aTyr Pharma, Inc. (ATYR) Q4 2019 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by, and welcome to the aTyr Pharma Fourth Quarter and Full-Year 2019 Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker, Ms. Jill Broadfoot, Chief Financial Officer. Please go ahead.

Thank you, and good afternoon, everyone. Thank you for joining us today to discuss aTyr's fourth quarter and full-year 2019 operating results and corporate update. We are joined today by Dr. Sanjay Shukla, our President and CEO. On the call, Sanjay will provide an update on our corporate strategy, including the clinical development of ATYR1923, our recent licensing agreement with Kyorin Pharmaceutical and our antibody program. I will then review the financial results and our current financial positioning before handing it back to Sanjay to open the call up for any questions. Before we begin, I would like to remind everyone that except for statements of historical fact, the statements made by management and responses to questions on this conference call are forward-looking statements under the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Please see the forward-looking statement disclaimer in the Company's press release issued this afternoon as well as the risk factors in the Company's SEC filings and included in our most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as facts and circumstances underlying these forward-looking statements may change. Except as required by law, aTyr Pharma disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. I will now turn the call over to Sanjay.

Thank you, Jill. Good afternoon, everyone, and thank you for joining us for year-end 2019 results conference call. During 2019, aTyr significantly progressed the development of our clinical program and preclinical pipeline of potential first-in-class therapies for diseases with high unmet need and strengthened our balance sheet to enable us to further advance these programs towards important and potentially value-creating milestones. Since we last spoke in November, we achieved two important milestones for our lead product candidate, ATYR1923. First, from our Phase Ib/IIa clinical trial in patients with pulmonary sarcoidosis, we announced interim safety results showing study drug, either 1923 or placebo was observed to be generally safe and well tolerated with no drug-related serious adverse events. And second, we entered our first strategic partnership with Kyorin Pharmaceuticals for the development and commercialization of 1923 in Japan, worth up to $175 million in upfront and milestone payments. In addition, let me review our other recent news from this current quarter. We published a paper in the Nature Journal Cellular and Molecular Immunology highlighting the essential role that histidyl tRNA synthetase or HARS plays in the modulation of immune cell engagement in a broad range of disease states, including interstitial lung diseases or ILDs. We raised gross proceeds of approximately $20.7 million from a public offering of common stock. We appointed Dr. Arthur Mercurio, a leading cancer researcher as a scientific advisor to the company. And finally, earlier this week, we announced the award of a Hong Kong government grant to build a high-throughput platform for the development of bi-specific antibodies, further building out on NRP-2 antibody development program. 2019 was a productive year for us and this momentum has continued in early 2020. Today, I will provide further details regarding our progress with our lead therapeutic candidate, ATYR1923 and advancements in preclinical research and development efforts on NRP-2 and tRNA synthetase biology. Jill will conclude with a review of our financial position. Before outlining these details, I want to discuss the effect of the COVID-19 pandemic on our operations. We are utilizing our best efforts to maintain compliance with government directives and keep our patients, investigators, site personnel and employees safe with as a little business disruption as possible. Clinical studies across the globe are being negatively impacted by COVID-19 and we are also seeing the effects in our 1923 clinical study. We are currently enrolling patients for cohort 3 of our study. However, completion of enrollment has been impacted as many sites have curtailed clinical trial operations. In addition, continued dosing for some existing enrolled patients will be delayed. We will continue to work closely with sites and investigators. However, we expect this pandemic to delay the timing of our topline Phase Ib/IIa study results. Everyday, we learn more about the impact of this pandemic. Therefore, it is difficult to estimate what type of delays we will see in our clinical trial results at this time. We are operating our business remotely and we will provide further updates as this public health crisis unfolds. Now I'll return to a review of our 1923 program. As a reminder, 1923 is currently being evaluated in a Phase Ib/IIa randomized, double-blind, placebo-controlled, multiple ascending dose clinical trial in 36 pulmonary sarcoidosis patients. In December, we announced the results of a pre-planned, blinded interim analysis of safety and tolerability, the primary endpoint of our trial. Interim safety data results announced were from 15 pulmonary sarcoidosis patients who had received a minimum of one dose of blinded study drug. Study drug was observed to be generally safe and well tolerated with no drug-related SAEs, consistent with our Phase I study results in healthy volunteers. We’re encouraged by these initial findings, which provided an early indication for 1923 meeting the primary study endpoints of safety and tolerability in trial. Further validation of our 1923 program came earlier this year when we announced a collaboration and license agreement with Kyorin for the development and commercialization of 1923 for ILDs in Japan. Under the terms of the agreement, we received an $8 million upfront payment and are eligible to receive up to an additional $167 million in the aggregate upon achievement of certain development, regulatory and sales milestones, as well as tiered royalties on net sales. We structured the milestones to be weighted more on the development side to allow us to realize value from this partnership as the program progresses through the clinic. Kyorin is a leading respiratory-focused pharmaceutical company. They have a strong R&D and commercial presence, with an existing footprint covering all of the key ILD centers in Japan. As in the U.S., ILDs represent an area of significant unmet need in Japan, and Kyorin’s development and commercial capabilities will enhance our ability to improve the lives of patients with these serious conditions. We believe this collaboration further validates 1923 and potentially helps us accelerate development in other ILDs. Global development strategy for 1923 will be led by us and we will remain responsible for all operational activities outside of Japan, including manufacturing. Kyorin will be responsible for funding and executing all research, development, regulatory, marketing and commercialization activities in Japan and has initiated development activities, including dialogue with the relevant regulatory agency, the Pharmaceuticals and Medical Devices Agency or the PMDA. We look forward to working with Kyorin as a strategic partner for the advancement of 1923. Pulmonary sarcoidosis and other interstitial lung diseases present a significant opportunity for novel therapeutic approaches that can ideally slow or halt disease progression and the resulting decline in lung function. The favorable interim safety results allow us to advance our trial towards establishing preliminary evidence of the potential 1923 as a treatment option to improve the lives of patients with pulmonary sarcoidosis. Our partnership with Kyorin also allows us to potentially accelerate the development of 1923 in other ILD indications. We are focused on all forms of ILDs, with the exception of idiopathic pulmonary fibrosis or IPF, which is the least inflammatory ILD. These inflammatory ILDs represent a unique area of opportunity where there is a lack of clinically proven therapeutic options and limited development activity. We believe these conditions combined could represent a $2 billion to $3 billion market opportunity for 1923. Overall, we believe our value proposition in the areas of ILDs is significant and leading pulmonary experts remain very interested in our compound. Let's shift gears and discuss our efforts to understand the role of NRP-2 and various other diseases outside of ILDs as we move forward towards developing new differentiated NRP-2 targeted pipeline opportunities. NRP-2 is a potentially novel therapeutic target for cancer and inflammatory disorders, whose expression is up-regulated, both in immune cells during inflammation and in tumors, with high tumor expression of NRP-2 linked to worsened patient outcomes. We continue to expand our leadership position in NRP-2 and currently have active scientific collaborations with leading academic institutions. Through these collaborations, we are exploring potential therapeutic use of selectively targeting the NRP-2 receptor in the context of specific diseases. Our panel of antibodies developed in-house targeting distinct NRP-2 signaling domains offer the compelling possibility of developing multiple new, well-differentiated product opportunities. We have recently partnered with Dr. Arthur Mercurio as a key scientific advisor to the company. We've previously been working with Dr. Mercurio’s lab at the University of Massachusetts Medical School. Under the collaboration, we explored the use of one of our NRP-2 antibodies in triple-negative breast cancer models, one of the many cancers where NRP-2 is implicated. Results from this collaboration are included in abstract. It has been accepted by the American Association for Cancer Research for a poster at its Annual Meeting. We will keep you updated as to when this important data can be shared. In addition to the well-established role of NRP-2 in mediating cancer growth, metastasis and drug resistance, there are a number of novel applications for selective NRP-2 antibodies, which we are also actively exploring. Earlier this week, we announced that our Hong Kong subsidiary, Pangu BioPharma Limited, together with the Hong Kong University of Science and Technology has been awarded a grant of approximately $750,000 to build a high-throughput platform for the development of bi-specific antibodies. Initially this research will focus on diseases, including cancer in which NRP-2 over-expression is strongly implicated. A bi-specific antibody approach presents a further differentiated opportunity to elucidate the therapeutic potentials in NRP-2 and its co-receptors as drug targets. The fact that NRP-2 interacts directly with various co-receptor molecules, including certain plexins, integrins and chemokine receptors like CCR7, make it a prime target for bi-specific antibodies that can target both receptors simultaneously and modulate the activity of the signaling complexes. The two-year project is being funded by the Hong Kong Government's Innovation and Technology Commission under the Partnership Research Program. The grant will fund approximately 50% of the total estimated project costs, with aTyr contributing the remaining 50%. We've collaborated with the HKUST for many years and place great value on this long-standing relationship. Finally, our research collaboration with CSL Behring, a leading global biotherapeutics company is progressing as planned. As a reminder, the goal of this collaboration is to identify up to four new IND candidates from our portfolio of tRNA synthetase IP. We plan on providing an update on this collaboration on our next quarterly call. Overall, we are very encouraged with our progress and look forward to completing our trial as expeditiously as possible given the current COVID-19 crisis. Additionally, our pipeline efforts around NRP-2 and tRNA synthetase biology are advancing both internally and with key strategic collaborators. I believe we have a unique opportunity to help significant and underserved populations, while at the same time creating long-term value for our shareholders. With that, I'd like to turn it over to our Chief Financial Officer, Jill Broadfoot to review our financial results.

Thank you, Sanjay. Total revenues were $422,000 for the year ended December 31, 2019, consisting of collaboration revenue from our research and collaboration and option agreement with CSL, where we also have the opportunity to receive up to a total of $4.25 million in auction fees per synthetase program, up to a total of $17 million if all 4 synthetase programs are advanced by CSL. Research and development expenses were $14 million and $20.4 million for the years ended December 31, 2019 and 2018, respectively. The decrease of $6.4 million was due primarily to a $2.8 million decrease in personnel associated costs mainly as a result of a reduction in force initiated in May 2018, a decrease of $1.7 million in costs associated with our research collaboration with The Scripps Research Institute which we terminated effective November 2018, a $1.7 million decrease in preclinical research and development expenses and a decrease of $0.7 million related to lower product manufacturing costs. The decreases were offset by an increase of $0.7 million related to our 1923 Phase Ib/IIa clinical trial. General and administrative expenses were $9.4 million and $12.4 million for the years ended December 31, 2019 and 2018, respectively. The decrease of $3 million was due primarily to a $2.2 million decrease from the May 2018 reduction in force, and a $0.8 million decrease in professional fees. As of December 31, 2019, we had $31.1 million in cash, cash equivalents and investments. Subsequent to the end of the year, we received an $8 million upfront payment in connection with the Kyorin Agreement. As Sanjay mentioned, under the Kyorin Agreement, we also have the opportunity to receive $167 million in additional milestones as Kyorin progresses in their development of 1923. We also recently raised gross proceeds of $20.7 million in early 2020 from the public offering of common stock, which is also not reflected in our year-end cash balance. Including the year-end cash, the Kyorin upfront and proceeds from our public offering, we estimate we will have approximately $50 million in cash, cash equivalents and investments at the end of the first quarter of 2020. We believe these cash resources will comfortably allow us to reach significant and potentially value-creating milestones during 2020. Also our long-term debt decreased from $16 million at year-end 2018 to $8.7 million as of December 31, 2019. We are on target to have our loans fully repaid by November, 2020. We believe the combination of licensing revenue, grants, equity proceeds and continued cost saving measures over this year gives us sufficient cash to comfortably end 2020 with over $20 million in cash. Now I'd like to turn the call back over to Sanjay before we open it up to Q&A.

Thanks Jill. Before opening the call for questions, I want to highlight, over the last month, we have received several questions and queries from investors and analysts about the potential utility of 1923 in treating COVID-19 patients. As the COVID-19 outbreak continues, we are learning more about this virus, what it does to the body and the damage it can cause particularly to the lungs. Although, many people with COVID-19 have no symptoms or only mild symptoms, a subset of patients develop acute respiratory distress syndrome, or ARDS and may need to be admitted for intensive care. Based on our understanding of the mechanism of actions of 1923, including its effect in a number of acute lung injury animal models where we have demonstrated efficacy, we believe 1923 has the potential to help COVID-19 patients, who develop ARDS. We have formally approached the FDA on the potential development of 1923, including clinical testing, in this setting. This engagement is preliminary. However, we felt it was important to let investors know where we're at as our company looks for ways to help with this public health crisis. We will keep you informed as our discussions with the agency progress. We appreciate your interest and continued support and look forward to providing updates in the future. At this time, Jill and I will be happy to take your questions.

[Operator Instructions] Our first question will come from Zegbeh Jallah with ROTH Capital Partners.

Thanks for the updates. Just for clarification, are all the sites for 1923 currently on hold? And when they do come back online, do you expect them to all be up at the same time? Or will some of them take longer than others? And will you also consider opening new sites?

Sure. Thanks, Zegbeh, for the question. So just to clarify, they're not all off-line. They're at various different stages. There are some centers that are continuing to screen and dose. There are other centers who have said, we're going to continue dosing but we're going to maybe take a little pause on screening. There are other centers where if they made that decision to sort of halt both of those aspects, they're being a little bit more aggressive. I would anticipate it's going to be really dependent on each center, what they see is the burden of COVID-19 to that center and basically reapportion resources while, at the same time, minimizing risk for patients. So it's going to vary. I think what you can anticipate is, hopefully, as centers get a better handle on this, if there are any of those that have sort of been a little bit more impacted with our site, our trial, they'll be able to actually maybe open up, whereas others, hopefully, we'll have to just kind of see how this progresses. So there's going to be some variation there.

Thank you. And then just another follow-up here. The grant that was awarded to Pangu and HKUST, with that grant in hand now, do you anticipate an acceleration of efforts to develop the neuropilin antibodies? And any additional comments on indications or anything based on what you now know preclinically?

Sure. So we had done a nice job developing kind of in-house neuropilin antibodies to specific subdomains of NRP-2. This grant specifically is looking at another angle here and that is a bi-specific platform. A bi-specific platform will allow us to potentially create antibodies that not only target a neuropilin-2 receptor, but also those adjacent, important receptors that are proximal to neuropilin-2. And those include things like plexins, integrins and some of those other co-located receptors. And if you think about those pathways, now you have an additional mechanism to potentially agonize multiple pathways. So I want to highlight that the project with HKUST and what's going on with Hong Kong is a bi-specific approach. We currently still have our in-house antibodies, but this might be a nice way for us to create even another candidate that targets multiple pathways at once.

Thank you. And then just last question here about AACR. We do know that some presentations will be virtual, so wanted to know if we can anticipate seeing yours as well.

Yes. So we haven't gotten details yet from AACR, but we suspect they are prioritizing clinical-level data and clinical abstracts to be presented more so online next month. But we don't know yet. Right now, we're planning, of course, to have this poster display at their annual meeting, which I think is being rescheduled for the fall. Should we be asked to present an electronic poster or anything online in April, we'll certainly let you know right away.

Thank you.

Thank you. And our next question comes from Joe Pantginis with H.C. Wainwright.

Hi Sanjay and Jill. Thanks for taking the question. I hope you and your families are well. Just wanted to start with the clinical update you gave obviously with regard to the sites update and potential impacts from COVID, which certainly is unfortunate. The one part I wanted to ask about, if I heard you correctly, I think you said it's also potentially impacting those patients already being dosed. So I guess I wanted to get a sense about – so are there some patients that might not get their full regimens? And a lot of this, I'm sure you don't know the answer to because the FDA is still trying to figure it out, but if regimens are being impacted, how it might impact statistical looks or how you can apply the data to the overall plan of the study even though it's early, et cetera.

That’s right. So I think it's an excellent question. We're going to have to see how those patients who perhaps are already enrolled, how the PIs want to handle these folks. You could have some individuals that were delaying a monthly dose and it could be delayed for two to four weeks, in which case it would be a relative period there that would be off-schedule. I think the FDA is acknowledging that and understanding that this is something that a lot of sponsors are dealing with. At the same time, you also may have a patient towards the end. Maybe they've already gotten five doses. We have to determine, is it useful for them to get that sixth dose. So it's really going to be dependent on the PI and the patient. We have a number of patients that want to continue, but the centers themselves want to be a little bit more careful about them coming back in. Flip side, we also have some patients that might have some concerns about coming back in. So this is something that we're going to have to monitor, but I think you can expect to see that some patients who have previously been enrolled potentially could have a skipped dose. Others may could have a dose that is slightly off-schedule, and then we'll look to kind of get them back on the schedule. I want to highlight here that we have a pretty long-acting PK with our drug. And I would say even patients if they haven't been dosed for five or six weeks even, we still expect to see PD effects based on the PK of our drug. So we have that kind of helping us out here during this period. But again to determine how long these delays are, it's something that we're working closely with our centers at this time.

Sure. Totally understandable. Thanks for that. And then just moving to the recent announcement out of Hong Kong. Very exciting that the bi-specific program's moving forward. So just curious, what makes sense – not clinically, I'm sorry, scientifically with regard to what might be on the other side of the bi-specific? Are you looking to target sort of more classical targeting like anti-CD3 or the checkpoint types of components? Or are you looking at also novel things? Are you just pretty much open to all options at this point?

I think we have to look at what the literature and what the evidence already indicates. And I think the important thing here is neuropilin-2 is known to co-locate with things like the plexin pathway or the integrin pathway or CCR7. These are important pathways that have been mined and targeted for, for example, cancer and other inflammatory diseases. I think the advantage we have now is we have a potential with a bi-specific platform to modulate both pathways at once, not only the neuropilin pathway, but also some of those other co-located receptors. So I think this is something that we still broadly are looking at cancer and inflammation, but now there's another avenue through this ability to create a bi-specific platform that can lead to potentially more IND candidates from our antibody program.

Sure, sure. You mentioned that in your prepared comments, so I appreciate that. And then maybe a housekeeping question for Jill if you don't mind. Just wanted to see with regard to the $8 million upfront payment, how you're going to be accounting for that. Is there going to be a chunk that you'll recognize immediately and then amortize some? Or just wanted to get a sense.

Yes. There are a couple of obligations under the licensing agreement that we will be carving out some revenue for that. We are just starting our analysis of that and we'll have to have evaluation done. So I can't say exactly how much will be recognized and how much will be deferred until those obligations are fulfilled, but I would say the majority of it probably will be recognized. A majority should be assigned to the license portion.

Understood. Okay. Thank you, guys, and stay well.

Okay. Thank you.

Thank you. And our next question will come from Hartaj Singh with Oppenheimer.

Great. Thank you for the update and the commentary and I'm glad to hear everybody is safe during these times. Just had a few questions, Sanjay. One is – so thanks for – so that gave a lot of color with Joe's questions. What cohort are you at sort of – just to get a rough idea? Are you sort of at that second cohort or the third cohort as you're dosing up in terms of where are you with the actual cohorts?

We are in our final – so these are really the final patients in our study that we're looking to complete enrollment.

Got it. The other question is, I know that some of these patients were – one of the things that you were looking to was try to demonstrate that steroid tapering, which I think if that can be done, getting down to five milligrams per kg a day of prednisone, I think that's a really great initial kind of surrogate end point. How would you handle that? I mean some of these patients who probably already have their steroids tapered, some of them are going through the tapering process. So how would that be handled as you're going through this sort of – through this time?

Yes. So I think the tapering, as a reminder, occurs kind of in the first 50 days from being dosed. So we were attempting to get everyone down to five milligrams in the first eight weeks of the trial. So certainly, if anyone's on that taper schedule, that can still occur if they've received a dose. I think the important thing here is if you don't want re-dosed or have another dose of 1923, that's where I think a decision has to be made clinically with the investigator around monitoring their cough and shortness of breath. So it's still very much a real-world assessment using those two validated symptom indexes that we have, and titration is basically done based on the Leicester Cough Index and the Transitional Dyspnea Index. So that's still going to occur. The key component here is really where they are, I suppose, in our trial. The earlier they are in the trial, that's the active titration and for steroid taper. Once you get past week seven, week eight, that's where much of the real-world component kicks in. So that's still going to occur. I think the important thing here is going to be working with the PIs to determine how they want to manage dosing here of our drug during this – what we hope is a short-term of pause at some of our centers.

Got it. And then I was looking on ClinicalTrials.gov. I think you have 17 centers recruiting. I believe you want to get 34 patients on this study, so just roughly two patients per center. Do you have some sort of flex built into the protocol, whereby, let's say for sake of argument, one or two or three centers could not recruit any patients or you could still maybe add additional patients to centers that can or that are in states where there's less of a shutdown and then any kind of flex like that built into the protocol?

Sure. Good question. So we wrote the protocol without a patient recruitment cap at any of our centers. I think that's actually working to our advantage right now because there are several centers that are still moving forward. So there was not a cap at any of our centers that we could only enroll two, three, four patients. It is competitive enrollment. So this allows for us to, if you will, see some centers pick up some of the slack here. We're trying to get 36 patients into our study, and I think the 17 centers allow us the ability to, hopefully even if this is a longer-term delay, weather some of the delays here in the sense that different regions are going to have a different level of incidence of COVID-19 impacts.

Yes. No. That helps a lot. And then, Sanjay, just one quick update on that. Is that – how far away from you from getting all the 34 patients?

How far are we from completing enrollment?

Yes.

Yes. I mean we're really in the final stages here, a handful of patients that still need to be enrolled. So I would say that we were approaching the really final stages of completing enrollment here before hitting this delay. And I would anticipate that once we get started again a little bit more actively at all of our centers, I believe we'll be able to complete enrollment in a fairly short amount of time. The issue is going to be, let's just see how long this health crisis really impacts the more of the trial operations.

Yes. Last question on this, which is that FDA has already put our guidance to companies. I think – I mean it's a fairly thin document on clinical trials that are ongoing. Aside from safety assessment, is there enough flexibility built into your protocol, whereby even if it gets sort of pushed back and, let's say, these things happen, like you said, some patients go longer, a few maybe miss a dose, you might want to get patients from one or two centers, et cetera. But even if the readout gets pushed back, would you still feel comfortable with there being enough power or statistical validity in the study to be able to get a good insight?

I mean certainly from a safety perspective, we have more than adequate patients to make a safety and tolerability assessment, and we are testing multiple ascending doses here. If it was just a safety-only trial, we have enough patients to start to really look and have a view on whether or not making 20 is safe and tolerated in these patients. With regards to an activity signal, I think we had built this out so that it's not necessarily powered for a Phase III level statistical significance. However, I believe we'll still be able to detect trends of activity and efficacy in our trial, looking at our key end points around steroid sparing, looking at pulmonary function testing and then also some of the symptom scores as well, PET scans as well. So these are all things that I think, over time, we'll still be able to assess and determine whether or not we see a signal of activity here. I think had this occurred towards the beginning of the trial, it would be a lot more detrimental. As I said here, as we're trying to complete enrollment and finish up here, we think we still feel good about the readouts and being able to make these calls once we actually get to that point.

Yes. No. That makes a lot of sense. We had Scott Gottlieb on our call a couple of weeks ago and he said FDA is already in intensive discussions about how to work with companies to assist on this. So I assume that these will be things that will – that each of them will be working with them also. Last question is on the – on what you had mentioned with the COVID-19 and patients that are suffering under ARDS. I do remember thinking to myself that you had some animal models that seemed to go down that path. If you were – if the regulators were to give you a thumbs up in these regards, and I know we don't want to unnecessarily build up expectations, but how do you see sort of next steps? Would it be a one or two-center trial? Would you need more? Or would you have to work with NIH or any idea as some other companies are doing? What would be sort of the next steps that we could see kind of coming out of this if this was to progress forward? Thank you, again.

Sure. And I think the important point there, it is early. It's preliminary to get into some of this dialogue. It was important to first listen to what the FDA has to say here. I think some of the things that you pointed out around some of the evidence we have in acute lung injury models, that is compelling, demonstrate that we can down-regulate cytokines, and many of the same cytokines are involved in some of the inflammatory damage that you see in some of these early ARDS case reports. Given the fact that we have a good safety margin, a good safety data from Phase I data and the fact that we also have an existing IND, these are all things working to our advantage. In addition, we had adequate drug supply that if we wanted to do something in kind of a compassionate-type model, these are sorts of things that we're looking to get some feedback from the FDA. As far as design of that nature, I think it's a little bit early to start to talk about that. Typically, if you just look at what the other companies, some of them, are doing, they're looking for a signal in 20, 40, 60 patients first and then determining whether or not you want to move into a larger case-control type of study here to really demonstrate efficacy. So I would just say right now, it's exploratory, it's early. There is a rationale certainly from the evidence that we already have. And we have, as I said, formally engaged the regulator. And pending some feedback there, I think I'll have a better idea of next steps.

Great. Thank you all for the questions.

Thank you. Speakers, I’m showing no further questions at this time. I will now turn the call back over to management for any further remarks.

Well, thanks, everyone, for your interest and questions from all the analysts. As I said, we look forward to providing updates in the near future, and thank you for your support.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect, and have a wonderful day.