Athersys Inc (ATHX) 2015 Q3 法說會逐字稿

Good afternoon. My name is Jennifer, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Athersys Third Quarter 2015 Earnings Call. (Operator instructions.) Thank you. I now would like to turn the call over to Athersys.

Thank you. Good afternoon, everyone. I'm Laura Campbell, 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 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 SEC 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 November 5, 2015. Since then we may have made announcements related to the topics discussed, so please refer to our most recent press releases and SEC filings.

With that, I would like to turn the call over to BJ Lehmann. BJ?

Thank you, Laura. Good afternoon, and welcome, everyone. I'm BJ Lehmann, President and Chief Operating Officer at Athersys. I'll briefly review our third quarter 2015 financial results, and then turn the call over to Gil for a corporate update, followed by a question and answer period.

For the third quarter of 2015, revenues were $396,000 compared to $293,000 for the same period in 2014, and are comprised of grant revenues and royalties from our collaboration with RTI Surgical. In October, in connection with the recently announced license termination, we will recognize in full the $10 million upfront cash payment received from Chugai Pharmaceuticals.

Research and development expenses were $5.1 million in the third quarter of 2015 compared to $5.8 million in the prior year third quarter. The difference reflects decreases in clinical and preclinical development costs, sponsored research, personnel costs, research supplies, and travel costs.

General and administrative expenses increased to $1.9 million in the third quarter of 2015 compared to $1.7 million in the same period in 2014. The increase was due to an increase in professional fees and consulting costs. The change in the fair value of our warrant liabilities resulted in income of $255,000 in the third quarter of 2015 compared to income of $2.5 million in the comparable 2014 period, reflecting primarily the impact of changes in our share price.

Net loss for the third quarter of 2015 was $6.5 million compared to net loss of $4.7 million for the third quarter of 2014. The increase in net loss reflects a $600,000 reduction in loss from operations as offset by $2.3 million decrease in non-cash income from our warrant liability valuation when comparing the two periods.

It's worth noting that our reported net loss of $6.5 million for this quarter includes $400,000 of net non-cash expense comprised of $255,000 non-cash income related to the change in fair value of our warrant liabilities, and non-cash expense of approximately $700,000 related to stock-based compensation. Further, our reported third quarter net loss does not include any impact from the Chugai collaboration, since all of the revenue from the upfront payment was deferred as of September 30, 2015. Net loss per share was $0.08 per share in the third quarter of this year compared to $0.06 per share in prior year period.

As of September 30, 2015, we had $28.5 million in cash and cash equivalents compared to $26.1 million at December 31, 2014. During the third quarter of 2015, cash used in operating activities was $3.7 million compared to cash used in operating activities of $6.2 million in the third quarter of 2014.

With that, I'd like to turn the call over to Gil for a corporate update.

Thanks, BJ, and thanks, everyone, for listening in today.

Athersys is focused on the development of innovative medicines to address areas of great unmet medical need where current standard of care is limited, or where there is no effective form of treatment available for many patients.

We believe that our proprietary regenerative medicine technologies and other capabilities will enable us to develop safer and more effective treatments in the clinical areas where we are focused, which include treating neurological, cardiopulmonary, inflammatory and immune conditions, and other indications where our technologies have shown promise.

Our current clinical focus is in three areas. First and foremost is advancing our clinical program for the treatment of ischemic stroke. Over the past few months, we have continued to analyze the data from this study, and we believe that the results demonstrates that administration of MultiStem provides substantial benefits to patients that have suffered a debilitating stroke.

In particular, administration of MultiStem within 36 hours of the occurrence of the stroke is associated with substantial improvement across each of five important areas that together comprised what might be regarded as an optimal outcome for these types of patients. These five metrics includes the following.

Achieving good or excellent recovery in each of the commonly accepted clinical rating scales used in these types of studies including the Modified Rankin Scale, which assesses global disability, the NIH Stroke Scale, which evaluates cognitive and motor scale deficits, and the Barthel Index, which accessed the patients' ability to independently performance activates of daily living such as feeding, grooming, bathing, use of the toilet, and other functions that we generally all take for granted, and no occurrence of life-threatening adverse events for mortality, and the absence of secondary infections that can prolonged hospitalization and impede patient recovery.

When we evaluate patient recovery through this lens, the data showed that administration of MultiStem within 36 hours is strongly associated with better patient recovery. In particular, the data show that a substantially higher percentage of patients achieve recovery across each of these pre-specified clinical metrics when compared with patients receiving current standard of care, approximately 41% of MultiStem treated patients versus only 11.5% of placebo treated patients.

It's worth noting that, while this particular metric was not a pre-specified end point for the study, it is exactly the type of progress that patients and their families, clinicians, hospitals, and third-party payers are all hoping for when it comes to stroke patients since it reflects better recovery with fewer complications. And this is what we see from this study, consistent evidence that administration of MultiStem is associated with better recovery and substantially reduced hospitalization and time in the intensive care unit.

This is further supported by the evidence that shows that patients treated with MultiStem are achieving better and faster recovery. As we have presented at recent conferences, the data reflect that patients treated with MultiStem within 36 hours show a clear and consistent pattern of better recovery at day seven, day 30 and day 90 post stroke, as evidenced by robust and statistically significant differences in each of the individual clinical scales, as well as in the modified Rankin shift analysis, which is another commonly utilized and pre-specified end point used in this study.

Importantly, the mechanistic data that we have analyzed provides further support for these observations. In particular, the biomarker data provides clear evidence that the administration of MultiStem is associated with a substantial and statistically significant reduction in inflammatory immune cells and inflammatory cytokines in the days following the stroke, which are believed to create much of the permanent damage that occurs in the region of the brain where the stroke has occurred.

This reduction in the inflammatory cascade is even more pronounced when we assess the patients that received earlier treatment with MultiStem within the 36-hour window. There are several additional observations that are important as well, namely we see clear and consistent evidence of meaningful benefit among patients that received early treatment with MultiStem irrespective of whether they received reperfusion therapy with TPA or mechanical reperfusion, or whether they received no form of reperfusion therapy.

In addition, we evidence that even among patients that are considered non-responders, there were consistent trends towards better recovery relative to the corresponding group of patients that receive placebo. So, in total, we see a clear and convincing pattern of evidence that gives us confidence that administration of MultiStem within 36 hours of the occurrence of an ischemic stroke can provide substantial benefits to patients, and we are committed to validating these results in the next phase of clinical development. If we are successful in that regard, we will be in a unique position, at the forefront from one of the greatest opportunities in clinical medicine today.

The regulatory environment that we are working within has meaningfully improved over the past couple of years. In particular, in Japan, it was less than two years ago that the new regulatory framework governing regenerative medicines was passed with overwhelming support by the Japanese Diet, or legislature, and signed into law a few weeks later. This system is designed to accelerate the advancement and regulatory approval of regenerative medicine therapies that are demonstrated to be safe, and where there is meaningful evidence of therapeutic benefit. It was less than one year ago that the detailed regulations related to the new regulatory framework were unveiled, describing how this new system will operate. Yet, in less than two years, we are already seeing the first fruits of this new system, with the recent approval of two regenerative medicine therapies in Japan.

The first, an MSC-based treatment for graft-versus-host disease, based on an open label study of 25 patients in Japan and supported by additional data from a clinical program outside of Japan, which importantly, while it did not need the primary endpoint, did provide evidence of safety and therapeutic effect. This program was recommended for full regulatory approval, which it has subsequently received.

The second program involves a tissue engineered product for treatment of patients suffering from cardiovascular disease, which is recommended for conditional approval in accordance with the new regulatory system. In our view, both of these approvals signify that the new system is being utilized exactly as the regulatory authorities in Japan envisioned and described, and as we had hoped.

Over the past two years, we have engaged in a systematic series of discussions and meetings with the PMDA and healthcare authorities in Japan. Based on our discussions, it became clear that consideration under the new system will require evidence of safety and efficacy from Japanese patients in clinical institutions, in addition to data from the international study we were conducting.

In our earliest discussions, we explored whether we might expand the ongoing Phase II trial to possibly include clinical sites in Japan in an effort to utilize the new framework. As we've described previously, however, it became clear that we would have had to delay of completion of the study in order to achieve an appropriate level of enrollment in Japan, which we were reluctant to do.

So, as an alternative, we discussed with PMDA the possibility that we would complete the ongoing international trial first, evaluate the result of the study, and then use those results to guide our subsequent clinical development efforts. We would then meet with PMDA to brief them and submit our detailed plan for an additional study in Japan in the context of our envisioned international development efforts.

In the meantime, we announced earlier this year that had we entered into a partnership with Chugai. While we were in discussions with Chugai, we were also engaged in discussions with other potential partners that expressed a strong interest in our stroke program, as well as certain other areas of mutual interest. While we and Chugai were both hoping for unequivocal success from the trial in the form of being our pre-specified primary endpoint, as we now know, sometimes things aren't that simple.

While we have strong evidence of consistent safety and clinical benefit, as I summarized earlier, it became clear over time that Chugai intended to propose some modifications to key financial aspects of the deal, and also expressed the desire to pursue a development approach that would have placed a greater emphasis on outside of Japan, which meant that we or other partners would have had to shoulder more of the financial burden. While we and Chugai worked in earnest to find common ground, ultimately we were unsuccessful and decided that it would be better to end our partnership.

We did so knowing that there was strong interest from other groups that we had remained in touch with. As it became clear that we would not be able to resolve key issues with Chugai, we were able to move quickly with one of the groups to define a new partnership framework that we believe is consistent with our development objectives in Japan.

It envisions the potential development of MultiStem across several clinical indications, including stroke and additional areas, and also envisions collaboration in some other exciting areas of our opportunity where our respective technologies maybe complementary to one another. Given the broader potential scope of the partnership, it also entails more meaningful economics structure as defined in the LOI, or letter of intent, that we have executed, and that we believe is consistent with our commercial objectives in Japan.

We are now focused on completing relevant diligence and other activities with our new prospective partner so that we may formalize this partnership and move forward accordingly, including working with PMDA to define the next phase of clinical development in Japan, which is a priority for us. Understanding that there is still work to do related to diligence activities and contract negotiations, and obviously there are no guarantees in that regard, we would expect to formalize and announce this partnership over the next several months, likely sometime early next year.

Another key priority is the active exploration of partnering opportunities outside of Japan. We are currently engaged in multiple discussions with potential partners around our stroke program, as well as in other areas. We believe that there is a strong body of data that illustrates the consistent safety profile of MultiStem, and the clinical data from our stroke program, as well as other clinical studies that we have conducted, provides us with meaningful evidence of therapeutic effect. Supported by mechanistic data, it validates key aspects of our therapeutic hypothesis, which is critical.

In total, this creates a very strong foundation to pursue multiple avenues of opportunity in partnership with other organizations, and we are optimistic that we will be able to implement new partnerships that will put us in a strong position to achieve efficient development in key areas, and that will enable us to create substantial value for our shareholders.

Aside from our partnering activities, our key operational priorities are the clinical trials we are conducing in the cardiovascular and pulmonary areas. In the cardiovascular area, our current focus is on advancing our ongoing Phase II clinical trial evaluating the administration of MultiStem to patients that have suffered substantial damage from an acute myocardial infarction. In the past few months, we have added additional clinical sites in accordance with our clinical plan as we continue to work toward our goal of completing enrollment as efficiently as possible and reporting top line results sometime in the latter part of next year.

As we have disclosed previously, this study is funded in part with a grant awarded from the National Institutes of Health. This study will evaluate patient recovery using well-established clinical metrics, including using MRI to assess heart function, with a primary efficacy assessment in 120 days post-treatment, including evaluating incidence and severity of adverse events, as well as assessing major adverse cardiovascular events, or MACE, up to one year post-treatment.

In the pulmonary area, in the past quarter, we successfully obtained regulatory authorization in both the US and in the UK to conduct our trial evaluating the administration of MultiStem to patients that are suffering from ARDS, or acute respiratory distress syndrome. ARDS is a condition that affects hundreds of thousands of patients each year in the primary geographies we care about, and carries a high rate of mortality and visibility particularly among the patients over the age of 55, where there is a higher rate of visibility and mortality relative to younger patients.

The cost of care for these patients is extremely high since they are typically cared for in the intensive care unit and, due to their compromised pulmonary function, typically require ventilator-assisted breathing for an extended period of time. We believe that administration of MultiStem in the early phase of ARDS, could reduce the inflammatory complications associated with the condition and help promote recovery, as well as potentially reduce the time on ventilator, time in the intensive care unit, and overall hospitalization.

We are now in the process of launching this trial and expect to initiate patient enrollment soon. I'd like to remind everyone that we have obtained meaningful grant funding from Innovate UK in support of this trial, and are actively working with our collaborator in the UK, the Cell Therapy Catapult, who's assisting us in the management and execution of this trial.

In addition to our ongoing clinical programs, we've continued to mature the extensive preclinical programs we've conducted in neurological, cardiovascular, inflammatory and immune, and other areas, as will be reflected in upcoming publications and presentations at various conferences.

Our objective in these programs is to complete the necessary preclinical work that help to rely a basis for moving efficiently into clinical development when resources permit. By leveraging the growing body of relevant safety data, and the information we are generating around relevant dosing and mechanistic data, we believe that we will be able to advance these programs in an efficient manner, thereby enabling us to further expand our clinical development portfolio in a highly cost-effective manner and establish additional opportunities for clinical validation and commercial development.

So, in summary, we are focused squarely on implementing new partnerships and executing against our clinical development plan, reflecting our ongoing commitment to creating substantial value for our shareholders.

With that, we'd be happy to take a few questions.

(Operator instructions.) Jason Kolbert, Maxim.

Hi, Gil, thank you so much. I'd just like to -- can you take a minute? There's a new whisker plot that you're showing in the press release, and I wondered if you could just kind of walk me through this plot a little bit, and I find it really interesting.

Then, I want to talk with you a little bit about your experience in negotiating with the Japanese and what you're thinking in terms of a new partnership? Will it be restricted to just stroke? Will you be looking for -- when you're talking with a partner, what have they learned from the experience of the Phase II clinical trial that sets the stage for, in my mind, a potentially richer deal than the original terms you had with Chugai? I mean a partner is going into this with more information, not less information.

And I guess in that regard, you could argue that it's connected to this whisker plot. So, maybe could you just take a minute and walk me through the whisker plot, and then help me understand how that is influencing negotiations in Japan?

Yes, absolutely. So, I'm going to just make a couple of comments, then I'm going to turn it over to BJ, who is actually going to walk through the whisker plot. But basically, the whisker plot is meant to provide a visually rich and kind of graphical illustration for people that may not be analysis with some ?- may not be familiar, sorry, with some of the statistical approaches that are used to kind of illustrate benefit when it comes to the type of metrics that we're talking about.

So, I'm going to let BJ kind of walk through the visual metrics that are used here and kind of what they mean. But, I think, on the whole of it, as you'll hear from BJ, this provides I think a pretty clear and candid visual way to convey the consistency and the strength of the benefit that we're seeing when MultiStem is administered within the 36-hour time window.

Yes, let me add to that, Jason. What we're looking at here are odds ratios, and we've looked at a variety of different analyses. We look at differences, et cetera. And I think the key point here is, as Gil mentioned, it's to show the effect across single and combined variables. And what you see here are a number of the pre-specified endpoints from the study, the MRS less than or equal to two, NIHSS change of 75%, the Barthel Index greater than or equal to 95%, and this is measured at 90 days post-stroke. Those were pre-specified secondary endpoints that form the component in our kind of multi-variated assessment called the GEE in this particular case, and we've called it global test statistic as well. It's built off the approach that was taken in the [NINE] studies in the 1990s for approval of TPA.

And that takes into account in an integrative way the impact of each of those three variables. That was our primary endpoint in this particular study. Included here as well is the excellent outcome, which was a pre-specified secondary endpoint for the study.

And then, two important safety endpoints, secondary infections and survival, and long, life-threatening AEs. And so, what we've done is we've listed all these things so you can see the totality of the impact, and we focused on the target patient population for going forward, and that is patients that will be treated within 36 hours of the stroke. And we have two groups here, and we have the group that represents all MultiStem that were treated in less than 36 hours versus all placebo, and then to the right of that we include the group, our post-hoc analysis, which we've shared data on before, which represents that same group, excluding patients who received both TPA and mechanical reperfusion.

And you can see in both cases a very strong and consistent impact for MultiStem treatment. And what this means is the odds of a MultiStem-related treatment effect are substantially greater for each of these variables as you walk through them. And so, you can see that across the board.

All right. So, BJ, if I look at ?- well, help me understand the odds of one, the odds of two--.

--Yes, so anything ?- right, sure. Anything greater than one is in favor of MultiStem, and you can see all the dot points are greater than one. And if you had a odds ratio of two, you have a two times greater impact, and MultiStem is going to have a treatment effect than placebo, all right? So, that's how you generally read these. And these lines are confidence intervals, so they're 95% confidence intervals. And so, what that translates into is ultimately statistical significance. And so, if your confidence interval is on one or to the right of one, you have a significant outcome.

And so, if you look at our post-hoc group, which is the whisker plot to the right, if I look at excellent outcome, for instance, we have the substantial odds ratio there, greater than four, and that's statistically significant because the confidence interval is to the right of one, right? You can see that this applies to a number of the key endpoints, but the general trend is also very, very strong, as well. So, we find this very exciting in a way to comprehensively show this impact across a variety of different metrics that we had pre-specified, and then several which we've looked at from an exploratory perspective in the post-hoc analysis.

Got it, okay. Thank you, that's very helpful. Now, help me understand how is this translating in your discussions with potential partners. Are they seeing what you're seeing, and is that ?- what's their excitement and interest level? And then, I'm sorry to ask the question, but I have to. What do you think the timing might be to bring this to fruition so that we can -- you're essentially ready to announce a partnership, and then march back towards initiating a stroke trial?

Yes. So, our ?- so, in general, the response that we've been getting from clinicians, from potential partners, from a range of other people that have looked at a lot of the data that we've generated from the study has been extremely positive. And that's been a pretty consistent response, particularly among clinicians both in Japan and outside of Japan, that are very keen to participate in the next phase of clinical development.

And I think that that high level of enthusiasm is really consistent with the things that we've learned from the data, and it's really helping drive some of the partnering discussions that we're currently engaged in right now. People see the consistent safety profile, and they see the strong evidence of efficacy as we described it. And I think they're able to interpret that in a very meaningful way, and ultimately I think that puts us in a very good position to complete the type of partnerships that we intend to complete.

In terms of the current prospective partnership that we're in discussions with with this one particular group in Japan, we have a timetable, but, by agreement with the partner, we're not really going to lay out the specifics of that. But, as I alluded to in my prepared comments, we think the relevant timetable that people should be thinking about should be the early part of 2016. It just takes a little bit of time to get through the contract and some of the other things that we need to. And as I mentioned, although there's no guarantees that we'll successfully complete that process, we're certainly optimistic that we will.

But, in parallel with that, we're engaged in a systematic partnering outreach program actually, which we're working with an outside firm to help us conduct, and the responses that we've been getting through that outreach have also been very, very positive. So, I think we've learned a lot, both in terms of what we're looking for from potential partners. We're certainly being crystal-clear about what our expectation are in terms of how we want to approach development. And I think that type of clarity and that type of transparency is really what sets the stage for a successful long-term partnership.

Let me just also say that we worked very hard with Chugai. So, first off, we have the highest regard for Chugai as an organization. It's a very well-run organization, a lot of very experienced and capable professionals from the leadership team on down. Just ultimately there was a difference of opinion on some key substantive issues that we couldn't reach common ground on, and that was unfortunate, and so we had to make a choice, and we made our choice.

And I think that ultimately we feel like this is the right thing to do. We're excited about the future of the program. We think that the recent activities in Japan, in terms of the approval of products under this new regulatory framework, bodes very well for what we want to achieve. And I think there are some other things coming up related to, for example, reimbursement of some of these products that are also going to be very illustrative, in terms of helping show people what's possible under this new system.

Gil, we really appreciate the data, especially as it continues to mature, and we look forward to seeing the stroke trial getting resurrected and a partner announced. Thank you so much.

Thanks, Jason.

Steve Brozak, WBB.

Hey, good afternoon, gents, and thanks for taking the call. This is really an unusual situation here, where you've got obviously -- you're in negotiations, and your work with Japan leading the way when typically you would see a US-centric type of approach. Can you go back in and describe -- give any color, clarity, on what you're starting to see in terms of interest? Because obviously, with any positive data that takes place over in Japan, there's got to be a boatload of interest, considering TPA being the standard of care, that you're going to start to see here in the United States. What are your thoughts on that? And I've got one follow-up after that, please.

Yes. Well, we are seeing very good interest internationally, and we're encouraged by that. And I think it's interesting, because I think the ?- to the first part of your question, the new regulatory system in Japan, in a way, has kind of tipped things over relative to the way things have been historically, at least for the past 10, 15 years. And in fact, it's precisely that dynamic that has existed in Japan for the past 10 to 15 years that I think had the regulatory authority so concerned, and the healthcare authority so concerned. They were beginning to see meaningful evidence of an innovation gap that they were trying to address by putting in place this new regulatory framework precisely so that they would actually drive more activity in the direction that they needed it, and in the clinical indications that are scariest to them, quite bluntly, because they fear what this -- the impact of things like stroke and other indications will have on the exploding elderly population in Japan, and that they're obligated to provide coverage for under their National Healthcare System.

So, in a way, we wouldn't really be focused on trying to put as much effort into the system in Japan were it not for the fact that this new regulatory system has gone into effect. But, I think that everything that they envision and that they've described the past of couple of years has now come to fruition in terms of the implementation of the system and the first approvals that are occurring under the system.

And I think your comment about, and your question about is this having a positive impact on other things outside of Japan, it clearly is, at least from my estimation. I think that it's actually providing encouraging evidence. And in fact, interestingly, from a regulatory perspective, we're seeing strong signs and trends, both in the United States and also in Europe, where similar types of initiatives are either being contemplated, or in some cases have already been implemented in the case of Europe, where they're utilizing conditional approval as a legitimate pathway to for therapies in certain types of areas, and regenerative medicine, or cell therapy, is actually contemplated specifically as part of that new system.

Okay. Going back to Japan now obviously, if you could just, say given the -- obviously the Chugai relationship, and now all the questions that are being raised in the new partnership discussions, what are the top two interest items that you think are giving you some clarity as to where you're going to go next? I don't want you to speak for your future partner, but what are the top two things that you think will be the takeaway? And I'll hop back into the queue. Thank you.

Well, I think two of the key drivers are the consistent safety profile of the product, and the second is is the product profile itself, the off-the-shelf utility, the ability to actually administer it and deliver it in a very efficient and simple-to-use format.

As awareness and knowledge of different types of cell therapy approaches, some of the autologous approaches, for example, has increased over the past few years, I think people have becoming increasingly aware of the limitations of some of those types of approaches and what they mean when it comes to the clinical implementation. I think the model that we have laid out and have been driving towards for the past few years, which is very simple, can be administered from within a hospital pharmacy without specialized facilities or highly specialized personnel training, is something that is becoming more and more appealing to people, because it's something they can relate to. It's consistent with their experience of biologics or other forms of therapies that can be administered within a hospital setting, whether it's within the acute care or non-acute care type of environment.

So, I think scalability, obviously, is another huge factor, but I think these three things in combination, coupled with the growing body of evidence that shows that the product is working -- and not just working, but working in areas where it's been extremely difficult historically to get any traction with conventional approaches to development of new therapies. I think these things together are really what is driving the interest that we're seeing.

Well, again, good luck. Obviously what we're all going to be waiting for is that partnering announcement, so we're looking forward to that. Thank you.

And we have no further questions in queue at this time, and I would like to turn the conference back over to our presenters.

Well, thanks, Jennifer. So, in closing, I'd like to just thank everyone once again for their time and attention today, as well as your continued support to the Company. We look forward to providing additional updates in the coming weeks and months, but in the meantime we'd like to thank you again and say good-night, everyone.

Thank you for your participation. This does conclude today's conference call, and you may now disconnect.