Q4 2020 Regenxbio Inc Earnings Call
Good afternoon, and welcome to the reach and ex bio fourth quarter and full year 'twenty and 'twenty earnings Conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will be given at that time as a reminder, this conference call is being record.
Good.
I would now like to turn the call over to Mr. Patrick Christmas Chief Legal officer for reach and next Daniel you May begin.
Okay.
Good afternoon, and thank you for joining us today with US are Ken Mills, <unk>, President and Chief Executive Officer Dr.
Dr. Steve Nicola our Chief Medical Officer.
Doctor Olivier Danos, our chief scientific and scientific Officer, and Mr sister, Our Chief Financial Officer.
Earlier this afternoon, <unk> bio released financial and operating results for the fourth quarter and full year ended December 31 2020.
The press release reporting our financial results is available on our website at www dot for genetics bio Dot com.
Today's conference call will include forward looking statements regarding our financial outlook, and addition to regulatory and product development plans.
Forward looking statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted and can be identified by words, such as expect plan will may anticipate believe should intend and other words of similar meaning any such forward looking statements are not guarantees of future.
And involve certain risks and uncertainties. These risks are described in the risk factors and the management's discussion and analysis sections of <unk> annual report on form 10-K for the full year ended December 31, 2020, and comparable risk factors sections of <unk> quarterly reports on form.
And 10-Q, which are on file with the Securities and Exchange Commission and available on the SEC's website.
Any information we provide on this conference call is provided only as of the date of this call March four 2021.
And we undertake no obligation to update any forward looking statements. We may make on this call on account of new information future events or otherwise.
Be advised that today's call is being recorded and webcast.
In addition, any unaudited or pro forma financial information that may be provided is preliminary and does not purport to project financial positions, where operating results of the company.
Actual results may differ materially.
I would now like to turn the call over to Ken Mills Okay.
Thank you Patrick good afternoon, everyone and thanks for joining us I hope that everyone is staying safe and healthy today's conference.
This call we will provide a recap of our recent progress advancing and expanding our NAV technology platform.
And discuss expected future milestones for the company.
Even livia and join us to discuss our pipeline and we'll provide an update on financial results for the fourth quarter and the full year 2020.
Well then open up the call for questions.
Throughout 2020 and already in 2021, I believe we're making great strides towards achieving our goal of realizing the curative potential of gene therapy.
We have advanced and broadened our internal pipeline of programs and several important ways.
Touch on just a few pipeline highlights before turning the call over to the team.
Starting our first pivotal program is an important and exciting milestone that we're proud to achieve this program is to evaluate our gene therapy candidate for wet age related macular degeneration retinal disease that is a leading cause of total and partial vision loss affecting more than 2 million people and the United States.
Okay.
Our treatment called <unk> 314 is a novel onetime gene therapy that is designed to work by delivering therapeutic genes to the retina and of the patient in order to interrupt pathway of the disease.
The sub retinal delivery technique that we are using and our pivotal program is an established and targeted route of delivery for gene therapy for retinal disease.
And then it'll program builds on data that we have seen from our ongoing phase one two study where we have observed that rdx 314 has been generally well tolerated and durable effects of the onetime gene therapy are now out to three years after dosing patients in the trial.
In 2020, we also initiated new clinical trials evaluating <unk> hundred one for using a different delivery approach.
These trials are the first to evaluate the delivery of any gene therapy to the Super Choroidal space of the eye.
And this form of delivery as a non surgical approach that can be administered and an office setting and potentially allow for targeted delivery to the retina.
Overall, our rdx three one and four programs are evaluating these two routes of administration because we believe we can provide these onetime treatments to the largest population of patients with wet AMD and diseases. If similar origins like diabetic retinopathy by providing access to gene therapy, and all settings of care.
Our RG X one to one candidate is being studied as a single administration treatment for neuro degeneration associated with Hunter syndrome.
Treatment and is designed to work by delivering a new gene to the patient cells and the brain and central nervous system.
<unk> is administered directly into the cerebrospinal fluid.
And we've shown evidence of consistent biomarker reductions and continued neuro cognitive development from patients in the RG X one to one trial.
And we're also encouraged by new data providing evidence that after treatment is delivered to the cerebrospinal fluid it may be able to address disease and patients and other parts of their body.
This includes data from patients who were never treated with the standard of care enzyme replacement therapy prior to enrolling in our trial and.
And this is exciting to us because we know that Hunter syndrome is a disease that affects nearly every oregon.
We also recently announced development of RG X two zero to a potential single administration gene therapy for the treatment of Duchenne muscular dystrophy.
Olivier has been spearheading the development of this program, which is based on a novel advanced micro dystrophin construct he will provide further details, but we're excited to bring this program forward this year.
In addition to our pipeline progress and potential we're well capitalized with the resources to achieve our next planned program milestones.
We have completed two recent transactions that have added over $400 million to our balance sheet and this enables us to continue to advance our programs as well as support investment and our commercial ready manufacturing platform and the build out of our own manufacturing facility.
Finally, before turning it over to the team I want to take a moment to acknowledge what's going on and the wonderful background worldwide events that have taken place and messages that have emerged and supportive rare disease day observed yesterday February 28th and celebrated across many days recently.
On February 26 last Friday, <unk> bio hosted an event that allowed our teams a special opportunity here directly from families and caregivers and advocates in order to continue to enhance our awareness of the needs of those living with rare diseases.
Overall I wish to express my sincere appreciation, especially this year from me and the Regenesis by our leadership team to our dedicated employees clinical investigators partners and most importantly patient communities for their unwavering support as we work hard to advance our mission.
With that and turn the call over to Steve for a more detailed update on the active clinical programs.
Thanks, Ken.
I'll begin with our pivotal program <unk> 314 for the treatment of wet AMD, which we announced in January.
Our end of phase II meeting with the FDA was primarily focused on establishing the pivotal program design, which we believe will support a potential BLA filing in 'twenty and 'twenty four.
And the pivotal program is expected to include two randomized well controlled clinical trials to evaluate the efficacy and safety of our JAK 314, and we expect to enroll approximately 700 patients and total.
We have already begun enrolling patients and the first trial named atmosphere for our JAK $3 14, using sub retinal administration.
The key design elements of the trial were informed by data from our phase one two way dose escalation trial <unk> 314.
Yeah.
Atmosphere is expected to enroll approximately 300 patients across two <unk> 314 dose arms.
Ranibizumab and.
And we'll evaluate and non inferiority to Ranibizumab based on change from baseline and best corrected visual acuity at one year.
We intend to initiate our second pivotal trial and the second half of 2021, which is expected to be designed similarly to the atmosphere.
In addition, we believe we have a clear path to support our cgmp commercial ready manufacturing plans and the pivotal program.
We have initiated the pivotal program using cgmp material produced from our existing manufacturing process.
And we plan to incorporate our scalable suspension cell culture manufacturing process to support future commercialization upon completion of a bridging study and the pivotal trials.
The bridging study is expected to initiate and the first half of 2021.
We recently presented additional long term data from our phase one two trial of <unk> 314 for the treatment of wet AMD and the long term follow up study.
As we reported earlier this month, our JAK $3 14 can you continue to be generally well tolerated across all dose cohorts.
And patients have continued to demonstrate durable treatment effects up to three years after onetime dosing of <unk> 314.
We are very encouraged by the durability of treatment effect seen in patients dosed with our JAK $3 14, including stable vision and reductions in anti VEGF injections, which are meaningful endpoints for patients and the clinical management of their disease.
Additionally, in January and January we announced the completion of enrollment of cohort one and the aviate the phase II trial evaluating Super Choroidal and delivery of <unk> 314, using the SCS micro and.
<unk> system.
For the treatment of wet AMD.
We plan to reported interim data from cohort one of 88 and the third quarter of 2021.
Cohort two is now enrolling patients and we remain on track to complete enrollment and the second quarter of 2021.
Altitude, our phase II trial to evaluate RG X 314, and patients with diabetic retinopathy is enrolling patients and we expect to report initial data from this trial and 2021.
And our rare disease portfolio. We are pleased with the continued progress and recent expansion of our portfolio of gene therapies targeting rare genetic diseases.
And look forward to further advancement in 'twenty and 'twenty one.
We recently presented encouraging positive interim data at the 17th annual World Symposium from cohorts, one and two of our ongoing phase one two trial of <unk> hundred 21 for the treatment of patients with Mpls, two or Hunter syndrome.
As reported in February and Archie ex 121 was well tolerated and eight patients dosed.
Io markers and the CNS indicated and encouraging signals of <unk> enzyme activity following onetime administration.
<unk> hundred 21 and.
And patients demonstrated continued neuro cognitive development up to two years after dosing.
Patients also demonstrated evidence of <unk> enzyme activity and plant and.
And following administration of <unk> 121.
Notably two patients who were naive to enzyme replacement therapy showed rapid reductions in euro and total gag levels. Following Archie ex 121 administration.
One of these patients had significant reductions in liver and spleen volume.
We plan to evaluate a higher dose of <unk> 121, and cohort three and expect to begin enrolling patients in this cohort in the first quarter of 2021.
We also previously announced plans to expand our R. J F 121 program to include a second phase one two trial to evaluate <unk> hundred 21, and pediatric patients with severe NPS too over the age of five years old.
And this trial is expected to begin dosing patients and the first half of 'twenty and 'twenty one.
In addition, enrollment has begun and our phase one two trial of <unk> 111 for the treatment event and PFS one.
Our other rare disease programs continue to advance towards the clinic, we plan to submit an IND for the interest sternal delivery of RG <unk> and 81 for the treatment of C. O N two disease and the first quarter of 2021.
We also expect to submit an IND or foreign equivalent price. He's one two trial of <unk> 381 for the treatment of ocular manifestations of C. O N two disease and the first half of 2021.
With that I will turn the call over to Olivier who will discuss our recently announced <unk> two O two program for <unk>.
The treatment of DMD.
Olivier.
Thank you Steve.
In January of 2021, we announced the development of <unk>, two two and a onetime gene therapy for the treatment of Duchenne muscular dystrophy or DMD.
Do you and he is caused by mutations and the DMD gene, which encodes for dystrophin.
And the protein involved and muscle sales structure and seniors and proteins.
Without these posts and muscle degenerates and becomes weak.
And should we read into lots of movements and independence required support for breathing tells you a myopathy and premature death.
I've been working day seal for many years and I'm really proud of the world here and so we can explore and portions of this program.
Our design is based on the innovative vector engineering by <unk> Biosciences and.
And it incorporates learning from the laboratory of George Dixon from the University of London, a potent Inc. <unk> figure and the Swift and research.
<unk> two is designed to deliver a novel micro dystrophin transgene equipped with an extended coding region of the sito mineral domains phoned in naturally occurring dislocated, which we believe can bolster cash.
Sales signaling pathways and muscle membrane integrity, leading to improved muscle strength and resistance in patients with DMD.
<unk> is the only known conflicts and development to include this feature and it will debate.
<unk> also has other fundamental improvements, including Covid and optimization and reduction of CPG content, which has the potential to improve gene expression increase transitional and efficiency and reduce immunogenicity.
<unk> uses our NAV.
<unk> vector, which has been using numerous clinical trials and.
And well characterized muscle specific promoter to support the delivery and targeted expression of genes true scripted muscle skeletal and heart muscle.
Yeah.
Proof of concept data from preclinical preclinical studies of <unk> in the mouse model of C and D demonstrate robust micro dystrophin expression in muscle recruitment of key proteins to the muscle sales improvement of muscle histology and meaningful increases in muscle strength and function.
Using a suspension cell culture and manufactured manufacturing process, we have already produced commercial scale cgmp material at a settled and leader and capacities and we plan to use that material into clinical development of <unk>.
We're currently competing ideally bridging studies and expect to submit an IND to the.
D a.
2021.
With that I will turn the call back over to Ken Ken.
Yeah.
Thanks, Olivier and Steve for your updates about our clinical programs and the emergence of a new program for Duchenne muscular dystrophy.
I wanted to add to Olivier summary, just to extend that the construction of our new corporate research and cgmp facility here in Rockville, Maryland continues as planned we expect to move into our new offices in the coming months and the new production facility is expected to be fully operational next year.
GMP facility is expected to allow for production of NAV vectors that scales up to 2000 liters using our platform suspension cell culture process.
We set out to develop a facility that would deliver high quality now vectors at a scale to match clinical and commercial demands our entire pipeline and it's exciting to see the construction progress so far.
With that I'm going to turn the call over to Vince for a review of our financials.
Thank you Ken <unk> ended the year on December 31, 2020, with cash cash equivalents and marketable securities totaling $522 5 million compared to $400 million as of December 31, 2019, the increase.
And was primarily attributable to gross proceeds of $200 million.
Received from the monetization oversold sensible and royalty rights and was partially offset by net cash used in operating activities and the purchase of property and equipment in 2020.
Revenues were $154 6 million for the year ended December 31, 2020, compared to $35 $2 million in 2019. The increase was primarily attributable to sell gens won't royalty revenue, which increased by $48 million and 2020.
And as compared to 2019 and increase in revenue for the year ended December 31, 2020 also included an 80 million dollar milestone fee recognized as revenue and the third quarter of 2020 upon the achievement of $1 billion and cumulative net sales of Xeljanz volume.
Research and development and expenses were $166 $3 million for the year ended December 31, 2020, as compared to $124 $2 million and 2019.
This was primarily attributable to personnel costs.
As a result of increased head count and expenses associated with manufacturing services and conducting clinical trials for our lead product candidates.
General and administrative expenses were $63 8 million from the year ended December 31, compared to $51 $8 million and 2019. The increase was primarily attributable to personnel cost as a result of increased headcount and professional fees for advisory and other services.
Net loss was $111 $3 million for the year ended December 31, 2020, as compared to a net loss of $94 $7 million and 2019.
As of December 31, 2020.
Proximately $37 5 million common shares outstanding.
On January 12, 2021, <unk> announced the closing of an underwritten public offering of four to six zero million shares of its common stock at a price to the public of $47 per share as well as exercise and full of the underwriters' option to purchase 600 and.
<unk> 9000 additional shares at a public offering price.
Including the option exercise the total gross proceeds received by <unk> from the offering from <unk>.
Proximately $233 million before deducting, the underwriting discounts and commissions and other operating expenses based on our current operating plan, we expect the balancing cash cash equivalents and marketable securities of $522 $5 million.
As of December 31, 2020, as well as the $233 million of growth.
Proceeds received from our follow on public offering of common stock completed in January 'twenty and 'twenty, one to fund our operations, including the completion of our internal manufacturing capabilities and clinical advancement of our product candidates into the second half of 2023 with that.
Look forward to a great 2021, and putting the stake and the dumpster fires that was 2020 now over to Ken for some final thoughts.
Yes.
The progress we've made at ridge and expire throughout 2020 has been something that's moved us closer to bringing our therapies to patients in need and.
And we now look to 2021 to further advance the entirety of our internal pipeline.
And supporting our capabilities for that mission.
I think at this stage, we will turn the call over operator for questions.
Thank you presenters, ladies and gentlemen, if you have a question at this time. Please press the star and then the number one key on your Touchtone telephone EBIT question has been answered or you wish to remove yourself from the queue. Please press the pound key please standby and while we compile the Q&A roster.
Yeah.
Your first question comes from the line of Geoff Meacham.
And with Bank of America. Your line is open.
Hey, guys and some to Alec on for Geoff. Thanks for taking my question and congrats on the progress in 'twenty and 'twenty.
And I had one question on the design from Phase III studies from three important team.
And so we're thinking about the size of the studies and powering assumptions.
From a range of change and visual acuity and would expect based on published studies for the control arm.
And would you expect and we get and maybe performed slightly better than those centers and.
Additional patients from a second studies and.
And I guess as a follow up to that.
Phase III and some 52 week cutoff, but I'd be curious to know whether your views have changed at all following the recent club right.
Okay.
Thanks, Alex Steve I think you can probably best handle the powering question about vision for Lucentis Eylea control arm sure Alright, Great Hey, Alex Yeah, Great question.
It's one of the bed.
Benefits of drug development, and the space, where there's such a plethora of historical data.
And being very well controlled trials with.
Active control arm, including.
Both the line Lucentis.
Lucentis monthly injection as well as I lay a every other month dosing after loading dose so.
To answer your first question, we took that into account in terms of thinking of of the powering.
And basically what we look forward there is the variability that you expect to see in terms of chain.
Change in visual acuity from baseline and.
And that's also relevant in terms of discussions with the FDA where there's.
And there's there's certainly a very good precedent for how to think of non inferiority and powering.
In terms of both of those treatment arms, if you use those as a control arm.
So that's why we were frankly excited too.
Take this opportunity to and one study use lucentis monthly injection and and either.
To use eylea.
What's interesting is if you think of VA change there theyre very close to what you see in terms of every other month dosing with Eylea and what you see with monthly dosing with Lucentis and.
And pretty similar in terms of the variability that you expect to see.
With those two treatment arms.
Okay.
Alright. Your next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is open.
Hello, everyone and D. C has cost us on for Matthew.
Two questions from us on the CX <unk> two program.
One is what do you need to do prior to IND filing in mid 2021.
And the second one.
Is that all day improvement in the micro dystrophin gene that you described can you. Please give some color around how do you expect these improvements to differentiate to TUI and clinique for answers.
And that investigation on treatment. Thank you.
Thanks, Kocis and Olivier this sounds like great questions for you.
Yes, great question. Thank you.
So before we file our IND.
And we need to wear and the final phase of finalizing the preclinical data package that we have social fall we have oh.
We've pretty much.
Don't everything and and finalizing that.
And we will see the final phases of <unk>.
Designing a clinical trial.
But apart from that it's sort of true yes.
No.
And this thing together all these.
And I said it.
Thank you package.
In terms of the the multitude of yourselves and micro dystrophin and so again, we were hitting our micro dystrophin, which is slightly.
Is actually bigger than that Michael just flow things out there.
And the community.
Because it has an extra domain and I can see terminal.
And this is for domain.
<unk> for recruiting additional proteins and the membrane and this is key to the function of the for the full function of dystrophin.
It's just to think and can work without this domain.
And you can work as something which is just a simple shock absorber that preserves the integrity of the muscle membrane and bones.
Construction.
But.
Each will lack a number of.
Key functions.
We're just swiftly and triggers and number of.
Other proteins, including and it would seem to us or calcium channel that are very important and the way that muscle recovers. After these repair and distress. So how does it translate exactly.
And in animal models.
I'll deal with you.
Can measure force of the muscle that shows you that the bustle that has been treated with such a micro dystrophin is actually more resilient and that is it breaks down less after being submitted several.
Trains of stress and contraction.
Now this is something that.
We will.
We'll eventually we hope to see and the Clinique and this is also where our clinical design just coming into and to play exactly what endpoints, we're going to look at that this will be.
And.
East Coast, when we filed the IND.
But this will be about.
And.
Resistance to.
And sorry to go.
The way.
<unk>.
Billions, eventually fatigue and exercise and that's measuring this amount of fatigue that will be key.
And from initiating our product from eventually others, although well who's going to do the Inc.
This trial will compare directly so.
And talking about.
And if point at school and definitely come later into the equivalent of the tourists.
Thanks Olivia.
Your next question comes from the line of Sarah <unk> with UBS. Your line is open.
Hey, guys. Thanks for taking my question and.
As a follow up to the angiogenesis data.
Can you talk about that and the beef CBA otp distinctions between cohort C and cohorts four inch and it looks like and what she had that'll be CVA non.
Okay.
Trying to understand that and then I also wanted to confirm that the key here.
And with BT data from cohort Chi is not available yet.
Yes, I can.
Take that one Steve here so.
Yes, I'd angiogenesis, we were excited too.
And.
The latest results we had in terms of one five year follow up or and C. Five as well as the three year data for cohort three.
<unk>.
And you raised a good point of how and how we look at both visual acuity response, but also anatomy and terms.
Retinal thickness changes one of the aspects and trials of this size, where you have six to 12.
Patient arm ads and this study is you can have a slightly different baseline levels, where there can be less of an ability to have.
A significant decrease for example, and CRT.
And basically a ceiling effect, if you start off with a little drier retina so to speak so.
And that's what we believe explains the distinction between.
What you see in Phase III for example in terms of the fact that we see.
Almost a three line improvement in visual acuity.
I'll be and add any the central retinal thickness.
And stays relatively stable.
The other aspect there may be.
And the possibility that having stable anatomy.
Without the typical peak and trough variability that you have with traditional.
Bolus repeat injections may translate into better visual outcomes than what you would anticipate based on anatomy.
But I think that really would need to be borne out and and larger trials.
The other cohorts that started off with higher baseline CRP levels central retinal thickness levels, we did see those levels come down over time, and we've seen them.
And continue to be stable at those decrease levels ease.
Even with the dramatic reduction and and treatment burden and that's really why we were.
Exciting and continue to be excited with the continued maturation of the data with that range of doses from C. III upward.
In terms of all of the efficacy signals that we have been looking at.
Thank you. Your next question comes from the line of Gena Wang with Barclays. Your line is open.
Hi, This is David on for Gena, I think and for taking my questions and just wanted to congrats on your progress from 2020 as well.
A couple of questions on <unk>.
<unk> hundred 14 gene therapy subtract mills injections.
First question is regarding the phase III trial could you just remind us.
Retrieve and criteria for your phase III trial design.
Sure so going into our controlled phase III program, we felt it was important to have.
Standardized.
And re treatment criteria across the board and to do this based on objective measures.
And specifically best corrected visual acuity, which is done and our math fashion and also anatomy central retinal thickness change, which is also done and are masked fashion by a central reading center.
So to be very specific or treatment criteria.
For our pivotal study or.
A.
Worsening and visual acuity.
And at least five letters compared to the average of the prior two visits or a decrease of 10 letters compared to the best prior visit.
And a similar concept in terms of anatomy.
A worsening and retinal thickness of 75 microns compare to the average of the prior two visits.
Or 100, micron and worsening or increase compared to the best prior.
CRT level prior to that visit and those measures and those criteria fit somewhat and the mix of what you see.
Some of the other precedents that are out there in terms of.
Some of the other programs that are looking at attempting to increase durability of treatment effect.
The difference here being that this is an attempt that a one time treatment option.
Two potentially obviate the need for re treatment.
Thank you ladies and gentlemen, just a reminder, you May press star one to have a follow up question or if you have and any questions. Thank you your.
Your next question comes from the line of Manny total O'hara with SBB.
Leerink Your line is open.
Hey, good afternoon.
And this is Rick online from Mani Thanks for taking my question.
And so my question focuses on the DMD program. Since you first announced RG next year or two there was a clinical update from throughout this gene therapy program.
And we were wondering if you could comment and any potential learnings from a clinical readout of your competitor and if it was able to help inform any aspect of trial design for your upcoming trial, such as patient selection selection of endpoints or goals for the initial dose escalation.
Okay.
Yes, Rick.
Not going to comment on data from someone else's study, obviously, we wouldn't have that available to us and a way that would be meaningful.
And to help interpret compared to what Olivier has already described is really robust.
Preclinical program as well as work that's gone into preparing for a trial design that we think will be important to illustrate not only elements of things that have been demonstrated by micro dystrophin as a class, but also differentiation potentially along the program before.
And the advancement of this novel construct using the C terminal domain and of course, we're using a proprietary.
Manufacturing platform as well so.
There is not.
Much that we're going to learn from sort of top line results from a study that someone else is running.
Thank you. Our next question comes from the lineup Luca <unk> with RBC. Your line is open.
Oh, great. Thanks for taking my question. This is a lethal Altair Altair and Luca.
Just wanted to ask about your supercritical program it looks like for the phase two trial.
And that you were starting at the highest dose average adjusted for the sub retinal and you are also doubling that dose Inc.
Cohort two can you provide any color on why that is the case and also maybe more broadly what some of the key dosing consideration and bar when switching from separate and lumber Super Cradle.
Yes so.
Thats really takes advantage of all the learnings that we had from our sub retinal program. So.
There Youll recall, Lisa we had the benefit of a full dose ranging where we started super low with.
A dose where we didn't see anything.
And then so progressively more clear signal as we went up with.
With a plateau from from our perspective, once we got to level three onward.
Hi.
This is a new route of administration.
However, I think it is important to note that.
It still achieves the goal of getting the infuse eight very close to the target tissue of the RPE and the photo receptors.
Particularly compared to other routes of administration and like.
So since we had very good safety and Tolerability and the full range of doses with sub retinal.
We chose to go from a position of Aqua pose and start with the dose level five that we had from sub retinal and we were pleased that our preclinical package, both our pharmacology studies as well as our G. L. P package gave us that opportunity to start.
From that standpoint.
We were also pleased to be able to to start with a design, where we do not include.
Prophylactic steroids for either of our initial.
Super Choroidal delivery studies.
So, yes, I think a good question.
And it's always.
A key aspect when youre thinking of starting dosing where.
And where you start.
And I think we just had the benefit of a lot of prior experience with sub retinal delivery with the same exact.
The transgene and the.
Same exact AAV factor to.
To take advantage of that to start with it dosed to.
<unk> not only <unk>.
<unk> and tolerability, but potential signal.
Thank you there are no further questions at this time I'd like to turn the call back over to Ken for closing remarks go ahead Sir.
Thank you very much and thanks, everyone for joining US today, we look forward to providing further updates soon and throughout the year and have a great night.
Ladies and gentlemen, this concludes today's conference today and thank you for your participation and have a wonderful day you may all disconnect.
Sure.
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And the momentum.
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