Good morning, everyone, welcome to the Selecta Biosciences second quarter 2021 financial results and corporate update conference call. Currently, all participants are in a listen-only mode. This call is being webcast live on the Investors and Media section of Selecta's website at www.selectabio.com and is being recorded. For opening remarks, I would like to introduce Kristen Baldwin, Chief People Officer of Selecta. Please go ahead.
Thank you, and good morning. Welcome to our second quarter 2021 financial results and corporate update conference call. The press release reporting our financial results is available in the Investor and Media section of Selecta's website, www.selectabio.com, and the quarterly report 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 Kei Kishimoto, 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 the 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 under reliance on these forward-looking statements, which speak only as of today, August 12th, 2021. Selecta disclaims any obligation to update such statements, even if management views change. I would now like to turn the call over to Carsten Brunn.
Thank you, Kristen. 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 tolerogenic therapies. Selecta continues to take a leading position in the immune tolerance field, and in the last quarter, we achieved several milestones that advanced our clinically validated ImmTOR 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. SEL-212, which was licensed to Sobi, is comprised of ImmTOR co-administered with our proprietary urate oxidase, pegadricase, for the treatment of chronic refractory gout. As a reminder, our phase III DISSOLVE clinical program kicked off in the third quarter of 2020 and consists of two double-blind, placebo-controlled trials of SEL-212.
In both trials, SEL-212 will be evaluated at two doses of ImmTOR, 0.1 mg per kg and 0.15 mg per kg, and one dose of pegadricase, 0.2 mg per kg. Each trial aims to enroll 105 patients, with 35 at each dose and 35 on placebo. Enrollment is progressing on schedule, and top-line data from DISSOLVE is expected in the second half of 2022. We intend to leverage the success of SEL-212 for a second enzyme program indication in IgA nephropathy, which is a kidney disease that occurs when immune complexes of an antibody called immunoglobulin A1 or IgA1 accumulates in the kidneys. Genetic or environmental factors that cause abnormal IgA1, hence accumulation in the kidneys, can result in the development of IgA nephropathy and lead to kidney disease.
Although there are no approved therapies, we believe our novel approach, which combines ImmTOR with IgA1 protease, has the potential to treat the root cause of the disease and overcome previous limitations associated with IgA protease development. Due to delay in securing a qualified CDMO to conduct the process development and manufacturing work, we expect to push our anticipated IND filing into 2022. Although COVID-19 and the recent surge has impacted supply chains and resulted in challenges, we've successfully secured a CDMO, and IND-enabling studies are currently underway. We'll 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 AskBio, we initiated the first in-human phase I dose escalation trial of SEL-399, an AAV8 empty vector capsid, or EMC-101, containing no DNA combined with ImmTOR.
The trial is being conducted in healthy volunteers and aims to determine the dose regimen of ImmTOR to mitigate the formation of antibodies to AAV8 capsid used in gene therapies. We're pleased with the progress made to date and remain on track. We expect to report top-line data in the fourth quarter of 2021. Building on our ongoing anti-AAV8 capsid study in the first quarter of 2021, we also strengthened our wholly owned gene therapy portfolio by regaining exclusive rights to MMA-101, an AAV gene therapy vector for the treatment of methylmalonic acidemia, or MMA, a rare metabolic disease in which the body cannot break down certain proteins and fats.
The previously disclosed MMA-101 third-party manufacturing issue was resolved, and we are pleased the 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, SEL-302, which is a combination of MMA-101 plus ImmTOR in MMA during the third quarter of 2021. Further, our recent publication in the Journal of Molecular Therapy: Methods & Clinical Development demonstrated our observation that ImmTOR enhances transgene expression after both initial and repeat dosing of an AAV vector in a mouse model of MMA. The publication further validates the use of ImmTOR in our gene therapy pipeline and is especially relevant for the clinical development of SEL-302. The phase I/II SEL-302 program, which is expected to commence in 2022, will evaluate biomarkers of the disease, neutralizing antibodies, safety, and tolerability.
Our second wholly owned proprietary gene therapy product candidate, SEL-313, is being developed to treat ornithine transcarbamylase or OTC deficiency. OTC deficiency is an X-linked genetic disorder caused by genetic mutations in the OTC gene, which is critical for proper function of the urea cycle. Looking ahead, we expect to file a clinical trial application or CTA and/or an IND in 2022. We submitted the pediatric investigation plan, or PIP, for SEL-313 to the European Medicines Agency Paediatric Committee in February 2021. Before we wrap up on gene therapy, Sarepta Therapeutics continues to conduct pre-clinical work looking at the combination of ImmTOR in certain neuromuscular disorders, including Duchenne muscular dystrophy or DMD, and limb-girdle muscle dystrophies or LGMD subtypes. We recently achieved a $3 million milestone payment for successfully meeting the criteria in this pre-clinical study under a research license and option agreement with Sarepta.
This further validates the potential of ImmTOR's platform. Overall, we're seeing excellent progress, and we look forward to building on this momentum as we move one step closer to addressing immunogenicity constraints in AAV-driven gene therapy, as we strive to overcome repeat dosing limitations by preventing the formation of neutralizing antibodies, and as we enable more durable and robust expression of the transgene after the first dose. Now, moving on to our autoimmune program. Our recently published data in Frontiers in Immunology demonstrate that ImmTOR enhanced the tolerogenic environment in the liver, showed induction of a tolerogenic phenotype in all major hepatic antigen-presenting cell populations, and was protective in an acute model of autoimmune hepatitis.
The publication further supports development of Selecta's ImmTOR platform for the treatment of liver-specific autoimmune diseases, including primary biliary cholangitis or PBC, a chronic progressive autoimmune liver disorder that leads to inflammation, damage, and scarring of the small bile ducts. PBC has a well-defined target antigen, significant unmet medical need, and is well suited to the application of our ImmTOR immune tolerance platform. Our autoimmune program is advancing through IND-enabling studies. We expect to file an IND in PBC in the second half of 2022. I'll run through our financial results for the second quarter ended June 30th, 2021. We remain well capitalized. We had $151.5 million liquidity as of June 30th, 2021, 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 2023.
Net cash used in operating activities was $18.2 million for the six months ended June 30th, 2021, as compared to $23.5 million for the same period 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 license agreement with Sobi, which began in July 2020, resulting from the shipment of clinical supply and the reimbursement of costs incurred for the phase III DISSOLVE clinical program. Additionally, during the second quarter, we recognized less than $0.1 million for shipments under the license agreement with Sarepta and $0.1 million resulting from the expiration of the contractual audit term under the Skolkovo Foundation grant. Research and development expenses for the second quarter 2021 were $14.5 million, which compares with $10.7 million for the same period in 2020.
During the quarter ended June 30th, 2021, there was an increase in expenses incurred for consulting, salaries, and the discovery and preclinical programs, offset by a decrease of AskBio collaboration costs. General 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 expenses. For the second quarter 2021, we report net income of $4.6 million or basic net income per share of $0.04, compared to a net loss of $24.1 million or basic net loss per share of $0.25 for the same period in 2020. Before concluding today's call, we have a few corporate updates to share.
As we enter a critical inflection point in development, we're excited to welcome gene therapy pioneer, Dr. Jude Samulski, as special advisor. He's a professor of pharmacology and has been the director of the University of North Carolina Gene Therapy Center for over two decades. He was awarded the first patent for AAV as a viral vector and was the first recipient of the American Society of Gene & Cell Therapy Outstanding Achievement Award for lifetime achievements in gene therapy. Dr. Samulski has advanced gene therapies into human trials for hemophilia, Duchenne muscular dystrophy, giant axonal neuropathy, Pompe disease, and heart failure. He's currently the president, chief scientific officer, and co-founder of AskBio. We're also pleased by the addition of industry leader Nishan de Silva to Selecta's board of directors. Dr. de Silva has extensive leadership experience, most relevantly in gene therapy development, manufacturing, and regulatory activities.
Dr. de Silva 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 AFYX Therapeutics, a private venture-backed biotechnology company focused on addressing unmet needs in mucosal diseases. Previously, Dr. de Silva served as President, Chief Operating Officer, and Director of Poseida Therapeutics, a cell and gene therapy-focused biopharmaceutical company where he oversaw clinical development, regulatory, manufacturing, finance, and business development activities. Together, Dr. Samulski and Dr. de Silva's 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. 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 Selecta.
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 are using a speakerphone, we do ask you to please pick up the handset prior to pressing your numbers to ensure the best sound quality. Once again, that is star and then one to join the question queue. We will pause momentarily to assemble the roster. Our first question today comes from Kristen Kluska from Cantor Fitzgerald. Please go ahead with your question
Hi, good morning, and thanks for taking my questions. There was a recent publication which surveyed hemophilia patients asking them to rank the most important aspects of a gene therapy treatment, where dose frequency and durability were actually found to rank as the greatest importance for Hem 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 ImmTOR and gene therapy. Would 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 ImmTOR could have on durability, including through potential redosing and other aspects.
Yeah, thanks for the question, Kristen. You're right. Dose frequency and durability is a key issue both for physicians and patients. We're pleased with the data we have to date. I'll let Kei comment a little bit more in detail on the findings in that study. Kei?
Good morning. Yes. I think that study highlighted two things. One, not only can we redose, but we're actually seeing significant enhancement of transgene expression and activity after the first dose. We think that there's a benefit of adding ImmTOR to gene therapies, both at the first and second dose. Obviously, durability, as you say, is a concern. By and large, actually, hemophilia has been so far restricted to adult patients. The question of durability becomes even more pressing, I think, for pediatric indications.
Okay, thanks. As you're currently conducting the first-in-human study now, I wanted to ask what key questions you think could be helped answered with the empty capsid study and the data later this year, including the assessment of AAV8 neutralizing antibodies, and then which items do you think will be important to focus on next year with the MMA trial? I know you're 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. As we guided, we'll have results from the empty capsid study in the fourth quarter of this year. Really what we're looking at is are we able to prevent levels of antibodies when co-administered with the AAV8 capsid with ImmTOR. What we expect in terms of what we've seen with the non-human primate data, that we would primarily look at the 30-day data and are we able to prevent the formation of antibodies. It's a very important readout for us. The primary goal is really to find the right dose of ImmTOR.
It's in essence a dose escalation study, so we're looking at two doses. In terms of the MMA trials, we haven't guided in detail, Kristen, as you know, but we're pleased that we're able to file the IND in the third quarter of this year, so a little bit ahead of the previous guidance that we've given. We'll give more detailed guidance after the FDA reviewed the IND file, but I think it's fair to say that there is possibility that we'll be able to show some biomarker at least of the first cohort in 2022. Obviously, it's a safety study primarily, and we're also focusing, obviously, on the ability to prevent formation of human antibodies. Biomarkers will be something we're going to look at for sure.
Great. Thank you.
Our next question comes from Raju 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 the different doses of ImmTOR that you're testing in the 399 study, and how are you going to look at that data in regards to some of the disease-specific trials that you're running next year? I have another question.
Yeah, that's a great question, Raj. In terms of doses, we're looking at two doses in the anticapsid study. We're looking at 0.15 mg per kg and 0.3 mg per kg. Both doses that have been in the clinic in humans. As you know, we're taking the 0.15 dose forward in the phase III currently for chronic refractory gout. We haven't guided yet on the dose we're going to use in MMA. We'll do that once we have submitted the IND application to the FDA and received feedback. I think, maybe just Raj, one additional comment around this. In gout, we're dosing up to 12 times, so in the phase III. Whereas we see in gene therapy, we likely need less doses. If you look at the non-human primate study, we require three doses to prevent inflammation of human antibodies.
I think there's a possibility to use a higher dose, actually, in gene therapy, given we don't plan to give up to 12 doses. I think that's a further consideration, but we'll give guidance after we've filed the IND.
Is there anything you're 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 an important question, actually. I'll let Peter talk a little bit high level. I don't think we're ready to disclose details yet, but just some general understanding we have in rapamycin in pediatric use. Peter?
Sure. There is some information on the use of rapamycin in pediatric patients, including renal transplant, a number of cancer treatments. We do know a bit about the pharmacokinetics in pediatrics. While we haven't dosed ImmTOR in children, we believe that our approach will be safe and tolerable from the standpoint of comparison of clearances between pediatrics and adults, where actually, children have a higher clearance rate and therefore lower levels of rapamycin in comparison to adults. 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. We will guide our continued dosing with rapamycin levels.
Great. Maybe just one quick follow-up. I think at ASGCT you had a preclinical presentation on the dosing in the presence of preexisting maternal antibodies. You're still thinking about using ImmTOR in patients with maternal-derived antibodies versus kind of bonafide preexisting antibodies?
Yeah, that's a good question, Raj, as well. Currently in humans, we don't think that ImmTOR addresses preexisting antibodies. The current thinking is that we would use the same criteria as for other gene therapies in terms of excluding patients with preexisting antibodies. Obviously, that population is a bit lower in kids than adults. We think there are other potential treatment approaches outside of ImmTOR to address that unmet need, such as an IgG protease, for example. I'll let Kei maybe comment or give a bit of context to that presentation we gave.
Hi. Yeah, we have seen some effect of ImmTOR on low levels of preexisting antibodies. As Carsten said, I think it's limited in terms of patients that with high levels. I think that when we give ImmTOR with AAV gene therapy for naive patients, in other words, patients that are antibody negative, we see very robust data for enabling redosing in 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. Carsten, there's been a couple of questions asked already regarding the empty capsid data coming up later this year. I'm going to ask something along a different vein. The question is: do you see much competition in this area? Not aware of many companies, really any companies, that are able to effectively redose to prevent neutralizing antibody formation at the moment. Just curious as to what you're seeing out on the landscape. Then in terms of the MMA study, next year, I know you're not commenting on ImmTOR dosing, but would it be reasonable to assume that you would look at a multi-dose regimen of ImmTOR? Should we assume that the ImmTOR dosing would remain constant, that you wouldn't, for example, sort of step up the ImmTOR dosing at some of the later doses next?
Yeah. Thanks, John. Great questions. Yeah, in terms of competition, we do believe we're quite in a unique position when it comes to address this issue, to prevent formation of neutralizing antibodies. To our knowledge, we're the only company actually that has demonstrated the ability to reduce the formation of neutralizing antibodies and enable redosing, actually. I think we have dosed now in mice, I think up to three times or four times. To our knowledge, we're the only company that has done this. Obviously we have very broad clinical experience with ImmTOR in other indications, like in chronic refractory gout, where we have now, I think, close to 280, 290 patients dosed with ImmTOR up to six months.
I think there's one approach which we find quite interesting actually, which might be complementary to ImmTOR, is the use of an IgG protease to address the preexisting antibodies. The actual enzyme is quite immunogenic itself. In terms of the ability to prevent formation, we believe we're in a unique position. Obviously we'll have data in the fourth quarter. In regards to your question on MMA, definitely you're right. Based on the non-human primate data, it looks like three doses are required to prevent the formation of antibodies. Have not changed the dose. We've always used the same dose throughout. As we mentioned earlier, we're not in the position yet to guide in detail on that phase I/II study. We'll do this after we file the IND with the FDA.
Okay, great. Thank you.
Our next question comes from Difei Yang from Mizuho Securities. Please go ahead with your question.
Hi, good morning. This is Dan Clark on for Difei. Just two from us. To start, actually piggybacking off of John's question. We'd be curious to get your thoughts on non-viral gene therapy delivery methods versus the combination of AAV and ImmTOR. I have a follow-up as well. Thanks.
That's a great question, there's a lot of excitement and noise in non-viral approaches. I think it's also fair to say that it's fairly early, in terms of just clinical evidence. There are right now, and don't quote me the exact number, but I think there's over 1,000 gene therapy trials registered on clinicaltrials.gov with AAV capsids. Obviously, those will not go away. I think non-viral approaches are interesting, but I think they're very early stage.
Great. Thank you. Do you have any data on ImmTOR improving transgene expression in targets other than the liver? Is this sort of part of what's going on in the Sarepta collaboration? Thank you.
Yeah. That's a great question. I'll let Kei comment as well, but to my knowledge, all the work that we have done was in liver-based diseases. Unfortunately, we can't comment on the Sarepta data. Other than that, we received a $3 million milestone for meeting the success criteria for a preclinical study, which we're obviously very thrilled about. It is obviously in a neuromuscular disease model and also in a higher dose than we've previously used, but that's as far as we can comment, unfortunately. Unless Kei, 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 Yun Zhong from BTIG. Please go ahead with your question.
Great. Thanks very much for taking the question. A question on the empty capsid study, and I just wanted to confirm that, are you looking at different doses of AAV8 as well, or just a single dose? Whether the effect of ImmTOR will be dependent on the dose of AAV capsid, given that for different indications for different capsids, probably companies will have to try different doses?
Thanks for the question, Yun. That's a good question. We're using a single dose of two E12 of AAV8 capsid. Obviously, it's important to keep in mind this is a healthy volunteer study, we didn't feel it was appropriate to go with a higher dose. We're testing two doses of ImmTOR, the 0.15 mg per kg and the 0.3 mg per kg. We have some non-human data with higher doses of AAV and showed good control of neutralizing antibodies. It's 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 & Company. Please go ahead with your question.
Hi, and good morning, and thanks for taking our question. As you guys are probably well aware, there's an upcoming advisory committee meeting around safety for AAVs. Do you guys think that, first of all, will re-dosing come up as a topic at all? Secondly, considering ImmTOR is an immunosuppressant, is there potential for it to improve the safety of general administration of AAVs? Thank you.
I'll let Kei or Peter comment on the AdCo m, which we're obviously aware of. We do have some encouraging data around safety. We have demonstrated that ImmTOR has hepatoprotective properties. Obviously, the elevated transaminases are only observed in humans, not in animal studies. Obviously, we're not able to conduct experiments specifically around that. We have pretty, I think, compelling data that shows that ImmTOR is highly hepatoprotective. The other, I think, safety approach is we've also shown a dose-sparing effect. With the first dose benefit having a higher efficacy after the first dose, which means you could potentially use a lower dose to begin with, which also is positive in terms of safety, as most of the safety events reported or deaths reported were at the very high doses of AAV. Peter, you have anything to add on the outcome?
No, I don't have anything to add except that we are quite interested in this, and we're fortunate that Kei has had a lot of input into the FDA talking about ImmTOR and its ability to potentially change the game in gene therapy. They're well aware of Selecta's technology and very interested in it. I would just mention one thing that, Gil, when you made the comment, you talked about ImmTOR being an immunosuppressive. Actually, that's one of our advantages is that we really don't globally immunosuppress with ImmTOR. We specifically immune tolerize to the antigens that we give at the same time. We're getting tolerance to AAV in the animal studies that we've seen, and we hope to be able to replicate that in humans.
That's a very important point because, across the board, immunosuppressants have a lot of side effects because they're reducing immunogenicity to all kinds of antigens, whereas we have a rather targeted approach. I would also say that we hope, based on what Carsten said about the liver approach, that ImmTOR may be able to spare using steroids in people who get AAV therapy. Steroids, in fact, are relatively contraindicated in a number of indications, such as MMA and OTCD. So a steroid-sparing effect could also be useful in addition to reducing the hepatotoxicity.
Yeah, I might also add that one of the concerns of FDA is the liver inflammation, that liver transaminase elevation that's often seen in patients. Unfortunately, we can't study that specifically in animals because it's only been observed in humans in response to AAV. What we have seen is that in animal studies, we've seen inhibition of T cell activation and the appearance of CD8 expressing cells in the liver. Previously, the AAV specific CD8 T cells have been associated with this liver enzyme elevation. Finally, as Carsten mentioned, we have shown that ImmTOR does mitigate inflammation in the liver in other animal models of liver inflammation.
Our next question comes from Ram Selvaraju from H.C. Wainwright. Please go ahead with your question.
Hi, this is Boobalan dialing in for Ram Selvaraju. Thanks for taking my question. Obviously, you hired Professor Samulski. Are there particular programs where his expertise will be very helpful to you?
Yeah. Great question. Yeah, we were pleased that we were able to work with Dr. Samulski. He'll support us across all our gene therapy programs that we have wholly owned. Obviously, by now the focus is clearly on MMA, a program he's very familiar with, as we had this as part of the Selecta agreement. As you know, they've returned this program. He brings a lot of expertise in. That's really the initial focus. He's also working with us on the OTC deficiency indication as well, and other preclinical programs just to strengthen our understanding of how ImmTOR can be used in the clinic.
Great. One more from me. How does your IgA nephropathy program stack up against a drug like narsoplimab?
Yeah, I think we have quite a unique approach in IgA nephropathy and just to kind of step back what we're trying to do here, we're really building on the learnings of our program in chronic refractory gout, SEL-212, where we basically debulk patients of sodium urate acid deposits. Here, we're using an IgA protease, which is also quite an immunogenic, it's of bacterial origin, to debulk patients of IgA1 immune complex deposits. To our understanding, we're the only therapeutic approach at the moment that addresses the underlying root cause of the disease, the actual IgA1 complex deposit. We think that it's quite differentiated from that perspective.
Okay. That's it from me. Thank you.
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 redosing in gene therapy. I guess question for the team. I just wondered if you could remind us some of the issues that are faced. I think when we think about redosing in gene therapy, we're mainly thinking about not being able to give a second or third dose, but what are some of the other issues that you've seen in your work in the field that 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? The key challenge is often to find the first dose in a phase I study. If you dose too low, you're not able to give a second dose. That could be a potential application for ImmTOR. You're able to titrate up if you were too low in your first dose. Another theoretical approach, we haven't really studied this yet, is, but especially indications where you give very high viral vector doses, like in neuromuscular disorders, we're in the [mecha of E14]. The potential to give multiple lower doses, potentially, I think that's a very interesting approach as well, where you might be able to avoid some of the safety concerns that were discussed earlier.
We at least, in animal data, we have pretty compelling data that this approach is potentially quite dose-sparing as well. I mean, that's another potential application. I think that the biggest need right now is really the limitation of not being able to give a second dose and [group A] is clearly the key driver in terms of limitation right now.
Great. Thank you.
Ladies and gentlemen, with that, we'll conclude today's question and answer portion of the call. I would now like to turn the conference call back over to Selecta's CEO, Carsten Brunn, for closing remarks. Carsten?
Thank you, operator. Thank you everyone who joined us this morning. Stay safe and healthy. 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.