Q1 2022 Iveric Bio Inc Earnings Call
Hello, Walter I have Rick Bio, Inc. First quarter 2022 earnings conference call all.
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Good morning, and welcome to like Dark Bio's conference call, representing iceberg today are Mr. Glenn <unk>, Chief Executive Officer, Dr. Praveen, Dougal, President Keith Westby, Chief Operating Officer, David Carroll, Chief Financial Officer, Mr. Double decide Chief Development Officer Christian.
Chief Commercial officer, and Tony give me Chief business and strategy Officer, I would like to remind you that today, we will be making statements relating to I'm very biased 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 1995. 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 by any forward looking statement.
I refer you to our SEC filings and in particular to the risk factors included in our annual report on Form 10-K filed on February 24, 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 except as required by law.
I would now like to turn the call over to Glenn.
Thanks, Kathy and good morning, everyone and thanks for joining our first quarter conference call.
This is an exciting time for <unk> bio as we prepare for topline data readout from gathered two our second phase III clinical trial for some more for the treatment of geographic atrophy or Gi in the third quarter of this year.
This is approximately one year after the enrollment of the last patient for some time needed for database lock and analysis.
Which Keith will discuss in more detail in a moment.
Our key objective and plan is to make some more commercially available to physicians and their patients with G. A as quickly as possible.
Assuming a positive data outcome from gathered to and regulatory approval.
As we prepare for gathered two results we are working diligently to assemble a thorough and complete new drug application or NDA.
Following a potential positive outcome gather too.
We plan to submit applications with the FDA and the European Medicines agency for marketing approval of some more of Virginia.
As a reminder, we received a written agreement from the FDA under a special protocol assessment or S. P. A for the overall design of gathered two in July of 2021 for those who may not be familiar the SBA S. P. A process is it procedure by which the F. D. A provides a clinical trial sponsor with an official.
Valuation and written guidance on the design of our proposed protocol intended to form the basis for an NDA.
As we get closer to reporting the Gaba to topline we made a number of new hires to lay the groundwork for a successful launch.
If some more is approved.
We are well positioned and with an established medical affairs team already in place and continue to build out our commercial infrastructure with the team that has extensive experience in launching drugs for retinal diseases with large market potentials.
As we announced in our press release. This morning, we continue to provide additional exploratory analysis from gather one.
Which we believe further supports the consistency of the positive data that we've previously reported for gather one and inform future potential development opportunities for Zamora in other indications.
Both Dr Dougal and doubled the size.
Review the details of the analysis.
A few minutes.
We also continue to execute our IP strategy for Zamora.
In March of this year the U S patent and trademark office granted a patent with claims covering methods of abuse.
To treat G E.
This issue patent is expected to expire in 'twenty 34, which we.
Which will extend our market exclusive exclusivity in the U S by several years.
We also plan to initiate a clinical trial studying zamora in patients with intermediate AMD in the fourth quarter of 2022.
Our development strategy in this indication is subject to global regulatory feedback from the FDA and other regulatory authorities, which we plan to obtain.
Before initiating this trial.
Looking ahead at the potential of Zamora, we continue to invest in additional lifecycle initiatives tourism Mora in order to expand the patient population with additional indications and we are also evaluating multiple sustained release delivery technologies.
We look forward to the exciting opportunities that lie ahead of us in 2022 including receiving top line data for gather two and being closer to reaching our goal of providing patients and physicians with a treatment for G E for which there are currently no treatment options available.
I'd like to now turn the call over to Keith.
Thank you Glenn and good morning, everyone. We're pleased to report that gather two continues to exceed our expectations for patient retention and injection fidelity.
As we enter into the home stretch for obtaining and reporting year, one data for gather to a major priority for US is to continue to aggressively drive patient retention and there by further derisk the clinical trial.
We continue to target patient retention, where they gather two clinical trial as measured by injection fidelity rate through month 12 of greater than 90%.
Jetson fidelity is calculated by dividing the total number of actual injections drug and sham for all patients by the total number of expected injections drug and Sham based on the total number of patients in the 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's eye.
As of today, we continue to maintain an injection fidelity rate of well above our 12 month target 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 G. A progression at 12 months was 87%.
We continue to focus on injection fidelity, not only to derisk and protect the integrity of our data, but also to potentially observed the early and increasing reduction in G. A growth that we previously observed in gather one.
To date, we are excited we have reached a trial completion rate of 94% for year one of gathered two clinical trial.
The time point for the primary efficacy analysis, after which based on a positive outcome. We plan to apply for F. D. A N E MAA approval.
Therefore, with only approximately 6% of your one visits remaining and gather too we are encouraged to see that our efforts to maximize patient retention and gathered you have resulted in even greater patient retention than was observed in gather one through the same time period.
As you May recall, we completed patient enrollment and gather to you in July 'twenty 'twenty. One four months ahead of our original schedule.
Based on this timeline, we expect topline gather to data to be available in the third quarter 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. We believe patient retention is an integral part of the gather to outcome.
Patient enrollment in star our fees to be screening clinical trial of Zamora for the treatment of autosomal recessive <unk> disease is ongoing the results of this trial are expected after the topline results with the other two.
Turning to IC 500, our H T. R. E. One inhibitor, we initiated we initiated a number of preclinical tolerability and pharmacokinetics studies last year and we are planning for IND.
Enabling toxicology studies to begin this year, we expect to submit an investigational new drug application or I N D to the F. D. A I see 500 during mid 'twenty 'twenty three thank you.
You for your time I will now turn the call over to double.
Thank you Keith and good morning, everyone.
As Glenn mentioned, we're excited to share with you today the results of a new post hoc analysis from gathered one.
This analysis evaluated the reduction in G. A lesion growth in patients receiving zamora as compared to patients receiving sham based on the distance of a patients G. A lesion to the full wheel center at baseline.
This analysis is scheduled to be presented this Friday may 13th at the retina World Congress in Fort Lauderdale, Florida by Dr. Glenn Jaffe, Robert Montgomery Professor of Ophthalmology, and Chief of the Retina Division at Duke Center.
In line with the overall results of gather one we observed a reduction of lesion growth in patients receiving zamora compared to patients receiving sham.
This reduction was consistent across all baseline distances from the four wheel center.
In addition.
The greater the distance of the G. A lesion from the four wheel center at baseline the greater the reduction in growth in the Zamora group as compared to the Sham group.
Yeah.
Previous studies have shown that Jay lesions further away from the four wheel center grow faster and that these faster growing J lesions may show, a greater growth reduction following complement inhibition.
Our observations were consistent with these previous studies.
We believe the results from this post hoc analysis suggests that early administration of Zamora when GE lesions are further away from the Foveole center and growing the fastest may be the most beneficial.
We believe these results are consistent with the previously reported results for gather one.
And we look forward to testing this hypothesis further with the larger data set from gather too.
Please see the press release, we issued earlier this morning for details of this analysis.
Thank you for your time I will now turn the call over to Bernie.
Thank you all for joining the call. This morning, I hope that all of you are well.
Thank you David Great work by you and your team.
As we continue to provide.
Moratorium allison's form gather one.
We continue to see a pattern of the potential for us to observe in gathered.
A reduction in the rate of <unk> for patients receiving zamora as compared to patients receiving sham.
Similar to that observed in gather one.
Equally importantly, we continue to see.
Results, which gives us a great deal of confidence in the robustness of the gathering one data.
At this year's angiogenesis Exudation and degeneration conference results from a post hoc analysis that evaluated various G H.
Parameters to explore the rate of disease progression within various regions.
In a subset of patients from gather one 4%.
Consistent with the overall results of gathered wall in the post hoc analysis, a reduction in lesion growth.
Fight standardized standardized regions surrounding and including the central area.
Was observed for patients receiving some more two milligrams as compared to patients receiving sham over a period of 18 months.
We believe that.
Preservation of the Central OBO region may be associated with clinical and functional outcomes important for patients.
Summarize.
We believe this data has the potential to bridge the anatomical results that we observed.
Functional outcomes.
By preserving the central Fovea, we hypothesize that patients may have the opportunity to continue to drive we'd live independently et cetera.
Longer periods of time.
To the natural history of the disease.
It must be stressed however.
That this is an exploratory post hoc analysis that requires further confirmation.
We anticipate performing similar analysis or gathered to further build upon these insights.
Last month, working with an independent and masked reading center, we provided the results of a post hoc analysis of the cases of choroidal Neovascular innovation or E. N V and there's the more two milligram group.
Six to seven patients total from gathered one.
As we previously reported.
Students investigator reported.
Indeed in the study eye and there's more to the milligram and gather one with six patients or 9% at 12 months and eight patients.
11, 9% at 18 months.
The post hoc analysis was performed by the internationally recognized.
For ocular research and evaluation also known as core.
Cool.
Oh I Institute of the Cleveland Clinic.
The leading central Red optical coherence tomography or <unk>.
The images for.
For the eight patients in the similar two milligram.
Dnb and the <unk>.
Yeah.
OTT images, we're wed to determine the number of E M B pieces.
That will Macedonia, vascularization or M M E, which.
Which is Neil vascularization that affects the maximal versus Henry Papillary, Neovasc sensation with a near vascularization located around the uptick more and not encroaching on the match.
All eight cases work and B.
Or those eight cases, the leading central Florida classified cases, either exuded it.
Nonexecutive.
<unk> almost following OTT quite linear.
Exuding M N B is and then be that presents with new onset fluid.
These are the sub retinal space for intra retinal space.
Sublet space.
On OTT between the retinal pigment epithelium.
And total receptor cells.
Intra retinal space is the area on the OCC.
<unk>.
This photo receptors and other numerous sensory cells of the retina.
Based on this definition.
Among eight NIMBY pieces.
<unk>, two milligram group and gathering one at month 12.
14th of Exuded, It and then be translating to 6% of patients and two cases of non exhibited and then be translating.
Translating to 3% of patients.
Reported and at month 18, six cases of exuded, it and then be translating to 9% of patients.
Suitcases nonexecutive MMP translating to 3% patients.
Reported.
The weeding Central also reviewed the baseline otp images for the eight patients in the similar two milligram group, who develop CMV in the study are looking for the presence of a double layer sign at baseline.
A study published in 2019, and the peer review Journal Ophthalmology retina found with the <unk>.
So the double layer sign is correlated with the presence or development of non exhibited and then.
In Ais with AMD.
And the clinical experience.
As shown in this type of nonexecutive, and then be often progresses to exude are due.
And then b.
Based on scientific literature, and clinical understanding among the retina community. We believe the presence of a double layer sign on OTT, maybe a useful biomarker to predict.
With feature onset of cases of exhibited.
And then B and may potentially be a biomarker that allows for it.
Personalized management and follow up strategy.
In this retrospective review the leading central found.
Among the six gather one patients in this the more tumor look land developed exuded if MMP.
Two months.
Five of those patients had a double layer sign at baseline.
A leading central also found that neither of the.
Gathering one patients in the us the more two milligram group, who have nonexecutive and then be at 12 months.
14, an 18 month time point.
The Devil layer sign at baseline.
Yes.
For this retrospective with OTT images were weighted at.
Leading central by two mass independent meters with the ratings confirmed.
Two additional mass independent senior leaders.
All OCC gradings for those patients where unanimous.
Among all readers.
All of the regions remained mast.
The treatment arm throughout the review.
We are excited to share the gathering one analysis with you.
We plan to perform the same analysis on the gathered some data.
Thank you for your time.
I will now turn the call over to Dave.
Thank you Praveen and good morning, everyone.
To highlight a few items from our press release of this morning, and provide some guidance on our expected year end cash balance and our expected cash runway.
For the quarter, our net loss totaled $34 5 million or 29 cents per share compared to a net loss of $26 8 million again, where 29 per share for Q1 'twenty. One this 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 progression of our gathered two clinical trial increased manufacturing activities for Zamora and increased personnel costs, including share based compensation associated with R&D staffing.
G&A expenses increased primarily due to increased personnel costs, including share based compensation associated with preparations for the potential commercial launches tomorrow.
Turning to our expected year end cash balance and cash runway as of March 31, our cash totaled approximately $346 million. We continue to estimate that our yearend cash balance will range between $215 million and $225 million, we estimate that our cash will be sufficient to fund our <unk>.
<unk> capital expenditures and operating expenses through at least mid 2024.
These estimates are based on our current business plan, which includes continuation of our ongoing clinical development programs for some more in <unk> and Stark arts, the initiation of an intermediate AMD clinical trial.
The preparation of potential filing of an NDA and MAA for us more NGA continuing preparations for the potential commercial launches of more N G E investing and sustained delivery technologies for Zamora.
And the advancement of our IC 500 development program.
Excluded from these estimates or any potential approval or sales milestones payable to the architects corporation or any potential expenses for the actual commercial launches in lora, including Salesforce expenses, and then any additional expenses related to potentially studying zamora in indications outside of G E.
Star Guards or intermediate AMD, where resulting from the potential in licensing or acquisition of additional product candidates or technologies or any associated development that we may pursue.
Thank you for your time, I will turn the call back over to Glenn.
Well, thank you Dave and thank you.
And for your time this morning, and your continued support of the company. We look forward to providing you data in the third quarter and updates as they come throughout the year now turn the call over to the operator, so that we can open up the line for any questions.
Operator thank.
Thank you.
And at this time, we will begin the question and answer session.
That's a question you May press Star then one on your Touchtone phone.
Speaker phone please pick up your handset before pressing the keys.
To withdraw your question. Please press Star then two.
At this time.
Some of the roster.
And the first question comes from.
Cowen and company.
Thank you so much for taking our questions and congratulations on all the progress.
So.
Just a few from us on first on.
Analysis of nuance at C. N V cases, and got their one or these new results more closely comparable to the results presented from your competitors and related to that maybe if.
If you could talk about in discussions with Kols.
Where is usually they're focused on when comparing the safety of different assets.
And then maybe start with that one and then how about just a couple of short follow ups.
Okay, Youre going to think are.
I will turn it over to Praveen.
Thank you Glenn you already thank you for the questions in regards to the first question.
I can't really give you a great answer on that because I really would prefer to talk about our data.
I I don't want to pretend to know what our competitors definitions are but what I will tell you is that this is this notion of exaggeration.
It is very important and it's important to understand the way we went about grading. This what we did was we went to the Cleveland clinic.
And we had four graders as mentioned who were completely masked.
The <unk>.
Unanimous and we asked them to simply great.
New onset sub RPE fluid, new onset sub retinal fluid and new onset info retinal fluid not related to accuracy and.
And once those were graded which was really a very very systematic procedure. We asked them to define what they would define as exudation and what they said was what you would define eggs mutation as new onset sub retinal fluid and new onset <unk>.
Info retinal non after a few related cystic fluid.
And based on that that is our definition of explanation and we gave that definition and the numbers about as transparently and openly as we possibly can in regards to your question about safety I think it's important to put the safety in two different buckets, one bucket would be non exudation related safety and the other.
Would be exploration related safety issues in terms of the Nonexempt Asian related safety issues I think it's important to look at inflammation as well as endophthalmitis or infection of the eye.
We believe that our safety profile was excellent.
No cases as you know from gather one in regards to information or endophthalmitis. The other bucket as we've discussed in detail is the conversion bucket, which is the.
The conversion to a C and big bucket, which you know in detail and we've described.
So with the traditional definition of <unk> as well as this.
<unk> that we've discussed in detail today, so I hope that answers your question, but thank you for your question.
No that's great and just a couple of follow ups I guess first you mentioned impressive injection fidelity rate that continues.
To trend to trend above your target you also took a number of measures to improve the amount of missing data and gather to is there do you have any update on are we still tracking above this other one levels and then secondly regarding the NDA filing.
Soon after the data is disclosed later this year would you be in position to file and what are the remaining gating items.
Yes, sure Jay I'll take the second question on the NDA and then I'll turn it back to Keith to talk a little bit about what's going on together too.
So obviously, we're doing a lot of work now to get the data out I think one thing that.
Should take note of we had said.
Originally the second half of the year for data I think because of the great work being done by the team we're able to now refined that and in today's call we talked about having the data in the third quarter.
So you can tell the team is working on everything they they can we're in a very fortunate situation to have one or two.
Trials completed so it gives our regulatory team who've been working on the NDA for some time.
The opportunity to work with one data set obviously need the second to prepare second it goes back to the some of the comments I made we are.
Our highly motivated.
To hopefully get this drug to patients as soon as possible. So I think as a team. It's an experienced team we're doing everything we can to narrow that time between.
Positive data readout, if that comes and getting the NDA and so more to come on that it would be very difficult even if oh.
A late health plans today to do that with precision until obviously, we see the data, but I think the important takeaway. There is the motivation of the company to get this info review as quick as possible and most importantly to get this.
A new drug to patients.
Keith.
Sure. Thanks for your question Yuri on patient retention and injection of fidelity. So.
Youre actually correct, we we put a target out there for ourselves of greater than 90% for injections fatality is as of today, we're well above that target.
Also in terms of also mentioned for gather one we were at 87%.
For the patient retention efforts that we've put in place started at the beginning of the trial and then continue to ensure that we had the right efforts in place throughout the duration of the recruitment as well as as up until this point, but we're really happy to see that our efforts to maximize patient retention have have resulted in greater retention that we had.
And gather one through this time point, so we're really tracking well to derisk the study as much as possible.
Yeah.
Add to Keith's comment that may be helpful.
Keep also in his commentary, we talked about being at the 94%.
Visit completion. So I think that's that's also an important metric. There is as you think about where we are and getting closer to the data.
No that's great. Thank you so much and congratulations again on all the progress.
Thanks I appreciate your questions.
Thank you.
The last question.
Stifel.
Hi, Good morning, this is stacy.
Going in for Annabel congratulations on the post hoc analysis on that.
Thank you for taking our questions and we have to if we may the first is the best rate reduction and growth is what you're saying.
You know further from there so that's consistent with everything you guys spend telling us football.
Testify trading early.
To what extent do they postpone carbon Paramount Wonder lesions are you now want their one five millimeters from the center, which is where the rate of reduction with it.
So in other words this is validating for treating early but what it does motivate patients to get treated early and secondly, how it internally.
To find their place.
Hum and how might you go in Wilmington terminal the child well.
You know about the rate of production.
Weibo has on what patients will feel the most clinical benefit. Thank you.
They say great questions I'm going to ask a double too.
Dress both of those questions in protein may have some comments as well.
Yes. Thanks for the question so as it relates to your first question regarding the degree of impairment for these lesions that are further out I think it is highly variable depending on which patients that were talking about certain folks that have.
Veteran professions that kind of use a lot of that peripheral vision could be highly impacted by this where others may not I think the important thing to remember here, though is that like most chronic diseases. The sooner you get in and you treat them the less likely they are to have impact on downstream health.
And when we're talking about vision that becomes even more critically important and so let me ask for me to weigh in here as well.
Isn't that has seen these patients for many many years.
Yes. Thank you and thank you for the questions are really really good questions.
Let me, let me answer one at a time.
First thing that I would like to point out is what you mentioned Stacey which is the consistency of the data.
We started out by saying, there's a good biologic who use them.
To assume that complement inhibition will work best and.
And have the biggest delta in the fastest growing lesions and sure enough that's been shrunk because extra foveole patients have a larger delta.
Then patients where the bogie is affected and that's been shown.
Many times, including by our competitors and I think one of the big take home messages here is that we've targeted a patient population that is absolutely correct and appropriate and I believe we've derisked our trial greatly.
By targeting this patient population.
After that what we've also shown in the angiogenesis presentation is.
Is that within that area of extra Fulvio lesions.
You look into the micro away at the lesions area that would be expected to grow fastest which is in a circumferential pattern. Indeed that is exactly where the delta is even greater than that that the presentation that Glenn Jaffe presented in angiogenesis.
And now what we have.
Is that the fastest growing lesions that are the furthest away indeed have the largest delta so.
In fact, there are three different studies or three different analyses that have been that we have shown that show exactly. The same result in the same consistency. So I think the first thing that I would stress is the consistency of the data, which makes this data a lot more robust now how this translates clinically here's what I.
I would say.
Probably heard me statements before.
If anybody wears glasses, the easiest way to translate this is by putting the smallest piece of Scotch tape that you, possibly can on the sides of the bottom of your glass away from our Central Division and I guarantee that you won't be able to work during the day.
Point of saying that is that it's not about visual acuity, it's really about any amount of distortion of any amount of blind spot that you may see that will prevent you from doing your job if you're an architect and theres a slightest bit of distortion Thats All center, it's very difficult to work if you're a lawyer that can't finish reading a sentence because theres a b.
<unk> spot that prevents you from completing your are your symptoms.
That's a problem there are many many many of those patients out there and those patients tend to be younger they tend to be in the workforce and those patients will be specially motivated. So we are very happy that we have potentially.
<unk> a treatment for these patients.
The other one that I would tell you in terms of the intermediate AMD is that the definition is really not our definition of the definition that's been adopted by the by the community the retina community, which is the size of the Dru.
As well as changes that occur on top of the crews and which are changes in the photoreceptor cells that we call IRA or incomplete RP and outer retinal atrophy, which will then progress to see lora or complete RP and outer retinal atrophy. We also look at other items such as a hyper reflective foci.
Which looks which reflects the RPE cells that moved out from their natural area onto the retina. So there are a number of these criteria that our OTT base that will define what we call intermediate geographic atrophy. So thanks for the question I Hope I answered it and sorry to take such a long time answering your questions.
That was super helpful. Thank you so much.
Thank you Stacey.
Thank you and the next question comes from Thiago <unk> with credit Suisse.
Thank you Barbara and thank for taking the question so.
We've discussed this a little bit in the past, but theres still a lot of the data in detail Cross trial comparison between gather one in those trials.
But despite all the warnings.
So.
And a lot of focus on holiday buying characteristics might be impacting the efficacy and safety results.
Again, if you can just kind of highlight the most significant baseline characteristics.
And differences in inclusion exclusion criteria between the Gadberry studies.
And the program that was wrong by by your competitors.
The LOI P N P criteria fairly different for example, but perhaps emphasizing how they actually help to contextualize either efficacy or safety results for.
Toward the gather studies.
In a perfect comparison, but at least prospectively what might some of those differences all translate to in terms of efficacy and safety.
Well thanks Thiago.
Thanks for the questions. So let me let me start out from the top and I'll ask Keith to get into some of the details and for being to give.
As you.
The way we are looking at this as the results of gather one when we look at that.
On its own.
Safety profile and also the efficacy profile.
The data from both the safety and also the efficacy or quite good and when we look at what is out there in the market with other trials that are going on or have been completed.
The results are the best that are out there and that means those are potentially the best for patients.
We'd have the potentially if gathered to replicate as kind of a one.
The best efficacy profile and.
Second.
Potentially the best safety profile. So that's the way we look at it and Youre right Cross trial comparisons are very difficult, sometimes misleading so I'm focusing on our data and what we can do.
For patients.
If gathered two does replicate.
That we have a very strong dataset that we believe the regulators will take a look at.
Especially in light of the fact that there's unmet medical need.
We believe that.
As a very good chance of gaining approval and.
Getting to patients. So that's kind of my my top level trying to avoid the comparisons because at the end of the day, we do not know all the details of those other trials. So it's very hard to make that comparison.
We're making an assumption, which we believe is supported by data that we see from gather one and will be additional analysis, whether it be an extra data.
C N V for the data that double spoke about today about location of lesions. So we're feeling really good about our data I'm not sure that we've seen those types of analysis.
From other companies or the depth of definition.
Behind those analysis so.
I know that's not answering your question, specifically, but that's the way we're approaching it.
Prevent thoughts from you.
Yeah. Thank you Glenda and Tiago. Thank you. Thank you for the question.
I just wanted to sort of step back and ask you to take a look at gather one.
What I would say is the emphasis here it really should be in the consistency of the data.
<unk> got two independent arms that are therapeutic completely independent of each other one of the two milligram arm. The other is a four milligram arm.
The efficacy profile of those two arms are almost identical.
Two statistically.
Biology, but just statistically have two different arms that are entirely independent of each other.
Have an efficacy profile, that's almost identical with a dose response, both on the efficacy side as well as the safety side and to have all of that happened by chance.
It is is really infant pass them up so the fact that there is the consistency of the data that we see and gather one and then in the post hoc analyses as we've discussed that same consistency with the biology that complement inhibition should have a bigger delta in the areas.
But grow faster is repeated over and over and over again it gives us a great deal of confidence that if we're able to simply get the drug in the eye and have a patient retention as defined by injection fidelity.
We will be able to derisk gatherer too.
And replicate the dataset that we haven't gathered one so.
I think we feel very confident.
In the inclusion criteria, we will get the same patient type because our inclusion criteria really hasn't changed at all and I think the consistency of the data and gather one and the consistency that we see over and over again in the sub analysis that we do the post hoc analyses and gather one gives us.
A great deal of confidence that gather two has the potential to replicate the results of gathered one but thank you for your question.
I think we're getting called back on track.
Thank you tiara.
Your next.
Next question comes from Chris Howerton with Jefferies.
Okay.
Hey, good morning, Thanks, everybody.
And I appreciate you taking the questions.
Where.
I think just hey, thanks Glenn.
So I wanted to start off is maybe something that I wrote in a note previously around anti veg F use.
And that perhaps that could be used as a good proxy for important safety events that happened in one of these G. A trials and subsequently obviously I've had the benefit of our conversations with the team. So I guess my question to you is that how should we view veg F use in your trials in house.
That translate.
To some of the personalized approaches that you mentioned in your prepared remarks.
Praveen I think.
First point of view.
Yes, Thank you Glenn and Chris Good morning, Thank you political for the for the question.
The first thing that I would say is the difference between gather one and gathered two is not an inclusion criteria, but there is one slight change in the exclusion.
Which is that in gather one when we started that trial with Duke Reading Center did not know when.
Other in those few patients who developed a quota neovascular membrane, whether they lesion could be accurately measured or not so because they.
They did not know when in order to protect the integrity of the data what we did was to exclude those patients.
There are a measurement of the geographic atrophy.
Retrospectively, Duke has now a.
Reconsidered that data and is convinced that that those lesions can be accurately measured so what we're doing and gather too is we're continuing to follow those patients. However, we are also asking that those patients be treated with an anti VEGF. We're supplying the a labeled anti VEGF eylea or lucentis.
And we're requiring that those patients to be treated on label.
Now we know from previous studies that zoom or has been to use with an anti VEGF mainly lucentis.
We have two separate studies. These are small open label studies that had been done with quite impressive results, which is about 60% of patients or three lines or more gainers. So we have evidence that these two products can be used simultaneously without any ill effects whatsoever in fact.
It may be a beneficial effects. So we're requiring that they'd be used on label now the other part of the question. Chris is is the anti VEGF use a proxy to the rate of Neovasc amortization and the answer is absolutely not.
And I say this because unlike our competitors all of our patients.
At baseline had an intact Bolivia.
So we have every reason to make sure that these patients have their phobia protected.
We will require on label use for that reason, because we want to be absolutely certain that these patients get optimal treatment.
And continue to have the whole get protected so I hope that answers. Your question Chris. Thank you again for your question.
Yeah, No that's great and I My apologies gone for earlier, the I guess, if if I may a follow up question to some of the discussion around the intermediate AMD study that will be started later this year.
You know what is your view on the endpoint, there and kind of you know the palatability.
Ability of running that type of study given that you know.
<unk> have decided not to pursue that opportunity.
Yeah, Thanks, Chris I'm here with double niece, he's going to take that.
Yeah. Thanks, Chris I think one of the things that we always think about when we think about the development programs here is how do we continue to push the disease curve left.
And intermediate AMD, obviously is the next step for us in doing that and I've given some of the news that has come out lately about endpoints.
End points and what the FDA will and won't accept our plan here is we think we have a clear line of sight on what the agency might except as a proposed endpoint and we're planning on meeting with them. Later this year to confirm that I think it's probably a bit premature to.
To say this or that as an endpoint, but we have a a.
A host of different endpoints and we think the agency will kind of buy in on.
And we're committed to taking that to the agency and getting their feedback on that shortly so stay.
Stay tuned more news to come on that a little bit later on this year.
Okay Alright.
Thank you very much and I appreciate you taking the questions.
Thank you Chris.
Thank you and the next question comes from Colin Christie with Baird.
Great. Thanks, Good morning, and thanks for taking our questions. So for the post hoc analysis that you shared today, how many patients are included in the subset analysis.
And are you able to share the patient numbers for the different distances from Oh, yeah.
And as a follow to that I guess is there anything in place that would ensure that gather two would have a roughly similar breakdown of patients in terms of their distance from that in terms of I am I right together one.
Hey, Kelly.
Thanks for the question. So so the number of patients that were done using the analysis were the same that were used in the analysis that was presented at angiogenesis.
These are 47 eyes from the two milligram grew 57 from the four milligram group and 79 from Shan and Youll see that as Glenn Jaffe presents that data later next week.
At the RWC Congress.
As it relates to whether gather two will break down the same way it's impossible to say.
The good thing that we've seen is the consistency of the data that we've seen in kind of a one theres no reason for us to believe we haven't changed any of the inclusion exclusion criteria that it would be significantly different but we won't know that until we open up that database to see exactly where these lesions fall.
Great. Thank you that's helpful and realizing this is a very heterogeneous disease that might be hard to answer, but when the roughly 70% of incident patients present with G. A an extra for that region.
How far from the Soviet All center and he does lesions typically present, it's part of why I ask is could the real real benefit in newly prevalent patients actually be much higher than what can be seen in the clinical trial.
Yeah, So I'll I'll take that the first part of that in the last praveen to jump in with his clinical experience I think it really just depends on where you where these patients are coming from I think most patients that you wind up seeing in retina clinics. These days are referred there from either the G O or the O D based on having disease that is either.
And Chris onto the Foveole center or is getting very close and so you'll you'll typically you tend to see now Ah patients that have disease, that's probably pretty close as treatments become available and more eye care physicians and professionals understand that they can refer these patients earlier I think we will see a movement of those lesions.
Being further and further out in patients getting more benefit from treat potentially getting more benefit from treatments like these.
As they get into the retinal offices earlier for being do you ever additional thoughts.
Yeah.
Thank you for and pulling thank you for your question look we've seen this movie before and we saw that it would be anti VEGF story, right, where in the beginning and I'm old enough to remember this.
Where patients.
We would say look we would just have patients come in if the other eye is damaged and youre looking at a monocular patient that's coming in.
Late in the course of the disease with Bad vision, and then we realized that the anti VEGF will actually do better if we treat them earlier and now we're treating patients really as early as possible as soon as we see any new vascularization whatsoever, and I think exactly the same thing is going to happen here. The difference here choline is that we've got data.
Two actually.
Group that and this is what you see consistently which is that the earlier you treat with a complement inhibitor the better the results. So I fully expect that these patients will come in earlier and earlier and I think that all the numbers that we have.
Our really.
Quite a large under estimate of the number of patients that are out there. We will have a better idea. Once we have the treatment and hopefully we'll have the treatments are in.
The market, but yet I do believe that these patients will come in earlier and earlier. These patients may not have a decrease in visual acuity, but they certainly have a great compromise in terms of visual function.
Got it that's helpful. Thank you and one more quick follow on if I can you mentioned plans to file in Europe , assuming gathered to this positive have you have you spoken to regulators there on whether the study would be supportive of filing and what sort of market exclusivity that you're expecting the European markets.
Yeah, Kelly it's Glenn.
No we have not yet spoke to the regulators we have been preparing working with our consultants and our regulatory team, but we do have a plan to engage them, which will give us the guidance on a filing strategy as you know we've had those discussions already with.
With F D a here.
And the second was on market exclusivity in Europe .
Yes, that's the question.
So we would expect that we would.
We have market exclusivity through 10 years, which is allowed in Europe .
Great. Thanks for taking my questions.
Thank you. Thanks. Thank you.
This concludes the question and answer session I would like to turn the Florida events.
For any closing comments.
Thank you Keith and appreciate you hosting the call today and thank you everybody for listening I think you hear it in the voices today and I Hope you can the excitement here.
I would gather too and how we're getting to the point, where we're going to get to see the data a few takeaways gathered to execution.
By the team has been outstanding through a pandemic.
In which we put in a number of operational things that benefited patients and the investigators to hopefully finish with an ejection fidelity rate, that's well above the target that we said I.
I think you heard a lot about that today and it's really a testament to the the patients to come to these vision investigators commitment to continue to treat these patients and the team and I very the second thing I want to mention that I am truly.
Excited about is the buildout of our commercial team that will be engaging.
Health care providers in the future and that is the building out of the medical team by double and the commercial team by Chris as we do this and as we get out and engage.
Different aspects of commercializing this product we're learning a lot about the market in ways that we can shape this market with a great drug.
And finally.
We did refine our guidance on data output from the second half to the third quarter and we look forward to having that discussion with you in the near future. So thanks, everybody for listening and have a great day.
Yeah.
Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.