Applied Genetic Technologies Corporation
Q4 2019 Earnings Call Transcript

Published: 27 Sep 2019

[Operator:]

Good afternoon, and welcome to AGTC Fourth Quarter and Fiscal Year 2019 Financial Results Conference Call. Today’s call is being recorded. Before we get started, I would like to remind everyone that during this call AGTC may make forward-looking statements including statements about the Company’s financial results, financial guidance, its future business strategies and operations and its product development and regulatory progress. Actual results could differ materially from those discussed in these forward-looking statements due to a number of important factors including uncertainties inherent in the clinical development and regulatory process and other risks described in the Risk Factors section of AGTC’s Annual Report on Form 10-K for the fiscal year ended June 30, 2019.For introductions and opening remarks, I would like to turn the call over to Sue Washer, Chief Executive Officer of AGTC. Please, go ahead.

[Sue Washer:]

Good afternoon, and thank you all for joining us today. With me on today’s call is Bill Sullivan, our Chief Financial Officer; Mark Shearman our Chief Scientific Officer; Theresa Heah, our Chief Medical Officer; Matt Feinsod, our Executive Vice President of Global Strategy and Development; and David Knop, our Executive Director of Process Development.While this is a larger group than we’ve had on previous calls, I’ve asked the broader team to join us in order to share with you a wealth of new data and information that we believe validates our technology platform. I am certain you will find our expertise and insights helpful.We are excited to share with you today new data that includes the planned topline six-month XLRP dose escalation data, as well as preliminary three-months data from the XLRP dose expansion cohort showing stability of visual function in the periphery and improvement of visual function centrally.We are also pleased to provide an early look at data indicating biologic activity in our achromatopsia trial. Much of this information is included in the slide deck accompanying our prepared remarks, which will be available on the AGTC website following this call. We believe these data across three clinical indications and the company’s extensive preclinical data and manufacturing excellence enhance and strengthen AGTC’s leadership in the ophthalmology gene therapy arena.We’ve made great progress over the last twelve months across our clinical programs in XLRP and achromatopsia and we are leveraging our expertise in AAV gene therapy to expand our development activities into additional disease areas.Later in the call, Mark will discuss the progress we’ve made in our preclinical programs, all of which take advantage of our existing expertise, knowledge, resources and infrastructure in order to maximize our likelihood of success while streamlining the development progress.In the fourth quarter, we made several strategic management enhancements in anticipation of late-stage clinical development and commercialization activities shown in Slide 4. These include appointing Theresa Heah as our new CMO. Theresa joins us with more than ten years of senior executive pharmaceutical experience including successfully overseeing late-stage drug development and commercialization and will help her to guide our ongoing clinical programs to the clinical and regulatory landscape toward approval and we look forward to her valuable contributions.With Theresa’s appointment as CMO, Matt Feinsod has transitioned to Executive Vice President of Global Clinical Strategy and Development. We also appointed Brian Krex as General Counsel. Brian has extensive commercialization experience, most recently having served as Vice President and Global Head of Commercial and Regulatory Law with Alexion Pharmaceuticals.We believe this added expertise will enhance our ability to successfully develop and commercialize our innovative product price points. We are confident we have the right executive team in place to advance our company through late-stage development and eventual regulatory approval.I will now turn the call over to Theresa, who will provide our clinical update.

[Theresa Heah:]

Thank you, Sue. We are excited to provide the planned XLRP topline, six-months data from the dose escalation groups, as well as the preliminary look at three-month data from the XLRP dose expansion group showing a favorable safety profiles with stability of visual function in the periphery dose patients and improvement of visual function in 50% of centrally dosed patients.We are also providing an early look at data from the achromatopsia B3 and A3 trials showing signs of clinically meaningful improvements in light discomfort at three months. Taken together, we believe these data provides solid rationale for the advancements of our clinical programs and our assets to bring important new products to patients’ needs.I’ll now start with an update for our XLRP program and a brief disease overview. As shown on Slide 7, patients with XLRP do not produce the RPGR protein, which leads to poor photoreceptor function and then retinal degeneration. This results in early night blindness and progressive construction of visual fields. Typically, XLRP patients are legally blind by age 45.Slide 7 also shows patients with XLRP see the world through constructed visual fields. As a reminder, this study use a soft retinal injection at the root of administration and patients were injected centrally or peripherally in order to provide maximum benefit on each patients baseline characteristics. There are currently no effective therapies for XLRP.Slide 8 AGTC’s product candidates is designed to provide a functional copy of the RPGR gene to photoreceptors delivered by a novel engineered AAV capsid as we believe it could transform the care outcomes and quality of life for patients living with this disease.The dose groups I’ll be discussing today are summarized in Slide 9 and include ten patients who have completed six-month follow-up and seven patients who have completed three month follow-up. In addition to the 17 patients we will be discussing, we have dosed an additional five patients for a total of 22 patients dosed to-date.We will continue dosing additional patients under the Phase 1/2 protocol to further enrich our analysis and build a robust set of safety and efficacy data to support our Biologics License Application or BLA filing. We believe this approach will maximize the benefit to the greatest range of patients putting us in a solid position for potential approval and commercialization.Before I review the clinical data, I would like to note that we have shared this information with a group of retinal experts who have extensive expertise in treating XLRP and they conclude that the data if sustained would mark an inflection point in the treatment of these diseases.Slide 10 outlines the patient demographics we will discuss today. For each patient, we chose to dose the eye with the lower visual function. As described on Slide 11, the data continues to demonstrate a favorable safety profile across the 17 patients treated for our XLRP candidate. Importantly, no dose-limiting inflammatory responses have been observed in patients treated to-date and we have had no secondary inflammatory response requiring readministration of any steroids.Based on the safety and tolerability, our Data Safety Monitoring Committee, DSMC supported continued dose escalation in the trial, as well as dosing of pediatric patients.Slide 13, let me begin with the six-month data from the patients dosed peripherally. Eight patients from the dose escalation portion of the study were dosed peripherally. Peripherally dosed patients showed stable visual function at six months as measured by visual fields and visual acuity. This encouraging data in the periphery is unique to AGTC.Slide 14 shows the stable visual sensitivity both for all patients combined and by dose group. Slide 15 shows the stable Best Corrected Visual Acuity or BCVA, both for all patients combined and by dose group.Slide 16, while patients will need to be followed for additional time to truly show stabilization in this degenerative disease based on the data to-date, we can conclude that our XLRP candidate is generally well-tolerated and leads to stable visual function at six months. This maintenance of peripheral vision is an important milestone for these patients.Let me turn to the three month data from the centrally dosed patients. Moving on to Slide 18, we are excited that preliminary data from nine patients who have reached at least three month time point dosed centrally shows evidence of improvement in visual function.We have seen measurable improvements in visual sensitivity for four of eight patients, one at the middle dose and seven at the high dose, a response rate of 50%.We define a responder as a patient who have improvement in visual sensitivity within the treatment area that is beyond the testing variability on at least two different test dates. Note that for one of the nine centrally dosed patients, we do not have a complete dataset for sensitivity measurements.Moving to Slide 19, another way to analyze improvements in visual sensitivity is by identifying the percentage of patients who have greater than five Loci in the treated area with at least 7 decibel increase compared to baseline. We have seen that 8% of patients meet this cohort at month three. For context, the best reported result seen to-date was 33%.As shown on Slide 20, all 9 patients treated centrally also had stable or improving visual acuity, a traditional hallmark of visual function results that have not been disclosed in other XLRP clinical trials to-date.Moving to Slide 21, we can see that Optical Coherence Tomography or OCT analysis for all 9 patients have no measureable decline in photoreceptor structure in either the treated or untreated eyes. We believe that all these outcomes taken together strongly suggest that our product candidate could provide significant clinical benefits to patients.Now, let’s take a more detailed look at the data from the four identified responders. Slide 22 shows the mean change in sensitivity from baseline within the bleb at months one, two and three, compared to the untreated eye. This data compared favorably to what has been reported from others which are also shown on the slide.Slide 23 shows an example of microperimetry results within the treated area as a sheet map for the mid dose responder indicating meaningful improvements in visual sensitivity, compared to the untreated eye and compared to baseline. Increases in visual sensitivity can provide vision under lower light conditions, sharper vision, and/or a wider field of vision and this patient shows both wider fields of vision and brighter fields of vision.Similarly, Slide 24 shows microperimetry results for the three high-dose responders. As you can see, all three show meaningful improvements in visual sensitivity, compared to the untreated eyes and to baseline, all showing brighter vision and one also showing wider fields of vision.To reiterate, stabilization of peripheral vision and improvement in central vision is important and clinically meaningful because reductions in visual sensitivity are a key hallmark of this degenerative disease and negatively impact patients’ ability to fully engage in daily living and work activities.Importantly, anecdotal statements from the patients support our analysis of the measurable improvements as they are meaningful to their daily lives. And many of these statements are captured here on Slide 25. For example, one patient said, objects appear brighter.Slide 26, the biologic activity observed to-date in this clinical trial assuming is sustained through the 12 month time point reinforces our confidence that the trial design will yield the data we need to advance our XLRP program to a pivotal trial. We believe stabilization of decline in the peripheral vision in combination with improvement in central vision with a favorable safety profile will be of great importance to patients.Our current expectation is that we will be communicating with the FDA on the data to-date and the proposed design of the pivotal trial over the next several months. Our goal is to advance our discussions with the FDA, such that at the end of Phase 2 meetings, we will come to a definitive conclusion on the design of the pivotal trial allowing us to initiate the trial in 2020.We have also initiated all activities to support manufacture of the pivotal clinical trial material in Q1 of 2020.Slide 27 summarizes our current thoughts on the next steps in product development. We expect the trial to include two dose groups with an active phase of 12 months and that the most likely endpoint will be microperimetry supported by continued safety.Now, let me turn to our Phase 1/2 clinical trials in achromatopsia and again begin with a brief overview of the disease. As shown in Slide 28, patients with achromatopsia either did not produce the CNGB3 or do not produce the CNGA3 protein which leads to a lack of function in cone for the receptors. As a result, achromatopsia patients have extremely poor vision and are legally blind.They also have extreme light discomfort which makes them day blind and have a complete loss of color discrimination. AGTC’s programs are designed to provide functional copies of the CNGB3 or CNGA3 gene depending on the patient-specific mutation to cone photoreceptors delivered by an engineered AAV capsid and a cone-specific promoter.Here again, we believe that our treatment approach has the potential to transform the lives of patients with achromatopsia who currently have no effective therapies. Today, we are pleased to report early data from both ongoing achromatopsia trials.As with XLRP, the safety profile in both trials remain favorable. The DSMC has supported continued dose escalation and dosing of pediatric patients. To-date, we have enrolled 15 patients in the B3 trial and 12 patients in the A3 trial.Today, we will be discussing data from a subset of those patients and the dose groups I’ll be discussing are summarized in Slide 30. Light discomfort is a significant issue for achromatopsia patients as we have developed a quantitative measurement with our academic collaborators.Slide 31 provides a visual depiction of how loglux values, the output of the measurement correspond to typical illumination levels and demonstrate how in 1 loglux improvement in light discomfort is clinically meaningful to patients.Slide 32 and 33 summarize the early biologic activity results from both achromatopsia trials. Light discomfort measurement quantifies the highest light level tolerated by patients.As shown in Slide 32, one patient in the mid dose group and two patients in the high dose groups of the B3 trial have had clinically meaningful improvements defined as greater than one log change from baseline in light discomfort at three months.As shown in Slide 33, one patient in the mid dose level in the A3 trial has shown clinically meaningful improvements using the same definition. Importantly, anecdotal statements from the patients shown on slide 34 support these improvements as being meaningful to their daily lives. For example, one patient has said his headaches from eye strain have stopped.Slide 35, as with XLRP, this evidence of biological activity furthers our confidence in the design of these trials and the potential to advance both achromatopsia programs to pivotal trials. As we analyze the data, we envision we will continue to see this type of meaningful improvement in light discomfort as well as other measures of visual function.We believe the collective encouraging data for all three of our ongoing clinical trials is supportive of our product design, construct and manufacturing process and highlights our technical excellence and is reflective of the teams’ execution over the past year.I will now turn the call over to Mark who will briefly review our recent efforts and new preclinical program.

[Mark Shearman:]

Thank you, Theresa. Slide 37, as we have previously disclosed, over the past year, we have conducted a strategic review of our preclinical pipeline. We believe that each of these programs have significant technical, clinical and commercial potential and represent attractive market opportunities in which gene therapy can potentially change the treatment paradigm.I want to emphasize Sue’s point that all have been build on the very strong foundation and vector design, manufacturing, preclinical developments and clinical trial design that we have established in the course of conducting our current clinical trials. We are excited to report that we are expanding our ophthalmology portfolio with two new programs.The first targets the dry form of age-related macular degeneration (NASDAQ

[Bill Sullivan:]

Thank you, Mark. Our fourth quarter and full year 2019 financials were included in our press release, which was distributed a short while ago and Slide 41 provides an overview of our financial results.For fiscal year 2019, we generated a net loss of $2.0 million, compared to a net loss of $21.3 million for fiscal year 2018. The decrease in net loss was primarily due to, a $17.5 million increase in revenues and a $1.5 million decrease in G&A expenses, which was partially offset by a $1.0 million increase in R&D expenses.The $17.5 million increase in revenues is primarily due to recognizing revenue of $20.4 million associated with the termination of the collaboration agreement with Biogen effective March 8, 2019. Going forward, no additional collaboration revenue related to the Biogen agreement will be recognized.The $1 million increase in R&D expenses is primarily due to incurring sub-license expense of $2.3 million associated with receiving a milestone payment for Biogen and increased employee-related costs, partially offset by decreased preclinical R&D spending. The $1.5 million increase in G&A expenses was primarily driven by a decreased employee-related and share-based compensation expenses.Now move on to our financial guidance. We ended fiscal year 2019 with a strong balance sheet. Total cash, cash equivalents, and investments as of June 30, 2019 were $82 million.We believe these funds will be sufficient to allow AGTC to generate data from our ongoing clinical programs, move our preclinical optogenetics program in collaboration with Bionic Sight into the clinic, initiate activities to ensure efficient transition into pivotal trials and fund the prioritized preclinical programs discussed today into the first half of 2021. We expect that total cash, cash equivalents and investments as of June 30, 2020 to be between $30 million and $40 million.That concludes the team’s remarks today. Operator, we may now open the call to question and answer period.

[Operator:]

[Operator Instructions] Our first question comes from the line of Joe Pantginis from H.C. Wainwright. Please state your question.

[Joe Pantginis:]

Hi everyone. Good afternoon. Congratulations on the data. Very nice to see these early data. So, couple things if you don’t mind. So, when you look at the Slides 14 to 15 for stable visual sensitivity, I just want to make sure I get some color on the interpretation of the data.Are the – say, like on Slide 14 for example, for peripherally dosed patients, the bars that are approximately 6 to 8, the ones that go horizontally, are those the balance you were talking about with regard to all of the pretesting that was conducted essentially is what you would consider the noise?

[Sue Washer:]

Well, Joe, that’s a really good question and thank you for attending the call today. The bars there represent the variability in the patient data. So, patients start with different baselines and when you kind of smoosh those together, that’s what the arrow bars represents. The arrow bars are patient to patient differences, not the repeatability coefficient that we were discussing before.

[Joe Pantginis:]

And I am just talking about, like the horizontal lines, not the deviation bars.

[Sue Washer:]

I’ll let Theresa go into some more details.

[Theresa Heah:]

So, in the graph, we can see the dotted line is treated in the legend, dotted lines equal baselines. So those are in reference to baselines for the treated eyes and also to the untreated eyes.

[Joe Pantginis:]

Okay. Now I understand. Thanks for clarifying. And then, so, when you have the baselines that were created, I guess, when you look at now I guess a comment about the natural history, because being able to see stabilization as you mentioned, I mean, this is very powerful data in my opinion and hopefully it should be received such as well.What you would expect to see even at months three for some of the deterioration in XLRP patients?

[Sue Washer:]

That’s another good question. XLRP patients actually do move their peripheral version first. So some kind of stability in the periphery is very important to patients. Theresa did mentioned that six months is a short period of time to really make a definitive call and so that’s why we will be continuing to follow these patients over the next several months to see if that stability is maintained.

[Joe Pantginis:]

Now that’s really helpful. And my last question, and thanks for your patience. I guess, just talking about, as the studies move forward and going into pivotal studies, any further optimization of delivery that you might be looking at or changes to the procedure and what I am getting at for example is, like for example, patients that don’t necessarily respond. Do you believe that there is any potential say, vector that sort of spills out from the injection side of the bleb that maybe might reduce efficacy?

[Sue Washer:]

So that’s a very good question and I am going to let Theresa answer that.

[Theresa Heah:]

These are subretinal injections, and these are cell-based proteins that do not spread throughout the retina. So, the treatment effects really in the area of the blebs. So in terms of lessons learned throughout, we have enhanced our surgical training, our surgeons are very well trained in terms of subretinal injections.

[Joe Pantginis:]

Thank you, very much guys and congrats again.

[Sue Washer:]

Thank you, Joe.

[Operator:]

Our next question comes from the line of Matthew Luchini with BMO Capital Markets. Please go ahead with your question

[Matthew Luchini:]

Hi, great. Good afternoon and thanks for taking the questions and congrats on the progress. So, I guess, I have kind of one overarching question and with it some subparts. And what that question is, is it seems like this is the six-month data, there are 10 evaluable patients and there is some initial discussion of the stabilization of those that were treated peripherally at six months.But I don't see anything about the two patients that were centrally dosed post three months. So, I guess, to that point, I'd like to know a little bit more about what happened to those two patients between months three and six. Maybe being a little bit more specific, could you talk a little bit about were they included in the 50% responders that you highlighted at week 12? And if so, maybe what happened between months three and six, and if not, why not?Similarly, sort of the same question you mentioned the seven decibel game patients. Were any of the – were either of those two patients in that group? And then lastly, the one patient that was non-evaluable, I thought I felt it’s for microperimetry. Could you just provide a little bit more color about what happened there? And then maybe I'll get back in the queue after those.

[Sue Washer:]

So, this is Sue, Matt. And thank you for those questions and having six questions in one question. So, hopefully we can – we would walk through them all and please jump in and remind us if we forget something. So, there were two patients from the dose escalation that were dosed centrally.Those two patients from the dose escalation dosed centrally are included in account of nine centrally dosed patients. So, we have provided in our analysis and those patients are included in the analysis that gets us to that 50% response rate, that gets us to the four responders. So the four responders include, one dose escalation patient and three dose expansion patients.The patient that we don’t have full data on is one of the dose escalation patients, because we don’t have the microperimetry. But that patient is included in the visual acuity analysis. We only included in the analysis three months data from those two patients because that’s the only data that we had for all nine patients together.So, wanted to be comparing apples-to-apples and we are not providing the six months data on those patients. And so we have six months that data on all of the patients.

[Matthew Luchini:]

Okay. So, just to confirm, you're saying that one of the four patients that constitute your 50% responders includes one of the patients that has six months worth of follow-up? Is that also true for the patients with the seven decibel game?

[Sue Washer:]

Yes.

[Matthew Luchini:]

Okay. Great. Thanks. I’ll hop back in the queue.

[Operator:]

Our next question comes from the line of Jim Birchenough with Wells Fargo. Please go ahead with your question

[Jim Birchenough:]

Yes, hi guys. Just want add my congratulations for the data and the promising early result. So, maybe just high level question, you kind of alluded to it in your comments, but how would you contrast the data that you reported today versus what we’ve seen from Nightstar.I think you alluded to it, but I’ll ask specifically when you look at their results and your results, how do you position your results against what we saw from them?

[Sue Washer:]

So, I think that – Jim, thank you for the question and thank you for dialing in. I think there is three things that we want to talk about. First of all, we do think our data is stronger and more robust and broader. We have a broader set of data. On specifically visual sensitivity, we think we are very comparable. On visual acuity, we are able to present some data that we think is very encouraging. That has not been reported by others.And lastly, we think that the peripheral data showing stability and something no one else has been presenting and we think this is very important to patients because of course that’s where they lose their vision first is in the periphery. So the breadth of data we have we think is very strong.

[Jim Birchenough:]

And Sue, just in terms of that peripheral benefit and stabilizing visual fields, is it too early to make comparisons to untreated areas or comparable areas that are untreated? And would you expect to make those comparisons at 12 months?

[Sue Washer:]

So, we do think it is very early. We think the data is very encouraging and Theresa pointed out, but it is early to show real stability over time compared to the untreated eye. And so that’s why we will be continuing to follow these patients out through 12 and 18 months and actually the peripherally dosed patients are in active follow-up through two years.

[Jim Birchenough:]

And then, maybe just one final question and clarification. I thought I heard Theresa mentioned when considering parameters of potential pivotal study that microperimetry would be used. So, is that to say the main focus will be on central vision? And I guess, the second part of it is, when you have a profile that shows both stability of the periphery and improvement centrally, could you envision a paradigm where you dose in both locations?

[Theresa Heah:]

We have data now at three months showing improvement centrally. Hence, our pivotal trial will be based on the microperimetry at the primary endpoint as we continue to look at a longer time points on the peripherally dosed patients, we will enhance our clinical programs to include peripherally dosed patients in the later stage of the pivotal trial.

[Sue Washer:]

And I also think that – sorry for the train noise, I also think that it is important to note Mark’s comments about all of the non-human primate work that were done - we are doing that we are developing the dataset to show that multiple blebs in the same eye are appropriate and that redosing into the eyes is appropriate. So, again that shows that we are thinking about long-term development and developing that complete set of data necessary to move forward.

[Jim Birchenough:]

I am going to ask one more question I promise not to, but I have to ask when you consider focus on improvements in vision, that’s usually easier to say that’s a divergence from natural history. And so, given that, do you think the pivotal study could get away without a control group or how would you see the control of your pivotal study?

[Sue Washer:]

I think that the guidance on the FDA has been pretty clear on what they like pivotal studies to look like and that they like to see two arms in the pivotal studies to be able to show a dose differentiation and to be able to randomize patients and eliminate bias.

[Jim Birchenough:]

Great. Well, thanks for taking the questions.

[Sue Washer:]

Thank you, Jim.

[Operator:]

Our next question comes from the line of David Nierengarten with Wedbush Securities. Please go ahead with your question.

[David Nierengarten:]

Hey, thank you for taking the question and maybe to follow-up a little bit on the prior questions. I guess, when or how would you communicate dosing to focus on the central part of the eye in RP patients or to the peripheral or both peripheral and central portions?And then, additional question would be, given the lack of information that we see or that you’ve seen in the study, is it possible to go up to another dose level? Or is that contributing to your confidence and perhaps being able to dose in two different areas in the eye? Thanks.

[Sue Washer:]

Thank you for those questions, David. I think that, and Theresa stated we are focusing on the microperimetry right now, because we have seen this improvement in vision in the centrally dosed patients and that is more straightforward as a couple of you pointed out. So that would be our initial focus. But we are definitely focused on continuing to develop the data in the periphery.So we could add that into clinical development as we move forward. And your last dose escalation question is about that always in a Phase 1/2 trial, you always have the opportunity to amend your protocol and expand your dosing as long as you continue to see safety. I think what we are most excited about, about the lack of information is as we say that much better for the patients in the long-term and gives you a lot of optionality to be able to dose in multiple locations, et cetera.

[David Nierengarten:]

And maybe just a quick follow-up to confirm or to ask were there – remind us are there any steroid protocols or anti-inflammatory agents used in the arm study?

[Sue Washer:]

Yes, all of our subretinal programs, whether it’s XLRP or achromatopsia, all have a standard steroid regimen.

[David Nierengarten:]

Okay. Thank you.

[Operator:]

[Operator Instructions] Our next question comes from the line of Yun Zhong from Janney. Please go ahead with your question.

[Yun Zhong:]

Hi, thank you for taking the questions. So, first, a follow-up on the peripheral dosing versus central dosing and it looks like the most recent seven patients in the dose expansion cohort all received central administration.So, I wonder is that because you saw the kind of encouraging data from the two patients from the previous phase, I hope, got central dosing that you decided to dose all patients in the central region or was that the original design that you were going to dose all patients in the central region of the retina?

[Sue Washer:]

So, thank you for the question, Yun. We had always planned to dose patients according to what was best for the particular patient. I think as we develop – as the data was developing, and we saw more encouraging improvements even though stabilization is very important to these patients in the periphery when we saw the improvements in the centrally dosed patients both in cohort two and in the higher dose, we did shift such that we dose more of the patients. We looked for more patients that we could dose centrally in the expansion cohort.

[Yun Zhong:]

Okay, I see. And on the improvement in the visual acuity, I wonder – are you able to share how many letters – or is it close to the 15 letters that are typically required to show clinical – meaningful clinical benefit?

[Sue Washer:]

So, we do have the letters on the slide of what the improvement was. I think that 15 letters is really a standard if that was for large market products such as AMB and I’ll let Theresa go through that data in a little bit more detail.

[Theresa Heah:]

So to your question on our Slide 20, that’s that's the arrow bar that show you the minimum and maximum vision acuity improvement. We saw patient up to close to two lines improvement.

[Yun Zhong:]

I see. Okay. And a last question, I believe the study included some patient reported outcome as the efficacy measure. Are you able to provide any information or is that still premature?

[Sue Washer:]

So, we haven’t fully analyzed the actual patient reported outcome survey. But we did include in our slides today many of the patient reported anecdotal comments that were quite supportive of the quantitative improvement.

[Yun Zhong:]

Okay. Great. Thank you for taking the questions again.

[Operator:]

Since there are no further questions left in the queue, I would like to turn the call back over to Sue Washer for any closing remarks.

[Sue Washer:]

Well, thank you all for joining us today on the call. I believe that the data presented position us for leadership in the field of gene therapy. The preliminary data from these trials show improvements in key endpoints and are very promising.As Theresa noted earlier, we have shared this information with a group of retinal experts who have extensive expertise in treating these diseases and they concur that, if sustained, these results would mark an inflection point in the treatment of these diseases.We look forward to sharing the top-line six-months data from the XLRP expansion cohort and the top-line six-months data from the achromatopsia dose escalation cohorts with you later this year. We are already engaged in multiple activities that will allow advancement to pivotal trials as quickly as possible.And we expect to move forward to pivotal trials in 2020, once we have final agreement with the FDA on trial design. We will also continue additional dosing in all three trials under the current protocol to enrich and build a robust dataset to support our BLA filing, thus maximizing the benefit to the greatest range of patients and create the strongest package for approval and commercialization.We have great confidence in our manufacturing capabilities to support all our preclinical programs, as well as the clinical programs and have in place the resources and infrastructure we need to successfully advance the pivotal trials and approval.As I always do, I will close today’s call by thanking the patients, physicians, and the AGTC team for their dedication to our cause and their support of our efforts to transform the treatment for rare ophthalmic, otologic and CNS diseases. I look forward to sharing our joint achievements with you in the months ahead.

[Operator:]

This concludes today’s teleconference. You may now disconnect your line at this time. Thank you for your participation and have a wonderful day.