Q1 2022 Applied Genetic Technologies Corp Earnings Call
[music].
Good morning, and welcome to the <unk> financial results conference call for the first quarter of fiscal year 2020 to today's call is being recorded before we get started I would like to remind everyone that during this conference call a GTC 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, including statements about its ongoing and planned clinical trials and preclinical programs.
Actual results could differ materially from those discussed in these forward looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process, the extent and duration of the impact of the COVID-19 pandemic and other risks described in the risk factors section of <unk> most recently.
<unk> annual report on Form 10-K, and other periodic reports filed with the S. E F E C H.
Hey, J T. C undertakes no obligation to update any forward looking statements. After the date of this call for introductions and opening remarks, I'd like to turn the call over to Sue Washer Chief Executive Officer of <unk>. Please go ahead.
Good morning, and thank you all for joining us during our last quarterly call in September I had the pleasure of inter.
Or do you think John lever as our new Chief Financial Officer today, I am pleased to entities Snyder, our new Chief Medical Officer, who brings extensive expertise and a track record of success in ophthalmology drug development, including the approval and launch of Lucentis her experience and insights will be invaluable as we.
Work to advance our XRP into Chromatopsia trial towards approval and as we expand our clinical portfolio with the advancement of our two lead preclinical programs towards IND filing both Susan and John join me on today's call.
Last week, we welcome Sara <unk>, Vice President of clinical operations, and we expect that her strategic leadership and contributions to the FDA approval of multiple rare disease therapies further enhances our robust clinical development capability.
Our ability to attract high quality talent like Susan John and Sarah reflect the great potential of our pipeline and technology as well as our amazing corporate culture, which is built on a shared commitment to improving patients' lives and values. The contributions that each member of our team brings towards achieving that vision.
Now turning to our ongoing clinical trials are excellent program is our nearest term opportunity to bring a potentially transformative therapy to patients living with the disease that today have no treatment option.
As many of you are aware, we presented promising data from the ongoing phase one two trial earlier. This year. This includes 12 month data from patients in the two highest dose groups in this trial, demonstrating a 50% response rate among patients who meet the inclusion criteria for the ongoing skyline in beta trials as well as improved.
And visual acuity across a wide range of patients that provide supportive evidence of biological response.
Additionally, data from a subset of patients in the high dose group, who are available for analysis at 24 months provide evidence of response durability and continued safety as a reminder, we believe that our skyline and Mr. Trials will be successful. If we are able to demonstrate the same 50% response rate as we did in patients in the <unk>.
Ongoing phase one two trial that meet the inclusion criteria and assuming too.
That we see a favorable safety profile.
In September our clinical collaborator Dr. Paul Gang assistant Professor of Ophthalmology at the Casey Eye Institute.
And data from a 12 month analysis of macular structure using optical coherence to evaluate patients in the phase one two XRP trial, the data, which Susan will review in a few minutes.
Quantify a correlation between mass and restructure and visual function.
Of course, the treatment effect of our XR P gene therapy candidate.
These data add to the growing body of evidence supporting the industry's leading potential of this product candidate and further increases our confidence and the possibility for positive results in both the skyline of Mr clinical trials.
Based on the totality of the data generated to date improvements in visual sensitivity improvements in visual acuity positive patient anecdote and doctor gangs observations of improvements in macular structure, we believe that our XR P gene therapy may provide meaningful and durable benefits to patients.
We are currently conducting the skyline phase one two expansion trial and the Vista Phase two three trial and we expect the data from both trials will support a potential filing of a biological license application or BLA.
We anticipate multiple data readouts from our excellent clinical trial between now and the end of 2022, which Susan will outline in a moment.
Each of these readouts as an opportunity to further demonstrate the potential value of our XRP product candidate and we believe that collectively these trials will provide the most robust and differentiated set of data or any XRP gene therapy currently in clinical development.
Now, let me turn to our Chromatopsia clinical program. The data reported to date support the continued development of our Chromatopsia clinical candidates and have also allowed us to identify a maximum tolerated dose in pediatric patients.
As previously reported we are moving forward with the clinical development of the <unk> program and are preparing an end of phase two briefing docs I meant for submission to the FDA, which we expect their feedback in the first half of 2022.
Path forward for our <unk> product candidate will be determined after additional pediatric patient and preclinical data are available for evaluation.
Before moving to our preclinical pipeline I also wanted to remind everyone about our collaboration with bionic sight and after genetics.
Earlier in 2021, Bionic sight announced promising initial phase one two data that showed that treated patients all of whom are complete or near completely blind can now see light and motion and in two cases tend to attack the direction of motion.
Our diversified preclinical pipeline provides multiple opportunities to expand into additional disease areas outside of inherited retinal diseases, including in central nervous system, or CNS indications and otology indications and to address large markets outside of the rare disease space such as the dry form of.
Age related macular degeneration or dry AMD.
Previously reported we have prioritized our programs in dry AMD and frontal temporal dementia for the advancement and DFAST filing and are on track to initiate toxicology and bio distribution studies for both programs in 2022.
As part of our strategic collaboration with autonomy. The Otology program is moving forward with an IND application expected to be filed in the first half of 2023.
Key to our ability to advance our clinical and preclinical candidates as quickly as possible is ensuring access to high quality scalable and high productivity manufacturing are leased build to suit current good manufacturing process, Theyre cgmp manufacturing and quality control facility remains on track.
Back to become operational in the fourth quarter of 2022, we have already made several key hires to support the design and construction of the building and intend to continue to bring in additional staff to support the validation of the facility in the second half of 2022.
Our goal for this custom manufacturing capacity is to enable an expedited BLA filing and commercial launch of our XR P product candidates subject to FDA approval and support late stage development of our Chromatopsia program.
Our investment in and commitment to this facility reflects both our confidence in the clinical and commercial potential of our accelerating chromatopsia clinical programs and our commitment to supporting more rapid advancement of our entire product pipeline.
Critically this facility will also provide supply chain redundancy and reduced manufacturing risk.
Now I will turn the call over to Susan who will provide additional detail on our excellent being a chromatopsia clinical program Susan.
Thank you Sue for the warm welcome I am pleased to join my first call as a G. P. CS Chief Medical Officer, and I'm excited to have the opportunity to share several positive updates for both of our ongoing clinical programs.
As Sue mentioned, Dr. Paul Yang presented promising new data from the ongoing phase one two XL RP clinical trial at the 14th International Symposium on retinal degeneration in September.
The data he presented were from an analysis of macular structure in patients 12 months after receiving a single dose of our XL RP product candidate.
A hallmark of XL RP is that the ellipsoid zone or E C, which is a defined region within the photoreceptor layer of the retina degenerates overtime and is eventually lost.
The data Dr. Yang presented shows that intact retinal anatomy at baseline predicts potential for improvement.
Of 20 patients evaluated in our XL RP phase one two clinical trial.
13 had intact baseline retinal anatomy.
Of which nine or 69% had either complete recovery or improvement in E. C at six months.
By contrast, the seven patients who had end stage retinal anatomy as evidenced by absence of the E Z shows no structural or functional improvements post treatment.
The data also showed that there was a significant association between improvements in visual sensitivity measured by Maya and improvements in retinal health measured by improvement in E C and groups four to six.
Among these patients four of six with Maya improvement also had E Z improvement and there was a statistically significant association between Maya improvement and easy improvement with a P value of 0.0 to one two.
We believe that these data further support a treatment effect from our XO RP product candidate and continue to differentiate the datasets for our product candidate from competitive products in development.
As Sue also mentioned, we are actively enrolling and dosing patients in both the skyline and Vista trials and expect to report multiple datasets from these trials in 2022, including.
Three months interim skylight trial results in the first half of 2022.
24 months trial results from the ongoing phase one two clinical trial in the third quarter of 2022.
12 months Skyline trial results in the fourth quarter of 2022.
And six month interim this the trial results in the fourth quarter of 2022.
Our clinical collaborator Dr. Robert Sisk of Cincinnati Children's Hospital, and University of Cincinnati College of Medicine will also make an encore presentation of the 12 month data from the phase one two trial at the American Academy of Ophthalmology annual meeting taking place from.
November 12 to 15 2021.
We're pleased to have this additional opportunity to help educate the ophthalmology community about the potential potential benefits of our XL RP candidate.
With respect to the achromatopsia programs, we recently enrolled six pediatrics.
C H M B, three patients and five pediatric hgh and three patients and higher dose groups five eight and six <unk> and identified a maximum tolerated dose.
As we have previously reported.
To address suspected unexpected serious adverse reaction for since our safety events in pediatric patients in the highest dose group.
The stomach and local steroid doses were increased.
And patients are being monitored closely.
I am pleased to say that the patients are doing well and our investigators are tapering these patients to lower steroid doses.
Importantly, we did not see comparable inflammation in the six pediatric patients across both trials at dose groups five a norm.
Nor in any of the adult patients.
Or lowest group for pediatric patients on which we previously reported and we plan to continue development of our achromatopsia product candidate.
We expect to report interim three months data for the pediatric patients and both are Chromatopsia trials before the end of 2021.
For the B three program. We're also developing an end of phase two briefing package for submission to the FDA and expect to receive feedback from the agency in the first half of 2022.
The agency's input will play a foundational role and our plans for advancing the achromatopsia <unk> candidate toward a pivotal trial.
Now I will turn the call over to John for a review of our financial results.
Thanks, Susan for the first quarter of fiscal year 2022, we recorded a net loss of $17 $1 million compared to a net loss of $15 $4 million for the first quarter of 2021.
The increase in net loss was primarily due to an approximately $700000 increase in research and development expenses, an approximate $700000 increase in general administrative expenses and an approximate $300000 increase in interest expense.
We ended the first quarter of fiscal year 2022, with a strong balance sheet, including total cash and cash equivalents of $90 5 million.
We believe these funds will be sufficient to allow us to generate data from our ongoing and planned clinical programs.
Fund currently planned research and discovery programs into calendar year 2023.
That concludes the team's remarks today operator, you may now open the line for a question and answer period.
Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
Confirmation tone will indicate your line is in the question queue.
You May press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys, one moment. Please while we poll for your questions.
Okay.
Our first questions come from the line of Joe Pam goodness with H C. Wainwright. Please proceed with your question Hey.
Hey, everybody good morning, and thanks for taking the questions.
So first I just wanted to ask about or maybe a logistical question about the <unk> events in the Achromatopsia study.
Is it safe to assume sorry, no pun intended that this is really a function of just the higher concentrations that lead to this in pediatric patients and it really as expected.
Good morning, Joe. Thanks for your question Yeah, Yeah, we really do believe that this is a dose effect and very young patients remember that these pediatric patients between the ages of four and eight years old and we didn't see any of this kind of inflammation in any teenagers in any of the lower dose or any.
Of the adult so we really believe it's a dose effect in these very young children.
Got it that's very helpful. And then more on the macro front that you guys are obviously very very busy with regard to the build out of your new facility.
You say should come online next year. So I was just curious have you had any issues or additional planning that you've had to embark upon regarding the global supply chain issues.
Yeah.
But that's a very good issue because I have a question because I think overall, Joe we're all experiencing some level of constraints due to supply chain issues for that reason, we did take a very proactive stance on the manufacturing facility and even though it is that we're breaking.
Ground in emerging dirt around we've actually already ordered the equipment that we're going to need in the facility was the idea that if it comes in on time or early that we can store it in our existing facility before we move it in there so where we're really trying to do a ton of advanced planning to make sure.
We hit our Mark of the engineering runs and in late 2022.
Got it and my last question, if you don't mind and thanks for.
Indulging me I don't know if its too early to ask this question, but are you willing to take any broader strokes with regard to the design of your future dry AMD program and how you might mix end points of.
Drew Sims geographic atrophy and also visual acuity.
Yeah, I do think Joe that it's a bit too early I can understand the interest there, but we're really right now putting together a package for the pre IND meeting with the FDA and are developing the protocol synopsis with experts and so I think we would like to wait and comment on that.
Until we have that protocol synopsis complete <unk>.
Totally understood. Thanks, a lot for the comments Sue.
Have a great day.
Thank you. Our next question is coming from the line of Doug <unk> with Stifel. Please proceed with your questions.
Hi, good morning, Thanks for taking our questions and congrats on all the progress Sue maybe if I can just go back to the Soo Saar question understanding that it's probably more dose and patient baseline age related can you I guess, maybe talk a little bit about <unk> and its function or is this something.
That's probably going to be more broad two other serotypes of AAV is there anything unique about <unk> or do you think this is going to be applicable to other perhaps ocular gene therapy programs addressing the pediatric population and then secondly, just with regards to that Dr. Yang data that you guys are just debriefed.
I saw on very interesting, but I guess, just thinking about development forward. I know previously you were thinking about mobility maze from skyline and trying to draw correlations to the visual function data I'm, making that as a potential regulatory endpoint.
I guess, where does easy come in given the correlation data that Dr. <unk> presented if you guys already interacted with the FDA about perhaps using that also as a supportive measure. Thanks.
Thanks for the questions.
Take the <unk> question, and then probably give you a top line on the CSR versus Mays, and then give susan and opportunity to to weigh in on her thoughts there as far as the capsid being differences in caps it being potentially.
More or less inflammatory we have presented data and I think we've reviewed that reviewed it publicly in our corporate presentation, where we've looked at multiple capsid side by side and when you do these multiple caps of side by side manufacturers. The same way tighter at the same way purified the same way.
We don't see a difference in the inflammatory response.
What we see is that despite whatever capsid you have at certain high doses you do see an inflammation response that tapers overtime and resolves itself, sometimes even without any steroids whatsoever and so we don't believe that anything we're seeing in the CSR has anything to do with us.
Pacific Capsid, there are some taxes, some engineered capsid that you can screen out of libraries and and some more off the beaten track. If you Wanna say campuses that do create a higher inflammatory response, but not among the T Y F or 85 or 88 or.
Or other taxes that we've looked at over time, we don't see that as a as a cognitive effect just total dose T Y S itself.
Part of how it was engineered is to actually allow it to dwell within the so longer and get into the nucleus and a higher percentage such that the DNA is.
Available to have higher expression of protein and that's exactly what we see in side by side comparisons of our T Y S. Capsid with others is that it does support in nonhuman primates about twice the expression of the intended protein as other capsid. So.
Now moving onto the Doctor gangs data, we do we have already written and talked to the FDA about our protocols for skyline and Vista, we do intend that visual sensitivity as a primary endpoint and wisdom mobility maze as a secondary endpoint along with visual acuity, we will be collecting the EZ line data.
And so I'll turn it over to Susan for her comments on its usefulness and supportive nature of supporting our product candidate.
Thank you Sue yeah for Dr. Yang.
Movements in anatomy are really quite interesting and we always look for.
Association in alignment with changes in anatomic structure and visual function.
So for that sense, the alignment with the functional changes.
<unk> are very important to be both clinically meaningful and hopefully clinically significant and outcomes and again this helps us differentiate our product.
From others and help us to meet the unmet need in these patients.
Thank you our next questions come from the line of Jonathan.
<unk> with Wells Fargo. Please proceed with your questions.
Good morning, Thanks for taking my questions. So first on <unk>.
Have a couple of questions on enrollment.
Into the Skyline and Vista trial, mainly not the enrollment status I know you generally don't provide updates to those on a ongoing basis, but.
What about the cadence and whether you think that cadence.
Give you confidence for the now.
Now our first quarter 'twenty, two three months skyline readout.
Given that you know in the past Covid has impacted enrollment and also how do you prioritize the enrollment of Vista and skyline, given the you know the potential bottleneck.
But impact thank you.
So Ian and thank you for the questions and I Hope you are having a good morning.
We don't usually provide exact enrollment statuses in numbers and types of patients, but we did report earlier as you mentioned that over the summer we had had a fairly high cancellation rate for screening and initiation of patient visits.
And that has largely gone away, we are not having those issues. The sites are seeing patients on a regular basis. We also have slowly used our mobile vision centers I think many of you have heard us talk about the mobile vision center as a way to capture data during.
The pandemic and we use that especially for Oklahoma top tier patients.
Mobile vision center that travels directly to the patients home to be able to test data. We now actually have two fully operational mobile vision centers and not only are they doing follow up visits in certain cases, theyre also screening or prescreening patients for us and this is something that.
The patients and the sites are very appreciated above because when the patients actually have to travel to the sites. They already know that they have been pre screened in the past much of the inclusion exclusion criteria and so the site knows that its time is going to be well spent with these patients. So we're we're very calm.
[noise] that we've worked through those issues in the summer and we're confident in our data guidance that we've provided.
Great. Thanks for that very helpful.
Date and also another question on the competitive landscape.
Landscape front I think a competitor reported last month data from our Entravision truly put administered AAV gene therapy for XL RP I know the dataset is pretty small and early.
Could you share your thoughts on that data set and how.
Should we think about the competitive Uh huh.
Filing of that a gene.
Gene therapy. Thank you.
So again and thank you for that question, we do believe that the data presented what was limited we have no insight other than the data that others have seen and we would think it was.
Way too early to make a statement about that data and we would wait to see more fulsome, we do believe that our product with the sub retinal delivery really supports higher expression of the protein needed to have an effect in the photo receptors in Argentina is very strong and as we've talked about.
We now see improvements in visual acuity visual sensitivity and patient anecdotes, a clean safety profile and then now the encouraging data from Doctor gang.
Got it. Thank you Susan that's that's very helpful and maybe if I may have a one last question that is for the 12 months data readout update for the ongoing phase one two study at a O what incremental data will we see a competitor with a.
The last 12 months data readout. Thank you.
So that the Doctor is this will not be presenting brand new data. It's really Susan described an encore presentation of the data, but what he will be doing is linking the data in a way that hasn't been concentrated on before.
Really showing the visual sensitivity data in conjunction with Doctor gangs analysis of the EZ line and and also going through some surgical procedures and improvements that have been there. So it's really a way of capstone presentation, you kind of pull together all of the data that's been released over the long.
Last 18 months into one consolidated fashion.
Right. Thank you Susan.
Thank you our next questions come from the line of Gela.
<unk> with Roth Capital Partners. Please proceed with your questions.
Good morning, Thanks for taking my questions and congrats on the new hires.
Two quick ones for me the first one.
The <unk> data.
As Susan noted the.
<unk> not being productive.
Bob's Oregon's back then so I was just wondering if your baseline primary perimetry.
Cash all of that is that is actually going to be able to also capture that same patient population.
So, saying well good morning, and happy to have you on the call and that's a good question because we've previously talked about how we altered the inclusion exclusion criteria between the phase one two and the skyline in Vista and I can say that we were already making.
That there there was a correlation here but.
Tweens that baseline Maya and what we would want to see in a healthy retina. So skyline and Vista already include a look at this this this imaging the EZ line and we do believe that what we have set for skyline and Vista will capture.
The intent and the findings that Doctor and gang head.
I remember last when he was just about the same study and this is our wishes wondering beyond.
Treating those patients with steroids on location is still being enrolled into the study how do you.
Plan to proceed regarding Joe's and you know any.
Any thoughts on whether or not that suits, our may have impacted or will impact our involvement into the study.
So we had completed enrollment in phase three of all intended patients and.
I think as we noted previously in a three there was only one more patient intended to be enrolled in that very high dose and the young age group and we have held off on that we are not dosing that final patient in that very high dose, but we think it's prudent to collect long term data and make sure those things.
<unk> are doing well.
And don't have plans at this time to dose that last patient.
Thanks.
Thank you. Our next question is coming from the line of Matthew Luchini with BMO capital markets. Please proceed with your questions.
Hi, good morning. Thank you so much for taking the questions.
Maybe just to start to with a bigger picture question wanted to ask about the recently announced.
B CTG, the bespoke gene therapy consortium.
On among other things I'm just wanted to get your perspective on that effort and try to understand how the DTC.
May be able to leverage whatever findings are eventually resolved from that group.
Then secondarily and more specifically to the company wanted to ask.
Following the RSO debt up Crazy presentation of XR predated are so you know.
One of the larger meetings, where the state is 1% I was just curious if you could provide.
Any anecdotal physician feedback have you gotten at the meeting.
Then lastly on Chromatopsia, just housekeeping wanted to confirm.
If any of the <unk> patients are now fully off of steroids. Thank you very much.
As far as the V. C. G T. We think that this is.
And excellence program that has been started and we are very much engaged in and participating in in learning what they bring.
Bring forward and we'll definitely and definitely think that sharing at some level of information and data around gene therapy treatment is positive for everyone in the industry and so we'll be watching that very carefully.
As far as physician feedback we've had very positive physician feedback on our actual ERP program and as I have mentioned before going from skyline and into Vista, we're expanding the number of sites dramatically and really have not had an issue with <unk>.
<unk> been interested in becoming sites in going through the surgical training and really expanding our reach across the country and into the EU.
Based on the data that we have seen so far so very positive physician feedback there and honestly Sars and the chromatography of patients as Susan noted all of those patients are tapering off steroids, but none of them are completely to zero yet it hasn't been.
A long enough period of time to get down to baseline.
Okay. Thanks for that.
Thank you as a reminder, if you would like to ask a question. Please press star one on your telephone keypad.
Our next questions come from the line of Kristen <unk> with Cantor Fitzgerald. Please proceed with your questions.
Hi, Good morning, everybody. Thanks for taking my question just a quick one here as you really had the first back to back six month data in January last year literally right before the pandemic I wanted to ask how these in person medical meetings that are taking place, including a O are really going to be.
Helpful. In terms of you getting the word out, especially because you haven't had too many in person opportunities. Since this initial data as well as the follow on updates have been presented.
Thank you for the question Kristen I do believe that as a meeting.
<unk> returned to a more normal cadence and we have more opportunity to interact with people more broadly, but that will be generally helpful. But as I stated, we've been very effective reaching out to the physicians and educating them through our key opinion leaders and we've really.
Anticly expanded as I mentioned the number of sites that are involved in the trial and referring to the trial. So while I think initially there was some lag and and I'm concerned about getting the word out I think that that has really we've been able to be very effective later during.
That makes sense.
But you're certainly right.
I went to my first large conference a couple of months ago and it really reminded me how well you can do interacting with people really getting out there questions really providing good feedback when you're when you're face to face. So we're looking forward to a oh, we're very much looking forward to ARVO and <unk>.
D C T and in the first half of 2022, and we do think that this will increase our ability to get the word out on our programs.
Thank you and then just in light of this recent data at the international Symposium and really starting to put all of the endpoints together and see some correlation it seems which is not necessarily unique to the company that of course earlier intervention is really what's going to lead to.
To the best potential outcomes. So as you start to think about this and awareness increases.
But implementations or factors are you considering right now to make sure that the patients that are out there are really getting diagnosed or tested earlier on where there is potential for greater benefit at that point.
So as far as getting the word out person I think that that's another good point that you're making now how do we get the word out to physicians will get the word out to patients and that's where I think our long standing commitment to patient advocacy and our partnership with the foundation fighting blindness as well.
There's a wide range of patient advocacy groups really stands us in good stead and we do a lot of work on education and outreach within this area.
Foundation fighting blindness, now has a registry called my my retina, whereas it actually provides services to genotype patients and we're very supportive of that effort and I think that this is the way the grass roots on connections to the different patient advocacy groups. This is how are you.
Get the word out and make sure people are genotype and aware of potential clinical trials and then eventually a potential product.
Great. Thank you very much.
Yeah.
Thank you. Our next question is coming from the line of <unk> Zhang with <unk>. Please proceed with your questions.
Hi, good morning, and thank you very much for taking my question. So a follow up question on the <unk> I'm, sorry, if I missed it but did you say that you looked at those patients at six months and did you look at untreated eyes, and how do they compare to treated eyes and also did you look at the patients at 12 months and maybe up.
Four months.
And I have a follow up question. Please.
Thanks for the question and you know the data that Dr.
Being analyzed as really very interesting he was looking and in the presentation given and the data that we're describing at the 12 month time point.
And certainly based on what we observed at 12 months, we would be very interested to see what at what how that data matures at the 24 month time point and then Susan do you have any further comments to add.
No as I said, it's you know it's important to have an alignment with what is a functional changes as well as the structural changes.
Some of these and there was a comment made earlier about treating earlier when we have treatments and I think that that's supported by these data at looking at the baseline retinal anatomy to hopefully predict outcome.
Outcomes functional outcomes very exciting data and I agree longer term data will be very important for us to look at as well.
Okay.
Remember that most of our previously reported virtually.
No change in terms of the structure.
So RP patients, but recently under the company reported.
Two questions, one probably a little over 10% decrease and the other one probably around 25 decrease from baseline and treated on so it seems to be a lot of inter patient variability and is that mainly due to baseline disease severity or anything else can contribute to them.
Very.
Variability in this area.
That's another good question I cant comment in detail on the data that you're mentioning from Knight Star, which was a program picked up by Biogen, but I can say that excellent P is heterogenetic heterogeneous and its patients and it can.
Sometimes we very age related depending on what age of the patient is compared to the age of another patient.
But all of these patients do have a steady decline.
In there there the health of their macula as it's being measured in our case by the EZ line. So it's not surprising that untreated eyes do decline over time, that's very well documented that that's what's happens in these patients and that's why we're so committed to bringing a product forward because without treatment all of these.
Patients are going to go blind there there is there that's what the natural history studies says that's what all these patients expect.
Okay.
Last question on the briefing documents for the B III program.
Chromatopsia any changes in terms of.
Efficacy endpoints, you would like to propose to the FDA.
No, we're still putting that briefing package together and like my comments about the protocols for the dry AMD I think until we have that briefing package put together and have received feedback from the FDA will will withhold comment, but as we did with <unk>, we will fully.
We report our interactions with the FDA and they agreed upon protocol.
Okay, great. Thank you very much.
Thank you there are no further questions at this time I would like to turn the call back over to Sue washer for any closing comments.
Okay.
Thank you our first quarter of fiscal 'twenty to reflect the continued execution of our clinical trial strategies, where our excellent Fianna Chromatopsia gene therapy candidates, we are generating robust clinical and patient reported data that we believe will support the submission of our BLA for our industry, leading excellent T product candidate <unk>.
And will also enable us to engage in productive discussions with the FDA with regards to the next steps in our Chromatopsia B III program. We are proud of the quality quantity and diversity of data that we have shared with our medical scientific patient and investor communities for excellent opinion of Chromatopsia programs and we are excited.
About the potential for each of these products to transform patient care, because we're committed to pursuing visionary science to advance the quality of care for our patients.
Our investment in our new leased manufacturing and quality control facility are a key part of our strategy to advance the development of both <unk> and our chromatography and programs as rapidly as possible towards potential approval and commercialization.
We know that patients with these diseases have waited their whole lives for a therapy that could have make a meaningful difference and we're committed to addressing this urgent need.
The addition of John Susan and Sara our team has never been better positioned to prepare for the multiple opportunities that lie ahead.
The substantial progress we have made in our clinical programs would not be possible without the continued support of our clinical partners and our investors and most importantly, without the continued space is it patients who believe in our technology and our commitment to their cause I think all of them and I look forward to sharing our progress with them and with you.
In the months ahead.
Thank you that does conclude today's teleconference. We appreciate your participation you may disconnect your lines at this time.
Great day.