This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk04: Hello, and welcome to the Iverick Bios second quarter 2021 conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchstone phone. To withdraw your question, please press star then two. Please note, today's event is being recorded. Now I'd like to turn the conference over to Kathy Galante, Senior Vice President, Investor Relations. Ms. Galante, please go ahead.
spk01: Thank you, Keith. Good morning and welcome to IvericBio's conference call. Representing IvericBio today are Mr. Glenn Splendorio, Chief Executive Officer, Dr. Praveen Dougal, President, Mr. Keith Westby, Chief Operating Officer, Mr. Dave Carroll, Chief Financial Officer, Dr. Double Desai, Chief Development Officer, Dr. Abraham Scaria, Chief Scientific Officer, and Mr. Chris Sims, Chief Commercial Officer. I would like to remind you that today we will be making statements relating to Iberic Bio's future expectations regarding operational, financial, and research and development matters. These statements constitute forward-looking statements for the purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. These statements cover many events and matters that are subject to various risks that could cause actual results to differ materially from those expressed in any forward-looking statement. I refer you to our SEC smilings and, in particular, to the risk factors included in our quarterly report on Form 10Q filed on May 5, 2021, 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.
spk02: Thanks, Kathy, and good morning, everyone, and thank you for joining us for our second quarter conference call. It's an exciting time for the company as we have delivered on several transformational milestones, particularly with regard to the execution of our Zamora Pivotal Program. We announced on July 6, 2021, that we received a written agreement from the FDA under a special protocol assessment, or SBA, for the overall design of GATHER2, our second pivotal clinical trial of Zamora in the development for the treatment of geographic atrophy, GA, secondary to age-related macular degeneration, or AMD. We believe this is the first and only SPA in GA 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 SPA solidifies our plans to file an application with the FDA for marketing approval of Zmora for GA secondary to AMD if the ongoing Gather 2 clinical trial meets its primary endpoint at 12 months. Zmora 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 Zamora for the treatment of GA secondary to AMD. On July 26, 2021, we announced we completed the enrollment in GATHER-2, specifically four months ahead of our original schedule. We are on track for initial top-line data from GATHER-2 to be available during the second half of 2022. approximately one year after the enrollment of the last patient in GATHER2 clinical trial, plus obviously the time needed for database closure and analysis. GATHER2's patient retention, as measured by the injection fidelity rate, continues to exceed our expectation. We are targeting the 12-month injection fidelity rate to be greater than 90%, and we are entirely committed to maintaining patient retention in GATHER2 clinical trial. And importantly, the results of a post hoc analysis of Gather 1 in Druzen and Nation GA were presented at our Zamora symposium in June. These results suggest that Zamora may have a therapeutic benefit in earlier stages of GA. Following the Gather 2 SPA, we strengthened our balance sheet with a public offering, raising approximately $108 million in net proceeds. They 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 Zamora Gather 2 Phase 3 program. Second, it allows us to prepare and potentially file a new drug application or NDA and a marketing authorization application, or MAA, for Zamora. Third, allows us to begin preparations for a potential launch of Zamora in GA secondary to AMD. Next, to initiate a Jerusalem clinical trial program. And finally, invest in sustained release delivery technologies for Zamora. On the personnel front, we are thrilled, and he's on the call today, to welcome Chris Sims to Iverick Bio as Chief Commercial Officer. Chris is an accomplished healthcare leader with more than 20 years of diverse commercial leadership experience at Johnson & Johnson, Gentech, and Novartis, including focused 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 U for WET-AMD. Before Novartis, he served as marketing lead for the Genentech ophthalmology business, which included creating a new brand, positioning, and launch campaign for Lucentis. At IvericBio, Chris's 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 MA filings and begin to prepare for the potential launch of Zmora for the treatment of geographic atrophy secondary to AMD. On the gene therapy front, we welcome Dr. Hemet Khanna to iVergBio as Vice President, Preclinical Ocular Research. Hemet joins us from the University of Massachusetts Medical School, where he was the principal investigator for our Mini-Sept 290, Mini-ABCA4, and Mini-Sept USH 2A sponsored research programs. We are working to transition the research and preclinical development activities for these programs of University of Massachusetts Medical School to us. We are also preparing to establish laboratory space for Hemet and three other employees who joined us from University of Massachusetts to continue to work on these mini gene programs and other preclinical research activities that we have ongoing. We are excited to welcome well-accomplished and talented new members to the iveric bio team. The company over the past year has grown by a number of people, and we welcome them all. We couldn't get here without their help. I'll now turn the call over to Keith.
spk09: Thank you, Glenn, and good morning, everyone. On July 26, 2021, we announced that patient enrollment of Gather 2 was complete, and that top-line data is expected in the second half of 2022, as Glenn mentioned, approximately one 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 Gather 2 are positive, we plan to file applications with the U.S. Food and Drug Administration and the European Medicines Agency for marketing approval of Zimora for GA. The successful completion of enrollment Four months ahead of schedule and the successful ongoing patient retention levels for Gather 2 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 have been impressive at any time. However, it is more impressive during a global pandemic. As previously discussed during our Zamora Symposium in June, we are targeting patient retention as measured by the injection fidelity rate through month 12, of greater than 90%. The injection fidelity rate for the GATHER-1 study, which showed a statistically significant reduction in GA 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 eye. 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 GATHER1. In GATHER1, Zamora 2 milligram demonstrated a difference versus sham with the very first measurement at month six, 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 GATHER-1 data. We believe that the early and continuous treatment effect demonstrated in GATHER-1 helped to expedite patient recruitment and continues to be a key motivator with patient retention in GATHER-2. We want to thank our Gather2 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 2b screening clinical trial of Zamora for the treatment of autosomal recessive Stargardt disease, referred to as the STAR trial, is ongoing with the goal of enrolling approximately 25 new patients for a total of 120 patients. Results from this clinical trial are expected after the 12-month initial top-line results from GATHER2. There are currently no therapies approved for Stargardt disease in either the U.S. or the European Union. Our main priority is to maintain patient retention in the GATHER2 clinical trial at 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 atrophies. Thank you for your time. I will now turn the call over to Praveen.
spk10: Thank you, Keith. Thank you all for joining the call this morning. I hope that you are all well. As we have previously stated, a key goal of ours is to expand and advance our footprint in multiple stages and types of AMD. We intend to execute a development strategy that will involve both Zmora and IC500 in a complementary fashion to impact multiple forms and stages of AMD. The SPA, which Glenn highlighted earlier, marks a significant development for Zmora, as it underscores our alignment with the FDA in a written agreement for the overall design of GATHER2, which we believe reflects the FDA's current thinking. In connection with the SBA, the FDA recommended and we accepted modifying the primary efficacy endpoint for the GATHER2 trial from the mean rate of change in GA area over 12 months measured by fundus autofluorescence or FAF at three time points, baseline month six and month 12 to the mean rate of GA growth or slope estimated based on GA area measured by FAS in at least three time points, baseline, month six, and month 12. In connection with the SBA, we submitted and the FDA reviewed a revised clinical trial protocol and statistical analysis plan, or SAP, for the GATHER-2 trial reflecting the revised primary efficacy endpoint and agreed upon statistical analysis method. The original primary efficacy endpoint estimated the mean rate of change in GA area from baseline to month 12 as measured by FAF readings at three time points, baseline, month six, and month 12, without assuming a constant rate of growth over the period. Using the same raw data, the FDA preferred method estimates the mean rate of growth of GA area from baseline to month 12 based on SAF readings at the same three time points, baseline month six 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 a change in how the data are analyzed. In parallel discussions with those for the GATHER-2 SBA, the FDA indicated to us that as part of a 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 using the same FDA preferred method that will be used for GATHER2. The data from GATHER1, when analyzed on a post-hoc basis using the FDA's preferred method, shows results that are highly consistent with and strongly supportive of the results we originally reported for GATHER1. We continue to believe GATHER-1 will serve as one of two adequate and well-controlled pivotal clinical trials required for purposes of obtaining marketing approval of Zumura in GA. We believe that a positive 12-month result in GATHER-2 will allow us to file an NDA with the FDA. We also believe that Zumura has the potential to be a safe and effective therapy for GA. which is a leading cause of blindness in this country for which there are no approved treatments available for patients. In our GATHER clinical program, our inclusion criteria specified patients with extra foveal GA, and we excluded patients with fovea involving GA. As part of the GATHER program, in addition to evaluating overall rate of GA growth, We look forward to investigating through supportive analyses whether Zmora has the potential to slow the progression of GA into the phobia, thereby potentially delaying the onset of significant loss of central vision that can occur at this stage of the disease. During our Zmora symposium in June, we were excited to have Dr. Vas Sada of the Doheny Eye Institute at UCLA present post-hoc analyses from the GATHER-1 clinical trial on the progression of drusen to nascent GA or irora and serora, which are earlier forms of dry AMD in patients with zamora 2 milligram as compared to patients in the sham group. Dr. Sadas reported a decreased conversion of irora to serora and a decreased conversion of drusen to irora or serora. Both rates showed an increasing effect over time, consistent with Zumora's effect on geographic atrophy in GATHER1. While the former shows that Zumora may have a therapeutic benefit in earlier stages of geographic atrophy, the latter suggests that Zumora may have the potential to prevent progression to geographic atrophy altogether in patients with drusen. These post hoc analyses suggest that Zamora may have the potential to impact 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 potentially sight saving impact of Zamora on millions of high risk AMD patients could be a massive leap forward in treating this disease. As part of our near-term lifecycle management plans, we expect to initiate a DRUZEN clinical development program in 2022. And as Glenn mentioned earlier, we will invest in sustained release delivery technologies for Zimura. Turning to IC500, we announced during the second quarter that the company commenced its first preclinical tolerability study for IC500 and is currently planning additional preclinical studies using pharmacokinetic and target engagement studies. Formulation optimization and other manufacturing activities are also ongoing. We continue to remain excited about the development potential of IC500 and expect to submit an to the FDA for IC500 and GA secondary to AMD in the second half of 2022. As a reminder, we believe IC500 has the potential to be the best in class as it inhibits HDRA1 both intra and extracellularly. We remain committed to our mission statement 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.
spk08: 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 32 cents per share, compared to a net loss of 18.6 million, or 32 cents per share, for Q2 2020. This increase in net loss was driven primarily by an increase in R&D expenses associated with our Zamora clinical programs and manufacturing activities. For the six months ended June 30th, the company reported a net loss of 56.9 million, or 61 cents per share, compared to a net loss of $33.7 million, or $0.61 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 our Zamora 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 Zamora, and increased personnel and headcount-related expenses. Turning to our expected year-end cash balance and cash runway, in July, we raised approximately $108 million in net proceeds in an underwritten public offering of common stock. We 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 and potential filing of an NDA and MAA for Zamora in GA, beginning preparations for a potential commercial launch of Zamora, initiating a Druzen clinical development program, investing in sustained release technologies for Zamora, the progression of our IC100 and 200 programs into the clinic, and the advancement of our IC500 development program. Excluded from these estimates are any potential approval or sales milestones payable to Archimix or potential expenses for the actual commercial launch of Zamora, any additional expenditures related to potentially studying Zamora in indications outside of GA and Druzen, or any expenditures resulting from the potential in licensing or acquisition of additional product candidates or technologies or any other associated development that we may pursue. I'll now turn the call back over to Glenn. Thank you for your time.
spk02: 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 SPA for Gather 2 and the strengthening of our financial position really allows us to, as Dave said, complete, gather two, continue to invest in CMC, prepare for an NDA and commercialization, and invest in new opportunities, including the Drusen clinical trial and also sustained release technologies that Praveen spoke about, positioning us potentially to be a leader in AMD and hopefully provide patients suffering from GA with an opportunity for treatment. So I want to thank all of you for listening this morning and your continued support, which is always welcome. And I'd like to turn the call over to the operator so we can open up the line for questions. Keith, please open the line.
spk04: Yes, thank you. At this time, we will begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you're using a speakerphone, 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 assemble the roster. And the first question comes from Stacy Ku with Cowan.
spk03: Hi, all. Thanks for taking my questions. Congratulations on the progress, and welcome to the new team additions. So I have a few questions. First, we're really encouraged by the FDA's decision to allow the new endpoints. But to better understand the onset of action, can you just talk about your earlier six-month time point and how it might differ from some of your competitors and how we might be able to view this as differentiated? And then second, Praveen, we've had a few questions on Novartis' intravitreal C5 inhibitor in advanced GA patients. So we're just wondering if you could comment on the data and specifically the baseline patient characteristics that might be different from Samora's program or study design. And then finally, one potentially for Chris, with completed enrollment faster than expected, can you speak to this demand as it relates to the GA population with extra foveal lesions? Just the level of diagnosis in the population and maybe the willingness to get monthly injections now with this increasing possibility of actually having treatment options. Thanks so much.
spk02: Well, Stacey, thank you for the questions and thank you for your comments. Since we're all remote, I'm going to kind of direct this. I'll ask Praveen to talk about the six months and how that differentiates us and also your second question. And on Chris, go easy on him. This is his first call, so I'll ask him to make some brief comments, but we're thrilled to have him on board.
spk07: Praveen?
spk10: Glenn, thank you. Thank you, Glenn. And Stacey, thank you so much for the question, and good morning to everybody. I wrote them down, so let me go one at a time, Stacey. So the earlier time points of separation in six months is what you asked about, and we have always maintained the narrative that we believe that inhibition at C5 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, it's very different than C3 inhibition. And I think we see that consistently. We see a separation that occurs at month six, and with each measurement, that delta gets bigger and bigger and bigger, with the biggest delta being at the end 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 a square root transformation or non-square root transformation. In fact, that's even true when we did a post-hoc analysis and looked at the conversion of irora to serora or drusen to irora and or serora. So we really do believe that that efficacy profile is a direct result of the target that we inhibit. And I would also say... As you all know, the safety profile is quite different than C3 inhibition in terms of the rate that we have of conversion to wet macular degeneration, as well as the fact that there are no cases in the GATHER program of inflammation or endophthalmitis. So, again, the efficacy profile is distinct, the safety profile is distinct, and we believe that this is a direct result of the target that we have, which is a C5 inhibition as opposed to C3 inhibitions. Stacy, to your second question regarding the LF program that Novartis has, you know, 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 two programs that were commenced. It was the LF316 program and the antiproperton program. With the geographic atrophy program, that was an intravitreal injection. The optimal dose was the 10-milligram dose, and the suboptimal dose, which in a dose-ranging study was the 5-milligram dose. What I do know is that the 5-milligram dose was recruited completely. However, there was a dropout rate in the 5-milligram dose that approached 50% or so. In the optimal dose, I believe there were seven patients who were recruited, six, I believe, in the treatment dose, and one in the sham. And the entire program was abruptly stopped. It was never published. And all I can tell you is that I'm not really sure there's any conclusion that can be made based on a suboptimal dose with almost a 50% dropout and an optimal dose where there are only seven patients. Again, it's never been published, so I can't tell you more than that. But we strongly feel that that incomplete study really does not have any kind of a impact on the development of Zamora. And finally, let me just take a stab from a clinical point of view before I hand it over to Keith, I'm sorry, to Chris, regarding your question about extra foveal geographic atrophy. It's important to know how geographic atrophy progresses. What we know is that regardless of your risk factors and regardless of where you are, there's a standard progression to geographic atrophy, which is that it occurs extra foveally and then it progresses circumferentially fairly rapidly. And I use the term rapidly purposefully because the impression is that this is a 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 in a matter of months, meaning two to three to four months, certainly not more than that. That's when it's extra foveal. So it progresses circumferentially, and then when it hits the fovea, it tends to slow down. So note that our patient population is very different than our competitors. We specifically chose patients with extra foveal geographic atrophy for many reasons, one of them being that if we're able to slow down the fastest-growing geographic atrophy, we believe that we've also met a much higher bar of stringency than slowing down the slower-growing geographic atrophy. The second part of this is market access. Now, we also believe that there are many, many more patients with extra foveal geographic atrophy who may have 20-20 vision but are visually handicapped and are visually dysfunctional. And these may be engineers that can't see a straight line. These may be accountants that can't read an Excel sheet because there's a blind spot. And these patients often tend to be younger and in the workforce. So we believe that our target really allows us a much broader patient access than just depending on phobia affecting geographic atrophy. And finally, what I would say is we know from natural history studies that once geographic atrophy starts outside the phobia, it takes anywhere from two to five years to involve the phobia. So what we can start talking about, given our patient population, is we can start talking about a phobial sparing intervention. So if you are in the workforce, for instance, and if you notice that you were able to work just fine as an architect but start seeing a line three or four months ago that is slightly crooked and you know that available to you is an intervention that will allow you to spare your phobia for another 10, 15, 20 years and maintain your lifestyle, I think those patients would be very motivated to come in and have this intervention with some work. So with that, I'll hand it over to Chris to see if he wants to add a few words here.
spk05: Thank you, Praveen, and Stacy, thank you for your question and for the welcome to the new role. I don't think I have a whole lot more to add on day three of being in the new role other than to say, as Praveen outlined, we believe the clinical story for treating earlier and therefore the patient population that's associated with that is quite compelling. More to be, I think, understood in terms of physicians' current thinking and 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 in a compelling way. Thank you for the question.
spk02: So Stacy, you'll have more opportunities to press Chris. It is day three and he is drinking from a fire hose, so you could just see the combination of folks that we're building on this theme. It's, you know, as Praveen said, we're all about retina, and we continue to hire great people that have great retina experience. So thanks for your questions today.
spk04: Thank you. Thank you. And the next question comes from Tiago Favre with Credit Suisse.
spk07: Hey, thanks for taking the question. I just have a quick one on formulation, since some cases of inflammation for a competitor program could have been related to reconstitution and formulation. Can you just remind me exactly what's the formulation that was used in Gather 1, and if there were any specific differences to Gather 2 or potentially a commercial formulation for Fruzumura? Yeah, that was it. Thank you.
spk02: So, Praveen, you want to take that, and I can add to that maybe?
spk10: Sure. What we're using is an intravitreal injection, of course. That's 100 milliliters in dose. The formulation is exactly the same. It comes in a vial that is then injected into the eye in a sterile fashion, and there's really no difference whatsoever in the constitution of that formulation between GATHER1 and GATHER2. In terms of inflammation, Tiago, I'm not really sure that we can comment on that because in the GATHER program, we really have had no incidence of a drug-related adverse event, and that includes endophthalmitis, and that includes inflammation in contradistinction to other programs. The adverse events that we've had have all been related to the injection procedure itself and not to the drug in the Gather-1 program. We also expect that because there's really no change, we thoroughly expect our safety profile to be really no different in Gather-2 than Gather-1, which has been excellent.
spk02: Got it, perfect. Tiago, I really have nothing to add to that. Thanks for the question. Anything else, Tiago?
spk07: So, yeah, just to the extent that the SPA discussion, I mean, of course, that was related together too specific, but I'm curious if you can comment at all on any specific interactions during that process that relates together. One, I know they've kind of signed off on the acceptance of the post hoc analysis, but Anything else that was discussed related to GADR1 for the registrational trial or any color around that would be helpful. Thanks.
spk02: Tiago, I'm going to also ask Praveen to answer that because he had some firsthand discussions with that. But, you know, we're very comfortable with the discussions on FDA on an MDA strategy forward. But, Praveen, maybe a little color will help Tiago.
spk10: Sure, Tiago. And thank you for that question. Let me just kind of step back a little bit and say that we felt as a company that we had two big boxes to check. You know, one was the box regarding execution, and Glenn addressed that. And I think we've checked that box by being extremely transparent and showing that we've recruited four months early with injection fidelity. You know, that is, I think, beyond what anybody would expect and 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 fair and absolutely collaborative. So we've had no issues with the interactions whatsoever and 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 contacted the FDA and said, look, we have an issue where we would like to formalize our interactions. We are very comfortable with it, but we want to make sure that it's formalized. How do we do that? So there are really two important take-home messages here. The first take-home message is that it was the FDA that advised us to apply for a spa, and that's while the Gather 2 study was recruiting, as you know. So that's an important take-home message. And what that showed us, in our opinion, is that it showed us the comfort level and the alignment that the FDA had with our previous interactions with the entire Gather program. The second part and we were really thrilled with this, is that the FDA went out of their way to comment on GATHER-1. Of course, the spot can only be applied for one study, and that was GATHER-2, but they went out of their way to comment on GATHER-1. And what they said was, they said, when you file for approval, we will look at the GATHER-1 program with your pre-specified analysis as well as our FDA preferred analysis. because we believe that both are valid and that one would be supportive of the other. And we were thrilled with that because we really felt that that not only showed us a clear path 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 One, we felt that it was most appropriate and thoroughly transparent as you saw in our press release, to show you all the calculations the way the FDA would see it, which is with our pre-specified analysis as well as the FDA preferred analysis. And as Glenn mentioned, both are really quite consistent. So in short, we believe that we've checked both those boxes in terms of execution as well as our regulatory strategy. as transparently and as openly and as clearly as we possibly can. Thank you for the question.
spk07: I appreciate the caller there.
spk04: Thank you. And the next question comes from David Nearingard with Bush Securities.
spk06: Hey, thanks for taking our question. Just a quick one for me. I know you updated your recruitment, of course, and injection fidelity rate recently, but I was wondering if there have been any changes. I know it's probably small numbers, but given the bulk of your patients were recruited maybe a little bit later in the study, if there was any changes in injection fidelity over the recent weeks. Thanks.
spk02: David, we did finish the recruitment, as we mentioned, in July. We recruited over the target of 440. I think we ended up at 445, 448. So that's all good. And we gave a number on injection fidelity that was at that point in time. And although we can't comment on the ongoing, I think I said in the script before that we continue to be satisfied with the injection fidelity rate that we're seeing. So no specific numbers to support that, but commentary and narrative that we like the trends. So I hope that is helpful. And one other point I will mention, which there was emphasis both by, actually I think by all three of us, myself, Keith, and Dravine, as we're in this second phase of the trial, the retention part of the trial, because the enrollment's 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 in a safe way so that they feel safe with the world around them. So we're doubling down on those efforts in the second phase of retention. So high priority for the company as we go forward, and I hope that's helpful without numbers.
spk06: Maybe a quick follow-up. I'm not sure if you keep this data, but is it safe to assume that the patient population is vaccinated against a coronavirus to at least a similar level as their age groups would indicate, or is that a fair assumption?
spk02: Yeah, we can't comment on that because we don't know. That's left up to the investigators, but what I will say is that With Keith's team, there's an active dialogue with the investigators around, you know, what can we do to keep these patients safe. And I know in our newsletters, et cetera, you know, to the extent that we could be helpful, you know, we obviously want the investigators and the patients to be vaccinated, but don't have specific data on that that we can help answer that question.
spk04: Got it.
spk02: Thank you. Thank you, David.
spk04: Thank you. And this concludes the question and answer session. I would like to return the call to Vince Vittorio for any closing comments.
spk02: Yeah, Keith, thank you for your help today, and thank you, everybody, for listening and for the questions. And we, as I said in my closing, remain committed to execute on what we've laid out for you. Thank you for listening today. Bye-bye.
spk04: Thank you. The conference has now concluded. Thank you for attending today's presentation. May God disconnect your lines.
Disclaimer