Q4 2021 Applied Genetic Technologies Corp Earnings Call
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Good afternoon, and welcome to the <unk> fourth quarter and fiscal year end 2021 financial results Conference call today's call is being recorded.
Before we get started I would like to remind everyone that during this conference call.
T. He 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 projects, including statements about its.
Current and planned clinical trials 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 COVID-19 pandemic and.
The risks described in the risk factors section of a G. T. Six most recently filed annual report on Form 10-K, and other periodic reports filed with the SEC.
A G T SEC undertakes no obligation to update any forward looking statements. After the date of this call for.
And opening remarks, I'd like to turn the call over to Sue Washer, Chief Executive Officer of H T. T. SEC. Please go ahead.
Good afternoon, and thank you all for joining us today.
With me on today's call are Jon Lieber, Chief Financial Officer, Stephen Tucker, Our Chief business Officer and.
<unk> find that our executive Vice President of global clinical strategy. During today's call I'll review, our recent accomplishments Steven will review recent business development activities and John will provide an overview of our financial position and then all of US will take your questions.
We've had many notable accomplishments during.
And Matt here and several since our last quarterly call in May all of which enhance our vision of using our gene therapy expertise to develop groundbreaking therapies for people with rare diseases.
In May we reported positive data from the ongoing XRP phase one two clinical trial, including 12 months data.
Oh from groups, five and six reflecting a 50% response rate among patients who would meet the inclusion criteria for the skyline and Vista trials and 24 month data from two or three groups for patients fighting preliminary evidence of response durability.
Taken together these data add to the body of evidence.
Suggesting that durable improvements in visual sensitivity in visual acuity, maybe achieved in patients receiving a D. D. C X L. R. P product candidate, while continuing to demonstrate a favorable safety profile.
As we said at the time, we believe these data are an important advance for the field of gene therapy.
Our pizza retinitis Pigmentosa and we look forward to the presentation of that data at the Rd 2021 meeting next week by the Doctor Paul Gang and if the a O meeting in November by Dr. Robert Tick two of our principal investigators.
We are proceeding with our skyline investor trials due to several.
Challenges related to the Covid pandemic, including a greater than 50% patient screening cancellation rates in July and August we are amending our guidance on the three month interim data release for skyline to the first half of 2022 but maintaining our vista six months interim data release.
For fourth quarter of 2022, we have made several logistical improvements to support patient recruitment, including adding a second mobile vision center to prescreen screen and conduct follow up visits for patients as well as the significant expansion in the number of sites initiating for Vista.
Turning to our programs developing products to treat a chromatopsia in June we reported 12 month data from our ongoing phase one two of Chromatopsia clinical trials, including data from all adult patients and low dose group for pediatric patients for our chromatography it'd be three candidates results demonstrate.
<unk> biological activity based on improvements in visual sensitivity in the treated area measured by static perimetry as well as improvements in light discomfort measured by the ocular photosensitivity annualize or are open and are supported by anecdotal patient reports.
The safety profile for.
All adult patients and low dose pediatric patients remains generally safe and well tolerated of course, we are incredibly pleased with these data, which further support our position as a leader in the field of ophthalmic gene therapy. We are confident that these data provide important validation for the broad potential of our AAV technology platform.
Or and build on and extend the favorable safety and efficacy profile observed to date in the clinical trials of our XR P product candidate.
We are advancing their chromatopsia biscuit trial to the next stage of clinical development by preparing assays for pivotal ready testing planning production of the clinical trial material.
A form and drafting an end of phase two briefing package to submit to the FDA. We expect feedback on the end of phase two submission in the first half of 'twenty to 'twenty two.
We recently enrolled six pediatric chromatopsia be three patients and five pediatric achromatopsia Ace III.
Zero chance in higher dose groups, five eight and six a myth.
The six patients across both trials in group five a had a generally safe and well tolerated safety profile similar to all adult and the low dose group for pediatric patients previously reported.
And.
Patiently three of the five patients at the highest dose group six a developed new S. H E. A significant inflammation at approximately one month. After dosing. These are considered suspected unexpected serious adverse events or sue Sars.
Of the three patients too.
Unfortunately, three trial and third is in the BP <unk> trial and additional B three pediatric patient at the same dose also developed significant inflammation during approximately the same post operative time frame.
But this event while considered an ethic he did not meet the definition of CSR.
We're in the who address the above safety events systemic and local steroid doses have been increased and patients are being monitored very closely.
These events lead us to believe that we have found the maximum tolerated dose in pediatric patients.
He's doing data do not change our plans to continue development of their chromatopsia.
Candidates as the body of data gives us confidence in our plan to move forward at appropriate doses.
In March 'twenty, 'twenty, one bionic sight, which has responsibility for conducting our partner after genetics phase one two trial reported promising results in its first two cohorts of patients.
The unexpected.
Product reported that the treated patients all of whom have complete or near complete blindness can now see light and motion and in two cases can detect the direction of motion based on this report the product appears to be safe and well tolerated and bionic sight is continuing to enroll patients at the highest dose levels.
Children Nurenberg the C E O a bionic sight presented an overview of the trial, including additional positive interim results at the gene therapy for ophthalmic disorders conference earlier today.
Now I'd like to turn briefly to our preclinical pipeline our preclinical pipeline now focuses on one additional ophthalmic.
Ophthalmic program, which targets the dry form of age related macular degeneration, or dry AMD and two programs targeting central nervous system or CNS disorders.
The CNS programs address frontal temporal dementia or F. T D N a.
Oh Tropic lateral sclerosis, our ALR.
Tom.
These disorders represent diseases that have substantial patient populations and well defined genetic and clinical phenotype.
The genetic targets for these indications are pro granular for F. T D and C nine or 72 for E. L F.
In each case, we have used our deep scientific skills.
A L up to design a unique product candidates optimized to meet specific needs of patients with these indications.
Our dry a M D and F. C. D programs are moving forward to I N D and.
Despite the current global shortage of nonhuman primates caused by the Covid pandemic, we have been able to secure enough nonhuman.
Gilead to initiate toxicology and bio distribution studies in 2022.
A G. T. C. Also has a collaboration with autonomy for a genetic form of hearing loss with an I N D submission anticipated in the first half of 2023.
Our pipeline programs build on our industry leading AAV.
You'd be manufacturing technology, and expertise, while enabling us to expand into a broader array of indications that have substantial unmet clinical need for example, a 50 liter manufacturing wrong has produced an estimated 2000 ophthalmology doses.
Just on to any data generated at our facility and by our CD mode.
We believe that our manufacturing process is not only more productive than other methods, but also produces material with greater purity in that the percent of vectors containing the desired gene of interest is nearly 90% and process residuals are generally below the detectability of current test methods.
Earlier this year.
<unk>, we presented data at the S. D C. T annual meeting that describe improvements in the manufacturing process for our XR P product candidates to support future development, including potential commercialization. These same improvements will also be used manufacturer material.
Taking him a great addition to our team and you will hear from him shortly.
Finally in February 2021, we strengthened our financial position with a public offering resulting in gross proceeds to the company of about $79.0 million. We are confident that this will provide us sufficient runway to accomplish our near term.
Goals I.
I'll now turn the call over to Steven for comments on business development.
Unless you Sue on the corporate development front.
This past year, we entered into two license agreements that will allow our technologies and data to support continued development for potentially transformative therapies for inherited retinal diseases.
While also creating new potential revenue opportunities sugar licensees to successful in that endeavor.
In April we entered into a licensing agreement provides our proprietary cone specific promoter technology to staring vision SaaS.
<unk> Medicine company, developing Britain saving treatments for ocular diseases ADT.
<unk>.
And <unk> share a common mission to improve the health envision a patient suffering from inherited retinal disorders.
<unk> received an upfront payment and is eligible to receive milestone payments for successful clinical development and royalties on future sales on a per product basis.
Also in April we entered into a licensing agreement with <unk>.
International under which we provide team Don with the clinical trial material preclinical and clinical data generated for the development of our investigational intra vitriol gene therapy candidate for the treatment of excellent Gartner keeps us or XL Rs, which is an inherited disease that causes loss of vision two degeneration of retina.
<unk> <unk> is eligible to receive milestones and royalties based on clinical progress.
Now I'd like to turn over the call to John to review our financial results.
Thank you Steven for the fourth quarter of 2021, we recorded a net loss of $13.0 million compared to a net loss of $19.0 million for the fourth quarter of 2020.
The decrease in net loss was primarily due to license fee revenue of $500000 from our sparing vision arrangement a reduction of $500000 in R&D expenses, primarily due to the timing of such activities and an income tax benefit of $4.0 million from the reversal of certain income tax reserves.
<unk>.
Partially offsetting these items was an increase in interest expense of 500000 from borrowings under our secured loan agreement, which closed on June 30 of 2020 and was amended and increased in May 2021. Additionally, general and administrative expenses were up slightly year over year.
For fiscal year 2021, we recorded a net.
<unk> $65.0 million compared to a net loss of $54.0 million for fiscal year 2020. The increase in net loss was primarily due to reduction in total revenue of 2.0 million an increase in R&D expense of $14.0 million and an increase in G&A expenses of <unk> 9 million and a decrease in other.
Other income expense of $8.0 million par.
Partially offsetting these items was the income tax benefit of $4.0 million attributable to the reversal of income tax reserves, which I mentioned earlier.
The change in revenue is due to certain fiscal year 2020, noncash collaboration revenue from our bionic sight arrangement that did not recur in fiscal 2021.
Loss and increase in R&D expenses is primarily the result of increased external XL RP spending for planned manufacturing clinical site preparation and other activities related to our skyline and Vista trials as well as increased external spending for planned material production costs in connection with our CNS preclinical program targeting <unk>.
Partially offsetting.
Pieces were lower external achromatopsia costs.
The increase in G&A expense was primarily due to higher legal fees, which were partially offset by a reduction in employee related costs.
The decrease in other income expense resulted from lower investment income and higher interest expense during fiscal year 2021.
Now I.
I'll move onto our financial guidance, we ended the fourth quarter of 2021 with a strong balance sheet, including total cash cash equivalents and investments of $107 million as of June 32021. We believe these funds will be sufficient to allow us to generate data from our ongoing and planned clinical programs and fund currently planned research and discovery.
These <unk> programs into calendar year 2023 that concludes our remarks today operator, you may now open the line for question and answer period.
Certainly ladies and gentlemen, if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue. Please press the pound key.
Our first question comes from the line of Matthew.
<unk> from BMO capital your question. Please.
Hi, good afternoon, and thanks, everyone for taking the questions.
First on <unk>, just wanted to understand a little bit more.
The revised.
Guidance timing.
And I guess in particular trying to understand how much of a function of cancellation, which is sort of implied in the press release versus screen failures or perhaps said another way how much of this is going back to those people that you've identified that just canceled versus needing to go out and actually get more patients.
Good afternoon, Matt. Thanks for the question, that's something that really is very pertinent to to explain and to understand we did have a 58% cancellation rate is the exact number that we had in July and August and so a great deal of what we're gonna be doing is going back to.
All these patients and rescheduling them in two.
<unk> to actually be screened we did every trial is the screen failure rate in that place that plays a role, but we really feel like by bringing these patients back in that we'll be able to meet our guidance and we're working as fast as we can.
And we also think another big part of being able to ramp back up is that we have added that second mobile vision center.
That our first one has been very well used very appreciated by the site and by the patients and so we think by having the second.
Mobile vision.
Center that will also really help us to finish enrollment of the trial.
Okay, great. Thank you and maybe on a chromatopsia.
A couple of safety events here.
Maybe the first one would just be is there anything about those patients that experience.
The few Sars that was somehow differentiate.
From a baseline characteristic perspective or anything else from the others.
And Matt do you want to address that question sure sure. Good question Matt.
What really differentiates them is out there with pediatric subjects and they were at the <unk>.
Highest dose youre talking about much younger patients.
The adults, who had been dosed and who did not have any.
Issues of inflammation at that same dose.
Okay, and maybe just lastly, and would be.
Can you.
Just I guess confirm that the.
You mentioned pediatric patients, but that the product that they received was.
Yes cleanly are properly manufactured in other words, there's nothing from a contamination perspective or anything like that and with that I'll get back in the queue.
Yeah, Matt.
That's a very good question and it's very simple. It's the exact same lot. We have used one lot to treat all patients in the trial. So there was no difference in the lot and the material had actually just undergone a a stability point. So we're very confident that.
This is not manufacturing related for sure and and not related to profit.
Okay. Thank you for taking the question.
Thank you. Our next question comes from the line of Joe pension is from H C. Wainwright. Your question. Please.
Hey, everyone. Good afternoon, and thanks for taking the question as well.
And just with regard to these aes first I just wanted to find out are the other steroids working well in the.
And these kids are doing okay at this point.
So Matt you want to address that question from Joe sure sure. Good question, Joe Unfortunately, with the adjusted steroid regimen and other treatments.
So I can.
Have been responding.
This is early days of course, and so we continue to monitor the patients are being seen more frequently than originally planned as you would expect.
And we're hoping that the FDA.
Adjusted regimen continues to control it.
These patients perfect and its and its great also to the detail you just gave about all coming from the same lot. So I guess I would combine my question with the comment saying.
If I recall I believe that this higher six a dose at this highest dose is approximately three fold higher than the dose before.
Information of that and if you can confirm and then I guess I I hope. This is a rhetorical statement that you know you've essentially delivered on how the clinical study was designed to be able to you know appears to be the maximum tolerated dose you know and this is what dose escalation studies are four and now you have.
For the correct information to move forward with.
Well. Thank you for that question and comment Joe and I can confirm that that highest six eight dose is an easily talking about.
Ultimately three fold higher than the dose group five.
And so if you have remembered that correctly.
Appreciate your comment we actually talked about this at a meeting today that part of the reason to do a dose escalating study is to identify if there is a maximum tolerated dose and that's exactly what we think we've identified here for pediatric patients and it shouldn't be all that surprising in the realm of drug.
And I meant that a maximum tolerated dose for pediatrics might be different than a maximum tolerated dose for adult patients.
Got it and then I don't know if this is going too much into the weeds, but was just curious with regard to the timing of the suits are.
Being about one months later or does this have anything to do with say the kinetics.
The amount of the transgene expression or distribution.
Matt do you want to try and address that question.
We probably don't have enough information to know, but but Matt maybe that's right no I think that's exactly right. So I don't think we know okay.
No problem and that's if I could just switch gears really quickly and this is more of a microscopic type of comment obviously been making a lot of progress with bionic sight. You are in the clinic now and just recently Novartis bought another after genetics company. So it looks like we're seeing a real increase in the visibility about after genetics.
<unk> for them I'm, just wondering if you had any.
It's more generalized or macro comments about the space.
Well, we we have always felt Joe that Astrazeneca is a really exciting space and you know we thought out and partnered with bionic sight several years ago and we're we're very excited.
Plot out the space and think it could be a real benefit to patients that have lost their photo receptors. So no amount of Jinan week patients is going to help those patients weight gain any vision and so we think it's a very exciting space not surprising that novartis would be interested in it we feel like we have.
At about <unk>.
Advance program, we're generating the human clinical data now so certainly farther forward in development than the other two programs that novartis is involved in.
Got it thanks for all the details.
Thank you. Our next question comes from the line of John from.
Capital Partners your question please.
Okay.
Thanks for the update and thanks for taking my question I think the first one for me is also about the information I was just kind of concerned or I'm curious about.
What kind of link you began to see some signs of information.
Yeah, Thanks for that question and I'll pass.
With that over to Matt and he can review with you the timing in course of the inflammation that we've seen.
Alright so.
Is that good that inflammation has been seen approximately one month after the surgery.
And the majority of the.
Of course, it varies by a few days in one direction or another it is approximately one month post dosing.
Thanks, Matt that's good to Nashville, the patients that have cleared that hurdle and it's unlikely that that will probably see something in those patients beyond let's say two months or so.
Then well go next to unemployment is just confirming that you're probably going to move forward with a separate pediatric down.
Separate adult dose and then when might we see back from the pediatric patient population.
So as far as what we're going to move forward with our Chromatopsia.
Three we are still compiling all of the data and developing our protocol. We did have a very productive meeting.
Meaning with all of our investigators and Kols about the protocol design for the from perhaps the a b C and we think right now it's premature to decide.
Right I mean exact dosing plan, obviously as we finalize that protocol and submitted to the FDA well, we will decided upon a dose for adults and teens.
And going forward and so you know that's what we can say as far as our guidance on loan will provide.
Peter on the pediatric patients that we dose we were standing by our guidance of by year end that we will have efficacy data for these patients.
Thanks, and then the last one for me is kind of a combo question that the first part is just about bionic sight any update on additional patients I haven't.
Got it and then the last thing any comment on your preclinical pipeline.
I know you are still kind of working on the timeline of things, but any color as to what could be moving further up the pipeline. Thank you.
So kind of friends Bionic sight program that would really be a question.
For Bionic sight. They have they are in charge of and have responsibility for the completion of the phase one two so we let them speak to the timing.
Sheila as I said did present today at about 130 at at a conference and so I would it was at the second annual.
Been gene therapy, and Ophthalmology conference and so potentially.
I haven't listened to it yet, but potentially she noted some timing there. So I would direct you to bionic sight for that as far as our preclinical programs as I mentioned, we've been able to secure the nonhuman primates, which was really no small path by our.
Research group, such that we are going to conduct the toxicology and bio distribution studies for both pro granular and dry AMD next year.
So that those studies will be beginning in 'twenty two.
And then we also noted that the histology program.
Is the I N D is under autonomy fans.
They have messaged that that I N V will be following in the first half of 'twenty three.
We are moving those report program forward rapidly the AOS program is still in discovery.
Page in that where we're defining the exact product construct but we've had some very exciting data coming out of R&D.
D and are hopeful to identify that that product construction.
Thank you.
Thank you. Our next question comes from line of U N jump from B P. I G. Your question. Please.
Hi, Thank you very much particular question.
So my question is what.
But do the comfort that you don't have to change the Vista the timing for visa data Brito is that because the number of patients is not specified where do you think.
You will be able to catch up in terms of patient enrollment.
So yeah. Thanks for the question and I think that's a that's a very good question.
Good for them that we did adjust the timing for skyline in it and the reason we're not adjusting the timing for Vista is because we're benefiting from a couple of things. One we will have the mobile to mobile vision centers fully on board and we'll be able to use those for Vista also.
And give us significantly more sites initiating per visitor than we have for skyline skyline, we relied on our phase one two sites instead of the expanded number of sites. We've activated and are activating for Vista. So it's a combination of the greater number of sites, having two mobile vision.
Vision centers and having been out in the marketplace working on skyline. If there is some overlap between the sites and so these sites those sites at least are very engaged in and moving forward and then obviously we are hopeful that in the Oh that's it.
Asking bandwidth issue at the academic referral centers due to the pandemic will be alleviated somewhat so those are the factors that that play. We've also dramatically increased our patient outreach campaign and our website.
At present, our patient advocacy interactions et cetera, So we still feel very confident in our Vista guidance.
Okay and the second question. So a follow up question on the inflammation and is it normal for pediatric patients to have a lower maximum tolerated doses compared to adult patient four.
Hum.
Type of firm injection.
So as you.
You know and I think that that's a complex problem.
I think that overall in the life Sciences, it's certainly not unusual for pediatric patients to have lower doses of a wide variety of medications.
<unk> then the adult doses I think that's quite common.
For even over the counter medications.
In gene therapy, I think it's hard to say, what's common because there are not a lot of examples out there, but certainly many gene therapy products are our dose.
Vector genomes per kilogram, which by definition means that piece will have lower doses.
Don't think that we have enough data out there in the ophthalmology space to be able to say, what common or not and then I would ask Matt. If he has any other insight into the question.
No I think you answered it.
Thank you.
Okay, great. Thank you.
Thank you. Our next question comes from the line of Kristen <unk> from Cantor Fitzgerald. Your question. Please.
Hi, good afternoon, everyone. Thanks for taking the questions and John Congratulations on your appointment.
I wanted to first ask a question I noticed throughout the summer or some of your press releases and your Linkedin media channels that you do a lot of work with different sponsorships and activities across some of the different patient organizations and obviously, while talking to Kols plays an important role of your job.
I wanted to ask is you've spent a lot of time with these groups, particularly for Chromatopsia what have been some of the key takeaways or things that you're learning about the patient groups that perhaps you didn't know.
When you first started trials here or things that have been perhaps heightened can start.
Well Kristen. Thank you hear the question. Thank you for joining us today and I really appreciate the question because we believe that our role and patient advocacy is is very very important and you know early on I'll just I'll tell one story and then I'll pass.
Pumps, it over to either Steven or Matt to expand but you.
I'm going on it was our relationship with the Chromatopsia patient groups that allowed us to understand how important light discomfort was to them as is interfering with their quality of life and that's where we started working with Bascom Palmer to develop the new light discomfort testing.
We think these close connections with patients are critical to really understanding their journey and to be doing the right tests and get the right information to help them make health decision. So you know I think that's just one example, and I'll I'll I'll encourage Stephen and Matt.
And to chime in.
Before they do I'll, just also mention that having these relationships and getting the information out to them also is very helpful in recruiting patients into trials.
So first one on one other aspect of this is that these organizations have.
Networks.
Two dimensions to the health care providers are actually treating patients.
So in the same vein as a very effective way to.
Leverage our communication out to the right people, who are going to communicate with the patients who might be affected by the disease and that might be eligible for treatment.
Great. Thank you for sharing that and then a question on X L. R. P understand of course that the pandemic is playing a role and the trial, particularly related to these greater than 50% patient screening cancellation rates, but I wanted to get your thoughts about just interest in enrolling in trials whether.
Ah patients is actually able to as a result of the pandemic. At this time are you seeing any different trends and this related to what you saw when you were initially recruiting for that phase one two trial, so essentially what I'm trying to get at here is outside of the COVID-19 pandemic implications, whether having positive.
Whether or not on hand has made it easier to recruit patients in general.
So I think that's a very good question and it kind of tries to pull apart probably what what what is the patient outlook and what is the specific impact of the pandemic and we certainly believe that the.
Live nation very much wants to participate we have many many patients that want to participate in and some of them don't qualify for some reasons based on our inclusion exclusion criteria and they can be very disappointed in that information. So the cancellations have been due.
To travel issues due to the pandemic, alright, or due to just staffing and bandwidth at the site and so it has not been a reflection of the patient excitement about the program we have many more patients calling in expressing interest.
And we then we have room for in the trial. So we think that the positive data, we've put out and the and the favorable safety profile has been very helpful. In moving this program forward.
Thank you appreciate it.
But you weren't next question.
Tristan line of Dae Gon ha from Stifel. Your question. Please.
Hi, Good afternoon, guys. This is jacques on for Dave Thanks for fitting us in here and taking our questions.
First on <unk>.
So mobility test.
To be utilized in the Skyline trial can you remind us how different.
It is from other mobility tests out there.
Well that that's a very good question because we're we're you know we're very excited about the addition of the mobility test in the information that it can provide for us.
Because we were one of the few groups in the XRP space that has seen improvements not just in micra perimetry, but it also.
Improvements in visual acuity and so the mobility maze really is kind of an umbrella task, which will be able to pick up both of those kinds of improvements and then I'll pass it to Matt to talk about the the test itself and what the characteristics of the tests are sure.
Also a good question, yes sure. So it's a mobility course, it's not too dissimilar from the course of the years.
That's the basis of approval from external.
It was roughly models on it but it does have improvements because the field has continued to advance.
Have there been learnings and so we continue to optimize these tests.
It is of course that is adapted each time the patient goes through the course, it's a different course of course.
I'd say that it's less predictable.
And incorporates different price levels and assesses.
Most light levels of patients able to navigate within a certain time period.
And we use an external vendor who has an expertise in developing this course and its airport standardized across all of our clinical trial sites.
Got it thanks, and then and then.
Leggett fit in one more here on your R&D day, you spoke.
The importance of quality of life measurements to contextualize the therapeutic benefit.
Just where are you currently in terms of developing one and.
It validated.
Matt do you want to address that question.
Sure.
There are existing quality of life instruments in the ophthalmic space.
That has been validated and are you is there a tape and standardized is used for a long time.
None of.
It was <unk>.
Instruments is specifically designed for XRP. Unfortunately, so while it does cover some of the aspects of the FRP patient experience.
Not specific to their experience we've looked into developing.
Question.
Of those that are more specific and that's an ongoing process.
We haven't yet finalized any particular question here are there yet.
Got it got it thanks.
Great. Thanks for taking our questions and congrats on the progress.
Thank you. Our next question comes from the line of genuine Ju from Wells Fargo Securities. Your question. Please.
Hi, Thanks for taking my questions.
So only.
Inflammation for banks.
Wondering have you.
I've been able to determine whether.
The only option was directed towards the trans team.
The factory itself.
Thank you for the question Yana and Matt do you want to address it.
Yes, that's not something that unfortunately, we've been able to.
[laughter] identify yet I think that's.
Got.
It's still early days these events are still fairly recent.
And so again as we mentioned being monitored very closely but we don't yet have the data that would allow us to grow that kind of conclusion.
Got it.
And.
Also wanted to ask about.
Any potential read through to the XL car T program.
It might be helpful. If you can review.
The SAE is that you've seen in Europe.
Our T trials so far.
And perhaps also whether you have dosed any pdx.
The expectations.
Our T trial.
The same group six those are seen.
With the information with the AC H M. Oh, Thank you very.
Very good question and it's a pretty short answer so we did not.
Patients between four and eight years old and XRP trial at any dose.
And we're moving forward in the Skyline and Vista with the group five though we did not move forward with the group six dose.
So even though we plan to treat page younger patients at.
So going forward in XRP, we are not going up to go script six week selecting dose groups five to move forward into the skyline and Vista trial.
Yeah.
Yeah, Yeah got it that's very helpful. Thank you.
Yeah.
Thank.
And this does conclude the question and answer session of today's program I'd like to hand, the program back to Sue washer for any further remarks.
Well thank you.
We are excited to close out our 2021 fiscal year with a great sense of pride in all that we have accomplished over the last 12 months and the momentum we have created as we progressed.
Gross towards multiple data readouts, the growing body of clinical data that gives us confidence that our excellent key candidate has best in class potential and we are matching our clinical progress with critical advances in manufacturing and quality control capabilities as we chart a path toward commercializing a potential transformative treatment for this.
Disease.
We are excited to be moving forward, our chromatography or be free program, which will become our second late stage asset and we look forward to receiving FDA feedback on our end of phase II submission.
We are also proud that we have identified licensing opportunities that will allow our technology to support other organizations that share our.
Our commitment to improving outcomes for patients and their efforts to develop ocular disease therapies.
We have multiple critical data readouts and our excellent opinion of Chromatopsia clinical programs expected later in 2021 and in 2022 that we believe will further solidify our position as a leading gene therapy.
Company support our efforts to commercialize therapies for patients with no current treatment options and provide additional opportunities for value creation.
As I always do I'll close today's call by thanking the patients physicians and the a G. T C team for their dedication to our cause and their support of <unk>.
Our efforts to transform the treatment of rare ophthalmic otology and CNS diseases.
I would also like to thank all of the health care workers and first responders, who are carrying tremendous burden in order to protect our health and care for our friends families and colleagues.
I look forward to making additional.
<unk> progress and sharing our joint achievements with you in the months ahead and I Hope you and your families are safe and healthy.
Yeah.
Thank you, ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.
[noise].
Yeah.
[music].
[music].
[music].