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Edited Transcript of ATHX earnings conference call or presentation 6-Nov-18 9:30pm GMT

Q3 2018 Athersys Inc Earnings Call

Cleveland Dec 3, 2018 (Thomson StreetEvents) -- Edited Transcript of Athersys Inc earnings conference call or presentation Tuesday, November 6, 2018 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Laura K. Campbell

Athersys, Inc. - SVP of Finance

* William B. J. Lehmann

Athersys, Inc. - President, COO & Secretary

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Conference Call Participants

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* Chad Jason Messer

Needham & Company, LLC, Research Division - Senior Analyst

* Jason Howard Kolbert

H.C. Wainwright & Co, LLC, Research Division - Former MD & Senior Healthcare Analyst

* Jason Wesly McCarthy

Maxim Group LLC, Research Division - Senior MD

* Katherine Xu

William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research, Partner & Biotechnology Analyst

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Presentation

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Operator [1]

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Good afternoon. My name is Catherine, and I will be your conference operator today. At this time, I would like to welcome everyone to the Athersys Third Quarter 2018 Earnings Conference Call. (Operator Instructions) Please note that today's conference is being recorded.

Thank you, Ms. Laura Campbell with Athersys, you may begin your conference.

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Laura K. Campbell, Athersys, Inc. - SVP of Finance [2]

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Thank you, and good afternoon, everyone. I am 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. B.J. Lehmann, President and Chief Operating Officer, and I will host today's call. The call is expected to last approximately 30 minutes and may also be accessed at athersys.com. A replay will be available 2 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 6 of 2018. 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 will now provide the third quarter 2018 financial results and then turn the call over to B.J. for a corporate update, followed by a question-and-answer period.

During the third quarter of 2018, revenues increased to $2.3 million from approximately $400,000 during the third quarter of 2017.

The increase related to fees for manufacturing-related activities that we provide to our collaborator Healios. Our other revenues remain consistent compared to the same period last year.

Research and development expenses increased to $9.5 million in the third quarter of 2018 compared to $5.4 million in the prior year 3-month period. The $4.1 million increase relates primarily to an increase in clinical development cost of $3 million, increased personnel cost of $600,000, increased license fees of $200,000 and other increased research costs of $300,000.

The variance in our clinical development costs resulted from increased clinical manufacturing costs, covered in part by Healios. Technology transfer services associated with planned manufacturing for Healios in Japan processed development activities to support large-scale manufacturing, and costs related to our MASTERS-2 clinical trial that began enrolling patients in the third quarter of 2018.

General and administrative expenses increased to $2.6 million for the 3 months ended September 30, 2018, from $2.1 million in the comparable period in 2017. The increase was due primarily to an increase in professional fees, consulting services, personnel costs and other administrative costs. Our net loss for the third quarter was $9.7 million in 2018 compared to a net loss of $7.2 million in 2017. The difference of $2.5 million reflects the above variances as well as an increase of $200,000 in other income.

Net loss per share was $0.07 in the third quarter of 2018 compared to $0.06 per share in the third quarter of 2017.

In the 9 months ended September 30, 2018, net cash used in operating activities was $8.8 million compared to $17.9 million in the 9 months ended September 30, 2017. The difference reflects, in part, $15 million of license fees paid so far by Healios in 2018, in connection with the collaboration expansion and an increase in clinical development activity in 2018. Healios is required to make 2 more licensed fees payments of $2.5 million each in December 2018 and March 2019, in accordance with the collaboration expansion.

At September 30, 2018, we had $48 million in cash and cash equivalents compared to $29.3 million at December 31, 2017.

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

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William B. J. Lehmann, Athersys, Inc. - President, COO & Secretary [3]

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Thank you, Laura, and thanks, everyone for joining the call today. I will begin with some of the highlights.

First, we're pleased to announce that we have completed enrollment of our study of MultiStem treatment for acute respiratory distress syndrome, otherwise known as ARDS or ARDS. As we described in the last call, this study is a small, exploratory trial to evaluate the safety and feasibility of MultiStem treatment to patients who are affected by ARDS. The study is intended to provide information about the patient population and a cell therapy that can help in planning our subsequent clinical development, including about which of the patients are most likely to benefit from treatment and about the nature of MultiStem administration. We are also collecting some data intended to help us understand the potential for biological and clinical effect. But as we have said previously, with just 36 subjects, the study is neither designed nor powered to demonstrate efficacy, meaning that we are looking only for information or signals that would be relevant to future development. We expect to have the results available from the study in a couple of months, after we assemble and analyze the data, so during the first quarter of 2019. After we have shared the results publicly, we would begin to disclose our plans for the program moving forward.

We believe that there is a big opportunity to help patients suffering from ARDS around the world, and we believe that ARDS represents a substantial market opportunity for a successful therapy, which we hope MultiStem treatment will be.

ARDS is a serious inflammatory condition that severely affects lung function. It may result from a number of underlying causes including severe pneumonia, major trauma, aspiration or near drowning, and sepsis, among other things. ARDS can vary in intensity among patients and can result in lasting damage to the lungs, and for more severe cases, or among older patients, there is typically a high mortality rate.

ARDS patients generally are critically ill and they spend weeks to months on a ventilator and in the ICU. From a healthcare policy perspective, these are high-intensity, high-cost patients, who face substantial side effects, loss of function, additional post-discharge healthcare cost and decline in quality of life to the extent that they recover. We believe that successful therapy has the potential to substantially reduce intensive care hospital time, improve long-term outcomes, providing a strong foundation for favorable reimbursement.

Furthermore, on the development front, Healios licensed from us several months ago the rights to treat ARDS with MultiStem in Japan, and given its work with MultiStem in stroke in Japan, Healios could be in a position soon to move forward with its own ARDS study in Japan.

Under the progressive regulatory framework in Japan supporting regenerative medicine, there may be an opportunity depending on the results for contingent or accelerated approval for this treatment.

We looked forward to continuing to support Healios' efforts to develop a MultiStem product to address this area of significant clinical need in Japan.

Second, during the third quarter, we initiated the MASTERS-2 study, our registration study of MultiStem therapy for the treatment of ischemic stroke. We have had good enrollment so far following the initial limited launch. As we described in the last call, we are ramping up the study in phases, initiating with the small number of sites in the U.S., adding a larger number of U.S. sites starting early next year, followed by European sites after that. This approach reflects a number of factors, including our ongoing support of Healios' TREASURE study, management of the operational requirements associated with initiating a large number of sites, and regulatory considerations in Europe. Overall, as we have summarized previously, the study will include 300 subjects and will be conducted approximately 50 clinical sites in North America and Europe. Our target is to complete enrollment sometime in 2020, though it is difficult at this early stage to project firm study time lines.

With respect to the TREASURE study, Healios has continued to enroll subjects and add sites in its study of MultiStem treatment of ischemic stroke. We cannot comment more on Healios' enrollment or its time lines, and further updates will come as Healios comments publicly about the study in our scheduled earnings calls and other events.

Third, we announced in September, the extent -- extension of the option and negotiation period for a further expansion of our collaboration with Healios. As we have disclosed previously, these discussions include an exclusive option to a license for rights to develop and commercialize MultiStem therapy for certain indications in China, and other potential indications in Japan. The negotiation period was extended to early December, and we continue to engage in constructive discussion with Healios about how we might proceed together. We believe that there is a substantial opportunity for regenerative medicine and advanced therapies in China, which will come into clear view as our development advances and the regional landscape matures.

We see the scope of the current expansion negotiations as a good business opportunity for both Athersys and Healios, and we continue to explore with them as we think about potential ways to extend the partnership and create additional value together.

I would now like to update on other areas and then address some recent shareholder questions. As we described in our last call, we are working with the University of Texas at Houston and the Memorial Hermann-Texas Medical Center, one of the busiest Level 1 trauma centers in the United States, in our preparations to conduct a study evaluating MultiStem treatment for trauma. The study is intended to evaluate the safety and efficacy of the cell therapy treatment with the objective of reducing the severe inflammatory complications of trauma that increase patient susceptibility to severe adverse events that impede recovery, including acute kidney injury, ARDS, vascular compromise and multiple organ failure among other things. We and our partners are currently refining study design details, preparing the regulatory package, and working through the site operational aspects with the objective of starting a study in 2019. We plan to provide further information as our ongoing preparations advance.

Without a doubt, the advancement in efficient completion of our clinical programs, in particular the Healios TREASURE study and our own MASTERS-2 study, are critical to our near-term mission.

Additionally, preparing for the potential approval and commercial launch of MultiStem cell therapy is very important to our success.

As we discussed in our last call, over the next 18 to 24 months, we will be focused on building the capabilities and laying the groundwork to enable us to apply for approval for -- gain approval for and successfully launch MultiStem therapy for stroke and potentially other treatments. In addition to favorable clinical results, success will require a productive and efficient regulatory effort, favorable positioning of the therapy and its value proposition with reimbursement agencies and payers, sufficient manufacturing capacity in product quality, and ultimately, a strong commercial outreach in management. We are already engaged in most of these areas and are focused on achieving success in each of them.

Today, I would like to take a little time to focus some comments on manufacturing. As we have discussed in the past, we have established production at several contract manufacturers, or CMOs, with facilities represented in the U.S., Europe and Asia to build some redundancy into our manufacturing network.

Additionally, we have continued to develop and refine methods for manufacturing the MultiStem product, with the objective of putting in place manufacturing approaches that are suited for larger-scale commercial manufacturing.

Our sales biology and robustness have enabled us to manufacture product across different expansion platforms. Our current product manufacturing is limited in scale and is suited to meeting the requirements for our clinical trials, without requiring the larger investments required for commercial scale production. Each manufacturing batch takes a little over a week to complete, and the testing and QC QA process can take 10 weeks or more. We have used this straightforward, clinical scale approach for many years, and we have added dedicated capacity in our CMOs to meet our needs.

However, this capacity can be limited by production suite availability, operators and support personnel. As a result, at any given time, we have limits to the production that can be done, meaning that we have to conduct a series of smaller runs over time to complete a production campaign. It also means that typically, we are still manufacturing product for a study even after that study has been initiated. From time to time, it's exposed us to some risk of supply disruption due to operational issues and material supply constraints among other things. We have worked to address these risks through coordinated production planning with our CMOs, integrated clinical development planning, establishment of some manufacturing and redundancies such as our relationships with multiple organizations including Lonza, Nikon CeLL innovation and other groups.

Our priority now, working with our CMO partners is to complete production, release and supply for the TREASURE and MASTERS-2 studies, as well as other activities such as our planned trauma trial.

Naturally, we are taking a different approach for our commercial manufacturing to serve larger markets, such as ischemic stroke. We are focused on bioreactor manufacturing, which is much more scalable and efficient than our current clinical scale approach.

Our clinical scale approach relies on cell factories, a 2 dimensional area-driven production approach, while our commercial-scale approach uses a 3 dimensional volume-driven approach. The bioreactor approach allows us to achieve much, much higher yields and equivalent production space, with significantly less labor and better manufacturing controls. The result is favorable scalability, better quality control and a much lower cost of goods, and a distinctive platform that will be a source of sustainable, competitive advantage. With our deep knowledge of our cells' biology and critical manufacturing parameters, we have developed internally, the core aspects for our bioreactor manufacturing approach to ensure control is an important intellectual property. Eventually, our commercial manufacturing capacity can consist of a combination of third-party CMO and internal production, with the specific configurations and time lines to be determined. Considerations will include available capacity, investment requirements for our CMO partner, or for us, overall product demand expectations, operating performance and financial parameters among other things.

We will likely launch commercial production with a third-party CMO that can meet our initial volume and geographic needs, assuming no major changes to our current development plans. We would then plan to integrate in our own internal production, which would give us better control over production.

Our intention, working with our partner CMOs, is to put in place in a stepwise in capital-efficient manner, the commercial manufacturing capacity to support a product platform, with the potential eventually to treat millions of patients across the globe.

We are actively planning and preparing for potential approaches to commercial manufacturing and will provide further information on that as our planning and efforts progress.

As we have done recently, before we take questions from today's participants, we'd like to address a couple of questions that have been submitted to us from shareholders and others with interest in our technology.

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Questions and Answers

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William B. J. Lehmann, Athersys, Inc. - President, COO & Secretary [1]

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Question 1 was submitted by Bill. Athersys is on record as saying it can produce hundreds of thousands to millions of doses from a single donor and that it can store its products for years. Can you comment and please clarify?

With respect to the first part of the question, the MASTERS cell bank created from a single healthy consenting donor, has the potential to yield a large number of doses as a result of the robust growth properties of the cells that comprise MultiStem and the use of work -- the working cell bank and production methods we have described previously. In short, the cells can be expanded dozens of generations in culture and maintain their potency, biologic fidelity, safety profile and other fundamental characteristics, as we have shown in prior published work in presentations. From a mathematical perspective, if we assume 40 population doublings in the manufacturing process, this translates into an increase of 2 to the 40th times or more than trillion times the original cell population, which is isolated from a single donor. Assuming a dose of approximately 1 billion cells for example, this provides more than a million doses with the starting cell population from the donor. Additionally, we have demonstrated comparability of product for MASTERS cell banks created for multiple donors, providing us with the ability to generate a very large supply of doses to meet the demands that we anticipate. With respect to the second part of the question, as we have presented previously, the product can be cryopreserved and stored for years and maintain potency upon thaw. This feature will give us flexibility in managing commercial manufacturing and the product supply chain once we are approved for commercialization.

Question 2 comes from Brett. Can we get some clarity on the Europe stroke strategy? Is Athersys planning on partnering for the trial for distribution or not at all?

Healios is developing a MultiStem product for stroke in Japan with its TREASURE study, and we are developing the product for stroke in North America and Europe with our MASTERS-2 study. As I noted earlier, our plan with MASTERS-2 is to initiate in the United States and ramp up, and then bring European sites on after that. The results generated by MASTERS-2, as well as results from the TREASURE study, will be used to support applications for registration in the United States and Europe. From a commercialization perspective, we have not yet finalized our strategy for Europe. However, with multiple countries with varied utilization and reimbursement approaches, it could be beneficial for us to partner with a European company for commercialization and/or distribution to achieve optimal reimbursement and penetration and maximize the value creation in Europe.

We will continue to evaluate and export partnering options as our efforts advance in this and other areas, and update our strategy as our clinical development progresses.

Now we would be open to answering a few more questions from the participants today.

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Operator [2]

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(Operator Instructions) Your first question comes from the line of Katherine Xu with William Blair.

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Katherine Xu, William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research, Partner & Biotechnology Analyst [3]

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So B.J., I'm just wondering in terms of the European partnership, I understand it could be commercial, but does it make sense to establish one before data? Or you think it's more after data and then basically form a true commercialization partnership? And then the other question is on the clinical execution. So Athersys is conducting the MASTERS-2 study all by itself. Can you just comment on how big your clinical team is? Are you expanding? Or you already have sufficient resources to push this study to completion?

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William B. J. Lehmann, Athersys, Inc. - President, COO & Secretary [4]

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Thanks, Katherine. I'll respond to your questions in turn. So with respect to European partnership, first, I would say that we are in discussions with partners at any given time and we consider the opportunities they present themselves. And it's possible we would consider partnership in Europe before we have data from the MASTERS-2 study. I'll remind everybody, it's quite likely we're going to have data from Japan before we have the data from the MASTERS-2 study. And that may, in fact, be an opportune time to consider European partnership because we will have essentially a data set that would be expected to be representative of what we would see with MASTERS-2. So it may make sense to do that before we have that data set, it would certainly allow for planning. And with the Japan data in hand, we may be able to realize the kind of value that we think is deserved for this particular opportunity. So in short, we'll continue to consider the opportunities for partnership in Europe, we'll consider those even before we have the MASTERS-2 data, but it really depends kind of on the situation at the time. And if it does make sense to do a partnership before we have that data from MASTERS-2, we'd certainly going to consider it. Secondly, with respect to clinical execution, I'll make a couple of comments there. First off, we do have an experienced clinical team here at Athersys, we've been doing clinical development with MultiStem for some time and importantly, the people that we have managing this for us are experienced in late-stage clinical development from kind of past pharmaceutical experience. So we have a good core here to kind of manage the activities. Number two, we do use outside CROs to help drive the activity, and they provide a lot of boots -- a lot of the boots on the ground to kind of drive clinical activity. And we have a strong support team here that kind of manages the important kind of clinical relationships, but we do that hand-in-hand with the outside CRO support that we have. We have worked with the organization that is supporting our stroke study before, we've had good success with them, and it worked well with the team. I do feel like we have in place the capabilities to drive this study efficiently and effectively. That said, over time, we may add some additional capability to support the effort, but I think we're in a good position right now.

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Operator [5]

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Your next question comes from the line of Chad Messer with Needham & Company.

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Chad Jason Messer, Needham & Company, LLC, Research Division - Senior Analyst [6]

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I was just wondering if there was anything to report on AMI? I know you guys have been having some enrollment issues with that in the past. Just wondering if there was anything new to say?

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William B. J. Lehmann, Athersys, Inc. - President, COO & Secretary [7]

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Chad, thanks for the question. There's not a lot new to say there. We've continued to have challenges in enrollment. We continue to enroll patients, but it's been a slow slog. We've looked at a variety of different approaches to help us increase enrollment. We're fighting against some changes in practice with respect to treating the target patient population we're looking at. And we're continuing to consider different options with respect to pushing that study forward. So there's nothing new to report at this point in time, other than to say that we're continuing to look at the different options that could help us get to a point that's a success for us with respect to that study.

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Operator [8]

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Your next question comes from the line of Jason Kolbert with H.C. Wainwright.

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Jason Howard Kolbert, H.C. Wainwright & Co, LLC, Research Division - Former MD & Senior Healthcare Analyst [9]

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Just want to come back to the some of the manufacturing issues. If you make changes in the process and you go to a 3D bioreactor, do you have to do any transfer or equivalency studies to make sure that the clinical trials product you're using matches the manufacturing changes for a commercial supply?

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William B. J. Lehmann, Athersys, Inc. - President, COO & Secretary [10]

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Thanks, Jason. First off, I didn't really talk about manufacturing issues, necessarily, I just laid out our manufacturing strategy and approach. But with respect to your specific question, equivalency or comparability, yes, you have to show that the product is comparable. What that entails specifically, ultimately we'll be discussing with the regulators. At this point, we've developed a substantial amount of information about products made on any of the manufacturing platforms we've developed, which include, obviously, the current approach, but also bioreactor. We have a couple of other approaches as well that we've developed. And we've demonstrated strong comparability with respect to the key characteristics of the product and have used it in a variety of different studies and so forth. Ultimately, we'll have discussion with the regulators with respect to the comparability requirements and what might be required from a clinical perspective. And we have a couple of strategies already that we're executing against that would provide us with clinical data from a product manufacturers with the bioreactor should we need it to support what we'd ultimately do on the stroke side.

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Jason Howard Kolbert, H.C. Wainwright & Co, LLC, Research Division - Former MD & Senior Healthcare Analyst [11]

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And B.J. help me understand, how involved is Healios in this process? It looks like they'll be in a position to commercialize first. So will -- is the intention that Athersys will supply commercial-scale product to Healios? Or that Athersys will work with Healios to kind of build a local manufacturing operation in Japan?

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William B. J. Lehmann, Athersys, Inc. - President, COO & Secretary [12]

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Well, the answer is a little bit of both. I mean, I think under the current arrangement, we are essentially set up to supply them products for any additional clinical work in commercialization. However, we would also consider exploring with them local manufacturing in Japan. And in fact, we have set up, as we've disclosed publicly, relationship with Nikon CeLL innovation with the specific intent to provide or supply product that's manufactured in Japan and supply to the Japan market. So they are involved in the manufacturing process, the planning, strategy and have a fairly significant role right now with respect to manufacturing, as it relates to their license indications, in particular, in Japan. So we anticipate we'll continue to have that close integrated collaborative relationship with respect to manufacturing the product for their indications. And over time, that might turn into a more direct role for them in managing manufacturing in Japan. But we'll see and we'll update as that occurs over time.

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Operator [13]

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Your live question comes from the line of Jason McCarthy with Maxim Group.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [14]

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Can you talk a little bit about the trauma program as we're -- with the stroke, the 2 Phase IIIs on track, and kind of a 2019, 2020 event and we look to the next set of catalysts for Athersys, the trauma program is particularly intriguing because it's really the -- on the same critical care axis of stroke just in your revision. And we look at the study with about 150 patients, that's what was previously stated at a center in Texas. Can you walk us through what endpoints in a study like trauma would entail? And given that it is critical care, stroke is critical care, would you look to expand that study to other centers that are involved in your stroke trials now?

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William B. J. Lehmann, Athersys, Inc. - President, COO & Secretary [15]

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Yes. There are several questions there, so let me try to take them one at a time. So with respect to critical care and kind of the portfolio of opportunities we have around critical care, yes, you're right, this is a very robust set of opportunities for the company. Obviously, stroke is kind of lead program, but trauma is part of that, ARDS is also a part of that, it's an acute care situation, high-intensity ICU treatment, et cetera. And we have actually some other things in the portfolio that we haven't spent much time talking about publicly that would fit within this kind of portfolio as well. So we're very excited, I mean the themes that underline the opportunity are very similar across these indications and it has to do with managing the immune system response to the event, or the condition, and we've seen a lot of transferability across these indications with respect to what the cells do. So that's pretty exciting. When you think about it in terms of, kind of, the time line, obviously, the events around stroke, the TREASURE study results, the MASTERS-2 results, those -- the time line you talk about is kind of what's targeted. ARDS is interesting, I think there might be some opportunity for development in Japan that could be accelerated just given the favorable -- the regenerative medicine regulation they have there, we will see, but I think that could be something that has the potential for accelerated development. Trauma as well could be developed relatively quickly, we believe. The study that we're planning to run right now with the Texas Institution is single center. But I think it's important to note that this is essentially one of the busiest trauma centers in the United States. They've had experience from running kind of larger trauma studies before, they can do it very efficiently. That's our expectation with respect to this particular study. With respect to the types of endpoints you're looking at and so forth, I'm not going to go into detail now, I think we will lay out the specifics of design and so forth over time, and I don't want to get ahead of ourselves, in particular before we finalize the discussions with the FDA. But you can imagine, we're going to be looking at things like organ function, which is affected pretty substantially any of these kind of trauma cases is one of the key evaluative measures. We're certainly going to look as well at some of the other things that tie back to the biological mechanism. So some of the inflammatory markers and so forth. We'll provide a lot more clarity on that once we get to a final and kind of blessed protocol and trial design from the FDA, we're working on that right now. But those are the sort of things we would look at. With respect to sites and so forth, the current plan is not to expand trauma in this study to other sites. I mean, I suppose we could look at that over time, but I think we're very confident that our partner in Texas can get this thing done relatively quickly. I think the real planning would take place as that study evolves and we develop a perspective on how the cells can work in that setting. We will have a network of sites focused on various aspects of trauma, it could be neurological injury, it could be general trauma sites, et cetera, and we certainly would want to leverage those relationships and that experience as we develop kind of the next wave of opportunities in this broader acute care portfolio. So it's something we're thinking about for sure as you mentioned it. And we think it'll be leverageable as we move things forward kind of beyond this next -- this trauma stage that we had planned.

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Operator [16]

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And ladies and gentlemen, I thank you. That is all the time we have allotted for questions today. I'd like to turn the call back over to B.J. Lehmann for any closing remarks.

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William B. J. Lehmann, Athersys, Inc. - President, COO & Secretary [17]

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So I just want to thank everyone for participating today. We look forward to continuing to update you on our progress. And finally, I just want to say to everybody have a good night. Thanks.

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Laura K. Campbell, Athersys, Inc. - SVP of Finance [18]

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Bye-bye.

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Operator [19]

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Thank you, ladies and gentlemen. This does conclude today's conference call. You may now disconnect.