Athersys, Inc.
Q4 2016 Earnings Call Transcript

Published: 10 Mar 2017

[Operator:]

Good afternoon. My name is Angel, and I’ll be your conference operator today. At this time I would like to welcome everyone to the Athersys’ Year End 2016 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] Thank you. Laura Campbell, You may begin your conference.

[Laura Campbell:]

Thank you, and good afternoon, everyone. I’m Laura Campbell, Senior Vice President of Finance for Athersys. Thank you for joining today’s call. If you do not have a copy of the press release issued at the close of market it is available on the Athersys’ website at athersys.com, or you may call Matt Celesnik at 216-431-9900 to receive it via email. Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer; and BJ Lehmann, President and Chief Operating Officer will host today’s call. The call is expected to last approximately 30 to 45 minutes, and may also be accessed at athersys.com. A replay will be available two hours after the call’s conclusion and access information for the replay is in today’s press release. Any remarks that we 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 the forward-looking statements as a result of various important factors, including those discussed in our Forms 10-Q, 10-K and other public filings. We anticipate that subsequent events and developments may cause our outlook to change. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. For the benefit of those who may be listening to the replay, this call was held and recorded on March 9th of 2017. Since then, we may have made announcements related to the topics discussed, so please reference our most recent press releases and SEC filings. With that, I'd like to turn the call over to BJ Lehmann. BJ?

[BJ Lehmann:]

Thank you, Laura. Good afternoon and welcome everyone. I’m BJ Lehmann, President and Chief Operating Officer at Athersys. I’ll briefly review our fourth quarter and annual 2016 financial results and then turn the call over to Gil for a corporate update, followed by a question-and-answer period. For the fourth quarter of 2016, our contract revenues were $828,000 compared to $10.1 million for the same period of 2015. During the quarter, we received a $600,000 milestone payment as part of our long-standing collaboration with Bristol-Myers Squibb. The variance from year-to-year reflects the recognition of $10 million of license fee revenue related to the termination of our collaboration with Chugai Pharmaceutical in October 2015. We expect our future contract revenues to be comprised primarily of revenues associated with our collaboration with Healios in Japan, royalty payments and potential commercial milestone payments from RTI Surgical and potential proceeds from any new collaboration. Our grant revenue decreased to $155,000 in the fourth quarter of 2016 from $501,000 in the prior year's fourth quarter. Grant revenues fluctuate from period to period with the timing of grant related activities and with the award and expiration of grants. Research and development expenses increased to $7.1 million for the fourth quarter of 2016, compared to $5.3 million in the fourth quarter of 2015. The increase was primarily due to higher clinical and process development costs, which vary based on trials underway, and clinical manufacturing campaigns. General and administrative expenses were relatively consistent at $2 million in the fourth of 2016, compared to $1.8 million in the fourth quarter of the prior year. We had a net loss of the three months ended December 31, 2016 of $7.1 million, compared to net income of $3.6 million for the same period of 2015. The $10.6 million net variance results primarily from the $10 million Chugai license fee in 2015 and to a lesser extent the net impact of the variances in R&D expenses, G&A expenses and other net expenses, including the non-cash effect from the change in fair market value of our warrant liabilities. Turning to the results for the full year, our contract revenues were $16.2 million in 2016 and $10.3 million in 2015, reflecting both the $15 million license fee revenue from Healios in 2016 and $10 million license fee revenue from Chugai in 2015. Our grant revenues decreased to $1.1 million in 2016 from $1.6 million in the prior year. Research at and development expenses increased $24.8 million in 2016 from $21.3 million in 2015, due to an increase in clinical and process development costs, personnel costs, legal and professional fees, and research supplies for our internal process development research. We will continue to have same types of expenses in 2017, as we continue to advance our clinical programs and our cost may very from quarter-to-quarter based on clinical manufacturing campaigns, the timing and our stage of clinical trials underway and manufacturing process development activities. General and administrative expenses increased to $7.8 million in 2016 from $7.5 million in 2015, due primarily to increased personnel costs and other outside services. We recorded non-cash expense from the change in the fair market value of our warrant liabilities of $557,000 in 2016, compared to non-cash income of $772,000 in 2015, reflecting the impact of warrant issuances and expirations, the price and remaining lives of the warrants, and changes in our stock price. Cash used in operating activities was $10.9 million in 2016 and $13.8 million in 2015. Financing activities provided cash at $3.1 million in $2016 and $10.8 million in 2015, but variance primary related to our equity sales under our equity purchase arrangement with Aspire Capital, to a lesser extent proceeds from warrant exercises. Our net loss for 2016 was $15.3 million, compared to $16.4 million in 2015. The difference reflects the impact of a $15 million license fee from Healios in 2016 and a $10 million Chugai license fee in 2015. The decrease in grant revenues, the increase in R&D expenses, the increase in G&A expenses, the variance of non-cash expense from the fair value of warrant liabilities and a decrease in net other expenses. At December 31, 2016, we had $14.8 million in cash and cash equivalents, compared $23 million at the end of 2015. Additionally, in February 2017, we received net proceeds of $20.9 million from an underwritten public offering. With that, I'd like to turn the call over to Gil for a corporate update. Gil?

[Gil Van Bokkelen:]

Thank, BJ and good afternoon, everyone. As we've discussed on our prior earnings calls and in another public presentations, Athersys is committed to the development of innovative medicines that address substantial areas of unmet clinical need. Our clinical programs are focused on the development of practical, scalable, off the shelf for generative medicine therapies that we believe have the potential for substantially advanced the standard-of-care in the areas where we are focused. We have emphasized development of a robust, well characterized, highly standardized and simple to use product format, in the form of MultiStem, which we believe exhibits a unique combination of therapeutic properties, scalability and ease-of-use and convenient off-the-shelf format. We believe MultiStem has the potential to overcome the obstacles and issues that have prevented cell therapy from becoming a widespread and practical clinical treatment option. Over more than a decade, we conducted basic and translational research across a range of preclinical and clinical programs that have been designed to systematically evaluate the safety and potential therapeutic relevance of MultiStem. This work is included indications in the neurological, cardiovascular and inflammatory and immune areas, as well as other applications where we feel our technology be maybe relevant and where there is unmet medical need. Over the past few years, our research teams, working in collaboration with key investigators in their labs at numerous institutions across the United States and Europe have published many papers in leading peer-reviewed journal and have presented data and evidence at prominent scientific conferences and events through talks and posters. These papers and presentations illustrate how MultiStem has shown promise in important clinical areas, and also reflect our deep understanding of how MultiStem cell therapy can impact recovery in healing through multiple biological mechanisms, and the consistency of those effects across a range of indications. In the neurological field, this includes our work ischemic stroke, neonatal or prenatal hypoxic ischemic injury, traumatic brain injury, spinal cord injury and other neurological indications, as well as models of neurological damage that occur in chronic degenerative conditions, like multiple sclerosis. A recent example of his work is the new publication this week in the Journal, stem cells, that illustrates some of the pioneering preclinical studies done by researchers at the University of Texas Health Science Center, and McGovern Medical School in Houston, that was conducted in collaboration with researchers here Athersys and our European subsidiary, ReGenesys. This work further illustrates the importance of MultiStem's influence on the spleen and the brain in preclinical models of ischemic stroke. Consistent with other publications, using models of acute neurological injury and the biomarker and clinical data from our recently completed MASTERS-1 study, these results demonstrate that administration of MultiStem following the occurrence of an acute ischemic stroke has the potential to impact multiple inflammatory factored pathways, neurotrophic or neurogenic pathways, as well as other mechanisms that are important to healing and repair. It is part of the growing body of scientific evidence and mechanistic understanding that suggests MultiStem can promote more effective recovery from a stroke or other acute neurological injuries. In the cardiovascular area, we have previously conducted and published work in standardized model of acute and chronic cardiac ischemia, as well as vascular ischemic injury. This work, along with the published results from our Phase I clinical trial involving administration of MultiStem - MultiStem to patients that have suffered significant damage from an acute myocardial infarction, have provided the foundation for our current Phase II trial focused on treating patients that have suffered damage from a heart attack. In the inflammatory and immune area, we've evaluated several indications of potential interest, including working with independent investigators to assess MultiStem in models of acute pulmonary inflammation that have provided important evidence and mechanistic understanding and have led to our ongoing exploratory clinical trial in patients diagnosed with acute respiratory distress syndrome or ARDS. So perhaps most importantly, and despite the obstacles that stood in our way, we have successfully laid the foundation that has enabled us to transition from a preclinical organization to now becoming a late stage development company, with a clear leadership position in one of the most significant areas of unmet clinical need in medicine today, treating patients that have suffered the debilitating effects of an ischemic stroke. We have achieved this stage of development because unlike many other organizations that have avoided or given up on hard-to-treat indications like stroke, we have maintained a focus on the science and trust the growing body of data and evidence. Although we clearly have further work to do, this evidence is convinced us, our partner in Japan, leading scientists and clinical experts around the world and regulators that have reviewed our available data and conveyed their support of this program to the clinical authorizations and designations we have received. We believe that our technology exhibits the potential to offer up the first, safe, effective and truly practical treatment for stroke victims, in direct contrast to the currently available clinical approaches which while effective for some patients are not relevant to the vast majority of stroke victims due to the narrow time windows for treatment or other restrictions on their use. The achievement of the authorization last September of the Special Protocol Assessment, or SPA for our Phase III clinical trial design has now been reinforced by the recent designation of priority review for the program by the Ministry of Health, Labor, and Welfare in Japan, or MHLW, which was announced just a few days ago. In our view, both achievements underscore the regulatory support we have received for our stroke program in the US, Japan and elsewhere. The SPA is particularly important to our development efforts outside of Japan. It lays out a clear and efficient development path and is therefore important both from a clinical perspective and in terms of our ongoing partnering discussions around the program. To help facilitate those partnering discussions, late last year, we retained an advisory firm that specializes in partnering transactions in biopharma space and that has a long history of success in that regard. Working in conjunction with this advisory firm, we are actively engaged in discussions and diligence activities with potential partners around the stroke program. In parallel, over the past few months, we have been independently engaged in partnering activities in certain other programs where we've conducted work. Although these types of efforts require patience and a sustained effort, as we've seen in the past, we remain intensely focused on pursuing multiple partnering paths in parallel and are optimistic about the possibilities. Similarly, the designation of the MultiStem program for priority regulatory review in Japan under the recently implemented SAKIGAKE framework emphasizing innovative new medicines being developed in Japan is an important milestone, both for Healios and for us. According to a recent analyst report regarding the announcement by MHLW, four conditions must be met in order for an investigational therapy to receive priority review designation under the framework. First, the therapy must be considered innovative. Second, it must be focused on treating patients suffering from life-threatening medical conditions. Third, the program must exhibit potential for quote, extremely high efficacy, unquote. Fourth, there must be an explicit intention to develop a treatment and submit for approval in Japan, prior to other countries. According to this analyst report, since SAKIGAKE was first announced by MHLW in mid-2014 there have been a total of seven product candidates that have received priority review designation under the framework, including three medical devices and three regenerative medicine products. We congratulate Healios in the success of their efforts to obtain this priority review designation, which shortens the regulatory review cycle to as little as six months and we look forward to continuing to support their efforts with the program. Clearly there is substantial momentum and excitement about the TREASURE study in Japan. Recently, at the International Stroke Conference, Dr. Kyohiro Houkin, the lead investigator of the TREASURE study described the trials rationale, design and status. Additionally, he noted that the study is expected to be completed in the second half of 2018. There are number of factors that ultimately affect the trial timeline, including the number of sites, sites start-up timing, recruitment rates and product availability among other things, and many of these factors are outside of our control. We are focused on supporting Healios during the study, to the fullest extent possible, particularly during the commencement phase and in planning for potential commercialization. As we noted in our last earnings call in November, the PMDA authorization for the study was an important step in the process, but in reality its just one of many things that need to be accomplished when initiating a study. Over the past few months, there's been significant additional work in terms of site assessment, followed by institutional review board, or IRB, review, an approval of the study protocol, contract negotiations with each of the clinical sites, and preparation of the material for the conduct of the trial by our contract manufacturing organization partner. As we have explained previously, none of these activities happen instantaneously. And typically there are challenges in the preparation, launch and conduct of these kinds of studies, but we always work to address any issues as efficiently as possible. In any event, Healios is excited to be getting the trial in Japan underway and based on the response of the International Stroke Conference a few days ago, there is a lot of excitement about the commencement of the study. Outside of Japan, we've continued our engagement and work with the FDA and international regulators to achieve alignment regarding the design of our study. As we've explained previously, this is absolutely necessary and must be completed prior to the initiation of the trial. We have already received initial expressions of support from international regulators and are confident that we will achieve our remaining regulatory objectives over the next few months, so that we will be in a position to initiate the study later this year. In our other active clinical programs, as we have described previously, our progress has been more measured. As we have described previously, over the past few months we have made certain protocol refinements to enhance enrollment. We've added clinical sites and trained additional study investigators. Our goal remains to complete enrollment of both the Phase II AMI study and the ARDS trial as soon as possible, ideally by around the end of this year. So to summarize, our primary objectives for 2017, are as follows. First, support Healios in their conduct of the Treasure trial in Japan. Both we and Healios are committed to completing this trial as quickly and efficiently as possible. Second, complete or preparations for our MASTERS-2 trial, so that we are in a position to initiate the trial later this year. Third, continue our ongoing discussions with potential partners, related to our stroke program and other program areas where we've been actively evaluating opportunities over the past few months, so that we may implement one or more meaningful partnerships to strengthen our financial development and strategic position. Fourth, progress and complete our other active clinical programs in AMI and ARDS as quickly as possible. Finally, we will continue to focus on advancing our overall portfolio of programs and refining our capabilities so that we are prepared to achieve both clinical and commercial success for ourselves and our partners. To achieve these goals, as we have stated in the past, we must occasionally access the capital markets in order to maintain a reasonable balance sheet, which is sometimes necessary for a development stage company like Athersys. But our shareholders should recognize that prior to this most recent financing, we last raised capital in January of 2014 more than three years ago. Since that time, we have successfully executed initiatives that have meaningfully increased the non-dilutive revenue, generated from partnering other activities and that has enabled us to make the most of our available capital, while also minimizing clinical development costs. However, despite our success in building revenue through partnering initiatives and other activities over the past couple of years, our promising clinical data announced last year, and the recent significant regulatory achievements that illustrate our clear and efficient path forward, we believe our stock remains meaningfully undervalued. Accordingly, we have taken steps to address that issue. In particular late last year, we engaged both a new media relations and communications firm and a new investor relations firm. Over the past few weeks, we have been working actively with both firms to refine and implement a strategy designed to increase visibility and awareness and we are confident those efforts will be successful. Although it's worth noting that achieving the type of visibility that we believe we deserve will take time and sustained effort. In the meantime, however, we appreciate the continued loyalty and support of our shareholders and others that follow the company. We remain excited and optimistic about the future of the company and the potential of our key programs. With each milestone successfully accomplished, we come closer to our goal of establishing Athersys as the leading biopharmaceutical company and to rewarding our shareholders for their trust and patience. With that, we'd be happy to take a few questions.

[Operator:]

[Operator Instructions] Your first question comes from the line of Jason Kolbert with Maxim Group. Your line is open.

[Jason McCarthy:]

Hi, guys. It’s actually Dr. McCarthy for Jason Kolbert. Just two questions. I think you kind of briefly went over the 21st Century Cures Act. That really is my question is, you know, how does that pave a more rapid path to approval for MultiStem, given that it's shown or it's demonstrated such significant safety already, so we think that there would be an easier path forward. And my second question is, what's the status of the trial in Japan with Healios? And in particular, when will that trial be in a position to enroll the first patient, you know, remind us what the N-value is in the study and how long it could take to enroll and when we could see data? Thanks, guys.

[Gil Van Bokkelen:]

Thanks. Jason. I appreciate you joining the call today. I actually didn’t talk about 21st Century Cures during the commentary today. I have talked about it previously. The reality of it is that the SPA that we obtained last year for the ischemic stroke program is by far in a way the most relevant to our development activities here in the United States and the other parallel regulatory activities that we are engaged in with European international regulators, working off of the foundation that’s been laid by the successful achievement of the SPA. I do believe that the 21st Century Cures initiative is a very important piece of legislation that will actually create new opportunities or mechanisms for the expedited development of regenerative medicine therapy and there are specific pieces of the legislation that I and others were proud to work to be - to be part of working for and towards and ultimately we're successful in that initiative. The Alliance for Regenerative Medicine and the leadership at ARM really kind of lead the charge on that. And I think ARM is correctly regarded as being the leading advocacy group and frankly an honest broker in terms of these types of legislative issues or things that relate to creating a more efficient and effective regulatory landscape, working in collaboration with the FDA as opposed to working in an adversarial with the FDA. With regard to the other questions in terms of Japan, again, the lead investigator for the study presented at the International Stroke Conference just a few days ago, announcing the commencement of the study, we – he also announced and Healios is said, they expect to complete the study and have results in the second half of 2018. And really beyond that there's not a whole lot more that I can say at this point, other than you did ask a question about how large is the study, the study is actually 220 patients, this was actually presented at the International Stroke Conference by Dr. Houkin during his presentation, and its double-blind placebo controlled randomized study, where a 110 patients will receive treatment with MultiStem and a 110 patients will receive or approximately 110 patients will receive placebo. And it really applies the learning in the lessons, a lot of the relevant data and fundamentals that we obtained from the MASTERS-1 study, which we've talked about extensively. Obviously, I didn't review any of that data today. But it really applies to the important findings from this study. And in a particular, the execution of the study is focused on treating ischemic stroke victims within 18 to 36 hours after the stroke has occurred, which we think is a highly relevant window and frankly a highly effective window given what we've seen previously for our technology to really benefit those patients and I think that’s best evidence by the results from the MASTERS 1 study, which obviously Healios, our partner in Japan, and the clinical investigators in Japan have found very exciting.

[Jason McCarthy:]

Great. Thanks for taking the questions, Gil.

[Gil Van Bokkelen:]

Yes, absolutely. And thanks again for joining.

[Operator:]

Your next question comes from the line of Chad Messer with Needham & Co. Your line is open.

[Chad Messer:]

Great. Thanks. Good evening and thanks for taking my question. Please accept my sincere appreciation of the progress you guys have made under difficult circumstances. I believe the next actual data we're going to get is in ARDS likely. And just wondering if you could give us an idea of what you hope to see in that data, what you would consider a positive outcome?

[Gil Van Bokkelen:]

Yes. So the - interestingly the ARDS trial and the AMI trial could read out in pretty close proximity to one another. But in any event, since your question was about ARDS, this was designed as an exploratory study to assess really sick patients that have sick patients that have placed on a ventilator that have been diagnosed with acute respiratory distress syndrome. This was not designed to be a robustly powered Phase II study, it’s an exploratory Phase IIa type study. So what we will be looking for in this trial are meaningful signs and indicators that we are helping patients get better. And the evidence for that will be that the patient pulmonary function improves following treatment, that we are able or the clinicians that are attending to these patients are able to take them off the ventilator and that the patients end up spending less time in the intensive care unit. And those are really three of the most direct clinical indicators that are being evaluated in the study. Obviously, we're looking at other things in the context of the study. But those are three of the most relevant. And frankly, we are optimistic that this study is going to be successful and the reason for that optimism is some of the published data and also some of the un-published data that I've referred to previously that shows that when there is active inflammation in the lungs, that MultiStem distributes to that inflammatory pulmonary tissue and has a dramatic effect on restoring compromised pulmonary function and neutralizing that inflammatory mediated damage, which is exactly what you need to have happen when you're trying to help these patients recover, restore their one capacity and get lung function back to normal and get them off the ventilator. Furthermore, that data is what led to the significant grant award that we got to support the study. This was an intensely competitive peer-reviewed process, and the investigators and the experts in the field that reviewed it, the application all felt that this was a study that should be funded because these patients are desperately ill.

[Chad Messer:]

All right. Thank you. I appreciate that it's good to have some perspective on what we should expect. And maybe just a couple on sort of the finances as we go forward. Can you give us an update on your stock purchase agreement with Aspire, what's left on that. I assume there's been no recent activity on that. And then fourth-quarter R&D, was there anything that was kind of one-time in that? I know you guys are starting your stroke trial later in the year. Just trying to figure out whether the fourth quarter, how much I should weigh the fourth-quarter rate of spend on R&D as I look through the first part of '17?.

[BJ Lehmann:]

Yes, Chad. I can address the questions. With respect to the R&D in the fourth quarter, we've got kind of a heavy load in the manufacturing side and that we're doing lot of prep work, and support work for the Healios study. And so we can see in there, some of that manufacturing costs. We also have pretty heavy process development work underway that’s ultimately related to continuing to establish scale up manufacturing, anticipating potential needs and commercialization. You know, with respect how that plays going forward, you know, manufacturing campaigns are going to vary from quarter-to-quarter. We're pretty active in the manufacturing front over the next couple of quarters supporting the study in Japan and our own study. I think the hope is and expectation, you know, at some point we will have completed manufacturing for the studies, and that the costs related to those studies will largely be you know, the patient pass-through cost, the CRO cost et cetera. But generally, when we do clinical work, some of the manufacturing costs tend to be a little bit frontloaded with respect to our step. With respect to the other question, we do have an equity line in place with Aspire. It’s the third kind of facility we've had over the past seven or so years. We've used it you know, really to round out the balance sheet to support specific projects. We've not used it recently, so it’s not been used this year. But we do use it opportunistically and when needed to kind of support some of the activities we have ongoing. Now, we do have additional capacity on it. We have a certain number of shares that we can sell under the facility. I think all that is public. I think what we have remaining us you know, in the range of call it 13, 14, 15 million shares or so. And it’s available for us to use if needed to support our activities. So we have that as a backstop, if you will to do the things we need to do.

[Chad Messer:]

All right. Great, thank you.

[BJ Lehmann:]

Thanks, Chad. Really appreciate it.

[Operator:]

Your final question comes from the line of Tracy Marshbanks with First Analysis. Your line is open.

[Tracy Marshbanks:]

Thanks for taking the question. And a tremendous amount of work and effort starting to show up in the activities and the progress you are making. So congrats to the whole company on a very busy 2016.

[BJ Lehmann:]

Thanks, Tracy. Appreciate it.

[Tracy Marshbanks:]

Yes. Couple questions. Just a little bit related to that, you mentioned having an intermediary, if you will, start to look for partners and leading that charge. Were there specific things that you guys just didn't have the time to do? I guess this is a little bit what are they doing and what do you need to do to make them successful?

[Gil Van Bokkelen:]

Well, I mean, in part, I wouldn't say it was so much of a bandwidth issue, although I will say that we are spending a lot of time and effort on the other activities that BJ and I talked about in terms of either supporting Healios's efforts on the TREASURE trial, preparing for the International Stroke Study, managing our other operations, including our other ongoing clinical trials and a whole range of other things that we didn’t really talk about today. In terms of the decision to actually retain this firm, they have a very good track record in helping companies like us, achieve their goals and establishing high-value strategic partnerships that are important, particularly in our case for ultimately accomplishing some of our other objectives over time. And we spent a lot of time in assessing the various approaches that we could take. We knew when we got the SPA from the FDA that this was going to trigger interest among potential partners, and sure enough, it did. And the fact that we've continued to make study progress in other dimensions and other ways that I really didn’t go over today, I think is very beneficial for us in terms of accomplishing our goal of putting a high value partnership in place around this program. And as I mentioned, we are also actively evaluating program or partnering opportunities in other pogroms. And some of that work is been going on for a while. So I think that we understand that our partnering objectives are extremely important. We want to make sure we have the right for partner, that it has the right structure, the right terms obviously, the right scope. And so we felt like it was appropriate for us in this instance to be working with an intermediary like this, because of their demonstrated accomplishments and experience in helping companies like us to achieve our goals. We will not disclose who the company is, or the entity is just to protect and preserve the safety and the integrity of the ongoing process that we're actively engaged in. But as I said, I feel like we're in a very good position and we're optimistic about what our future holds. And I realize that there are people out there that are frustrated about various things and believe me they don’t hesitate to express their frustration when they have the occasion to do so. But we are doing what we feel the things that are already in the best interest of helping us accomplish our goal, of establishing Athersys as a leading biopharmaceutical company. We have a long-term vision for what we want to do and we understand that we have to do it one step at a time, one stage at a time and that’s exactly what we're focused on doing.

[Tracy Marshbanks:]

Good. On the other key activity maybe, the key activity obviously is the Healios trial. You mentioned doing everything in your power to help them and get that accomplished as quick as possible. What do you define as your sphere of really being able to help or assist? I understand maybe production manufacturing. But are there other things that are a bit in your court that you are going to have to be standing by, particularly as the trial progresses, their needs may change?

[Gil Van Bokkelen:]

Yes. Absolutely. I mean, I'll give you a good example. Not too long ago there was a meeting with PMDA, where members of our leadership team flew to Japan, were present at the meeting, actually help make a presentation and just to cover off on some specific issues, maintaining an active close relationship with PMDA, as we do with FDA and other regulators around the world, we believe is a critical part of our strategy. And frankly its one of the things that I think distinguishes us from many other organizations out there, that view regulators in an adversarial way or through an adversarial lens. And so, this is an example of members of our team flying halfway around the world to actively support what we felt was an important appropriate discussion with regulators just to make sure that everybody was on the same page. And so we engage in those types of activities, whether it’s going to Japan or doing it remotely, we want to make sure that we are thinking through with Healios and supporting their efforts to accomplish all of their goals and that encompasses multiple different dimensions. But I am very pleased to report, we have a very close relationship with Healios and the leadership team and their organization. And I think there is deep mutual respect on both sides. We know that their success is our success and they also feel like our success is their success. So I am very happy with the directness, the close working relationship, the philosophy and the implementation of that philosophy, that we have seen in both companies working together since we announced the partnership a little over a year ago. Its frankly - its working pretty much the way that I hoped it would and its reflective of what I think will be a long and very successful relationship between the two companies.

[Tracy Marshbanks:]

Thanks a lot, and congratulations.

[Gil Van Bokkelen:]

Thank you very much. I appreciate it.

[Operator:]

That’s all the time we have questions today. I will now turn the call back over to Gil Van Bokkelen.

[Gil Van Bokkelen:]

Well, just in closing, I'd like to thank everybody once again for your time and attention and for your continued support. And we will certainly provide you with updates as appropriate in our next earnings call and we look forward to doing so. Thanks again.

[Operator:]

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