IVERIC bio Q4 2022 Earnings Call Transcript

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Provided by Quartr
March 1, 2023

There are 12 speakers on the call.

Operator

Good morning, and welcome to the IVERIC Bio 4th Quarter 2022 Earnings Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Kathy Galante, Investor Relations. Please go ahead.

Speaker 1

Good morning, and welcome to

Speaker 2

the IVERIC Bio conference call. Representing IVERIC Bio today are Glenn Spondorio, Chief Executive Officer Doctor. Praveen Dougal, President Keith Westby, Chief Operating Officer David Carroll, Chief Financial Officer Doctor. Devild Desai, Chief Development Officer Chris Sims, Chief Commercial Officer and Tony Gibney, Chief Business and Strategy Officer.

Speaker 1

I would like to remind you that today we will be making statements relating to IVERIC Bio's future expectations regarding operational, financial and research and development matters. These statements constitute forward looking statements for the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. These statements cover many events and materials that are subject to various risks that could cause actual results to differ materially from those expressed or implied any forward looking statement. I refer you to our SEC filings and in particular to the risk factors included in our quarterly report on Form 10 I would now like to turn the call over to Glenn.

Speaker 3

Well, thanks, Kathy, and good morning, everybody. In 2022, we continue to deliver on our goal to deliver to provide Potential treatments to patients suffering from retinal diseases with avocintacaptevpegol or ACP achieving a statistically significant reduction in the rate of geographic atrophy progression at the 12 month pre specified primary endpoint across 2 Phase 3 clinical trials. We begin 2023 with the FDA's acceptance of the filing of our new drug application for ACP for the treatment of geographic atrophy or GA secondary to age related macular degeneration. With the achievement of this important milestone, we move closer to our goal of providing patients with a treatment for GA, a devastating disease that leads to irreversible blindness. Additionally, our NDA has been granted priority review by the FDA and given a Prescription Drug User Fee Act or PDUFA date of August 19, 2023.

Speaker 3

We were also informed that at time of the FDA acceptance letter, the FDA had not identified any potential review issues and the FDA was not currently planning to holding advisory committee meeting for ACP. This morning, we announced results of a post hoc analysis on the data from the ACP GATHER-one and GATHER-two clinical trials signaling in up to 59% risk reduction in the rate of vision loss for the ACP 2 milligram groups compared to sham at 12 months of treatment. Praveen will discuss this new data in more details in a few moments. As we move closer to potential approval, Our key focus in 2023 is to make ACP commercially available to physicians and their patients Suffering with GA as quickly as possible. About a year ago, we started to build a world class commercial team that includes sales leadership, reimbursement, marketing and market access.

Speaker 3

Our commercial leadership team brings extensive experience in launching drugs for retinal diseases in large markets. We continue to accelerate our launch plans and expect to have a full U. S. Team, including a field based sales team Hired by early April of this year, our commercial team, which is led by Chris Sims, expects to have a field force of approximately 50 to 70 Sales representatives in an organization of about 120 in total. Since this is our year end call, I wanted to back on some of the significant accomplishments of 2022.

Speaker 3

We received top line data from GATHER2 in early September and finished our rolling submission of the NDA for ACP in late December. This was done in just over a little just over 3 months. In November 2022, we announced the FDA granted Break drug to receive breakthrough therapy status for this indication, which was granted based on the 12 month results from both GATHER-one and GATHER-two. We also intend to pursue further discussions with the FDA about utilizing The GATHER-one and GATHER-two clinical trial data included in the current NDA submission to support treatment of GA associated with earlier stage disease, including patients with intermediate AMD. We do not plan to conduct a new clinical of ACP in patients with intermediate AMD.

Speaker 3

We initiated an open label extension study for patients who have completed their month 24 visit in the GATHER-two clinical trial, with the aim of providing patients long term access to ACP and collecting additional safety data. And we continue to invest in additional lifecycle initiatives for ACP to expand the patient population and evaluate multiple Same Delivery Technologies for ACP. On the financial front, in December of 2022, we raised approximately 300 $24,300,000 net proceeds in an underwritten public offering of our common stock. Also in 2022, we secured a term loan Credit facility providing us with up to $250,000,000 in non dilutive debt financing under which we have drawn down $100,000,000 to date. These financings further strengthen our balance sheet and provide financial flexibility as we continue to build our U.

Speaker 3

S. Launch readiness plan and prepare for the potential commercialization of ACP. Dave is going to provide some more details on our cash position in a moment. I also want to acknowledge Praveen's election to the Board of Directors at the beginning of this year. Praveen has been instrumental in helping to shape the company's business Before I turn the call over to Praveen, on behalf of IVERIC Bio, We want to take a moment to congratulate Atellus for their approval of SYFORI, which finally provides patients with the first treatment for GA.

Speaker 3

We also want to commend the FDA for their ongoing commitment to finding treatments for patients suffering from AMD. I want to thank all of you for your continued support of IVERIC bio. And I will now turn the call over to Praveen.

Speaker 4

Thank you, Glenn, and good morning, everyone. I could not agree more with you, Glenn, a big congratulations to our friends at Apellas. Our plans to drive ACP to a potential approval in GA has been clear and consistent throughout this journey. We believe our special protocol assessment for GATHER-two, fast track and rolling review of our NDA, Breakthrough Therapy Designation and now Priority Review further strengthens our position as we get closer to a potential near term launch of ACP for GA patients. We look forward to collaborating with the FDA throughout the remaining NDA review process.

Speaker 4

We are excited to announce A post hoc time to event analysis of the data from the GATHER-one and GATHER-two trials that signaled a reduction in the rate of vision loss for the ACP 2 milligram groups compared to sham after 12 months of treatment. In this analysis, we measured at any 2 consecutive visits. These results were consistent in the GATHER-one and GATHER-two clinical trials when analyzed independently, which signaled a 44% reduction with a hazard ratio of 0.56 and a 59% reduction with a hazard ratio of 0.41 respectively and the rate of vision loss for the ACP 2 milligram groups compared to sham after 12 months of treatment. In the combined analysis of GATHER 1 and GATHER Two patients in the ACP 2 milligram groups experienced a 56% reduction with a hazard ratio of 0.44 and the rate of vision loss compared to sham after 12 months of treatment. This post hoc analysis evaluates the potential Vision loss signal through 12 months of treatment and is an exploratory analysis in nature.

Speaker 4

On average, it takes only 2.5 years for GA lesions to start impacting central vision. It is encouraging to see vision loss reduction data at early time intervals in the 1st 12 months, which further supports the statistically significant GATHER-one and GATHER-two primary endpoint. This time to event analysis will be presented at Arvo in April. We believe this is the first time a reduction and the risk of vision loss will be presented for a potential treatment being investigated for GA. With the completion of our NDA submission in December of last year, we have been able to turn our We believe the reduction in vision loss data we announced today is Additionally, this timing provides us the opportunity to have the data presented at a major scientific meeting ARVO in April.

Speaker 4

Cross GATHER-one and GATHER-two combined, the most common adverse reactions experienced by 5% or more of patients over 12 months in patients who received ACP 2 milligrams was conjunctival hemorrhage 13% increased IOP 9% most of which were transient and resolved within 30 minutes of injection and CNV 7%. In both GATHER-one and GATHER-two in the ACP 2 milligram groups, there were no cases of endophthalmitis, No serious intraocular inflammation events, no vasculitis and no ischemic optic neuropathy events reported through month 12. We look forward to our PDUFA goal date of August 19, 2023. In the meantime, we will continue to work collaboratively with the FDA on review of our NDA. We believe we are well positioned to become a leader in the development and commercialization of safe and effective treatments for retinal diseases and to create long term value for our shareholders.

Speaker 4

We thank you for your time and support and look forward to updating you on our progress going forward. I will now turn the call over to Dave.

Speaker 5

Thank you, Praveen, and good morning, everyone. I'd like to highlight a few items from our press release of this morning and provide some guidance on our expected cash runway. For the quarter, our net loss totaled 59,100,000 or $0.47 per share compared to a net loss of $33,000,000 or $0.29 per share for Q4 2021. For the full year, our net loss totaled $185,200,000 or $1.53 per share compared to a net loss of $114,500,000 for $1.12 per share for 2021. This increase in net loss was driven by increases in both R and D and G and A expenses.

Speaker 5

R and D expenses increased primarily due to the continued progress of the GATHER 2 trial, increased manufacturing activities for ACP and increases in personnel costs associated with additional R and D staffing, including share based compensation. G and A expenses increased primarily due to increases in commercial launch preparation expenses for ACP and increases in personnel costs associated with additional staffing, including share based compensation. Turning to our cash balance and expected cash runway. At December 31, we had approximately 646,800,000 in cash, cash equivalents and available for sale securities. With our successful equity financing and the flexibility provided by our term loan facility with Hercules if approved and to meet our planned capital expenditures, debt service obligations and operating expenses for at least the next 12 months.

Speaker 5

This estimate does not include any potential new borrowings under our term loan facility beyond the $25,000,000 that we plan to borrow in 2023 based on the FDA's acceptance for filing of our NDA. Upon the FDA's approval of ACP, we may borrow an additional $75,000,000 from our term loan facility. Thank you for your time. I'll now turn the call back over to Glenn.

Speaker 3

Well, thank you, Dave, and thank you, Praveen. Operator, Andrew, if you can open the line for calls, please for questions, please.

Operator

Yes, sir. We will now begin the question and answer session. The first question comes from Annabel Samimy with Stifel, please go ahead.

Speaker 1

Hi, everyone. Thanks for taking my questions and congratulations on the progress. Getting to be really exciting and heated. So the vision loss benefit, I guess it's really interesting, I guess the way it's been phrased is that nobody really expected it this early on. So should we view this as a Possible functional benefit that you can put in a label today will they put post hoc data Endpoints and the label, is this something that you can use to sort of, I guess, Present yourself competitively to the market.

Speaker 1

And is there any more tangible functional measurement Is this like the ultimate functional benefit that you can measure here?

Speaker 4

Annabel, this is Praveen. Good morning and thank you for your question. In regards to our labeling discussions, Look, we are under review currently by the FDA and we obviously don't want to be talking about our discussions with the FDA. So I really have no comment on that whatsoever. The message that I think this post hoc analysis gives us and again I want to emphasize that this is a post hoc analysis of a pre specified safety endpoint.

Speaker 4

And we should look upon this as exploratory data. However, having said that, We also believe that it's quite impactful. The message here really is that vision matters and time matters. And let me take each one of them separately. The regulatory agencies have said that ultimately function will follow anatomy.

Speaker 4

And we've looked at an endpoint that involves a slope analysis. And I think what we've been able to show here with this post talk analysis is that that loop may be closed. This The first time that we've really demonstrated a vision delta vision benefit based on the anatomy. So function did actually follow anatomy. In terms of time, time does matter.

Speaker 4

This is not like treating wet AMD for instance. In wet AMD, you can Look, you can have fluid there. The fluid may be resolved with anti VEGF usage and function may come back. Here, once the photoreceptor The time of onset was early in this retrospective analysis. So I think at the end of the day, this we consider supportive of our primary endpoint, which is the slope analysis.

Speaker 4

This is supportive data of the primary endpoint. And again, I think the message here is that vision matters and time matters. And yes, there will be data coming out that will be additive to this And we will be talking about this in major meetings and you will see other supportive data coming out as well. Thank you for your question.

Speaker 1

Okay, great. And if I can ask one more question, a lot of people are talking about target populations, who is the low hanging And, I think you've even stated in the past, bilateral patients who've lost vision in one eye and have risk of loss in another eye, as well as possibly patients with gene-one eye and wet AMD And another because they're already in the practices. So I guess I'm curious about the latter Target population, you had not studied patients with what AMD And the other eye, just want to make sure I understand it correctly. You had excluded patients with wet AMD in the other eye, I think, Just to reduce the risk of conversion, so how do we square that with the target populations that you might go Sure. Or maybe I just didn't understand it correctly.

Speaker 1

Maybe you can clarify. Thanks.

Speaker 4

Yes. To be very clear, the reason that we excluded patients with a Remembering in the fallow eye is really quite simple. It's because if we want to ensure that there is no crossover effect, these patients would effectively having to come in for up to 2 years every other week to be injected in one eye at a time. And we felt that that was an excessive burden to be placed on these patients in clinical trials and that's why those patients were excluded. That was the only reason no other.

Speaker 4

In terms of the target patient population, I don't I think the FLOI exclusion has any bearing on the target population whatsoever. I think what clinicians are looking for is an effective, efficacious and Safe treatment and I believe that as a clinician, I think all of my patients with Geographic atrophy and also with severe intermediate macular degeneration are patients that I would consider for treatment. So I think again what we provided here today the post hoc analysis is a basis for that conversation which is that there is potential here. Again, this is But there's potential here to prevent catastrophic vision loss, and I think that is quite impactful.

Speaker 1

Okay, great. Thank you so much.

Operator

The next question comes from Ken Cacciatore with TD Cowen. Please go ahead.

Speaker 6

Hey, team, congratulations on all the progress. Wondering if maybe you just step back and take a little bit of a crack at talking about the market itself, the size and maybe how we should be thinking about the evolution of it. And then Praveen, you get to be You're someone who's sat in front of real patients with this real issue. Can you just talk about their motivation to treat. I know there's a lot of discussion about the frequency of treatment, but would really like to get your perspective on it.

Speaker 6

And then maybe within that, how the real world use on dosing may play out? And then just lastly, you keep on highlighting intermediate and it makes lot of sense. Can you just talk about what the implications of that would be on utilization and how would it differentiate the label if you were able to get it? Thanks so much.

Speaker 4

Ken, thank you and good morning and thank you for your questions. Let me first ask Chris Sims, who is our Chief Commercial Officer to answer the first part of the question that you asked and I'll handle the rest. Chris?

Speaker 7

Yes. Hey Praveen. Hi Ken. Thanks for the question. I think the first part of your question is related to market size.

Speaker 7

And I think you'll share what we've shared previously. We believe it's a significant market. As we've said publicly, best measures is that we think there's about 1,500,000 to 2,000,000 patients in the U. S. Alone that have Some level or some stage of geographic atrophy.

Speaker 7

We also believe that number could be undiagnosed based on the sources of those data and the fact that Some of that data is from a number of years back. And one of the things that we believe is important for this market As the education notably upstream, where we believe a lot of these patients are not sitting with retina practices today, we believe the majority are under the care of an upstream ophthalmologist or an optometrist. So therefore, the need, I think, to educate and engage with that community is critical to help facilitate awareness and ultimately diagnosis and referral for treatment. So Our modeling on the market has not changed. We still believe it's quite a significant market.

Speaker 7

However, the need for that education remains pretty high. I hope that helps.

Speaker 4

Thank you, Chris. The other questions I can. So the conversations with the patient and what this means to me as a Clinician that this retrospective data. And as I mentioned to Annabel, this allows me a language of that I can have with the patient, which is to say, When you have a loss of vision of 15 letters or more that truly changes a fake patient's life. That is catastrophic.

Speaker 4

And to be able to decrease the risk of that is really quite meaningful. So that allows me an avenue to have A very direct and very transparent conversation with the patient. And the other question might be, well, what kind of patient? And I know there's been a lot of discussion regarding Centra involving or non Centra involving patient. And I just want to clarify that as a clinician.

Speaker 4

Look, I believe all patients with geographic atrophy, Centra involving and non central involving early and advanced all of these patients are eligible. A patient who has center involving geographic atrophy may not progress as quickly as a patient that doesn't have center involving geographic atrophy. However, A lot of these patients when I was in practice would come in, their head may be a little bit tilted. They would be looking from an island of This drug will be very valuable for those patients. I would argue that those patients would benefit directly from this drug.

Speaker 4

Now Would I enroll a patient like that in a clinical trial? Probably less likely because it's less measurable, the delta would be. But that doesn't mean that The patient wouldn't have a great deal of benefit from this drug. So the bottom line to my answer is that, yes, I think all patients regardless How big the geographic atrophy is and where it is unless of course it's completely burnt out would be eligible for safe and efficacious drug. In terms of dosing, look, you know that we will have every other month data in our second half of the year and of the second half of the study of course.

Speaker 4

And our 1st year card turn was on September 7th. So You can do the mathematics there. However, dosing is, in my opinion, is really not going dosing frequency is not going to be determined by what's in the label. It's determined by what the patient can do. The conversation is going to go something like this.

Speaker 4

I'd say, Mrs. Smith, we have a drug that will help you and reduce your chance of having catastrophic vision loss potentially. And to get the best results, You would come in every month, as close to every month as you can. And Mr. Or Mrs.

Speaker 4

Smith would then come in as close to every month as And that will determine the frequency of treatment not necessarily what's written in a label. As far as your question on intermediate macular generation goes, look there's a very broad range here. Intermediate macular generation can be anywhere from 1 drusia to etcetera with large drusen and serous fluid. We have said publicly that we will not be doing an intermediate macular degeneration study in order to target this patient population and we believe that having a safe and efficacious drug as we believe ACP has the potential to be will allow us to target that patient population as well. Thank you for your question, Ken.

Operator

The next question comes from Ellie Merle with UBS. Please go ahead.

Speaker 8

Hey guys, thanks so much for taking the question and exciting data on vision loss. Maybe can you just comment

Speaker 4

Thanks. Yes, Ellie, good morning and thank you for your question. The 15 letter Milestone or landmark is really traditionally accepted as one that is a Devastating amount of vision loss or a significant amount of vision gain and that's the doubling of the vision angle. And that's traditionally Now having said that, yes, we've done sensitivity analyses on several other landmarks as well. And we're convinced Because of the sensitivity analysis that we've done exhaustively that this trend is a real trend.

Speaker 4

Again, I want to emphasize that this is a pre specified safety endpoint. It is a post hoc analysis. Yes, we've done numerous and exhaustive sensitivity analyses on this and are convinced that this trend is real and that it is impactful.

Speaker 8

Great. Thanks. And maybe just in terms of the sensitivity analyses, is that data that we'll see at the presentation? And just if you can comment if There were any subgroups where you saw perhaps an even greater effect? Thanks.

Speaker 4

Yes, Ellie, we have not yet put together that Presentation as yet, so I can't comment on that. We will certainly be showing the data that we've released today. And what I can tell you is that we will we Are doing extensive studies based on providing you additional information regarding this functional benefit or potential functional benefit, Which will be presented in other major meetings as well. Thank you for your question.

Operator

The next question comes from Mike Ulz with Morgan Stanley. Please go ahead. Good morning. Congratulations on all the progress as well and thanks for taking the question. Maybe just a follow-up on the promising Vision loss data you provided this morning, just curious if you're considering maybe exploring that further and maybe

Speaker 4

Mike, good morning and again thank you for your question. What we've shown today is a post hoc retrospective study and we believe that this is very impactful, very important data that supports the primary endpoint. That's the reason we presented this. We also believe that it forms a basis for doing future studies that may well be prospective and randomized. Certainly, these are things That we can add on to with future studies.

Speaker 4

And all future all prospective randomized studies are really based on data that you get from encouraging retrospective analyses. So it certainly forms a path and a basis for future studies. Having said that, however, Remember our expectation and our goal per our agreements that we've outlined with the regulatory agencies And that hasn't changed. I just want to make sure that we don't confuse those two things. Our expectation is that the NDA will be reviewed based on Our pre specified agreements that we've had with the FDA based on the SPA, based on the breakthrough designation and based On the primary endpoint, which is at month 12.

Speaker 7

Great.

Speaker 4

Thank you.

Operator

The next question comes from Greg Harrison with Bank of America. Please go ahead.

Speaker 9

Hey, good morning and thanks for taking the question. Are there any thoughts that you can share with us on the breadth of the APELUS label? And And without going into your discussions, maybe just if there's any implications that for your label as a result of what we've seen with them?

Speaker 4

Greg, good morning and thank you for your question again. It really would be inappropriate for any of us to comment About EPALIS other than to say what and after this maybe Glenn wants to say a few words as well. Other than to say, we are Very happy that patients are getting a treatment. It's long overdue and Apellis and the entire team deserves a great deal Credit for coming across the line here in terms of having a medicine that will help patients. We look forward to seeing How their launch is, we wish them very, very well, but it really would not be appropriate for us to comment on a competitor's label.

Speaker 4

Maybe I can pass it to Glenn and see if Glenn has a few words to say as well.

Speaker 3

Yes, Greg, and thank you for And I go back to what we just said in the script, I congratulate them. It's really exciting to see a company Finally be able to have a drug that patients could use. And I think that's just outstanding. As Praveen said, we wish them luck. We will learn a lot from them.

Speaker 3

And we're just thrilled that Patients and we're thrilled the patients have a drug available to them and we're thrilled for Apellis.

Speaker 9

Okay, great. And then as You're in the review process here and preparing for U. S. Commercialization. Where are you at in the process of potentially finding an ex U.

Speaker 9

S. Commercialization partner and what are you looking for in such a partner?

Speaker 3

Yes. So Pareen, do

Speaker 7

you want

Speaker 3

to take that? Yes. Sure. Thanks. And thanks for the question, Greg.

Speaker 3

I think with today's data, we continue to build on the data set. And I think all of this is very important to finding a future partner. As we said in the past, we do have a number of Meetings in the first half of the year with European regulators, which will give us more guidance. Having data like we presented Today, we believe may be helpful in those discussions. So that all continues to move forward.

Speaker 3

Our objective, as we have said in the past, is to focus on the U. S. Markets and to find help overseas. Today's just another point of reference or data that will be helpful in that ex U. S.

Speaker 3

Discussion.

Operator

The next question comes from Eddie Hickman with Guggenheim Securities. Please go ahead.

Speaker 10

Hi, good morning and congrats on the progress. Just a few from me. Throughout Gather 2, you were able to provide updates on the injection fidelity, which gave you confidence on meeting that primary endpoint. Are you able to give any Color on how that's tracking so far in the 2nd year?

Speaker 4

Eddie, good morning and thanks for your question again. What I can tell you is as of now we haven't guided to the numbers as yet, but what I can tell you that we're very, very pleased with the way that that's tracking. We've got a fantastic clinical operations team and they're very, very hard at work to make sure that all Patients are retained and that the injection fidelity is as high as possible. So we haven't given guidance as to the numbers as yet, but I can tell you that We're doing very well and are very pleased with the ongoing process.

Speaker 10

Great. And then really interesting visual acuity data that you presented. I'm curious if that's something you can Share with the FDA as part of your back and forth that you get with your breakthrough designation without needing to file any additional amendments, just to Show them the confidence that you're seeing on that functional endpoint throughout the early part of the review. Thanks.

Speaker 4

Yes. Eddie, as you know, we're under review at this time. We've said publicly that we're very pleased with our interactions with the FDA. We found them as expected to be extraordinarily collaborative and

Speaker 11

we feel

Speaker 4

want to be publicly commenting on any details regarding the discussions that we're having with the FDA. But thank you for your question.

Operator

The next question comes from Kambez Yazdi with Jefferies. Please go ahead.

Speaker 11

Good morning, team. Can you provide us any more color on your interactions with the FDA on intermediate AMD? And then may I have a few more follow ups after that?

Speaker 4

Khambhi, good morning and thanks for the question. What we've said publicly is that with the interactions that we've had, We will not be doing an intermediate AMD study. As we've announced I think some time ago, We feel that we'll be able to target intermediate AMD without doing a specific study as to any further details regarding our interactions with the FDA.

Speaker 5

Excellent. Thank you.

Speaker 11

And then if ACT is approved in August, What would be the general timeframe for receiving a permanent J code for ACP?

Speaker 4

Chris, maybe I can pass that question on to you.

Speaker 7

Yes. Thanks Praveen and thanks for the question. So following our August PDUFA date is an important question by the way. So we plan to file at the first quarterly opportunity, which again based on the August PDUFA date would be the 2nd October, would be the first opportunity to file for the permanent J code. And then following that time, we would expect to get the permanent and hope to get the permanent J code in the early Q2 of 2024.

Speaker 11

And one final one, just to put a final point on every other month dosing. If the data are positive from year to gather to would you pursue every other month dosing for ACP? Would this have to come as a sNDA? Appreciate all the answers today. Thank you.

Speaker 4

Yes, Camby, we have not guided us to that. We obviously want to see the data. We want to see what the situation is like at that time. That's a decision to be made down the road. But we really don't believe that having every other month dosing really provides Any kind of a competitive advantage because we believe that physicians will treat according to what's best for the patient.

Speaker 4

And what's best for the patient is going to be Dependent also on how often the patient can come in and that's going to be the primary determinant of the frequency of treatment not what's written in the label. And Just to kind of put an emphasis on this, if you look at the anti VEGF experience for instance, the vast majority of us treat and extend and that's not in any label. So there is a history of my colleagues really doing what's right for the Given the particular situation regardless of what the label says. So the answer to your question is I'm not really sure what we will do with the 24 month data, whether it be on the label or not, that's yet to be determined.

Speaker 11

Thank you so much.

Operator

This concludes our question and answer session. I would like to turn the conference back over to Glenn Splendorio for any closing remarks.

Speaker 3

Thank you, Andrew, and thanks So everyone for listening this morning and we're very happy and pleased with our progress and we look forward to our continued work with the FDA and our NDA filing and hopefully a potential approval in late August of this year. We're also committed as we talked about today to building a world class And finally, we look forward to having our vision loss data presented at ARVO. So you can expect

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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