Clearside Biomedical Inc (CLSD) 2016 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Clearside Biomedical fourth quarter 2016 financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's conference, Mr. Stephen Kilmer, Clearside Investor Relations. Sir, you may begin.

Thank you. Good morning, everyone, and thank you for joining us.

Before we begin, I would like to remind you that during today's call, we will be making certain forward-looking statements. Various remarks that we make during this call about the Company's future expectations, plans and prospects constitute forward-looking statements for the purpose of the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent quarterly report on Form 10-Q on file with the SEC, which can be accessed on the EDGAR database at www.SEC.gov, and the other filings we make with the SEC from time to time.

In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some future point, we specifically disclaim any obligation to do so, even if our views change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to today.

On the call today representing Clearside are Daniel White, our President and Chief Executive Officer; Charlie Deignan, our Chief Financial Officer; Glenn Noronha, our Chief Scientific Officer; and Dr. Rick Beckman, our Chief Medical Officer. With that, I'll turn the call over to Daniel.

Thank you, Steve. Good morning and thank you all for joining the call today. The release of our Q4 year-end financial results marks an end to an historic year for Clearside. With our IPO in June, and a number of significant clinical milestones reached over the course of 2016, we continue to be well positioned to pursue our mission of transformative, elegant, precise solutions to restore and preserve vision.

By leveraging exclusive access to, and proprietary technology for, delivering drugs to the suprachoroidal space to the retina and cornea of the eye, we believe that you can more effectively treat diseases like uveitis, retinal vein occlusion, or RVO as it may otherwise be called, diabetic macular edema, or DME, and wet age-related macular degeneration, known as wet AMD.

With that mission in mind, I'd like to start by providing you with a brief update of our clinical development programs. First, you may recall in the third quarter of last year, we reported additional topline data from our Phase 2 clinical trial in macular edema associated with retinal vein occlusion, where suprachoroidal injection of our triamcinolone acetonide formulation, CLS-TA, along with an intravitreal anti-VEGF agent, showed the potential to improve outcomes relatively rapidly compared to outcomes seen from anti-VEGF monotherapy with an approved agent like Eylea and with a significant reduction in the number of additional intravitreal Eylea injections by 60%.

Based on these positive results and incorporating feedback from our end-of-Phase 2 meeting with the FDA late last year, I'm delighted to tell you that we've initiated Phase 3 clinical trial in Q1 2017 known as the SAPPHIRE trial, enrolling the first patient just a few weeks ago.

SAPPHIRE is a multicenter, randomized, masked, controlled trial designed to evaluate the safety and efficacy of suprachoroidal CLS-TA used together with intravitreally administered Eylea in patients with RVO. Our Chief Scientific Officer, Glenn Noronha, will discuss the trial in more detail momentarily.

During our Q3 call, we also discussed how the success of our Phase 2 trial in RVO has laid the groundwork for us to expand our development program for CLS-TA to include another retinal vascular condition, DME.

We are very pleased to announce in Q4 the enrollment of our first patient in a Phase 1/2 clinical trial, the HULK trial, of CLS-TA for the treatment of DME. The HULK trial is an exploratory, multicenter study designed to assess the safety and efficacy of the administration of suprachoroidal CLS-TA both alone and in combination with intravitreal Eylea in cases of DME.

We are targeting enrollment of approximately 20 patients in the trial. Safety and efficacy data will be collected at each monthly visit during the six-month evaluation period. We expect to report preliminary results from the HULK study in the second half of 2017.

Furthermore, we are also planning a multicenter, randomized, masked, controlled Phase 2 trial to assess suprachoroidal CLS-TA together with intravitreal Eylea as a well-established -- as well as suprachoroidal CLS-TA monotherapy in patients with DME over a nine-month evaluation period. We expect to enroll the first patient in this trial in mid-2017. Glenn will provide more details on that trial as well.

Turning to CLS-TA for the treatment of non-infectious uveitis, our first and most advanced program, we are continuing to enroll patients in the PEACHTREE Phase 3 trial. You may recall that Phase 3 trial will evaluate CLS-TA as a potential treatment for macular edema associated with non-infectious uveitis.

Non-infectious uveitis is a set of inflammatory conditions of the eye affecting over 350,000 people in the US alone. We observed significant improvements from baseline in both macular edema and best corrected visual acuity in patients with non-infectious uveitis in our Phase 2 DOGWOOD trial.

Overall, we expect to enroll approximately 150 patients in PEACHTREE, with approximately 90 patients being randomized into an active treatment arm to receive suprachoroidal CLS-TA and approximately 60 patients being randomized into a control arm to receive sham suprachoroidal procedure with no drug administered. We currently expect to report preliminary results from PEACHTREE in early 2018.

Also, a short update on our wet AMD program, in the middle of 2016, we announced we had selected axitinib as the lead compound for the treatment of wet AMD through suprachoroidal administration due to its potency in targeting the anti-VEGF and PDGF receptors and because of its long half-life when administered suprachoroidally.

However, recent trial results from other industry participants that were pursuing combination therapy agents for wet AMD, led us to reconsider the viability of further development of this proprietary suspension formulation of axitinib.

As a result, on February 27, we announced a strategic realignment of our research and development resources from the preclinical development program for axitinib for the treatment of wet AMD toward our ongoing clinical development program for the treatment of DME.

While we plan to continue to investigate axitinib and other compounds for the treatment of wet AMD, we no longer expect to submit an Investigational New Drug application to the US Food and Drug Administration for axitinib.

Finally, a word on our collaborations, with our development programs moved forward into the clinic, opportunities have arisen for us to collaborate with third-party proprietary programs. We continue preclinical efforts with multiple collaborations in gene therapy, complement inhibition and alternative mechanisms with treatment of complex retinal vascular diseases like wet AMD.

So before I conclude my remarks and turn the call over to Glenn, I'd like to officially welcome Dr. Rick Beckman to Clearside as our new Chief Medical Officer. Rick's employment was announced in January and he is already playing a key role in the continued advancement of our clinical development programs.

I'll now turn the call over to Glenn for a more in-depth update and discussion of our pipeline including our clinical development programs. Glenn?

Thank you, Daniel. The development teams have indeed had a busy and productive fourth quarter and year-end 2016 and we were really [appreciated] with these efforts.

As Daniel mentioned, we designed and completed a Phase 2 trial, TANZANITE, in patients with retinal vein occlusion. These data were presented for the first time at the Retina Subspecialty session at the American Academy of Ophthalmology annual meeting in October 2016 by Dr. David Brown, a prominent retinal physician from Houston in Texas.

In RVO, we are exploring whether suprachoroidal CLS-TA, along with intravitreal Eylea as a combination therapy, can provide improved visual acuity, reduced macular edema, and reduced injection frequency as compared to administration of intravitreal Eylea alone used as monotherapy. Corticosteroids and anti-VEGF agents each have known advantages in treating RVO.

In our completed Phase 2 clinical trial in patients with RVO, 23 patients in the combination arm initially received a suprachoroidal CLS-TA injection and an intravitreal Eylea injection, and 23 patients in the control arm initially received only an intravitreal injection of Eylea.

Patients in each arm were evaluated at months one, two and three after the initial treatment using three specified criteria to determine if they continued to experience macular edema reductions in visual acuity and therefore continued to require additional Eylea treatment.

The primary objective of the trial was met with patients in the combination treatment arm requiring an aggregate of 60% fewer additional Eylea treatments than patients in the control arm over the three-month observation period, a result which was statistically significant with a p-value of 0.013.

In addition, 18 of 23 patients, or 78% in the combination arm of the trial, did not require additional treatments during the three-month trial compared to seven of 23 or 30% in the control arm, a result that was also statistically significant with a p-value of 0.003.

In the same Phase 2 trial, patients in the combination treatment arm experienced greater improvement in visual acuity than those in the monotherapy control arm, with patients in the combination arm experiencing mean BCVA improvements from baseline at months one, two and three of 16, 20 and 19 letters, respectively, compared to improvements of 11, 12 and 11 letters, respectively, in the control arm at the same time point.

In October last year, we held an end-of-Phase 2 meeting with the FDA and, based in part on these discussions, a few weeks ago, we commenced our first randomized, controlled, double-masked Phase 3 clinical trial for the treatment of patients with RVO.

This trial will be conducted at approximately 150 investigational sites and will enroll approximately 460 patients with RVO, randomized either to a combination arm enrolling 230 patients, or to a control arm in which patients will receive intravitreal Eylea alone, also enrolling approximately 230 patients.

Patients in the combination treatment arm will receive suprachoroidal CLS-TA together with intravitreal Eylea at the beginning of the trial, intravitreal Eylea alone at week four, and suprachoroidal CLS-TA together with intravitreal Eylea at weeks 12 and 24.

Patients in the control arm will receive intravitreal Eylea alone at the beginning of the trial and follow-up treatments of intravitreal Eylea alone every four weeks through week 24. After 24 weeks, patients will be followed for an approximate additional six months under as-needed treatment criteria.

The primary objective of this trial will be to determine the proportion of patients in each arm with a BCVA improvement of greater than or equal to 15 letters from baseline at eight weeks after the initial treatment.

I want to turn our attention to the other major retinal vascular conditions we are seeking to treat, diabetic macular edema, in which we have our third clinical program. In November last year, we announced the enrollment of the first patient in an exploratory Phase 1/2 clinical trial called the HULK study, a suprachoroidal CLS-TA either with or without intravitreal Eylea for the potential treatment of patients with DME.

HULK is an open-label, multicenter study evaluating suprachoroidal CLS-TA both alone and in combination with intravitreal Eylea in patients with DME. We are targeting enrollment of approximately 20 patients in this study.

The objective of this trial is to gather preliminary information to further guide our DME program. We currently expect to report preliminary results from HULK in the second half of 2017.

As Daniel mentioned, we are also planning a multicenter, randomized, masked, controlled Phase 2 trial to evaluate suprachoroidal CLS-TA along with intravitreal Eylea compared to intravitreal Eylea monotherapy in patients with DME over a nine-month evaluation period. In this masked, randomized, controlled trial, patients with DME will be assigned in a one-to-one fashion to either a combination arm with suprachoroidal CLS-TA and intravitreal Eylea or to a control arm with only intravitreal Eylea.

The trial will have a fixed treatment portion for the first three months followed by an as-needed portion. While safety and efficacy both will be evaluated in this trial, the primary outcome measure will be best corrected visual acuity, where the combination treatment data will be compared to the monotherapy data.

We expect to enroll the first patient in this trial in mid-2017. We will continue to provide more details on this trial each quarter.

Finally, as Daniel mentioned, enrollment continues in PEACHTREE, our Phase 3 trial in patients with macular edema due to non-infectious uveitis.

Recall that early in 2016, we'd announced that we'd completed a Phase 2 trial, DOGWOOD, in patients with macular edema-associated non-infectious uveitis where patients received a single suprachoroidal injection of CLS-TA and had a statistically significant reduction of 164 microns in macular edema from baseline at week eight at a p-value of 0.002, which was the primary endpoint of the trial.

Patients receiving CLS-TA also had a statistically significant mean improvement in visual acuity of approximately 9 letters from baseline at week eight with a p-value of 0.0004. These data were presented for the first time last year by Dr. Steven Yeh, a well-known uveitis physician, at the American Society of Retina Specialists annual meeting in August last year.

These Phase 2 results were following a Phase 1/2 open-label, six-month clinical trial from which we had seen favorable safety and efficacy outcomes in non-infectious uveitis patients.

In PEACHTREE, our Phase 3 trial of suprachoroidal CLS-TA as a potential treatment for non-infectious uveitis, we are enrolling approximately 150 patients, with 90 patients being randomized into an active treatment arm to receive suprachoroidal CLS-TA and 60 patients being randomized into a control arm to receive a sham suprachoroidal procedure with no drug administered. This is a pivotal Phase 3 trial in patients with macular edema due to non-infectious uveitis.

I'm going to turn the call over to our Chief Financial Officer, Charlie, to review our fourth quarter and year-to-date financial results. Charlie?

Thanks, Glenn. As we reported this morning, our research and development expenses were $7 million for the fourth quarter 2016 compared to $3.8 million for the same period in 2015, with the increase driven by our ongoing clinical development programs for CLS-TA and an increase in device manufacturing costs.

General and administrative expenses for the fourth quarter of 2016 were $2.4 million compared to $1.2 million in that 2015 fourth quarter. The increase was primarily due to higher employee-related expenses and costs related to being a public company, including increased directors' and officers' insurance, professional fees and non-employee Director compensation.

In Q4 2016, net loss was $9.7 million or $0.45 a share compared to $5.2 million or $1.95 per share for the same period in 2015. As of December 31, 2016, cash, cash equivalents and short-term investments totaled $83.6 million.

As we noted in our press release, we had two public offerings in 2016; our IPO in June and a follow-on public offering in December, which also included the exercise of the underwriters' options to purchase an additional -- shares in January 2017 yielding aggregate net proceeds of $89.9 million.

As Daniel and Glenn highlighted earlier on the call, we have been both advancing and expanding our suprachoroidal CLS-TA development programs with the initiation of a Phase 1/2 trial for DME in November 2016, the continuing enrollment of a Phase 3 trial for non-infectious uveitis, the enrollment of a first patient in a Phase 3 program for RVO in February 2017 and the preparation for a Phase 2 trial for DME that we are planning to initiate in mid-2017.

As we mentioned on last quarter's call, we expect our research and development expenses to continue to increase in tandem with these clinical trials. That said, we currently expect our cash resources to take us forward for at least the next 18 months.

With that, I'll turn the call back over to Daniel for his closing remarks. Daniel?

Thank you, Charlie. This concludes the prepared remarks for today. Before I open the call to questions, I'd like to express my thanks to the entire Clearside team for the tremendous progress we made this year. We have a strong and highly capable team of professionals that have consistently delivered on our key corporate goals and we appreciate their commitment to our mission.

With that, we will now open the call up for questions. Operator?

(Operator Instructions) Anupam Rama, JPMorgan.

Hey, guys. It's Eric in for Anupam. Can you hear me okay?

Yes, we can hear you fine. How's the storm?

Doing okay. Kind of shuttered in here. Anyway, thanks for taking the question.

Just wondering if you are able to say at this point a little bit more about the powering assumptions for PEACHTREE in uveitis, what minimum difference in BCVA change over sham the trial might be able to detect? And, if not at this time, when might we be able to learn a little bit more about the powering assumptions getting closer to data?

Great, thanks for the question, Anupam. I think I'll turn that one over to Glenn. I think he is best to answer that.

Thank you, Daniel. So, Anupam, that's a really good question. The study is powered to show that the proportion of 15 letter or three line gain is superior from the treatment arm over the no treatment arm, and the study (inaudible) powered to show that that is indeed the case.

Got it, thanks. And maybe -- I mean, how should we be thinking about the rate of spontaneous resolution of symptoms in non-infectious uveitis out to six months?

So, generally, that's not seen in non-infectious uveitis patients. The literature -- it's relatively hard to get these data, but they are low-single digits in terms of those you see that resolve in their systems, but it's rare to see people that gain 15 letters spontaneously.

Got it. Thanks very much for taking the questions.

Annabel Samimy, Stifel.

Hi, guys. Thanks for taking my questions. I had several.

First, with regard to DME, is there any reason to believe that DME is going to perform any differently than the macular edema that you are going after in RVO or in uveitis? Can you just help us understand how we should think about DME and the chances for success?

The second question I have is with regard to uveitis. Can you talk about where you are with enrollment and what kind of hurdles or lack of hurdles have you encountered during that enrollment?

And then the last question I have is regarding the wet AMD. I can understand why you didn't move forward given that we haven't really seen activity in the PDGF inhibitors? Can you talk about what possible other options you might have to target that? Thank you.

Great, so Annabel, this is Daniel. So the first -- let's talk about DME first. If we look at -- if you look at the success of DME with steroids, there have been a number of successful approvals with DME with certain steroids including Iluvien, including Entocort -- sorry, [Arjadex] in as far as DME label.

What we still see, however, is that with DME, there is still a large number of patients who don't resolve all the way to their baseline with just VEGF therapy alone. And we've never seen a RVO treatment that has not been approved also in DME.

So using the number of steps there, we believe that we might be able to show an additive benefit, like we did in our RVO study, in DME, although DME is a very different disease than RVO, we'll conclude -- can see that. But, the opportunity there seems to be more favorable for steroids and we've been receiving a lot of interest from investigators and moving into this space. I hope I answered your question there.

Let's talk about uveitis enrollment. So uveitis, we understood uveitis is a bit smaller disease and very difficult to reach from an enrollment point of view. If you recall, we are asking that these patients come in with at least three line improvement of vision, or the opportunity for three line improvement of vision. And, therefore, it's very hard to predict where you are going to be in enrollment with uveitis has been the risk all along.

I think originally we were anticipating that we would be somewhere in late 2017 for topline data and, as you can tell, we've started to move -- or pivot our expectations more toward the first part of 2018.

Now, that is an opportunity for inflection point with plenty of cash on the balance sheet after we are able to report that topline data, but we see with a number of competing trials as well as the patient populations just taking us a little bit longer than we anticipated.

Let's go last to wet AMD. First of all, by no means are we discontinuing efforts around wet AMD. We believe that wet AMD is an optimal disease for us to be targeting given we are putting drug directly on top of the choroid for choroidal neovascularization.

And Axitinib is a very interesting compound and it's -- in some of our preclinical models, we saw some very nice duration effects, we saw a benefit in some of these animal models. But these animal models sometimes are not predictive of disease in wet AMD, as we anticipated.

So what we are looking for, the shift was really about resources. We wanted to, after reviewing what the outcome of the data from Regeneron as well as from [Opitec], for PDGF, we had to ask ourselves, and scratch our heads a little bit on whether or not this is the ideal place to put our resources or not versus the DME target. And so we elected to pivot toward DME given the interest from the investigators and the outcome of our RVO study. I hope I answered your question.

Okay, can I -- yes, can I just follow-up on the uveitis? What are the -- how hard is it to predict which patients are going to be able to come in with a potential for a three line improvement? How do you find these patients? Is that what a typical uveitis trial is like?

The come in with a -- requiring 20/40 or worse vision and they are assessed and they have to maintain it through the screening process we have. So, that's the only step there and it's hard to predict. It's harder for us to predict those patients with uveitis.

Are there any of those requirements for the RVO or the DME trial? I mean -- yes, for those two, is it the same kind of --?

Yes, yes.

Yes, it's the same. And are those harder to -- or are those also difficult to predict?

I think with RVO and with DME, I think these patients come in with more severe disease. And we anticipate most of those patients will have the need for treatment that would result in -- they would have worse than 20/40 vision. So it's the same target of patient, but I think they are more likely to have the vision as bad as 20/40 or worse due to the disease itself.

Okay, great. Thank you.

Liana Moussatos, Wedbush Securities.

Thank you for taking my questions. What are your anticipated modifications to the suprachoroidal space device before approval and commercialization?

And I know you haven't started yet, but the Phase 2 DME trial, do you anticipate data release by the end of 2018 or will this be more like 2019? And how likely is a collaboration announcement this year or next year and will it be on wet AMD?

So let me -- I'm going to grab those one at a time. Let's talk about manufacturing. So first of all, we are not changing the device from our Phase 3 to our manufacturing. This is -- we are scaling manufacturing to meet the needs that we have -- that we anticipate having in the marketplace. So that's -- there won't be any changes.

Devices will be the same devices we see in our Phase 3, which we are getting great feedback on from the physicians who are currently involved in -- or from the investigators, sorry. So, we are really excited about how well that's going in our Company and the team is on that program.

As far as the DME Phase 2, we are actually planning on an interim look at the DME Phase 2 sometime in the initial part of 2018. And the idea there is having an additional pivotal end point, or additional inflection point, that we can point to as well as the uveitis study. And, again, still having a target of plenty of cash on the balance sheet. So, I would be focused on more the first part of 2018 than I would be the back half of 2018. So for our first -- for the first time that we comment on the trial.

And the last questions on collaborations. I can't really go into any detail around the collaborations; I wish I could. But we've had quite a few parties contact us as far as looking at suprachoroidal delivery for their proprietary compounds, and in all fields, both gene therapy and complement inhibition and in wet AMD. And, so far, we are excited how those are returning.

Will we be able to make an announcement by the end of the year? I hope so, but I'm not exactly counting -- it will be more toward the end of the year than it would be in the beginning.

Thank you.

Serge Belanger, Needham & Company.

Hi, good morning. Thanks for taking my questions. First, on the uveitis program, I think in the past you've told us the FDA would only require a single Phase 3 study. So with results, or preliminary results, expected in early 2018, would that put you on a timeline to file an NDA by mid-2018 and what additional data would be required for that NDA filing?

So the FDA did -- has a single pivotal study that's required for this -- for uveitis, for macular edema associated with uveitis and we plan on getting the topline data sometime in the initial part or in the first half of 2018 or early 2018.

I can't make any promises as far as whether or not I'm going to -- whether or not we will have or be able to file in the middle part of 2018, but the -- I think it is probably more toward the second half of 2018 before we'll file.

The only other -- we have to do literature support to also support that study and that's a program that's not going to hit the critical path as far as our research is concerned.

So -- but I think you are thinking in the right way about when -- if topline data is successful, being able to (inaudible) everything into an NDA package, likely in the second half of 2018.

Okay. There's been a couple press releases on new patent allowances. If you could just review your IP position on CLS-TA.

Yes, I can. So we are excited about some of the new patent releases that have come out. So recently -- the original license technology from Emory and Georgia Tech covered the use of a microneedle to deliver these drugs to the suprachoroidal space and that's been -- that was quite exciting.

That gave us confidence that if you are going to take a needle and you're going to stick a drug through the orifice of that needle and it would end up in the suprachoroidal space, it would be covered.

The new patents are starting to come out. They are more, in my mind, more exciting, where they cover the difference in drug distribution within the eye when delivered suprachoroidal versus intravitreal, and having that difference in drug distribution, and having a pharmacodynamic effect is what is the underpinning of what these patents represent.

So it doesn't matter what -- the way -- any way you put it into the eye. If it goes in, it has that similar drug distribution that is different than an intravitreal or other drug administration that it will be covered under that intellectual property.

And so as that family continues to show allowances, we are getting good support from the Patent and Trademark Office on the new patent and further supports that we have exclusive access to this area of the eye, the 17 square centimeters of the human eye.

And then further, the intellectual property covers the procedure, the devices, some of the new technologies that we recently had allowed, also is a adjustable needle approach. So we have a lot of innovation continuing to come out of Clearside, quite a lot.

And in terms of medical meetings for this year, what have you met in terms of data presentations for the major ophthalmology conferences?

So, help me with your question there. Where are we going to be next? (multiple speakers)

If you are planning any data presentations at the major ophthalmology conferences?

Right. We'll continue to present the information for the retinal vein occlusion data.

I think one of the things that you will find is that we are going to be speaking at Macular Society and ARVO probably in this part of the year. From the -- speaking specifically about the retinal vein occlusion, I'm excited to see when the HULK's -- the results come out so that we will be able to talk about HULK later on this year.

And, possibly, we are looking at some of the patients from the retinal vein occlusion study for how long they actually lasted, and it was more of a retrospective look on the 18 patients -- 18 to 23 patients -- that didn't receive any treatment during the three months.

And so we are trying to get our finger on the pulse of what is the potential interval that we could have between anti-VEGF treatment when used in combination with triamcinolone. And certainly, a large number of these patients went longer than three months, so that's what we are attempting to try to understand. So we'll be presenting some information on that here in the near future.

Okay, one last one for Charlie. Just the updated share count post the December equity financing?

Approximately 25 million.

Perfect. Thank you.

(Operator Instructions) Yi Chen, Rodman & Renshaw.

Hi. Thank you for taking my questions. Could you give us some rationale in the design of the Phase 3 trials, of the two Phase 3 trials between SAPPHIRE and PEACHTREE. They are both addressing macular edema, of course. For SAPPHIRE, the time period to the measurement of primary outcome is much shorter than PEACHTREE while requiring almost three times the number of patients to be enrolled. Is this simply because it is a combo therapy study?

So let me turn that to Glenn to answer that question.

Thank you, Daniel. So, your question is it's a shorter primary endpoint timeframe but it requires more patients?

Correct.

So, in SAPPHIRE, they are going head-to-head against the monotherapy, Eylea, so the study is designed to show that at an early time point we can show a better visual acuity outcome.

It's styled to show that you will get that kind of result if we are successful at an early time point thereby providing patients with an early clinical benefit, so it's hard to show that.

It's completely different from PEACHTREE, which is run against a no-treatment and is a six-month study in terms of what's required for the primary outcome.

Okay, thanks. Could you give us some rough estimates of the cost of -- the cost for each of those Phase 3 trials to complete from this point on?

Yes, let me hand that one to Charlie and he'll answer.

Yes, so we don't give guidance on the individual cost of our trials, but typically in ophthalmology, or what we've seen, these trials can be between $60,000 and $100,000 per patient.

Okay, thank you.

Thank you. And I am showing no further questions at this time. I'd like to turn the call back to Mr. White for closing remarks.

Well, thank you again for joining the call. We appreciate your continued interest in Clearside and we look forward to updating you on our progress in the months ahead.

Operator, you may now disconnect. Thank you.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone have a wonderful day.