Q2 2021 Iveric Bio Inc Earnings Call
Hello, and welcome to the <unk> bio second quarter 2021 conference call on.
<unk> will be on listen only mode should the need assistance placement of all conference about the first of all of this by pressing the star key followed by zero.
After todays presentation, there will be an opportunity to ask questions to ask the question you May Press Star then 1 on your thoughts on the phone.
The try your question. Please press Star then 2 please note today's event is being recorded now I'd like to turn conference over to Kathy Galante Senior Vice President of Investor Relations. Please go on type of please go ahead.
Thank you Keith good.
And welcome to my very final conference call, representing I very bio today on Mr. President <unk>, Chief Executive Officer, Dr. Praveen Dougal President Mr. Keith Westby, Chief operating Officer, Mr. Dave Carroll, Chief Financial Officer, Dr. The double design, Chief Development Officer, Dr. Abraham Scarier Chief scientific.
For sure and Mr. Christian <unk>, Chief commercial 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. The.
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 of matters that are subject to various risks that could cause actual results to differ materially from those expressed 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 6.2021 for a detailed description of the risk factors affecting our business.
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.
Yeah.
Thanks, Kathy and good morning, everyone and thank you for joining us for.
For our second quarter conference call sort of an exciting time for the company because we have delivered on several transformational milestones, particularly with regard to the execution of our some more of a pivotal program.
We announced on July 6.2021 that we received a written agreement from the FDA under a special protocol assessment of our SBA for the overworld designed to gather 2 or second pivotal clinical trial of the more in the development for the treatment of geographic atrophy secondary.
The secondary to age related macular degeneration or AMD.
We believe this is the first and only S. P. A N G E.
This is quite an achievement very happy and proud of the team that they were able to do this in collaboration with the FDA the.
The S P. A solidifies our plans for the final application with the FDA for marketing approval of the more of the G. A secondary to AMD if the ongoing gathered to clinical trial meets its primary endpoint at 12 months.
The Maura met its.
Pre specified primary endpoint at 12 months and reached statistical significance in the previously completed gather 1 trial, our first pivotal clinical trial of the more for the treatment of G. A secondary to AMD.
On July 26, 2021, we announced we completed the enrollment in gathered too.
Specifically for months ahead of our original schedule. We are on track for initial topline data from gather 2 to be available during the second half of 2022, approximately 1 year. After the enrollment of the last patient and gather 2 clinical trial, plus obviously the time needed for database closure and analysis.
Gathered twos patient retention is measured by the injection to tell it for.
Fidelity rate continues to exceed our expectation.
We are targeting the 12 month injection fidelity right to be greater than 90% and we are entirely committed to maintaining patient retention and gather 2 clinical trial.
And importantly, the results of a post hoc analysis of gather 1 intrusion of nation G. A were presented at our some more of the symposium in June. These results suggest that some more of it may have a therapeutic benefit in earlier stages of G E.
By the following the gatherer to Spa, we strengthened our balance sheet with the public offering raising approximately $108 million in net proceeds Dave will cover our cash and cash runway later in the call.
We believe this capital allows us to advance a number of critical initiatives first.
It enables us to further support the efficient trial execution and maintain a high degree of integrity in our some maura gather 2 phase III program.
Second it allows us to prepare and potentially file a new drug application or N D E and of marketing authorization application or MAA for tomorrow.
Third allows us the begin preparations for a potential launch of the more in G. A secondary to the M D.
Next to initiate of drew some clinical trial program.
And finally invest in sustained release the.
The Liberty technologies for us of Maura.
On the personnel front, we are thrilled and he's on the call today to welcome Chris Simms, the Wifi arc bio as Chief Commercial Officer Christmas on accomplished health care leader with more than 20 years of diverse commercial leadership experience at Johnson, <unk>, Johnson Genentech and Novartis.
<unk> focus expertise in retina, ophthalmology and optometry, Chris joins us from Novartis, where he successfully managed commercial operations for the U S. Ophthalmic franchise launching b of view for what a M D.
Before Novartis. He served as marketing league for the Genentech Ophthalmology business, which included creating a new brand positioning and launch campaign for Lucentis.
Derek Bio of Christmas responsibility will include developing and implementing our commercial strategy and establishing our commercial infrastructure as we complete the gather 2 clinical trial and prepare for a potential NDA and MAA filings and begin to prepare for the potential launch of the Mora for the treatment of geographic atrophy.
The secondary to AMD.
On the gene therapy front, we welcomed Dr. Hemant Khanna joined <unk> bio as Vice President of preclinical ocular research Herman joins us from the University of Massachusetts Medical School, where he was the principal investigator for our many steps to 90, many a b C a for and many of.
Bush 2 way sponsored research programs.
We are working to transition the research and preclinical development activities for these programs for the University of Massachusetts Medical School to US. We are also preparing to establish laboratory space for him. It on 3 other employees, who joined US from University of Massachusetts to continue to work on these many gene programs in.
Other preclinical research activities that we have ongoing.
We are.
Excited to welcome well accomplished and talented new members to be I very bio team the company over the past year has grown by a number of people and we welcome the mall, we couldn't get here without their help I'll now turn the call over to Keith.
Thank you Glenn and good morning, everyone. On July 26, 2021, we announced that patient enrollment of gather 2 was complete and the topline data is expected in the second half of 2022 as Glenn mentioned approximately 1 year after the enrollment of the last patient in the gather 2 clinical trial.
Plus the time needed for database closure and analysis. If the 12 month results from gathered you are positive we plan to file applications with the U S food and drug administration and the European Medicines agency for marketing approval of the Tomorrow for G E.
The successful completion of enrollment for months ahead of schedule and the successful ongoing patient retention levels for gathered to reflect the tremendous work and innovative programs. Our clinical team has executed and is a tribute to our patients investigators and their study staff.
This milestone would've been impressive at any time. However, it is more impressive during a global pandemic.
As previously discussed during hours the Morris Symposium in June we are targeting patient retention as measured by the injection of fidelity rates of 3 months 12 of greater than 90%.
The injection of fidelity right for the gather 1 study, which showed a statistically significant reduction in G. A progression at 12 months was 87%.
Injection fidelity is calculated by dividing the total number of actual injections by the total number of expected injections based on the number of enrolled patients.
We consider injection fidelity to be the most important and stringent measure of patient retention because it reflects the timely administration of the drug into the patient's home.
We continue to focus on injection fidelity not only to protect the integrity of our data, but also to potentially demonstrate the early and continuous treatment effect. We previously observed in gathered 1.
And the other 1 Zamora 2 milligram demonstrated a difference versus sham with the very first measurement at month 6 and this difference continued to increase at each subsequent measurement with the biggest difference being observed at the end of the study.
Many principal investigators have shared with us their enthusiasm about the gather 2 clinical trial and the quality of the positive got the 1 data.
We believe that the early and continuous treatment effect demonstrated and gather 1 helped to expedite patient recruitment and continues to be of key motivator with patient retention and gather too.
We want to thank our gathered to investigators and their site staff for their strong support as we collaborate to conduct a global clinical trial during the difficult conditions of the COVID-19 pandemic.
Patient enrollment in our phase <unk> screening clinical trial of Zamora for the treatment of autosomal recessive Star Guard disease referred to as the Star trial is ongoing with the goal of enrolling approximately 25, new patients for a total of 120 patients.
<unk> from this clinical trial are expected after the 12 month initial top line results from gatherer too.
There are currently no therapies approved for star of our disease in either of the U S or the European Union.
Our main priority is to maintain patient retention in the gathered 2 clinical trial had a high level and we are working to address the major unmet medical need where there are no treatment options available for people living with geographic atrophy.
Thank you for your time I will now turn the call over to provision.
Thank you Keith Thank you all for joining the call. This morning.
Hope that you are all well.
As we have previously stated.
Key goal of ours is to expand and advance our footprint on multiple stages and types of AMD.
We intend to execute a development strategy that will involve both zamora and IC 500 and of complementary fashion to impact multiple firms in stages of AMD.
The S P, a which Glenn highlighted earlier marks a significant development for tomorrow.
As it underscores our alignment with the FDA in a written agreement for the overall design of gather 2 which we believe reflects the fda's current thinking.
In connection with the SBA the.
The F D. A recommended and we accepted modifying the primary efficacy endpoint for the gather 2 trial.
From the mean rate of change in G. A area of over 12 months measured by fundus auto fluorescence or S. A F.
The lead time points baseline month, 6 and month 12.
For the main rate of G a growth or slope estimated based on G. A area of measured by Fas in at least 3 time points baseline month, 6 and month 12.
In connection with the SBA, we submitted and the FDA reviewed and revised clinical trial protocol and statistical analysis plan or S. P.
For the gather 2 trial, reflecting the revised primary efficacy endpoint and agreed upon statistical analysis method.
The original primary efficacy endpoint the estimated the mean the rate of change in G. A area from baseline to month 12.
Cash as measured by FAA F readings at 3 time points baseline.
The 6 month 12, without assuming a constant rate of growth over the period.
Using the same raw data the.
F D. A preferred method of estimates the mean rate of growth of G. A area from baseline 2 months of 12 based on S. A F readings at the same 3 time points baseline month, 6 and month 12, assuming a constant rate of growth over the period essentially fitting a straight line.
Based on the data.
The modification of the primary efficacy endpoint does not require collecting any new data, but instead reflects the change in how the data are analyzed.
In parallel discussions with those for the gather to S. P. A the FDA indicated to us that as part of the future NDA submission for Zamora. The gather 1 results will be considered using the original pre specified primary efficacy endpoint analysis.
Together with a post hoc analysis.
The same F D. A preferred method that will be used for gather too.
The data from gather 1 when analyzed on a post hoc basis using the Fda's preferred method shows results that are highly consistent with them strongly supportive of the results. We originally reported for gather 1.
We continue to believe gather 1 will serve as 1 of 2 adequate and well controlled pivotal clinical trials required for purposes of obtaining marketing approval of some more N G E.
We believe that of positive 12 month result, and gather 2 will allow us to file an NDA with the FDA.
We also believe that Zamora has the potential to be of safe and effective therapy for G E, which is the leading cause of blindness in this country.
For which there are no approved treatments available for patients.
And our gather clinical program, our inclusion criteria specified patients with extra for mobile G E and we excluded patients with phobia involving G E S.
As part of the GABA program. In addition to evaluating overall rate of <unk> growth.
We look forward to investigating through support of the analysis, where theres more of has the potential to slow the progression of G. A into the fovea, thereby potentially delaying the onset of significant loss of central vision that can occur at this stage of the disease.
During ours, the Morris Symposium on June <unk>.
We were excited to have doctor of vast sada of the Doe Hany Eye Institute at UCLA present post hoc analyses from the gather 1 clinical trial on the progression of crews into the nascent G E R I Aurora and see Lora.
Which are early of forms of dry AMD patients with Zamora, 2 milligram as compared to patients in the on the Sham group.
Doctors thought us reported a decreased conversion of IRA to see Aurora on a decrease of conversion of Jerusalem to IRA or see Lora book.
Both rates showed an increasing effect over time.
System with Zamora is the fact on geographic atrophy and gather 1.
While the former shows the Zamora may have a therapeutic benefit in earlier stages of geographic atrophy. The ladder suggests that the more I may have the potential.
To prevent progression to geographic atrophy altogether in patients with the truth.
These post hoc analyses suggest that's the more may have the potential to impact the AMD, even before atrophy occurs.
These post hoc analyses should be considered hypothesis seeking.
Nonetheless, if these results are substantiated with prospective randomized studies the ports.
Tinselly sites seething impact of the more on millions of high risk a M D patients could be of massive leap forward in <unk>.
Treating this disease.
As part of our near term lifecycle management plans, we expect to initiate a gruesome clinical development program in 2022, and as Glen mentioned earlier, we will invest in sustained release delivery technologies for Zamora.
Turning to IC 500.
We announced during the second quarter that the company commenced its.
Its first preclinical Tolerability study for IC 500, and is currently planning additional preclinical studies using pharmacokinetic on target engagement studies for.
<unk> optimization and other manufacturing activities are also ongoing.
We continue to remain excited about the development potential of IC 500, and expect to submit an IND to the FDA for IC 500, G. A secondary to AMD and the second half of 2022.
As a reminder, we believe I see 500 has the potential to be the best in class as it inhibits H D already won both intra and extra sale early.
We remain committed to our mission statement to.
To develop transformative therapies for retinal diseases.
We look forward to keeping you updated on our progress in the months to come.
Thank you for your time.
I will now turn the call back 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 update our expected year end cash balance and our expected cash runway.
For the quarter, our net loss totaled $30.1 million or <unk> 32 per share compared to a net loss of $18.6 billion of 32 per share for Q2.2020.
This increase in net loss was driven primarily by an increase in R&D expenses associated with ours of more of clinical programs and manufacturing activities for the.
The 6 months ended June 30, the company reported a net loss of $56.9 million for 61 per share compared to a net loss of $33.7 million or <unk> 61 per share for the same period in 2020.
This increased net loss was driven primarily by again, an increase in R&D expenses associated with those of more of a clinical programs and manufacturing activities and an increase in legal costs associated with ongoing litigation.
R&D expenses increased due to the commencement of patient enrollment and the progression of our ongoing gather 2 trial increased manufacturing activities for tomorrow, and the increased personnel and headcount related expenses.
Turning to our expected year end cash balance of cash runway.
In July we raised approximately $108 million.
Net proceeds in an underwritten public offering of common stock.
Now estimate our year end cash to range between $215 million and $225 million.
We also estimate that our cash will be sufficient to fund our planned capital expenditures and operating expenses for at least mid 2024.
These expenses. These estimates are based on our current business plan, including the continuation of our ongoing clinical development programs for Zamora preparation of potential filing of an NDA and MAA for Zamora NGA.
<unk> preparations for potential commercial launch of Nomura initiating of choosing clinical development program invest.
Investing in sustained release technology for tomorrow.
The progression of our IC 102 hundred programs into the clinic and the advancement of our IC 500 development program.
Excluded from these estimates of any potential approval of our sales milestones payable to Arca mix where potential expenses for.
For the actual commercial launch of Zamora and the additional expenditures related to potentially studying zamora in indications outside of GAA intrusion.
The expenditures, resulting from the potential in licensing or acquisition of additional product candidates where technologies for any other associated determined that we may pursue.
I'll now turn the call back over to Glenn. Thank you for your time.
Yes.
Well. Thank you Dave and we are very excited with the progress made in the second quarter and remain committed to executing on our plan.
The regulatory clarity provided by the SBA for gathered too on the strengthening of our financial position.
It really allows us to as Dave said complete gather to continue to invest in CMC prepare for an NDA and commercialization and invest the new opportunities, including the drews on clinical trial and also of sustained release technologies that provision spoke about.
Positioning us potentially to be a leader in AMD and hopefully provide patients suffering from Gi with an opportunity for treatment.
So I want to thank for all of you for listening. This morning, and your continued support which is always welcome.
Like to turn the call over to the operator, so we can open up the lines for questions. Keith. Please open the line yes. Thank you at this time, we will begin the question and answer session to asking the question you May Press Star then 1 on you touched on the phone.
If you are using a speaker phone please pick up your handset before pressing the keys to withdraw your question. Please press Star then 2 at this time, we will pause momentarily to Osama of the roster.
Yeah.
And the first question comes from Stacy <unk> with Cowen.
Hi, Thanks for taking my questions congratulations on the progress and welcome to the new team additions.
A few questions first we're really encouraged by the Fda's decision until about the new endpoints.
To better understand the onset of action can you just talk about your earlier 6 month timeframe.
How might differ from some of your competitors, how we might be able to see this as differentiated and then second Caribbean. We've had a few questions on Novartis says on.
In terms of the trail of C..5 inhibitor in advance to the patients. So we're just wondering if you could comment on the data on specifically the baseline patient characteristics that might be different from similar as per Gram of course.
The design and then finally, 1 potentially for Chris with completed enrollment faster than expected can you just speak to the man as it relates to the day population with extra for the old lesions.
Just the level of diagnosis in the population in need of the willingness to get monthly injections now with the increasing possibility of actually having treatment options. Thanks. So much.
Yes.
Stacy Thank you for the questions and thank you for your comments.
Since we're all remote I'm going to kind of direct as well as provision to talk about the 6 months and the other.
It differentiates us and also your second question and on Chris go easy on him. This is the first call. So I'll ask him to make some brief comments, but we're thrilled to have him on board.
For me.
Thank you.
Thank you Glenn on states and thank you so much for the question on good morning to everybody.
Let me, let me I wrote them down So let me go 1 at a time Stacy so the earlier time points of separation of the 6 months of what you asked about and we have always maintained the narrative.
That we believe that inhibition of the Fi will provide for a more robust inhibition that is also safer.
And we've pointed to the fact that if you look at the efficacy profile as well as the safety profile is very different than the 3 inhibition and I think we see that consistently we see a separation that occurs at month, 6 and with each measurement that delta gets bigger and bigger and bigger with the biggest delta be.
At the end of the of the study and that is true for the 2 milligram dose that's true for the 4 milligram dose that's true whether you measure it by of square root transformation of on non square root transformation. In fact, that's even true when we did a post hoc analysis and looked at the conversion of IRA to sue or.
Or drews into IRA and or see Aurora. So we really do believe that that efficacy profile is a direct result of the target that we can hibbett and I would also say as you all know that the safety profile is quite different than <unk> 3 inhibition in terms of the rate that we have of conversion to wet macular degeneration.
<unk> as well as the fact that there are no cases in the gathered program of inflammation of the endophthalmitis. So again the efficacy profile of the distance the safety profile is distinct and we believe that this is the direct result of the target that we have which is C. C..5 inhibition as opposed to see 3 inhibition.
Stacy to your second question regarding the Lf program that Novartis has.
What I can tell you is what we know from the public domain.
And I realize that nothing has been published.
Very little has ever been presented and here's what we know there were 2 programs that were commenced there was the.
The <unk> hundred 1.6 program on the anti preferred and program with the geographic atrophy program that wasn't in for the tool injection. The optimal dose was the 10 milligram dose.
And the sub optimal dose, which in a dose ranging study with the 5 milligram dose what I do know is that the 5 milligram dose was recruited.
And the completely however, there was the dropout rate in the 5 milligram dose that approached 50% of ourselves and the optimal dose I believe there were 7 patients who are recruited.
6 I believe in the in the treatment dose and worn on the Sham and the entire program was abruptly stopped.
It was never published.
And all I can tell you that I'm not really sure. There is any conclusion that can be made.
<unk> on a suboptimal dose with almost a 50% drop out at an optimal dose of where the only 7 patients again, there was never been published so I can't tell you more than that but we strongly feel that debt incomplete study really does not have any kind of in the other.
Impact on the development of Tomorrow, and finally, let me just take the staff from our clinical point of view before I hand, it over the Keith I'm, sorry, Q2 of Chris regarding your question about extra phobia of geographic atrophy.
It's important to know how geographic atrophy progresses, what we know is that regardless of your risk factors in regardless of where you are there is the standard progression.
2 geographic atrophy, which is that it occurs extra flow Gilly and then of progressive circumferential it fairly rapidly and I use the term of rapidly purposeful way because the impression is that this is the very slowly progressive disease.
It really is not I mean, it certainly doesn't progress as rapidly as wet macular degeneration, but it does progress and of <unk>.
Matter of months, meaning 2 to 3 to 4 months not not certainly not more than that that's 1 of the extra fulvio.
Progressive Circumferential and then when it hits the full view of it tends to slow down so note that our patient population.
Very different than our competitors, we specifically chose patients for the extra Foveole geographic atrophy for many reasons of 1 of them being the if we're able to slow down the fastest growing geographic atrophy. We believe that we have also met of much higher bar of <unk>.
And Jensen and slowing down the slower growing geographic atrophy. The second part of this is market access, but we also believe that there are many many more patients with extra mobile geographic atrophy, who are who may have 2020 vision, but are visually handicapped and are visually dysfunctional and these maybe these may be.
Engineers, they can't see of straight line. The these may be accountants that canceled the we'd ask the el Sheikh because theres, the blind spot and he's patients often tend to be younger and in the workforce. So we believe that our target really allows us a much broader patient access.
Then just just just depending on phobia affecting geographic atrophy and finally, what I would say is we know from natural history studies that once the geographic atrophy starts outside the phobia. It takes anywhere from 2 to 5 years to involve the phobia. So what we can start talking about given our patient population is looking for.
<unk> talking about <unk>.
Youll sparing intervention. So if you are in the work force for instance, if you noticed that you were able to work just fine as an architect of the starts scheme of line 3 of 4 months ago with debt is slightly crooked.
And you know the available to you is an intervention that will allow you to spare you of Covia for another 10, 15, 20 years and maintain your lifestyle I think those patients would be very motivated to come in and have the center of engine with similar so with that I'll hand, it over the Christmas.
If he wants to add a few words here.
Okay. Thank you for being in the Stacey. Thank you for your question and for the for the welcome to the new role I don't think I have a whole lot more to add on to day 3 of being in the new role.
On the other than to say as for being outlined we believe the.
Clinical story.
For treating earlier.
And therefore, the patient population of associated with that is quite compelling.
More to be I think understood in terms of physicians current thinking on their intent to treat this population, but that's work that will be undertaken in the coming days and weeks ahead to make sure that we're prepared to tell that story.
Anyway. Thank you for the questions.
So stay so you'll have more opportunities for price suppression Chris.
It is it is day 3 of the is drinking from a fire hose. So.
If you could just say that the the combination of folks that we're building on the same.
As for being said.
We're all about retina, and we continue to hire great people that have great retina experience. So thanks for your questions today.
Thank you.
Thank you and the next question comes from Thiago of fall off with credit Suisse.
Hey, Thanks for taking the question I just have a quick 1 on formulation since some cases of inflammation for a for a competitive program couldnt have been related to the constitution of formulation. So it was can you just remind me exactly what's the formulation that was using the other 1 and if there were any specific differences together 2 or potentially of <unk>.
Commercial formulation for for Zimbra.
Yeah that was it thank you.
So the Praveen the you want to take that and I can add to the maybe.
Sure. It's what we're using is a individual injection of course, that's the that's 100 milliliters in dose the formulation of the exactly the same if it comes in and of vial that is then injected into the eye on apparel fashion and there's really no difference whatsoever in the constitution.
Of that formulation between gather the 1 on gathered too in terms of inflammation Thiago I'm not really sure that we can comment on that because in the gather program will really have had no incidents of a drug related adverse event and that includes endophthalmitis and that includes <unk>.
Inflammation in contradiction in contradistinction to other programs the.
The adverse events that we've had have all been related to the injection procedure itself.
And not to the to the drug and the gather 1 program. We also expect that because theres really no change.
The thoroughly expect our our safety profile to be really no different than gatherers, who then the other 1 which has been excellent.
Yeah.
Got it got it really had nothing nothing to add to that.
Question on anything else Thiago.
So again, I'll say too just to the extent that the the spa. The discussion I mean of course that was related together too specific.
But I'm curious if you can comment at all on the specific interactions during that process the release together 1.
I know they they've kind of sign off on the.
Of the acceptance of the post hoc analysis book.
Anything else out of there was discussed related together 1 of the Registrational trial or any color around that would be helpful. Thanks.
She has a lot of it also is preventing to answer that because he had some firsthand the discussions with that but we're.
We're very comfortable with the discussions on the FDA on the Monday, a strategy forward, but for me, maybe a little color will help thiago.
Sure Yeah, Glenn. Thank you for that question and let me just kind of step back a little bit and say that we felt of the company that we had 2 big boxes to check.
1 was the box regarding execution and Glen addressed that and I think we've checked that box bye bye.
By being extremely transparent and showing that we have recruited for months early with the injection fidelity.
That is I think beyond what anybody would expect than has ever been described.
The second box that needed to be checked was that of the regulatory strategy.
And we have always been very comfortable with our interactions with the FDA and as you know.
That's really led on the FDA side by Dr. Wiley Chambers, who we have known for a long time, who has consistently been a fair.
Fair and an absolutely collaborative so we've had no issues with the with the with the interactions of whatsoever on felt very comfortable about our regulatory pathway and we've been consistent in saying that however, it was true that we didn't have any formal meetings.
It was true that we didn't have any formal documents. So we needed to check that box because not everybody was as comfortable and understandably. So so what we did was very simple we contact the FDA and said look we have an issue where we would like to formalize. The interactions we are very comfortable with it but we want.
To make sure that it's formalized how do we do that so they are really 2 important take home messages here. The first take home message is that it was the FDA advised us to apply for a spa and that's a while the gathered 2 study was recruiting as you know so that's the important take home message and of what that showed us.
In our opinion is that it showed us the comfort level and the alignment debt.
The FDA had with our previous interactions with the entire gathered program. The second part and we were really thrilled with this is that the FDA went out of their way to comment on gathered for 1 of course the spot can only be applied for 1 study and that was gathered to but they went out of their way to comment on gather 1.
And what they said was they said when you when you file for free.
For approval.
We will look at the gap of 1 program with your pre specified analysis.
As well as our FDA preferred analysis, because we believe that both are valid and that 1 would be supportive of the other and we were we were thrilled with that because we really felt that debt not only showed us a clear path for.
For our regulatory strategy, but validated what we were doing and given the fact that the FDA told us how they were going to look at gather 1 of we felt that it was most appropriate and thoroughly transparent as you saw on our press release to show you all of the calculations the way the FDA would see it.
Which is with our pre specified analysis as well as the FDA preferred analysis of anything as Glenn mentioned, both are really quite consistent so in short we believe that we've checked both of those boxes in terms of execution as well as our as our.
Sure.
Our regulatory strategy.
As transparently as openly as clearly as we possibly can thank you for the question of it yet.
I appreciate the color there.
Thank you and the next question comes from David near and go on with Bush Securities.
Hey, Thanks for taking the question just a quick for 1 for me I know you updated your.
Recruitment of course on an injection of fidelity rate recently, but I was wondering if the.
Other than any changes I know, it's probably a small numbers, but given the bulk of your patients are recruited.
Maybe a little bit later in the study if there was any.
Changes in injections fidelity of the.
Recent weeks thanks.
Yeah, David we did finish the recruitment as we mentioned.
In July.
We recruited over the target of.
440, I think we ended up at $4.45.
For 48.
So that's all good and we gave a number.
Number on injection fidelity that was at that point in time.
Although we are.
I can't comment on the ongoing.
So I think I said nor in the.
In the script before that.
We continue to be satisfied with the injection of fidelity rate that we're seeing so no specific numbers the support that but you know commentary of narrative debt.
We like the trends so I hope that is helpful and the 1 other point I will mention for which there was emphasis both by actually I think by all 3 of us myself Keith intervene.
As we're in this second phase of the trial the retention part of the trial because of the enrollments complete being sure that we continue to actively work with the sites with the patients.
With a global pandemic remains our top priority and to do everything we can to have those patients continue to come back to their visits and a safe safe.
Safeway so that the.
Feel safe with the world around them.
So we're doubling down on those efforts.
And the and the second phase of retention, so a high priority for the company as we go forward and I hope that's helpful without numbers.
Sure.
A quick follow up I'm not sure if you keep the state of it.
Is it safe to assume that the patient population is the vaccinated against a corona virus to at least for a similar level as the.
The age groups sort of indicator.
Is that a fair assumption.
Yeah.
We can't come on on that because we don't know.
So that's left up to the investigators, but what I will say is that.
With the with Keith's team, there's an active dialogue with the investigators around what can we do the to keep these patients safe and I know 1 of our newsletters et cetera, you know to the extent that we could be helpful. We obviously want the investigators on the patients should be vaccinated, but don't have specific data on debt that we can help.
The answer that question.
Got it thank you.
Thank you David.
Thank you.
This concludes our question and answer session I would like to turn on the call of events of Royall for any closing comments.
Yeah, Keith Thank you for your help today and thank you everybody for listening and for the questions and we also said in my closing we remain committed to execute on what we've laid out for you. Thank you for listening today Bye bye.
The conference has now concluded thank you for attending today's presentation.
Disconnect your lines.
Yes.