Greetings. Welcome to Aurinia Pharmaceuticals Inc. Q2 2018 financial results. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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.
Thank you, operator. Good afternoon, everyone, and welcome to Aurinia's Q2 2018 earnings call and general business update. With me on the call today from Aurinia are Richard Glickman, Chief Executive Officer, and Dennis Bourgeault, Chief Financial Officer. Joining us for the Q&A will be Michael Martin, our Chief Operating Officer, and Dr. Neil Solomons, our Chief Medical Officer. This afternoon, we issued a press release detailing our Q2 2018 financial results and corporate updates. 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 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 6-K with the U.S. Securities and Exchange Commission. All of our statements are made as of today, August ninth, 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?
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. I'm excited to talk about the momentum of our organization is developing after a period of what I would refer to as heavy lifting. With respect to our phase III clinical program in LN, our most advanced program, we are excited to announce that 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 52 weeks, after which there is 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 end of 2019. For a bit more granularity, we have 225 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 III trial, where we opted to initiate and activate as many sites as possible from the beginning rather than activating a few at a time. You may recall that patients that have active lupus nephritis are very ill, and our phase II 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 III trial and are monitoring these very closely in a blinded manner.
The DSMB also reviews all adverse events on an ongoing basis. So far, we believe the study is progressing very well. We continue to have motivated patients and investigators participating in this trial. We remain very encouraged by the level of interest in the trial it has been generating around the globe. Our team is working diligently with the goal to assess the efficacy and safety of voclosporin in 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. We expect to complete the rolling submission in Q2 2020. During the second quarter, we also saw the first patients roll over into the AURORA-2 blinded extension study from the AURORA phase III clinical trial.
The purpose of the AURORA-2 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 CNI should prove to be a great value 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 5,400 new patients are diagnosed with FSGS in the U.S. alone each year, accounting for the largest segment, almost 30%, 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 reduction in 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, this is a rare disease. We expect enrollment could take up to 12 months. 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 proteinuria diseases synergistic with our current strategy and long-term vision of the company.
Now, 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 a 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 fruitful 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, nanomicellar solution containing 0.2% voclosporin. 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 patents with exclusivity until 2030. 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 20 million people in the U.S. alone. While there are two FDA-approved products for the treatment of dry eye, one of which is a calcineurin, there is the potential and need for improved effectiveness for the treatment of dry eye, particularly by enhancing tolerability and the onset of action and alleviating the need for repetitive daily dosing. We believe that the calcineurin inhibitors will remain a mainstay for the treatment of dry eye and that VOS has the potential to be the best-in-class CNI 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 II 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 2019. 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 a 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. 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 of 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 Bourgeault, our CFO, to review the Q2 financials with you. Dennis?
Thank you, Richard. At June 30th, 2018, we had cash equivalents and short-term investments of CAD 150.2 million, compared to CAD 159.1 million at March 31st, 2018, and CAD 173.5 million at December 31st, 2017. Net cash used in operating activities was CAD 12.3 million for the second quarter ended June 30th, 2018, compared to CAD 14 million for the second quarter ended June 30th, 2017. In the second quarter ended June 30th, 2018, we received proceeds of CAD 3 million from the exercise of warrants, which were set to expire in June of 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 CAD 15.7 million, or CAD 0.19 per common share, for the three months ended June 30th, 2018, as compared to a consolidated net loss of CAD 2.4 million, or CAD 0.03 per common share, for the three months ended June 30th, 2017. The increase in the loss for the three months ended June 30th, 2018, 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 CAD 9.4 million. The three months ended June 30th, 2018, reflected a CAD 1.9 million increase in the estimated fair value of derivative warrant liabilities, compared to a reduction of CAD 7.5 million in the estimated fair value for the three months ended June 30th, 2017.
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 CAD 13.8 million for the three months ended June 30th, 2018, compared to CAD 9.9 million for the same period in 2017, with the increased loss amount primarily reflecting higher research and development expenses.
For the six months ended June 30th, 2018, the consolidated net loss was CAD 31.2 million, or CAD 0.37 per common share, compared to a consolidated net loss of CAD 54.3 million, or CAD 0.78 per common share, for the comparable period in 2017. [The six-month net loss included a non-cash charge/loss of]CAD 4.6 million in the estimated fair value of derivative warrant liabilities, compared to [a non-cash charge/loss of] CAD 33.3 million for the comparable period in 2017. The net loss before the non-cash change in estimated fair value of derivative warrant liabilities was CAD 26.6 million for the six months ended June 30th, 2018 compared to CAD 21.1 million for the same period in 2017. The increased loss, again, primarily reflected higher research and development expenses. Research and development expenses increased to CAD 10.5 million for the three months ended June 30th, 2018, compared to CAD 7.1 million for the three months ended June 30th, 2017.
We incurred research and development expenses of CAD 19.4 million for the six months ended June 30th, 2018, as compared to CAD 14.4 million for the same period in 2017. The increased research and development expenses reflected higher AURORA clinical and drug supply costs, as well as start-up costs for the AURORA 2 extension study and the FSGS and dry eye studies. Corporate administration business development expenses increased to CAD 3.5 million for the three months ended June 30th, 2018, [compared to CAD 3.0 million for the three months ended June 30th, 2017. For the six months ended June 30th, 2018, corporate administration and business] development expenses [were] CAD 7.3 million, compared to CAD 6.3 million 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?
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 II trial in LN, more patients rolling over into the AURORA 2 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, 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.
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&A. Operator?
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 star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, to ask a question, press star one on your telephone keypad. Our first question comes from Ed Arce with H.C. Wainwright & Co. Please state your question.
Great. Thanks for taking my questions. Congrats on all of the progress this quarter in transitioning from one to three clinical programs. I have three questions. First, you had mentioned the pivotal phase III 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 2, sounds like from your perspective, this is really more about communicating the long-term safety ultimately with prescribing physicians, and just wondering how you. 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. Thanks so much.
Okay. Thanks. Answer the question. Before I answer your first question, I 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 [extends to] 2031. [The program started in] 2013 . I apologize for that. Neil, did you want to sort of tackle that first question about enrollment, and how things are progressing?
Yeah. I think, Ed, good question. We've obviously had a lot of very close contact with our PIs throughout the world. They continue to be extremely enthusiastic about this study. That's feedback that we get, and that results in them continuing to enroll patients. It also obviously highlights the unmet medical need in the very severe patients that we're recruiting. Obviously, the physicians and ourselves are blinded. We have no way of knowing what therapy these patients are assigned to. However, clearly, they see their patients overall benefiting from entering this study. I think that's probably all we can say about that for the moment, Ed.
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 sort of naturally has its own momentum. With that, we still turn away a lot of patients that are probably not appropriate for the study. 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 2 study. I could just quickly comment that, when you're on a calcineurin inhibitor, whether you're on it for a transplantation. When you look at drugs like voclosporin and you look at these patients, we generally believe that patients will be on for a fairly substantial period of time.
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. It's a natural thing to do, a several-year follow-up extension. I think it's going to be very valuable for us, because I really do believe that when decisions are made as to which drug to remove a patient from, whether it's complete removal of steroids or whether it's reduction of CellCept, that having this long-term data is going to be very useful. I think it also becomes useful as well, when you start looking at registries and you start looking at other things such as, patient pregnancies, et cetera, 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. 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. We're relatively new in this disease, or very new in this disease, and we're looking at patients that are naive. 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 podocyte, its impact on the immune system, it makes it an ideal candidate. We really don't know what the next step looks like, I think, until we really take a look at our actual data that we generate.
If our generate is consistent with what we expect this drug to perform, then we'll have more granularity about what a phase III program would look like. Neil, did you want to add anything to that?
No, I think you said most of it. I think the key point about this is that nobody's ever done a naive steroid-free therapy before. The very fact that everybody thinks it's a great idea, I think is key to us. I think we're going to see the benefits of this particular therapy performed and the study done in a rigorous fashion in 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 think when we get enough data that gives us enough of a signal, then we will be obliged to release certain results. We'll move quickly on to discussing our further development when we get the adequate amount of data. I think.
Okay, great. That was very helpful. Thank you, Neil and Richard.
Thank you.
Thank you. Our next question comes from Joseph Schwartz with Leerink Partners. Please state your question.
Hi. Thanks very much, and congrats on all the progress. I wanted to ask a question on the dry eye program as well as the FSGS program. You mentioned that the dry eye program is a tolerability study, but it's fairly large, and I would imagine potential partners would be interested in the clinical profile as it pertains to efficacy. How well suited is the phase II 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.
Neil, did you want to address that?
Yeah, I'm happy to do that. Joe, again, it's always a challenge with these relatively limited size proof-of-concept studies and what you're going to see, what you hope to see, and what you expect to see. 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. If there is a dramatic early effect, the study is certainly designed to be able to show that. For example, it's a short study. If we do see early separation in some of the efficacy, the study is designed to be able to see that. Of course, again, I think we have to caution the fact that from a statistical perspective, if we don't see it doesn't mean the effect's not there.
That's the way we design these proof-of-concept studies, that if we do see early differences, they will show up in the results. I think we just have to caveat and caution that if those results are not seen, it doesn't mean that the drug's not doing its job. I think that's probably the most important thing, Joe, from the eye perspective.
I think clearly from the 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 RESTASIS is this tolerability issue. I think that there could be several benefits of this program. I 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. 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 12 and 16 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.
We would hope that we see that carry through in the human clinical side. Certainly, in the limited phase I experience that was seen with this drug, we did see early signs and trends. This is a much larger population to do that on. I think we've got a fair shot, although I take the caution that's been expressed. I do think we have a fair shot of seeing some trending, at least of early efficacy with this molecule.
Okay, great. Thanks. That's helpful. On the FSGS program, in phase II, it looks like you're targeting patients with more than or greater than or equal to three mg/ mg of urine protein, creatinine ratio. That seems like it's a lot higher than certainly your lupus nephritis inclusion criteria, and some other FSGS inclusion criteria that we've seen, which is like one to two mg/ mg. I was just wondering if there's a specific reason behind that. Are you purposely targeting sicker patients here? FSGS is a pretty catchall classification of patients with a lot of different diseases. I think this is a relatively small study. Do you think that could confound the results in any way, given the wide variability in presentation that people with FSGS have?
Neil, could you-
Yeah. 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, specifically calcineurin inhibitors, as well as other drugs on the podocyte disorders. Sometimes we don't see this really disordered podocyte effacement in patients with lower levels of proteinuria. 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. I really think that these are the patients who are going to see the benefits in.
These are the patients that the physicians are currently incredibly interested in treating with our FSGS podocytopathy. The nephrotic syndrome, not just the proteinuria, but hypoalbuminemia, hypercholesterolemia still represents the greatest unmet need. These are the patients that do the worst. These are patients that we believe that our drug could have the greatest benefit in, Joe.
Excellent. Very helpful. Thanks again.
Thanks, Joe.
Thank you. Our next question comes from Elemer Piros with Cantor Fitzgerald. Please state your question.
Good afternoon, gentlemen. What I'd like to understand is, if you could tell us a little bit more about AURORA 2. What is the duration of the trial, or this extension phase, and what was the rationale to keep it in a blinded fashion?
Hey, Neil, you're getting a lot of questions today.
Yeah. They're all good questions. The rationale, I think the first question was the duration. We're doing two further years, so that we hope to get, in total, I guess, three years of comparative data. The comparative data answers the second part to 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 big piece, apart from the long-term safety data, long-term renal function effects on other aspects of lupus, is potentially assessment of relapse.
As we know, lupus nephritis is a relapsing or remitting disease. Not only are we getting patients into remission, but we wish to stop them going back into disease flare again. These are some of the things that we're going to see in our continuation study. We're also going to be looking at extrarenal parameters and where these patients' non-renal lupus flares, and again, that could also trigger further clinical work in the extrarenal space further down the line. 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 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 surfaces, but also in SLE, with some of the extra data that we get, we believe that being in a comparative continually blinded study adds both statistical but also clinical power to our arguments.
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, experiences a modest or minor response. When you take this out to 3 years, wouldn't it be more likely that you would lose those patients? The comparison between the two arms may not be as balanced.
Right. I'm not exactly sure. I understand. Certainly over the prolonged three-year period, what Michael just said, over a three-year period, even on standard care, patients do continue to go into remission, after three years of therapy. I think it's important to have the comparator to make sure that what we're seeing is not just the sort of background quiescence of the disease over time. I'm not exactly sure I've answered your question.
Yeah. Thank you very much.
I guess, I was sort of thinking, certainly, we're not using AURORA 2 for part of our approval process. 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 II trial. Having that additional data, I think is beneficial. I think you're right, there's a risk over time that you're going to lose patients. The tendency, though, is for these patients is to stay on drug. 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 expansion study. I think that's really important because you'll be showing really long-term stability in those patients. I think at the end of the day, it will impact how physicians decide to treat. I think having that data is going to 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 more likely to stay in the study because they are doing better. Time will show us that answer. The important thing is it doesn't put our other trial at risk.
Yes. Thank you very much, Richard and Neil.
You're welcome.
Thank you. Our next question comes from Douglas Miehm with RBC Capital Markets. Please start your question.
Yeah, good afternoon.
Hey, Doug.
Hi. 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?
Interesting question. Neil I don't
Yeah. We've obviously not finished recruiting yet. There is some overlap. One of the things that we've learned both from the AURORA trial, but also actually if we cast our mind back to the ALMS trial, is two things. One is sites that are good recruiters that manage their patients well. Also the flip side is those that perhaps haven't recruited well and are more difficult to cooperate with. It's kind of a Venn diagram in some ways that in some sense that we cherry-picked some of the better performing sites from a recruitment perspective, but also from a compliance perspective. Also, we've got some new sites on board, new countries on board that we didn't use before for a variety of reasons. I think we've mentioned before on calls that we've attempted to get more patients in the U.S.
Europe in this study to try and get a more representative population for the markets in which we plan to launch this drug in. Other than that, I think is probably a moving target at the moment, and we'll have more information when recruitment is complete.
Yeah. Of course. You will have more patients enrolled from the U.S. and Europe, of course.
Yeah.
Okay. Good. Second question just has to do with the sort of makeup. I know you made one slight revision just with respect to-
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.
Yeah. I think the first thing to say is that in terms of the patients that are going into the study, overall, there'd be very, very little difference. In the AURA-LV trial, we required there to be a biopsy within six months of entry into the study. We still expect the large majority of patients coming to the study to have a biopsy, not only within six months, but actually most of them are actually within weeks of coming to the study. That's the population that we allow in.
What we found in the AURA-LV trial was that some patients, especially patients from the U.S. 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. 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 the study as long as they could demonstrate that the elevated proteinuria coming into the study was actually of very recent origin, so that it represented 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, a bit like recruitment numbers, it's a moving target. What we do know is that it's a very small minority of patients coming into the trial.
Okay, that's excellent. Thank you.
Thank you. Just a reminder, to ask a question, press star one on your telephone keypad. Our next question comes from David Martin with Bloom Burton. Please state your question.
Afternoon, David.
Good afternoon. Congratulations on your progress. I've got a couple of questions. At one point, I think there had been a discussion that there may be a separate study or a sub-study within the larger study with before and after biopsies. I'm wondering if that is happening or if it's planned.
Okay. Neil, did you want to deal with that question as well?
Sorry. A separate study for before and after biopsies? We haven't any plans to do that. What certainly some physicians will be doing as part of their ongoing clinical practice is to do repeat biopsies. They do that anyway. We're certainly interested in the outcomes of any of those.
You'll have access to that data as well.
We will do, should they be performed. It's certainly not standard practice everywhere to do so, because obviously it's an invasive procedure.
Okay. 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?
Those are ongoing. We have initiated several of those, and there's some additional ones planned. I don't have a very tight timeline. On our list of priorities for us, the clinical work has been the highest priority for us as well. Given all the new programs, we have been funding those through academic operations. I will get you sort of a better timeframe on when we expect those. 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, et cetera. Those things have become very important just to have as sort of just additional knowledge of mechanism and how this drug works. Fair question. I don't have an accurate answer. I'll get you an accurate answer on the timeframe for those studies.
Okay, thanks. Last question. You refer 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?
Fair enough. Mike?
Yeah. They were both on signs and symptoms, Dave.
Okay. Was it patient assessment of their own symptoms, or did the physician measure things like tear amount and that type of thing?
Yeah, the Schirmer test scores were used on the physician side, so that's on the signs side. On the symptoms side, the patients and the physician filled out an OSDI questionnaire, Ocular Symptom Disease Severity Score questionnaire, which is standard in the field.
Okay. Thank you.
Thank you, ladies and gentlemen. There are no further questions at this time. I'll turn it back to management for closing remarks. Thanks.
Thank you, operator. Once again, thanks 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, particularly the uveitis program. 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 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. Look forward to the rest of this year, and, of course, next year we'll actually have our data. Thank you all for being on today's call. Once again, thank you.
Thank you. This concludes today's call. All parties may disconnect. Have a great day.