As we announce the initial positive phase I data for the ongoing adaptive phase I/II clinical study of VBI-2902a, our monovalent eVLP COVID-19 vaccine candidate. Joining me on the call from VBI Vaccines are Jeff Baxter, President and Chief Executive Officer, and David Anderson, Chief Scientific Officer. We do have slides to accompany this call, which you can access through the webcast portal or by going to the investors' page of our website under the Events Presentation section. Before we begin, I would like to remind you that this call will contain certain forward-looking statements. Specifically, I would like to remind everyone that all statements other than statements of historical fact included in this presentation are forward-looking statements. Although we believe that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Given these risks, uncertainties, and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement and are made only as of the date of this presentation. For additional information and detail, I refer you to our SEC and Canadian filings. I would now like to turn the call over to Jeff Baxter, President and Chief Executive Officer of VBI Vaccines. Over to you. Thanks, Nicole. Good morning, everyone, and thank you all for joining us on our call today. We are absolutely delighted to share with you the initial positive data from the phase I/II study of VBI-2902a, the first of our prophylactic vaccine candidates targeting COVID-19, developed using our proprietary enveloped virus-like particle, eVLP platform technology. The data we will discuss with you today are a validation of the particulate delivery of the eVLP platform against COVID-19, demonstrating its ability to induce potent immune responses significantly higher than those seen in convalescent sera at a low dose without the need for a next-generation adjuvant. Moreover, 2902a was well-tolerated without any vaccine-related SAEs observed. Our objective at VBI is to develop long-term protection against coronaviruses, adding meaningfully to those vaccines already approved. This includes the development of multiple monovalent and multivalent vaccine candidates designed to address known and emerging variants of COVID-19, including the Beta variant B.1.351, as is the case with VBI-2905. Our multivalent candidate, VBI-2901, and the undisclosed preclinical candidates are designed to increase the breadth of protection against COVID-19. VBI-2901 is seeking to achieve this through the inclusion of SARS-CoV-2, SARS-CoV, and MERS-CoV spike antigens. The undisclosed multivalent candidates are looking at the expression of multiple spike antigens of COVID-19 variants of concern. The data discussed today will focus on one of these candidates, VBI-2902a, a monovalent eVLP candidate that expresses an optimized prefusion form of the SARS-CoV-2 spike antigen and is adjuvanted with aluminum phosphate, a standard adjuvant that has a very well-established safety profile given its use in multiple FDA and worldwide approved vaccines for both adults and children. With that introduction, I'll now hand over to David Anderson, VBI's Chief Scientific Officer, to discuss the VBI-2902a study design and the data. Dave, over to you. Great. Thanks very much, Jeff, and good morning. Thanks for your interest in VBI and for your interest in our coronavirus vaccine program more generally. This was a randomized, observer-blind, placebo-controlled adaptive phase I/II study. We enrolled healthy seronegative adults aged 18 to 54 and stratified them across 3 different cohorts. We had a placebo cohort so that we could assess the safety and tolerability of VBI-2902a, and then we had 2 different active groups where subjects received either a 1 dose of the vaccine at day 0 or two doses at days 0 and 28. A primary time point to assess safety and tolerability was at day 56, with the secondary and very important endpoint being the immunogenicity at that time point as well. Given the importance of assessing the immunogenicity of this candidate, we relied on a panel of 25 sera from patients that had recovered from COVID-19. All of them were symptomatic with mild or moderate symptoms. If we go to the next slide. In terms of safety, importantly, VBI-2902a was very well-tolerated with no safety signals observed. It's very consistent with the safety and tolerability profile that we've observed for a previous eVLP-based candidate that went into a large phase I study 7 years ago. It's also very consistent with the known safety and tolerability profile of alum-formulated vaccines. I think relative to some of the vaccine data that's out there, it's important to emphasize that there was no increase in local or systemic reactogenicity or tolerability with the 2nd dose given. In terms of immunogenicity, I think there are 2 important points to make. The first is that we use fully validated assays to measure both antibody binding as well as neutralization titers at arm's length with a well-established CRO. Secondly, we have excluded from the analysis those subjects that, prior to day 56, either chose to get an available approved vaccine or became infected with COVID-19. Now, having said that, what you can see here is that 100% of participants after the second dose had seroconverted, meaning they had antibody titers. Those were titers were about five times greater than the titers seen with the convalescent sera benchmarking panel. I think even more encouragingly, when we looked at the functional or neutralizing antibody titers, we saw very good translation in the sense that the geometric mean titer after the second dose was over fourfold greater than that of this convalescent sera panel. Now, I want to come back to the point that Jeff just alluded to briefly a moment ago about how this clinical data supports the eVLP platform more generally. When you set out to develop a potent, potentially efficacious vaccine, you really have two choices. Either optimize the antigen design and delivery or presentation of that vaccine to the immune system, or rely on a potent next-generation adjuvant. I think based on the type of results we're seeing here, particularly the neutralizing antibody titers, which are the presumed correlate of protection, these data really do validate that the eVLPs generally can be used to develop very potent, potentially efficacious vaccines with an incredible tolerability profile. Having said that, let me turn it back over to you, Jeff. Thanks, David. Just to summarize, the results we've seen today are a very important human proof of concept for the development of the eVLP vaccine candidates against COVID-19. We really do see this as a very important first step in helping and being part of the global solution to the societal challenge of this pandemic. We certainly should remember that many nations of the world are still absolutely gripped by this pandemic. This is going to be a challenge with us for many, many years to come. Whilst the Big Five have produced a fantastic solution and opportunity for many of the more developed nations, as I say, there are many parts of the world that are still struggling. Of course, we want to protect those developed nations against future variants, which is why VBI-2905 against the Beta variant is a very important development and next step and next study. As part of that global challenge, we are really proud to be supported by a number of world-class agencies, both government and NGOs. The Canadian government and CEPI between them have awarded us nearly $80 million to fund our candidates, and that really has enabled us and facilitated the rapid development of these breadth of candidates, some of which we've disclosed and some of which are to be disclosed. I really do say today is a very, and this data is a very important first step in that production of a suite of coronavirus candidates. With that, I'll hand back to Nicole and open up for questions. Now open the line for any questions. If you would like to ask a question, please use the raise hand button at the bottom of your screen. The first question will be from Steve Seedhouse of Raymond James. Steve, please go ahead and unmute your line. Hi, guys. Good morning. Can you hear me okay? Perfectly. Oh, great. Thanks. Well, thanks for hosting the call and sharing the data. A couple questions. Just wanted to know, you mentioned you excluded subjects who got COVID-19 or went to commercial vaccine. I'm curious how many patients did that comprise, and does that imply that it might be challenging to run anything other than maybe a booster study, going forward for your candidates? Yeah. I'll let David answer the first question about number of candidates, and then I'll answer your question about the next study. Yeah. Steve, I think there were a total of 11 subjects that opted to get available vaccines as soon as they could, because they didn't know, it was a blind study, so they didn't know if they had received the placebo or 2902a. I believe there were three individuals that had confirmed COVID-19 infection throughout the course of the study. With regards to the next study, Steve, I mean, you're absolutely right. As I mentioned in my concluding remarks, much of the emerging world is now vaccinated, and therefore to find seronegative subjects is somewhat difficult. Of course, a registration trial and a phase III study, you can run in North America or northern Europe, because you can go against either a standard of care or hopefully very soon, the discussions on the correlate of protection are advancing rapidly, and the various regulatory bodies will sort of validate and approve a correlate of protection. That aside, for VBI-2905 in the next study, we haven't released the details of it yet, but there clearly are a number of countries around the world where vaccines are incredibly short in supply. With our partners, both Health Canada and with CEPI, we will be able to access some of those developing markets to be able to rapidly enroll seronegative subjects with a 2-dose, 5 microgram regimen of the Beta variant VBI-2905. We also mentioned and allude to in the press release, using a single-dose booster. We certainly saw the induction of neutralizing antibodies with the single dose, and that encourages us to think about using a single dose of VBI-2905, i.e., the Beta variant, on top of other vaccine, so seropositive subjects, so recipients of vaccine, in other words. There's a number of opportunities for us to think about how we run that study and test the concept of whether or not if people have been vaccinated with the original, what was tagged the Wuhan strain, and then are boosted with a Beta variant vaccine, then what is the breadth of neutralizing antibodies, and what do those neutralizing antibodies look like against those two specific variants? We will be announcing that study design in due course as we finalize discussions with the regulators, both in Health Canada and other potential markets, and of course, as we produce the GMP clinical study materials over the next several weeks. Okay, thanks. Well, a couple of questions just on the immunogenicity data. What was the test used to determine the neutralizing antibody titer? Was it PRNT50 or something else? Then also convalescent control, sounds like it was sort of a standard reference panel. Just curious if you could characterize how those samples were selected and just what's the nature of that convalescent control panel. Yeah. It was a pseudoparticle neutralization assay. The CRO had confirmed that there was a very good correlation between titer seen with the pseudoparticle assay and antibody binding titers against the receptor binding domain, and against true bona fide PRNT50 titers. As I said, a fully validated assay. We used a panel that they had acquired and used in the validation of their assay. As I mentioned very briefly, Steve, they were all symptomatic patients with mild to moderate disease symptoms. They were not hospitalized or in the ICU. We will, as part of this trial, actually look at PRNT50, 80, and 90 neutralization titers in this study. It's just those are very labor-intensive, and so it's taking longer to get that data. That will be forthcoming at a later date, as well as assessment of T-cell responses with this candidate. Okay, terrific. Lastly, on the safety profile. No SAEs, as you mentioned, safety looked good, but can you just comment on the tolerability profile with respect to mild events, things like myalgia, arthralgia, fever, headache, chills, like what we know to be the profile for other COVID vaccines. Is it similar to what you see here for the mild events? I can. It was overwhelmingly mild, Steve. If you have grade 1 through 4, 3 and 4 being more severe, I think overwhelmingly it was grade 1 with a little bit of a grade 2. That tended to be just injection site reactogenicity, which typically resolved within 24 to 40 hours. We did not have a large number of individuals with fevers or chills as an example. I'll just squeeze 1 more in if I could. The 3 cases of COVID-19, do you know which arms those occurred in and what time they occurred post-dosing? I don't know the timing, Steve. They occurred in the placebo group. I think it was one case in a single-dose cohort. I don't know the timing, though, whether it was days after their first dose or if it was weeks. We were blinded until very recently. That's something we'll have to dig into. Thanks so much, guys. Appreciate the questions. Thanks, Steve. The next question will come from Akash Tewari of Jefferies. Akash, please unmute your line. Hello. Can you hear me? Yeah, perfectly, Akash Tewari. Good morning. Perfect. Good morning, and congratulations on the data here. Just a couple of questions on my end. I know it's hard to do cross-trial comparisons. I wanted to ask you, can you try to put into context the fold increase over convalescent serum that you're seeing here versus some of the other players like the mRNA vaccines or the protein-based vaccines with, like you say, powerful adjuvants? Any color there would be extremely helpful. Let me attempt to answer that, Akash Tewari. First and foremost, as you well know, everyone uses different kind of reference standards or different panels for their convalescent sera. We're actually using one from a third-party supplier, which is actually used commonly across the industry and a number of the other vaccine manufacturers, including a couple that are approved. I won't disclose X. It's unfair of me to disclose it against other companies' data. Whereas, for example, the messenger RNA vaccines, you saw sort of a 2X and we're at 4.3X. What I can tell you against that reference standard, they are kind of comparable. Obviously, the messenger RNA vaccines are providing 93%, 95% efficacy. Once you hit a certain level of neutralizing antibodies, and there's big debate in the industry about what that correlate of protection is, then you are protected. The important thing is that the higher you start with neutralizing antibodies, it's reasonable to assume, because we don't know at this point in time because we only have limited data, it's reasonable to assume that the kinetics of decay will last that much longer. I think that's the point. Against some of the other vaccines, I think like the sort of adenovirus vaccines, we are somewhat higher. Now, the messenger RNA vaccines do inherently include TLR7/8 type of adjuvant effect. Most of the other parts of particulate vaccines are using either TLR9 CpG, or they're using a very powerful combination of TLR3/4 or with squalene, in the case of ISCOMATRIX and Pandemrix. As Dave explained, this really is exciting because, and this is particularly appealing to our partners at CEPI, that we're at a very low dose using simply alum, which has literally been in hundreds of millions of people around the world safely. As Dave said, without any, particularly in the post second vaccination scenario, no significant SAEs. I think, as I said, this is a very important human proof of concept against the base strain, and we're really excited to see what it looks like in terms of VBI-2905 against the Beta variant. Got it. Thank you. That's extremely helpful. I was hoping, can you provide at least an initial read on, I guess, durability? Just wanted to get any color there, if possible. I know you have a number of data points that you'll be collecting over the, I guess, over the next year. Any initial read on durability would be great. Yeah. We know based on previous preclinical and clinical studies with similar eVLP candidates that we induce very strong CD4 T-helper cell responses, and that's really critical for getting good, sustained antibody titers. While it's still very early in this trial, I think that bodes well for the durability of this vaccine. As you said, we're positioned to collect additional time points. As soon as you have 3 time points, you can really kind of create that decay kinetic and extrapolate to get a sense of durability. I think that's never been something that we've been too concerned about. We want to make sure that we really did have sufficient potency by using, as Jeff said, an alum-based adjuvant, and I think that's what we've seen here. Thank you. I guess my last question is just related to, do you have a sense of what the other alum-based vaccines have shown on the neutralizing antibody front? Is that essentially an adjuvant that's used in other vaccines that produce high neutralizing antibody titers, or are you essentially the only one at this particular stage? Yeah. I think as Jeff alluded to earlier, there are several commercial vaccines, incredibly potent, that use alum formulation. You can think about ENGERIX-B, you can think about GARDASIL, the HPV vaccine, with incredible safety track records going back decades, literally. In terms of COVID-19 vaccines, I'm really not aware right now of anyone who's advanced into the clinic using alum, because I think as we've kind of intimated, you really need to have a very potent way of delivering these antigens. I think many have found that alum just doesn't get it done using their vaccine approaches. We're fortunate again that we have this particulate delivery. It's precisely the way the immune system wants to see and be activated. These are really very good viral mimics, these eVLP particles. Got it. Thank you. Sure. This concludes our question and answer session. I would like to turn the call back over to Jeff for closing remarks. Thanks, Nicole. Thank you, everybody, again for taking the time today to participate in the call and more generally for your support of our efforts here at VBI. As demonstrated by the data today, our eVLP candidates are capable of eliciting robust and highly competitive immune responses at low doses and without the need for a next-generation adjuvant. VBI-2902a was well-tolerated without increasing reactogenicity after subsequent doses, a safety profile in line with what we've seen in clinical studies of our other eVLP candidates. With an eye towards the next phases of development for our COVID-19 pipeline, we look forward to sharing further data with you as we continue to focus on the development of long-term effective solutions against COVID-19. We are, of course, available to answer questions individually. Please contact us with any questions that you may have around any of our candidates, but in particular against our coronavirus vaccine candidates. With that, we sign off, and thank you all once again for your support. Thank you.