Ocugen, Inc. (OCGN) Earnings Call Transcript & Summary

Good morning, everybody, and thank you for joining our panel on the COVID-19 vaccine COVAXIN. I'm Kristen Kluska, one of the biotech analysts at Cantor. Participants on this panel include Dr. Shankar Musunuri, the Chairman, CEO and Cofounder of Ocugen as well as 3 members of Ocugen's Vaccine Scientific Advisory Board. Dr. Satish Chandran, CEO of Somahlution, former CTO at Pfizer's BioTherapeutics, COO and CFO of Nucleonics, and Head of DNA Vaccines at Wyeth Vaccines; Dr. David Fajgenbaum, Assistant Professor of Medicine and Translational Medicine and Human Genetics at the University of Pennsylvania and Founding Director of Center for Cytokine Storm Treatment and Laboratory and; Dr. Bruce Forrest, former Senior Vice President at Wyeth Vaccines. Thank you all for your participation today. While today's conversation will focus on COVAXIN, we previously hosted the Ocugen team for a fireside chat on the ophthalmology programs, and we'll be happy to follow up with anybody on that. So first, I'd like to get to know everybody on this team a little bit better and pose a few introductory questions.

The First for Dr. Musunuri, Ocugen has primarily focused on therapies related to ophthalmology conditions since its inception. So when you announced plans to codevelop COVAXIN with Biotech in December, this was viewed as a surprise. Could you please walk us through why EY to lead the company in this direction?

Kristen, thank you for having us today. And again, many of folks on the call may not know. I played a significant control at Pfizer. Prior to that, it's Wyeth Vaccines in leading the global operations team for Prevnar 13, which became the largest selling vaccine in the world over 100 countries. And also, this is a pandemic, right? I mean, many people are losing lives. And we know we have a lot of expertise. We can put a very strong vaccine team together, and we can contribute, that's the reason we jumped in and steer the company in the direction. And I think we cannot sit on the sidelines, if you have knowledge, you have experience, you have a network, I think people will have to jump in and contribute. And that's why we jumped in. We really want to be a solution, one of the solutions for the pandemic and bringing this under control.

So you alluded to your previous experience with Prevnar 13 at Pfizer. Could I ask you to highlight some of the key learnings and synergies you could bring from this experience to potentially marketing COVAXIN, if approved?

Yes. I mean again, I mean, when you work in a large pharma, you got global teams and then how do you handle. I mean, again, Bruce here managed our global clinical trials. He managed very well. He ran many of them, right? And so I mean, looking from R&D perspective, how do you move the process into the clinic? Manufacturing is really key element of it. I think you have seen vaccine manufacturing is very complex. How do you line that up and make sure you have robust processes so that you don't have supply interruptions when you get something approved. And then from a commercial perspective, I think -- I mean, that's, again, even with the COVID, it's even more relevant than before because you do have to work with the governments. And I think all the people in the U.S., they all got commitments and that's how every government is doing across the globe. And those learnings will be very, very useful. How do you do the clinical trials? How do you get the product approved? How do you manage the manufacturing and supply? And how do you work with the different governments? And how do you position your product?

Thank you. So the next question is for Dr. Chandran. Your career has spanned from academia to industry in both pharma and biotech companies over the course of 3 decades, including a wealth of experience in the regulatory and commercialization side of the business. How do you think that your broad perspective and deep experience has benefited you now that you are focusing on responding to global pandemic and what could only be described as an all-hands on deck type of movement?

Yes. Developing a product from an idea to a product in the commercial space, done this several times. But this is a different ball game altogether. The speed is of the essence. We have to crush the traditional time lines down to very small numbers. I think the biggest asset we have here is not just one person is my experience here and knowledge in the regulatory and developing products, but it is the team as Shankar mentioned here we have -- Ocugen has assembled a great team of people who have accomplished in multiple spheres along the pathway from the research and development, to manufacturing, to supply chain management and regulatory and so on. I think that, together, the hands on that is, I think we have a great team to be able to execute that.

And Dr. Fajgenbaum, your own experience and work around Castleman disease inspired the Penn Center for Cytokine Storm Treatment and Laboratory just at the Corona project. Further, a lot of your work around understanding COVID-19 has been featured in prominent publications. Can you tell us more about this and perhaps the challenges that this leads to in treating and preventing the disease perhaps also from a vaccine perspective?

Sure. You're absolutely right. I became particularly interested in wanting to try to make a difference in this pandemic when it became clear the similarities between the most severe cases of COVID-19 and what called a cytokine storm. Cytokine storms are conditions that involve the immune system getting out of control and wreaking significant havoc in killing patients. This is why COVID is so deadly. And given the similarities between COVID and cytokine storms and the conditions that I've been studying for the last decade, I felt that I had this responsibility to really dive in, launch the Corona project, begin to serve for treatment that may be effective for the most severe cases. And you can imagine that there's a lot that we learned about the most severe cases and how COVID can wreak so much havoc that can also be applied trying to prevent COVID in the first place. And better understanding what is the immune response to COVID. What could that immune response look like to a vaccine, they can actually prevent developing COVID in the first place. So I felt a real responsibility to join the effort, both from a therapeutic perspective, searching for drugs to save lives, but also earlier stage on the vaccine side and really thrilled to be a part of this team, as was mentioned earlier, we've been assembled.

And Dr. Forrest, you are involved in vaccine pharmaceutical and biologic development for 25 years as a physician in the industry. Further, you have a lot of international experience, which is relevant for COVAXIN, including launching multiple trials ex U.S. Could you tell us more about the insights you gained, especially when it comes to bringing something safe and efficacious to the market as rapidly as a COVID-19 vaccine?

In fact, in the last 25 years has been a major improvement in the quality of global clinical trials, we see it across the board with small companies and large. The International Conference on Harmonization, which was mutually set up between the U.S. and Europe and Japan, but has now expanded to include other member countries has set standards that enable clinical trials performed in any given country to meet the standards required by other countries for their approval. And that's what we're seeing with the quality partners such as Biotech in this is that they have made that commitment to do clinical trials to comply with those global standards, those international requirements that will satisfy approvals in countries well beyond just that, but they've done in India and especially here in the U.S. So one of those key things is its consistency, quality and commitment to that. And that's what we're seeing, and that's why Ocugen has progressed with that partnership.

Thank you. So now let's dig into some questions specifically related to COVAXIN. So the first question I have for the panel is when you first announced plans to pursue COVAXIN development in the U.S. last December. The world was focused on the recent EUAs that were granted to Pfizer and Moderna. Around the same time, we were learning about the first why we reported variant that emerged from the U.K. So could you tell us what you think is important to understand about the whole variant inactivated vaccine approach of COVAXIN in light of these mutable variants? And how this could potentially interact with our immune systems to produce lasting immunity? And how else might COVAXIN differentiate from some of these other vaccines? And here I'll start with Dr. Fajgenbaum, please?

Sure. So one of the things that I'm most excited about with the COVAXIN is that this is a well-established platform, inactivated vaccines have been around for decades and more recently, have continued to be approved for a number of different conditions. So I think the fact that it's a well-established platform that has a long track record that's safe is the #1 differentiator that I'm optimistic about. The second piece of that, which is very much related is that a number of individuals that are hesitant to get a COVID vaccine are actually afraid of the technology. They're afraid of something that's brand new, whether it's an AAV or RNA. So this idea that you can use an existing platform that nearly everyone in the United States has actually already received inactivated vaccine. This, I think, can lead towards further expanding vaccine uptake. I also should mention that I am a patient with a disease called Castleman disease. And so it involves immune system hyperactivation and that sort of experience going through cytokine storms as this maybe realize just how serious this condition is. And so the idea that patients like me can receive protection from a vaccine like COVAXIN, I think is really important. And then the last point to get to your comment around variants is the fact that we have complete coverage of the entire virus through a whole inactivated vaccine means that we're much more likely to have complete coverage against variants as they emerge.

Thank you. And Dr. Chandran, the same question, please?

Yes. I second everything that David just pointed out. I do want to share some of the results that were presented in the Phase I and II particular which has been published in the reputed Journals Lancet, for example. And clearly shows the value of presenting multiple entities. We talk about other vaccines, Pfizer, Moderna or the AstraZeneca, Johnson & Johnson, Novavax, for example, they are all focused on the S-protein, the one protein that is changing the way these variants. And we're all concerned about escape mutants and so on. The beauty of this vaccine is that what it showed was it was able to promote a solidly good immune response against the invariant portion of the virus, so that's the androgen. So presenting a number of antigens gets around the possibility of variant. I'm not saying there will never be variants that will probably escape COVAXIN, but the probability is extremely small. You review -- and just another point that I would like to add to what David said, given the safety profile and the decades of use, what it means is the acceptance. In dealing with the pandemic, it is not about just being able to manufacture enough to be able to supply the global demand, but it's also about acceptance. Given what it is, the learning curve of inactivated virus that we've gone through over tens of years, probably nearly 50 years, I think the comfort level is greater. And therefore, acceptance is probably good. We're not dealing with the new technology that is yet, I mean, that has come about only in the context of COVID. So I think those are the key things I want to point out. One other thing, just going back to adding on padding up on the previous discussion that I had -- I stated is that we talk about variants. So is this -- is it possible that a COVAXIN, and given the data that they have presented, if they able to neutralize multiple variants, could this be the solution for all variants even as a booster.

Thank you. Appreciate that insight. So the next question I have is, what is the history of the whole variant inactivated vaccine platform? And why did Bharat realized that this would be a successful way to deliver a COVID-19 vaccination? Further, could you also describe some examples of where this platform has been successful in the past such as in the case of Polio? And here, I'll start with Dr. Forrest, please.

In fact, if you look at how each of the companies have reacted. Historically, when there's a crisis, and you need to make a vaccine, you dig deep into your toolkit. What is it that you have that you're comfortable can be used to move quickly to address that crisis? And in Bharat's case, the inactivated vaccine platform has been one that they have very successfully developed and commercialized throughout the world outside of the United States. They have an inactivated Rabies virus vaccine, inactivated Polio vaccine and including the Japanese encephalitis, so all serious diseases that can be associated with significant mortality as we all know. And so they had a very successful platform, established manufacturing standards that made them think back and say, if we want to make the best possible vaccine that addresses the broadest possible immune response, then let's go with the technology that will deliver that. And so from their platform, that's what they did, and they have done so as we've seen from the interim data to date very successfully. In the U.S., this is also not an unusual situation. The inactivated polio stopped an epidemic in the 1950s with an inactivated vaccine. And it came back again when we needed to have a vaccine with a better safety profile than the existing product we have with the live oral vaccine. So we've done that with Polio, and it's a recommended vaccine for our children. It's also true with hepatitis A vaccine. The advisory committee on immunization practices that the CDC recommends matured in this country get an inactivated hepatitis A vaccine. So once again, this is not some radical unusual technologies, not one where there is significant safety questions, the technology that they've established very successful internationally, making vaccines that are comparable with approaches that have been used in the U.S. for routine vaccines to date.

Thank you. And Dr. Musunuri. You are on mute.

Okay. Bruce highlighted very well and the salient points here. I think once again, this is a platform which has been used for ages and produce like hepatitis and polio vaccine, where all of our children and babies in this country infants receive it even today. And it's safe and Bharat Biotech has a significant experience producing various vaccines on the same platform over 300 million doses delivered to date. I think that's really important, right? I think having that experience, and as I mentioned to you during the pandemic, it's not only developing it and make sure the product has a probability of high safety. How do you get that in the middle of it, it's based on the experience and history. What else was developed before? How did our infants children do with that or adults? I think we need to take all this into consideration. And also, as I mentioned before, manufacturing is complex with any vaccine, okay? And in the middle of the pandemic, if we're trying to scale this up. I mean, this will be the best option, right? These guys have a lot of experience, and they are not doing this for first time. They've been producing vaccines on the same platform for many, many years. And now they're plugging this in. That helps a lot to robust scale up and take transfers even for us in the future when we are bringing manufacturing to U.S.

Great. So moving on to some of the efficacy findings we've seen. As of today, Bharat Biotech has reported Phase I data from about 375 subjects. Phase II data from about 380 subjects and the interim readout of the Phase III study in about 27,000 subjects, which saw 36 cases of COVID-19 in the placebo group versus 7 in the COVAXIN group, which translated to an efficacy profile of 81%. Perhaps digging into these recent Phase III data, can I ask you to highlight the most important takeaways from the earlier trials including the IgG responses, the T cell responses and other humoral and cell response findings and anything else do you think we should consider? I'll start with Dr. Chandran here, please.

All right. Thank you. You're right. We saw -- we all saw the results of the interim analysis with [ 81% ] point estimate of efficacy. But it's all about contextual. So when we talk about -- it appears to be as specific cases as any other leading vaccines out there, the Moderna and Pfizer vaccine, for example. But I think what remains the most exciting part of the story was the responses to, as I mentioned earlier, both the S and the N protein, both humoral and cellular responses were observed in there. The IgG classes, the cytokine profile favored the PH1 response, that's absolutely great. We're talking about in the -- from a major efficacy point of view, it is as comparable as the ones out there. When I compare COVAXIN and comparing it to the Moderna, Pfizer. But I think what remains to be seen is what is the longevity of the response, how well it is going to deal with the variant? Feel good about the variants because of the multiple antigenic responses, the little data that we have seen, there is no diminishing of the response over the period of time, the last few months of the Phase I and Phase II patients that will continue to be followed, and they seem to remain approximately where the peak activity was. The immunological correlates were identical or better than any other vaccines that have been tested so far. So those are the major highlights that I would like to point out about COVAXIN, that distinguishes it and the probability of it being able to address variants in the more I think probably the biggest takeaway from the Phase III study.

Thank you. And Dr. Forrest.

The Ocugen's partner Bharat has been phenomenally transparent in publishing the data in a way that you're not seeing perhaps so many of the other opportunities out there. They have published all their early data, all the immunogenicity and their T cell data. The efficacy so far from the interim is looking very positive and very favorable to date. But also remember, going back to Dr. Fajgenbaum, Dr. Chandran's comments on immune response, the press and public and even public health officials are enamored with antibody responses because they're easy to measure. The easiest thing in the immune system to measure. And yet there are only 1 part of making it a successful immune response. And a lot of the things that you don't hear about the cellular immune responses, which are the critical part of the immune system responsible for the recovery for providing you with the improvement in your outcome is really looked at. Bharat has done that, and they've published those data looking at their markets for measurement of cellular immunity. And you're going to see with a lot of these other proteins, the other antigens that are in this vaccine are critical for making those responses. So while many companies are narrowly focused on that part of the virus for which you can make and measure antibodies. And that is certainly an important part of it. Not only do you get that with Bharat, you also get an improvement potentially in outcomes where people will make it a breakthrough who might get an infection because they will make, and they've demonstrated they're making good cellular immune responses against broader panel of antigens. So this is consistent with what we're seeing with this efficacy profile to date.

And then the Phase III data that was reported earlier this month, could you please speak to the diversity of the subjects in the trial and your take on the data disclosed? And how does this compare to some of the other vaccines in development or approved under EUA? And Dr. Forrest, if I can have your thoughts on this first.

Absolutely. The diversity is found in many different ways in vaccine studies. Remarkably, vaccines have essentially similar profiles worldwide in the populations to date. You see this with vaccines such as Prevnar. You see it with Rotavirus vaccines, such diverse vaccines. There are certain select populations for which you may get less of immune response, but they still have a degree of protection they wouldn't otherwise have. So the vaccines data worldwide for the most part, is easily portable and demonstrates uniformity of coverage within the boundaries that we work. The other thing is India is not a monolithic block of homogeneous people, is a very diverse community. It has the same diversity in age, weight, body mass index, underlying conditions. And so the data is coming from a very broad cross-section of that community, both economically and socially. And so you're getting a spread of data in a population that is reassuring that the data you're seeing is one that can be reliably expected to be translated around the world. And I think that's important. Now remember, a lot of the other countries are doing their vaccines only in select communities, for example, only in the U.K. or perhaps only in Brazil. And that may not necessarily on the face of it look like that is going to be translatable to other parts of the world. But let's go back to the fact that for the most part, the human immune response behaves the same way in each of us within variabilities from not so great, some better, and the results that we see fit within that band are likely projections. So far, this is very likely to be translatable, experienced and can be seen around the world.

And Dr. Musunuri, please.

Again, it is translatable as Bruce stated, on the data, again, in the -- there is a lot of diversity. And also, if you look at the vaccines, in general, there are no different vaccines like even if you take the pediatric vaccine, it's not a different vaccine in different parts of the world, right? When they conducted clinical trials, I mean, they have the same exact dosing, same exact regimen. Why is that? So I think in general, in the middle of the pandemic, I think this can be easily translatable. And also important thing is also focus on the variants. The original, they all started with Wuhan variant and they're all changing. I think that's very important. I think when you're focusing on it, how these vaccines are effective in the current and the futuristic variants, how we are going to analyze all that. I think scientifically, everybody has to look into all those aspects. Just like Dr. Satish Chandran and Dr. Fajgenbaum, they all stated looking at the holistic approach, not only just translatable data, what is this vaccine bringing I think, and also the safety, again, it applies, right? And so they're doing in a large population and the safety looks from the early studies, which are published in Lancet looks impeccable. And I think it's following how traditional vaccine safety is and look at the mild-to-moderate side effect profiles very reasonable, significantly lower than other vaccines, which is going to be beneficial when you're talking about large demographic.

Great. And I definitely do want to spend some time on safety. But first, let me just open it one last time to see if there's any other comments anybody wants to make on the efficacy profile. Go ahead.

No, I don't have any comments.

Okay. Great. Well, let's talk about safety then. So again, with safety here, COVAXIN has now been authorized under EUA in India. So could you please tell us approximately how many people you believe have been administered COVAXIN at this point? And between the trial data and then this real-world experience, how has the safety profile been? And again, if you could talk specifically how it might compare to others? And Dr. Musunuri, I know you spoke about this a little bit, but just wanted to see if you have any other comments to add.

Yes. Again, they got to EUA. And of course, before they got, they had a restricted EUA before they get into full EUA under clinical. So they did -- I don't have the exact number, but we do know they did those millions after they got the EUA. And so far, I mean, we don't have the actual data with us, but they do indicate they don't have any concerns. From a safety perspective, it is looking good. It's following the trends like expected to follow. Once again, from the Lancet article, you can see it and also the high-level data coming out, these vaccines, if you look at the mild-to-moderate, but you're seeing around 10% or so approximately. I think that's a pretty good safety profile. And I can't -- I mean, there are vaccines which are under EUA in the U.S. You can look at their mild-to-moderate side effect profiles. I think compared to those, I think it's a very reasonable, much lower. I think that's important to note. I think that's once again, their vaccination and national immunization program is going very well.

Thank you. And Dr. Chandran.

Yes. I mean I agree with what Shankar just pointed out, but I do want to add that the typical safety profile of the whole inactivated virus we talked about it has been traditionally been good and they are in the same ballpark as one. If you look at the interim data, the safety profile, we don't have granularity to that yet, but there were no serious enough disease, serious disease, there were mild to moderate, they were in the 10% range. And where -- they were remarkably close to each other when compared with the placebo. So I think it's important for me to state that the safety profile is as good as it gets in a vaccine.

Okay. Great. Thanks. So I want to talk about the market opportunity now, and I'll ask Dr. Musunuri a couple of questions on this topic. The first one is that manufacturing is always a concern in the biotech development process, especially during the COVID-19 era when a large portion of the contract manufacturing capacity in the industry has now turned towards working towards this pandemic. So what is your plan for producing COVAXIN for the U.S. market? And how far along in this process are you executing on this plan?

It's -- again, as you pointed out, in the biopharmaceutical industry, many companies are struggling, right? There are a lot of supply chain issues. There's a priority given to COVID-19 vaccine or therapeutic effect. And just as we are working with potential CMO partners. And once again, I mean, I have to say it's not an easy path. And there are -- I mean, companies which are much larger than we are. And obviously, there are limited capacities. And again to secure, I think this and smoothly sail through what others have done? I mean you have seen the 3 people who got EUAs and they all have support from the government, that's important, right? I think -- because under the COVID-19 and when you have the support from the government, which we are seeking and that will also prioritize supply chain and routing various components you need for the manufacturer. And so we are working on all those avenues, again, do we face hurdles, of course, we are going to face hurdles. And I mean there are much larger players, they may be able to have adequate capacity, a block of adequate capacity, right? So I mean, we believe we have an important vaccine, we can really contribute to this pandemic in the U.S. We believe we are having good discussions with the government. And in addition to our own network and how we are working with potential CMO partners, we are hoping our government is going to support us and further enhance our opportunities to work with others to produce this product in the U.S.

Great. And can you please remind our audience about the publicly guided time lines for COVAXIN data? And do you anticipate running any studies yourself? And then can you remind us about the terms of the agreement you have with Bharat on manufacturing and potential sales?

Yes. Yes. Again, the publicly guided time lines, I think we kind of updated recently that we have filed a master file with FDA. I mean if you look at the EUA, emergency use authorization, vaccines to prevent COVID-19, guidance from FDA, which came out in February. And one of the paths on the way to EUA, one could file a master file with a lot of relevant data before you get the efficacy. So that is the first part, it's done. We're in discussions with the agency and understand hoping to get their feedback. The second step is filing the EUA when you have sufficient efficacy from the clinical trial like others have done and also safety data. There is a certain element of safety has to be collected on the subjects. And again, according to our partners, they're anticipating, they have 2 interim looks and one final look. And they believe the second interim look, data is going to come out this month and next month, which is April. And along with that, they believe we will be also getting adequate safety data, what we require for the submission for the EUA. So once again, we're anticipating our partners going to -- they're working extremely hard and they're going to get the data from efficacy and safety after the second interim look, we believe that may be sufficient to put the data together for the EUA submission. So that's what we are working on. Once again, we still have to wait until they have a second interim look and provide the efficacy and adequate safety data for our filing.

Thank you. And how are you thinking about the potential market opportunity for COVAXIN in the U.S. if EUA is granted? I know you recently emphasized the pediatric population. And what evidence have you seen here?

So yes, I think we do have data generated to date from our partner, covering 12 plus age group. And once again, there's a significant unmet medical need right now. I think there's only 1 vaccine, which brought EUA for 16 plus over to 18 plus. And you take the 12 to 16 segment, right? You got a lot of kids which are going to middle and high school, and their lives have been changed so dramatically. And it's not only important to vaccinate the teachers, right? We need to vaccinate the kids. How do you bring them back to normal lives, it's having an enormous impact on the shorter life of these kids and learning. And I think if you take that 12 to 16 age group, there are about 16 million to 20 million kids who can be vaccinated. If we do get approval, I mean EUA. And at least we have data covering 12 plus age group. That could be a good contribution in the middle of this pandemic from us. And the second thing, again, I will let Bruce speak about what additional things we are planning to do because as we stated in this panel, because of the way this vaccine is made traditionally including like a big vaccine, all the infants get in this country, Polio. We believe this is a good safe vaccine for all the different demographics. And therefore, we are going to do -- we are planning and potentially looking at to pediatric trials, covering daycare and school children, which is important. That could be a great contribution. And then the second thing, again, we have to look into -- based on the broad immune response, right? We're exploring potentially in future looking at a trial where people have received other vaccines, can they get a booster, a potential booster from our vaccine. And so that we can help out having the broad immune response, can we minimize and [indiscernible] can we control the pandemic. Because that's the key. People have to focus on how do you control the pandemic. And so I think those are all the things we are exploring right now. And I mean, our goal is to make sure not only bring this differentiated vaccine and do appropriate studies opposed to EUA so that this vaccine is available to all demographics, all age groups. And its much needed support we can provide. Bruce, I mean, you can...

Yes. Dr. Forrest, did you have any...

Dr. Musunuri has covered it very well. When we can't vaccinate part of the population and expect to have a significant impact on how this disease is progressing. And so while we are targeting various segments for the highest risk, which will contribute somewhat to reducing poor outcomes and disease amongst them. As long as you have reservoirs, anybody who is otherwise healthy, who can be infected and continue to circulate the virus, which includes children, you'll never going to get a handle on this. So a successful well thought-through program with a vaccine against COVID has to reach out to not just the groups that we see visibly with the most risk, but also folks who are not necessarily in those pools who have a lower case fatality rate. You've got to get children covered to get it back to school, but also remember, even in flu, if you vaccinate flu, you protect the elderly by vaccinating children. And we know this for 40 years. So I think that high-risk groups are those with underlying conditions, those who are immunocompromised or -- and in children has to be in a plan, as you go forward after the EUA has been established to continue to make sure that we build up a population that is able to be resistant to whatever this virus continues to throw at us.

Great. Thank you. So I'm going to close with one last question, which I'm going to ask each member of our panel to answer. So that question is what do you think is the greatest misunderstanding from the general public regarding COVID-19 and these vaccines? Further, also wanted to give you the opportunity to discuss any other takeaways that we didn't get to talk about that you think our audience should hear? And I'll start with Dr. Chandran here, please.

All right. I think the biggest one is the misinformation or multitude divergent information that is out there regarding the severity of the disease, how to intervene and how to protect oneself and so on. Vaccine is a no-brainer approach. We have done this many times over, protected the world many times over for various reasons. I think that is what needs to get out there. And the demonstration that COVAXIN is one of the safest of technologies, most traditional technologies, and it does as well with a great safety profile, right? That is a communication that needs to be out there.

And Dr. Fajgenbaum, please?

Sure. I think there's an old adage that vaccines don't save lives, vaccination save lives. And I think that that's something we have to remember right now, and that's yes, there are vaccines, but we've got to get those vaccines into people, and I would even take it a step further and say that not only does it need to be an effective vaccine against current variant, that it need also have protection against emerging and future variants. And so I think that, that is probably the biggest misunderstanding that just because we've had a vaccine out since December, that this pandemic is going to be over. We have to actually get it into people and we have to make sure what we get into people is going to have a lasting and broad protection. As far as the kind of a closing comment, I think I would just say that the work that this group is doing and the team is doing it's all about patients. And we know all too well the devastating impact that COVID has had in so many of us in so many ways. But in particular, with about all of those people who will get COVID and will have bad outcomes in the future, if we don't get this vaccine to move forward quickly enough. And so that's really our driver is all those people who are out there that would potentially have a bad outcome. But if we can move this forward quickly, get it into people's arms that we can prevent that suffering.

Thank you. And Dr. Forrest.

Okay. So I think the general misunderstanding in the public is that somehow, we can predict who it is that's going to get the disease and have a poor outcome. I have heard from many people, I don't get viral infections. I don't get sick. I have a good diet, I have nutritional outcome. I'm strong in workouts, I can go through the list. But many of us, maybe all of those have known at least someone in that category who has had a severe outcome or even died from COVID. There is no way that we can look at you and predict that you're going to, if infected have a favorable outcome that you're going to be fine. I just can't do that. Humans at least doesn't allow to do that at this stage. And so that's the first general misunderstanding is that they don't necessarily need the vaccine because they have a good lifestyle and they feel they don't get sick until they did. And then the other piece when it comes to vaccines is vaccination is not an either or. You don't have to give up a healthy lifestyle, nutritious diet is not in conflict with a general belief system that you have used to maintain your health or to raise your family or to look after your life or live your life. It is just one more thing. It's like wearing a seatbelt when you get in a car or putting a child in the car seat. So yes, you're a safe driver, but it's everybody else out there that you worry about. And the vaccination is just another tool to help you build on the things that you're doing right. Or if you're not doing them quite so well and you've got risk factors, it is something that will help manage that risk and reduce the outcome. Vaccine is not a 100%. We have a misconception is that it stops you getting infected. What it really does is stops you from getting a severe disease, potentially dying and reduces your ability to infect others. So it is one of the best community things you can do. If you're part of a society and you live in a community that shares values, you get vaccinated so that you don't and if you're infected for some reason, spreading it to those who have not yet been vaccinated, can't be vaccinated or the vaccine doesn't for whatever reason work so well. And I think that's the big issue that these are not about either or choices. The last one that we haven't really talked about is that, remember, Bharat's vaccine also contains a component that was developed in the United States through the National Institutes of Health. So one of the components of it has been a very successful development program that was funded here in the States. And this is the largest demonstration of how you can safely use one of these components to make the immune response bigger, better and broader and given an opportunity to work in a broad group of people. So when you've given a choice of the vaccine, yes, take whatever vaccine is being offered to you now, even if anyone does get it. But when -- as we build this program with as Ocugen does with Bharat, remember, you're getting a vaccine that has a broad coverage of the types of proteins that the virus makes. It makes a broad immune response, not just antibody, also stimulate cells to kill infected virus cells and it also contains a component that was developed here with U.S. government funding that has been moved forward as one of the largest demonstrations to how you can safely do that. And I think that's my pitch at this stage that you're getting -- get vaccinated as this program offers something that you're not seeing with any of the other vaccine development opportunities. That's my pitch.

And Dr. Musunuri.

Yes. This is, again, my colleagues have nicely explained. Again, I think there is a -- it's about community, right? When you're living in the community and many people have questions about vaccines. And we're in the middle of the pandemic. I think everybody who has access to the vaccine, they should take it. And it's really important. That's the only way we can control the pandemic. I mean when you get people vaccinated in a limited time and you reach 70%, 80%, and that's how you get the herd immunity. Of course, you have to worry about this variant, which is emerging. And I think, I mean, we highly recommend people to take vaccines because that's the only way not only protecting yourselves, you're protecting others. And so that, I mean, the more you do that, the more herd immunity you develop, you can actually establish normalcy, right? People want to look into their normal life, and they're struggling for more than a year now, and it's going to continue if you don't cooperate. I think people have to really think about -- I mean they have to think about their health and they need to protect themselves, but they also think about community and others where they live in, right? And so that's important. Obviously, to that, we are bringing this differentiated vaccine, which has a broad immune response humoral as well as cellular, which we believe can protect potentially from other variants and which can have a -- it's not about just antibodies like Dr. Forrest suggested, it's about a lasting immunity and the cellular response and the memory which can actually prevent and protect you from future potential infections and the variants. I think in addition to that, one of the things I didn't mention none of us got a chance, this vaccine is stable at refrigerate temperatures. It has data at room temperature. So what it means is when you're doing a mass immunizations like we are doing today in the middle of a pandemic, you open up big centers and you line up hundreds and thousands of people. And so you take the product at the room temperature, you're vaccinating them. You want to make sure the vaccine is still efficacious. It doesn't become unstable. So I think there is a big plus on distributing vaccines in a normal, their supply chain, which is a refrigerated condition for storing supplying. And also in the middle of the pandemic, you've got multi dose, right, because that's the fastest way to deploy. So eventually, people are coming in and you opened one vaccine with 10 doses in there, you got next patient coming in. And then what do you do with unused. I think you can look at the report, there's a significant amount of doses are being thrown out because they're unused. I think in the middle of the pandemic, it's a shame. We cannot use each and every dose to protect people. That's very, very important. I think our vaccine can provide that, minimize that risk for supply and distribution and implementation of the vaccines at various sites and pharmacies. And that's another big plus. I think once again, I mean, we do encourage everyone who is eligible to take the vaccine, please, get the vaccines. And I think we have to do more as Dr. Forrest pointed out and others. And we really need to look at all the children. I think we need to move fast. We need to do whatever trials we need to do to support them. I think we need to cover all the demographics. We need to cover high risk, we need to cover children. And then we also have to worry about variants, how do you get the coverage. Those are the 3 things we really have to work on as a country and as a globally, how do you control the pandemic. I think that's the only way you can control, encompassing everything, not looking at specific segments. That's only going to continue the problem pushing it away. That's it.

Great. Well, I'd like to thank each of you for all of your insights and for taking the time to answer my questions. Also thanks to the audience for your interest as well. And hope everybody out there stays safe and have a good day. Thank you.

Thank you, Kristen. Thank you for having us.

Thank you.