Applied Genetic Technologies Corporation
Q3 2017 Earnings Call Transcript

Published: 11 May 2017

[Operator:]

Good afternoon and welcome to AGTC Third Quarter 2017 Financial Results Conference Call. Today's call is being recorded. For introductions and opening remarks I'd like to turn the call over to Larry Bullock, Chief Financial Officer at AGTC. Please go ahead sir.

[Larry Bullock:]

Good afternoon and thank you for joining us today. Before we get started, I'd like to remind everyone that during this conference call we may make forward-looking statements, including statements about our financial results, our future business strategies and operations, and our product development and regulatory progress. Actual results could differ materially from those discussed in the forward-looking statements due to a number of important factors including uncertainty inherent in the clinical development and regulatory process and other risks described in the Risk Factors section of our annual report on Form 10-K for the fiscal year ended June 30, 2016. I would now like to turn the call over to Mike Goldstein, our Chief Medical Officer to review our clinical programs.

[Mike Goldstein:]

Thank you, Larry, and welcome to all who have joined us on the call today. I'll begin the call with a brief overview of our clinical trials and then Sue Washer, our President and CEO will review our pre-clinical programs. Larry, will then review our third quarter 2017 financial results and we'll take your questions. I'm providing an update on patient enrolment in our lead clinical development programs, which are gene therapy candidates for treating X-linked retinoschisis or XLRS and achromatopsia caused by defects in the either of the CNGB3 or CNGA3 gene. XLRS is characterized is by abnormal splitting of the layers of retina resulting in poor visual functioning in young boys that can ultimately result in legal blindness in adult men. This program is part of our collaboration with Biogen and our product candidate is in an ongoing Phase 1/2 clinical study. To-date, we've enroled and treated a total of 12 patients which completes the dose escalation phase of the trial. We expect to provide a data update for these patients across safety and potential efficacy and biological activity endpoints this summer. The Data Safety and Monitoring Committee or DSMC met recently to review the current safety data set including the most recent high-dose group and the company is screening patients to enrol in the expansion group of the highest dose. While adults in the group can be enroled without any intermediate evaluation between patients, for protocols they'll be in an evaluation period of approximately two weeks between each of the first three children after which we can proceed without further intermediate evaluation. The primary endpoint of this clinical trial is safety and available data thus far have shown that our XLRS product candidate has been generally well tolerated. As previously disclosed, we observe mild to moderate ocular information in the majority of treated patients which resolved either without a treatment or after treatment with topical or oral corticosteroids. The frequency and intensity of inflammation to date has been similar at all three dose levels tested. Now I'll turn to our clinical programs targeting achromatopsia, an inherited retinal disease in which 75% of the patient population has diseased caused by mutations in either of the CNGB3 or CNGA3 gene. Individuals with achromatopsia have markedly reduced visual acuity, extreme light sensitivity and complete loss of color discrimination. As most of you are aware, AGTC is developing two distinct product candidates to treat patients with either of the CNGB3 or CNGA3 gene mutation. For the ongoing Phase 1/2 clinical trial studying our achromatopsia B3 product candidate we've enroled three patients in the low dose group. As we reported during our last call, DSMC requested follow-up testing on patients in this group to gather additional information on initial differences observed in patient outcomes. As we believe that the initial differences were most likely due to surgical variation the company plans to enrol two more patients in the low dose group utilizing a surgeon who is also treated one of the prior patients in the group sets at a total of three patients will be treated by a single surgeon. Scheduling of patients is ongoing. We'll provide an update when we've enroled the additional patients and met with the DSMC. Other than moving to the use of a single surgeon in linear term, there have been no material changes to the clinical trial. We have made adjustments to our achromatopsia A3 clinical trial based on our achromatopsia B3 experienced to-date, to use a single surgeon for the near term. Scheduling of patients is ongoing and we do not expect enrolment to be limited by the additional patients being enroled in the achromatopsia B3 trial. Sub-retinal injection to deliver gene therapy products is not a common procedure and we've developed an extensive vetting process to expand number of surgeons for achromatopsia and XLRP trials for the near term. In the long-term, we're working with our KOLs to develop detailed training materials to build expertise that we feel will assist the entire field of ophthalmic gene therapy as many companies are seeking to bring these transformative products through clinical development and commercialization. I would now like to turn the call over to Sue Washer, AGTC's President and Chief Executive Officer.

[Sue Washer:]

Thank you, Mike. I'll start by review of our pre-clinical portfolio with our program in X-linked retinitis pigmentosa or XLRP which is the fourth product candidate in our pipeline. XLRP is a disease that mainly affects young boys and results in initial night blindness and constriction of visual fields overtime leading to legal blindness in adult men. In our XLRP program which is part of our collaboration with Biogen, we're on track to file an investigation new drug application or IND with the US Food and Drug Administration in the third quarter of this year. Additionally, in January 2017, the company was awarded a US patent related to our code on optimized RPGR gene which is used in our XLRP product candidate. As most of you are aware in the first quarter, 2017 we entered into a collaboration agreement with Bionics Sight to develop an optogenetic product candidate for patients with advance retinal disease. Through AGTC - Bionic Sight collaboration the companies will seek to develop a new optogenetic therapy that leverages AGTC's deep experience in gene therapy and ophthalmology and Bionic Sight's innovated neuro-prosthetic device and algorithm for retinal coding. This is a truly innovative and exciting approach that could have broad potential in restoring vision regardless of the underlying cause of vision loss or impairment allowing us to expand the number of patients whose lives we may be able to improve. We also continue to make substantial progress in our discovery programs with Biogen as well as our own research program. An important initiative for 2017, is the ongoing work in capsid and promoter selection as they assay development and process development to keep AGTC at the forefront of AAB [ph] technology. Examples of these efforts include our collaboration with 4D Molecular Therapeutics, the University of Florida and Synpromics as well as our own ongoing internal research effort. Testing a non-human primates comparing novel capsids with standard capsids is ongoing and preliminary cell culture testing of novel promoters is yielding promising results. I will now turn the call back to Larry, who will briefly review our third quarter 2017 financial results.

[Larry Bullock:]

Thank you, Sue. Total revenue for the three months ended March 31, 2017 was $8.4 million compared to $12 million during the same period in 2016. A collaboration revenue recorded during the three months ended March 31, 2017 and 2016 resulted primarily from the amortization of upfront fees received under our collaboration agreement with Biogen which began in August, 2015. Grant revenue decreased by $24,000 during the three months ended March 31, 2017 compared to the same period in 2016 largely attributable to reduced research and development activities on grant funded projects. Research and development expense for the three months ended March 31, 2017 decreased by $1.6 million to $6.3 million compared to the same period in 2016. The decrease was largely driven by the reduction of licenses and related fees which were lower during the three months ended March 31, 2017 compared to the same period in 2016 due to non-recurrence in 2017 of expense related to technology access fees that were incurred in 2016. In addition, outside program costs decreased during the three months ended March 31, 2017 compared to the same period in 2016, due largely to temporary delays encountered during the conduct of our Phase 1/2 human clinical trials for our XLRS and achromatopsia CNGB3 product candidates. The impact of these decreases was partially offset by higher employee-related and share based compensation costs that were driven primarily by the hiring of additional employees offset by lower leverage laboratory supply and other costs. General and administrative expense for the three months ended March 31, 2017 increased by approximately $600,000 to $2.9 million compared to the same period in 2016. The increase was primarily driven by higher employee-related costs and share based compensation costs which resulted from the hiring additional employees to support our continued expansion. The legal and professional fees and other costs both increased slightly during the three months ended March 31, 2017 compared to the three months ended March 31, 2016. Total revenue for the nine months ended March 31, 2017 was $31.1 million compared to $35.2 million generated during the same period in 2016. Collaboration revenue recorded during the nine months ended March 31, 2017 and 2016 resulted primarily from the amortization of upfront fees received under our collaboration agreement with Biogen which began in August of 2015. Grant revenue decreased by $400,000 during the nine months ended March 31, 2016 compared to the same period in 2016 largely attributable to reduced research and development activities on grant funded projects. Research and development expense for the nine months ended March 31, 2017 decreased by $14.2 million to $17.9 million compared to the same period in 2016. The decrease was largely driven by the impact of collaboration related costs and license fees that were incurred in 2015 as a result of our entry into and receipt of fees and payments under the collaboration agreement with Biogen and which did not recur in 2017. Also licenses and related fees decreased during the nine months ended March 31, 2017 compared to the nine months ended March 31, 2016 due to a non-recurrence of expense related to technology access fees that were incurred in 2016. In addition, outside program costs decreased in 2017 compared to 2016 due largely to temporary delays encountered during the conduct of our Phase 1/2 human clinical trials for our XLRS and CNGB3 related achromatopsia product candidates. The impact of these decreases was partially offset by higher employee-related and share based compensation expenses that were driven primarily by the hiring additional employees and the incremental impact of new share based incentives awarded in 2017, as well as higher laboratory supplies, licensing fees and other costs during 2017 compared to 2016. General and administrative expense for the nine months ended March 31, 2017 increased by approximately $800,000 to $8.5 million in the same period as 2016. The increase was primarily driven by higher employee-related and share based compensation cost, which resulted from hiring employees to support our continued expansion, partially offset by lower legal and professional fees and other expenses. The higher legal and professional fees incurred in 2016 were largely attributable to professional consulting expenses associated with the negotiation and entry into our collaboration with Biogen. For the three months ended March 31, 2017 the company recorded net loss of approximately $800,000 compared to net income of approximately $2 million for the same period of 2016. For the nine months ended March 31, 2017, the company recorded net income of $4.9 million due to the net loss of $4.1 million for the same period of 2016. As of March 31, 2017 we had cash, cash equivalents and investments totaling $148 million. We expect to have $135 million and $140 million in cash on hand at the end of our fiscal year, which is June 30, 2017. We believe that our existing cash, cash equivalents and investments as of March 31, 2017 will be sufficient to enable us to advance planned preclinical studies and clinical trials for our lead product candidates and currently planned discovery programs for at least the next two years. That concludes my remarks today. I'd like to thank you for your time this afternoon and your ongoing interest and support of the work we are doing here at AGTC. Operator, you may now open the line for questions-and-answer period.

[Operator:]

Today's question-and-answer session will be conducted electronically. [Operator Instructions] and we'll take our first question from Mike [ph] Luchini from BMO Capital.

[Matthew Luchini:]

A couple if I can on achromatopsia. Then I have one on XLRS. So first on achromatopsia, I was wondering if you could expand a little bit on the differences - you mentioned differences and outcomes, I was hoping you could expand on what specifically was seen in the initial low-dose patient set and it seems like the goal here is to now see a bit of similar result in the last two patients. So is this a reflection of how the initial surgeons were screened or is there something else we're looking for here. And given this change how confident are you in your prior year end 2017 timeline for data guidance or guidance in terms of data release?

[Sue Washer:]

Good evening, Matt and thank you for the questions. And I understand that really being able to get some good visibility on what we saw and what we're trying to accomplish moving forward is important and I will let, Mike start to address that question from a clinical point of view and then I'll follow-up on the data guidance.

[Mike Goldstein:]

We saw differences, as we reported we saw differences in the clinical outcomes in the first three patients that were enroled, three different types, by three different surgeons. So we needed to go through a process, analyze the data from each patient and the respective longer term outcomes before we could determine the most likely cause of the differences in the patient outcome. We also needed to review all of this data with the DSMC before we could finalize our course of action going forward. And after extensive data review and surgical video analysis, so just the variability was most likely due to differences in the specific surgical techniques. So, here I would say it's important to note that what we're talking about here is sub-retinal procedure for the achromatopsia patients which is very different than what you might be familiar with, with an individual approach which is done with the XLRS trial, approach that's used very typically with age-related macular degeneration patients with anti [indiscernible] therapy. So with the sub-retinal approach there is much more complexity to the surgery and there is with the individual approach. Therefore when you - there's more even though they're following same sort of protocol there's more variations that can occur. So we think that's the most likely [technical difficulty] for the variation that we've seen. Moving forward after reviewing the data with the DSMC, we've elected to go with a single surgeon and this is the surgeon in the trial, one of the most experienced surgeons in the country and so we're very confident moving forward this is going to eliminate that source of variability.

[Sue Washer:]

And then as far as data guidance goes Matt, we're going to dose these two patients meet with the DSMC and then we'll update you on our guidance for the remainder of the year.

[Matthew Luchini:]

Okay, but I guess the question is, these changes and outcomes. I mean are we talking about say signs of vision loss or changes in ocular structure or anything like that. Can you just be a little bit more specific on what these changes were - what the differences were?

[Mike Goldstein:]

So as expected and observed in other gene therapy clinical trial, all patients visual activity that was seen immediately after surgery with improvements noted as the perioperative decreased. We're not reporting any further specific data on patient outcomes at this time and keeping with our practice of accumulating data on the dose escalation of the trial prior to reporting the data, so we can give a more complete picture.

[Matthew Luchini:]

Okay and I guess just quickly on XLRS. With the expansion cohort now underway enrolment and that cohort underway, do you have a sense as to when we can expect any data out of that part of the study and will it be likely single release or do you expect to provide some kind of interim work along the way.

[Sue Washer:]

So as we've guided, we're going to be providing information this summer on the first 12 patients and that will include safety outcomes, efficacy endpoints and biology activity endpoint so that will be on the full dose escalation phase of the XLRS trial and we'll be updating you along the way as we complete enrolment of the expansion cohort. I think it's important to understand in the expansion cohort that we don't need to wait [technical difficulty] adult patients will be able to expand into children as young as age six in that cohort as well, for the first three kids we still will maintain a wait period but then kids will also be able to enrol without a wait. But we'll be providing you at our regular updates information on enrolment in that expansion group.

[Matthew Luchini:]

Okay, thanks. I'll get back in the queue.

[Operator:]

And your next question comes from Steven Willey of Stifel.

[Steven Willey:]

So I guess when you initiate dosing and enrolment in the achromatopsia A3 trial, is the objective now to use the same trained surgeon that will be administering the next two low doses of B3? Is that the plan for the A3 study now as well?

[Mike Goldstein:]

Yes, that's correct.

[Steven Willey:]

Okay and then I guess just on the XLRS natural history data that was announced yesterday. Maybe if you can just provide a little bit of commentary around how that data now may inform your thought process around the evaluation of efficacy in the dose expansion phase in - I guess I think a takeaway here right was that, there was essentially these patients remained pretty stable throughout the 18 months follow-up period across the variety of different endpoints including I think cystic volume and also visual acuity. So just kind of wondering how that natural history data now shapes your thought process around the generation of expansion cohort data.

[Sue Washer:]

So thank you for that question, Steven and we really were pleased to be able to report the complete set of data from that study that we've been working on for some time as you know and on that Mike's comment what we feel we learned from that study that we can apply to the active trial. Mike?

[Mike Goldstein:]

Yes and I think there are three major take homes [ph] that help us with the after trial. So one as you mentioned the stability of the endpoint that we're looking at and so, the ability to actually intervention and see a change, we now have a good baseline. Relative comparability of the eyes and again as you think about how you're going to analyze the data in the treatment trial we've only treated one eye and we do have potential for a comparator eye internally and the third is, the message that we're looking at. There is some variability and that is recorded in the literature across a wide group of subjects, but we can actually go in and assess each of the individual metrics and look in this particular population. We can see what the internal variability is, which will help us to identify clinically meaningful changes. So I think lots of interesting information that will be very helpful for us moving forward.

[Steven Willey:]

Okay and do you know I guess what proportion of the 36 [ph] patients in this study were I guess considered to be pediatric in terms of age. I think the median age was about 30 and then I guess, was there any attempt to look at progression in younger patients versus the overall patient population?

[Sue Washer:]

So I'll take the first, answer to that and then pass it to Mike, potentially for some more detail. But less than half of the patients for pediatrics in that trial and many of the endpoints were analyzed, look at whether there was age variability. So we looked at cyst volume does it trend with age, we looked at visual acuity, does it trend with age? So that's the kind of analysis we did to look at what age could, data and we really didn't see any difference. There is no correlation to visual acuity or cyst volume or any of the other endpoints to age.

[Steven Willey:]

Okay and then, can you maybe just remind us when you provide the dose escalation update this summer? What the median duration of follow-up in these patients will be? Thanks.

[Sue Washer:]

All patients will have had at least six months.

[Steven Willey:]

And the longest treated patients will have?

[Sue Washer:]

18 months.

[Steven Willey:]

Okay. Thanks for taking my questions.

[Sue Washer:]

Approximately.

[Operator:]

And your next question comes from David Nierengarten from Wedbush Securities.

[David Nierengarten:]

Maybe it's a little bit of follow-up to Steven's question. Are there, any endpoints or any measurements that you think or your opinion could be changing in the follow-up period that shall have for the patients, when you're reporting summer? And then on dose expansion was there any - just remind me was there any plans or any thoughts about adding an even higher dose or is that just, not possible enough for [indiscernible]. Thanks.

[Sue Washer:]

So on the higher dose, we don't have any current plan to change the clinical protocol. So we're moving forward with the clinical protocol as originally described.

[David Nierengarten:]

Okay.

[Sue Washer:]

For the endpoints, I'm going to have Mike speak more closely to that.

[Mike Goldstein:]

So I mean, yes we're looking at functional and structural endpoint and so if your question is, did thought process change about what endpoints we're using based on the natural history study, then no, again what it help us is with is establishing but the variability would be expected for each of the metrics in this particular patient population, but we're still [technical difficulty] asking, we change any of the endpoints again. The answer is no, we're looking at both the structural endpoints and the functional endpoints and looking at the correlation.

[Sue Washer:]

And David as you remember for XLRS the two most applicable probably clinical endpoints visual acuity and visual field and then the supportive functional endpoints are OCT and ERG.

[David Nierengarten:]

Yes, I was curious. The natural history update provided any - it sounds like no but provided any changes or any additional information on how is the preferred measurements change overtime, but it sounds like it was, in line with your prior expectations.

[Sue Washer:]

Yes we think it was very supportive of the decisions we made and how we've been guiding people going into the trial.

[David Nierengarten:]

Got it, thanks.

[Operator:]

And your next question comes from Mara Goldstein from Cantor Fitzgerald.

[Mara Goldstein:]

If I could just ask on the XLRT IND. What is that IND is filed and assuming that FDA is comfortable with that? Can you just talk about that process to get ramped up to dosing patients? And should we think about that long lines of the other clinical trial or is there something from these that will essentially allow to occur any more rapid or sort of accelerated timeframe.

[Sue Washer:]

Well that's a good question, I think it's a very pertinent question and I think, what it brings to, it gives us a chance to talk about. Is that I think a lot of people do kind of engage [technical difficulty] by the filing of the IND and there's actually many other stuffs that need to be accomplished especially in these rare diseases where we're using academic referral centers and so we have to really coordinate with the clinicians and the IRBs at each site to have the internal review at those sites. And many times those reviews cannot be initiated until the IND is filed and the timelines of the different sites vary greatly. And so the IND itself and the review by the FDA rarely ends up being the gating step to getting a trial initiated. So yes we've learned a lot about moving through that process, but it doesn't eliminate having to move through that process at each sites.

[Mara Goldstein:]

Okay and will you be using say this in more sites for XLRT as you have been for XLRS and ACHM?

[Sue Washer:]

They're slightly overlapping but they're not exactly the same.

[Mara Goldstein:]

Okay, so when you should really anticipate that, we'll able to speak to this sort of from a clinical perspective really in 2018, is that fair?

[Sue Washer:]

Our guidance says that we would be starting enrolment by the end of this year, but I think that's fair to say that initial clinical data would come in 2018.

[Mara Goldstein:]

Okay and if I could just ask a question, so Larry is not feeling lonely, on the deferred revenue. The piece of the client on a deferred revenue line is slightly accelerating and I'm just wondering and should we think about that from a straight line function or?

[Larry Bullock:]

Mara it is typically done on a straight line basis, but we've had some delays in terms of the duration of recognition of that revenue, so that's causing the number to go down on a monthly basis or quarterly basis.

[Mara Goldstein:]

Okay is there a specific or sort of range of increment we should we thinking about, just because we're doing modeling.

[Larry Bullock:]

Well originally it was between two and three years now, it's between two and four years. It's closed. So we have extended it a bit.

[Mara Goldstein:]

Okay, all right. Well thank you very much.

[Operator:]

[Operator Instructions] and your next question comes from Jim Birchenough of Wells Fargo Securities.

[Unidentified Analyst:]

This is Yana [ph] in for Jim today. So maybe I'm not sure you can provide more color on this, but for the achromatopsia study the thing that prompted the DSMC to request additional testing. Is that an efficacy signal or a safety signal? For example, is that because some patient had better outcome like sensitivity than others or is that because some patient have worse like safety outcomes now there is, that prompted the request for more testing.

[Sue Washer:]

So as we've discussed, that there was a variation across a wide number of parameters for those three patients that didn't seem to correlated just to enter patient differences and so that's what led us to want to understand what the variability that we had anticipated and so as we were developing the additional data as Mike said and then compared them and pulled all the information we had and compared it to including watching through all of the surgical videos, we determined that the variability in this wide range of parameters was indeed most likely due to surgical variability. So it wasn't some of the difficulty and complexity of analyzing this information and the reason we needed more information was because there wasn't a consistent thing that was [technical difficulty] patient.

[Unidentified Analyst:]

Got it. That's very helpful. And I think for the animal study if we go back to the, you have shown very convincing dog studies for achromatopsia. I was just thinking, is there a difference a between the animals and human eyes or is that, difference between the diseases that might underlie in one situation. It's pretty easy to achieve a good demonstration of proof of concept, but in humans the surgical procedures could become a variable.

[Sue Washer:]

So the eyes are different. I think we talked about the fact before that dog eyes aren't physically, exactly the same as primate eyes. However the main difference that was occurred with the animal data is that, every single one of those animals and every single study we did was done by the same surgeon. So if we went back and looked at four, five surgeons doing those dog studies we may very well see the kind of variability where we saw in these first three patients in the human. So we do not believe that what we're seeing and differences in the structure of the eyes, we think it's the fact that the same veterinary surgeons did all of the dosing in the dogs, where as we used different surgeons in the first three patients.

[Unidentified Analyst:]

Got it, that's very helpful. And then two questions on XLRS. With the baseline nicely set with the natural history study, do you have a - could provide a guidance on what might constitute a meaningful change in those patients?

[Sue Washer:]

So that's interesting question and I think that because this technology is not been used - these patients before we cannot predict that's why we do first demand study with a wide variety of endpoints and do dose escalation, so that we can gather the data and understand, what is which endpoint is going to have that kind of meaningful change for the patient.

[Unidentified Analyst:]

Great and lastly, the lack of dose response in the ocular AE. How do you interpret that?

[Sue Washer:]

Well, thank you for that question and I'll have Mike address that for you.

[Mike Goldstein:]

Yes, so I think when you're saying the lack of dose response is in the ocular AE is used specifically referring to ocular inflammation which is the primary adverse event that we've seen and it is accurate that across the different cohorts we have not seen frequency and severity of the ocular information has been stable, that said, [technical difficulty] different steroids and that has changed a little bit. So it's a little hard to completely interpret that data, 100% when there's that variability as well.

[Sue Washer:]

Because as we said some of the patients there inflammation resolved without any treatment, some patients had topical steroids and it resolved because we wanted to treat appropriately for what was actually occurring with individual patients, so I agree with what Mike said is that because the patient is been getting exactly [technical difficulty] to have the inflammation resolved you can't make a direct interpretation like that.

[Unidentified Analyst:]

Got it. Thank you that's very helpful.

[Operator:]

And your next question comes from Debjit Chattopadhyay from Janney Montgomery Scott.

[Debjit Chattopadhyay:]

This is based on the need for the specialized training, is the achromatopsia product commercially not viable at this point. If not, could you help us understand how many centers of physicians manage these patients and how long will it take from the dose escalation to expansion to a pivotal program?

[Sue Washer:]

We've looked at this carefully and in most Phase 1/2 trials and gene therapy products. The number of surgeons is limited because you're trying to get some very early data and you're trying to make things as consistent as possible, we currently have plans to [technical difficulty] as Mike discussed about expanding the number of surgeons through a rigorous vetting process and also surgical training. There are probably between and 10 and maybe 18, 20 centers in the United States that our centers of excellence, treat these patients and because these are orphan indications and because they were not be a need, we do not believe, we think these are durable products. So you don't need repeat injections. We do believe that with a small focus at surgeons that product is perfectly commercially viable.

[Debjit Chattopadhyay:]

And in terms of, in case you had to project how long this escalation and expansion phase would take before you can think of a pivotal program?

[Sue Washer:]

So I think that, these are one-year follow-up trials, so we wouldn't be able to move to a pivotal program unless until the one-year, we had our end of Phase 2 meeting, at the one-year follow-up, the last patient dose and as we noted earlier, we're going to dose these two patients, meeting with the DSMC and then provide you an update on timing. With the understanding as you know, that for this trial identification of patients has been fairly straightforward.

[Debjit Chattopadhyay:]

And the training that's involved for these surgeons, typically is that a routine kind of procedure shouldn't take more than few hours for them to get up to speed or how should we think about that?

[Sue Washer:]

So I'll let Mike address that.

[Mike Goldstein:]

Yes, so. Would start with experience rich surgeons and they do learn sub-retinal surgery as part of their training. There are a number of nuances when you get to gene therapy related sub-retinal surgery and that's where the unique expertise comes in. and so we would envision a training program that would involve some background materials and slide decks, some surgical videos, one-on-one. There's more than few hours. [Technical difficulty] process of bringing very experienced surgeons and understanding the nuances of what we're doing.

[Debjit Chattopadhyay:]

Great, thanks so much.

[Operator:]

There are no further questions. I would turn the line back to Sue Washer for closing remarks.

[Sue Washer:]

Well, thank you and thank you all for your time today. We are pleased to provide you with these updates on the designs and timelines of our clinical trials. At AGTC our top priority will always be the safety and health of our patients. We believe that adhering to rigorous safety and clinical standards is critical to maintaining the strongest possible relationship with our patient communities and is ultimately the best way to create value for shareholder, as our efforts in these early stage trials will allow us to efficiently complete the development of our product. Through the use of the single surgeon over the near term for our achromatopsia trials, we also believe that we will obtain more consistent data to evaluate the promise of our novel gene therapy product. We're very optimistic about 2017 and expect to make important strides in executing the development plans for our very promising price line, so as to ensure that it is a productive year for our company. We have an exciting a diverse pipeline of clinical programs and recent coverage of our ongoing trials in several key media markets has help to increase the number of patients who have expressed interest in participating in these investigational studies. Our significant pre-clinical pipeline and our partnerships with Biogen and Bionic Sight provide additional opportunities in a variety of indications including ALB, which is a non-ophthalmology indication. Our platform technology and our research programs focused on strategies for enhancing gene delivery, gene expression and protein stability are powerful engine for driving future innovation and increasing our ability to address diseases with significant unmet medical need. Additionally, we have a strong balance sheet and the financial resources achieve the milestones we've laid out for our clinical and pre-clinical programs. I want to thank the patients participating in our trials, we truly could not succeed without their dedication and determination to enable safe and effective treatments with the potential to improve their lives and the lives of the larger community of patients with inherited retinal diseases. We are grateful for their partnership in endeavour. Thank you to everyone on the call for participating.

[Operator:]

And that concludes today's call. All parties may now disconnect.