Selecta Biosciences, Inc.
Q4 2021 Earnings Call Transcript

Published: 10 Mar 2022

[Operator:]

Good morning. And welcome to the Selecta Biosciences Fourth Quarter and Full-Year 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 it is being recorded. For opening remarks, I would like to introduce, Kevin Tan, Chief Financial Officer of Selecta. Please go ahead.

[Kevin Tan:]

Thank you and good morning. Welcome to our fourth quarter and full-year 2021 financial results and corporate update conference call. The press release reporting our financial results is available in the Investors & Media section of Selecta’s website, www.selectabio.com and our annual report on Form 10-K for the year ended December 31st, 2021, which will be filed today with the Securities and Exchange Commission or SEC. Joining me today are Carsten Brunn, President and Chief Executive Officer; Peter Traber, Chief Medical 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 SEC, including the most recent annual report on Form 10-K. You are cautioned to not to place undue reliance on these forward-looking statements, which speak only as of today, March 10th, 2022, 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?

[Carsten Brunn:]

Thank you, Kevin. Good morning. I appreciate everyone joining us today. Before we begin, I'm thrilled to announce that on March 9, the FDA cleared the investigational new drug or IND application for Phase 1 gene therapy clinical trial of SEL-302 to treat Methylmalonic acidemia or MMA; a serious and life threatening metabolic disorder. This clinical trial is a critical step in our efforts to treat MMA and enable re-dosing of AAV mediated gene therapies. We expect to initiate the Phase 1 trial in the second half of 2022. And we look forward to bringing hope to all those patients and families affected by this terrible disease. 2021 was a very busy and transformational year and we're extremely pleased with a significant progress to propel our business forward. Over the past year, we advanced our pipeline of wholly owned and partner programs, we entered a number of key strategic partnerships and are close to catalyzing an evolution of our precision immune tolerance platform. By combining ImmTOR with a Treg-selective IL-2 molecule, we have observed synergistic effects in the induction and expansion of antigen-specific regulatory T-cells for Tregs. We believe this transformative combination, which we call ImmTOR-IL has the potential to enhance the induction and durability of antigen-specific immune tolerance; a substantial leap forward for ImmTOR platform. I would now like to walk you through key updates and recent strategic partnerships pertaining to the three pillars of our pipeline

[Kevin Tan:]

Thank you, Carsten. We remain well-capitalized with $129.4 million in liquidity as of December 31, 2021, which compares to $140.1 million in liquidity as of December 31, 2020. We believe our liquidity will be sufficient to meet our operating requirements into the third quarter of 2023. This is important notes that this is the most conservative forecast for our cash runway that considers none of the potential incoming milestones and royalties from our numerous partnerships. Net cash used $60.4 million for the 12-month and fiscal year ended December 31, 2021, as compared with $34.9 million net cash provided by operating activities for the same period in 2020. Collaboration and license revenue recognize the fourth quarter and fiscal year 2021 was $29.9 million and $85.1 million compared to $12 million and $16.6 million for the same periods in 2020. Revenue was primarily driven by the license agreement with Sobi resulting from the shipment of clinical supply and the reimbursement of costs incurred for the Phase 3 DISSOLVE clinical program. Additionally, during the fourth quarter, Selecta recognized $1 million for shipments of clinical supply under the license agreement with Takeda and $0.4 million for shipments under license agreement with Sarepta. Research and development expenses for the fourth quarter and fiscal year 2021 were $20.3 million and $68.7 million respectively, which compares with $15.1 million and $54.5 million for the same periods in 2020. The quarterly and annual increases were primarily driven by expense incurred for preclinical programs, payroll costs and AskBio collaboration costs. General and administrator expenses for the fourth quarter and fiscal year 2021 were $5.5 million and $20.9 million respectively, which compares with $4.8 million and $18.9 million for the same periods in 2020. The quarterly and annual increases were primarily driven by increases in stock compensation expenses and consulting fees offset by a reduction in professional fees. For the full year 2021, Selecta recognized an income tax expense of $16 million. The expense with the results of our decision to opt out of the installment sale methods that would have been applied to the sale of the Sobi license for income tax purposes. By electing out of the installment method, the company was taxed on the estimated fair value of the current and future proceeds from the Sobi licensed as part of our 2020 income tax return filing. As a reminder, the Sobi agreement provides for up to $630 million in development, regulatory and sales milestones, as well as royalty payments based on contractual sales tiers. As a result of this selection, any revenues resulting from these future milestones and royalties will be excluded from collective taxable income. For the fourth quarter and fiscal year 2021, we reported net income of $12 .2 million or basic net income per share of $0.10 per share, and a net loss is $25.7 million, or basic net loss per share of $0.22. For the fourth quarter and full year 2020, we reported net losses of $15.4 million or net loss of $0.14 per share, and $68.9 million or a net loss of $0.68 per share. I will now turn it back to Carsten for closing remarks. Carsten?

[Carsten Brunn:]

Thank you, Kevin. In summary, 2021 was an incredibly productive year for Selecta. We're excited to enter the clinic with SEL-302 about the continued growth of pipeline, or multiple shots on goal and numerous validating partnerships. Furthermore, we remain confident in the broad applicability of our position in immune tolerance platform to potentially restore self tolerance in autoimmune disease and overcome immunogenicity in gene therapies and biologics. We believe ImmTOR-IL an evolution of the ImmTOR platform, potentially represents a generational leap forward. The strong synergistic effects we've seen in our preclinical work demonstrates ImmTOR-IL has the potential to unlock antigen-specific immunotherapies for autoimmune diseases, as well as improve the efficacy and safety profile of therapies across our entire pipeline. With multiple anticipated catalysts in 2022, we look forward to providing additional updates on our progress as we explore gene therapy enabling opportunities, advanced SEL-302, complete the DISSOLVE Phase 3 trial of SEL-212 in chronic refractory gout and continue to expand our diversified pipeline to autoimmune diseases. Looking ahead, we believe we're well-positioned to deliver on our sharpen clinical development strategy with a focus on autoimmune disease indications, explore gene therapy and aping applications and realize the full potential of our evolving ImmTOR platform. Before we conclude today's call, I would also like to thank the entire Selecta team, our investors, and the many people who have been supportive along the way, including our patients and their families. With that, we're happy to take questions.

[Operator:]

We will now begin the question and answer session. . Our first question will come from Kristen Kluska with Cantor Fitzgerald. Please go ahead.

[Kristen Kluska:]

Hi. good morning. Thanks for taking my questions and congrats on addressing this hold and getting it lifted in under four months. So wanted to ask at a high level. If you could talk about some of the CMC related items for this hold. And by addressing these now, do you think that running future studies whether in MMA or other indications, it could be more seamless from making some of these changes now, but then also understanding what the agency is looking for an IND packages on CMC?

[Carsten Brunn:]

Yes. Good question, Kristen. So we haven't disclosed the exact nature of the questions. But I think I've been clear in the past, we are all around the AAV capsid and then 101. They had questions around additional analytics, which usually have been asked more in a Phase 3 setting. But as you said, I think it's great. We got those out of the way early, before we even started the trial. And just give you one specific example, the FDA is looking at the ratio of empty to full capsid for example, I'm asked one very specific question. So, we completed all the analytical work and then supplied the answers, provided the answers on February 9th, and then got the wonderful news yesterday to move forward into the clinic. And it's definitely learnings for us, but also for our partners as well. I think it's important that we have a clear clinical path with three monthly doses in kids, actually. So I think that provides a lot of certainty for our partners as well. There's a clear regulatory path for ImmTOR in gene therapy.

[Kristen Kluska:]

Got it. Thanks. And recently, the FDA published a draft guidance on immunogenicity information for therapeutics including a focus on anti-drug antibody formation and thoughts about how they should be labeled and communicated. So obviously, this phenomenon isn't new across biologics, but curious to hear your thoughts on how some of these criteria across the labeling might impact physician behavior, especially if alternatives come to the market, including with your ImmTOR technology?

[Carsten Brunn:]

Yes. It's not a great question. And obviously, the FDA has been focused on ADA mitigation for quite a while and I think the most recent guidance even puts more emphasis on the importance of ADA mitigation. And I think to our knowledge, we're the only company actually with clinical stage assets that specifically address ADAs. And I think we have demonstrated now across a number of modalities and obviously most advanced with our gout assets, where we recently published a Phase 1 data where we clearly address ADAs. And with a very immunogenic enzyme, for that to chase you pretty much have ADAs in 100% of patients if you don't add ImmTOR. So we're extremely encouraged by this and I think this will foster even more interest in our platform, because it can help overcome the challenge of many of the biologics who all have in to some degree induce ADAs, which impacts efficacy and more importantly, maybe patient safety.

[Kristen Kluska:]

Thank you. And you're clearly very excited about the data you've seen for ImmTOR-IL and the potential broad applicability. So, how are you thinking about integrating this into your current pipeline including some of these earlier stage programs versus looking at newer indications and targets?

[Carsten Brunn:]

Yes. We're definitely very excited about ImmTOR-IL. We really think that's a generation lead for us. And there's excitement around the Treg-selective IL-2 alone already. The IL-2 basically, expand preexisting Treg, but don't address the antigen-specific Treg. Versus ImmTOR alone induces antigen-specific Treg but unnecessary expand and the combination really we saw high synergistic effects where we both induced and expand antigen-specific Treg, which is really an amazing evolution of the platform. We see the application really across all three pillars of the pipeline. We've shown some data in a preclinical model of AAV gene therapy. We saw very good control of using antibodies, actually at a quarter of the dose of ImmTOR, which is, I think, very targeting as well. So that's potential for this combination to be dose sparing. We are extremely excited about the application in autoimmune disease. As antigen-specific immune tolerance is kind of the Holy Grail, if you like. And with our approach we're trying to re-imagine immunotherapy for autoimmune disease. Obviously, we've just released this exciting data around JPMorgan Conference, and we're in the process to identify target indications. But you see us focus a lot more on the autoimmune disease space based on this exciting data.

[Kristen Kluska:]

Thank you again.

[Carsten Brunn:]

Thanks, Kristen.

[Operator:]

Our next question will come from John Newman with Canaccord. Please go ahead.

[John Newman:]

Hi, gentlemen. Thanks for taking my question. And congrats on the progress. I have a specific question regarding the potential design for the SEL-302 study in MMA. I know that that study will be initiated later this year. But I wonder if you could just talk to us about some of the potential aspects of that design regarding things like frequency of ImmTOR dosing, et cetera, just whatever you might be able to share? Thank you.

[Carsten Brunn:]

Yes. Thanks for the question. I'll hand this to Peter, our CMO.

[Peter Traber:]

Yes. Hi. This is Peter Traber, and thanks, John, for that question. With the agreement of the FDA on the clinical trial proceed, I think we can now provide some details regarding the MMA clinical trial. Just his background, as we stated previously, the trial will be conducted at the NIH by Dr. Chuck Venditti, a leading investigator with the largest MMA population in the United States. The trial will be conducted in cohorts of patients starting with adolescents, age 12 through 18, and then progressing to children ages two through 12. The AAV gene vector carrying the mute gene replacement designated MMA-101 will be administered at a dose of 1E 13 viral genomes per kilogram. This is a dose which has been shown to have excellent efficacy in non-clinical animal models. And we expect this dose to have therapeutic efficacy in humans. The dose of MMA-101 will be given with three doses of ImmTOR to potentially prevent the development of antibodies, which might allow future re-dosing, mitigate hepatic toxicity associated with gene therapy and enhance the first dose effect of gene therapy as Carsten had mentioned. The first dose of ImmTOR will be administered at the time of the gene therapy administration and then doses two and three will be given on day 28 and day 56 following the MMA-101 administration. There are provisions in the protocol for dose escalation of ImmTOR depending on the effect on anti-AAV antibody production, and there will be an adolescent subject treated without ImmTOR for comparison with that patient will get steroid prophylaxis whereas those treated with ImmTOR will not have steroid prophylaxis as that's not a relative contraindication in subjects with MMA. Each subject will be treated sequentially with the assessment of safety and efficacy by a data safety monitoring board at three months following the infusion of the gene therapy before progressing to the next patient. The adolescents will be treated. The three adolescents will be treated followed by three children with a dose of 1E-13. The primary efficacy measures will be done at three months and they'll be serum methylmalonic acid levels of C13, propionic, prep tests, which is a direct measurement of enzymatic activity, as well as clinical status including episodes of the compensation and dietary prescription. In addition, the primary immunologic endpoint will be the development of neutralizing antibodies to AAV8 to assess the effect of ImmTOR. Following enrollment and assessment of the six treated subjects, three adolescents and three children, we will hold discussions with the FDA to determine whether to continue the program with 1E13 dose of MMA-101 or to consider dose escalation or even potentially deescalation. And as Carsten mentioned now with the program off clinical hold, we anticipate infusing the first subject in the trial in the second half of this year. So John, those are some details of the trial. Happy to answer any questions regarding that.

[John Newman:]

Great. Thank you. That's a lot of detail. It's really helpful. The only follow up I had was just curious how long you'll be able to follow patients in the study?

[Peter Traber:]

Yes. So the initial assessment of efficacy and safety will be as I mentioned that three months, but -- the study will follow closely the subjects for a full year. And then intermittent follow up over the next four years. So we will follow the subjects for at least five years following the dosing.

[John Newman:]

Excellent. Thank you.

[Operator:]

Our next question will come from Raju Prasad with William Blair. Please go ahead.

[Raju Prasad:]

Thanks for taking the question. On the Phase 1 trial for 399, did you mention the potential to re-dose and how that determination be made?

[Peter Traber:]

Yes. Carsten, I can answer that if you'd like. It's a very good question. Re-dosing of gene therapy or dosing of gene therapy is primarily related to whether there are neutralizing antibodies presence. So, anywhere from 20% to 50% of people have neutralizing antibodies to AAV and they're generally not eligible for gene therapy. So we have a guidance. So the eligibility for redosing would be based on the level of neutralizing antibodies at the time when redosing was going to be done. And we think that that's a regulatory endpoint, which will be defensible. In the 399 study, with the 0.3 mg per kg dose, we had antibodies at 30 days that were at the level that would allow redosing. By 90 days, as you'll recall, the neutralizing antibody levels rose. And that's the same thing we had found in animal studies. In animal studies, when we gave three doses of ImmTOR we were able to suppress antibody production at 90 days and beyond. And so, that's why we think that giving three doses of ImmTOR will allow us to suppress antibodies long-term and it's why the FDA agreed that we should give three doses of ImmTOR in the MMA trial. I don't know if that answers your question Raj or if you have a follow-up?

[Raju Prasad:]

Yes. No, that's helpful. Is there a plan to go any two ages below two years, two years in the trial and at any point obviously another MMA program is put on clinical hold for TMA and two cases of TMA in younger patients, so I was just kind of curious to hear your thoughts there as well?

[Peter Traber:]

Yes. So, that's also a very good observation. We know that as the adverse effect profile gets filled out both for gene therapies as well as particular indications. So, each gene therapy is not just related to the vector that's given, it's also the underlying disease. And of course, given the two cases that LogicBio announced TMA. That's very concerning. And it's why we're taking the approach of treating first adolescents than children. And then of course in the future, the goal would be to extend therapy to children less than two years old. By that time, we'll have a lot more data on the efficacy and safety of our dosing. The other thing is our dose of AAV8 is lower than LogicBio and what we've seen so far with both hepatotoxicity as well as TMA, that it's the higher doses of gene therapy approaching or going over 1E14 which is a log higher than where we're starting, is where most of the problems have been, the major problems have been seen.

[Raju Prasad:]

Great, thanks Peter, And then, you mentioned Carsten in the prepared comments and the press release on the DISSOLVE II trial being kind of impacted by the conflict in Russia -- sorry in Ukraine. But how many patients in the DISSOLVE I trial were enrolled at those sites and are there any potential complications on follow-up there, just kind of curious to hear the impact kind of seen in the program overall. Thanks.

[Carsten Brunn:]

Yes Raju, that's a great question. And I'm going to give that to Peter. He's going to get all the difficult questions today.

[Peter Traber:]

Yes, thank you. Yes, that's a very good question. And just to review, the DISSOLVE I and II trials are identical Phase 3 trials with a primary endpoint at six months. The only difference between the two is that DISSOLVE I has a six month extension treatment extension period. So, the total treatment period is 12 months. The DISSOLVE I study is U.S. only and enrolled already completed enrollment as Carsten mentioned of a 112 subjects by November last November. And we will have top line data by the end of the year. So, there is nothing in the Russia/Ukraine situation that will affect the completion of subjects in the DISSOLVE I trial. The DISSOLVE II trial which has not yet completed enrollment and but still has a six month endpoint, has several European sites including Russia and Ukraine. The disruption of our clinical programs of course due to the Russian invasion is an industry wide problem. Our main issues have been operations disruption such as the supply of resupply of drugs and other supplies, the lack of in-country personnel, limited communication, payment uncertainty and interruption of patient visits. And we're closely working with our CRO portal to address and while maintaining the safety of the personnel and patients. We have four active sites in Russia and three active sites in Ukraine representing about 12% of the total number of sites in our study and that's kind of representative of many other companies clinical trials. We've temporarily closed the Russian and Ukrainian sites to patient screening and enrollment of new patients so that we can focus on conserving resources and supplies to complete the already enrolled subjects. And given the very fluid situation, at this time we don't have an estimate of what percentages or numbers of subjects we'll be able to complete. We have undertaken a couple of really key mitigation measures. As Carsten mentioned, we've added 11 study sites to the DISSOLVE trial all in the United States. And nine of those have already been activated and the final two will be activated this month. And second, we've requested a meeting with the FDA to discuss the statistical handling of subjects enrolled in Russia and Ukraine should they not be able to complete the study due to the war. This will be important to our understanding whether additional subjects need to be enrolled in the trial to maintain study power and so forth. So, while our guidance right now is top line data for DISSOLVE II in addition to DISSOLVE I by the end of the year, we continue to assess our continued assessment of the status of the enrolled subjects in Russian/Ukraine are consultation with the FDA and the performance of our newly added sites will be monitored and we'll update guidance as the situation is clarified. At the present time, it's a little hard to project while we have all these different moving parts.

[Raju Prasad:]

Thanks.

[Operator:]

Our next question will come from Gil Blum with Needham. Please go ahead.

[Unidentified Analyst:]

Hey, this is Chen for Gil. Thank you for taking our question. I just want to ask if you have observed any default immunity against the PEG-10 in ImmTOR previously.

[Peter Traber:]

Generated immunity to what, I'm sorry?

[Unidentified Analyst:]

Generated immunity against the PEG-10, in at ImmTOR.

[Peter Traber:]

The packaging, is that what?

[Unidentified Analyst:]

That's PEG-10, "P-E-G-10" in the particles.

[Peter Traber:]

I am not sure.

[Unidentified Analyst:]

Sorry. Probably have it at the back hold, 10s in the particle.

[Peter Traber:]

Regulation?

[Unidentified Analyst:]

Yes.

[Peter Traber:]

What?

[Unidentified Analyst:]

Because there was speculation in a particle. So, is there any developed immunity against that?

[Peter Traber:]

Yes, okay. Yes, that's a good question. Because there is PEG in the case of ImmTOR particle. And no, we have not identified specific antibody generation against the nanoparticle associated PEG. Now there is the enzyme pegadricase, is also heavily PEGylated. But the antibodies that we've seen, that have been generated to pegadricase is more to the protein epitope rather than the PEGylation. With KRYSTEXXA, pegloticase, that uricase, the antibodies have been generated to the PEGylated portion but that's not what we've seen with pegadricase.

[Unidentified Analyst:]

Thank you.

[Peter Traber:]

Sure.

[Operator:]

Our next question will come from Yun Zhong with BTIG. Please go ahead.

[Yun Zhong:]

Hi. Thank you, for taking the question. So, the first one is on MMA program. Can you remind us the origin of the MMA-101 capsid, was it derived from some type of wild-type capsid, please?

[Carsten Brunn:]

Yes. It's an AAV8 capsid.

[Yun Zhong:]

That's it, okay. So yes, I just kind of a follow-up on the TMA observation from another study. I know that you're in combination with ImmTOR to deal with the immunogenicity but any lessons that you can potentially learn from that observation and do you think you'd have sufficient mitigation already incorporated in the study to prevent any potentials immunogenicity related side effects?

[Peter Traber:]

Yes. Obviously, and we were building on the learnings that we have with ImmTOR and one of the potential benefits is that we're addressing the immunogenicity off the AAV capsid. So, but we have extensive experience with ImmTOR in the Gout trial where it's demonstrated, we prevent the formation of ADA's and we have indication from 399 trial, the empty capsid, that we prevent the formation of NAbs and that's really what we're building on our assumption and that's how we discussed with the FDA. And they were comfortable that this is a very interesting approach which could be 3actually transformational for the field if we're able to prevent the formation of Nabs. And ultimately re-dose and addressed many of the secondary issues such as the high doses and toxicity associated with the high doses. And we've also demonstrated in at least in animal models that ImmTOR also has hepatoprotective properties as well probably related to autophagy but obviously we'll have to see in the actual trial, But we feel comfortable that and the FDA most importantly is comfortable that we have a safe set up here.

[Yun Zhong:]

Okay. So, with the decision to deprioritize OTC deficiency program, does that mean that in the long-term enzymatic therapy and also autoimmune diseases could potentially be more interesting or more promising in that direction for the company? And did you say that the combination of ImmTOR and IL-12 -- I'm sorry, IL-2 and the combination also has the activity in on or potential use in gene therapy as well?

[Carsten Brunn:]

Yes. So, I think pausing the OTC program is really given the market backdrop we're very cautious and how we spend our money. We're not saying we're discontinuing the program, we're pausing it for now which leads to obviously cost savings and we put our efforts behind the MMA program. This is not an indication that we're less excited about the gene therapy but we think the deployment of capital is most efficient and focusing on the MMA program for now. We obviously also have a number of partnerships growing partnerships most recently with Takeda. So, we see a lot of potential use of ImmTOR in gene therapy, not only ImmTOR but also with Xork. And you're right, we have generated very compelling data with ImmTOR-IL. So, the combination of ImmTOR with an IL-2 receptor agonist in a mouse model of AAV gene therapy where we demonstrated basically a complete control of NAbs after two AAV doses at a quarter of the dose of ImmTOR, so which would usually be a sub-therapeutic dose. So, we definitely see application also in gene therapy down the line.

[Yun Zhong:]

Okay, great. Thank you, very much.

[Carsten Brunn:]

Thank you, Yun.

[Operator:]

Our next question comes from Uy Ear with Mizuho. Please go ahead.

[Uy Ear:]

Hey guys, thanks for taking my question. Just going back to the trial design for SEL-302. Could, can you -- I wasn't sure if I heard correctly. Is there any, in the protocol is there anything for re-dosing at the -- I guess at the end of the first three months if patients if you don't see efficacy in the patients?

[Peter Traber:]

Yes. No -- there, in this protocol there's no provision for re-dosing during the first three months or within year. Re-dosing is going to depend on the level of efficacy of the gene therapy and how long it lasts and so forth. The FDA however was very interested in that possibility and opened the door for us coming back to them at any point in time if we see results that would allow re-dosing but there's nothing in the protocol.

[Uy Ear:]

Okay. So, even after three months after the assessment, doesn't -- I guess what you seem to be saying is that you could go back to the FDA and retreat the patients. Is that correct?

[Peter Traber:]

Yes. So, in our discussions with the FDA, they left that open for us to return to talk to them about that. They didn't want to approve that a priority but they were very open for us to come back and discuss that.

[Uy Ear:]

Okay, thanks. And I guess a second question I have is on DISSOLVE II. I am just wondering like what was the targeted number of patients that were expected to enroll in Ukraine and Russia and what how many patients have been, I guess, treated and have completed treatment? If you can share that.

[Carsten Brunn:]

Yes. We haven't disclosed exact numbers of patients per country and or how many were enrolled and so forth. And the situation is quite fluid, we've enrolled a certain number of subjects in Ukraine and Russia. And we're not certain at this point, we will over the next month or so understand how many of those are going to be complete and evaluated. So we're not, we haven't disclosed the exact. What I will say is that the total number of projected picks for Russia in Ukraine was nearing capacity that we had initially at up. So, we did have a targeted number for those countries as well as other countries and it was reaching that target. So, now the key thing is where are each of those subjects in the six month treatment and can we complete them and that's a very fluid situation.

[Uy Ear:]

With -- do you think that I mean it's kind of hard to assess now I guess I shouldn't indicate it but based on the number of patients I guess that have completed, do you think that you would need to enroll additional patients in order to not have it meaningfully change your, I guess, your statistics?

[Peter Traber:]

Yes. That's what we're in the process of assessing. And the study was highly powered already. And as you know, it's a comparison of treat versus placebo. And the treatment and the placebo has basically a zero response rate. So it was high powered for a straightforward end. But nevertheless, that's one of the reasons why we'll be talking to the FDA and trying to see how they would have us consider any subjects that do not complete in Ukraine and Russia assess whether we change the target for enrollment. The target for enrollment was already increased from 105 to 120 sometime ago, and our target right now is still approximately 120.

[Uy Ear:]

Okay. Last question I guess for Kevin. Kevin. Yeah. Could you sort of help us think about the quarterly cadence for the R&D spend? I guess the last few quarters sort of been in the 20 million and would it be something similar or would you sort of expected to grow modestly over the year on a quarterly basis?

[Kevin Tan:]

That's a great question. With the reprioritization of our spend I wouldn't expect to be markedly different going forward. Obviously we have pause one program so we reprioritizing our spend and trying to optimize our cash resources for the highest value assets we have. I think that .

[Unidentified Analyst:]

Okay. All right. Thank you so much.

[Operator:]

Our next question will come from Boobalan Pachaiyappan. Please go ahead.

[Boobalan Pachaiyappan:]

Hi, can you hear me okay.

[Carsten Brunn:]

Yes. We can hear you fine.

[Boobalan Pachaiyappan:]

Okay, great. Couple of questions from our end. So firstly, how do you envision that Ginkgo partnership to evolve over the next three to five years? And what will be the key indicators for success in this partnership?

[Carsten Brunn:]

Yes. That's a great question. We have as you know, two partnerships for two of our pillars. One is around the biologics where they're working on a second generation IgA protease. And there's obviously predefined milestones where they have to deliver certain advancements of the enzyme over time. The same is true for the AAV capsid as well. And obviously, the goal is to have clinical candidates as quickly as possible. But overall, as you can tell, the cadence of deals, we're quite excited about the partnership, we're in close collaboration with them on both programs.

[Boobalan Pachaiyappan:]

Okay. And secondly, do you think there might be opportunities for ImmTOR to be combined with existing approved gene therapy drugs to make the safety profile better? If so, which drugs would be most appropriate to assess from a combination regimen perspective?

[Carsten Brunn:]

Yes man, it's a great question. And obviously, with our portfolio with both ImmTOR and Xork we have the opportunity to address some of the unmet needs or some of the key unmet needs of the marketplace. Obviously, right now, there are a limited number of gene therapies. But I mean, that's definitely a potential approach to leverage both Xork and ImmTOR in the future.

[Boobalan Pachaiyappan:]

All right. Thank you.

[Carsten Brunn:]

Thank you.

[Operator:]

This concludes our question and answer portion of the call. I will now turn the call back to Selecta CEO, Carsten Brunn for closing remarks. Carsten?

[Carsten Brunn:]

Thank you, operator and thank you to everyone who joined us this morning for the numerous questions. Please stay safe and healthy. And this concludes today's call. Thank you.

[Operator:]

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.