Q3 2022 IVERIC bio Inc Earnings Call
Good day and welcome to the third Q2 thousand 22 earnings Conference call.
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I would now like to turn the conference over to Kathy Goldman Senior Vice President Investor Relations. Please go ahead.
And welcome to <unk> Bio's conference call, representing I'm very glad today are Glenn <unk>, Chief Executive Officer, Dr. Praveen, Davao, President Keith Westby, Chief Operating Officer, David Carroll, Chief Financial Officer, Dr. Double decide Chief Development Officer, Christian <unk>, Chief Commercial officer.
Tony Gidney, Chief business and strategy Officer.
I would like to remind you that today, we'll be making statements relating to <unk> future expectations regarding operational financial and research and development matters.
These statements constitute forward looking statements for the purposes of the Safe Harbor provision under the private Securities Litigation Reform Act of 1995.
These statements cover many events and matters that are subject to various risks that could cause actual results to differ materially from those expressed or implied by 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 July 26, 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 except required by law I would now like to turn the call over to Glenn.
Well, thank you Cathy and good morning, everyone and thank you for joining us for our third quarter conference call.
During the third quarter, we were thrilled to announce positive efficacy and favorable safety results from gathered two our second phase III clinical trial of <unk> kept the pedal or ACP also known as the more for the treatment of geographic atrophy.
While two of achieve something that has never been done before NGA deliver two phase III studies that met the pre specified primary endpoint at 12 months of slowing G a progression.
Our key focus now is to make ACP commercially available to physicians and their patients, which he a as expeditiously as possible subject to regulatory review and approval.
Quantitative results from gather one our phase III clinical trial of ACP for the treatment of G. E N gathered too as well as our special protocol assessment or S. P. A with the FDA provide the basis for our new drug application.
As a reminder, we receive written agreement from the FDA and are in SBA, but the overall design of gathered two in July of 2021.
The SBA process is a procedure by which the FDA provides a clinical trial sponsor with an official devaluation and written guidance on the design of our proposed protocol intended to form the basis for an NDA.
The earlier completed gather one clinical trial allowed us to get a head start on assembling the NDA prior to receiving the gather to results.
Importantly, we are ahead of schedule and preparing our NDA for ACP for the treatment of G E and therefore are moving up our submission timeline to the end of this year.
We look forward to continuing to engage with the FDA throughout the review process. We're also planning to submit a marketing authorization application or MAA. The European Medical medicines agency in 2023 subject to feedback from planned interactions with regulatory authorities in Europe .
We're also delighted that gathered two efficacy and safety results for ACP were presented in two oral presentations as part of the retina Subspecialty day at the American Academy of Ophthalmology annual meeting on September 30th 2022 in Chicago.
We appreciated the opportunity to share the results of gathered two with eyecare specialists from around the world at this highly respected medical meeting. Additionally, this week gathered one and gather two data will be presented at the retina Society in Pasadena, California, and we will highlight the observed efficacy data.
From both studies for me is going to talk about this in more detail in just a moment.
Looking ahead, we're excited about the possibility to expand ACP into earlier stages of AMD.
We received favorable feedback from the FDA on our development plans for intermediate AMD.
We are more determined than ever to evaluate ACP for this important patient population.
We look forward to continuing our productive and collaborative discussions with the FDA and updating you further as we clarify our strategy.
We continue to invest in additional lifecycle initiatives for ACP to expand the patient population and to continue to evaluate multiple technologies for ACP.
During the third quarter, we secured a term.
Loan credit facility, providing us with providing us with access to $250 million in non dilutive debt financing with Hercules and Silicon Valley Bank.
This financing financing further strengthens our balance sheet and provides financial flexibility as we continue to build our U S launch readiness plan and prepare for the potential commercialization of ACP.
In July we borrowed 50 million at closing.
With the positive gathered to results. We believe we have set a satisfied the first performance milestone under the facility, which allows us access to an additional $50 million tranche from the facility, which we plan to borrow before the end of the year.
Well again, thank you for your support and I will now turn the call over to <unk>.
Thank you Glenn and good morning, everyone.
As Glenn stated.
ACP our complement <unk> inhibitor is the only investigational therapy to have two positive phase three studies in <unk> with high.
High statistical significance at the 12 month primary endpoint and a favorable safety profile.
We believe that the reduction in G. A progression that we have seen and gather one and gather two is clinically meaningful.
We look forward to submitting a package to the FDA by the end of this year.
Gather one gather to that provides consistent efficacy and safety profiles.
And gather one a post hoc analysis.
So that the reduction in the mean rate of G. Eight gross or slope analysis over 12 months was 27, 7% with a descriptive P value of 0.0063 for the ACP two milligram group as compared.
To the corresponding Sham group using the square root transformation and.
And 35, 4% with a descriptive P value of 0.0050.
Without using square root transformation, which we referred to as an.
Observed <unk> area.
In gathered to ACP also met its tweak specified primary efficacy endpoint of reducing the mean rate of growth.
Bloke analysis NGA area over 12 months compared to Sham.
The reduction in the mean rate of <unk> growth over 12 months was statistically significant at 14, 3% with a P value of 0.00644, <unk> two milligram group compared to the Sham group using the square root transformation and 17, 7%.
With a P value of 0.0039, using the observed G a area.
In addition to the slope analysis and gathered two we also performed a quaint analysis on the mean rate of change NGA area, which you may recall was the pre specified primary endpoint analysis and gather one.
The results for the 12 month point analysis were consistent with the slope analysis across both trials.
This data was also presented during <unk>.
Importantly, and gather one and gathered so we observed a reduction in the change in <unk> area for the ACP group as compared to Sham early in the trial, which continued to increase over 12 months.
This observation suggests that therapeutic benefit of ACP may occur early and continue to increase over time.
We are thrilled with the consistency throughout gather one and gathered two efficacy results.
<unk> favorable safety profile and other potential key differentiating factor was also maintained throughout the gather one and gather two clinical trials.
In both gather one and gather two through month 12, there were zero.
C P related events of and optimize.
The euro.
<unk> related intra ocular inflammation events.
Zero vasculitis.
And zero ACP related ischemic optic neuropathy events.
The most frequently reported ocular adverse events were related to the injection procedure <unk>.
Including transient.
For ocular pressure.
And gather one the incidence of choroidal, neovascular ization or CMV rates through month, 12 were six or 9% in.
And the ACP, two milligram group and three or two 7%.
The corresponding sham or.
Exuded is macular, new vascularization or E. M N V rates, we're four or 6% in.
In the non executives.
And nonexistent as Macedonia Vascularization, a R M E N V, where two or 3%.
And the ACP group.
And gather to the incidence of coil neovascular ization or CMV rates.
<unk> 12, or 15 or six 7%.
And the ACP, two milligram group of nine or four 1%.
<unk>.
E M N V rates were 11 or four 9% in the ACP, two milligram group and seven or three 2% in the Sham group.
There was one or 0.5% case of nonexecutive M N V and three or one 3% cases.
Apparel papillary CMV the ACP, two milligram group and no cases, nonexistent, F&B and two or 0.9% paces current capillary CMV and the Sham group.
While the FDA has not requested the CMV cases being reported using a non traditional recently defined terms of <unk>.
Exuding versus nonexecutive, we provide this distinction of cases for both gathered and gathered too.
The definition of ex mutation has been detailed by core the reading center at the Cleveland Clinic and can be found in our current report on form 8-K filed with the SEC on April 4th 2022.
Additionally, we are encouraged that we saw a positive trend in mean change in best corrected visual acuity one of the pre specified supportive endpoints consistent in both <unk> and gather too.
Remember NGA, we considered D C. The H b.
Really a measure of safety.
For a mean change in low luminance best corrected visual acuity, we did not see the same trend and gather too.
We believe we have a solid complete filing package with two clinical trials gather one and gather team that each separately and independently.
They are pre specified primary endpoint with a high degree of statistical significance.
A favorable safety profile.
We believe this clinical data package meets the requirements for an NDA submission.
We recently initiated an open label extension or OLED trial for patients who completed their month of 24 visit and.
The gathered two trial with the aim of providing patients access to ACP and collecting additional safety data.
We plan to treat patients with ACP for 18 months or until potential regulatory approval of ACP and the applicable region whichever is earlier.
G H is a debilitating disease.
For which there are currently no approved treatments.
We believe ACP has the potential to be life changing for patients with <unk>.
Turning to our <unk> inhibitor.
We plan to conduct additional preclinical studies to optimize formulation dosage and delivery of IC 500.
As a result, we do not expect to submit an investigational new drug application for <unk> 500 mid next year.
As we had previously planned.
We remain committed to this program, we will provide additional information as it becomes available.
We thank you for your time and support.
And look forward to updating you on our progress going forward.
I will now turn the call over to Dave.
Thank you Praveen and good morning, everyone.
I would like to highlight a few items from our press release of this morning, and provide some guidance on expected year end cash balance and our expected cash runway further.
For the quarter, our net loss totaled $42 4 million or <unk> 35 per share compared to a net loss of $24 6 million were 23 per share for Q3 2021.
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 progress of the gather two trial increased manufacturing activities for ACP.
And increases in personnel costs, including stock based compensation associated with additional R&D staffing.
G&A expenses increased primarily due to increases in personnel cost, including stock based compensation associated with staffing for commercial launch preparation for ACP.
Turning to our expected year end cash balance and cash runway as of September 30, we had cash of approximately $321 million, which reflects the initial $50 million borrowing from our term loan facility with Hercules and SVP, we estimate that our year end cash will range between $265 million and $275 million.
This estimate does not include any new borrowings from our debt facility, including the $50 million, we plan to borrow during the fourth quarter of this year.
We estimate that our cash and committed loan facilities will be sufficient to fund our planned capital expenditures.
Debt service obligations and operating expenses through at least mid 2024.
These estimates are based on our current business plan, which includes the continuation of our ongoing clinical development programs for ACP, and GAA and Star Guards, including the recently initiated open label extension trial evaluating ACP for intermediate AMD preparation and submission of an NDA and MAA for ACP.
N G E.
Continuing preparations for potential commercialization of ACP NGA in the U S pursuing Delta, Texas thing released delivery technology, and exploring additional sustained delivery technologies for ACP and the advancement of our IC 500 development program as currently planned.
These estimates do not include any potential new borrowings under the term loan facility with Hercules and SVP, including the $50 million that we plan to borrow in the fourth quarter of this year.
Also excluded from these estimates or any potential approval, our sales milestones payable to the architects Corporation.
Any potential expenses for the actual commercial launch of ACP, such as Salesforce expenses and any additional expenditures related to potentially studying ACP in indications outside of G. A starbucks or intermediate AMD or resulting from the potential in licensing or acquisition of additional product candidates.
Technologies or any associated development that we may pursue.
Thank you for your time and I'll turn the call back over to Glenn.
Well, thanks, Dave and just to summarize a few key takeaways for the quarter first the positive results from gathered to provides us with two phase III trials met their primary endpoint as a basis to file the NDA second we've moved up the NDA submission date to the end of this year third we re.
Received favorable feedback from the FDA on intermediate AMD does.
Element and as we talked about more to come as we continue our discussions with the FDA.
Fourth we will continue to present, the gather one and gather two data at major medical meetings with the next presentation that retina Society. This week, where we will highlight the observed data for <unk>, nor gather one and gathered to us for being just discussed.
And finally as Dave talked about we secured access to up to $250 million of non dilutive debt the strength of our balance sheet.
Quite a good quarter for us and at this point I'd like to turn the call over to the operator, so that we can open up the line for questions.
Now for you.
As a reminder, if you'd like to ask a question. Please press Star then the 100 Touchtone phone.
If your question husband addressing like to remove yourself from queue. Please press Star then two.
Today's first question comes from Ken Cacciatore with Cowen.
Cowen and company. Please go ahead.
Congratulations team on all the progress great to hear about the accelerated filing I was just wondering on gathered to results for being you went through great details about that really nice safety profile can you just talk about why we may be seeing a differentiation in your formulation in terms of safety and then also on gather one together to you touched briefly on the where stock.
To see a little bit of a separation on BCP V. A and I know Dr. Chambers talk more about lesion growth that needing a functional end point, which maybe you could comment on as well coming out of a a O.
April as you've had more time to maybe identify any subgroup of patients or anything new as you analyze that data that you might want to discuss in more detail and then lastly, and I'll get back into the queue. Just on your extended release formulation can you discuss maybe when we might hear any of the earliest data or decisions on what we.
Might be moving forward. Thanks, so much.
Permian go ahead, I think there's three questions there has jumped in as well.
Appropriate but.
I think Ken wants to hear from.
From you at least by more than two.
Great. Thank you and Ken good morning, and thank you so much for being here and thank you for your question.
So the first part regarding the safety and what I would say, it's not just the safety ultimately efficacy I think.
What we're seeing is the consistency of results that we see in both gather one and gathered to I mean.
I just want to highlight that regardless of how we look at the safety how we look at the efficacy how we look at the subgroup analyses in gather one youll see this remarkable consistency both in gathered one and gather two and you asked specifically about the safety profile, yes, we're very very happy with the safety profile again very.
Consistent.
Gather one and gather too.
As a highlight zeroes for any drug related adverse events, both in gather one guy there too.
The reason for that can I believe and this is my opinion is really two one is the biologic part and the other is the CMC part from a biologic point of view, we have always maintained that inhibiting <unk> five and keeping the C. Three loop alive is very important in terms of Downregulates downregulates inflammation.
And potential.
Infection from pathogens and.
And we believe we see that in both gather one and in gathered too. So that's the biologic explanation and there's good preclinical science to support that from a manufacturing point of view remember what we have is an RNA aptamer. So that means that the entire process of scaling up a.
Synthetic the original biologic intermediary there is no E coli or Cho. So as you know when a lot of the assets that we've seen.
These biologic intermediaries are aware of a foreign antigens are introduced and we bypassed that entirely by having a purely synthetic process. So I believe that.
It's really both reasons that accounts for this consistent safety profile of your question regarding visual acuity, we've looked at the trends in visual acuity and gather one.
At month 12, as well as the month 18, and we've looked at the visual acuity trend and gather two at month 12 and.
The trends are positive, meaning that the visual acuity trend is positive in both in all three so it's three out of three and we want to remind everyone that visual acuity really as a safety measure and we're very happy again consistent with your previous question regarding safety that the visual acuity trends are in the proper direction.
Regarding the extended release as you know we have a collaboration that's ongoing with Delta Tech, we're very happy with the progress of that.
We have not detailed any further guidance as to.
When milestones may be reached where we continue to report that we're very pleased with the progress. We've also stated.
We are investing heavily in terms of sustained delivery because we believe that this asset is perfectly suited for sustained delivery.
And we've also publicly announced that we will be looking at multiple sustained delivery.
Opportunities and we continue to do so back to you Glenn.
Operator next question.
Thank you and our next question today comes from Greg Harrison of Bank of America. Please go ahead.
Hey, good morning, Thanks for taking the question definitely great to see the.
Filing timeline moved up.
So.
The question is what remains to be done in preparation of the MAA filing.
And maybe you could talk about your expectations for the EMA is requirements for endpoint relative.
What the FDA.
Has asked for and especially in terms of functional benefit or any others.
Yes, Greg. Thank you, it's Glenn and good morning, Thanks for the question.
So with EMEA and we've been consistent on this subject.
First step in that discussion.
<unk> will be to complete the NDA I mean, once we have the NDA done. We believe we have the dataset that would form the same information that goes until the MAA. The next step which is an important one.
We have not yet met with them is to meet with the regulators in Europe .
About the package.
This will be and I think one of the key points of Permian raise today.
Is the first time that the EMEA, we'll see two.
Phase III trial that have met their primary endpoint. So we think there is a discussion that we had there. We also believe in that business I think it's been a discussion point that they're.
There is a.
Our need for functional data.
By the European regulators, we think we have a data package that could satisfy them.
But we can't confirm that until we meet with them, but we're very excited about talking to them about our data with our data means the safety profile. Once we have that discussion that will define the timeline for an MAA.
So that's our current clients.
Got it that's helpful and if I can sneak one more in.
Sure do you characterize.
The feedback that you received from FDA on the intermediate and deep program I think the prior guidance was that the trial will start this quarter. So is that is that not the case right.
So that's why we wanted to.
Put out there that we've had very favorable interactions with them.
And the second part of that is that we continue those things with them really to further define the strategy, but what we have discussed with them. Thus far has been very favorable.
The reason why we're mentioning it to go beyond that at this point, we don't have all the details.
We could be that specifics, we need further conversation with them, but we believe there's a path forward on intermediate AMD. So as we said in the in the conversation before with more to come on that.
Okay.
Great. Thanks for taking the questions and congrats again on all the progress.
Thanks, Greg.
Our next question today comes from coloring Juicy with Baird. Please go ahead.
Okay.
Hi, good morning, Congrats on the progress and thanks for taking our questions.
So can you just talk to what.
Some of the factors that contributed to shortening at the timelines for the NDA and what are the remaining gating factors before filing and then can you just clarify your you expected timelines to approval.
Yes. So thank you for the question Great question. So we originally as we had the data we have we had to put a stake in the ground for the NDA.
And we saw it before the end of the first quarter as we and as we always said.
The team was.
Working on gather one data populating the NDA as we continue to go through gather too.
And looked at the data.
It's quite good.
<unk>.
The team is temporary because it's good because we believe it's straightforward.
The team has been able to accelerate their timeline. So its really that as we go through the day that's cooperating.
Gather one clearly having gather one definitely helps.
As we also said coming off the data you're kind of overwhelmed when you first turn the data cards.
As to what's there we now understand it we know how it needs to be put into the package.
We put two.
Tremendous resource behind coming out of the data I said the number one priority was to get the NDA filed.
So all of those factors have contributed to us revising our guidance to get this NDA before the end of the year.
So I hope that's helpful.
<unk> continues to work real hard on it so the second part as to win let's get the NDA in everybody knows the timelines, we do have fast track.
You know there's defined timelines for fast track approval, but I think the first thing is to get a date in the fourth quarter with the NDA is complete which will start the clock and then we can update the timing.
Okay. Great. That's helpful. Thank you and then I know it might be early for the open label extension study, but any comment on the rate of patients converting from gather Q2. The open label extension and then can you just clarify I think on Clinicaltrials Gov. It only shows the monthly dosing freezing merit in the open label extension can you just.
Clarify what the dosing in that study.
Sure Praveen you want to take that one.
Sure Colin we haven't detailed the open label extension publicly as yet that has just started and yes, we as you as you recall.
We will be dosing monthly.
Okay and any reason.
Every other month patients will be converted to monthly.
Thanks, you guys.
That right.
They will continue as it yes that is correct.
Okay. Thank you.
Thanks for taking my questions.
Thank you and our next question today comes from Annabel <unk> with Stifel. Please go ahead.
Hi, Thanks for taking my question and congratulation on the progress. So I know this question has been.
Estimated times, but.
But given the results that you've seen now in Q2 and maybe some of the.
Patients he made about largely ship sizes versus smaller lesion sizes.
If you saw the strong argument for a broad label, what's the rationale that you can give.
To argue for that.
That's the first question. The second question I have is.
I know the messaging for patients.
To.
Can you give us some have taken or will it be that if you go on shipment you'll be able to drive for another five years of work for another 10 years.
I know that's still somewhat intangible for them given it's so far out does the physician community has more objective tolls yet.
To monitor how these patients are improving.
Within our standard if anything to keep them I guess motivated to continue on treatment.
And then I guess the third question I have is an intermediate AMD I guess given that there is a debate.
Ms patients.
<unk> already heard Jay stage, what type of opportunity.
Expect for intermediate and gave our system.
Straight G E.
Yeah.
Good morning, and thank you for three questions for me and I'll turn this one to you.
Yes, Thank you Glen and NFL good morning, three very important questions.
Regarding labeling Annabel as you know it's premature at this point to have had any labeling discussions with the FDA. So I want to make sure I mentioned that we have not entered any labeling discussions our expectations and our hope are that we will have a broad label that is that required that is consistent with with <unk>.
We injections.
Let me take each one of them individually as we have seen and gather one and we have not done this and gather to us yet, but the vast majority of the patients were within what is really defined the clinical phobia, which is within 500 microns of the central point.
We presented that in several meetings.
In fact.
If patients or one micron literally one micron away from the central point that those patients would be eligible.
There are many patients in clinical practice and who have <unk> fixation.
And Theyre Centrepoint may be involved but theres, a little island photoreceptor cells that allows them to navigate not bump into chairs not burn their hands on stoves et cetera.
So we believe that.
We would be eligible for a broad label and that those patients who wouldn't be denied access to a safe and effective drug because of one micron.
Now as far as monthly application is concerned we want to have monthly injections on our label as you know.
My colleagues don't really treat according to the label you can see this from the anti VEGF experienced for instance, most of our street with a treat and extend the extend regimen.
And there is no anti VEGF that has treat and extend on the label. So the label is really therefore reimbursement purposes. So logically. It makes sense that you would want to have the maximal usage on the label.
Got any less would still be reimbursed. So again, our expectation is that we will have a broad label that says our monthly application and again I want to say that we have not entered into any formal labeling discussions with the FDA.
As far as your second question in terms of function is concerned you have identified a very important topic, there annabel, which is that we really don't have a good measure a function at all in fact as we may have discussed earlier visual acuity is not a good measure of visual function at the end of the day rarely are we in a dark tunnel with a bright light at the.
And are they consists of contrast sensitivity changes color changes.
Minimal pharmacy or things like that so there really is no great function test.
We see that this is an opportunity to expand the patient experience into an entirely new dimension. This has been done for instance in glaucoma with visual acuity tests and so forth.
And we are investing heavily in terms of expanding the patient experience for now what I can tell you because the patients to know there are lots of patients out there who may have a visual acuity of 2020.
But will not be able to work will not be able to live a normal life.
Cause visual function changes and you can imagine that if you had a spot on the side of your vision and you Couldnt finish reading a simpsons it'd be very difficult for anybody to to work.
And have a normal functional life, so regardless of the visual acuity results. There is a visual function deficit, which will allow patients to come in this happens all the time and other diseases such as diabetes for instance, such as macular degeneration, where visual acuity, maybe 2020, but because of the visual.
<unk> deficit patients are in desperate need of help.
In regards to.
Intermediate AMD I think your question was.
What our plans are going forward as Glenn said, we've had very favorable discussions with the FDA their science to back up the fact that intermediate AMD.
Is it driven by complement activation and again I go back to what I said regarding the functional benefits that one can potentially have even with intermediate macular degeneration intermediate macular generation is a very broad range. There are patients with intermediate macular degeneration that have large crews that have serious fluid.
We're patient experienced minimal pharmacy or changes in color vision et cetera, and those patients I believe would benefit greatly from Zamora as is with virtual one the last thing that I would say is remember what we have here is a safe and effective drug for the first time with two positive phase III results.
This is version one of Zamora, we're investing heavily in version two which is the sustained delivery of.
But that's as far as we could go I do just want to emphasize that we believe is a path forward based on our discussions thus far.
And more to come on that but we can't be that specific at this point.
But we hope to be specific in the near future. So uhm, sorry for punting that one.
But in order to get an adequate answered we do need to continue the collaboration in dialogue with <unk>.
No problem. Thank you.
The next question today comes from early Merle with UBS. Please go ahead.
Hi, Thank you so much for taking my question.
In terms of the reset M. C M data I, just I need some learning in terms of you know the biology, a cop on that or any really throws in terms of how you can compare the different modalities. Fortunately I and then just in terms of thinking about labeling I know a lot of discussion around monthly versus every other month, but.
Into the palace produce that in a potential label are there are certain things that and also in your discussions and your feelings are there certain considerations that we can see and the label such as potential for perhaps even multiple like in or only every other month or just monthly I've gone and yours.
Do you see a potential to have every other month just given it studied even though I know, there's a preference for only monthly and anything you're thinking about to keep an eye out for in terms of safety as well in terms of the labels thing.
Hello, Good morning, and thank you for the questions I think there are three there <unk>.
Good morning, and thank you I I think with the questions are coming in triplets now so I.
<unk> I guess, what I would say regarding the competitors data L. A is that it it it's all preference really not to not to comment on uncompetitive data I think there's more data to be presented by.
I N G M in in the Retina Society conference, which is going on right now.
I believe they are talks are today. So in general we'd prefer as you as you will understand enough to comment on an uncompetitive data.
In terms of the labeling again I go back to what I'd said early to Annabel question, which is the our preference really is to have every month on the label and we expect every month and abroad label you know what I will tell you is if you look at what my colleagues do they will find what.
Is the appropriate for patience you know given the Biomarkers for response and what I mean by that is my my expectation personally is that the treatment of macular degeneration dry macular degeneration is really going to be the ultimate in personalized medicine I think what you'll find is that we will have some information regarding.
Baseline biomarkers that will.
Determined response, some patience as as as you might imagine will respond better some may not respond as well somebody's patients may be prone to to develop neovascularization, others may not and I think we'll see some biomarkers that will suggest.
Those kind of responses and I think with my colleagues will do is treat accordingly based on those biomarkers. The next step would obviously be a genetic biomarkers and then perhaps layered on top of that would be a I. So I think what you'll see really in the next five years or so is the ultimate in personalized medicine in the treatment of dry macular degeneration.
<unk>. This is just the beginning but ultimately going back to your question, what we would want for obvious reasons for logistic reimbursement regions.
Reasons is the flexibility. So we really would want every month on the label again I want to say one more time that we are have not entered into any formal discussions regarding a labeling with the F. D. A back to you one.
Three Q.
Another question today comes from her friend.
Guggenheim Securities. Please go ahead.
Thanks, Good morning, guys and congrats on on the progress just a few from me do you anticipate sharing any additional gather to data, whether it's slope or functional visual measures or even additional safety data overtime likes at 18 months or longer and would that plan change if you're EMEA interactions end up requiring functional end points.
Would it be worth reporting 18 months later and then regarding the spot agreement can you just provide some additional details on those discussions that you had with the agency on the design and statistical plan <unk> that any of those assumptions change over the course of gather to before you write out the data or was that the plan that sort of you agreed.
With with the F D I X.
Yeah, Good morning, and thank you and S for additional data.
We continue to emphasize the data from gather one and gather to in the medical meetings I think you'll see it in the Pasadena meeting the rental society. We will present observed data that has been presented before but I think as we further get an understanding.
What we have here. These presentations will highlight the full data set that we actually presented in the.
And the press release on the initial date, so I think its emphasis on the data set that we've put out there so far.
We put quite a ladder safety data out there we reinforce that again. So I think you you'll continue to see presentations that reinforce the full data set that we outlined when we first disclose the data. The important thing is now that I think we've had good discussions around gather too is to really present both.
Trials, together and I think you'll you'll see that.
And in future presentations, including the one that the society, you're gonna see both gather one and gather too I think it's very important that we're talking about the totality of the two trials with a focus over the last you know 30 30 plus days, that's really been on gather too so you'll see the totality and I think that will provide further in.
Sites on the the <unk>, the favorable safety profile as well as the efficacy.
Second question for being do you Wanna, you Wanna take that.
Sure I'd be happy to any good morning, and thank you for the questions. So remember we have a pre specified statistical analysis plan in which was reviewed by the F. D. A is part of <unk> and that plan I had an appointment at 12 and month 24, now we have absolutely no plans at all to look at the month 18.
Data.
And I realized that others have done that after missing their primary endpoint in months 12, but remember we hit our primary on point with two studies. So there's really no reason whatsoever to compromise the integrity of the study by opening it up at a month 18th So we have no plans to do so or spar agreement is as as as clear as can be and I'll refer you.
Back to a press release in July of a coupla years ago, and you'll see that the spa Greenland very transparently and nothing has changed at all in regards to further analysis of gather too.
I I'm not sure what more there is to show with with with safety their their zeroes all over and as I said earlier on zero plus zero point zero.
Zero so.
Will continue to show safety analyses, but nothing's gonna change other than the zeroes. The efficacy analyses you will also see but unfortunately, you're not gonna see you at the pace that you are I want because remember we're really focused entirely on the on the NDA submission at this time, all our resources are geared towards submitting and the.
N D a S efficiently and with the highest quality possible.
Thank you.
Just a quick follow up do you plan, what about blinded safety data from like the open label extension of the second year gather to or even the ongoing star scar trial, if that's something that you're seeing and can confirm that the safety continues.
In any further.
Treatment.
For being a <unk>.
So we're masters you know in the Star Guard trial, Eddie we have not you know we we we remain mask and we certainly don't want to compromise the integrity of that trial, but as you as you know in in these large trials there was a data safety monitoring committee that.
That meets on a regular basis and if there are any safety concerns. It is the responsibility of the data safety monitoring committee to alert the sponsor that has not happened historically at all with similar in any of the trials.
And there's been no change whatsoever, and the start that trial.
Great Thanks, and congrats again.
Thank you and our next question today comes from Chris Jefferies. Please go ahead.
Good morning. This is comedies on for Chris a couple of questions for me what is the main difference between B C V. A L. L. P C D a N.
Could have accounted for the differences in currency in between those measures at 12 months and gathered too.
I guess my third question would be for ear to gather too you have both a monthly and every other my arms.
Every other monthly successful would you want us to submit an S N da to get that on the label or could you provide some sort of literature physicians to help in their prescribing practices. Thank.
Thank you very much.
For being go ahead please.
The company is good morning, and thank you for the question so.
It is a great question regarding best corrected visual acuity and low luminance best corrected visual acuity. There is some preliminary evidence that in low luminous visual acuity.
May be more sensitive in terms of photoreceptor cells dysfunction, then in bright light and thus there've been some.
Some data, suggesting that the sensitivity in low luminous visual acuity for photoreceptor cells that are not healthy Ah may be greater however.
It's very difficult to do those tests. The luminous has to be completely controlled is not something that we're used to doing regularly there's a great deal of variability.
Quite honestly, it's not surprising to see a great deal of variability in these functional tests that were not used to doing on a regular basis, we do a regular visual acuity on every patient that comes in.
But low luminance visual acuity is really very rarely done I don't know if that has ever done in clinical practice as a routine.
But it is done in some clinical trials and thus the variability in terms of gather two year or two it really would be premature to discuss the results on the potential impact on the labeling as as I said earlier on our desire at this point is to have a broad label that has a monthly on the label. Thanks for the question.
Thank you so much.
Thank you and our next question comes from David Jordan with Wedbush Securities. Please go ahead.
Hey, Thanks for taking my question I, just had one on commercial preparations.
Just.
Yeah, how are you thinking about.
Discussing.
Yeah capacity with ophthalmologist do think they have the ability to.
Accommodate you're adding more fast with reschedule you know things like that and and then a follow up to that to your plan or are you thinking about strategies to get.
<unk>, new patients versus maybe patients who switched from.
Another therapy.
That might be approved shortly onto your hundreds more <unk>.
Yeah, David Thank you for the question and we do have for Sun today, but I I think all taken if I Miss anything first can add to it on the capacity issue I know that's been a theme that's been discuss the recently in the investment community and Christmas doing a lotta market research.
It also is you know we're engaging customers nail in an appropriate way talking about things like capacity get a new therapy successor.
And I think the the community will be be ready for this I think they are excited to have a treatment.
They will adapt accordingly, we've seen something that I was very fortunate to experience when the first anti <unk> for lunch and you know people talk about capacities, then and the and the retinal doctors are adapted very well. So there's different data points that have come out that says you know they may struggle with <unk>.
<unk>, our data and the contingent market research and and part of our job and getting the market ready just to be sure that these officers Ken.
Meet the patient for a big Big part of the issue for a doctor seeing J patience as they have no treatments. So now with a treatment we believe they'll adapt accordingly, and we don't see that as an issue.
And we will share as we generate a market research that supports that.
On the second question, just remind me David second question.
<unk>, if you have different strategies or or thoughts on the proportions of patients who might switch from approve therapy, yeah or yeah.
And also I think you also asked with US you know how do we get these patients were also looking at not only the retinal practices, but where these patients may be are they.
Seeing optometrist hasn't been referred to see an ophthalmologist, having been referred and I think that's gonna be a key part of the commercial plan is you know unlocked where these patients are and get them to intercede their retinal specialist.
Being set another part of the strategy here is the education not only for the for the Doc but also for the patience to get them in earlier, we believe that earlier treatment will have better outcomes.
More to come on that and we need to put more data behind that but that's our our beliefs and so that that's where we are and just a word about where where Chris is.
He's built his organization out and we have not yet higher the feel for so I think those type of discussions will come.
When the the NDA is filed they'll have a better time on potential approval dates, but we think we're in a very good position with our our commercial payment I will tell you just like the leadership team. The people that were hiring on the commercial team of extensive extensive breton experience. So I'm looking forward to discussing this <unk>.
Or as time goes on.
<unk>.
Thank you and what is this I remember this concludes our question and answer session.
<unk> closing remarks.
Yeah, well, thank you and thank you to everybody for listening today, a lot has happened in the third quarter as a summarized before and it looks like the saying the execution intensity and in the fourth quarter. We look forward to continue dialogue I appreciate the the interest and continued support from all on this call today.
<unk> Bye bye.
Thank you Sir <unk> conference calls we thank you all for attending today's presentation, you may notice furniture or as I have a wonderful day.