Q2 2022 IVERIC bio Inc Earnings Call

July 26, 2022

Good morning, and welcome to the Barrick Bio second quarter 2022 earnings Conference call.

All participants will be in listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero. After today's presentation there'll be an opportunity to ask questions. Please note. This event is being recorded I would now like to turn the conference over to Kathy Galante. Please go ahead.

And welcome to <unk> Bio's conference call, representing I have Eric Bio today are Mr. Glenn <unk>, Chief Executive Officer, Dr. Praveen, Dougal, President Keith Westby, Chief Operating Officer, David Carroll, Chief Financial Officer, Dr. Double design, Chief Development Officer, Chris Simms Chief commercial.

Sir and Tony <unk>, Chief business and strategy Officer.

I would like to remind you that today, we will be making statements relating to <unk> bio's future expectations regarding operational financial and research and development matters. These statements constitute forward looking statements for purposes of the Safe Harbor provision under the private Securities Litigation Reform Act of 1095. These statements cover.

Many events and matters that are subject to various risks that could cause actual results to differ materially from those expressed or implied in any forward looking statements I refer you to our SEC filings and in particular to the risk factors included in our quarterly report on Form 10-Q filed on May four 2022.

For a detailed description of the risk factors affecting our business that could cause actual results or events to differ materially from the forward looking statements that we make.

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 point in the future. We disclaim any obligation to do so as required by law I would now like to turn the call over to Glenn.

Thanks, Kathy and good morning, everyone. Thank you for joining us for our second quarter conference call Worksite.

We're excited to share that today marks the one year point since we completed patient enrollment of gathered two our second phase III clinical trial for Zamora.

<unk> complement inhibitor for the treatment of geographic atrophy or GAA.

We look forward to reporting the topline data gathered two in September of this year approximately one year after enrolling.

The last patient plus the time needed for database lock and analysis.

Our team executed well all year as we continue to exceed our expectations for patient retention and injection fidelity, which we believe further derisked gathers too and is an integral part of the clinical trial outcome chief.

Keith will discuss this important data in a moment.

Now, let's discuss our expectations for reporting.

The upcoming gather two topline data once available we will report the preliminary the Prespecified primary efficacy endpoint.

Analyzed by the mean rate of G&A growth or the slope estimated based on GTA area measured by from this portal for us.

In at least three time points baseline.

Six months and 12 months.

Calculated by using the square root transformation of the GI area. This is consistent with our written agreement with the U S food and drug administration or the FDA under a special protocol announcement or SBA.

In addition, we will present the same data with a point analysis.

We will also report a summary of the safety profile, including potential cases of Choroidal Neovascular station CMV has reported in the traditional manner, commonly defined in the retinal community as choroidal, neovascular membrane, where CN VM.

While the FDA did not request potential CMP cases to be reported using the non traditional recently defined terms such as exit data versus non extra data CMV. We plan to also provide these data.

For detailed definition of exit data and non exit date of CMV as defined by the center for ocular research and evaluation also known as core at the KOL Eye Institute of the Cleveland Clinic. Please see our form 8-K on April 4th 2022.

In addition to CMV, we plan to also provide rates of potential inflammation and endophthalmitis if any.

As a reminder, we received a written agreement from FDA.

<unk> and <unk>.

For the overall design of gathered two in July of 2021.

For those who may not be familiar the SBA process is a procedure by which the FDA provides a clinical trial sponsor with an official evaluation and written guidance on the design of our proposed <unk>.

Protocol intended to form the basis for our new drug application or NDA.

Yeah.

If the results from gathered two are positive our key objective and plan is to make some more commercially available to physicians and their patients with GE as quickly as possible.

Obviously, assuming regulatory approval.

Therefore, we have already begun to assemble an NDA.

Following a potential positive outcome with gathered too we plan to submit applications with the FDA and the European Medicines agency for marketing approval of Zamora for GE.

We're also very excited to have entered into a license agreement with Delta Tech, providing us a worldwide exclusive license to develop and commercialize the sustained release formulation of Zamora using delta tax silica based sustained release technology.

<unk> will discuss this in more details in a moment.

On the corporate front earlier today, we announced that we have an agreement for up to $250 million in non dilutive debt financing with Hercules and Silicon Valley Bank under a term loan debt financing facility.

Non dilutive financing further strengthens our balance sheet and provides flexibility as we look to finance a potential launch of Zamora.

Dave will provide more details in a few moments.

We continue to focus on the execution and bringing some more to patients suffering from this horrible disease geographic atrophy as our top priority.

I will now turn the call over to Keith.

Thank you Glenn and good morning, everyone.

As Glenn mentioned, we are thrilled to have reached the one year mark since the completion of patient enrollment and gathered.

In which 448 patients were enrolled across 209 global sites.

We are extremely excited to report that patient retention for the gather chief clinical trial as measured by the injection fidelity rate was 92, 5% through month 12.

Our month 12 target goal of greater than 90%.

As a comparison the 12 month injection fidelity rate for our gather one trial in which we observed a statistically significant reduction in VA progression at 12 months was 87%.

We are encouraged to see that our athletes to maximize patient retention in the gathered clinical trial have resulted in even greater patient retention and was observed in gather one through the same time period.

Injection fidelity is calculated by dividing the total number of actual injections shrugging sham for all patients by the total number of expected injections drug and Sham based on the total number of patients enrolled in that trial.

We consider injection fidelity to be the most important and stringent measure of patient retention because it reflects the timely administration of study drug into the patient side.

We believe patient retention is an integral part of the gather to outcome.

We focus heavily on injection fidelity, not only to de risk and protect the integrity of our data, but also to potentially absorb the early and increasing reduction in <unk> growth that we previously observed in gathered one.

We expect topline gather to data to be available in September of this year approximately one year. After the enrollment of the last patient plus the time needed for database lock and analysis.

We are actively working internally and with our third party vendors to prepare for the gather to database lock to be as efficient as possible.

Patient enrollment in star our phase <unk> screening clinical trial of <unk> for the treatment of autosomal recessive <unk> disease is ongoing.

The results of this trial are expected after the topline results together too.

Yeah.

Turning to IC 500, our <unk> inhibitor, we initiated a number of preclinical tolerability and pharmacokinetics studies last year and we are planning for IND, enabling toxicology studies, we expect to submit an investigational new drug application or IND to the FDA for IC 500 during mid <unk>.

2023.

Thank you for your time I will now turn the call over to Doug.

Thank you Keith.

Keith mentioned, we expect topline gathered to data to be available in September of this year.

Following the topline announcement, we are thrilled to have the opportunity to present, the topline data at the American Academy of Ophthalmology meeting.

On Friday September 30 of this year.

Earlier this month.

We were excited to share the results of a post hoc analysis from gather one.

Evaluating response based on location of GAA lesions at baseline.

We observed that 84, 4% of GAA region, where within 500 microns of the Foveole centerpoint at baseline.

And that 28, 3% at GE aviation.

Mm 100 microns of the Foveole centerpoint at baseline.

These findings were generally balanced across all three treatment arms and their corresponding sham control groups in the study.

Gather one result, and with Nomura was observed to have a greater reduction of GE aviation growth as compared to sham.

Occurred with the vast majority of patients having regions close to the Foveole Central point.

The post hoc analysis was presented at the American Society of retina specialists annual meeting.

Earlier this month David loudly.

Right.

These data are consistent.

This post hoc analysis of the gather one trial, which were presented at the angiogenesis meeting on the retina World Congress earlier this year.

Data from this post hoc analysis are also consistent with the result of our previously reported.

<unk> specified analysis of them.

More of them to gather one trial.

Demonstrating a reduction in GE lesion growth compared to sham observed regardless of lesion size or distance to the mobile centric.

Thank you for your time I will now turn the call over to Brittany.

Thank you double the multiple post hoc analyses from gather one of which have been presented at medical conferences around the world continue to provide consistent results, which gives us a great deal of confidence in the robustness of the gathered one data nice work by you and your team.

Turning to our lifecycle expansion for some morra, we previously reported.

<unk> talk analyses from gather one suggesting that the more I may have the potential to impact age related macular degeneration AMD.

Earlier stages before atrophy occurs in patients.

As part of this plan, we are pursuing multiple sustained release technologies for tomorrow for the treatment of GA and earlier stages of AMD.

A few weeks ago, we entered into a license agreement with Delta a Finnish company with a platform of silica based.

Drug delivery technologies.

Under which we obtained a worldwide exclusive license to develop and commercialize new formulations of somewhere I using delek silica based sustained release technology.

These technologies potentially could address patients being treated for gea and put in earlier stages of AMD such as intermediate AMD.

We believe Zamora, which is a chemically synthesized RNA aptamer.

Is amenable to injectable sustained release formulations.

This agreement underscores our commitment to invest in the lifecycle initiatives Force Tomorrow.

We are excited about the possibilities to expand zamora into earlier stages of AMD and potentially allow for a for a next generation treatment to help patients with GE.

Looking ahead potential of Zamora.

We plan to continue to invest in additional lifecycle initiatives for some more to expand the patient population with additional indications and continue to evaluate multiple technologies for similar.

Furthermore, we plan to explore the potential for us the more in earlier stages of AMD by initiating a clinical trial studying the current formulation of Zamora in patients with intermediate am and.

In the fourth quarter of this year.

The development strategy in this indication is subject to regulatory feedback from the FDA and other regulatory authorities.

Which we plan to obtain before initiating this trial.

Thank you all for your time and support.

I'll now turn the call over to Dave.

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 new credit facility and our expected year end cash balance for the quarter. Our net loss totaled $49 3 million or <unk> 41 per share compared to a net loss of $30 1 million or <unk> <unk> per share for Q2.

'twenty one.

The increase in net loss was driven by increases in both R&D and G&A expenses.

R&D expenses increased primarily due to the continued progress of the <unk> two trial increased manufacturing activities for some maura and increases in personnel costs, including share based compensation associated with additional R&D staffing.

G&A expenses increased primarily due to increases in personnel costs, including share based compensation associated with increased staffing for a potential commercial launch.

Turning to our balance sheet and our expected year end cash balance as of June 30, we had cash cash equivalents and available for sale securities of approximately $312 million.

<unk> of our new credit facility. The company is borrowing $50 million today, we now estimate that our current cash cash equivalents and available for sale Securities will range between 260 $270 million.

The credit facility provides us with access to up to an additional $150 million in total statutory achievement.

Specified development and regulatory performance milestones for Zamora.

An additional $50 million is available to us subject to lender approval.

We would view this additional $15 million as a potential source of working capital again, assuming approval.

We believe that this credit facility provides us with additional financial flexibility tied to major de risking milestones at a lower cost of capital and equity.

We intend to provide further details about our financing strategy to support launch following data release. Thank.

Thank you for your time and I'll now turn the call back over to Glenn.

Okay, Thanks, Dave and before we open up the lines for questions I wanted to recap a very productive quarter first today is the one year point for gathered to over the coming weeks, we will analyze the data and lock the database and we'll report gathered two data to you in September .

We have also outlined where top line data will be available in September .

Second we have entered into an exclusive license agreement with Delta Tech to develop and commercialize our sustained release technology and finally as Dave just mentioned, we entered into a credit facility that provides us with up to $250 million of non dilutive capital with $50 million coming to.

And the balance that is tied to derisking milestones. So I want to thank you all for listening and operator I'd like to ask you to open up the line for questions.

Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.

At this time, we will pause momentarily to assemble our roster.

Our first question comes from.

Michael <unk> from Morgan Stanley . Please go ahead.

Hey, guys. Thanks for taking the question and congrats on all the progress here.

In terms of the topline results.

We're providing all the color on the detail on what we should expect.

Just curious the primary endpoint you mentioned, providing both the slope end point analysis.

If we think about that should we expect those two analyses to be meaningfully different.

Yes.

Okay.

Hey, Mike This is double.

So if you look back on the gather one data and when we did the point in the slope analysis you saw that there wasn't really a big difference between the two.

That's mainly due to the fact that the growth is pretty linear on these lesions and so we don't expect there to be a big difference between the two analysis and get it to either.

Yes.

Got it thank you.

Okay.

The next question comes from Annabel <unk> from Stifel. Please go ahead.

Hi, and thanks for taking my question. So I just wanted to go back to.

Some of the data that you mentioned had been presented at the retina World Congress as well.

Regarding.

The I.

I guess I'm just trying to survive so clearly natural history indicates faster progression that further.

From the center.

Anything more.

There's also consistently shown more efficacy.

Further even if in a center as well I think probably because of the metabolic rate.

No.

Can you share with us whether the enrollment criteria for gather one is gathering the statements gather one and what are your suspicions about how you might be able to replicate this data given what you know about this slips analysis now.

Yeah.

So annabel its Glenn good morning, and thank you for the question. So we have double here today and also Praveen I'll, let double take the first part of that and then I'll ask for being too to comment as well.

Yes, Annabel so maybe just I'll take the first one first so in terms of enrolment criteria nothing different in.

In terms of gather one and gather two specifically as it relates to lesion distance just.

Just to recap for you. The two main criteria here are one disease cannot touch the center point of the Fovea and then second some part of the lesion needed to be within one five millimeters of the Foveal center that was the enrollment for grabbing one at the same thing for gatherer too in terms of whether or not one or two.

Two are going to look similar we haven't seen the data for gathered too. So it's hard to kind of make a judgment call on that what I can tell you is that if you look at the types of patients that typically hang around retina offices that are referred from tertiary care. They typically tend to be the ones that look like gather one and we would expect.

That to be the same case in <unk>.

Praveen.

Annabel good morning is praveen.

Thanks for the question again, so here's the here's the thing.

Home points from these are post hoc analyses that you referred to I think.

One is that Zamora works, regardless of the location of the lesion, but it will work better in earlier lesions as witnessed by lesions that are further away. So let's take home point number one take one point number two I think is that and gather one.

The lesions that were there were fairly severe most of these patients that level said had lesions that were right near the central point, so perhaps our idea of saying extra fulvio should be recapitulated now maybe we should start seeing non centrepoint. Because these lesions were really quite close to the center.

The fovea.

And also realize that most of these patients have bilateral lesion. So these lesions were really quite severe in the patients who were quite severe so although the inclusion criteria is exactly the same and gather to us and gather one. We're also hoping that if we can get lesions that are a little bit of an earlier stage that delta.

It will be even higher if <unk> seen them that ASR analysis, there's a very clear difference between the delta of treatment versus sham the firm.

There you go in the earlier lesion that you get so we're hoping that the lesions will be a little bit earlier again, we have no way of knowing that because we are completely masked but at the end of the day.

The main points here I think is that leaves the more it works regardless of where the lesion is but and gather one the vast majority of the lesions were right next to the central point.

Oh, great that was helpful for the color.

Just to go back to that.

A question about the points analysis versus a Philips analysis.

I guess part of the reason why they're with.

Such differences because he didn't have a tremendous amount of variability in that patient. So if we look at gathered to is.

Is it possible.

Earlier, the more variability might have it in the price analysis might be different from the slips analysis of how should we think about that.

Liability versus.

And and.

In terms of these points and slips analysis now.

Analyses.

So annabel this is double.

So what I'd say is I don't think we're going to see much of a difference as I mentioned previously from the population and gather two that we saw and gather one to begin with so again I think the full expectation amongst the focus of the company is that the results between those two analyses shouldn't differ very much based on what we saw and gather one.

Any additional comment.

Yes, I would agree with I would say the same thing antibody. The variability really comes from the patient population as opposed to the lesion location and what we've done.

Is to really limit the variability in the patient population.

As you know.

As has been shown earlier and by others as well the patients that we picked which now will call non central fovea involving where exactly the right patients to pick.

And those are the same patients that we expect to gather together too that there will be the same patients and gather to gather once so the variability again comes from the patient selection not not so much from a leisure. So we don't expect really any difference.

Okay, great. Thanks, so much.

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

Good morning, Thanks for taking my questions.

So when we see the data for.

Together too is there a percentage change that you feel would correlate well with clinical benefit.

Just trying to think.

If.

Any statistic.

Statistically significant benefit is sufficient.

Not only for approval, but also for your competitive position in the market.

Yeah.

Greg Thanks for the question prevent you want to take that one.

Yes, sure Greg Good morning, and thank you for the question.

I think the main thing to do is to make to keep two silos are very very clear one silo is the regulatory pathway and the other siloed would be I think what you're asking which is what would be the functional benefit to the patient and to payers and physicians that one can communicate with so let's keep those two a little bit separate at this point, although I realize that they are interrelated as <unk>.

Or is the regulatory pathway is concerned it couldn't be clearer. We got we have a spa agreement with the FDA. So all we have to do is to hit the primary endpoint.

For purposes of submission so the regulatory pathway via the Spa agreement I think it is absolutely clear. The second question, which is also quite important in Germany, which is what is what about the functional benefit for patients how do how do payers react to this.

Is it the physicians are going to say.

Having having practice retina for over 26 years I'll tell ya patients are not necessarily going to understand or care about the percentages relating to function or the square root transformation or anything else. What they are going to understand is there going to understand preservation of central vision on that time, and what I mean by that is that we know from <unk>.

<unk> studies.

Once you start getting geographic atrophy within a matter of two years over 60% of patients lose driving vision now we know that in four or five years. Most of these patients will have completely obliterated central vision. So the currency of language that everybody understands is that of time, so what we'll be able to show data.

For because of the patients who with selected who are non <unk>.

Our central point involving what we can say is if you take this treatment youll be able to drive for X years long, you'll be able to read for X years longer work for X years longer and I think that's the currency of language that patients will understand payers will appreciate and certainly physicians will use as a curve.

Steve communication.

Got it that's helpful and then.

One other.

How much of the filing has been completed at this point and can be completed ahead of having the final gathered to data and and how would how would the timing here compare with a typical timeline after in phase III.

Greg Hi, it's Glenn so as we mentioned in the past the regulatory team has been working on the data that they have available which was gather one having that I think gives us.

A real good head start on completing the following once we see the data from gatherer too. So we havent specified timing it really will be dependent on what the gather two data looks like which will.

Kind of round out our strategy on the regulatory path forward. So when we have that data, we'll consider giving guidance on the filing strategy.

Very important it is a competitive situation. So we know timing for investors is important but right now to answer that question really need to see the gather two data.

Great. Thanks for taking the question.

The next question comes from Ken Cacciatore from Cowen and company. Please go ahead.

Hey, guys real exciting time, but excited to see the data in September just wanted to ask about the.

The extended release formulation real potential commercial advantage that you might have if youre able to move this forward, obviously be real beneficial for patients Praveen I know you talked about some of the unique characteristics of some more maybe you could flush it out just a little bit more that you think make it real amenable for an extended release if you would.

It would be interesting if you could compare to a palace, we've not heard of them moving forward with an extended release. So if you were willing to maybe compare and contrast, why they may be behind that would be interesting and also maybe you could bring delta tech to life, a little bit how long you all have been working with them clearly going to be a very important partner tea Wal.

Can you talk about them and maybe a little bit of their history and success in developing extended release formulations, and then maybe timing to get into clinic would be interesting. Thanks. So much.

Perfect and you want to start.

Sure Ken Good morning, and thank you for the questions.

So first of all regarding our molecule, it's an RNA aptamer and there is really big.

Advantaged on RNA after him or not only is it a small molecule. So the capacity for loading is going to be greater but arent aptamer as opposed to a protein. It can be completely denature them re nature can be fully functional so that's a huge advantage for a sustained delivery type strategy.

We believe that this has advantages over our competitors.

Again, I'd, rather not speculate about the competitors.

Can certainly ask.

I have to ask them, but I do believe that we have.

Significant advantage here because of our molecule in regards to Delta Tech and other.

<unk> that we're looking at there are certain things that characteristics that were important for us first of all.

It had to be low double to a capacity that allowed for a sustained release.

And it's certainly check that box it has to be tunable and what I mean by that is that.

And then.

In the natural history of macular.

Macular degeneration.

Pending on where we target the disease the release characteristics.

They need to be different in other words, the way that the release characteristics would be optimal for drews them for instance, maybe a little different than for more advanced geographic atrophy. So the release characteristics have to be tunable, obviously would have to be safe.

And then it has to be scalable so with Delta Tech with the preliminary studies that we did we were quite confident that this fit all the boxes.

This would be a very very good strategy, having said that I must also say that.

Not going to be the only strategy. Obviously, we're looking at other strategies as well our intention as I've stated many times in our Glenn has as well is to be deep.

The company for all of macular degeneration, and other retinal diseases. So not just geographic atrophy, but for earlier stages of macular degeneration and what this sustained delivery strategy allows us to do is it opens up a new target of patients with earlier stages of macular degeneration that certainly allows for us to make.

The geographic atrophy patients be treated in a way that's much more sustainable as well. Thank you for the question Ken.

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

Good morning, and congrats on all the progress and looking forward to seeing the data soon just two from me could you confirm what the SBA agreements as specifically about gather one does it confirm that it sees them sees it as a supportive study or have they agreed to analyze them together as co Registrational studies.

<unk> say anything about that and then secondly on based on your physician feedback and experience with monthly anti VEGF is there sort of an expected rate of inflammation and to optimize that might be expected just from monthly entrepreneurial injections and if the FDA ever commented on what those acceptable levels may be from a safety perspective. Thank you.

Thank you and maybe it will work backwards, we have some logistics, we're trying to manage today so double take.

The second question first.

And then <unk> will take your initial question.

Thanks for the question so in terms of physician feedback on rates of endophthalmitis and inflammation.

The easy answer to that is they wanted to be zero.

But if you look at kind of a commonly prescribed retina therapeutics that are out there roughly in that one to less than 1% range is kind of where we see inflammation and less than 1% significant certainly for endophthalmitis is where we typically look.

For for safe drugs, and so that's kind of the number that we have in our mind at the end of the day. The number is going to be the number whatever it's going to be but that's what we're generally understanding in terms of.

The physician feedback on inflammation and up the Midas I will give it back to Glenn for the Spa agreement prevent.

Kevin you want to take that I mean, you had firsthand conversations with the regulators.

Sure Glenn I'll be happy to do that and Eddie Good morning, and thank you for the question. So what I would say regarding the Spa agreement is there are a couple of take home messages that are really important here in the first of all the FDA advised us to apply for a spa agreement.

And this was done when the gather two study would have recruited.

So what that should tell us is the level of alignment in the level of confidence that the FDA had in the earlier discussions we had with them, albeit all in.

Informal.

So that's the first take home message. The second one is after having gone through the entire spa process, which as you know involves an army of statisticians and clinical trial of <unk> and so forth.

They agreed on everything that was there the only thing that they want it slightly changed was they wanted a slope analysis in other words, they wanted us to assume a constant rate of growth we haven't assumed anything at all.

Nothing else was commented upon they agreed with the with the endpoint. They agreed with the mixed random effects model as well as the sample size all of those things and as you know we're happy to do that that really didn't change anything as per gathered one.

However, the Spa agreement really is for one study only and that was gathered to the FDA had really no obligation to comment on gather one however, they went out of their way to comment on gather wondering what they said was that they were they were in agreement that our pre specified analysis was absolutely valid.

Also thought that their preferred analysis was absolutely valid and when the application is made they will look at gather one and gather one both ways with the pre specified analysis as well as the preferred analysis.

So we are very confident because the FDA has commented on gather one and given us as far as room together to that they are very well aware of the entirety of the program.

But both the programs together will be certainly a valid for submission.

And Eddie what I'll add to that is you can go back to a prior press release, where we did both calculations for gather one.

Pre specified plus the FDA preferred analysis and what you will see is consistency in the rates of efficacy there.

Happy to provide that if you don't have access to it.

Thanks, and then actually one final one when it comes to the CMV versus sort of <unk>.

Do you plan to have at the top line release any data from the KOL Eye Institute or are you expecting the primary readers in the study to be evaluating CMV in the way that it was done in a post hoc manner by the Cleveland clinic or will it be done by Duke.

Great question, Eddie Permian do you want to cover them.

Sure I'll be happy to so I think there. The fact of it is that I don't think there'll be much difference at all because our definition is very very clear, but our plan. At this point is to continue to use the Duke Reading center as the primary point of analysis for a core the neovascular membrane formation as per the definition that is traditional and as they defined it.

And gather one now we also had the gather one analysis done by the KOL Reading Institute and the reason for that is because of the Duke was no longer mass to that data and we wanted to make sure that the reading center that.

Defined and we will look at the exhortation rates remains completely masked therefore, I don't think that analysis plan is going to change at all for gathered too.

Great. Thank you so much.

The next question comes from <unk> <unk> from Jefferies. Please go ahead.

Hi, good morning, <unk> on for Chris.

Few questions from me do you plan to do it in a filing as well as.

And FDA filing what are kind of the differences in those two the agency's stances on gene therapy.

Therapies.

Second question, what was the relative performance of Delta <unk> sustained release technology versus some of the other options you considered.

Third question, what endpoints are you going to propose to the FDA for intermediate and D&O part there. Thank you.

Okay. Great question. So I'll ask will go backwards, Keith do you want to talk a little bit about the Delta Tech technology first and then we will.

Address the other questions.

Sure happy to do that thanks.

It can be for the for the question.

In terms of Delta Tech I know <unk> talked a little bit about it but there were a number of factors that we looked at two two.

In terms of feasibility.

But really the silica based.

Joe is really important for us because the app tumor again is very compatible with that so the number of things that we looked at in terms of loading.

Terms of tune ability.

And we've also done a number of other feasibility studies with a number of other companies. So.

We continue to move on I'm sure, we'll put out additional data here, but this again will be our only this is not our only planned here, we're looking to do additional.

Drug delivery efforts around tomorrow.

Thanks, Keith and ill take the next two questions first on the regulatory filing strategy and as mentioned this morning in our conversation, we do plan to submit a filing to the EMEA.

And that will follow the NDA that we filed we have engaged experts and advisers in Europe to help us through that process and that planning for EMEA, but it is our expectation that we will have a filing we have not defined.

Timing just yet the.

The question related to endpoints for intermediate AMD also a very good question.

No. We had said we will engage with FDA prior to starting a trial with intermediate AMD. We believe the strategy may be a collection of different endpoints and I think the best way to handle that as we need to have the discussion with the regulators first and then get back to you on the results of those.

Discussions so a little bit hard to put bookends around that right now but.

Obviously the team has many ideas and we're looking forward to our discussion with FDA.

Awesome. Thank you so much Glenn and then maybe one final follow up.

From a functional perspective going back to that kind of distance from fovea analysis.

It does.

Can you help us understand how a patient.

With <unk> lesions.

100 microns from the center is different than 500 microns from the center.

Versus of course mobile and then kind of the time it would take to progress from 500 Micron 100 micron.

All the way to the Central vision. Thank you. That's my final question sure. Thanks. So again very good question and I'm going to ask both double and prevent to comment on that double will begin yes. Thanks for the question. So if you think about distance from the Fulvio center and kind of how a patient perceives that you just think about.

Looking into a kaleidoscope right and then the closer that lesion is Foveole center, just imagine not being seeing black spot right near the Middle and then if there are further way you kind of see it more out in the periphery. So obviously the closer it gets to that center point the more of your functional vision gets impaired.

In terms of the progression of those lesions is highly variable and thats one of the things about this disease that really.

Leaves us we need to treat it early and we need to get after it as aggressively as possible because depending upon the size of your lesions at baseline the distance what kind of banding pattern. They can all grow at different rates. So it's hard to say on average what will elysian grow how fast will it go from 500 to 100 microns away from me.

Yes, what I would say is I think there's very good evidence now that what we traditionally think of as an endpoint, which is visual acuity is not a good endpoint for visual function.

What we have where you can have for instance is excellent visual acuity, but still have terrible visual function.

If you think of how visual acuity works that youre in a dark room with a bright light at the end of life is rarely like that and if you think about your day today.

Really not going to have that situation at all.

Or very little if at all so the regulatory agencies and other agencies do recognize that there are other functional parameters that are really important and if you. If you wonder how it affects our patients a day to day life. If you wear glasses. All you have to do is take a little scotch-tape and put it a little bit off century.

In the bottom or on the sides and what you will realize that you simply can't function. So even if you're 500 micron as a way of further.

You will find is that there are lots of patients out there who are visually dysfunctional with lesions, even with even even though it seems further away.

For instance would be an architect that may not be able to see a straight line in the upper corner. It could be a lawyer, who may not be able to be we may not able to read a sentence because because of a dark spot. So there are lots of patients out there that are visually dysfunctional.

These patients are quite desperate to stop that lesion from progressing and how fast is it progressed well we know from studies as I mentioned earlier on a matter of time two years to lose driving vision about five or six years to lose complete OBO vision. So we can offer with Zamora.

Version, one and the patient is to be able to say look if you take this treatment. This is how much time, you will have to continue to function and do your functional activity and hopefully what we can do.

Is go even earlier and not just slow down the rate of death, but to prevent death altogether and that really would change the trajectory of the disease.

Okay. Thank you so much.

We have time for one more question and that's from Colleen <unk> from Baird. Please go ahead.

Hey, good morning, Thanks, so much for taking our questions and congrats on the progress.

And then.

Does the criteria for the next tranche of debt financing is meeting the primary endpoint and the data are supportive of filing can you talk about whether those are actually two different things and anything else you can say and what would be considered sufficient clinical data package to support submission.

And can you just confirm that the spot.

P value of <unk> five would be the threshold for significant thank you.

Thanks, Colleen I'll, let Dave take the first question. So thanks for the question Colin Yes. It is that's our position there.

The answer.

Yes.

Colleen on the on the Spa agreement.

Level five can you confirm that yes. It is.

And there was one other question mixed in there I think did we hit at all.

So I think the question was if those are two different things point me in the primary endpoint and the data as part of the filing.

And the responses, yes, those are two different things.

Okay. Thanks, Charlie I appreciate the question.

There are no more questions in the queue. This concludes our question and answer session I would like to turn the conference back over to Glenn <unk> for any closing remarks.

Well, thank you operator, and thank you everybody for listening to the call. This morning.

As I mentioned before great progress in the last quarter and were quite excited that we have reached the one year point with our gatherer too and we look forward to a conversation in September about that data.

Have a great day, everybody bye bye.

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

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Good morning, and welcome to the <unk> second quarter 2022 earnings Conference call.

And welcome to <unk> Bio's conference call, representing <unk> bio today are Mr. Glenn <unk>, Chief Executive Officer, Dr. Praveen, Dougal, President Keith Westby, Chief Operating Officer, David Carroll, Chief Financial Officer, Dr. Double design, Chief Development Officer, Chris <unk> Chief commercial.

And Tony Gidney, Chief business and strategy Officer.

I would like to remind you that today, we will be making statements relating to <unk> future expectations regarding operational financial and research and development matters.

These statements constitute forward looking statements for purposes of the Safe Harbor provision under the private Securities Litigation Reform Act of 1095. These statements cover many events and matters that are subject to various risks that could cause actual results to differ materially from those expressed or implied in 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-Q filed on May four 2022 for a detailed description of the risk factors affecting our business that could cause actual results or events to differ materially from the forward looking statements that we make.

Thanks, Kathy and good morning, everyone. Thank you for joining us for our second quarter Conference call. We're excited to share that today marks the one year point since we completed patient enrollment of gathered two our second phase III clinical trial for Zamora a novel <unk> complement inhibitor.

For the treatment of geographic atrophy or <unk>.

We look forward to reporting the topline data gathered two in September of this year approximately one year after enrolling.

The last patient plus the time needed for database lock and analysis.

Keith will discuss this important data in a moment.

Now, let's discuss our expectations for reporting.

The upcoming gather two topline data once available we will report the preliminary the Prespecified primary efficacy endpoint.

Analyzed by the mean rate of GAA growth, where the slope estimated based on GTA area measured by from this quarter for us.

At least three time points baseline.

Six months and 12 months.

Calculated by using the square root transformation of the area. This is consistent with our written agreement with the U S food and drug administration or the FDA under a special protocol announcement or SBA.

In addition, we will present the same data was appointed analysis.

We will also report a summary of the safety profile, including potential cases of Choroidal Neovascular station CMV has reported in the traditional manner, commonly defined the retinal community as choroidal, neovascular membrane, where CN VM.

While the FDA did not request potential CMT cases to be reported using the non traditional recently defined terms such as exit data versus non extra data CMV. We plan to also provide these data.

For a detailed definition of exit data and non exit date of CMV is defined by the center for ocular research and evaluation also known as core at the KOL Eye Institute of the Cleveland Clinic. Please see our form 8-K on April 4th 2022.

In addition to CMV, we plan to also provide rates of potential inflammation and optimize this if any.

As a reminder, we received a written agreement from FDA.

Sure.

For the overall design of gathered two in July of 2021.

Protocol intended to form the basis for our new drug application or NDA.

If the results from gather two are positive our key objective and plan is to make some more commercially available to physicians and their patients with GAA as quickly as possible.

Obviously, assuming regulatory approval.

Therefore, we have already begun to assemble an NDA.

Following a potential positive outcome was gathered to we plan to submit applications with the FDA and the European Medicines agency for marketing approval of Zamora.

Yes.

<unk> will discuss this in more details in a moment.

This non dilutive financing further strengthens our balance sheet and provides flexibility as we look to finance the potential launch of Zamora.

Dave will provide more details in a few moments.

We continue to focus on the execution and bringing some lora to patients suffering from this horrible disease geographic atrophy as our top priority.

I will now turn the call over to Keith.

Thank you Glenn and good morning, everyone.

As Glenn mentioned, we are thrilled to have reached the one year mark since the completion of patient enrollment and gather two in which 448 patients were enrolled across 209 global sites.

We are extremely excited to report that patient retention for the gathering <unk> clinical trial as measured by the injection fidelity rates was 92, 5% through month 12.

Our month 12 target goal of greater than 90%.

As a comparison the 12 month injection fidelity rate for our gather one trial in which we observed a statistically significant reduction in VA progression at 12 months was 87%.

We are encouraged to see that our efforts to maximize patient retention in the gather two clinical trial has resulted in even greater patient retention than was observed in gather one through the same time period.

Injection fidelity is calculated by dividing the total number of actual injections traveling sham for all patients by the total number of expected injections drug and Sham based on the total number of patients enrolled in that trial.

We consider injection fidelity to be the most important and stringent measure of patient retention because it reflects the timely administration of study drug into the patient side.

We believe patient retention is an integral part of the gathered shoe outcome.

We focused heavily on injection fidelity, not only to de risk and protect the integrity of our data, but also to potentially absorb the early and increasing reduction in <unk> growth that we previously observed in gather one.

We expect topline gather to data to be available in September of this year approximately one year. After the enrollment of the last patient plus the time needed for database lock and analysis.

We are actively working internally and with our third party vendors to prepare for the gather to database lock to be as efficient as possible.

Patient enrollment in star our phase <unk> screening clinical trial of Zamora for the treatment of autosomal recessive <unk> disease is ongoing.

The results of this trial are expected after that topline results as gather too.

Turning to IC 500, our <unk> one inhibitor, we initiated a number of preclinical tolerability and pharmacokinetics studies last year and we are planning for IND, enabling toxicology studies, we expect to submit an investigational new drug application or IND to the FDA for IC 500.

During mid 2023.

Thank you for your time I will now turn the call over to Doug.

Thank you Keith.

As Keith mentioned, we expect topline gathered to data to be available in September of this year.

Following the topline announcement, we are thrilled to have the opportunity to present, the topline data at the American Academy of Ophthalmology meeting.

On Friday September 30 of this year.

Earlier this month.

We were excited to share the results of a post hoc analysis from gather one.

Evaluating response based on location of GAA lesions at baseline.

We observed at 84, 4% of GAA Legion, we're within 500 microns of the OBL Centerpoint at baseline.

And that 28, 3% at GE aviation.

Mm 100 microns of the Foveole centerpoint at baseline.

These findings were generally balanced across all three treatment arms and their corresponding sham controlled groups in the study.

Gather one result, and with Nomura was observed to have a greater reduction of GAA lesion growth as compared to sham.

Occurred with the vast majority of patients having lesions close to the Foveole centerpoint.

The post hoc analysis was presented at the American Society of retina specialists annual meeting.

Earlier this month, David Lally of New England.

These data are consistent with previous post hoc analysis of the gather one trial, which were presented at the angiogenesis meeting.

Our retina World Congress earlier this year.

Data from this post hoc analysis are also consistent with the result of our previously reported.

Specified analysis of the more often they gathered one trial.

Demonstrating a reduction in GE lesion growth compared to sham observed regardless of lesion size or distance to default youll central.

Thank you for your time I will now turn the call over to Permian.

We previously reported post hoc analyses from gather one suggesting that the more I may have the potential to impact age related macular degeneration AMD.

Earlier stages before atrophy occurs in patients.

As part of this plan, we are pursuing multiple sustained release technologies for tomorrow for the treatment of GA in earlier stages of AMD.

A few weeks ago, we entered into a license agreement with Delta a Finnish company with a platform of silica based drug delivery technologies.

Under which we obtained a worldwide exclusive license to develop and commercialize new formulations of Zamora using delta silica based sustained release technology.

These technologies potentially could address patients being treated for gea and put in earlier stages of AMD such as intermediate AMD.

We believe Zamora, which is a chemically synthesized aptamer is amenable to injectable sustained release formulations.

This agreement underscores our commitment to invest in the lifecycle initiatives for Us tomorrow.

We're excited about the possibilities to expand zamora into earlier stages of AMD and potentially allow for a for a next generation treatment to help patients with <unk>.

Looking ahead potential of Zamora we.

We plan to continue to invest in additional lifecycle initiatives for some more to expand the patient population with additional indications and continue to evaluate multiple technologies for zimbra.

Furthermore, we plan to explore the potential for us the more in earlier stages of AMD by initiating a clinical trial studying the current formulation of Zamora in patients with intermediate am.

In the fourth quarter of this year.

The development strategy in this indication is subject to regulatory feedback from the FDA and other regulatory authorities.

Which we plan to obtain before initiating this trial.

Thank you all for your time and support.

I will now turn the call over to Dave.

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 new credit facility and our expected year end cash balance for the quarter. Our net loss totaled $49 3 million or <unk> 41 per share compared to a net loss of.

$30 1 million or <unk> <unk> per share for Q2 'twenty one.

This increase in net loss was driven by increases in both R&D and G&A expenses.

G&A expenses increased primarily due to increases in personnel costs, including share based compensation associated with increased staffing for potential commercial launch.

Turning to our balance sheet and our expected year end cash balance as of June 30, we had cash cash equivalents and available for sale securities of approximately $312 million.

Under terms of our new credit facility. The company is borrowing $50 million today, we now estimate that our current cash cash equivalents and available for sale Securities will range between 260 $270 million.

The credit facility provides us with access to up to an additional $150 million in total.

Detour achievement.

Specified development and regulatory performance milestones for Zamora.

An additional $50 million is available to us subject to lender approval.

We would view this additional $15 million as a potential source of working capital again, assuming approval.

We believe that this credit facility provides us with additional financial flexibility tied to major de risking milestones at a lower cost of capital and equity.

We intend to provide further details about our financing strategy to support launch following data release.

You for your time and I'll now turn the call back over to Glenn.

Hey, Thanks, Dave and before we open up the lines for questions I wanted to recap very productive quarter. First today is the one year point for gathered to over the coming weeks, we will analyze the data and lock the database.

Report gather two data to you in September .

We have also outlined where top line data will be available in September .

Second we are we have entered into an exclusive license agreement with Delta Tech to develop and commercialize our sustained release technology and finally as Dave just mentioned, we entered into a credit facility that provides us with up to $250 million of non dilutive capital with $50 million coming today.

And the balance that is tied to derisking milestones. So I want to thank you all for listening and operator I'd like to ask you to open up the line for questions.

Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.

Youre using a speakerphone please pick up your handset before pressing the keys to withdraw your question. Please press Star then two at this time, we will pause momentarily to assemble our roster.

Our first question comes from Michael <unk> from Morgan Stanley . Please go ahead.

Hey, guys. Thanks for taking the question and congrats on all the progress here just.

Just in terms of the topline results. Thanks for providing all the color on the detail on what we should expect.

Just curious the primary endpoint you mentioned, providing both the slope end point analysis.

If we think about that should we expect those to <unk>.

<unk> to be meaningfully different.

Hey, Mike This is double.

So if you look back on the gather one data and when we did the point in the slope analysis you saw that there wasn't really a big difference between the two.

I think thats, mainly due to the effect of the growth is pretty linear on these lesions and so we don't expect there to be a big difference between the two analysis and gather to either.

Got it thank you.

Okay.

The next question comes from Annabel <unk> from Stifel. Please go ahead.

Hi, and thanks for taking my question.

Just wanted to go back to.

Some of the data that you mentioned had been presented at the retina World Congress as well as high Srs regarding.

I guess I'm, just trying to service clearly natural history indicates faster progression that further you get from the center that Sylvia and thank you Laura.

There's also consistently shown more efficacy.

Further even if some et cetera, as well I think probably because of the metabolic rate.

Can you share with us whether the enrollment criteria for gather one is this <unk> change the statements gather one and what are your suspicions about how you might be able to replicate this data given what you know about the slopes analysis now.

So annabel its Glenn good morning, and thank you for the question. So we have double here today and also praveen.

On the double take the first part of that and then I'll ask <unk> to comment as well.

Yes, Annabel so maybe just I'll take the first one first so in terms of enrollment criteria nothing different.

In terms of gather one and gather two specifically as it relates to lesion distance.

Just to recap for you. The two main criteria here are one disease cannot touch the centerpoint.

The fovea and then second some part of the lesion needed to be within one five millimeters of the Foveal center that was the enrollment for grabbing one at the same thing for gather too in terms of whether or not one or two are going to look some of them. We haven't seen the data for gather too. So it's hard to kind of make a judgment call on that what I.

Can tell you is that if you look at the types of patients that typically hang around retina offices that are referred from tertiary care. They typically tend to be the ones that look like gather one and we would expect.

That to be the same case and gather too.

Praveen.

And about good morning is praveen.

Thanks for the question again.

The take home points from these post hoc analyses that you referred to I think one is that Zamora works, regardless of the location of the lesion, but it will work better in earlier lesions as witnessed by lesions that are further away. So let's take home point number one take one point number two.

I think as that and gather one.

Of the fovea.

And also realize that most of these patients had bilateral lesion. So these lesions were really quite severe in the patients who were quite severe so although the inclusion criteria is exactly the same and gather two hasnt gather one we're also hoping that if we can get lesions that are a little bit of an earlier stage that delta.

We will be even higher as you have seen them that ASR analysis, there's a very clear difference between the delta of treatment versus sham.

Further you go in the earlier lesion that you get so we're hoping that the lesions will be a little bit earlier again, we have no way of knowing that because we are completely masked but at the end of the day.

The main points here I think is that leaves the more it works regardless of where the lesion is but and gather one the vast majority of the lesions were right next to the central point.

Oh, great that was helpful for the color.

Just to go back to that.

At that point analysis versus the Philips analysis.

I guess part of the reason why there wasn't.

Such a difference just because you didn't have a tremendous amount of variability in that patient. So if we look at Catherine to is.

Is it possible that.

Earlier, you guys have more variability might have been in the points analysis might be different from the slips analysis of how should we think about that.

Liability versus.

And and.

In terms of these points will slips analysis analyses.

Yes, so annabel this is double.

So what I'd say is I don't think we're going to see much of a difference as I mentioned previously from the population and gather two that we saw and gather one to begin with so again I think the full expectation amongst the folks that accompanies the results between those two analyses shouldn't differ very much based on what we saw and gather one.

Any additional comment.

Yes, I would agree with I would say the same thing and about the variability really comes from the patient population as opposed to the lesion location and what we've done.

As to really limit the variability in the patient population.

No.

As has been shown earlier and by others as well the patients that we picked which now will call non central fovea involving where exactly the right patients to pick.

And those are the same patients that we expect and gather together too that it will be the same patients together to gather once so the variability again comes from the patient selection not not so much from the lesion. So we don't expect really any difference.

Okay, great. Thanks, so much.

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

Good morning, Thanks for taking my questions.

So when we see the data.

Our gathered to is there a percentage change that you feel would correlate well with clinical benefit.

Just trying to think.

If any.

<unk>.

Statistically significant benefit is sufficient.

Not only for approval, but also for your competitive position in the market.

Okay.

Greg Thanks for the question prevent you want to take that one.

Yeah sure Greg Good morning, and thank you for the question.

I think the main thing to do is to make.

To keep two silos are very very clear one silo is the regulatory pathway and the other siloed would be I think what you are asking which is what would be the functional benefit to the patient and to payers and to <unk>.

Physicians that one can communicate with so let's keep those two a little bit separate at this point, although I realize that they are interrelated as far as the regulatory pathway is concerned it couldn't be clearer. We got we have a spa agreement with the FDA. So all we have to do is to hit the primary endpoint.

For purposes of submission so the regulatory pathway via the Spa agreement I think its absolutely clear. The second question, which is also quite important in Germany, which is what is what about the functional benefit for patients how do how do payers react to this.

Is it the physicians that are going to say.

Having having practice retina for over 26 years I'll tell ya patients are not necessarily going to understand or care about the percentages relating to function or the square root transformation or anything else. What they are going to understand is there going to understand preservation of centralization of the time and what I mean by that is that we know from.

<unk> studies.

For because of the patients who were selected who are non <unk>.

Our central point involving what we can say is if you take this treatment youll be able to drive for X years longer you'll be able to read for X years longer work for X years longer and I think that's the currency of language that patients will understand payers will appreciate and certainly physicians will use as a curve.

You have communication.

Got it that's helpful and then.

One other.

How much of the filing has been completed at this point and can be completed ahead of having the final gathered two data and how would how would the timing here compare with a typical timeline after in phase III.

Yes, Greg Hi, it's Glenn so as we mentioned in the past the regulatory team has been working on the data that they have available which is gather one having that I think gives us.

A real good head start on completing the following once we see the data from gather too. So we havent specified timing it really will be dependent on what the gather two data looks like which will.

Kind of round out our strategy on the regulatory path forward. So when we have that data, we'll consider giving guidance on the filing strategy.

Very important it is a competitive situation. So we know timing for investors is important but right now to answer that question, we really need to see the gather two data.

Great. Thanks for taking the question.

The next question comes from Ken Cacciatore from Cowen and company. Please go ahead.

Hey, guys real exciting time, but excited to see the data in September just wanted to ask about the extended release formulation real potential commercial advantage that you might have if you were able to move this forward to obviously be real beneficial for patients that <unk> I know you talked about some of the unique characteristics of some more maybe you could flush.

It out just a little bit more that you think make it real amenable for an extended release, if you would like it would be interesting if you could compare to a palace, we've not heard of them moving forward with an extended release. So if you were willing to maybe compare and contrast, why they may be behind that would be interesting and also maybe you could bring delta tech to life a little bit.

How long you all have been working with them clearly going to be a very important partner <unk> can you talk about them and maybe a little bit of their history and success in developing extended release formulations, and then maybe timing to get into clinic would be interesting. Thanks. So much.

Perfect and you want to start.

Sure Ken Good morning, and thank you for the questions.

So first of all regarding our molecule, it's an RNA aptamer and Theres, a really big advantage on RNA after him or not only is it a small molecule. So the capacity for loading is going to be greater but arent apps number as opposed to a protein that can be completely the nature of that re nature can be fully functional so that's a huge advantage for a sustain.

Delivery type strategy, we believe that this has advantages over our competitors.

Again, I'd, rather not speculate about the competitors.

Can certainly ask.

Asked them, but I do believe that we have.

A significant advantage here because of our molecule.

In regards to Delta Tech.

And other.

<unk> that we're looking at there are certain things that characteristics that were important for us first of all.

It has to be low double to a capacity that allowed for a sustained release.

And it's certainly check that box it has to be tunable and what I mean by that is that.

And then.

In the natural history of macular.

Macular degeneration.

Depending on where we target the disease the release characteristics.

And then it has to be scalable so with Delta Tech with the preliminary studies that we did we were quite confident that this fit all the boxes.

This would be a very very good strategy, having said that I must also say that it is.

Not going to be the only strategy. Obviously, we're looking at other strategies as well our intention as I've stated many times in our Glenn has as well as to be deep.

The geographic atrophy patients be treated in a way that's much more sustainable as well. Thank you for the question Ken.

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

<unk> say anything about that and then secondly on based on your physician feedback and experience with monthly anti VEGF is there sort of an expected rate of inflammation and optimize that might be expected just from monthly <unk> injections and if the FDA ever commented on what those acceptable levels may be from a safety perspective. Thank you.

Thank you maybe I'll work backwards, we have some.

Logistics were trying to manage today, so double take.

Second question first and then <unk> will take your initial question yeah.

Thanks for the question so in terms of physician feedback on rates of endophthalmitis and inflammation.

The easy answer to that is they wanted to be zero.

But if you look at kind of a commonly prescribed retina therapeutics that are out there roughly in that one less than 1% range is kind of where we see inflammation and less than 1% significant certainly for endophthalmitis is where we typically look.

For safe drugs, and so so that's kind of the number that we have in our mind at the end of the day. The number is going to be the number whatever it is going to be but that's what we're generally understanding in terms of.

The physician feedback on inflammation endophthalmitis, I will give it back to Glenn for the Spa agreement.

When you want to take that I mean, you had firsthand conversations with the regulators.

Sure Glenn I'll be happy to do that and Eddie Good morning, and thank you for the question. So what I would say regarding the Spa agreement.

Couple of take home messages that are really important here in the first of all the FDA advised us to apply for a spa agreement.

And this was done when the Gallatin study with have recruited.

So what that should tell us is the level of alignment in the level of confidence that the FDA had in the earlier discussions we had with them, albeit all in.

Informal.

So that's the first take home message. The second one is after having gone through the entire spa process, which as you know involves an army of statisticians and clinical trial with <unk> and so forth.

Nothing else was commented upon they agreed with the with the endpoint. They agreed with the mixed random effect model as well as the sample size all of those things and as you know we're happy to do that that really didn't change anything as per gathered one.

However, the Spa agreement really is for one study only and that was gathered to the FDA. It had really no obligation to comment on gather one however, they went out of their way to comment on gather wondering what they said was that they were they were in agreement that our pre specified analysis was absolutely valid they all.

Also thought that the preferred analysis was absolutely valid and when the application is made they will look at gather one and gather one both ways with the pre specified analysis as well as the preferred analysis.

So we are very confident because the FDA has commented on gather one and given us the spar group together to that they are very well aware of the entirety of the program.

But both the programs together will be certainly valid for submission.

And Eddie what I'll add to that is you can go back to a prior press release, where we did both calculations for gather one the pre specified plus the FDA preferred analysis and what you will see is consistency in the rates of efficacy there and happy to provide that if you don't have.

Access to it got it.

Thanks, and then actually one final one when it comes to the CMV versus sort of <unk>.

Do you plan to have at the topline released any data from the KOL Eye Institute or are you expecting the primary readers in the study to be evaluating CMV in the way that it was done in a post hoc manner by the Cleveland clinic or will it be done by Duke.

Great question, Eddie Permian do you want to cover them.

Sure I'll be happy too so so any there.

The fact of it is that I don't know if there'd be much difference at all because our definition is very very clear, but our plan. At this point is to continue to use the Duke Reading center as the primary point of analysis for a core the neovascular membrane formation as per the definition that is traditional and as they defined it and gather one now we also.

So had the gather one analysis done by the KOL Reading Institute and the reason for that is because.

The Duke was no longer masks to that data and we wanted to make sure that the reading center that.

Defined and we will look at the exhortation rates remains completely mast. Therefore, I don't think that analysis plan is going to change at all for gathered too.

Great. Thank you so much.

The next question comes from <unk> <unk> from Jefferies. Please go ahead.

Hi, good morning, <unk> on for Chris.

A few questions for me.

You plan to do in the filing as well.

And FDA filing what are kind of the differences in those two the agency's stances on at GAA therapies.

Second question, what was the relative performance of Delphi Tech sustained release technology versus some of the.

Other options you considered.

Third question what.

Endpoints are you going to propose to FDA for intermediate and D&O part there. Thank you.

Okay, Great question so.

I will ask I will go backwards, Keith do you want to talk a little bit about the Delta Tech technology first and then we'll address the other questions.

Sure happy to do that.

Can be further for the question. So in terms of Delta Tech I know <unk> talked a little bit about it.

There were a number of factors that we looked at two two.

In terms of feasibility.

But really the silica based.

Joe is really important for us because the app tumor again is very compatible with that so the number of things that we looked at in terms of loading.

Terms of tuna ability.

And we've also done a number of other feasibility studies with a number of other companies. So as we continue to move on I'm sure. We'll put out additional data here, but this again it won't be our only.

Our only plan here, we're looking to do additional.

Drug delivery efforts around tomorrow.

Thanks, Keith and I'll take the next two questions first on the regulatory filing strategy and it was mentioned this morning in our conversation we do plan to submit a filing to the EMEA.

That will fall the NDA that we filed we have engaged experts and advisers in Europe to help us through that process and the planning for EMEA, but it is our expectation that we will have a filing we have not defined.

Timing just yet the question related to endpoints for intermediate AMD also a very good question.

As you know we had said we will engage with FDA prior to starting a trial with intermediate AMD. We believe this strategy may be a collection of different endpoints.

The best way to handle that as we need to have the discussion with the regulators first and then get back to you on the results of those.

Discussions so a little bit hard to put bookends around that right now, but obviously the team has many ideas and we're looking forward to our discussion with FDA.

Awesome. Thank you so much Glenn and then maybe just one final follow up.

From a functional perspective going back to that kind of distance from fovea analysis, how does.

Can you help us understand how a patient.

With <unk> <unk>.

100 microns from the center is different than 500 microns from the center.

We are of course, Fabio and then kind of the time it would take to progress from 500 Micron 100 micron.

All the way to the Central vision. Thank you. That's my final question sure. Thanks. So again very good question I'm going to ask both double and proving to comment on that double will begin yes. Thanks for the question. So if you think about distance from the Foveole center and kind of how a patient perceives that you just think about.

Looking into a kaleidoscope right and then the closer that lesion is the Foveal center, just imagine not being seeing black spot right near the Middle and then if there are further way you kind of see it more out in the periphery. So obviously the closer it gets to that center point the more of your functional vision gets impaired.

In terms of the progression of those lesions, it's highly variable and that's one of the things about this disease that really.

Yes, what I would say is I think there is.

There's very good evidence now that what we traditionally think of as an endpoint, which is visual acuity is not a good endpoint for visual function.

What we have where you can have for instance is excellent visual acuity, but still have terrible visual function and.

If you think of how visual acuity works you are in a dark room with a bright light at the end of life is rarely like that and if you think about your day today.

Really not going to have that situation at all.

In the bottom or on the sides and what you'll realize it that you simply can't function. So even if you're 500 microns away or further.

You will find is that there are lots of patients out there who are visually dysfunctional with lesions, even with even even though it seems further away.

Version the one in the GI patients is to be able to say look if you take this treatment. This is how much time, you will have to continue to function and do your functional activity and hopefully what we can do is go even earlier and not just slow down the rate of death, but to prevent death altogether and that really would.

<unk> the trajectory of the disease.

Okay. Thank you so much.

We have time for one more question and that's from Colleen <unk> from Baird. Please go ahead.

Great. Good morning, Thanks, so much for taking our questions and congrats on the progress.

B the thresholds for significant thank you.

Thanks, Colleen I'll, let Dave take the first question. So thanks for the question Colin Yes. It is.

Our position there.

<unk> answer.

Colleen on the on the Spa agreement double point of five can you confirm that yes. It is.

And currently and there was one other question mixed in there I think did we hit at all.

So I think the question was if those are two different things and the primary endpoint and the data as part of a filing.

And the response is yes, those are two different things.

Okay. Thanks, Charlie I appreciate the questions.

There are no more questions in the queue. This concludes our question and answer session I would like to turn the conference back over to Glenn <unk> for any closing remarks.

Well, thank you operator, and thank you everybody for listening to the call. This morning.

As I mentioned before great progress in the last quarter and were quite excited that we have reached the one to your point with our gatherer too and we look forward to a conversation in September about that data.

Have a great day, everybody bye bye.

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

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