Selecta Biosciences, Inc.
Q2 2021 Earnings Call Transcript

Published: 12 Aug 2021

[Operator:]

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. This call is being webcast live on the Investors & 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.

[Kristen Baldwin:]

Thank you, and good morning. Welcome to our second quarter 2021 financial results and corporate update conference call. The press release supporting our financial results is available on the Investors & Media section of Selecta’s website, www.selectabio.com. And the quarterly report on Form 10-Q ended June 30, 2021 which was filed today with the SEC. Joining me today are Carsten Brunn, our President and Chief Executive Officer; Peter Traber, Chief Medical Officer; and Takashi 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 our most recent Quarterly Report on Form 10-Q. You are cautioned to not to place undue reliance on these forward-looking statements, which speak only as of today, August 12, 2021, and Selecta disclaims any obligation to update such statements, even if management's views change. I would now like to turn the call over to Carsten Brunn.

[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 immune tolerance fields. 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 uricase pegadricase, for the treatment of chronic refractory gout. As a reminder, our Phase 3 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 milligrams per kilogram and 0.15 milligrams per kilogram, and one dose of the pegadricase 0.02 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 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 IgA 1 accumulates in the kidneys. Genetic or environmental factors that cause abnormal IgA 1 and its accumulation in the kidneys can result in the development of IgA nephropathy and leads to kidney disease. Although, there are no approved therapies, we believe our novel approach which combines ImmTOR with IgA 1 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 productive 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 have successfully secured a CDMO, and ID enabling studies are currently underway. We 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 AskBio, we initiated the first-in-human Phase 1 dose escalation trial of SEL-399, and AAV8 empty vector capsid or EMC-101 containing no DNA combined with the 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 capsids 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 EMC AAV8 capsids study in the first quarter of 2021, we also strengthened our wholly-owned gene therapy portfolio by regaining exclusive rights to MMA-101, and 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 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 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 transient expression after both initial and repeat dosing of an AAV vector in the mouse model of MMA. The publication further validates the use of ImmTOR in our gene therapy pipeline, and especially relevant for the clinical development of SEL-302. The Phase 1/2 SEL-302 program, which is expected to commence in 2022 will evaluate biomarkers of the disease, utilizing 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 excellent 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 pediatric committee in February 2021. Before we wrap up on gene therapy, Sarepta Therapeutics continues to conduct preclinical work looking at the combination of ImmTOR in certain neuromuscular disorders including Duchenne muscular dystrophy or DMD and limb-girdle muscular dystrophies or LGMD subtypes. We recently received a 3 million milestone payment for successfully meeting the criteria in this preclinical study under research license and option agreement with Sarepta. This further validates 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, demonstrated that ImmTOR enhances the tolerogenic environment in the liver, shows 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 it's well suited to the application of our ImmTOR immune tolerance platform. Our autoimmune program is advancing through IND enabling studies, and we expect to find an IND and PBC in the second-half of 2022. Now, I'll run through our financial results for the second quarter ended June 30, 2021. We remain well-capitalized. We had $161.5 million liquidity as of June 30, 2021, which compares to $149.2 million liquidity as of March 31, 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 30, 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 3 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 exploration of the contractual audit term under the Skolkovo Foundation grant. Research 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 30, 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 costs 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, there's 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 a special advisor. He is a professor of pharmacology and has been 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 clinical trials for hemophilia, Duchenne muscular dystrophy, giant axonal neuropathy, Pompe Disease and heart failure. He is 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 is 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, and we remain confident in our platform. I'd like to conclude by reiterating our gratitude to the many people who've 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?

[Operator:]

Ladies and gentlemen, at this time we'll begin the question-and-answer session. Our first question today comes from Kristen Kluska from Cantor Fitzgerald. Please go ahead with your question.

[Kristen Kluska:]

Hi, good morning, and thanks for taking my questions. So, 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 hemophilia B patient. So 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 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 ImmTOR could have on durability, including through potential re-dosing and other aspects.

[Carsten Brunn:]

Thanks for the question, Kristen. You're right, 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 Kei comment a little bit more detail on the findings in that study. Kei?

[Takashi Kishimoto:]

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 transgene expression and activity after the first dose. So, 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 of concern. And by and large, actually haemophilia has been so far restricted to adult patients. So the question of durability becomes even more pressing, I think, for pediatric indications.

[Kristen Kluska:]

Okay. Thanks. And then, as you're currently conducting the first-in-human study now, I wanted to ask what key question do you think could be helped answered with the empty capsids study in 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? And I know you're guiding to launch the trial next year, but you also think that we will see some initial biomarker and safety data in 2022, as well?

[Carsten Brunn:]

Yeah, that's a great question. So as we guided, we will have results from the empty capsids study in the fourth quarter of this year. And really what we're looking at is, are we able to prevent levels of antibodies, when co-administered with the AAV8 capsids with ImmTOR. And, what we expect in terms of what we've seen with a non-human primate data, that we would primarily look at the 30-day data, and are we able to prevent formation of empty antibody. So it's a very important readout for us. But the primary goal is really to find the right dose of ImmTOR, in essence, that dose escalation study we’re looking at two doses. In terms of the MMA trial, so 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 will give more detailed guidance after the FDA views and 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 off the first cohort in 2022. Obviously, it's the safety study primarily and we're also focusing, obviously on the ability to prevent formation neutralizing antibodies, but biomarkers will be something we're going to look at, for sure.

[Kristen Kluska:]

Great. Thank you.

[Operator:]

Our next question comes from Raju Prasad from William Blair. Please go ahead with your question.

[Raju Prasad:]

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 kind of that data in regards to some of the disease-specific trials that you're running next year? And I have another question.

[Carsten Brunn:]

Yeah, that's a great question, Raju. So in terms of doses, we're looking at two doses in the empty capsids study. We're looking at 0.15 milligrams per kilogram, and 0.3 milligrams per kilograms. Both doses that have been in the clinic and in-humans, as you know, we take into 0.15 dose forward in the Phase 3 currently for chronic refractory gout. We haven't guided yet on the dose we're going to use in MMA, we will do that once we have submitted the IND application to the FDA and receive feedback. I think one, maybe just Raj, one additional comment around this, in gout we're dosing up to 12 times, in the Phase 3, whereas we see in gene therapy, we likely need less doses, you look at the non-human primate study, we require three doses to prevent inflammation of neutralizing antibodies. So 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. So, unless there's further consideration, but we'll give guidance after we've filed the IND.

[Raju Prasad:]

Is anything you're thinking about with MMA and OTC, primarily being more pediatric disease indications regarding the prevalent population, or the antigen population and the dosing?

[Carsten Brunn:]

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 tropomyosin pediatric use. Peter?

[Peter Traber:]

Sure. There is some information on the use of labomyosin in pediatric patients, including renal transplant, a number of cancer treatments. And so, we do know a bit about the pharmacokinetics in pediatrics. And 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 labomyosin in 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 labomyosin levels.

[Raju Prasad:]

Great. And then maybe just one quick follow up. I think at ASTCT, you had a preclinical presentation on the dosing in the presence of preexisting maternal antibodies. So you're still thinking about using ImmTOR in patients with maternal derived antibodies versus kind of bonafide preexisting antibodies?

[Carsten Brunn:]

Yeah, that's a good question Raj, as well. So, currently in humans, we don't think that ImmTOR addresses preexisting antibodies. So we would -- 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 and adults. We think there are other potential treatment approaches outside of ImmTOR to address that unmet need, such as an IgA protease, for example. But I’ll let Kei maybe comment or give you with the context to that presentation that we gave.

[Takashi Kishimoto:]

Yeah, so we have seen some effect of ImmTOR on low levels of preexisting antibodies. But as Carsten said, I think it's limited in terms of patients that with high levels. But I think that when we give ImmTOR with AAV gene therapy for naive patients, so in other words, patients that are antibody negative, we see very robust data for enabling re-dosing in those animals.

[Raju Prasad:]

Thank you for the question.

[Operator:]

Our next question comes from John Newman from Canaccord. Please go ahead with your question.

[John Newman:]

Thanks for taking my question. So question is there's been a couple of questions asked already regarding the empty capsids data coming up later this year. I wanted to ask something along a different vein. So the 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 you're seeing out in the landscape? And 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? And should we assume that the ImmTOR dosing would remain constant that you wouldn't, for example, sort of step up ImmTOR dosing at some of the later doses? Thanks.

[Carsten Brunn:]

Yeah. Thanks, John. Great questions. Yeah, 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 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 re-dosing, actually. And I think we have dosed in mice, I think up to three times or four times. So to our knowledge that we're the only company that has done this. And obviously, we have very broad clinical experience with ImmTOR and other indications, like in chronic refractory gout, what 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, and which might be complimentary to ImmTOR is the use of an IgA protease to address the preexisting antibodies. But then the actual enzyme is quite immunogenic itself. But in terms of the ability to prevent formation, we believe we're in a unique position. And 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. We have not changed the dose. We've always used to dose, the same dose throughout. But as we mentioned earlier, we’re not in the position yet to guide and detail on that Phase 1/2 study. We'll do this after we filed the IND with the FDA.

[John Newman:]

Okay, great. Thank you.

[Operator:]

Our next question comes from Difei Yang from Mizuho Securities. Please go ahead with your question.

[Dan Clark:]

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. And I have a follow-up as well. Thanks.

[Carsten Brunn:]

Yeah, that's a great question. And there's a lot of excitement and noise in non-viral approaches. But I think it's also fair to say that, it's fairly early in terms of just clinical evidence. They are right now -- and don't quote me the exact number, but I think that's over 1,000 gene therapy trials registered on clinical trial of grout with AAV capsids, and obviously, those will not go away. I think, none of our approaches are interesting, but I think they're very early stage at the moment.

[Dan Clark:]

Great. Thank you. And then do you have any data on ImmTOR improving transgene expression and targets other than the liver? And is this sort of part of what's going on in the Sarepta collaboration? Thank you.

[Carsten Brunn:]

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 base diseases. Unfortunately, we can’t comment on the Sarepta data other than that we received it 3 million milestone for meeting the successfully tear up 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 as far as we can’t comment, unfortunately. I’m not sure Kei you have anything else to add?

[Takashi Kishimoto:]

Yeah, I don't really have anything to add to that.

[Carsten Brunn:]

Thank you.

[Dan Clark:]

Thank you.

[Operator:]

Our next question comes from Yun Zhong from BTIG. Please go ahead with your question.

[Yun Zhong:]

Okay. Thanks very much for taking the question. So, a question on the empty capsids study. And I just wanted to confirm that, are you looking at different doses of AAV8 as well, or just the single dose? And I wonder whether the effect of ImmTOR will be dependent on the dose of AAV8 capsids, given that for different indications for different capsids probably companies will have to try different doses?

[Carsten Brunn:]

Yeah, thanks for the question, Yun. That's a good question. So we're using a single dose of two E-12 of AAV8 empty capsids. 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 ImmTOR, the 0.15 milligrams per kilogram and 0.3 milligrams per kilogram. So we have some non-human data with higher doses of AAV and showed good control of those antibodies 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.

[Yun Zhong:]

Okay. Great. Thank you.

[Operator:]

Our next question comes from Gil Blum from Needham & Company. Please go ahead with your question.

[Gil Blum:]

Hi, good morning, and thanks for taking our question. So as you guys are probably well aware, there's an upcoming advisory committee meeting around safety for AAV. Do you guys think that first of all, will re-dosing come up as a topic at all? And secondly, considering ImmTOR as an immunosuppressant, is there potential for it to improve the safety of general administration of AAV? Thank you.

[Carsten Brunn:]

Yeah, so I’ll let Kei or Peter comment on the AdCom, which we're obviously aware of. But, we have some encouraging data around safety. We have demonstrated that ImmTOR has hyper protective properties. Obviously, the elevated trends MMA is only observed in humans, not in 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 ImmTOR is highly hepatoprotective. The other I think safety approach, as we've also shown that dose sparing effect, some of the first dose benefit having a higher efficacy after the first dose, which means potentially use the first lower dose to begin with, which also is positive in terms of safety, as most of the safety events reported or death record are worth a very high doses of AAV. Peter, you have anything to add on the AdCom?

[Peter Traber:]

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. And so 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 it ImmTOR being an immunosuppressive, actually, that's one of our advantages is that we really don't globally immunosuppress with ImmTOR, we specifically immune tolerized to the antigens that we give at the same time. So 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. And 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 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. And so, steroids sparing effect could also be useful in addition to reducing the hepatotoxicity.

[Takashi Kishimoto:]

Yeah, I might also add that, one of the concerns of FDA is the liver inflammation without liver transaminase elevation that's 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 in animal studies, we've seen inhibition of T-cell activation and the appearance of CDA expressing cells in the liver. And previously, the CDA-specific -- AAV-specific CDA T-cells have been associated with this liver enzyme elevation. And then finally, as Carsten mentioned, we have shown that ImmTOR does mitigate inflammation in the liver and other animal models of liver inflammation.

[Operator:]

Our next question comes from Ram Selvaraju from H.C. Wainwright. Please go ahead with your question.

[Boobalan Pachaiyappan:]

Hi, this is Boobalan dialing in for Ram Selvaraju. And thanks for taking my question. So obviously, you hired Professor Samulski, so are there particular programs where his expertise will be very, very helpful to you?

[Carsten Brunn:]

Yeah, great question. We're pleased that we're able to work with Dr. Samulski. He'll support us across all our gene therapy programs that we have fully owned. And obviously, right now the focus is clearly on MMA, a program he is very familiar with, as we have this as part of the AskBio Selecta agreement. And as you know, that return this program. So he brings a lot of expertise, and that's really the initial focus. But 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.

[Boobalan Pachaiyappan:]

Great. And one more from me. So how does your IgA nephropathy program stack up against a drug like narsoplimab?

[Carsten Brunn:]

Yeah, so I think we have quite a unique approach in IgA nephropathy. And just 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 and SEL-212, where we basically about patients of serum uric acid deposits. Here, we're using an IgA protease, which is also quite an immunogenic of origins to develop patients of IgA 1 immune complex deposits. And to our understanding, we're the only therapeutic approach at the moment that addresses kind of the underlying root cause of the disease, the actual IgA 1 complex deposit. So we think it's quite differentiated from that perspective.

[Boobalan Pachaiyappan:]

Okay. That's it from me. Thank you.

[Operator:]

And our next question is a follow-up from John Newman from Canaccord. Please go ahead with your follow-up.

[John Newman:]

Hi, there. Just a follow-up regarding re-dosing and gene therapy. So I guess, the question is for the team. I just wondered if you could remind us some of the issues that are faced, I think when we think about re-dosing and 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.

[Carsten Brunn:]

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 right -- the first dose in a Phase 1 study. If you dose too low, you're not able to give a second dose. So 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 and we haven't really studied this yet, but especially indications where you give very high bile ducts doses, like in your muscle disorders, we're in the magnitude 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. And at least in animal data, we have pretty compelling data that this approach is potentially quite dose sparing as well. So that's another potential application. But I think the biggest need right now is really the limitation of not being able to give a second dose and -- clearly the key driver in terms of limitation right now.

[John Newman:]

Great. Thank you.

[Operator:]

And ladies and gentlemen, with that we will 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?

[Carsten Brunn:]

Thank you, operator and thank you, everyone who joined us this morning. Stay safe and healthy. And this concludes today's call. Thank you.

[Operator:]

Ladies and gentlemen, that does conclude today's conference call. We do thank you for attending. You may now disconnect your lines.