Aurinia Pharmaceuticals - Earnings Call - Q2 2018
August 9, 2018
Transcript
Speaker 0
Greetings. Welcome to Aurinia Pharmaceuticals Incorporated q two two thousand and eighteen financial results. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded.
I would now like to turn the conference over to our 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 Q2 twenty eighteen Earnings Call and General Business Update. With me on the call today from Aurinia are Richard Glickman, Chief Executive Officer and Dennis Bourgeaux, Chief Financial Officer. Joining us for the Q and A will be Michael Martin, our Chief Operating Officer and Doctor. Neil Solomons, our Chief Medical Officer.
This afternoon, we issued a press release detailing our Q2 twenty eighteen financial results and corporate updates. The press release and financial statement package is available on our website at iriniapharma.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 today's 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 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 six ks with the U. S. Securities and Exchange Commission.
All of our statements are made as of today, 08/09/2018, 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
Thank you, Celia, and thank you to everyone for joining us today as we review our second quarter financial results and provide a general business update. This has been an extraordinary quarter for our company and tremendous progress has been made on a number of fronts. And I'm excited to talk about the momentum of our organization is developing after a period of what I refer to as heavy lifting. With respect to our Phase three clinical program in LN, our most advanced program, we are excited to announce the recruitment is running ahead of schedule and we foresee enrollment completion very early in Q4 this year. For me, this is an indication that the trial is progressing well.
As a reminder, the primary endpoint for this trial is at fifty two weeks after which there's a four week follow-up period before a subject officially completes the trial. Thus we expect to have data for the trial on time and on schedule before the 2019. For a bit more granularity, we have two twenty five sites activated and able to enroll patients in 29 countries around the globe. As a reminder, we took a different approach in recruitment for our Phase three trial where we opted to initiate and activate as many sites as possible from the beginning rather than activating a few at the time. You may recall that patients that have active lupus nephritis are very ill.
Our Phase two trial enrolled some of the sickest patients ever studied in this disease. Now as previously mentioned, we have implemented several additional safety parameters in our Phase three trial and are monitoring these very closely in a blinded manner. The DSMB also reviews all adverse events on an ongoing basis and so far we believe the study is progressing very well. We continue to have motivated patients and investigators participating in this trial and remain very encouraged by the level of interest in the trial that has been generating around the globe. Our team is working diligently with the goal to assess the efficacy and safety of voclosporin LN patients and are extremely determined to potentially provide the first FDA and EMA approved therapy for these patients in desperate need.
Just a reminder that LN is a debilitating disease that affects mostly women of childbearing age. We are actively preparing an NDA and we expect to complete the ruling submission in Q2 twenty twenty. During the second quarter, we also saw the first patients roll over into the AURORA two blinded extension study from the AURORA Phase three clinical trial. The purpose of the AURORA two is to assess the long term safety and tolerability of voclosporin in patients with LN. However, this study is not a requirement for potential regulatory approval for voclosporin.
Long term safety and efficacy data for our unique C and I should prove to be a great fight to the medical and patient community as we are committed to providing relevant data that could support treatment decisions in the future. That brings us to an update on new indications that we are pursuing with voclosporin, the first being FSGS. Approximately five thousand four hundred new patients are diagnosed with FSGS in The U. S. Alone each year, accounting for the largest segment, almost thirty percent of patients with nephrotic syndrome.
FSGS is a rare disease that attacks the kidney's filtering units causing serious scarring which leads to permanent kidney damage and even failure. Similar to lupus nephritis, an early clinical response to reduction proteinuria is thought to be critical to long term kidney health. While guidelines exist for treatment, 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 our study in June. This is an open label proof of concept study in 20 treatment naive patients with FSGS.
As we are essentially enrolling newly diagnosed patients and this is a release, we expect enrollment could take up to twelve months, but we intend to have planned interim data readouts throughout the course of the trial in 2019. As a company that has been focused on lupus nephritis since its inception, expanding our scope to include other protein of renal disease synergistic with our current strategy and long term vision of the company. One of the most exciting aspects of 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 which predictably come with multitude of well established side effects. An approved treatment for FSGS would be of tremendous value to both patients and furthermore to our shareholders.
As I mentioned, it's been quite a beautiful quarter. We recently initiated yet another exciting program with a new drug called voclosporin ophthalmic solution or VOS for the treatment of dry eye syndrome. This is a different formulation of voclosporin, which is a unique patented aqueous preservative free nano micellar solution containing 0.2% voclosporin. And as you know from previous disclosures, voclosporin has been shown to be three or four times more potent than cyclosporine A. VOS has its own separate formulation pads with exclusivity until 2013.
Dry eye syndrome is a chronic disease in which a lack of moisture and lubrication of the eye surface results in irritation and inflammation of the eye. Dry eye is estimated to affect greater than twenty million people in The US alone. While there are two FDA approved products for the treatment of dry eye, one of which is acafenibin, there is the potential and need for improved dafetene effectiveness for the treatment of dry eye. And particularly by enhancing tolerability and the onset of action and alleviating the need for repetitive daily dosing. We believe that the calcinephrine inhibitors will remain a mainstay for the treatment of dry eye and that VOS has the potential to be the best in class C and I within this multi billion dollar market.
A Phase I trial has previously been completed in 35 healthy volunteers and in patients with dry eye. In early July, we initiated a Phase two head to head tolerability study of VOS versus RESTASIS and we expect to complete this trial before the end of the year. Depending on the pace of recruitment, data could be available as early as the end of this year or early twenty nineteen. This will be a four week study and we will be recruiting 90 patients for this trial. The goal of this program is to develop the best in class treatment option and upon completion we will look to evaluate strategic alternatives for VOS.
I believe there's tremendous value in this asset. So that's it for our clinical programs. Aurinia is now in its substantial growth phase transitioning from an early stage clinical company with one indication to a late stage clinical company with multiple indications. We are thrilled with all the progress we've made so far this year and look forward to the productive second half of the year. With that, I'll turn the call over to Dennis Bergeau, our CFO to review the Q2 financials with you.
Dennis?
Speaker 3
Thank you, Richard. At June 3038, we had cash, cash equivalents and short term investments of $150,200,000 compared to $159,100,000 at March 3138 and $173,500,000 at December 3137. Net cash used in operating activities was $12,300,000 for the second quarter ended June 3038, compared to $14,000,000 for the second quarter ended June 3037. In the second quarter ended June 3038, we received proceeds of $3,000,000 from the exercise of warrants, which were set to expire in June 2018. We believe based on our current plans and activities that we have sufficient financial resources to fund our existing LN program, including the AURORA trial and the NDA submission to the FDA, conduct the Phase II trials for FSGS and dry eye, and fund operations into 2020.
We reported a consolidated net loss of $15,700,000 or $0.19 per common share for the three months ended June 3038, as compared to a consolidated net loss of $2,400,000 or $03 per common share for the three months ended June 3037. The increase in the loss for the three months ended June 3038 compared to the same period in 2017 was primarily due to the non cash change in the estimated fair value of derivative warrant liabilities in the amount of $9,400,000 The three months ended June 3038, reflected a $1,900,000 increase in the estimated fair value compared to a reduction of $7,500,000 in the estimated fair value for the three months ended June 3037. The change in the revaluation of the 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 an increase in our loss, 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 $13,800,000 for the three months ended June 3038, compared to $9,900,000 for the same period in 2017, with the increased loss amount primarily reflecting higher research and development expenses. For the six months ended June 3038, the consolidated net loss was $31,200,000 or $0.37 per common share, compared to a consolidated net loss of $54,300,000 or $0.78 per common share for the comparable period in $2,004,600,000 in the estimated fair value of derivative warrant liabilities compared to $33,300,000 for the comparable period in 2017. The net loss before the non cash change in estimated fair value derivative warrant liabilities was $26,600,000 for the six months ended June 3038, compared to $21,100,000 for the same period in 2017. The increased loss again primarily reflected higher research and development expenses. Research and development expenses increased to $10,500,000 for the three months ended June 3038, compared to $7,100,000 for the three months ended June 3037.
We incurred research and development expenses of $19,400,000 for the six months ended June 3038, as compared to $14,400,000 for the same period in 2017. The increased research and development expenses reflected higher AURORA clinical and drug supply costs, as well as startup costs for the AURORA two extension study and the FSGS and dry eye studies. Corporate administration business development expenses increased to $3,500,000 for the three months ended 06/30/2018, compared to development expenses of $7,300,000 for the six months ended June 3038 compared to $6,300,000 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. Once again, I'd like to thank the team for the tremendous progress they've made so far this year. We are diligently executing on our clinical programs and look forward to a very busy rest of 2018 with the completion of recruitment for our Phase three trial in LN, more patients rolling over to the AURORA two extension study and carrying out the FSGS and dry eye program successfully. 2017 was an extremely pivotal year for the company. We are now a late stage biotech company that's diversifying its portfolio and building out its core competencies.
We are a nimble and dedicated team that continues to successfully execute upon our corporate milestones. As a company, have a drug candidate that is successful in Phase three has the potential to be the first approved therapy for the treatment of LN. The efficacy and safety data supporting this drug is substantial. We have a clear regulatory path forward to approval. There is a large and solid intellectual property base and we believe the market opportunity for this drug to be significant.
It is with great confidence we continue to advance voclosporin to its final development phase for LN. With that, I'd like to turn the call back to the operator and open the line for the Q and A. Operator?
Speaker 0
Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press 2 if you would like to remove your question from the queue.
Our first question comes from Ed Arce with H. C. Wainwright. Please state your question.
Speaker 4
Great. Thanks for taking my questions. And congrats on all the progress this quarter in transitioning from one to three clinical programs. I have three questions. First, you had mentioned pivotal phase three has appeared to accelerate recently in enrollment.
Just wondering if you could share with us your thoughts on why that might be, and if there were some particular commentary from your site PIs that you could share that could shed more light on how they see things progressing. Secondly, with AURORA two, it sounds like from your perspective, this is really more about communicating the long term safety with,
Speaker 2
ultimately,
Speaker 4
with prescribing physicians. And just wondering how you how you program. And then lastly, you had mentioned interim readouts next year expected for your FSGS program. Just wondering how you see the ultimate target to move forward in that, and when we could expect sort of the final readout for completion.
Speaker 5
Thanks so much.
Speaker 2
Okay. Thanks the question. Before I answer your first question, do want to point out I made a mistake when I kind of flipped some numbers around when I was talking about the IP for VOS. The actual trial program's IP is 20312013. So I apologize for that.
And Neil, did you wanna sort of tackle that first question about enrollment and how things are progressing?
Speaker 6
Yeah. I mean, I think it comes Ed, good question. And, you know, we've obviously had a lot of very, very, close contact with RPI throughout the world. They continue to be extremely enthusiastic about this study. That's the feedback that we get, and that results in them continuing to enroll patients.
They also obviously highlight the, unmet medical need in the very, very severe patients that we're recruiting. You know, obviously, the physicians and ourselves are blinded. We have no no way of knowing, what, therapy these patients are are assigned to. However, you know, clearly, they they see, their patients overall benefiting from entering And I think that's probably all we can say about that at the moment, Ed.
Speaker 2
And I will say that as we recruit patients, we are very focused on trying to make sure we get the right patients in the trial, the right balance of ethnicity. We haven't rushed it. It's sort of naturally sort of has its own momentum. With that we still turn away a lot of patients that are probably not appropriate for this study. So we're pleased with our progress, particularly in light of the fact we've been very picky on how we've executed the trial.
Your second question related to the long term use of the drug in AURORA two study, and I could just quickly comment that, you know, you're on a Kafner inhibitor, whether you're on it for transplantation, but when you look at drugs like voclosporin and you look at these patients, you know, we generally believe that patients will be on for a fairly substantial period of time. And anything we could do to add to the safety database on the long term use of this drug is going to be very informative for clinicians in making their decisions. So it's a natural thing to do with several year follow-up extension. I guess it's going to be very valuable for us because I really do believe that when decisions made as to which drug to remove a patient from, you know, whether it's complete removal of steroids or whether it's reduction of CellCept, that having this long term data can be very, very useful. I think it also becomes useful as well when you start looking at registries and you start looking at other such as, you know, patient pregnancies, etcetera, where many of the drugs that are being used today are actually quite an issue when it comes to pregnancy.
When you look at CNIs, they have a fair history about their usage during pregnancy. So any long term type data we generate on this drug is going to be very valuable. In terms of your third question related to FSGS, you know, relatively new in this disease or very new in this disease and we're looking at patients that are naive. But we think it's really important. Physicians have been really demanding and patients are demanding an alternative to high dose steroids.
The current therapies are let's say six months worth of extremely high dose therapies. I think the nature of the way this drug works, its impact on the hepatocyte, its impact on the immune system, it makes it an ideal candidate. And, you know, we really don't know what the next step looks like I think until we really take a look at our actual data And if our generated consistent with what we expect the STRAC to perform, then we'll have more granularity about what a phase three program would look like. Neil, did you want to add anything to that?
Speaker 6
No. I think, you said I think the the key point about this is that nobody's ever done, naive, steroid free, you know, therapy before. But the the the very fact that everybody thinks it's a great idea, I I I think is key to us, and I think we're gonna see see the benefits, you know, of this particular therapy done and performed, the study done in a rigorous fashion that, you know, the manner that we tend to do these studies. I think people are very excited about that.
In terms of timing and what we report when, I I I think, you know, when we get enough data that gives us enough of a signal, then, you know, we will be obliged to release certain those results. And then, yeah, we'll move quickly on to discussing further development when we get the, you know, adequate amount of data.
Speaker 4
Great. That was very helpful. Thank you, Neil and Richard.
Speaker 2
Thank you.
Speaker 0
You. Our next question comes from Joseph Schwartz with Leerink Partners. Please state your question.
Speaker 5
Hi, thanks very much and congrats on all the progress. So I wanted to ask a question on the dry eye program as well as the f s FSGS program. You mentioned that the dry eye program is a tolerability study. It's fairly large, and I would imagine potential partners would be interested in the clinical profile as it pertains to efficacy. So how well suited is the is the phase two program to demonstrate or to be able to detect the potential positive attributes of the product.
You mentioned that you thought that it would be better tolerated, but also maybe have improvements in signs and symptoms with more time to onset.
Speaker 2
Neil, did you want to to address that? I and
Speaker 6
Yeah. I I'm I'm happy to do that. So so, Joe, you know, it's a again, it's always a challenge with these relatively limited size proof of concept studies and what you what you what you what you're going to see, what you hope to see, and what you expect to see. So, you know, certainly the way we've designed the study and the assessments that we're doing, the efficacy assessments that we're doing, for example, the Schirmer test, you know, we if there is a dramatic early effect, the study is certainly designed to be to show that. So for example, you know, it's a short study.
If we do see, early separation, in some of the efficacy, you know, then then the study is designed to be able to see that. But, of course, again, you know, I think we have to caution the fact that, from a statistical perspective, if we don't see it, it doesn't mean it's not the effect's not there. It's, you know, that's the way we design these proof proof of concept studies, that that if we if we do see early differences, they will show up, in the results. But, you know, I think we just have to caveat caution. If those results are not seen, it doesn't mean that, that the drug's not doing its job.
You know, I think that's probably the, you know, the most important thing, Joe, from the eye from the eye perspective.
Speaker 2
I think clearly from a tolerability perspective, I think that one is really important. I think when you take a look at one of the biggest issues people face in using, you know, Restasis is this tolerability issue. And I think that, several there could be real several benefits of this program. Think one is that this may be easier on the eye. Certainly historically when we did the Phase I it turns out to be that way.
And then second, you keep in mind this drug is three or four times more potent but you're also delivering almost four times as much drug to the eye as you are with restasis. That means you're delivering somewhere between twelve and sixteen times the amount of drug. When you do look at animal experiments in this area, you do see a fairly rapid impact of the drug. And we would hope that we see that carried through in the human clinical side. Certainly in the limited phase one experience that was seen with this drug, we did see early signs and trends.
This is a much larger population to do that on, so I think we've got a fair shot, although I take the caution that's been expressed. But I do think we have a fair shot of seeing some trending at least of early, early efficacy with this molecule.
Speaker 5
Okay. Great. Thanks. That's helpful. And then on the FSGS program in phase two, it looks like you're targeting patients with more than or or greater than or equal to three mgs per mg of urine protein creatinine ratio.
That that seems like it's a lot higher than, certainly your your lupus nephritis inclusion criteria and and some other FSGS inclusion criteria that we've seen, which is, one to two mgs per mgs. So I was just wondering if there's a specific reason behind that. And and and, you know, are you are you are you purposely targeting sicker patients here? And then FSGS is a pretty catch all classification of of patients with a lot of different diseases. So I think this is a relatively small study to think that, you know, that could confound the results in any way, you know, given the the wide variability in presentation that people with FSGS have.
Speaker 2
Neil, could you
Speaker 6
Yeah. Yeah. I mean, again, one of the things that we're really trying to find out, and there's a huge amount of interest in the renal community, is the effect of calcium, specifically calcium inhibitors as well as other drugs on the podocyte disorders. Now, sometimes we don't see this really disordered podocyte effacement in patients with lower levels of proteinuria. So in some ways, what we're doing is we're trying to enrich the population of FSGS patients for those who we believe are most going to benefit from the drug.
It is certainly conceivable that as we move into Phase III, we may be able to go into lower levels of proteinuria and hence patients with less disordered kidney biopsies. But I really think that these are patients we're going to see the benefits of in. These are the patients that the physicians are currently incredibly interested in treating with their FSGS post cytopathy. And the nephrotic syndrome, just the broken ear, hypo alpureinemia, hyperlipidemia still represents the greatest unmet need. These are patients that do the worst.
These are patients, you know, that we believe that our drug, could have the greatest benefit in, Joe.
Speaker 5
Excellent. Very helpful. Thanks again.
Speaker 2
Thanks, Joe.
Speaker 0
Thank you. Our next question comes from Elamir Pirros with Cantor Fitzgerald. Please state your question.
Speaker 7
Good afternoon, gentlemen. What I'd like to understand is if you could tell us a little bit more about AURORA two. What is the duration duration of of the the trial? Trial or What is this the extension phase? And what was the rationale to keep it in a blinded fashion?
Speaker 2
Hey, Neil, you're getting a lot of questions today.
Speaker 6
Yeah. They're all good questions. I mean, you know, so the rationale, the the I think the first question was the duration. So we're doing two further years, so that we hope to get, you know, in total, I guess, three years of comparative data. And that's where the comparative data answers the second part of your question.
The only way we can get good well, the best way of getting good quality safety data is to have a comparator. Certainly, companies with other drugs have gone into sort of open label continuation studies and that is definitely a way of doing it. We believe it's much more powerful and continues to allow our comparison of both safety but also some of the efficacy data as well by continuing patients in a blinded fashion. The other thing that we the other big piece apart from long term safety data, you know, term renal function effects on other aspects of lupus is potentially assessment of relapse. As we know lupus nephritis is a relapsing remitting disease.
Not only are we getting patients into remission but we wish to stop them going back into disease flare again. And these are some of the things that we're going to see in our continuation study. We're also going to be looking at extra renal parameters and where these patients' non renal lupus flares. And again, that could also trigger further clinical work in the extra renal space further down the line. So the rationale I would say is twofold.
I think it's always good to have more safety data even though it's not a requirement to have all the safety data. The regulators are certainly look favorably when it comes to the NDA approval on companies that have extra additional safety data to be able to strengthen the case with all lupus nephritis but also in SLE with some of the extra data that we get. And we believe that being in a comparative, a continued blinded study adds both statistical but also clinical power to our arguments.
Speaker 7
Yes. Maybe just a follow-up, Neil. I understand. Is there maybe just a small concern that over a year period, it's relatively easier to keep a patient who, in the trial, who experienced a modest or minor response. But when you take this out to three years, it's more likely that you would lose those patients, so the comparison between these two arms may not be as balanced.
Speaker 6
Right. I'm not exactly sure. I I I understand the I mean, certainly over the prolonged, you know, three year period, what just that over a three year period, even on standard of care, patients do continue to go into remission, you know, after three years of therapy. I think it's important to have the comparator to make sure that what what we're seeing is not just the the the sort of background quiescence of the disease disease over time. I'm not exactly sure I'll answer your question.
But
Speaker 7
Yep. Yeah. Yeah. It does. Thank you
Speaker 8
very much.
Speaker 2
I guess I know. Was sort thinking it. I mean, certainly, we're not using AURORA two for part of our approval process. We should clearly it's our belief we'll get approval if we're successful in a clinical program on the basis of the data generated in the actual Phase III trial. Having that additional data I think is beneficial.
I think you're right, there's a risk over time that you're going lose patients. The tendency though is for these patients is to stay on drug. And, you know, to look for durable responses, if you take a look at the Phase II trial, it was very curious that every single patient in the active arm of our trial in the Phase II that went into complete remission stayed in remission for the duration of the trial. It's my expectation that we will see, and my hope of course, that we'll see the similar results in the follow-up extension study. I think that's really important because you'll be showing really long term stability in those patients.
And I think at the end of the day it will impact how physicians decide to treat. So I think having that data is going be valuable. I think you're right, there's a risk that over time you could lose patients. I think you're more likely to lose patients that land up actually falling out of remission. It's my expectation and my hope that the patients that are on the combined therapy right now would actually like to stay would like more likely to stay in the study because they are doing better.
So time will show us that answer. But the important thing is it doesn't put our other trial at risk.
Speaker 7
Yes. Thank you very much, Richard and Neil.
Speaker 2
You're welcome.
Speaker 0
Our next question comes from Doug Neum with RBC Capital Markets.
Speaker 9
Two fairly simple questions. Number one, in terms of the patients that you're going to end up having in this trial, how many will have been recruited by sites that were used in your previous trials, roughly?
Speaker 2
Interesting question. Neil, I don't.
Speaker 6
Yeah. We we I mean, we've we've obviously, we're not finished recruiting yet. There is some overlap. You know? One of one of the things that we've learned both in the ORA trial, also actually if we cast someone back to the ARMS trial.
Two things. One is sites that are good recruiters that manage their patients well. But also the flip side is those that perhaps haven't recruited well and are more difficult to to cooperate with. So it's kind of a Venn diagram in some ways that in some sense that that we we cherry picked some of the the better performing sites from a recruitment perspective but also from a compliance perspective. But also, we've got some new sites on board, new countries on board that that we didn't use before for for for a variety of reasons.
So, I mean, you know, I think we've mentioned before on calls that we've attempted to get more patients in The US and Europe in this study, to try and get a kind of a more reference to population for markets in which we plan to, launch this drug in. Other than that, I think, know, it's probably a moving target at the moment, and we'll have more information when recruitment is complete.
Speaker 9
Yeah. Of course. So but you will have more patients enrolled from The US and Europe, of course?
Speaker 7
Yeah. Correct.
Speaker 9
Okay. Good. Second question just has to do with the sort of makeup. I know you made one slight revision just with respect to the time from biopsy. Maybe you can just give us a little more detail on that if you can, in terms of type of patients that are being recruited right now.
Speaker 6
Yeah. I think, the first thing to say is that, in terms of the patients that are going into study, there's, overall, there'd be very, very little difference. So in the in the AURA trial, we required there to be a biopsy within six months of entry into study. We still expect the large majority of patients coming to study to have a biopsy, not only within six months, but actually most of them are actually within weeks coming to the study. That's the that's the population that we that we allow that we allow in.
What we found in the AURA trial was that some patients, especially patients from The United States who had had a recent biopsy say seven or seven and a half months ago, decided not to enter the study because they didn't wish to have another repeat biopsy which was not going to change their management which the physicians did not think was medically necessary for them. And so what we did was we put in some very, very strict criteria to permit under very certain circumstances patients with a biopsy of greater than six months to enter study as long as they could demonstrate, that the elevated proteinuria coming to study was actually a very recent origin. So that, it represented a a flare in act a very recent flare in activity rather than a kind of a chronic leakage of protein. I can't give the exact numbers. We don't have those.
Again, they're like recruitment numbers. It's a moving target. But what we do know is that it's a very small minority of patients coming to the trial.
Speaker 9
Okay. That's excellent. Thank you.
Speaker 0
Thank you. Our next question comes from David Martin with Bloom Burton. Please state your question.
Speaker 8
Good David. Good afternoon, and congratulations on your progress. I've got a couple of questions. At one point, I think there would be the discussion that there may be a separate study or a substudy within the larger study with before and after biopsies. I'm wondering if that is happening or if it's planned.
Speaker 2
Okay. Neil, did you deal with that question as well?
Speaker 6
Sorry. A separate study from before and after biopsies. We haven't any plans to do that. What we certainly some physicians will be doing as part of their ongoing clinical practice is to do repeat biopsies if they do that anyway. And we're certainly interested in the outcomes of any of those.
Speaker 8
So you'll have access to that data as well?
Speaker 6
We will do should they be performed. It's certainly not standard practice everywhere to do so. It's obviously an invasive procedure.
Speaker 8
Okay. And then there has been plans to do some preclinical work looking at the effect of voclosporin on TGF beta levels and inhibition of calcineurin A alpha and beta. When might we see those results?
Speaker 2
So those those are ongoing. We have initiated several of those, there's some additional ones planned. I don't have a very tight timeline on a list of priorities for us. The clinical work has been the highest priority for us as well and given all the new programs, we have been funding those through academic operations. So I don't have but I will get you sort of a better time frame on when we expect those, but I imagine some of them probably by mid next year.
We also are doing studies looking at the podocyte now as well in terms of mechanism, etcetera. So those things have become very important to us to have as sort of just additional knowledge of mechanism and how this drug works. So fair question. I don't have an accurate answer. I don't want to I just want to I'll get you an accurate answer on the time frame for those studies.
Speaker 8
Okay. Thanks. Last question. You referred to the small Phase I VOS study that was done previously. And I guess there were healthy volunteers as well as some patients with dry eye.
The signs of efficacy that you saw, was that on endpoints that were subjective or objective?
Speaker 2
Fair enough. Mike?
Speaker 10
Yeah. They were both on signs and symptoms, Dave.
Speaker 8
Okay. Patients it was it patient assessment of their own systems, or did the physician measure things like cure cure amount and that type of thing?
Speaker 10
Yeah. The Schirmer test scores were used on the physician side. And, also, so that's on the the science side. On the symptom size side, the the patients and the physician filled out an OSBI questionnaire, ocular symptom disease severity score questionnaire, which is standard standard in the field.
Speaker 8
Okay. Thank you.
Speaker 0
Thank you, ladies and gentlemen. There are no further questions at this time. I'll turn it back to management for closing remarks. Thanks.
Speaker 2
Okay. Well, thank you, operator. And once again, for all of you attending. Thank you for your questions. It really has been an exciting quarter.
We set out at the beginning of the year to deliver a number of clinical programs and to execute the ones that particularly lupus nephritis program. And I can't be more thrilled with how the company has performed, how we've delivered against our milestones. But also now really excited as you know, we're getting close and it's a very exciting time for our employees. I think it's a very exciting time for our patients too. And so look forward to the rest of this year, and and, of course, next year, we'll we'll actually have our data.
So thank you all for being on today's call. Once again, thank you.
Speaker 0
Thank you. This concludes today's call. All parties may disconnect. Have a great day.