Athersys Inc (ATHX) 2017 Q3 法說會逐字稿

Good afternoon. My name is Erica, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Athersys Third Quarter 2017 Earnings Conference Call. (Operator Instructions)

Ms. Laura Campbell, you may begin your conference.

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 e-mail.

Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer; and B.J. Lehmann, President and Chief Operating Officer, 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 8, 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 would like to turn the call over to B.J. Lehmann. B.J.?

Thank you, Laura. Good afternoon, and welcome everyone. I'm B.J. Lehmann, President and Chief Operating Officer at Athersys. I'll briefly review our third quarter 2017 financial results and then turn the call over to Gil for a corporate update followed by a question-and-answer period.

During the third quarter of 2017, we recorded revenues of $399,000 compared to $311,000 during the third quarter of 2016. Our contract revenues for the 3-month period ended September 30, 2017, were $179,000 consisting primarily of royalties from RTI Surgical as compared to contract revenues of $150,000 for the same period last year. From time-to-time, contract revenues may also include manufacturing payments from Healios, our collaborator in Japan, that is conducting a clinical trial in ischemic stroke known as the TREASURE study.

Our grant revenue increased to $220,000 in the third quarter of 2017 from $161,000 in the third quarter of 2016. Grant revenues relate primarily to awards for our ongoing clinical trials and acute myocardial infarction and acute respiratory distress syndrome.

Research and development expenses increased slightly to $5.4 million in the third quarter of 2017 compared to $5.3 million in the comparable prior year period, reflecting increases in clinical and preclinical development costs, offset by decreases in research supplies, sponsored research and travel cost.

General and administrative expenses increased to $2.1 million for the 3 months ended September 30, 2017, from $1.8 million for the same period in 2016 with the increase primarily due to personnel related cost.

We incurred a net loss for the 3 months ended September 30, 2017, of $7.2 million compared to a net loss of $6 million for the same period last year. This $1.2 million difference includes minor increases in revenues, R&D expenses and G&A expenses in the current period and nonrecurring gains in the prior period of $682,000 from insurance proceeds for flood damage and $191,000 from gains on the fair value of our former warrant liabilities.

Net loss per share was $0.06 in 2017 third quarter compared to a net loss of $0.07 per share in the 2016 third quarter.

During the first 9 months of 2017, we used $17.9 million of cash in operating activities and we raised approximately $31.7 million from our common stock offering, warrant exercises and equity purchase facilities. With $28.2 million in cash and cash equivalents as of September 30, 2017, we remain well positioned to maintain our current operations and systematically evaluate our business development opportunities, including those involving our stroke program, which Gil will discuss in his update.

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

Thanks, B.J. Good afternoon, everyone, and thanks for joining the call today.

During the third quarter, we made additional progress towards the achievement of some key goals. Our major near-term priorities include the following: supporting our partner Healios in their conduct of the ongoing TREASURE trial in Japan, which is evaluating the administration of MultiStem therapy to patients in Japan that have suffered an ischemic stroke; continuing our preparations for the upcoming MASTERS-2 clinical trial, which is a Phase III study that will evaluate the administration of MultiStem to patients in North America and Europe that have suffered a stroke, including the pursuit of important regulatory designations that will help us -- help enable us to achieve our goals for product approval in an efficient manner; strengthening and expanding our capabilities so that we can fulfill our clinical development objectives as well as prepare for commercialization in the event of achieving our clinical development goals; advancing our discussions with potential partners regarding the development and potential commercialization of MultiStem in North America, Europe and in other key regions, including China; continuing our other key clinical and preclinical programs, including our ongoing clinical trials in the cardiovascular and cardiopulmonary areas; building awareness through our media relations, corporate communications and investor relations activities and as mentioned earlier in the call by B.J., maintaining a healthy balance sheet.

As it relates to our support of the ongoing clinical trial in Japan, being conducted by Healios, about 2 months ago, we discovered an error in the formulation of the placebo material for the study, which was prepared by Lonza, one of our contract manufacturers. As a result, the study was temporarily suspended as new placebo was manufactured and shipped to Japan. Given the nature of the deviation, which was a slight formulation error, no patients were ever at risk and no patients ever received the defective placebo.

Recently, Healios announced the resumption of the TREASURE study. While this was a frustrating experience for everyone, I want to emphasize that we believe it was handled appropriately under the circumstances. In any event, we're pleased that the issue has been resolved and that the study has recommenced.

We and Healios are both committed to the highest standards when it comes to the conduct of clinical trials and to fulfilling our shared goal of making MultiStem a treatment option for patients that have suffered a debilitating stroke. To support our longer-term goals, over the last year, we've been focused on planning for our manufacturing needs in the event of success of the TREASURE trial in Japan.

Recall that under the regenerative medicine regulatory framework, recently established in Japan, there are multiple paths to potential approval resulting in the first commercialization opportunity for MultiStem therapy to treat ischemic stroke. The first path revolves around obtaining conditional approval, which under the regulatory framework for regenerative medicine products established in Japan, requires confirming the safety profile of MultiStem and providing plausible evidence of therapeutic benefit.

Under this scenario, if PMDA believes that the standard has been met, conditional marketing authorization would be granted for a period of 7 years, enabling clinical and commercial distribution and making the product eligible for full reimbursement under the national health care system.

Conditional approval would be granted along with the requirement for the sponsor to conduct additional clinical evaluation within the 7-year time frame in order to generate additional evidence sufficient to support full approval.

Meeting the standard for conditional approval may be accomplished with a modest-size study, as has been demonstrated by prior precedent.

In designing the 220 patient TREASURE trial, which is a double-blind randomized placebo-controlled study, both we and Healios agreed that this larger study would enable a more robust clinical evaluation and based on PMDA input and guidance, could position this program for potential full approval, if successful.

In either scenario, meaning under either conditional or full approval, both we and Healios are committed to ensuring that an appropriate manufacturing capability exists to take advantage of the corresponding clinical and commercial opportunities. To that end, we made the recent announcement regarding our new alliance with Nikon CeLL innovation for the explicit purpose of helping us both prepare for future commercialization in Japan.

It's worth noting that this announcement also represents the culmination of an important objective that was first laid out by Japan's Prime Minister, Shinzo Abe, at the World Economic Forum in Davos, Switzerland in January of 2014. At that event, Prime Minister, Abe, stated that Japan is committed to becoming a global leader in the field of regenerative medicines and that his administration would make it possible for companies to manufacture stem cells in factories in Japan. Since that time, his administration has established programs providing capital and other incentives to help achieve that goal.

Our recent announcement with Nikon represents an important step towards making Prime Minister Abe's vision a reality. Importantly, since 2015, Nikon has been investing aggressively to plan and build the infrastructure and capabilities necessary to make this happen. Over that time, they've designed and constructed the state-of-the-art manufacturing facility in the Koto area of Tokyo. This facility represents one of the largest contract development and manufacturing facilities in Japan.

And is explicitly designed to meet the needs for commercial production of cell therapy products. Nikon's decision to invest to establish this facility and their solid execution over the past 2.5 years makes them a highly attractive partner for both Athersys and Healios anticipated commercialization and potential clinical development needs in Japan.

We were pleased to make the recent announcement regarding the partnership and are excited to be initiating the technology transfer process with Nikon as we now move forward together with support from Healios. This manufacturing partnership represents just one of the steps we've taken to help ensure that we have the necessary capabilities to achieve our clinical development and commercialization goals. Historically, we've maintained a long-standing relationship with Lonza, who has long been regarded as a leader in the biologics manufacturing area.

However, as they publicly described earlier this year, they've experienced a meaningful operational and regulatory challenges related to certain facilities and capabilities. If Lonza continues to have such challenges, they can pose an issue for Lonza clients to depend on. Accordingly, while we still consider Lonza an important and committed partner, we recognize that we cannot rely solely on their capabilities and capacity, which is one of the reasons why we implemented the relationship with Nikon and why we've established other contract manufacturing relationships as well.

Over time, we will continue to expand and diversify these types of external capabilities so that we're positioned to achieve our clinical development and commercialization goals and objectives, and are not vulnerable to any operational deficiencies or other issues that may incur at any single contractor or key service provider.

Additionally, we continue to explore strategic partnerships that will provide funding and additional capabilities to help us meet our goals, achieve development and commercialization success and create meaningful shareholder value in the process. As we've described previously, we've been actively evaluating potential partnering opportunities related to development and commercialization in North America, Europe and China, particularly, related to our lead stroke program.

Over the past several months, we've advanced our discussions with potential business partners that are well positioned to support development and commercialization activities. And we are currently engaged in active negotiations and discussions regarding specific proposals with qualified companies. We are intent on establishing one or more partnerships that balance the partner's contribution of capabilities and resources, commitment to the program and appropriate recognition of the value of the commercial opportunity.

Though we are currently focused on several possible options, we cannot provide guidance about the precise nature, scope and size of any potential partnership, while this process is ongoing. Needless to say, these initiatives remain an important priority for the company and we are making good progress towards achieving our goals. While we understand the intense interest this topic generates, given that we have ongoing negotiations and discussions that are being conducted under confidentiality, it would be inappropriate for us to characterize things further at this moment.

However, it is important for everyone to understand that we remain fully committed to achieving this important near-term goal for the company. In the meantime, we continue to maintain a healthy balance sheet, as B.J. described earlier, as we continue to finalize our preparations for the MASTERS-2 trial.

In the past year, we've made substantial progress achieving multiple important regulatory designations in the U.S., Europe and Japan. Most recently, the awarding of the Regenerative Medicine Advanced Therapy, or RMAT designation from the FDA for our ischemic stroke program, which is intended to expedite the development in regulatory review process for promising therapies that meet the requirements established by the FDA.

This follows the fast track designation we received from the FDA for this program earlier this year, a Special Protocol Assessment, to clarify the potential path to approval and more recently, a final scientific advice positive opinion from the EMA, establishing alignment between European and U.S. regulators regarding the potential for product approval following a successful MASTERS-2 study. And importantly, we note the Sakigake designation in Japan conferring priority review granted by PMDA to Healios earlier this year.

Each of these designations was based on a rigorous analysis of data and results from our completed MASTERS-1 clinical trial as well as other information that was provided. Collectively, these designations serve to underscore the strong regulatory support that we and Healios have received following that rigorous assessment of data and results.

We're also pleased to receive recognition from other organizations, such as the announcement this afternoon regarding our inclusion in Deloitte Technology Fast 500, which is a ranking of the 500 fastest growing technology, media, telecommunications, life sciences and energy tech companies in North America. We're proud to be included in that group.

Before we move to a few questions, I'd like to conclude my prepared comments by saying that we remain absolutely committed to advancing our programs and achieving our goals on behalf of our shareholders and the patients that we're dedicated to helping. While there are some that fail to fully appreciate how hard our team works and just how committed our organization is, we are grateful to have received tremendous support from physicians, nurses, patients and their family, regulators, shareholders and many others that recognize and appreciate what we're doing.

I'd like to acknowledge that support on behalf of everyone here at the company, express our gratitude and appreciation. As we do each quarter, we'll open it up for a few questions from those dialed in, in just a moment. However, before doing that, as I noted on the recent earnings call, we occasionally receive questions from shareholders that are conveyed to us. And I'd like to take the opportunity to address some of the questions that have come up recently.

Several people have asked about whether the placebo issue has been successfully resolved and whether the TREASURE trial in Japan has resumed? I've already addressed this issue in my comments, but just to reconfirm, yes, the placebo issue has been successfully resolved and, yes, the trial in Japan has resumed. People have also asked, when we can anticipate enrollment of the first patient in Japan? While the trial is only recently recommenced, we hope and expect that will occur soon.

Obviously, we have no direct control over that, but certainly Healios and we will make an announcement at the appropriate time.

Another question comes from Jesse, who asked is the company actively planning or currently conducting a financing with investment bankers? Thanks for the question, Jesse. The short answer is, no. We are not currently conducting a financing with any investment bankers or actively planning one. Our current focus is on the partnering initiatives I mentioned, in addition to our operational responsibilities and priorities. As we've demonstrated, we have tools in place that enable us to maintain a healthy balance sheet and we're committed to doing just that.

It's important to note, however, that we and the board maintain the option and flexibility to do whatever we feel is in the best interest of the company and our shareholders, including an equity financing if we believe it's an appropriate thing to do. But as I mentioned, right now, our focus is in other areas.

Another question comes from Ray, who also writes under name Wall Street Titan. He asks, can you please provide more information on the announcement regarding the recent filing related to an IT settlement with Garnet. Thanks for the question, Ray. While we're a bit limited in what we can say about this issue due to the agreement we entered into, let me try to briefly convey some information that will hopefully provide some additional clarity.

As we disclosed in public filings, for some time we've been engaged in an ongoing dispute with the group in question related to a specific aspect of intellectual property. This began approximately 10 years ago. While it has been a distraction at times, we've never viewed this as having any material impact on the development of our technologies or products or as patent attorneys refer to it as having an impact on our freedom to operate. Over the past few years, we've been engaged in specific actions in the U.S. and Europe involving the group in question.

Recently, they reached out to us to propose that we have a discussion regarding a potential settlement prior to the resolution of the ongoing actions. While we were confident in the eventual outcome and also confident that no matter what the outcome, it wouldn't alter our path forward, our choice was pretty straightforward. We could have continued the dispute, which would have cost additional resources and effort over time for both parties or we could see whether we might be able to achieve a mutually acceptable outcome that will result in clarity at a defined cost, eliminating the need to spend time, effort and money on further legal proceedings as we move forward.

In our discussions, we were ultimately able to define a mutually acceptable arrangement, in which we obtained a nonexclusive license in the event that they ultimately receive a patent on certain technology in exchange for a modest amount of cash and shares of our common stock. Importantly, we did not provide access to or license any of our technology to them. And we retained our ability to enforce our intellectual property rights against them if they develop cell therapy products or treatments.

Our board felt this was a reasonable and prudent course of action. It eliminated the distraction and expense and provided certainty at a defined cost as we move toward commercialization of our products. Accordingly, we entered into the settlement that we recently disclosed. Our IT portfolio remains broad and strong and we continue to strengthen and expand it over time. We are highly confident in the strength of our IT, and we'll continue to do whatever we need to in order to enforce, protect and defend our position.

Another question that several people have asked relates to our other ongoing clinical trials in treating patients that have suffered an acute myocardial infarction and a separate trial evaluating administration of MultiStem therapy, the patients that are suffering from acute respiratory distress syndrome, or ARDS. Specifically, people have asked what is the current status of these trials. Both trials remain active and are enrolling patients.

Our goal is to complete enrollment of the exploratory ARDS trial this winter, which tends to be when more of these cases occur since respiratory infection, flu, pneumonia or other seasonal occurrences can precipitate the condition in individuals that may be susceptible or at risk. As we've described previously, the primary clinical evaluation for these patients takes place over 30 days. So once the last subject has been enrolled, we anticipate completing the initial clinical evaluation pretty efficiently.

The AMI study continues to progress, although the progress in this trial has been slower than we would like. We have multiple sites actively screening patients and as the study has advanced, we've made several protocol amendments that our KOLs, or key opinion leaders, and clinical team felt were reasonable and appropriate in an effort to enhance enrollment rates, some of which were implemented in the past several months. We are committed to completing this study as quickly as possible. But we aren't giving a specific projection or guidance on trial completion at this point. We will provide further updates on both studies as things progress and as it's appropriate to do so.

One final question we wanted to address today relates to a recent blog written about the company, which contains false and misleading information about the company, our key programs and other activities. This article was authored by an unnamed individual writing under a pseudonym. On the morning the article first appeared, we received an alert from the NASDAQ market surveillance team, who promptly notified us of the article and also some unusual and suspicious trading activity.

We subsequently learned the true identity of the author, who manages a short-selling hedge fund, and learned that they, along with several other individuals, are currently the subject of litigation for alleged manipulative trading or so-called short- and-distort trading schemes. This matter is currently under investigation by FINRA and NASDAQ, and we're also referring it to the SEC. We take these types of issues seriously, and have been working with our legal counsel to take appropriate action so that we may hold the people in question fully responsible for their actions.

While we received a number of other questions, we feel that most of these have been adequately addressed in our comments or filings.

And so now I'd like to open it up to Q&A for those that are waiting on the phone.

(Operator Instructions) And your first question comes from the line of Jason Kolbert with Maxim Group.

Michael Okunewitch on behalf of Jason Kolbert. Though it seems like it's safe to say that manufacturing is now resolved, but I just wanted to know will the Japanese manufacturing be used to support just Healios or the rest of the world as well?

Well, we have the option to use that manufacturing capacity however we want. I mean, basically our longer-term objective is to establish redundant and diverse manufacturing capabilities, which are essentially built to common standard, so that we can utilize those capabilities, however we think it's appropriate.

I think Healios was quite interested in establishing a manufacturing capability in Japan and we agreed with their reasoning for that, and we felt that Nikon would be a very good partner for both of us. And that's why we implemented that capability.

Yes. All right. Now I just want to know if the processes for, let's say, Lonza and Nikon are comparable to, say, a Hitachi process?

Well the process -- the manufacturing process is established by us. The capabilities for different manufacturing facilities can be a bit different. There's obviously similarities, but the reality of it is that there are number of contract manufacturing organizations that are out there and we've looked at quite a few of them to determine which ones we think would be the best fit for us. So -- but, again, I think it's important to recognize that the manufacturing process, which we've established, is proprietary, we developed it and that is our primary responsibility.

And now just on the stroke trial. How many centers are now open in Japan? And around when do you expect full enrollment for those?

Well, I don't think Healios has disclosed the number centers that are currently active in Japan. They have disclosed that when all the centers are up and running, they expect to have more than 30 clinical sites actively participating. They've given some guidance on when they are hoping to have enrollment completed, which is around or before the end of next year. But they're going to periodically update that as things move ahead and as circumstances warrant.

All right. Now what about the U.S. and the European PIII trials as well for stroke?

Well, I guess, do you have a specific question about that?

I mean, when you're expecting those to get enrolled? And...

Yes. I mean, right now we're planning on completing the preparations for the initiation of the study. That's really our main focus right now at the current time, and we'll give more guidance with respect to the conduct of the study as we move ahead.

All right. Now given there's going to be a bit of a long time line to the data, what interim looks on plan, so we can get a feel on how these are going throughout the process?

Well, we provide updates quarterly, we provide updates at various events along the way, we usually don't give specific enrollment updates on trials. But, again, we define important milestones whether it relates to clinical activity, partnering activity or other things that we might be involved in and we make announcements as appropriate along the way.

And your next question comes from Katherine Xu with William Blair.

This is [Roland] in for Katherine. Number one, do you still expect to get started by year-end 2017 for the MASTERS-2 study? And do you need to get a partner to get started with that?

So we're actively preparing for the trial, and we're moving forward in the context with some of the ongoing partnering discussions that we have right now. It's a near-term goal. I'm not going to characterize it any more precisely than that other than to say that it's obviously a critically important priority for us. And we're making good headways towards achieving all the things we need to.

Yes, I think it's worth to adding. I think it's worth adding that I think it's worth us to play out the partnership discussions before we kind of finalize the initiation, timing, et cetera, right? So we need to let this play out a little bit before we provide specific guidance with respect to the timing, study, et cetera.

Yes. Understood. Are there any ideal factors you're looking for in a partnership?

Well, there's lots of factors that go into selecting the right partner. I'm not going to get into the specifics of that. I mean, obviously there's economic consideration. There is making sure that we have alignment on all the key aspects related to development and a whole bunch of other things, both near term and long term, alignment of vision capabilities, resources and a whole bunch of other things that go into that. As I mentioned, I think we're making very good progress in the areas that we need to, and we're optimistic about the outcomes.

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

Most of the ones -- foremost on my mind is just making sure I'm up-to-date on your latest thinking for timing of lot of programs. And I think between your prepared remarks and my colleagues' early questions, we probably gotten as good of answers as you could provide on that. But I just wanted to clarify one thing I think you said about Healios' guidance, about 1 year to enroll once they start enrolling patients, did I hear you correctly on that?

No. I think Healios has stated that their objective is to try and complete enrollment of the trial next year. And, obviously, with the recent issue related to the placebo, things got interrupted for a couple of months. But again, I think their goal remains to try and complete enrollment of that study as quickly as possible and to try and complete enrollment of the trial next year. And again, it's a 90-day primary endpoint for the study.

All right. Yes. That makes a lot of sense. And then you kept cash constant during the quarter. I wonder if you could just provide more details on the sources of the cash during 3Q. Was that mostly through your equity purchase agreement? And if so, can you tell us how many shares you ended the quarter with?

I can update a little bit on that. So over the course of the year, we raised capital on a couple of different ways via the equity offering. At the beginning of the year, of course, we had some warrants that were exercised as well. And then, we made some use of the equity facility in the third quarter, and we did a little bit in the second quarter as well. Just to provide a little bit of background on that, we have an equity facility with an institutional investor.

They are long-term investor in the company. They are a long holder in the stock. We've had a couple of facilities with them over the years and use the facilities periodically or opportunistically to support specific objectives and so forth. And I think as Gil mentioned, one of the key objectives here is to maintain a balance sheet that's healthy and gives us the strength and flexibility to complete negotiations on the business side effectively.

So that's what we've done here. So we did largely maintain the cash position through some activity on the purchase agreement. There may have been some potential impact on the working capital side as well, but to a larger extent, it's through utilization of the equity facility. I think at the end of the quarter and I'll ask Laura to correct me if I am wrong, but I think we have approximately 117 million shares outstanding, is that correct?

Correct, B.J.

After the utilization. Okay?

Yes. Very helpful.

And we have time for one more question, which comes from the line of Steve Brozak with WBB.

Gil, I know that you had basically said you didn't really want to talk about potential partners into the future, but in looking back, what makes your ability to look at partners different now considering that you have partnered with the who's who? What are some of the things you've learned about partnering and that you learned about what some of the pitfalls are? And that you learned about what you think you're looking for in terms of partner's abilities and your ability? How you're going to do things differently in terms of future partnering? And you can expand on this as much as possible.

Yes. It's a great question, actually. I think one of the lessons that we've learned from some of the prior relationships that we've been engaged in is that we need to establish if there's really good alignment upfront before we enter into the partnership with respect to the clinical development path. Now one of the things that I think a key difference maker here is, we've already done that. We've already put in place a very clear development and regulatory path.

We've negotiated it with the regulators, it's codified in the Special Protocol Assessment. It's supported and validated by the different regulatory designations that have been conferred along the way. So we have this very well mapped out already. So one of the things that I think, again, we've learned in the past is sometimes the partner might have different thoughts on how to approach certain types of clinical studies or development activities, and they may not be consistent with or in complete alignment with how or what we want to do.

In this case, I think we've neutralized that as a consideration because we have a very clearly defined plan that's already laid out. But it extends well beyond that, because I think that what you really want to make sure that you have is good alignment on some of the other big items or other big dimensions of how partnership might work. And I'm not going to get in and provide specific examples on that, but I think that there are number of different things that I think are very, very important to establishing long-term harmony and frankly long-term success of the strategic partnership.

This partnership is going to be a critical initiative for us. It's going to have a very big impact on almost everything we do. And that's why we are making sure that we're doing this right. And we're working very hard at it to make sure that we pick the best partner, do it the right way, have the right relationship parameters in place so that we can meet our goals and deliver the type of shareholder value that we're committed to delivering and achieve the kind of development success and commercialization success that we've been aspiring to accomplish for a long, long time.

And along those lines, I just have one follow-up final question. For the majority of time the way I have seen partnerships, it's been usually that the large partner goes out there, handles all the regulatory and everything else and the smaller partner basically is in a position of just being along for the ride. I would imagine given your relationship with FDA that you probably would have a stronger voice in that prospect, given your expertise in the space. Just as much clarity as you can give us on that?

Yes. Again, it's a good question. And you're absolutely correct. I think we've demonstrated pretty convincingly in many occasions that we have a very solid relationship with regulators. We know what we're doing when it comes to interacting with the FDA, with EMA, with PMDA or with other regulators that we may engage with. And I think that the companies that we have worked with and the companies that we might work with, on a going-forward basis, I think are aware of that and are confident in our capabilities in that regard.

And again, we are not willing -- obviously, any partnership relies on the ability of the partners to work together and to achieve things in a clear and efficient manner. But I think there was a tendency and this was kind of embedded in your question in a lot of relationships historically for it to be viewed as the smaller company just kind of tossing it over or handing it over to the bigger company and then they are taking it from there. That would absolutely not be the case, as we're moving forward.

And again, we've laid a very strong foundation already for not only defining exactly what needs to be done, but how it's going to be done and who is going to do it. And I think that type of clarity, actually, is an important ingredient into allowing us and the partner to establish what we need to do on the path from where we are right now to actually achieving regulatory success and getting approval. And again, there's other things that need to be defined along the way that relate to the whole range of different areas, but I'm confident that we're going to be in alignment with whoever we partner with to achieve that. And that's how you create value in my estimation.

We have reached the end of our Q&A section. Dr. Gil Van Bokkelen, your closing comments, please?

You're close. It's Van Bokkelen. But anyway, thanks very much. I appreciate everybody dialing in and participating in the call today. And we look forward to providing another update very soon.

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