Aurinia Pharmaceuticals Inc (AUPH) 2018 Q3 法說會逐字稿

Greetings, and welcome to the Aurinia Pharmaceuticals Inc. Q3 2018 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Celia Economides, Vice President of Corporate and Public Affairs. Thank you. You may begin.

Thank you, operator. Good afternoon, everyone, and welcome to Aurinia's Q3 2018 earnings call and general business update. With me on the call today from Aurinia are Rich Glickman, Chief Executive Officer; and Dennis Bourgeault, Chief Financial Officer. Joining us for Q&A will be Dr. Neil Solomons, our Chief Medical Officer.

This afternoon we issued a press release detailing our Q3 2018 financial results and corporate update. The press release and financial statement package is available on our website at auriniapharma.com, and a 6-K was filed with the SEC as well.

I'd like to remind you that today's call is being webcast live on Aurinia's Investor Relations website and a replay will also be available following the call. The content of today's call is Aurinia's property. It cannot be reproduced or transcribed without our prior written consent.

During the course of this call, we may make forward-looking statements based on our current expectations. These forward-looking statements are subject to a number of significant risks and uncertainties, and our actual results may differ materially. For a discussion of factors that could affect our future financial results and business, please refer to the disclosure in today's press release, our most recent filings with Canadian securities authorities and the reports that we file on Form 6-K with the U.S. Securities and Exchange Commission. All of our statements are made as of today, November 8, 2018, based on information currently available to us. Except as required by law, we assume no obligation to update any such statements.

With that, let me turn the call over to Richard. Richard?

Well, thank you, Celia, and thank you to everyone for joining us today as we review our third quarter financial results and provide a general business update.

Once again, this has been an extraordinary quarter for our company and tremendous progress has been made on a number of fronts. Our largest milestone was the completion of the enrollment ahead of schedule of the AURORA Phase III clinical trial for the treatment of lupus nephritis. The target enrollment of 324 patients was surpassed due to high patient demand, with 358 lupus nephritis patients randomized in sites across 27 countries. We would like to thank our trial patients, physicians, our trial staff, our staff and advocacy groups for their extraordinary efforts which led to this result.

We are elated by the significant interest in this trial that has garnered so much interest around the globe. It reinforces the need for new treatment options for patients living with lupus nephritis. I continue to be impressed by the level of dedication exhibited by our team to execute this trial with great diligence and expediency but without compromising quality.

As you will recall, the AURORA clinical trial is a global, double-blinded, placebo-controlled study to evaluate whether voclosporin, when added to background therapy of mycophenolate mofetil or CellCept, can increase the speed and overall renal response rates in the presence of low-dose steroids. The primary endpoint for the study is complete renal response at 52 weeks, after which patients can choose to enroll in a 104-week blinded extension study. We expect top line data for this trial towards the end of 2019.

As of today, approximately 80% of the total patients enrolled in the study have been in the trial for more than 3 months. We believe the enhanced safety monitoring for this trial has been effective. The clinical team continues to review all safety data in a blinded manner, while the Data and Safety Monitoring Board reviews safety in an unblinded fashion. We remain pleased with the trial's progress.

During Q3, we also saw more patients roll over to the AURORA 2 blinded extension study from AURA. The purpose of AURORA 2 is to assess the long-term benefit and risk of voclosporin in patients with lupus nephritis. However, this study is not a requirement for potential regulatory approval of voclosporin. Long-term safety and efficacy data for our novel CNI should prove to be of great value to the medical and patient community, as we are committed to providing the relevant data to support treatment decisions.

To that end, I'm also pleased to announce that the AURA Phase II trial data has been accepted for publication in a high-impact nephrology journal, which will be published this month. This is a true testament to the importance of this study to both the scientific and medical community, and I am very proud of the clinical team for this accomplishment.

As you know, LN is a debilitating disease, and our team is extremely motivated and working diligently to potentially provide the first FDA-approved therapy for patients who are in desperate need of new treatment options. We believe the totality of data from both the AURORA and AURA clinical studies will serve as a basis for a new drug application submission with the FDA following a successful completion of the AURORA clinical trial.

Under voclosporin's fast-track designation, we intend to utilize a rolling NDA process, which will allow us to begin the submission process following a positive pre-NDA meeting with the FDA, which we anticipate to occur in the first quarter of 2020. To that end, we are actively preparing the nonclinical and CMC modules required for the NDA submission. Our current plan is to complete the NDA submission, including clinical module, in the second quarter of 2020, and therefore we do not expect any delay in our originally planned regulatory timelines.

Lastly, you will recall, we are now conducting our drug-drug interaction study in lupus patients rather than healthy volunteers in order to generate more meaningful data. I am pleased to say that we are currently initiating sites and enrolling patients in the DDI study. In this study, patients will be monitored for a period of 2 weeks. We believe the results of the study will add to our knowledge of voclosporin in a multitargeted therapeutic approach and should have no impact on our submission timeline or potential approval of voclosporin.

That brings us to an update on new indications we are pursuing for voclosporin, the first being focal segmental glomerulosclerosis, or FSGS. According to NephCure, approximately 5,400 new patients are diagnosed with FSGS each year, accounting for the largest segment of almost 30% of patients with nephrotic syndrome. FSGS is a rare disease that attacks the kidneys' filtering units, the glomeruli, causing serious scarring, which leads to permanent kidney damage and even failure. Similar to lupus nephritis, an early clinical response can be measured by the reduction of proteinuria, in addition to maintaining podocyte structural and functional integrity, which is thought to be critical for long-term kidney health. While guidelines exist for the treatment of this disease, there are no currently approved therapies for FSGS in the United States or the European Union.

After productive consultation with regulators in the first quarter, we successfully initiated the study in June. This is an open-label proof-of-concept study of 20 treatment-naive patients with FSGS. As we are essentially enrolling newly diagnosed patients and this is a rare disease, we expect a 12-month enrollment period, but we intend to have planned interim data readouts throughout the course of this trial.

As a company, we've been focused on lupus nephritis since its -- since our inception. Expanding our scope to include other proteinuric renal diseases is synergistic with our current strategy and long-term vision of the company. What's exciting about this trial is that we are assessing the potential of voclosporin as a first-line therapy for these patients in the complete absence of steroids. Massive steroid doses are often given to these patients and have many well-established side effects. An approved treatment could be of tremendous value to both patients and, of course, to our shareholders.

In July, we initiated yet another exciting program with a new and patented topical formulation of voclosporin, the voclosporin ophthalmic solution, or VOS, for the treatment of dry eye. This is a novel formulation of voclosporin which is a unique, patented, aqueous, preservative-free, nanomicellar solution containing 0.2% of voclosporin, and as you know from previous disclosures, voclosporin has been shown to be 3 or 4x more potent than cyclosporine A. VOS has its own separate formulation patents with exclusivity through 2031.

Dry eye is a chronic syndrome -- is a chronic disease in which a lack of moisture and lubrication on the eye's surface results in irritation and inflammation of the eyes. Dry eye is a multifactorial, heterogeneous disease estimated to affect greater than 20 million people in the United States alone. While the FDA-approved products do exist for the treatment of dry eye, 2 of which are CNIs, there's an opportunity for potential improvement in the efficacy and enhanced tolerability, including onset of action and alleviating the need, potentially, for repetitive dosing. We believe the calcineurin inhibitors will remain the mainstay for treatment of dry eye and that VOS has the potential to be a best-in-class calcineurin inhibitor within this billion-dollar market.

A Phase I trial has previously been completed in 35 healthy volunteers and in patients with dry eye syndrome. Our Phase II head-to-head tolerability study of VOS versus Restasis is well under way, and we closed screening today, with enrollment expected to be completed in the next couple of days. We expect the trial to complete before year-end, and we plan to report top line data before the end of January. This is a 4-week study in approximately 90 patients. The goal of this program is to develop a best-in-class treatment option, and I believe there's tremendous potential value in this asset.

So that's it for our clinical programs. Now Aurinia is in a substantial growth phase, and it has transitioned from an early-stage clinical company with one indication to a late-stage clinical company with multiple indications and preparing for commercialization. To that end, I feel that it is an appropriate juncture for me to return to my retirement and begin the transition to a new CEO who will build on our clinical success and lead the company into its next chapter.

Nearly 2 years ago, which was a critical time in our company's growth, I came out of retirement to join Aurinia as the CEO. My decision was fueled by my absolute conviction in the potential of voclosporin to transform the LN treatment landscape. I'm incredibly proud of Aurinia's progress over the last 21 months, and I know, for me, this is an optimal time to bring on a new CEO. I had several goals when I returned from my retirement nearly 2 years ago, and I feel these have all been successfully completed, the most important being the diligent execution of our Phase III clinical trial in voclosporin in LN, advancing new indications for voclosporin and providing a financial runway for the company.

I intend to step away from my role as CEO sometime next year when an appropriate successor is identified. I'm in no rush to do that; we will look very diligently to find that replacement. While this is a very challenging decision for me, as I work with an extraordinary team of people and particularly enjoy my interactions with the physicians, patients and our investors who have supported the development of voclosporin, I believe this is the right step forward for the company. My commitment to the company and these patients remains steadfast, and I plan to remain a resource for the board and for the management team as we enter this next chapter.

With that, I will turn the call over to Dennis Bourgeault, our CFO, to review the Q3 financials with you. Dennis?

Thank you, Richard. At September 30, 2018, we had cash, cash equivalents and short-term investments of $138.9 million, compared to $150.2 million at June 30, 2018, and $173.5 million at December 31, 2017. Net cash used in operating activities was $11.3 million for the third quarter ended September 30, 2018, compared to $8.5 million for the third quarter ended September 30, 2017.

We reported a consolidated net loss of $18.3 million, or $0.21 per common share, for the 3 months ended September 30, 2018, as compared to a consolidated net loss of $13.1 million, or $0.16 per common share, for the 3 months ended September 30, 2017. The increase in the loss for the 3 months ended September 30, 2018, compared to the same period in 2017, was primarily due to the noncash change in the estimated fair value of derivative warrant liabilities of $5.2 million. The 3 months ended September 30, 2018, reflected a $4.8-million increase in the estimated fair value of derivative warrant liabilities, compared to a reduction of $355,000 for the 3 months ended September 30, 2017.

The change in the revaluation of derivative warrant liabilities is primarily driven by the change in our share price at each period end. An increase in our share price results in an increase in the estimated fair value of derivative warrant liabilities and vice versa. The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by the company.

The net loss before the noncash change in estimated fair value of derivative warrant liabilities was $13.5 million for the 3 months ended September 30, 2018, compared to $13.5 million for the same period in 2017. For the 9 months ended September 30, 2018, the consolidated net loss was $49.5 million, or $0.59 per common share, compared to a consolidated net loss of $67.5 million, or $0.91 per common share, for the comparable period in 2017. For the 9 months ended September 30, 2018, we recorded an increase of $9.4 million in the estimated fair value of derivative warrant liabilities, compared to $32.9 million for the same period in 2017. The net loss before the noncash change in estimated fair value of derivative warrant liabilities was $40.2 million for the 9 months ended September 30, 2018, compared to $34.5 million for the same period in 2017. The increased loss was primarily due to higher research and development expenses.

Research and development expenses increased to $11.2 million for the 3 months ended September 30, 2018, compared to $10.8 million for the 3 months ended September 30, 2017. We incurred research and development expenses of $30.5 million for the 9 months ended September 30, 2018, as compared to $25.2 million for the same period in 2017. The increased research and development expenses reflected costs associated with the commitments of the AURORA 2 extension study and the FSGS and dry eye studies.

Corporate administration and business development expenses increased to $2.9 million for the 3 months ended September 30, 2018, compared to $2.7 million for the same period in 2017. We incurred corporate administration and business development expenses of $10.2 million for the 9 months ended September 30, 2018, compared to $9 million for the comparable period in 2017. The increase was primarily due to higher noncash stock compensation expense in 2018, compared to the same period in 2017.

With that, I will turn the call back over to Richard for some closing remarks. Richard?

Thank you, Dennis. Once again, I want to thank the team for the tremendous progress that has been made over the last quarter. We are diligently executing our clinical programs and we are looking forward to a very productive 2019, with data from our VOS dry eye program in January, followed by ongoing data readouts on FSGS and top line data for our Phase III trial in LN before the end of 2019.

The last couple of years have been extremely pivotal for the company, and we are now a late-stage biotech company that's diversifying its portfolio and building on its core competencies. We are a nimble, dedicated team that continues to successfully execute against our pre-stated milestones. As a company, we have a drug candidate that, if successful in Phase III, has the potential to be the first approved therapy for the treatment of LN. We believe the efficacy and safety data supporting this drug could be substantial. We have a clear regulatory path forward to approval through a solid intellectual property base, and we believe the market opportunity for this drug is significant. It's with great confidence that we continue to advance voclosporin through its final phase of development.

With that, I would like to turn the call back to the operator and open the line for Q&A. Operator?

Our first question comes from Ed Arce with H.C. Wainwright & Co.

So I have a few. First is on FSGS. I know you've mentioned before your expectation for a 12-month enrollment period and some interim readouts throughout next year, but I was just wondering if you could give us a little more detail around how enrollment is going. I know it's a bit challenging as an ultra-orphan disease, but how that's going, and how do you think about when to read out these interim results? How should we think about those? And then . . .

A couple of -- I think I'll let Neil jump in on this, but I will state first that enrollment's definitely slow and, of course, challenging in FSGS in general. We have, as you know, a long history of doing very difficult trials and very difficult-to-access patients. And so sometimes you've got to sort of, like, rethink some of your strategies and build out upon that. So for example, we have significant presence in the U.S. and a number of sites open there. We're also adding sites elsewhere, potentially, in the world, because like when we did the open-label study, the AURION study, we found it just much easier to access certain patients. We always find in the U.S. to be the slowest recruiting sites. So I think without giving you a defined timeline, I can say that it's a slow process, as one would expect, but that we actually have ways to actually increase the speed of which, which we've used historically. And Neil, did you have anything to add on that?

No, I mean, I think that's fair to say. What we do have, Ed, is we have some interim readouts written into the protocol after a few patients have reached a certain amount of time. I can't go into the details in the statistical analysis part at the moment, but we have pre-specified some interim readouts. And I'd also just echo what Richard's saying. On one hand, a challenging disease, but on the other hand, a huge amount of enthusiasm in the community for this disease. This is a class of drugs which is known to be effective, and also, we're targeting this steroid-free regimen, which has been met with incredible enthusiasm by the nephrology community.

All right, okay. And then just turning to your VOS program, it certainly is the next near-term data catalyst for you, potentially, in a little over a couple of months now. I know that this was always thought of as a program where you could look at the options after this readout. Remind us how you're thinking about that once, say, we have a positive readout at the end of January, where to take it from there.

I'm beginning to love this program. It's -- the more I've learnt, the more I've learnt of the differentiation that I believe that exists with voclosporin, and the more that I understand about the issues that people face in treating this disease right now, I think there's a really, really exciting opportunity around this drug. And so when we get our data, we'll review it, and at that point in time, I think we'll make a decision. We're preparing a multitude of plans, presented to the board, and saying, here are the options, based on the kind of data we generate, and where we think an investment in this makes sense. Does it make the most sense to actually out-license this or sell it outright? Or is it really a second product for us with tremendous potential that we should develop further? And when you do the financial analysis on that, and the cost of actual development in these areas, it's not that expensive. So I think there's a lot of value that could potentially be created here, but I think it really does come down to how differentiated we show we are and the quality of the data we generate. And then, the options open up. So the option's still on the table, but I've got to tell you, we're starting to like this program a lot.

Right, great. Last question for me, Richard, this is for you. I know, as you said, this was a difficult decision for you to decide to move on, and it does appear that there is a good time now as you're getting into full enrollment now with AURORA and 10% over your target, so congratulations on that. My question is, and I know that you -- coming in, you had really, in my view, reinvigorated the team back 21 months ago, and so I know this was difficult and challenging for you, but the question is, I guess, looking for the most appropriate successor, strategies around that? I would imagine you'd want someone with some rare disease experience, most likely with some commercial background and track record. Perhaps just talk around what kind of criteria you and the board might be looking at.

Well, I think you probably could have written the ad for us. Look, you're right, it was a very difficult decision, and I want to make a couple things really clear. Number one is, I'm not running out the door. I'm staying around here until we have the right successor. We need to take our time. We need to be really, really cautious on who we bring into the company, because there's tremendous value here, and I'm certainly not going to let this value slip away. So if it takes a long time, if it takes a year, if it takes -- it'll take what it takes. And the reason I chose to do this now is it's the right time to begin the process. My background has been primarily, through my career, development-staged organizations. Some late-stage, but really not commercialization. And I really believe this company requires that experience, launching the drug, for positioning of the drug, some of the strategic expertise that a leader with the right background will bring to the table. So certainly, the issue on commercialization, the ability to have succeeded -- when you have a company in our situation, which has plenty of money in the bank and has an exciting technology that has delivered extraordinary clinical data, we should be able to find some really quality candidates, and we're going to take our time and do that. And so I hope I answered your question, but I also want to make it clear that this time it'll take to do this is the time it will take to do this. I'm not in any rush. I did make that decision for personal reasons, primarily because I came back out of retirement because the company needed me then. I have a family; I've got 6 kids, as you guys most often know from our discussions in the past, and I wanted to find a balance, and this process of beginning now will give me that balance back sometime next year, if we're successful. And it was really that balancing act between the personal aspects but also the enjoyment I get out of working with our team and my expectation that we're going to do really well, and I'm going to remain with the organization. I'm going to remain as CEO and I'm going to remain as -- or as Chairman until we find the successor, and at that point in time we're going to evaluate what should come next, what's in the best interest of the company. But I am very committed to being here until we have the right person that has the skills to take it to the next level.

(Operator Instructions)

Our next question comes from Joseph Schwartz with Leerink Partners.

Richard, you've done a great job, along with the rest of your team, and you've got some big shoes to fill when that time comes. So I was hoping that you could help set some expectations for what you would hope to see in your dry eye program. It's a fairly large trial with 90 patients, and I know there's a few endpoints beyond safety and tolerability, such as signs and symptoms that could offer a glimpse into the efficacy profile. So could you help us envision what would be a successful outcome on that front?

So I'm going to have Neil answer the clinical part of the question, and what I just want to focus on up front is that if you take a look at VOS as a product, and you take a look at -- you're delivering a drug that is 3 or 4x more potent than cyclosporine, and you're actually delivering 4x as much of that drug, potentially, to the eye. And if a drug is tolerated well, you'll tend to keep it on your eye longer. So what we really -- would be a success for us, of course, is not only tolerability, and superior tolerability, but also really strong early signs of potential efficacy. It's not powered to the extent of really being able to necessarily pull out all of the benefits, but I do think we might see some trending. And if it's -- but it's really early. But that would be -- sort of when you ask what would -- an outcome that would be exciting for us, it's, yes, tolerability and some of the very interesting endpoints showing -- trending early on. But it is our expectation due to the very nature of the drug we're giving that we should see differences. So Neil, did you want to qualify that a little bit more?

Yes. I mean, so, Joe, as you know, the -- I mean, the primary objective of this study as stated is actually drop discomfort compared to Restasis. And we do believe -- because we exclude patients who have used Restasis within 30 days prior to the study or, in fact, who have used Restasis for greater than a month. We're going to get fairly kind of naive -- Restasis-naive patients into this. And so as long as our drop discomfort scores are at least as good as those of Restasis -- I suspect they're going to be better, but -- and that's what the study's powered for, and we certainly saw in our Phase I study that there was no apparent drop discomfort, but a success for us is a drop discomfort at least as good as Restasis, and as Richard said, some trending of efficacy, early reductions in -- improvements, excuse me, in the Schirmer test, eye dryness scores, in the first couple of weeks, I think, would also be very encouraging as well. And this is just a 28-day study, as you know. In order to look at approval, we'd need to look at signs and symptoms right out to Day 84. That would come in the Phase II and III studies that follow that. But I would just echo what Richard's saying. Drop discomfort at least as good as Restasis, with some signal on improvements in Schirmer test over the first -- over the 4 weeks of the study.

Okay. That's helpful. And I know Restasis can take a long time to observe its effect; what are the thoughts around VOS and whether or not it would have an advantage on that front?

What I can tell you, and I've often talked -- we have this partnership, as I've mentioned, with Merck Animal Health. There's been a fair number of (inaudible) that have been conducted. They own the data, so we've never presented their data, but what we've learnt, in our experience, is that this drug does appear to work fairly quickly in what we believe will be a predictive model. And so -- and even our early -- the Phase I study that was done in the limited number of patients, we did see, actually, very early activity, signs of activity, on this drug. So that is one of the issues, I think. If you have a drug that works generally over 3 to 6 months that we see with Restasis, if we could shorten that time period, and if we could actually use it once a day, then you really do have a competitive sort of advantage. You have a differentiation point that'll actually matter for patients. Because I can tell you that one thing we've learned is, patients don't like taking their eye drops. And they're not very compliant. So if you can make it simpler and if you can make it not hurt, that really will differentiate you. Because CNIs are clearly effective in this disease.

Right, okay. That's very helpful. And then could I just ask, I'm intrigued by your statement that a significant percentage of patients who exited AURORA have been entering into the open-label extension study at their election. Can you put a finer point on that? And why wouldn't a patient enter into -- in the extension study if it were available to them?

So Neil, did you want to tackle that one first?

Yes. I mean, the -- we have certain criteria, Joe, about who can actually enter the study. Obviously, we don't know -- the study's blind, it remains blind, and it continues to remain blind. And so we have no idea who or -- who's going in and who isn't. But in general, those who have had a clinical response, and that tends to be either a partial or complete remission, or those who -- and sorry -- and those who are on therapy, so have not dropped -- had to discontinue therapy for any reason, are eligible to go on and go into the study. And that leaves, as you know, in a difficult disease such as lupus, there are patients who don't respond and who have to withdraw for many reasons. And I think that the point now that Richard's making is that at least to date, most of the patients are electing to go through into this -- into the continuation study. So it's. . .

It's pretty early -- yes, I do -- I think it's a little early to sort of look at the percentages and numbers. Like, we'd talked about over 80%. But quite honestly, I think it's early to sort of use those numbers. I'd wait. I think after another quarter or 2, we'll start getting a better sense of it, and my expectation, of course, is that those numbers, in my opinion, are more likely to drop in terms of overall percentages. And there's a lot of reasons people stay. If they're having some response, even if the response is not great, they still have access to good medical care. And so it's -- it's so difficult to predict from that success rate and entering into that on what it really means from a clinical response point of view, and it's very difficult to draw conclusions from that. So I'd just caution everyone on that.

Our next question comes from Savneet Uppal with RBC Capital Markets.

Just 2 quick questions for me: Just first, Richard, I think you mentioned something; will you be remaining on the board, or did I just mishear that? Or did you mention that you'd be a resource for the board? I just wanted to clarify that. Next . . .

I'll be clear on that.

Okay.

Did you want to . . .

And then the second question . . .

Did you want to ask the second one? And then I'll answer.

Yes, sure. The second question is just on, I'm just trying to understand the timing of this Phase III data. So you guys are talking about the end of 2019, but if you could provide a little bit more color on how long it would take to -- from the point that the last patient finishes treatment to analyzing the data and all that stuff. Just any color on that would be helpful.

Sure. So on your first question, I -- as Chairman of the company, I was sort of involved in founding the company, and I've been Chairman and -- as you know, for, well, since its inception. I'm quite content to remain committed to the company, but I also realize in any process of building out a board, building out a -- bringing in a new CEO, it depends on that whole dynamic and what the board feels at that time is right. So I have to trust my board, that my board will, in combination with myself and the new CEO, make the right decisions on what the composition should look like going forward. If you're asking me would I be prepared to stay on and committed to the organization, yes, I remain very committed to the organization. It's just that some of these things are -- they're not totally in my control. But that -- but I will remain as Chairman until such time as -- quite likely till the AGM. And at this point in time, it's really early to say. But there's -- no one's requested me not to be if you're asking that type of question. No one's asked -- requested at all that I not continue on in that role, so. But I will seek the guidance from my board once we've reconstituted the board with additional members.

Yes, that's helpful.

And to your second question, in terms of timing, I'll let Neil speak to this as well, but I will say that one of the things we have a good track record of is being able to clean our data and to move fairly quickly between the time of the last patient entering into the study and the availability of top line data. So Neil, did you want to provide a crisper answer?

Yes. So again, I think we just said that the top line data's going to be available towards the end of the year. We have a little bit more internal granularity, but there's also some uncertainty around that because it depends where the patient -- the last patient comes from that goes into the study. In addition, it depends whether that last patient then rolls over into AURORA 2 or whether they -- and whether they have a 4-week follow-up. So there's really -- there are some uncertainties around exactly when we're going to get that data. As Richard said, we're very, very quick at cleaning data, and we have a laboratory-based endpoint, so there's no issue about reporting the endpoint now. That's -- it's mostly programmatically. But I believe, and again, Richard, you can correct me if I'm wrong, but I believe that our guidance is just towards the end of next year, isn't it?

Yes. Thanks, Neil.

There appears to be no further questions at this time. I'll turn the floor back to management for closing remarks. Thank you.

Well, thank you, and thank you, one for being on the call today, and of course for your questions. I really am excited about what we are approaching this next year. There's a lot of activity for a change. We've been waiting for this for a while. So I'm excited about potential news flow we're going to have, and getting back in front of investors with news, because of course, we had a dry spell with a Phase III that's not uncommon. And I really remain very, very committed to moving this organization forward, and want to reemphasize that I won't be moving out of my role until I find someone who truly deserves to have that role. Thank you all very much for listening in today.

Thank you. This concludes today's conference. All participants may disconnect. Have a great day.