Aurinia Pharmaceuticals - Earnings Call - Q3 2018

Transcript

Speaker 0

Greetings, and welcome to the Aurinia Pharmaceuticals Incorporated Q3 twenty eighteen Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the presentation. 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.

Speaker 1

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

This afternoon, we issued a press release detailing our Q3 twenty eighteen financial results and corporate update. The press release and financial statement package is available on our website at oriniapharma.com, and a six ks 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 reports that we file on Form six ks with the U. S. Securities and Exchange Commission.

All of our statements are made as of today, 11/08/2018, 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?

Speaker 2

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 three clinical trial for the treatment of lupus nephritis. The target enrollment of three twenty four patients was surpassed due to high patient demand with three fifty eight lupus nephritis patients randomized in sites across 27 countries. We would like to thank our trial patients, physician, 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 speed and overall renal response rates in the presence of low dose steroids. The primary endpoint for the study is complete renal response at fifty two weeks, after which patients can choose to enroll in a hundred and four week blinded extension study.

We expect top line data for this trial towards the 2019. As of today, approximately eighty percent of the total patients enrolled in the study have been in the trial for more than three 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 review 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 two blinded extension study from AURORA. The purpose of AURORA two 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 ORA phase two 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 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 AURORA 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 losporin'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 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 2020. And therefore, we do not expect any delay in our originally planned regulatory timelines. Lastly, you will recall that 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 two weeks.

We believe the results of the study will add to our knowledge of voclosporin in a multi targeted therapeutic approach and should have no impact on the 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 NEF Cure, approximately five thousand four hundred new patients are diagnosed with FSGS each year, accounting for the largest segment of almost thirty percent 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. It's thought to be critical for long term kidney health. While guidelines exist for 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 this study in June. This is an open label proof of concept study of 20 treatment naive patients with FSGS.

As we're essentially enrolling newly diagnosed patients, and this is a rare disease, we expect a twelve 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 our inception. Expanding our scope to include other proteinuria 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.

And approved treatment can be a 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 of voclosporin, the voclosporin ophthalmic solution or VOSS for the treatment of dry eye. This is a novel formulation of voclosporin which is a unique patented aqueous preservative free, nano micellular solution containing point 2% of voclosporin. And as you know from previous disclosures, voclosporin has been shown to be three or four times more potent than cyclosporin A. VOS has its own separate formulation patents with exclusivity through 02/1931.

Dry eye is a chronic syndrome, is a chronic disease in which a lack of moisture and lubrication on the eye surface results in irritation and inflammation of the eyes. Dry eye is a multi factorial heterogeneous disease estimated to affect greater than twenty million people in The United States alone. While the FDA approved products do exist for the treatment of dry eye, two of which are CNIs, there's an opportunity for a potential improvement in the efficacy and enhanced tolerability, including onset of action and alleviating the need potentially for repetitive dosing. We believe that calcium inhibitors will remain the mainstay for treatment of dry eye and that VOS has the potential to be a best in class calcium inhibitor within this billion dollar market. A phase one trial has previously been completed in 35 healthy volunteers and in patients with dry eye syndrome.

Our phase two head to head tolerability study of VOS versus Restasis is well underway, and we closed screening today. It's expected to be completed in the next couple of days. We expect the trial to complete before year end, and we plan to report time top line data before the January. This is a four 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 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 two years ago, which was a critical time in our company's growth, I came out of retirement to join Aurinia as a 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 twenty one months and I know to me this is an awful time to bring on a new CEO. I had several goals when I returned from my retirement nearly two years ago, and I feel these have all been successfully completed. The most important being the diligent execution of our phase three clinical trial in and LN, advancing new indications for voclosporin, 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 development of voclosporin, I believe this is the right step forward for the company. My commitment to the company and these patients remain 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 Bergereau, our CFO, to review the Q3 financials with you. Dennis?

Speaker 3

Thank you, Richard. At September 3038, we had cash, cash equivalents and short term investments of $138,900,000 compared to $150,200,000 at June 3038, and $173,500,000 at December 3137. Net cash used in operating activities was $11,300,000 for the third quarter ended September 3038, compared to $8,500,000 for the third quarter ended September 3037. We reported a consolidated net loss of $18,300,000 or $0.21 per common share for the three months ended September 3038, as compared to a consolidated net loss of 13,100,000.0 or $0.16 per common share for the three months ended September 3037. The increase in the loss for the three months ended September 3038 compared to the same period of 2017 was primarily due to the non cash change in the estimated fair value of derivative warrant liabilities of $5,200,000 The three months ended September 3038, reflected a $4,800,000 increase in estimated fair value of derivative warrant liabilities compared to a reduction of $355,000 for the three months ended September 3037.

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 non cash change in estimated fair value of derivative warrant liabilities was $13,500,000 for the three months ended September 3038, compared to 13,500,000.0 for the same period in 2017. For the nine months ended September 3038, the consolidated net loss was $49,500,000 or $0.59 per common share compared to a consolidated net loss of $67,500,000 or $0.91 per common share for the comparable period in 2017.

For the nine months ended September 3038, we recorded an increase of $9,400,000 in the estimated fair value of derivative warrant liabilities compared to $32,900,000 for the same period in 2017. The net loss before the non cash change in estimated fair value of derivative warrant liabilities was $40,200,000 for the nine months ended September 3038, compared to thirty four point five million dollars for the same period in 2017. The increased loss was primarily due to higher research and development expenses. Research and development expenses increased to $11,200,000 for the three months ended September 3038, compared to $10,800,000 for the three months ended September 3037. We incurred research and development expenses of $30,500,000 for the nine months ended September 3038, as compared to $25,200,000 for the same period in 2017.

The increased research and development expenses reflected costs associated with the commitments of the AURORA two extension study and the FSGS and dry eye studies. Corporate administration and business development expenses increased to $2,900,000 for the three months ended September 3038, compared to $2,700,000 for the same period in 2017. We incurred corporate administration and business development expenses of $10,200,000 for the nine months ended September 3038, compared to $9,000,000 for the comparable period in 2017. The increase was primarily due to higher non cash stock compensation expense in 2018 compared to the same periods in 2017. With that, I will turn the call back over to Richard for some closing remarks.

Richard?

Speaker 2

Thank you, Dennis. You know, once again, I want to thank the team for the tremendous progress that has 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 Ireland before the 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 out its core competencies. We're 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 we continue advance Vocus4 through its final phase of development. With that, I'd like to turn the

Speaker 4

call back to the operator

Speaker 2

and open the line for Q and A. Operator?

Speaker 0

Thank you. At this time, we will conduct our question and answer session. If you would like to ask a question, press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue.

Our first question comes from Ed Arce with H. C. Wainwright and Company. Great.

Speaker 4

Thanks for taking my questions, Richard. And so I have a few. First is on FSGS. I know you've mentioned before your expectation for a twelve month enrollment period and 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, how do you think about when to read out these these interim results? How should we think about those?

Speaker 2

A a couple of things. I'll let him jump in on this. But I will state first that, you know, enrollment's definitely is slow and, of course, challenging in in in FSGS in general. You know, we have, as you know, a long history of doing very difficult trials and very difficult to access patients. And so sometimes you gotta sort of, like, rethink some of your strategies and build out upon that.

So for example, we've we have significant presence in The US and a number of of sites open there. We're also adding sites elsewhere potentially in the world because like when we did the open label study, the Orion study, we found it just much easier to access certain patients. We always find The US to be the slowest recruiting sites. So, you know, I think without giving you a defined timeline, I can't say that it's slow process as one would expect, but that we actually have ways to actually increase the speed at which which we've used historically. And, Neil, did you have anything to add on that?

Speaker 5

No. I mean, I I think that's 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 this statistical analysis part at the moment, but we have prespecified some some interim readouts. And I and I'd also just echo what Rich is 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 we're targeting the steroid free regimen, which has been met with, incredible enthusiasm by the nephrology community.

Speaker 4

Right. Okay. Thanks. And then just turning to, your your VOS program. That certainly is the the the next, near term data catalyst for you potentially in a little over a couple months now.

I know that this was, always thought of as a 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 January, where to take it from there.

Speaker 2

You know, I'm I'm beginning to love this program. It's, you know, the more I've learned, the more I've learned the differentiation that I believe that exists with, 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 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 options based on the kind of data we generate and where we think an investment in this makes sense. Does it make 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, 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 options are on the table, but I gotta tell you we're starting to like this program a lot.

Speaker 4

Right. Great. Last question for me, Richard. This is for you. I know I know, as you said, this was a difficult decision for you to decide to move on, and it it it does appear that there is a good time now as you're getting into, you know, full enrollment now with with AURORA and and and and 10% over your target.

So congratulations on that. My my my question is and I and I know that you're coming in. You had really, you know, in my view, reinvigorated the team back twenty one months ago. And so I 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 what kind of criteria you and the board might be looking at.

Speaker 2

Well, I I think you probably could have written the ad for us. Look. You're right. It was a very difficult decision, and and I wanna 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 gonna 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's take. And the reason I chose to do this now is it's the right time to begin the process.

My background has been primarily to my career development stage organizations, some late stage, but really not commercialization. And I really believe this company requires that experience launching the drug, the 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 of commercialization, the ability to have succeeded you know, 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 gonna take our time and do that. And so, you know, I I hope I answered your question, but I also wanna make it clear that this time it'll take to do this.

It's the time it'll take to do this. It 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 six kids as you guys most often know from our discussions in the past, and I wanted to find a balance.

And this process of being an email 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 of working with our team and my expectation that we're going to do really well. And I'm gonna remain with the organization. I'm gonna remain as CEO, and I'm gonna remain or as chairman till we find the successor. And at that point in time, we're gonna 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.

Speaker 4

Great. Thanks. Fully understood, Richard. Thank thanks again for that.

Speaker 2

You're very welcome.

Speaker 0

Our next question comes from Joseph Schwartz with Leerink Partners. Please state your question.

Speaker 6

Great. Thanks very much, and congrats on all the progress. Richard, you've done a great job along with the rest of your team, and you've got some big shoes to fill when the 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?

Speaker 2

So I'm gonna have Neil answer the clinical part of the question. And what I just wanna focus on upfront 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 three or four times more potent than cyclosporine and you're actually delivering four times as much of that drug potentially to the eye. And if a drug is tolerated well, you'll tend to keep it on your life longer. So what would really would be success for us of course is not only tolerability and superior tolerability, but also, you know, really strong signs of potential efficacy. Now 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 we, you know, 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 yeah. Tolerability and some of the very interesting endpoints showing trending early on. But it is our expectation to the very nature of the drug we're giving that we should see differences.

So, Neil, did you wanna qualify that a little bit more?

Speaker 5

Yeah. I mean, so, Joe, as you know, the the I mean, the primary, the primary objective of this study as stated is actually drop discomfort compared to Restasis. And, yeah, we we do believe because we exclude patients who have used Restasis within thirty days prior to the study or or, in fact, who have you who've used Restasis for growth in a month. We're gonna 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 are restasis, I suspect they're going to be better, but and that's what the study is powered for.

And we certainly saw in our phase one study that there was no apparent drop discomfort. But the success for us is is a drop discomfort, at least as good as, as Restasis. And as Richard said, some trending of efficacy, early, reductions in, improvement, excuse me, in the Schirmer test, eye dryness scores, in the in the first couple of weeks, I think, would also be very encouraging, as well. And, you know, this is just a twenty eight day study. As you know, we in order to look at approval, we need to look at signs and symptoms right out to day four.

That would come in the phase two and three studies that follow that. But I I I would just echo what Rich is saying, you know, drop discomfort, at least as good as Restasis, with some signal on on on improvements in in Schirmer test, over the first, of the four weeks of of, the study.

Speaker 6

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

Speaker 2

You know, 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 been conducted. They own the data, so we've never presented their data. But what we've learned in our experience is that 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 phase one 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, you know, if you have a drug that works generally over three to six 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 the 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.

Speaker 6

Right. Okay. So very helpful. Thanks. And then can I just ask I'm 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 patient enter in into in the extension study if it were available to them?

Speaker 2

So, Neil, did you wanna tackle that one first?

Speaker 5

Yeah. I mean, the the in we have certain criteria, Joe, about who can actually enter the study. Obviously, we don't know the study's blind, remains blinded, and continues to remain blinded. So we have no idea who or you know, who who's going and who isn't. But in general, those who have had a 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 who have not dropped had to discontinue therapy for any reason or eligible to go on and go into the study.

And that leaves, as you know, in a disease such as lupus, there are patients who don't respond, you know, and and who who have to withdraw for many reasons. And I think, the the point there that that Rich is making is that at least to date, most of the patients are electing to go through into this into the continuation study. So is it Yeah.

Speaker 2

I do. I think it's a little early to sort of look at the percentages numbers like we we talked about over eighty percent. But, you know, quite honestly, I think it's early to sort of use those numbers. I'd I'd wait. You know?

I think after another quarter or two, 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 lot of reasons people say 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 just caution everyone on that.

Speaker 6

Okay. Makes sense. Thanks again for taking my questions.

Speaker 2

No. It's always a pleasure.

Speaker 0

Thank you. Our next question comes from Savaneet Upal with RBC Capital Markets. Please state your question.

Speaker 7

Hey there. Just two quick questions for me. Just first, Richard, I think you mentioned something. Will you be remaining on the board, or did did I just mishear that? Or did you mention that you'd be a resource for the board?

I just wanna clarify that.

Speaker 2

I'll be I'll be clear on that.

Speaker 6

Okay. Want to You can ask the

Speaker 2

second question and then I'll answer.

Speaker 7

Yes, sure. Second question is just on just trying to understand the timing of this Phase III data. So you guys are talking about the 2019. But if you could provide a little bit more color 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.

Speaker 2

Sure. So on your first question, you know, I you know, as chairman of the company, I was, you know, sort of involved in founding the company, and I've been chairman in as you know, for since its inception. I'm quite content on remain committed to the company, but I also realize in any process of building out a board, building out a you know, bringing in a new CEO, it depends on the on the that whole dynamic and what the board feels at that time is right. So I have to trust my board that my board will, you know, in in combination with myself and the new CEO, make the right decisions on what the competition should look like going forward. If you're asking me, would I be prepared to stay on and and committed to the organization?

Yes. I I remain very committed to the organization. It's just that some of these things are, you know, they're not totally in my control. But that but I will remain as as chairman until such time as as quite likely till the AGM. And I at this point in time, it's really early to say.

But 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'm I will seek the guidance from my board once we've reconstituted the board with additional members.

Speaker 0

Yep. Yep. That's helpful.

Speaker 2

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 study and the availability of top line data. So Neil did you want to provide a crisper answer?

Speaker 5

Yeah, so again I think we just said that the top line data is going to be available towards the end of the year. You know, we have a little bit more internal granularity, but there's also some uncertainty around that because it depends where patient the last patient comes from that goes into the study. In addition, it depends whether that last patient then rolls over into AURORA two or whether they or and whether they have a four week follow-up. So there's a there there are some uncertainties around exactly when we're gonna get that data. We as Richard said, we're very, very quick at cleaning data, and we have a a laboratory based endpoint.

So there's no no issue about reporting the endpoint there. That's, you know, done mostly programmatically. But but I believe and, again, you know, Richard, you can correct me if I'm wrong, but I believe that our guidance, is just is just towards the end of, of next year, isn't it?

Speaker 7

Great. Thank you.

Speaker 0

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.

Speaker 2

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 with news because, of course, we had a dry spell with a a phase three that's not uncommon.

And I really remain very, very committed to moving this organization forward and wanna 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.

Speaker 0

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