Altimmune, Inc. (ALT) on Q1 2021 Results - Earnings Call Transcript
Operator: Greetings and welcome to the Altimmune, Inc. First Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ms. Stacey Jurchison, Senior Director, Investor Relations and Corporate Communications for Altimmune. Thank you. You may begin.
Stacey Jurchison: Thank you, Melissa, and good morning, everyone. Thank you for participating in Altimmune’s First Quarter 2021 Earnings Conference Call. Leading the call today will be Vipin Garg, our Chief Executive Officer. Additional members of the Altimmune team participating on the call today are Will Brown, our Chief Financial Officer; Scot Roberts, our Chief Scientific Officer; and Scott Harris, our Chief Medical Officer. Following the prepared remarks, we will hold a question-and-answer session. A press release with our first quarter 2021 financial results was issued this morning and can be found on the IR section of the company’s website. Before we begin, I would like to remind everyone that remarks about future expectations, plans and prospects constitute forward-looking statements for purposes of Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Altimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, including those related to COVID-19 and its impact on our business operations, clinical trials and results of operations. For a discussion of some of the risks and factors that could affect the company’s future results, please see the risk factors and other cautionary statements contained in the company’s filings with the SEC. I would also direct you to read the forward-looking statement disclaimer in our earnings press release issued this morning and now available on our website. Any statements made on this conference call speak only as of today’s date, Monday, May 17, 2021. And the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today’s date. As a reminder, this conference call is being recorded and will be available for audio replay on Altimmune’s website. With that, I will now turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimmune.
Vipin Garg: Thank you, Stacey, and good morning, everyone. We appreciate you joining us today for a discussion of our first quarter 2021 financial results and business update. We’re trying a new format for our call this quarter and have a slide presentation accompanying our remarks. As Scot Roberts will review momentarily, we have impressive new preclinical data for our AdCOVID vaccine candidate that we want to take you through and the slides will be helpful visual aids.
Scot Roberts: Thank you, Vipin, and good morning, everyone. While our AdCOVID vaccine candidate is progressing through our first-in-human trial, we continue to conduct preclinical studies with our collaborators at the University of Alabama, Birmingham, and Saint Louis University. We will be reporting on additional data from other preclinical studies shortly, including a study evaluating the ability of AdCOVID, to provide cross-protection against the emerging variants of concern. But today, I would like to share with you the results of 2 important preclinical studies that provide exciting insights into the activity of AdCOVID. The preclinical study results we are presenting today, build on the results of efficacy challenge studies we have previously shared with you, showing that a single intranasal dose of AdCOVID completely protected mice from clinical signs of infection and resulted to have been at greater than 1,000-fold reduction in SARS-CoV-2 virus in the lungs of vaccinated mice. If you refer to Slide 5, you will see that these results are graphically presented. One of the points I would like to emphasize about the Human ACE2 transgenic mouse model we have used is that it is a very stringent model for controlling viral replication with very high levels of infection and viral replication in the lungs. In our new analysis, we evaluated the effect of AdCOVID vaccination on the amount of infectious virus in the lungs of mice infected with SARS-CoV-2. The left and middle portions of this slide show the profound reductions in viral RNA that resulted from vaccination with AdCOVID. As you can see on the right hand portion of the graph, vaccination with AdCOVID resulted in an inability to recover infectious virus from the lungs of challenged animals 3 days post infection. Whereas nearly 300,000 plaque-forming units that is greater than log 5 of virus were recovered from the lungs of the unvaccinated control mice. It is important to emphasize here that these results were obtained following a single intranasal dose of AdCOVID. We are excited about the ability of AdCOVID to provide sterilizing immunity in vaccinated mice in the face of such high levels of viral replication, as it may have direct relevance for AdCOVID to provide protection from COVID-19, and more importantly, block transmission.
Scott Harris: Thank you, Scot. We are encouraged by the progress we have made in our Phase 1 AdCOVID clinical trial and our comprehensive plans for a global Phase 2 development program. Let me begin with a brief review of our phase 1 clinical design and the outcomes we anticipate reporting in June. Please refer to Slide 8 of the earnings call deck. As Vipin noted, we amended our AdCOVID Phase 1 protocol due to the challenges of recruitment in placebo-controlled studies in the U.S. as a result of the widespread availability of authorized vaccines. We have adjusted our enrollment in this study to approximately 80 subjects, randomized 5 to 1 to receive 1 or 2 doses of AdCOVID or placebo administered in 3 dose groups.
Will Brown: Thank you, Scott, and good morning, everyone. For today’s call, I will be providing a brief update on our first quarter 2021 financial results. More comprehensive information can be found in our 10-Q filed with the SEC today. Altimmune ended the first quarter with a robust balance sheet, including cash and short-term investments totaling approximately $227 million as compared to $216 million at the end of 2020. The increase in our net cash during the current period is attributable to $34.2 million of net receipts during the quarter, primarily due to our utilization of the at-the-market or ATM offering program, partially offset by approximately $20 million of cash used for operating activities. With these additional cash receipts, we remain solidly capitalized to advance our pipeline candidates through potentially value-generating inflection points in 2021 and beyond. Turning to the income statement, revenue in the first quarter of 2021 was $800,000, compared to $2.2 million in the first quarter of 2020. The change in revenue between the periods was primarily due to a decrease of $2 million in BARDA revenue due to the timing of clinical trials and development activities for NasoShield, which is partially offset by $500,000 in revenue attributable to the T-COVID program. R&D expenses were approximately $12 million in the first quarter, compared to $7.2 million in the first quarter of 2020, which represents an increase of $4.7 million. The change is primarily the result of an increase of $5.4 million related to development activities for our COVID programs, partially offset by a decrease of $1.5 million in charges related to the contingent consideration liability in connection with the acquisition of ALT-801. G&A expenses were $3.8 million in the first quarter of 2021 compared to $2.3 million in the prior period, primarily due to increased stock comp expense and additional labor-related costs. Net loss for the 3 months ended March 31, 2021 was $14.9 million or $0.38 net loss per share, compared to $3.9 million or $0.26 net loss per share for the first quarter of 2020. The difference in net loss is primarily attributable to higher research and development in general and administrative expenses. I will now turn it back over to Vipin for his closing remarks. Vipin?
Vipin Garg: Thank you, Will and Scot Roberts and Scott Harris, for joining me today and sharing your perspective. And thank you those of you on the call today or listening to the replay, for your continued support and interest in our programs. We have several promising and important shots on goal this year. As you have heard, we are eagerly awaiting the data readouts from both the AdCOVID and ALT-801 programs. We believe there’s tremendous opportunity to create value for our stockholders if either or both programs advance. I’m confident in the clinical development strategy we have laid out, to further the development of our AdCOVID and ALT-801 candidates, and look forward to sharing the initial top-line data and our continuous progress with you. Operator, that concludes my formal remarks. Could you please instruct the audience on the question-and-answer procedure?
Operator: Thank you. Our first question comes from the line of Seamus Fernandez with Guggenheim Partners. Please proceed with your question.
Seamus Fernandez: Oh, great. Thanks for the question. So just wanted to ask a few here, first on the AdCOVID program, has the agency approached your team with any questions with regard to the possibility of coagulation, safety issues and being able to disprove that pre-clinically? I know this is very challenging and perhaps not possible, but just wanted to get a better sense of that from your perspective. And then, in terms of the change from 180 patients and reducing that number down to 80, can you just give us the reasons for that? Is it just confidence in the data that you see upcoming in the in the Phase 1 clinical dataset? And then, that will be, obviously expanded and borne out in the full Phase 3? And was that agreed upon with FDA in terms of just the size of the required clinical study? And then, if I may, just 2 additional questions. As we think about the data that you are anticipating to be able to move forward with conviction in the Phase 2 clinical studies, what’s the threshold for neutralizing – IgG neutralizing antibodies that you believe is necessary to move forward with a single dose of AdCOVID? Thanks.
Vipin Garg: Yeah, good morning, Seamus. Maybe what we can do is divide and conquer. So, Scot Roberts, do you want to take the first part of the question, and then turn it over to Scott Harris and perhaps come back for the third part of the question?
Scot Roberts: Sure, happy to, and good morning, Seamus, and thanks for the questions. So with respect to the FDA and the TTS, no, there has been no communication about that. The FDA is clearly aware of our GLP toxicology studies, where we were able to demonstrate that there was no systemic dissemination of the vector following intranasal delivery. And while there are more questions and answers about the mechanism of this effect, one thing that does seem to be more likely than not, I would say, is that systemic exposure of the vector and vector components may have the catalytic effects on the PF4. So in the absence of that, I think we’re in good stead. As you said, trying to prove a negative there would be very difficult, especially given the rarity of this, but no formal communication or informal from the FDA on that point. And, Scott, do you want to go ahead and handle the clinical question?
Scott Harris: Right and then I’ll turn it back over to you, Scot, for the final question. So, Seamus, we have a lot of confidence in the size of the study. The readouts are clearly comparable to the size of the Phase 1 studies of the authorized U.S. vaccines. I think that gives us additional confidence and also based on the readouts of our prior studies. And, we’ve had no specific indication that this would be unacceptable to the agency, especially in view of what I’ve just mentioned. Scot, do you want to answer the third question?
Scot Roberts: Sure. And that question related to our expectations for neutralizing the antibody in order to continue the program forward, especially as a single dose vaccine. And to begin with, Altimmune will still refrain from numerical expectations, because of the variability in the assays and the way that they’re done. And so as far as a titer, I don’t think that it’s productive to go down that road. I think most people are comfortable with the relationship to convalescence sera. And, of course, the sera variant may need to be characterized and understood with the components that made up that convalescence there. So we certainly expect to be in the range of convalescence sera. I think one of the things that we’ve learned from the studies that have been conducted so far is that really surprisingly low levels of neutralizing antibody are associated with protection. And that we’ve learned that primarily from the inactivated vaccines, which really have what I would consider to be astonishing role neutralizing antibody titers. And so, when we think about that, and when we think about the other immunogenicity is that we are bringing to the table the mucosal immunity especially the strong T cell responses. We feel that neutralizing antibody response on par with convalescence sera is a homerun for us.
Seamus Fernandez: Great. Thanks, guys. Appreciate it.
Operator: Thank you. Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Please proceed with your question.
Yasmeen Rahimi: Hi, team. Thank you for the great updates. I also have a number of questions. I’ll just go ask them one by one. Maybe the first question for you is, can you comment on whether we would be seeing in June data on both the single and the dual shot or – if given, or just for one? And if you could just help us fine-tune a little bit more granularly, when in June you should be expecting this data, is that early June, mid-June and June to the extent you can comment on? And then the third question that I think is really important on top of minds of many of our clients that we speak with is what are the steps for it beyond that? Can you maybe highlight what would be the size of the Phase 2, Phase 3, the timelines around that? That would be really helpful.
Vipin Garg: Absolutely. Scott Harris, do you want to take the first question?
Scott Harris: Well, Yasmeen, thank you for your questions. Yes, we will have data on both the single and the double doses in the June timeframe. And right now, we are confident that we will be announcing in June, we haven’t provided specifics and exactly when that will occur in June. Regarding the future programs, as you can see, there is a robust list of studies that will support the Phase 2 program and build the target product profile. Obviously, these studies are in different sizes, because they have different objectives. So that, in all, the Phase 2 program will be large. And there are many different Phase 2 studies to compare against. But we have a multitude of Phase 2 studies. So it’s an approximation, I would say, that the Phase 2 program is large, and will be executed between the readout in June and toward the end of the year.
Yasmeen Rahimi: Thank you for the color. Maybe if I could just have a follow-up on that same question. We understand there are quite a number of debates depending on the geography whether a placebo would be needed in future Phase 2, Phase 3, and whether orthogonal vaccine approaches. So if you could just comment on those types of discussions, where maybe regulators stand on, that could be helpful. And then, I have 1 NASH question.
Scott Harris: Great. Well, because of the availability of authorized vaccines in the U.S., it’s been increasingly difficult for any sponsor to do a placebo controlled trial. That paradigm will change as we move to the variant vaccines and revaccination, where there would be some latitude to do that. Clearly, as one goes around the world, there are many opportunities to study the vaccine in unvaccinated populations, where a placebo control would be very acceptable. And that has been the basis of the strategy of moving some of the Phase 2 programs, at least one of the studies to a low access country.
Yasmeen Rahimi: Thanks, Scott.
Scott Harris: Yeah.
Yasmeen Rahimi: Yeah, go ahead, sorry.
Scott Harris: I would say that the regulators have not been very specific about the question of placebo control. Clearly, the FDA is quite interested in placebo controlled studies more so than comparator controlled studies that are more robust. But the specific requirements have not been announced by the agency.
Yasmeen Rahimi: Thank you, Scott. Maybe this is another question for you in relation to the announcement to file an IND for the obesity indication. Just if you could highlight to us the thoughts behind that and then why this is a focus for the second half, and maybe how different is the regulatory path or obesity versus the NASH, that could be very helpful for us.
Scott Harris: Right. Thanks for the question, Yasmeen. Well, as you know, when we announced our program in 2019, the regulatory space in NASH and obesity were quite different. And as you can see, since this time, there’s been somewhat more uncertainty, about the acceptability of surrogate endpoints in NASH, but much more confidence in programs like the Novo Nordisk and the Lilly programs to move ahead. As you know, we previously had ineffective and unsafe drugs in this space. And now we have the prospect of 2 approvals in the near future, both on GLP-1 based compounds in obesity with robust efficacy, but really very concerning tolerability with lots of discontinuations. We believe that we can beat that. We think that’s a low hurdle. And we think based on our faith in our preclinical studies, that we can achieve excellent, if not better, weight loss with better tolerability and the prospect of even not needing dose titration. And obviously, we’ll speak to that with our study results. So NASH and obesity are both $1 billion indications. And it behooves us to take on both, because we not only have a drug for NASH and obesity – and remember that more than 80%, if not, more than 90% of patients with NASH were obese. So consequently, if you’re treating obesity and you do get an indication of obesity, you’re naturally capturing most of the entire NASH space, and not just the people who have NASH, but also NAFLD. So it’s an opportunity that we’re strongly considering. It’s much going to be based on our readouts and the amount of weight loss that we see in our Phase 1 study, and consequently, the decision to file that IND and development program will be data driven.
Vipin Garg: Yeah, and I will just add, Yas, that we’re not deemphasizing NASH. We just think that there is a parallel opportunity here in obesity that became very clear to us as we go and talk to KOLs. We talk to potential strategic partners. Everybody wants to know what about obesity. It looks like you have a drug for obesity as well. So it became clear and our preclinical data clearly shows that. And if we see similar weight loss in our human trials, then by all means it makes sense to proceed with obesity in parallel with Nash.
Yasmeen Rahimi: Thank you, team, for taking our questions.
Operator: Thank you. Our next question comes from line of Kelechi Chikere with Jefferies. Please proceed with your question.
Kelechi Chikere: Yes, good morning, and congrats on all the progress you’ve made over the quarter. Just a few questions from me here. You mentioned you would like to see neutralizing antibody titers on par with convalescent serum. I’m hoping you can provide a little bit more details around that convalescent serum. Is that sera comparator mostly from mildly affected individuals hospitalized patients? Any color there would be greatly appreciated. And, I guess, also just related to another question I was asked earlier, I’m hoping you can provide a little bit more details around your latest thoughts on the dataset that you think you’ll need to generate to support a regulatory filing. Is it just immunogenicity data? Is it efficacy data? Any color there would be helpful. And, I guess, just – and is that something you think you can generate on your own or do you anticipate needing a partner for that? Thank you.
Vipin Garg: Scot Roberts – thank you, Chikere – Kelechi, sorry. Scot Roberts, do you want to take the first question?
Scot Roberts: Sure. All I can say at this point is we’ll be providing the description and composition of the convalescent sera, as we release the data, so that those data can be interpreted at that time.
Kelechi Chikere: Okay.
Scott Harris: Kelechi, this is Scott. Thank you for the second question. As you know, the landscape is rapidly changing. I think there is scientific consensus of a correlative protection being neutralizing antibodies, but the regulators have to accept that. If the regulators do accept the correlative protection, we could get authorization or approval based on an immunogenicity readout. And that may come with a later obligation of doing an outcomes type trial. But if the approval or authorization is based only on the correlative protection that is immunogenicity, the obligation to do trials, the size of the trials is much smaller. It’s probably a safety database of approximately 3,000 subjects. And as you know, it’s much larger for outcomes trial. So clearly, we could do a trial of that magnitude. A much larger trial is something we would anticipate doing with a partner because of the expense of the trial. And the landscape is rapidly changing. And we need to remain flexible and we are.
Vipin Garg: Yeah and, Kelechi, just add that with regards to future development and funding, we continue to talk to multiple sources. We think our Phase 1 data, the quality of that data is going to be critical in advancing those discussions. So both, we are in discussions with potential corporate partners, as well as with the government sources of funding to develop our vaccine. And we’ll continue to do that. It’s really going to be data driven, mainly the Phase 1 data that we are expecting here soon.
Kelechi Chikere: Thank you.
Operator: Thank you. Our next question comes from line of Jon Wolleben with JMP Securities. Please proceed with your question.
Jonathan Wolleben: Hey, good morning, and thanks for taking the question. Just a follow-up on ALT-801 and the indication, I was hoping you could give us a little more context on what you’d want to see to differentiate with just moving forward in NASH versus adding on the obesity indication? What kind of magnitude of change do you want to see, I guess, in body weight, and then also with the GI tolerability profile? What would make it interesting to compel you to move forward in obesity?
Vipin Garg: Scott Harris?
Scott Harris: Yeah, Jonathon, thank you for the question. So what I rather do is relate or bring in outside opinions, and these have been stated, and refer to Juan Pablo Frias, who is an expert in this space. And he’s publicly stated that anything greater than 2% at 6 weeks he thinks would be a success. Could you please refresh me on the second part of your question?
Jonathan Wolleben: So my question is that when you’re making decision before in obesity, what magnitude of difference do you need to see between just moving forward in NASH or adding on obesity? Just trying to kind of understand, when we do this data, are you going to, at the same time, say this is worthwhile in obesity? Or is there going to be a decision later on?
Scott Harris: Well, it’s really the same decision, because if we get that kind of weight loss that we’re anticipating we’re going to have a successful NASH drug, because weight loss is the most potent mechanism for treating NASH. And we think that all the beneficial effects of weight loss are going to convey to NASH. So we believe that the decision point would be to both on – would be the same on, say, both programs.
Jonathan Wolleben: That’s helpful. Thank you.
Operator: Thank you. Our next question comes from line of Liisa Bayko with Evercore ISI. Please proceed with your question.
Liisa Bayko: Hi, good morning, and thanks for taking the question. I’m just looking at Slide 5, where you’re discussing the sterilizing immunity in mice. And so, what is actually the definition of sterilizing immunity and what’s the difference between – how do you think about the replicating viral RNA versus the infectious virus? And maybe you can talk a little bit of the differences in between those and what actually is sterilizing?
Vipin Garg: Scot Roberts.
Scot Roberts: Sure. Happy to answer. So let’s start with sterilizing. I think a consensus definition of that would be no infectious virus. The inability of the virus to replicate in the host and that means also to spread. And that’s what we demonstrated in the lungs that no infectious virus could be found. Now, when we looked at the RNA, the total RNA, which includes both the input dose, the dose that was given to challenge the animals with the SARS-CoV-2 and any replication that occurs; that RNA is certainly representative of the virus being present. But it’s not equal to infectious virus. And the reasons for that are our numbers. The neutralization may happen a little bit later. But more importantly, not all of that RNA is necessarily encapsulated in a virus particle that represents an infectious unit. You’ve got live cells that release the RNA. So there is a lot of RNA signal that may or may not be associated with virus particles. And then those virus particles may or may not be neutralized by mucosal antibody, for example. So that’s the disconnect between the RNA and the infectious virus. But I will know that on that slide, if you look at the infectious, the replicating virus, you can see that 2 of the animals had no detectable replicating RNA either. And so, we are really driving down the ability of the virus to replicate, and to the extent that we cannot find in a very, very sensitive assay any infectious virus present in the lungs of those animals.
Liisa Bayko: Okay, that’s helpful. Thank you. And then, I guess, the amount you’re exposing, the amount of virus you’re exposing the animal to, is that consistent with what you’d see if you came – I mean, I’m just trying to understand how that relates to real world. If you could…
Scot Roberts: Probably higher, probably much higher.
Liisa Bayko: So really high level, okay.
Scot Roberts: Yeah.
Liisa Bayko: Okay, okay.
Scot Roberts: Yeah, yeah, much higher. I mean, and that’s typically how the – the challenge studies typically use around 10,000 infectious units. And that’s in the range of what we’re using here. That varies by experiment, but certainly around that. That’s probably a lot more than you’re getting from somebody’s sneeze or something like that.
Liisa Bayko: Okay, very helpful. Thank you. And then, as you kind of think about what’s going on, where we are with the pandemic, and in terms of our availability of vaccines, is it emergency use authorization? Sorry, always hard to say that EUA. Is that still something you think is available to sort of the next generation of vaccines or you think full approval is going to be in the cards? So how are you thinking about the regulatory strategy?
Vipin Garg: Scott Harris, you want to take that?
Scott Harris: Hey, Liisa. There are differences between authorization and approval. But the major difference is the amount of follow-up or time. Typically, with approval it’s 6 months, but with authorization it’s only 2 months. And we’re seeing that play out right now, as the Pfizer vaccine is being filed for approval. It’s basically the amount of safety data that you have. It’s fairly clear that there is a need for a multitude of vaccines even in the U.S., especially as the variants come out. And more than likely, the FDA will take a strategy to keep pace with the emerging need, which is every day. We’ll probably continue to issue authorizations that would be the prospects that we would see. But obviously, that’s up to the agency.
Liisa Bayko: Okay, and then, as you’re thinking about Phase 2 as well, how are you thinking about variants versus sort of, I guess, the wild-type variants? And that’s my last question. Thank you.
Scott Harris: Right. We have are in the process of manufacturing variant vaccines. I’ll let Scot talk more deeply into that, but we will have that vaccine for study towards the end of this year. And that will be a revaccination study or study in previously infected individual. So we built out the entire variant program. We’re manufacturing the vaccine. We will have it available. And we will put it into a Phase 2 study to go along with our other Phase 2 studies as outlined in the slides that have been presented.
Scot Roberts: I can go ahead and add my perspective on that. I think that we can imagine 2 scenarios, where as I indicated in the call, we’re very keenly interested in the ability of the prototype to AdCOVID vaccine, which is directed against Wuhan isolate, to neutralize in a very effective way variants of concern. And that stems from the fact that our approach is fundamentally different from the majority of vaccines were focused on the RBD. And that could bring interesting new antibody repertoire to the table, for example. So we certainly need to understand that. And in the context of variants that are mildly different, and that’s how it really characterizes the ones that are out there right now, they’re mildly different compared to the parental strain, we’d have to see. There may be an opportunity to continue using the prototypic one. But we’re not resting on that. We can’t assume that that’s going to be the case. And we can’t assume that a variant that is really very different – a different serotype for example, no longer neutralized on any level, or something like that, might – or it has clear enhancement of disease, might come along. And so, the importance of being able to match a vaccine to the variant is still vitally important. We’re prepared for that. And as Scott indicated, we’re going to conduct the clinical studies that are required to show that when we make a variant, everything is behaving the same, the safety, the immunogenicity. And that will pave the way for responding in real time as necessary for a variant that is really a departure from the prototypic strain of what might be circulating. So I think we’ve got the 2 plays here. One, involving the possibility that the prototypic provides protection, sufficient, and then one where we’re clearly engaged on and able to execute, where you do have the matched variant vaccine, for the variant that is at hand.
Liisa Bayko: Thanks.
Operator: Thank you. Our next question comes from line of Yuan Zhi with B. Riley Securities. Please proceed with your question.
Yuan Zhi: Hi, this is Yuan for Mayank. Thank you for taking our questions. So can you provide some updates on your preclinical rodent study you are conducting to study transmissions? And where do you think we are as a society in appreciating the residue unmet needs that remains to be addressed, considering the widespread use or availability of EUA approved vaccines and now easing of the mask mandates? And also, can you provide some updates on the T-COVID program? And is there any learnings about that platform from that experience? Thank you.
Vipin Garg: Scot Roberts, do you want to go first?
Scot Roberts: Sure. So with respect to the transmission study, that those studies are ongoing, we’re very much looking forward to those and to having clear data showing the ability of AdCOVID to block transmission. In the greater context, I think that the ability to effectively, and I should say most effectively, block transmission is still an important aspect of AdCOVID. Despite the clear indications that the authorized vaccines are having an effect on shedding and likely an effect on transmissibility, it’s not at all clear that that effect is as strong as it could be. And that’s something that you’d want in a second generation improved vaccine. So when we think about AdCOVID in the context of the EUA vaccines and what we’re learning there, we still see the advantages. They improve tolerability and the potential for even better or best-in-class ability to block transmission. And as you indicate, with the masks-off situation that we find ourselves in now, that is just as relevant now as it ever was. And then I’ll let Scott Harris to talk about the T-COVID program.
Scott Harris: Yes and thank you for your question. Obviously, one of the learnings that we’ve had is the difficulty of trying to conduct these studies. And it’s obviously impacted the T-COVID study as well. We’re continuing to enroll. We’re continuing to assess the readout, which is still scheduled in the second quarter in June. And if there’s any change to that based on the shifting dynamics, we’ll inform our investors.
Yuan Zhi: Thank you. That’s super helpful.
Operator: Thank you. Ladies and gentlemen, that concludes our question-and-answer session. I’ll turn the floor back to Dr. Garg for any final comments.
Vipin Garg: Thank you very much for joining us and participating on the call today. We hope you’ll join us on our next quarterly earnings call. Have a nice day.
Operator: Thank you. This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.
