additional top-line results around the end of this year.

Moving on to our cardiovascular program, positive results from the analysis of one year follow-up data from our Phase I clinical trial of MultiStem administered to individuals following acute myocardial infarction, or AMI, more commonly referred to as a heart attack, were presented at the Eighth International Symposium on Stem Cell Therapy in Cardiovascular Innovations in Madrid in June. Despite treatment advances over the past several decades, heart disease represents a significant burden on healthcare systems around the world and it remains the leading cause of death and a significant cause of disability.

In a recent study published by the American Heart Association in February of this year, the AHA points out that we are currently spending approximately $273 billion per year on direct costs associated with heart disease. Furthermore, given the aging and increasingly obese population, this number is expected to roughly triple to an estimated $818 billion per year by 2030. This analysis dramatically underscores the urgent need for more effective and more cost-effective forms of therapy. It also reinforces the point that this is not only a significant clinical need, it's a huge commercial opportunity.

Many people believe that the field of cell therapy and regenerative medicine can transform cardiovascular healthcare as we know it, leading to better clinical outcomes while also enhancing patient quality of life and significantly reducing costs. This cost reduction could be achieved by improving patient recovery and reducing the need for extended hospitalizations and institutional care.

Even modest improvement in various measures of heart function, such as left ventricular ejection fraction and other parameters, has been shown to correlate with better clinical outcomes and improve survival in heart attack patients, and could reduce the odds of eventual progression to congestive heart failure.

The Phase I clinical trial that we conducted was an open-label, multi-center, dose-escalation trial, evaluating the safety of a single administration of MultiStem following an AMI. All patients in the study received standard of care, or percutaneous coronary intervention, also referred to as PCI, which consists of balloon angioplasty and stenting, the standard treatment for heart attack patients.

The study included patients of three MultiStem treatment cohorts and a registry group, where patients received only PCI. Treated patients received MultiStem delivered via a catheter near the region of injury two to five days following PCI. 19 treated and 6 registry subjects participated in the study.

To evaluate heart function, echocardiogram data were collected per protocol over 12 months, blinded and evaluated at a central facility. Analysis of the one-year follow-up data suggests the trends observed at four months post-treatment, which indicated a benefit in heart function from treatment with MultiStem, were continued through 12 months post-treatment.

The mean left ventricular ejection fraction of the treated patients was substantially higher at 12 months than at baseline, with an increase of 11.3% or 4.9 absolute percentage points from baseline over the 12-month period for all patients that received treatment with MultiStem relative to the registry group. This compared to an increase of just 3.2%, or 1.3 absolute percentage points for the registry group.

Looking at two additional parameters of heart function, stroke volume and wall motion, in MultiStem treated patients, mean stroke volume and wall motion improved by 24.3% and 10.2%, respectively, from baseline over the 12-month period. Whereas, registry patients improved only 7.7% and 5.8% over the period. In addition to the substantial improvements over baseline, treated patients also improved from the four-month evaluation.

We announced prior to the initiation of the trial that we were especially focused on the potential impact of MultiStem on patients that exhibited significantly compromised heart function at the time of treatment. Among those patients with more severe heart attacks, as reflected by a left ventricular ejection fraction, or LVEF, of less than or equal to 45%, where 12-month data were available, the MultiStem-treated patients demonstrated a 19.9% improvement in mean LVEF over the period compared to only 6.2% for the registry patients.

Treated patients showed a statistically significant improvement in mean stroke volume relative to baseline with a 27.7% improvement and a p value of less than 0.01, compared to a 4.5% improvement for the registry group.

Mean wall motion improved 11.9% for the treatment group, while improving by only 3.6% in the registry group.

Analysis of data from Holter monitoring in the first month also demonstrated a trend for lower incidence of tachycardia in the treated patients compared to the registry patients, which narrowly missed statistical significance, at a p-value of 0.07. And no significant difference in arrhythmias between the groups.

Taken together, the data strongly suggests that MultiStem therapy could provide a meaningful improvement in heart function to heart attack patients and supports the advancement of the program to the next stage of clinical development.

In anticipation of initiating a Phase II study later this year, we conducted an end of Phase I meeting with the FDA in the second quarter, selected a qualified CRO to help us design and execute the trial, and we believe we are on track to initiate an approximately 150-patient, double-blind, placebo-controlled trial that will be conducted with leading cardiovascular treatment centers in the US. We intend to initiate this trial in the fourth quarter.

Turning to the neurological area, we continued to make progress in multiple programs in the second quarter. Most importantly, we are on track to conduct an extensive clinical evaluation of safety and efficacy of administration of MultiStem in patients that have suffered ischemic stroke, a condition affecting approximately 2 million people annually in the US, Europe and Japan. In the US alone, this represents an annual economic impact of approximately $73 billion a year, a number that the American Heart Association projects will increase dramatically in the years ahead.

We believe the clinical and commercial opportunity for treating ischemic stroke is enormous. Specifically, we believe that the development of a safe and effective therapy that could meaningfully improve clinical outcomes for patients that have suffered the debilitating effects of a stroke represents a potential market worth more than $15 billion annually.

By executing a well designed, rigorously conducted Phase II study, we believe we will have taken an important step forward both in terms of establishing initial clinical proof of concept and toward achieving commercial validation for an opportunity that could result in substantial value creation for our shareholders.

We intend to initiate a double-blind, placebo-controlled, multicenter Phase II clinical study in this indication, which we intend to begin around the end of the current quarter. This study is designed to evaluate safety and therapeutic effectiveness of MultiStem in patients that have suffered an ischemic stroke, and will involve approximately 136 patients. The study will be conducted at leading stroke centers here in the US.

We look forward to continuing to evaluate the potential utility of MultiStem in these and other indications in the cardiovascular, neurological and inflammatory and immune disease areas, as well as other potential applications. We also continue to actively assess which of our 5-HT2C receptor agonist compounds to advance to further development while exploring potential partnering opportunities in multiple areas.

We are engaged in discussions with potential partners around various programs, and we are confident that by continuing to cultivate multiple opportunities in parallel, we will be in the best possible position to create substantial shareholder value.

Finally, the past few days have seen tremendous market turbulence and loss of value. Like many of our peer companies, our stock price has been negatively impacted, and we have seen a substantial loss in share price and shareholder value. We have witnessed this type of market activity before, and while we cannot control the global market uncertainty or its short-term impact, we can continue to focus on advancing our programs in a carefully managed, cost-effective way.

We believe that our stock is substantially undervalued and represents a compelling investment opportunity, and we are committed to creating substantial long-term value for our shareholders. With that, we welcome your questions.

(Operator Instructions) Your first question comes from the line of Steve Brozak from WBB Securities. Your line is now open.

Hey. Good afternoon, gentlemen. I should say congratulations, because candidly you are making progress on your clinical programs, and that's more than a lot of large pharmaceutical companies can claim. In that last sentence you said, you basically said something that really stirred my interest. The parallel processing of your different programs, could you basically give us what we would expect to be in items 1, 2, and 3 over the next 12 months, what kind of results you would say in significance for what you would expect the shareholders to see of Athersys? And then I've got a follow-up question after that.

Well, I think over the next 12 to 18 months, I guess, I would expect progress in several important areas. First off, as I mentioned, we're on track to initiate a couple of additional clinical studies in some important areas, in AMI and then also in ischemic stroke, both of which will happen over the course of the next couple of quarters.

We also intend to complete enrollment. We are literally down to the last patients in the GvHD multidose study, so we expect to complete enrollment here near term for that, and then be on track to announce additional clinical data for that program before the end of the year. So, those are some important near-term events.

Next year, obviously, we intend to continue the progress in terms of getting these studies up and running and then advance them, but then also have data from the Pfizer IBD study towards the end of the year. So, on the clinical front, I think those are some of the near-term events that people should be watching out for.

As I mentioned, we are also very active on the business development front right now. I think there has been some recent activity over the past few months where people have seen some companies that are making significant strategic bets in the area of regenerative medicine. There is the Cephalon Mesoblast deal, which was announced at the end of last year and was followed up, actually, by some fairly promising data in a cardiovascular study that Mesoblast was running, that I think bodes well not just for them, but for companies that are focused on trying to treat cardiovascular disease using these types of approaches.

So, I think that we expect to make additional progress not only in our current partnerships, but also from additional relationships that we are actively evaluating. The nice thing about having a portfolio-based approach is that it gives us multiple opportunities to explore with potential partners. So, I think those are really some of the key areas that people should be focused on.

Okay. And I will actually talk about your portfolio in the last question and I'll hop back in the queue. Most people have been used to expect a pill a day or palliative treatment. Your approach is one where you're actually talking about restoration of function, and even though you have gone over and you have been exploring repeated dosing, your idea is to basically get a restoration of functionality, which candidly no one has ever seen before.

So, is that something that obviously more and more people are shifting towards, and more of your business partners are looking at saying instead of the old pharmaceutical model, you now have a new model that basically says you're focused on the restoration of functionality in a once or possibly a couple of doses. But the reality is you would actually go out there and break what is currently this model that is just unsustainable. Is that an accurate way of depiction?

Yes. No, I think that's exactly right. I mean, there's a couple of key points there. First off, from the clinical data that we've generated thus far, which have both involved single-dose administration of MultiStem, we have generated what we believe are some pretty compelling signals of therapeutic improvement and effectiveness. I mean, obviously these studies were not designed to show that; they were designed to show a consistent safety profile or determine the overall safety profile, and we saw a very consistent safety profile from the data that we generated.

But I think that the point you raise about addressing symptoms versus actually being able to stimulate repair and healing in a more effective way is a critical point, and it's critical for two reasons. One, not only could it have a substantial impact on enhancing clinical outcomes and improving patient quality of life, but it could also have a very substantial effect on healthcare cost effectiveness.

Some of the indications that we are currently pursuing and other indications that are at an earlier stage of development but which we're actively exploring through our broad network of collaborative relationships have a huge cost burden associated with them. Stroke is a really good example.

So, you mentioned palliative care. Only about 5% of the patients that have suffered an ischemic stroke actually get to the doctor in time to get treated with TPA, and 95% of the patients that have suffered an ischemic stroke are basically getting palliative care. And by administering MultiStem, potentially with a much more significant time window in what could be a substantial majority of the patients that have suffered an ischemic stroke, if we can actually demonstrate more effective healing and recovery in those types of patients, not only would it lead to much better clinical outcomes and enhance patient quality of life, but it could also substantially reduce the long-term institutional care costs that frankly have an enormous impact on our healthcare system. And you can make similar arguments for some of the other indications that we're going after.

Now, the interesting thing is, everybody recognizes, obviously healthcare, there is a lot of debate going on in Washington in terms of what to do about the healthcare system. But I think there is a deep appreciation in Washington -- I spend some of my time, actually, in Washington, talking with policymakers in my role as chairman of the Alliance for Regenerative Medicine. And I think there is widespread recognition that we have to think about healthcare both in terms of increasing clinical outcomes, but also how can we bend the cost curve in the right direction?

And with a therapy like MultiStem and frankly with the approaches that are being taken in regenerative medicine, I think they realize that for the first time we may be able to address some of these indications which represent huge cost burdens that are likely to just mushroom in the years ahead in ways that not only improve the landscape in terms of treatment, but also could really shift the cost curve in the right direction.

And so I believe that one of the keys to the long-term challenges that are facing our healthcare system really relate to achieving those types of objectives. And I think policymakers are becoming more aware of what the potential impact might be. And, of course, that creates an enormous commercial opportunity for us.

Now, the last point I'll make is, I think that the big pharmaceutical companies also recognize that the landscape has changed, and you have to think about the economics of some of these product development opportunities both in the context of what they can achieve, but also whether or not you can make a compelling pharmacoeconomic argument that shows that you can actually deliver it in a cost-effective way. And that is where, frankly, I think our strong suit is going to be over time, because I think we are going to be able to make that argument in a very, very decisive and compelling way.

Well, again, congratulations, gentlemen. I know it's a bleak day out there, but you are a singular bright spot, so I look forward to hearing the good news over the next 12 to 18 months. Thank you. I'll hop back in the queue.

Thanks, Steve.

Your next question comes from the line of Lauren Migliore from Morningstar. Your line is now open.

Hi. Thanks for taking the question. It looks like the firm ended second quarter with just over $20 million in cash. Can you give us a little more detail on how long of a financial runway that provides, especially as you prepare to launch two new Phase II trials for stroke? And, also, how does this impact the Company's willingness to find a larger partner for wholly-owned candidates?

I'll address that question. Yes, we ended up with over $20 million in cash at the end of the second quarter. I think as I noted, our burn for the first six months was roughly in the $6 million range. Our costs are going to increase a bit with the start of the new clinical development activities. We haven't provided specific guidance as to our cash runway, but we feel that we're in a good cash position. We'll have adequate cash to get launched with our clinical development activities run effectively next year. And, as Gil said, I think we'll have opportunities to bring additional cash into the Company, be it through business partnerships or potentially the capital markets over time.

Bottom line is, we feel like we're in a relatively good position from a cash perspective and we've got the Company operating efficiently and against a plan that gives us maximum runway.

Thanks.

(Operator Instructions) Your next question comes from the line of Julian Berger from University of Chicago. Your line is now open. Julian Berger, your line is open.

Hello? Hi. Congratulations on all your recent successes. I just had one question regarding your collaboration with Angiotech, and given their recent financial distress, do you think that this will in any way slow down the progression of you pursuing AMI as an indication? And is there any possibility of you retrieving that indication in its totality, commercial rights to it?

I'm sorry?

That is, commercial rights to it.

Yes. So, first off, Angiotech has been a faithful and committed partner. I know that they're very excited about the cardiovascular program. They have undergone some financial restructuring, as you noted, but they are actually through that process now, and I think they have emerged from it in better footing than they were when they actually went into the process a few months ago.

I think I can safely say that Angiotech senses that this could actually be a game-changing opportunity in terms of cardiovascular medicine, and it's an area that they know a lot about, meaning cardiovascular medicine. So, they have been a faithful and committed partner. I think their enthusiasm for this program is very high and, frankly, I expect us to be able to advance forward together with this program in a way that will generate some additional exciting results as we complete the Phase II study.

I think that, again, their having gone through their restructuring process now and having emerged from that puts them in a much better position to move forward.

That's great. That's great to hear. And the follow-up question to that is, given Angiotech's background in catheters, do you believe that there is any possibility for a commercial alliance associating MultiStem with a specific catheter or lumen type? And has there been any indication that this could be advantageous to the application of MultiStem in MI?

Well, we have actually license rights to a catheter-based delivery system that we used in the Phase I study in AMI. It's possible as we look at other cardiovascular clinical indications that we might explore additional delivery systems. It might be more relevant for certain indications and less relevant for other indications.

But I think that one of the nice things about MultiStem is we have actually explored -- in fact, in preclinical studies in pigs, we conducted studies with several different delivery systems and showed that these approaches were consistently safe and that they were each compatible with delivery of MultiStem.

And it's known with certain other cell types that have different physical properties that that's not the case with some of these other cell types, that certain catheter-based delivery systems are not compatible with those cell types.

So, we believe we actually have multiple different options in terms of how we deliver MultiStem. We believe that will create flexibility in terms of exploring some of these other cardiovascular or clinical indications that we are interested in, such as congestive heart failure and other indications in the vascular disease or cardiovascular area.

So, I think we've got good flexibility there. Certainly, Angiotech brings a lot of knowledge and experience to the table in terms of the overall landscape of devices and various options that might be explored.

All right. Thank you very much, and congratulations on all your recent success.

Thanks.

There are no further questions at this time. I turn the call back over for any closing remarks.

Well, just in closing, again, I know it's been a really chaotic past few days, in particular, in the market, and going back over the past week and a half or so. Not much we can do about that, but we are still extremely excited about where we're at and where we're headed. We think we're on a path to deliver compelling proof-of-concept data, and we think that in achieving that, that we're going to be able to create substantial value for our shareholders.

So, we continue to be focused on operating efficiently, making sure that we maintain a variety of different options so that we can continue to advance the Company and our programs in an efficient and effective manner, and we look forward to doing so and keeping you updated as we continue to make progress. So, thanks, everyone, for your time today.

This concludes today's conference call. You may now disconnect.