Q2 2021 Selecta Biosciences Inc Earnings Call
Good morning, everyone and welcome to the Selecta Biosciences second quarter 2021 financial results and corporate update conference call.
Currently all participants are in a listen only mode.
Call is being webcast live on the investors and media section of select as web site at Www Dot Selecta bio dotcom and.
And is being recorded.
For opening remarks, I would like to introduce Kristen and Baldwin Chief people Officer of Selecta. Please go ahead.
Thank you and good morning, welcome to our second quarter 'twenty 'twenty, one financial results and corporate update conference call. The press release reporting our financial results is available in the Investor and media section of selected web site Www Dot select out bio dot com and the quarter Larry.
Court on form 10-Q ended June 30th 2021, which was filed today with the SEC.
Joining me today are Carsten Brunn, President and Chief Executive Officer, Peter Traber, Chief Medical Officer and Kate.
Use my car.
Thank you she Modo Chief Scientific officer during today's call, we will be making certain forward looking statements, including without limitation statements about the potential safety efficacy and regulatory and clinical progress of our product candidates financial projections, and our future expectations plans partnerships and prospects.
These statements are subject to various risks that are described in our filings made with the securities and Exchange Commission, including the most recent quarterly report on form 10-Q.
You are cautioned not to take place undue reliance on these forward looking statements, which speak only as of today August 12, 2021 and two.
Selected its claim any obligation to update such statements, even if management's views change I would now like to turn the call over to Carsten Brunn.
Thank you Christine good morning, I appreciate you joining us today to start it's worth emphasizing our steadfast commitment to selectively mitigating unwanted immune responses through the development of next generation antigen specific tolerant genetic therapies.
That continues to take a leading position in immune tolerance field and in the last quarter. We achieved several milestones that advanced our clinically validated until platform across enzyme therapies gene therapies, and autoimmune diseases with that I'll walk us through some of our key pipeline updates and upcoming milestones.
First a few key points on our enzyme therapy programs.
S. L 212, which was licensed to Sylvie is comprised of <unk> co administered with our proprietary your case, the gastric case for the treatment of chronic refractory gout.
As a reminder, our phase III resolve clinical program kicked off in the third quarter of 2020 and consist of two double blind placebo controlled trials.
212.
In both trials <unk> will be evaluated at two doses of <unk>, one milligrams per kilogram and one five milligrams per kilogram and one dose after gastric case <unk> two milligrams per kilogram.
Each trial aims to enroll 105 patients with 35 at each dose and 35 on placebo.
Enrollment is progressing on schedule and topline data from resolve is expected in the second half of 2022.
We intend to leverage the success of <unk> for a second and then program indication and Iga nephropathy, which is a kidney disease that occurs when immune complexes of an antibody called immunoglobulin, a or Iga one accumulates in the kidney.
Genetic or environmental factors that caused abnormal iga, one and as the accumulation of the kidneys can result in the development Iga nephropathy and leads to kidney disease.
Although there are no approved therapies, we believe our novel approach, which combines into war with Iga, one protease protease has the potential to treat the root cause of the disease and overcome previous limitations associated with Iga Proteus development.
Due to delays in securing a qualified BD mo to conduct the process development and manufacturing work, we expect to push our anticipated IND filing into 2000 into 2022.
Although covid 19, and the recent surge has impacted supply chain and resulted in challenges we successfully secured a CD Moe and I'd, enabling studies are currently underway will provide updates on our progress later in the year.
Now turning to our gene therapy programs in the first quarter of 2021 in collaboration with AST Bio we initiated the first in human phase one dose escalation trial of <unk> 399, and 88 empty capsid vector capsid or EMC, one O one containing no DNA combine.
Within tour.
The trial is being conducted in healthy volunteers and aims to determine the dose regimen of <unk> to mitigate the formation of antibodies to AAV capsid used in gene therapies.
We're pleased with the progress made to date and remain on track.
Expect to report topline data in the fourth quarter of 2021.
Building on our ongoing anti AAV H cap study in the first quarter of 2021, we also strengthened our wholly owned gene therapy portfolio by regaining exclusive rights to MMA, one to one and a BD gene therapy vector for the treatment of medic, baloney, academia or MMA, a rare metabolic disease.
The body cannot breakdown certain proteins and fats.
The previously disclosed MMA one one third party manufacturing issue was resolved and we are pleased that manufacturing of a new lot has been completed and is currently undergoing final release testing.
We expect to file an IND for our lead gene therapy candidate SCL, three or two which is a combination of MMA one one plus in tour in MMA during the third quarter of 2021.
Further our recent publication in the journal molecular therapy methods and clinical development demonstrated our observation that aimed toward enhances transgenic expression. After both initial and repeat dosing of an AAV vector in a mouse model of MMA.
The publications further validates the use of in store and our gene therapy pipeline and especially relevant for the clinical development of <unk> three O two the.
Phase 123, or two program, which is expected to commence in 2022 milligram and biomarkers after disease utilizing antibodies safety and Tolerability.
Our second wholly owned proprietary gene therapy product candidates.
313 is being developed to treat only thing trumps Pablo my lease or OTC deficiency.
Obviously deficiency is an X linked genetic disorder caused by genetic mutations in the OTC gene, which is critical for probably a function of the year a cycle looking.
Looking ahead, we expect to file a clinical trial application or Cta and or an IND in 2022.
We submitted the pediatric investigation plan for <unk> for STL three months three to the European Medicines Agency Pediatric Committee in February 2021.
Before we wrap up on gene therapy direct <unk> Therapeutics continues to conduct preclinical work looking at the combination of <unk> in certain neuromuscular disorders, including Duchenne muscular dystrophy, or DMD and limb girdle muscular dystrophy or LG Indeed subtypes.
We recently achieved a 3 million milestone payment for successfully meeting the criteria in the preclinical study under a research license and option agreement with <unk>. This further validates potential of intuit's platform.
Overall, we are seeing excellent progress and we look forward to building on this momentum as we move one step closer to addressing immunogenicity constrained in AAV, driven gene therapy, as we strive to overcome repeat dosing limitations by preventing the formation and the bodies NFC enabled more durable and robust expression of the trans.
June after the first dose.
Now moving onto our autoimmune program. Our recently published data in frontiers in immunology demonstrates that into our enhanced its own orogenic environment in the liver shown induction of a ton of our journey phenotype in all major hepatic antigen presenting cell populations and what's protectors than acute model autoimmune <unk>.
Titus.
Publication further supports development of select us into a platform for the treatment of liver specific autoimmune diseases, including primary biliary cholangitis for PBC, a chronic progressive autoimmune liver disorder that leads to inflammation damage and scarring of the small buybacks PVC has a well defined.
Hagen antigen significant unmet medical need and is well suited to the application of our <unk> immune tolerance platform.
Our autoimmune program is advancing through IND, enabling studies and we expect to file an IND in PBC in the second half of 2022.
Now I'll run through our financial results for the second quarter ended June 32021.
We remain well capitalized we had $161.5 million liquidity as of June 32021, which compares to $149.2 million liquidity as of March 31st 2021, we believe our liquidity will be sufficient to meet our operating requirements into the third quarter of 2020.
Three.
Net cash used in operating activities was $18.2 million for the six months ended June 32021, as compared to $23.5 million for the same periods in 2020.
Revenue recognized for the second quarter of 2021 was $19.6 million compared to no revenue recognition for the same period in 2020.
Revenue was recognized under our license agreement with <unk>, which began in July 2020, resulting from the shipment of clinical supply and the reimbursement of costs incurred for the phase III dissolved clinical program.
Additionally, during the second quarter, we recognized less than $1 million for shipments under the license agreement with Repsol and point 1 million, resulting from the expiration of the contractual audit term under the Skolkovo Foundation Grant.
Search and development expenses for the second quarter of 2021 were $14.5 million, which compares with $10.7 million for the same period in 2020.
During the quarter ended June 32021, there was an increase in expenses incurred for consulting salaries and the discovery and preclinical programs offset by a decrease of ASP bio collaboration costs.
General and administrative expenses for the second quarter 2021 were $4.7 million, which compares with $5.6 million for the same period in 2020. The decrease in cost was primarily the result of reduced expenses for salaries professional fees and patent expenses offset by increased consulting and stock compensation.
For the second quarter 2021 reported net income of $4.6 million.
Or basic net income per share of <unk> <unk> compared to a net loss of $24.1 million or basic net loss per share of <unk> 25 for the same period in 2020.
Before concluding today's call with a few corporate updates to share.
As we enter a critical inflection point in development, we're excited to welcome gene therapy pioneer gypsum Molski, especially adviser.
As a professor of pharmacology and has been a director of the University of North Carolina Gene therapy Center for over two decades.
He was awarded the first patent for AAV viral vector and what's the first recipient of the American Society of Gene and cell therapy Outstanding Achievement Award for lifetime achievements in gene therapy.
I hope to some multi has advanced gene therapies into human trials for hemophilia.
Muscular dystrophy giant externally neuropathy, pompe disease and heart failure.
Currently the President Chang, Chief Scientific officer, and cofounder of that style.
We're also pleased by the addition of industry leader Nissan Desilva them to select US Board of directors adopted a silver has extensive leadership experience most relevantly in gene therapy development manufacturing and regulatory activities.
Silver brings over 20 years of experience in biotechnology operations biopharmaceutical venture capital and healthcare management consulting.
He's currently Chief Executive Officer, and director of Ethics Therapeutics, a private venture backed biotechnology company focused on addressing unmet needs in the course of the diseases previously it up to the silver served as President Chief operating officer, and director of <unk> Therapeutics, the cell and gene therapy focused biopharmaceutical company, where he oversaw.
All clinical development regulatory manufacturing finance and business development activities together took to some months gained up to the school bus contributions will be invaluable as we continue to advance into the clinic.
As mentioned earlier, we're extremely excited about the continued growth of our company.
And we remain confident in our platform.
I'd like to conclude by reiterating our gratitude to the many people who have been supportive along the way, including our patients and their families. Our investigators and our great team at select him with that we're happy to take questions operator.
Ladies and gentlemen at this time, we'll begin the question and answer session to ask a question you May Press Star and then one using a touchtone telephone to withdraw your question you May press Star and two if you.
You are using a speaker phone we do ask you. Please pick up the handset prior to pressing the numbers to ensure the best sound quality.
Once again that is star and then one join the question queue, we will pause momentarily to assemble the roster.
Our first question today comes from Kristen <unk> from Cantor Fitzgerald. Please go ahead with your question.
Hi, good morning, and thanks for taking my question.
So there was a recent publication, which surveyed hemophilia patients asking them to rank the most important aspects of a gene therapy treatment.
It does frequency and durability were actually found to rank as the greatest importance for heme b patients.
I know you've presented and published a lot of preclinical data this year, but I believe your recent molecular therapy publication was one of the longest studies that you've evaluated for inventory in gene therapy.
So we'd like to ask if you could please discuss the key trends that you've observed on durability here and generally speaking the implications you think <unk> could have on durability, including through potential re dosing and other aspects.
Yes, thanks for the question Kristen.
You're right.
Dose dose frequency and durability is a key issue both for physicians and patients.
And we're pleased with the data we have to date I'll, let Tony comment a little bit more in detail on the findings in that study okay.
Hi, good morning, yes. So.
I think that study highlighted two things one not only can we re dose, but we're actually seeing significant enhancement of the trans gene expression and activity. After the first dose. So we think that there is a benefit of adding inventory to gene therapies, both at the first and second dose.
Obviously, the durability as you say it is a concern.
By and large.
Actually the hemophilia husband, so far are restricted to adult patients. So.
The question of durability becomes even more pressing I think for pediatric indication.
Okay. Thanks, and then as you are currently conducting the first in human study now I wanted to ask a question do you think could be helped answered with the empty capsid study and the data later this year.
Joining the assessment of AAV neutralizing antibodies, and then which items do you think will be important to focus on next year with the MMA trial, and I know youre guiding to launch the trial next year, but do you also think that we will see some initial biomarker and safety data in 2022 as well.
Yeah. That's a great question. So as we as we guidance, we'll have results from the empty capsid study in the fourth quarter of this year.
And really what we're looking at is are we able to prevent levels of <unk> antibodies.
When co administered with the aviate captured within tour.
And what we expect in terms of what we've seen with the nonhuman primate data.
We would.
Look at the 30 day data.
We're able to prevent the formation of antibodies. So it's a it's a very.
Important readout for us, but the primary goal is really to find the right dose of inventories in essence, a dose escalation study.
We're looking at two doses.
In terms of the MMA.
Trials, so we haven't guided in detail Christian as you know, but we're pleased that we're able to file the R&D in the third quarter of this year. So a little bit ahead of the previous guidance that we've given.
We will give more detailed guidance after the FDA.
The <unk> file, but I think it's fair to say that.
There is possibility that we will be able to show some biomarker at least off the first cohort in 2022, obviously its a safety study primarily.
And we're also focusing obviously on the.
The ability to prevent inflammation ocular antibodies, but biomarkers will be something that'll look that's for sure.
Great. Thank you.
Our next question comes from Rajiv Prasad from William Blair. Please go ahead with your question.
Thanks for taking the question.
Maybe if you could just give us a little bit of color on you know the different doses of inventory that you're testing in the <unk> study and how are you. How are you going to look at kind of that data.
In regards to some of the disease specific trials that you're running next.
Next year and I have another question.
Yeah, that's a great question Raj.
So in terms of doses, we're looking at two doses in the empty capsid study, we're looking at one five milligrams per kilograms, and <unk> three milligrams per kilograms of both doses that have been.
In the clinic in humans.
We as you know we've taken the 0.15 dose forward into phase III currently for chronic refractory gout.
We haven't guided yet on the dose we're going to use an MMA.
We will do that once we have.
<unk> submitted the IND application to the FDA and received feedback.
But I think maybe just one additional comment around this.
We.
God, we're dosing up to 12 times.
So in the end.
The phase III, where should we see in gene therapy, we likely need less dosage you look at the non human Primate study.
Wired three doses to prevent inflammation, who doesn't antibodies. So I think there is a possibility to use a higher dose actually in gene therapy, given we don't plan to get up to 12 doses. So I mean, that's just further consideration, but what we will give guidance after we filed the R&D.
Is there anything you are thinking about with MMA and OTC, primarily being more pediatric.
Disease indications regarding the prevalent population or the incident population.
And the dosing.
Yeah. That's a that's a that's an important question actually and I'll, let Peter.
Talk about a little bit high level I don't think we want we're ready to disclose details yet, but just some general understanding we have just Brooklyn, Washington pediatric use Peter.
Sure.
There there is some information.
On the use of Rapamycin in pediatrics.
Ah patients, including renal transplant, a number of cancer.
Cancer treatments.
And so so we do know a bit about the pharmacokinetics in pediatrics.
And while we haven't.
Those in tour.
In children.
We believe that our approach will be safe.
Safe and tolerable from the standpoint of comparison of clearances between.
Oh, pediatrics and adults were actually.
Children that have a higher clearance rate and therefore.
Lower levels of Rapamycin and comparison to adults.
So we think we'll be able to dose with the same doses that we've used in adults.
With a bit of a safety margin and of course, then we will guide our continued dosing with.
With Rapamycin Loveless.
Great and then maybe just one quick follow up I think in <unk>.
Preclinical presentation on the dosing and the presence of preexisting maternal antibodies.
So you're still thinking about using <unk> in patients with maternal derived antibodies versus kind of quantified preexisting antibodies.
Yes, that's a good question Raj as well.
So currently in humans.
We don't saying that <unk> addressed this preexisting antibodies.
So we would the current thinking is that we would use the same criteria as for other gene therapies in terms of you know excluding.
Excluding patients with pre existing antibodies, obviously that population has it been lowering kids and adults.
We think there are other potential treatment approaches outside of in torture address that unmet need such as an ITT protease for example.
But I'll, let Kate maybe comment given the context to that presentation that we gave.
Hi, yes.
We have seen some effect of <unk> on low levels of pre existing antibodies, but as Carsten said I think.
It's limited in terms of patients that went high levels.
But I think that when we give in tour with AAV gene therapy or.
Naive patients so in other words patients that our antibody negative.
We see.
A very robust data for enabling re dosing in those those animals.
Great. Thank you for the question.
Our next question comes from John Newman from Canaccord. Please go ahead with your question.
Hi, guys. Thanks for taking my question.
There's been a couple of questions asked already regarding the empty capsid data coming up later this year.
Okay.
Something along a different vein so.
Question is do you see much competition in this area.
Not aware of many companies that are able.
Really any companies that are able to effectively re dose to prevent neutralizing antibody formation at the moment.
Just curious as to.
What youre seeing.
Out in the on the landscape and then.
In terms of the MMA study next year, I know youre not commenting on.
Toward dosing, but.
Would it be reasonable to assume that you would book.
At a multi dose regimen of <unk> and <unk>.
Should we assume that the inventory dosing would remain constant that you Wouldnt for example.
<unk> dosing at some of the later doses. Thanks.
Yeah. Thanks, John.
Great questions.
So in terms of competition, we do believe we're quite a unique position.
When it comes to address this issue to prevent formation of producing antibodies.
We're the only company that has demonstrated the ability.
To reduce.
Formation of antibodies and enable re dosing actually and I think we have dose in mice I think up to three three times or four times.
So.
To our knowledge that we're the only company that.
He has done this and obviously, we have very broad clinical experience with <unk> in other indications like in chronic refractory gout. What we have now I think close to 280 to 290 patients dosed with <unk> up to up to six months.
I think there's one approach, which we find quite interesting actually and which might be complementary.
Two in tour is the use of ITG protease to address the preexisting antibodies.
But then the actual enzymes is quite immunogenic itself, but in terms of the ability to prevent formation.
We believe we're in a unique position.
And obviously, we will have data in the fourth quarter.
In regards to your question on MMA.
Definitely you're right based on the nonhuman primate data it looks like three doses are required to prevent the formation.
<unk> antibodies.
<unk> have not changed the dose with what was used to dose the same dose throughout.
But as we mentioned earlier, but I'm in the position yet to.
Guidance detail on that phase one two study we will do this after we filed the IND with the FDA.
Okay, great. Thank you.
Our next question comes from <unk> Yang from Mizuho Securities. Please go ahead with your question.
Hi, Good morning. This is Dan Clark on for <unk> just.
Two from us to start actually picking that piggybacking off of Johns question, we'd be curious to get your thoughts on non viral gene therapy.
Delivery methods versus the combination of AAV and <unk>.
And I have a follow up as well thanks.
Yeah, that's a great question and there's you know there's a lot of excitement noise and non viral approaches.
But I think it's also fair to say.
Fairly early in terms of just clinical evidence.
They are right now.
Income at exact number but the thing thats over a thousand.
Gene therapy trials.
Interest search.
Clinical trial as golf's with AAV capsid.
Obviously, those will not go away.
Think no novel approaches are interesting, but I think they're very early stage.
Great. Thank you and then.
Do you have any data on inventory improving transgene expression in targets other than the liver.
And is this sort of part of what what's going on in the disruptive collaboration. Thank you.
Yeah.
Thats a great question.
And I'll, let Keith comment as well, but to my knowledge all the work that we have done what's in liver base diseases.
Unfortunately, we can't comment on the disruptive data other than that we received a 3 million milestone for meeting the success with T. Rowe from preclinical studies, which are obviously very thrilled about.
It is obviously in a neuromuscular disease model and also in a higher dose than we've previously loose use but as far as we can comment. Unfortunately, most of the team with you have anything else to add.
Yeah, I don't really have anything to add to that.
Thank you.
Thank you.
Our next question comes from UN Zhong from BTG. Please go ahead with your question.
Great. Thanks, very much for taking the question. So a question on the empty effects I'm, sorry empty capsid study and I just wanted to confirm that are you looking at different doses of AAV eight as well or just a single dose and wonder.
Whether the effect of EMCORE will be dependent on them.
Most of AAV <unk>.
Given that for different indications different capsid probably company.
Companies will have to try different doses.
Yeah. Thanks for the question you and Thats a good question. So we're using a single dose of.
<unk> 12 of AAV eight empty capsid, obviously, it's important to keep in mind. This is a healthy volunteer study.
So we didn't feel it was appropriate to go with a higher dose and we're testing two doses of <unk> <unk>.
One five milligrams per kilogram and a 0.3 milligrams per.
Pilgrim.
But we have some we have some non.
Non human data with higher doses of AAV and showed good control of those antibodies as just in this setting in healthy volunteers.
We didn't think it was a good idea to go with a higher dose for safety reasons.
Okay, great. Thank you.
Our next question comes from Gil Blum from Needham <unk> Company. Please go ahead with your question.
And good morning, and thanks for taking our question. So as you guys are Purdue probably well aware, there's an upcoming advisory committee meeting around safety for AAV.
Do you guys think that first of all we will re dosing come up as a topic at all and secondly, considering them towards an immunosuppressant.
Is there potential for it to improve the safety of General administration of AAV. Thank you.
Yes.
I'll add to care Peter comment on the on the AD Com, which we're obviously.
Aware off.
But yes, we do have we have some encouraging data around safety, we have demonstrated that that in tour has.
Public opinion have a protective.
Properties.
Obviously, the elevated transaminase as are only observed in human and animal studies. So obviously, we're not able to conduct experiments specifically around that but we have pretty.
I think compelling data that shows that in tour is highly hepatic protective.
The other thing safety approaches we've also shown a dose sparing effect so.
The first OS benefit having a higher higher efficacy after the first dose which means potentially use a first a lower dose to begin with which also is positive.
Positive in terms of safety as most of the safety events reported or desk quarter. We're at the very high doses of AAV.
Peter you have anything to add on the on the outcome.
No I don't have anything to add except that we are.
We're quite interested in this and.
We're fortunate that.
K has had a lot of inputs into the FDA talking about in tour and its ability to.
To potentially change the game in gene.
Gene therapy, and so they're well aware of select this technology are very interested in it.
I would just I would just mention one thing that you know.
When you when you go when you made the comment you talked about it.
<unk> being an immunosuppressive actually.
That's one of our advantages is that we really don't globally immuno suppressed with them towards.
Specifically immune tolerance to the antigens that we gave at the same time, so we're getting tolerance to.
A b in the animal studies, we've seen and we hope to be able to replicate that in humans.
And that's a very important point because across the board.
Uh huh.
Have a lot of side effects because or reducing.
This city to all kinds of antigens, whereas we have a rather targeted approach.
I would also say that we hope based on what parts instead about the liver approach that a.
Or the <unk> may be able to spare.
Using steroids in in people who get.
AAV therapy.
Steroids in fact are relatively contra indicated in a number of indications such as MMA and OTC D and.
And so a spare or steroid sparing effect could also be a useful in addition to reducing the hepatic toxicity.
Yeah, I might also add but you know what.
One of the concerns of FDA.
D a.
The liver inflammation.
Liver transaminase.
<unk> elevation that often seen in patients and unfortunately, we can't study that specifically in animals, because it's only been observed in humans in response to AAV.
But what we have seen.
Is that an animal studies, we've seen inhibition of T cell activation and the appearance of <unk> expressing cells in the liver.
Previously.
D eight specific.
AAV specific CDA T cells have been associated with liver enzyme elevation.
And then finally as Carsten mentioned, we have shown that.
Inventory does mitigate inflammation in the liver and other animal models of liver inflammation.
Our next question comes from ROM Silverado from H C. Wainwright. Please go ahead with your question.
Hi, This is mobile and dialing in for Ron So Roger and thanks for taking my question. So.
Obviously, you hired purpose of pharmacy so.
That particular programs, where his expertise will be very very helpful to you.
Yeah. Great question. Yeah. We were pleased that will work, we're able to work with such a small ski hill support us across all our gene therapy programs that we have wholly owned obviously right now the focus is clearly on.
On MMA program to use very.
Familiar with them as we have this as part of the ASP file so that agreement.
That returned this program. So he brings a lot of expertise and that's really the initial focus.
But he is also working with us on.
The OTC deficiency indication as well and other preclinical programs just to strengthen.
Our understanding of how <unk> can be used in the clinic.
Great and one more from me so how does your Iga nephropathy program stack up against a drug like Nossa and <unk>.
Yes so.
I think we have quite a unique approach in Iga nephropathy, and just kind of step back what we're trying to do we are really building on the learnings of our program in chronic refractory gout.
Two one to where we basically baulk patients see a merck asset deposits here, we're using an Iga protease, which is also quite an immunogenic material arguments about patients of Iga, one and complex deposits.
And to our to our understanding where you own. These therapeutic approach at the moment that unaddressed is kind of the underlying cost of the disease.
<unk> won a complex deposit so we think it's quite differentiated from that perspective.
Yeah.
Okay. That's it from me thank you.
And our next question is a follow up from John Newman from Canaccord. Please go ahead with your follow up.
Hi, there just a follow up regarding.
Re dosing in gene therapy. So I guess question for the team just wondering if you could remind us sort of the issues that are faced I think when we think about re dosing in gene therapy, where mainly thinking about.
Not being able to give a second or third dose, but what are some of the other issues that.
That you've seen.
And your work in the field.
They are an issue for example in clinical trials. Thanks.
Yeah. That's a great question, John I mean, there's a couple of applications here right.
Key challenges often to fight the rind, the first dose in a phase.
Phase one study.
If you dose too low you're not able to give a second dose so that could be a <unk>.
Potential application.
For inventory, so you're able to titrate up if you were too low.
Your FERC.
Another theoretical approach and we haven't really started this yet, but especially indications where you get very high viral vector doses like in neuromuscular disorders.
In 2014.
The potential to give multiple lower doses potentially I think that's a very interesting approach as well.
Might be able to avoid.
Avoid some of the safety concerns that were discussed earlier.
And we at least in animal data that we have pretty compelling data.
This approach is potentially quite dose sparing as well, so I mean thats another potential application but.
But I think that the biggest need right now is really the.
The limitation of not being able to give a second dose and throughput team.
Clearly the key the key driver in terms of limitation right now.
Great. Thank you.
And ladies and gentlemen, with that we'll conclude today's question and answer portion of the call.
I'd now like to turn the conference call back over to select a CEO Carsten brunn for closing remarks Carsten.
Thank you operator, and thank you everyone, who joined US this morning stay safe and healthy and this concludes today's call. Thank you.
Ladies and gentlemen that does conclude today's conference call. We do thank you for attending you may now disconnect your lines.