Earnings Call: Q2 2021

Aug 12, 2021

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 and Media section of Selecta's website at www.selectabio.com and is being recorded. For opening remarks, I would like to introduce Kristin Baldwin, Chief People Officer of Selecta. Please go ahead. Thank you and good morning. Welcome to our Q2 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 30, 2021, which was filed today with the SEC. Joining me today are Carsten Brunn, President and Chief Executive Officer Peter Traver, Chief Medical Officer and Kai 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 10Q. You are cautioned not to take place under reliance on these forward looking statements, which speak only as of today, August 12, 2021, and selected 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. Thank you, Kristin. 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. Celecta continues to take a leading position in immune tolerance field. And during 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. SAL-two twelve, which was licensed to Sobe, is comprised of ImmTOR co administered with our proprietary uricase, pegatricase, for the treatment of chronic refractory gout. As a reminder, our Phase 3 DASOLVE clinical program kicked off in the 3rd quarter of 2020 and consists of 2 double blind placebo controlled trials of SEL-two twelve. In both trials, SEL-two twelve will be evaluated at 2 doses of ImmTOR, 0.1 milligrams per kilogram and 0.15 milligrams per kilogram and one dose of pegapricase, 0.2 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 Dizolv is expected in the second half of 2022. We intend to leverage the success of SEL-two twelve for a second enzyme program indication in IgA nephropathy, which is a kidney disease that occurs when immune complexes of an antibiotic 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-nineteen and the recent surge has impacted supply chains and resulted in challenges, we've successfully secured a CDMO and ID 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 Q1 of 2021, in collaboration with AspBio, we initiated the 1st in human Phase 1 dose escalation trial of SEL-three ninety nine, an AV8 anticapsid vector capsid or EMC-one hundred and one 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 AVA 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 Q4 of 2021. Building on our ongoing anti AAV8 capsid study in the Q1 of 2021, we also strengthened our wholly owned gene therapy portfolio by regaining exclusive rights to MMA-one hundred and one, an AAV gene therapy vector for the treatment of metabolic acidemia or MMA, a rare metabolic disease in which the body cannot break down certain proteins and fats. The previously disclosed MMA-one hundred and one third party manufacturing issue was resolved and we are pleased the manufacturing of a new lock has been completed and is currently undergoing final release testing. We expect to file an IND for our lead gene therapy candidate, SCL-three zero two, which is a combination of NMA-one hundred and one plus mTOR in MMA during the Q3 of 2021. Further, our recent publication in the Journal of Molecular Therapy Methods and 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 SEL302. The Phase III SEL302 program, which is expected to commence in 2022, will evaluate biomarkers of the disease, mutilizing antibodies, safety and tolerability. Our second wholly owned proprietary gene therapy product candidate, SAL-three thirteen, is being developed to treat onethine 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 uro 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-three thirteen 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 dystrophy or LGMD subtypes. We recently achieved a $3,000,000 milestone payment for successfully meeting the criteria in a preclinical 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 losing 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 tolerogenic environment in the liver showed induction of a tolerogenic phenotype in all major hepatic antigen presenting cell populations and was protected in an acute model of autoimmune hepatitis. The publication further supports development of Selecta's intra 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 and we expect to file an IND in PBC in the second half of twenty twenty two. Now I'll run through our financial results for the Q2 ended June 30, 2021. We remain well capitalized. We had $151,500,000 liquidity as of June 30, 2021, which compares to 149 point $2,000,000 liquidity as of March 31, 2021. We believe our liquidity will be sufficient to meet our operating requirements into the Q3 of 2023. Net cash used in operating activities was $18,200,000 for the 6 months ended June 30, 2021, as compared to $23,500,000 for the same period in 2020. Revenue recognized for the Q2 of 2021 was $19,600,000 compared to no revenue recognition for the same period in 2020. Revenue was recognized under license agreement with SoVi, which began in July 2020, resulting the shipment of clinical supply and the reimbursement of costs incurred for the Phase III DASOLVE clinical program. Additionally, during the second quarter, we recognized less than $100,000 for shipments under the license agreement of Sarepta and $100,000 resulting from the expiration of the contractual audit term under the Skolcobo Foundation brand. Research and development expenses for the Q2 2021 were $14,500,000 which compares with $10,700,000 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 equipment programs, offset by a decrease of AskBio collaboration costs. General and administrative expenses for the Q2 of 2021 were $4,700,000 which compares with $5,600,000 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 Q2 2021, we reported net income of $4,600,000 or basic net income per share of $0.04 compared to a net loss of $24,100,000 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, Doctor. Drew Samolsky, as Special Advisor. He's a professor of pharmacology and has been Director of the University of North Carolina Gene Therapy Center for over 2 decades. He was awarded the first patent for AV as a viral vector and was the 1st recipient of the American Society of Gene and Cell Therapy Outstanding Achievement Award for lifetime achievements in gene therapy. Doctor. Zymovsky has advanced gene therapies in the tumor trials for hemophilia, Duchenne muscular dystrophy, giant external 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, Michonne de Silva, to select us Board of Directors. Doctor. De Silva has extensive leadership experience, most relevantly in gene therapy development, manufacturing and regulatory activities. Doctor. D'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 FX Therapeutics, a private venture backed biotechnology company focused on addressing unmet needs in mucosal diseases. Previously, Doctor. De Silvers 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, Doctor. Semalsky and Doctor. Dilba'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 have been supported 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? Our first question today comes from Kristin Kluska from Cantor Fitzgerald. Please go ahead with your question. Hi, good morning and thanks for taking my questions. So there is 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. 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 mTOR and gene therapy. So I 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 re dosing and other aspects? Yes. 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 that we have to date. I'll let Kaye comment a little bit more in detail on the findings in that study. Kaye? Good morning. Yes. So I think that study highlighted 2 things. 1, 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 a concern. And by and large, actually hemophilia has been so far restricted to adult patients. So the question of durability becomes even more pressing I think for pediatric indications. Okay. Thanks. And then 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? And I know you're guiding to launch the trial next year, but do you Yes, that's a great question. Yes, that's a great question. So as we guided, we'll have results from the empty capsid study in the Q4 of this year. And really, we're looking at is, are we able to prevent levels of molecular antibodies when co administered with the AAV8 capsid with ImmTOR. And 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 formation of antibodies. So it's a very important readout for us. But the primary goal is really to find the right dose of INFOR. It's in essence a dose escalation study. So we're looking at 2 doses. In terms of the MMA trials, and we haven't guided in detail, Kristen, as you know, but we're pleased that we're able to file the IND in the Q3 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 ocular antibodies, but biomarkers will be something we've got 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 mTOR 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. Yes, that's a great question, Raj. So in terms of doses, we're looking at 2 doses in the empty capsid study. Looking at 0.15 milligrams per kilogram and 0.3 milligrams per kilogram, both doses that have been in the clinic in humans, as you know, we're taking the 0.15 dose forward into 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'll do that once we have submitted the IND application to the FDA and received feedback. I think one maybe just Rod, one additional comment around this. We in gout, we're dosing up to 12 times, so in the Phase 3, whereas we see in gene therapy, we likely need less doses. If you look at the non tumor primate study, we required 3 doses to prevent formation of glutinous 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 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? Yes, 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 to prophylaxis 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. 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 rapamycin 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 rapamycin levels. Great. And then maybe just one quick follow-up. I think at ASCCT, you had a preclinical presentation on the dosing in the presence of pre existing maternal antibodies. So you're still thinking about using mTOR in patients with maternal derived antibodies versus kind of bona fide pre existing antibodies? Yes, that's a good question, Raj, as well. So currently in humans, we don't think that ImmTOR addresses pre existing 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 pre existing 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 are mid need, such as an ITG protease, for example. But I'll let Kaye maybe comment, give a bit of context to that presentation we gave. Hi. Yes. So, we have seen some effect of ImmTOR on low levels of pre existing 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 redosing in those animals. Our next question comes from John Newman from Canaccord. Please go ahead with your question. Hi, guys. Thanks for taking my question. So, question has been a couple of questions asked already regarding the MT CAPTAIN data coming up later this year. I wanted to ask 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 redose 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 book at a multi dose regimen of ImmTOR? And should we assume that the ImmTOR dosing would remain the Yes. Thanks, John. Great questions. Yes. 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 Lusi antibodies. To our knowledge, we're the only company actually that has demonstrated the ability to reduce the formation of these antibodies and enable redosing actually. And I think we have dosed now in mice, I think, up to 3x or 4x. So to our knowledge that we're the only company that has done this. And obviously, we have very broad clinical experience with ImmTOR in other indications like in chronic effector gout what we have now. I think close to 280, 290 patients dosed with ImmTOR up to 6 months. I think there's one approach, which we find quite interesting actually and which might be complementary to ImmTOR is the use of an IgG protease to address the pre existing 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 Q4. In regards to your question on MMA, definitely, you're right. Based on the non human primate data, it looks like 3 doses are required to prevent information of antibodies. Have not changed the dose. We've always used the dose, the same dose throughout. But as we mentioned earlier, we're not in the position yet to guide in detail on that Phase III study. We'll do this after we filed 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 2 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. Yes, I mean, 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 call me the exact number, but I think there's over 1,000 gene therapy trials registered on clinicaltrials.gov with AAV TAPCIDs. And obviously, those will not go away. I think non do you have any data on ImmTOR improving TRAN's gene expression and targets other than the liver? And is this sort of part of what's going on in the Sarepta collaboration? Thank you. Yes. That's a great question. And I'll let Kate 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 3,000,000 milestone for meeting the success criteria for 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 previously used, but that's as far as we can comment, unfortunately. Unless you have anything else to add? Yes, 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. So 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? And I wonder whether the effect of mTOR will be dependent on the dose of AAV capsid given that for different indications for different capsid probably companies will have to try different doses? Yes. Thanks for the question, Eun. That's a good question. So we're using a single dose of 2e12 of AAV8 anticapsid. 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 2 doses of ImmTOR, the 0.15 milligrams per kilogram and the 0.3 milligrams per kilogram. But we have some non human data with higher doses of AAV and short good control of neuroendobatics is 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. Our next question comes from Kjell Blum from Needham and Company. So 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 redosing 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 AAVs? Thank you. Yes. So I'll let Kay or Peter comment on the AdCom, which we're obviously aware of. But yes, we do have we have some encouraging data around safety. We have demonstrated that that Intor has hepatoprotective properties. Obviously, the elevated transaminases are 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 is we've also shown a dose bearing effect. So with the 1st dose benefit having a higher efficacy after the 1st dose, which means to potentially use a first a lower dose to begin with, which also is positive in terms of safety as most of the safety events reported or deaths recorded were at the very high doses of AAV. Peter, do you have anything to add on the AdCom? No, I don't have anything to add except that we are quite interested in this. And we're fortunate that Kay 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 selective technology and very interested in it. I would just mention one thing that when you Gil, when you made the comment, you talked about it, ImmTOR being immunosuppressive. Actually, that's one of our specifically immune tolerance to the antigen, specifically immune tolerize 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 a rather targeted approach. I would also say that we hope based on what Carson said about the liver approach that are 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 a steroid sparing effect could also be useful in addition to reducing the hepatotoxicity. Yes. I might also add that one of the concerns of FDA is the liver inflammation that that 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 CD8 expressing cells in the liver. And previously, the CD8 specific, AAV specific CD8 T cells have been associated with this liver enzyme elevation. And then finally, as Carson mentioned, we have shown that ImmTOR does mitigate inflammation in the liver and other animal models of liver inflammation. Our next question comes from Ram Selvaraju from H. C. Wainwright. This is Boobalan dialing in for Ram Selvaraju and thanks for taking my question. So obviously you hired Professor Samuski. So are there particular programs where his expertise will be very, very helpful to you? Yes, great question. Yes, we're very pleased that we're able to work with Doctor. Zymulski. He'll support us across all our gene therapy programs that we have fully owned. And obviously, by now, the focus is clearly on MMA, a program he's very familiar with as we have this as part of the As Bio select agreement As you know, they had returned this program. So he brings a lot of expertise in. 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 Intra 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 narsoplimab? Yes. So I think we have quite a unique approach in IgA nephropathy and just kind of step back what we're trying do here, really building on the learnings of our program in chronic refractory gout, SEL-two twelve, where we basically bulk patients of serum uric acid deposits. Here, we're using an IgA protease, which is also quite immunogenic of bacterial origin to develop patients of IgA1 immune complex deposits. And to our understanding, we're the only therapeutic approach at the moment that unaddresses kind of the underlying root cause of the disease, the actual IgE1 complex deposits. So we think it's quite differentiated from that perspective. 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 redosing in gene therapy. So 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. Yes, that's a great question, John. I mean, there's a couple of applications here, right? The key challenge is often to fight 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. So 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 is, but especially indications where you give very high viral vector doses, like in neuromuscular disorders, we're in a 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 we at least in animal data, we have pretty compelling data that this approach is potentially quite dose sparing as well. So I mean, that's another potential application. But I think that the biggest need right now is really the limitation of not being able to give a second dose and group of cleanly 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 would now like to turn the conference call back over to Selecta's CEO, Mr. Carson Brunn, for closing remarks. Carson? 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.