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spk01: Good morning, and welcome to the Ocugen Second Quarter 2022 Business Update and Financial Results Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the presentation. If you should require operator assistance, please press star zero on your telephone keypad. Please note that this call is being recorded. I will now turn the call over to Tiffany Hamilton, Ocugen's Head of Corporate Communications.
spk06: Thank you, Samantha. Joining me today are Ocugen's chairman, CEO, and co-founder, Dr. Shankar Musunuri, who will provide a business update, and our chief accounting officer and senior vice president of finance, Jessica Crespo, who will provide more on our financial results. Earlier this morning, we issued a press release detailing business activity for Q2 2022. We encourage listeners to review the press release, which is available on our website at ocugen.com. This call is being recorded, and a replay, along with the accompanying slide presentation, will be available on the investor section of the OccuGen website for approximately 45 days. This presentation contains forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995, which are subject to risks and uncertainty. We may, in some cases, use terms such as predict, believe, potential proposed continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include, but are not limited to, statements about the potential for neocart, autologous congenite-derived neocartilage, if approved, to provide an innovative new option for the repair of full-thickness lesions of the knee cartilage in adults, as well as Ocugen's intention to begin dosing in cohort two of the OCU 400 clinical trial this month. Such statements are subject to numerous important risks, excuse me, factors, risks, and uncertainties, and may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filing with Securities and Exchange Commission, SEC. including the risk factors described in the section entitled Risk Factors and the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this presentation speak only as the date of this presentation. Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation, whether as a result of new information, future events, or otherwise after the date of this presentation. Finally, OccuGEN's second quarter 10Q will be filed soon after today's call. I will now turn the call to Dr. Musunari.
spk09: Thank you, Tiffany. Good morning, everyone, and thank you for joining. We hope you and your families are safe and well. Courageous innovation is the driving force behind everything we do at OxyGEN. We are leading innovative clinical programs to ultimately make a significant impact on public health and address unmet medical needs around the globe. Developing great science requires harnessing the passion, persistence, patience, and intellectual prowess of our entire oxygen team, and I'm very proud of what we are accomplishing. Using this mindset of courageous innovation, we are strengthening our dedication to eye care, pursuing broader commercialization of our vaccines program, and we have expanded our pipeline into the orthopedic space, which we will discuss later. The oxygen team continues to charge ahead, and over the course of this past quarter, we saw great progress in establishing ourselves as a differentiated biotech company. As we continue to meet our regulatory milestones and engage with patients in a clinical setting, I'm especially confident that the team is well poised to advance our efforts. Today, we're going to provide updates on our vaccines, gene and cell therapy programs. Starting with vaccines. As we enter the third year of the COVID pandemic, We are facing new challenges as COVID-19 variants continue to emerge. At the World Vaccine Congress in late April, speakers all agreed that public health strategies need to expand and vaccine options beyond what is available in the current mRNA dominant landscape are necessary to contain the pandemic. This sentiment was reiterated during the recent White House summit on the future of COVID-19 vaccine. Additionally, consumers want effective options for vaccinating themselves and their children, including vaccines built on a traditional platform. We are up to this challenge as we advance the Covaxin program with our partner Biotech. Studies have shown Covaxin provides durability through immune memory and a broader immune response that may be important for realizing a booster strategy for annual vaccinations. We are still a few years away from seeing an end to this pandemic, and the need for delivering an additional COVID-19 vaccine option with a different MOA in the U.S. remains a priority. The Phase 2-3 immunobridging and broadening clinical trial, OCU-002 for Covaxin, is progressing well, and we are in the planning stages for starting the adult safety clinical trial this year, pending FDA discussions. Lancet Infectious Disease, which is a peer-reviewed journal, recently published the Phase 2-3 clinical trial results of 526 children who demonstrated a superior response in the study to that shown in adults. Nature Scientific Reports published a study where Covaxin generated a persistent cell-mediated memory immune response for up to 12 months. Additionally, it showed that a booster dose is safe and ensures persistent immunity to minimize breakthrough infections of COVID-19. These studies reinforce the point that Covaxin is effective with a favorable safety profile. Covaxin already has emergency use authorization in Mexico for adults, and we submitted an application for pediatric emergency use in the 2 to 18 age group that is under review. We are currently working on commercializing the vaccine in Mexico. Now, moving on to our gene therapy programs. And our founding focus, retinal diseases, is becoming clearer, especially with our vital work in retinitis pigmentosa, a disease for which there is no cure, no medicines to block disease progression, and limited treatments to help manage the patient's tragic journey that ultimately leads to blindness. Oxygen has a deep commitment to its research and development programs for inherited retinal diseases, for which there are no treatment options, only one gene therapy modality exists. Our modifier gene therapy, unlike traditional gene therapy, has shown in preclinical models to affect the regulation of genes called nuclear hormone receptors, or NHRs. Activating these NHRs modulates gene activity and maintains homeostasis. When gene networks are not functioning properly, this unbalanced state can lead to disease, including a family of inherited retinal diseases that cause blindness. We completed the dosing of subjects with retinitis pigmentosa in cohort one of our phase 1-2 safety and efficacy clinical trial for RQ400. And the independent data safety monitoring board for the clinical trial recommends proceeding to dosing in cohort two. We expect to begin dosing in cohort two this month and we will provide periodic updates. This is a significant accomplishment in an innovative therapeutic category because for the first time, we're evaluating this modifier gene therapy concept with the rhodopsin mutation and the ophthalmology disease space. By the end of this study, we will collect data from 18 patients which will constitute three cohorts of three different doses before moving on to a Phase III clinical trial. If successful, this therapy has the potential to treat many mutations under RP. Currently, RP has about 150 mutations, affecting approximately 2 million people globally. This is a dire, unmet medical need and shows where Octogen can bring courageous innovation to bear. Our sense of urgency for rescuing one site is critical, and for us, it's personal. Our next candidate, OCU410, has IND-enabling studies underway to support a future Phase 1-2 clinical trial targeting dry age-related macular degeneration. OCU410 is currently executing pre-IND studies consistent with FDA discussions to support a Phase 1-2 clinical trial, which the company intends to initiate next year. We have partnered with ConsinoBio to manufacture clinical trial materials and to support the CMC development for OCU-400 and OCU-410. It's also worth noting that we expanded our patent portfolio in June when the United States Patent and Trademarks Office issued the company an additional patent directed to methods for preventing or treating an ocular disease or disorder associated with retinal degenerative disease. Finally, we're expected to initiate a Phase 1-2A clinical trial next year for OCU-200, our novel biologic that has the potential to help those with diabetic macular edema, diabetic retinopathy, and wet age-related macular degeneration. We have completed the technology transfer of manufacturing processes to its contract development and manufacturing organization that will manufacture OCU-200 clinical materials. Now moving on to region-rated cell therapies. With the expansion of our pipeline into cell therapy and orthopedics, Neocort marks an experimental therapy with the potential to accelerate healing and reduce pain by rebuilding damaged knee cartilage and limiting the progression of osteoarthritis. Neocort is a tissue engineered disc of new cartilage that is manufactured by growing chondrocytes the cells responsible for maintaining cartilage health, which are derived from the patient. Recently, Opigen entered into a collaborative research agreement with Brigham and Women's Hospital, the teaching hospital of Harvard Medical School, to support neocard development and explore expansion of the pipeline. Earlier this year, the FDA granted a regenerative medicine advanced therapy, or RMAT, designation to neocard for the repair of full thickness lesions of the knee cartilage in adults. We believe this RMAT designation will accelerate our timeline in getting this product to market. Ocugen is currently working with the FDA to finalize the phase three clinical protocol necessary to advance the clinical development of Neocort for eventual market authorization. In summary, we have an ambitious clinical agenda and the rigor in our clinical development process to advance our pipeline in constant pursuit of our long-term vision. What's important to remember is that the strength of our pipeline is found in the diverse innovation we are exploring to address public health and unmet medical needs. I'm very proud of our team who collectively shares in our vision. We were recently named one of the region's best places to work by the Philadelphia Business Journal. This recognition is a reflection of all our colleagues and our culture focused on courageous innovation. I will now turn the call to Jess to provide our second quarter 2022 financial results.
spk07: Thank you Shankar and good morning everyone. I will now provide an overview of the key financial results for the second quarter of 2022. Our research and development expenses for the quarter ended June 30th, 2022 were $9 million compared to $18.9 million for the quarter ended June 30th, 2021. Research and development expenses for the second quarter in 2021 included a $15 million upfront payment to Barth Biotech in connection with gaining rights to the Canadian market for the vaccine. General and administrative expenses for the quarter ended June 30, 2022 were $10.6 million compared to $6.8 million for the second quarter of 2021. The increase in general administrative expenses relates to the increase an increase in infrastructure costs to support the growth of our organization. Our net loss was approximately $19.5 million, or $0.09 net loss per share for the quarter ended June 30, 2022, compared to a net loss of approximately $26 million, or $0.13 net loss per share for the quarter ended June 30, 2021. Our cash, cash equivalents, and restricted cash totaled $115 million as of June 30, 2022. compared to $95.1 million as of year end December 31st, 2021. We expect our cash on hand will take us into the second quarter of 2023. We're exploring opportunities to increase our working capital, which may include the use of our current at-the-market program for the sale of our common stock. That concludes my update for the quarter. Tiffany, back to you.
spk06: Thanks, Jess. With that, we will open the call for questions. Samantha?
spk01: At this time, if you would like to ask a question, please press star, then the number one on your telephone keypad. Again, that is star and then number one.
spk00: We will pause for just a moment to compile the Q&A roster. And your first question comes from a line of Jennifer Kim with Kantor.
spk04: Hi, everyone. Thanks for taking my questions, and congrats on the quarter. I have a couple of questions here. Maybe to start off with Kovacs, and I'm wondering, have you... finalize what exactly studies need and the protocols around those studies. And with the development of bivalence that could come in the fall, has anything changed in your mind in terms of your market opportunity? Thanks.
spk09: Good morning, Jennifer. Yeah, the current study, immunobridging and broadening study that is required that bridges the clinical data from U.S. demographic to data generated by our partners elsewhere. a large phase three clinical trial they have conducted to collect safety and efficacy. The second one, which is required, we believe, is a safety trial in the U.S. demographic, and we're still awaiting feedback from FDA. As soon as they provide that information, we're going to initiate the clinical trial. We're planning for that. So we believe those two are needed to get the primary series indication for the BLA as we plan. The second part of your question is in the biovalent. FDA recently changed the strategy. I think it's still upcoming. Science is evolving. So if this is the strategy we're going to go into the future with the biovalent variants and we'll be working towards that. However, we will be getting some data from our clinical trial and we will do sub-analysis of those subjects or patients who have received currently mRNA vaccines and how our vaccine is performing because we do provide broad immune responses compared to spike-based mRNA vaccines, and we also have long-term durability with memory response. So we have to see how those factors play out. Do we really need a bivalent vaccine strategy with our vaccine? We're going to carefully monitor that, and if we have to develop a bivalent vaccine, Our partners are working on that and they're standby, so we'll be ready to do that for bolsters.
spk04: Okay, great. My second question is, on the AHQI 400 program, you mentioned that you're going to start dosing cohort two this month and you're going to give periodic updates. Could you give any color on what level of granularity will be in those updates and when can we expect to see, I guess, some real data from the patients in that program.
spk09: Yeah, so these periodic updates, so the primary objective of phase one to clinical trial is safety. And we are monitoring multiple efficacy endpoints. We call them observational endpoints. Depending on the mutation, you know, every mutation may have a different primary endpoint before we move on to the phase three. So currently, the primary objective on it three-month periodic basis subjected to our protocol and what we agreed with FDA. We'll be monitoring these patients. Safety outcomes will come out. And again, they get reviewed by DSMB on a periodic basis. That's our number one outcome. And we can share with the market as it comes along. The second part is efficacy endpoints based on our observational endpoints. And that data typically, you know, I don't think we're going to get anything before anything before six months visit for patients and from six months to one year with it when these patients go through that transition we may be able to see some observations and we see them obviously will go through the internal process and controls then we'll be able to share that information to the markets okay so does that mean I guess with your the first patient cohort one
spk04: that I think they were just in March. We could see it like six to 12 months from there is when we could see some signals. That's right. Okay, great. Okay, and then my last question on with your introduction to Neocart, I'm wondering what are your thoughts on further expanding or diversifying your pipeline? Is that a priority in your mind?
spk09: Neocart, I mean, are you asking specifically about Neocart or further diversifying into cartilage space.
spk04: More just so how you view priorities of the company, are you comfortable with where your pipeline sits today or are you thinking about further opportunities to expand?
spk09: Yeah, that's a good question. So NeoCart obviously was sitting in our back, came through the reverse merger, and now we have very strong R&D and other teams in the organization with a solid biotech footprint. And so we started looking at it and obviously it looks very, very promising. There's so much of unmet medical need. That's why we started working on it. And obviously we believe we have a strong biotech team that can support it for now. And obviously this is a tip of the iceberg as you can look into the regenerative space in the cartilage. There's only one product available in the marketplace and we believe we have a superior technology with the 3D, how we grow the cells with this proprietary technology and a strong patent portfolio. And this is the product we're going to focus on initially. Obviously, through our research and development, including the collaboration with Harvard Medical School, if any future pipeline expansion opportunities come up, we'll try to explore them. But our goal for now in the next couple of years is really focus on this, work with FDA, and work on the manufacturing, work on the clinical program, and take it to the clinic sooner than later.
spk02: Okay, that's very helpful. Thanks, guys.
spk00: This question comes from the line of Jonathan Ashcroft with Roth Capital Partners.
spk12: Thank you. Good morning, guys. I was curious. what do you think is your best Covaxin pitch for the three different areas of North America out there? Granted, it's differential among the three countries, but what is your best pitch in each of those countries, you think, for pushing the utility of Covaxin against what's already out there?
spk03: Good morning.
spk09: Yeah, I mean, again, the differentiation with Covaxin compared to three countries or four authorized vaccines in the U.S., they're all spike-based. That's a distinct difference. Ours is based on the whole virus-based vaccine with two adjuvants. So that means it's really a broad immune response. That means you get antibody responses beyond spike, which may be needed. And also, there is a Nature publication which talked about, which actually followed the patient up to 12 months and showed a T-cell and B-cell memory responses. which are important for durability. So when you have a broadened immune response, when you have durability, when you're going through the future, it's not practical to get booster shots every three months. One has to look for, you know, almost like a matching, like a flu season, annual booster shots. So for that, what you're looking for is an ideal vaccine which has a durability and which also has potential with a broadening immune response. Broadening immune response will potentially result in adaptive immunity. That means, you know, not only current variants, but the future variants. And if you have a, your system is already prepared with the broadening immune responses, with the memory, and if you do see some variants, and which is going to happen in the future, and at least you'll have ability to create, you know, with your adaptive immune system, attack it. And that's why it's really important. I think this is a very distinct and unique vaccine in the North American market. But one other thing I would like to make is in Mexico, we are working on emergency use authorization for pediatric population, and that's very important too. I mean, obviously, we will be looking into that going into the future when we go into these annual boosters. The reason is the data our partners have generated in India on pediatric population is very strong. And not only it showed very good immune responses, it also showed solid safety. I mean, they had a surveillance data after 36 million kids, a teenage group, got first dosed with the vaccine, and they collected surveillance data, and the surveillance data clearly showed no cases of myocarditis, pericarditis, or thrombosis, which are associated with current vaccines here in North America. So those are the distinct features of this vaccine. That's why we believe we can strongly position this product.
spk12: Okay, thank you. How are talks going for the manufacturing facility in Ontario? That wasn't part of the Q2 release. I was wondering how that was going.
spk09: Yeah, that's going on. Obviously, we are also working with the Canadian government to get support on that, as we mentioned before. And obviously, it's progressing. In fact, you know, we're getting good support from the Canadian government, and we're happy to share that. And as soon as we have something concrete, and it takes time to work with governments, but they're very supportive, and as we have something concrete, we'll definitely update the markets.
spk12: Okay, and need I await the impending 10Q for this answer, or can you give it to us now? How much of the ATM has been used?
spk07: Hi, this is Jess. We have not utilized any of the ATM at this point. we're going to be optimistic about our use of it.
spk12: Great.
spk02: Thank you very much, guys.
spk00: Thank you. Your next question comes from a line of Hugh Ear with Mizuho.
spk05: Hi, guys. Can you hear me? Yes. Good morning. Hi. Good morning. So I guess my first question is just to sort of elaborate a little bit on or get some more color on OCU 400. Just wondering when you do report data for the efficacy endpoint, just curious like how would you kind of define success and which of those metrics that are listed in clinicaltrials.gov are more important to you? or more important, I guess, to clinicians in terms of how it would sort of help define success for this program. I think the question... No, go on. I'll ask my... No, no, please go ahead. My second question, again, probably has to do with manufacturing. Just curious, you know, how the manufacturing, I guess, in the Washington sites is going... in terms of preparing for, you know, ramping up for any kind of capacity that you may need for the co-vaccine. Thanks.
spk09: Yeah. Yeah.
spk12: Thank you.
spk09: So, I'll start with the ARCA 400 efficacy endpoints. As I mentioned, we are exploring multiple observational endpoints for efficacy. So the way we monitor them is when the patient comes in, when getting to the study, we establish a baseline based on multiple endpoints. So every endpoint gets monitored when they have this periodic three-month visits. And so if there is no decline, it's stable, it's still good. And so that's how we look into that. And that's what you want to look at, no further degeneration. And is the baseline stable, steady state? That's good news too. So I think those are things we'll be slowly observing. And once again, these are some of the mutations we are getting into, may not have a lot of data out there. We may be the first ones to look into that. And some of the mutations may have some information out there. So again, that's why we wanted to be flexible. And we believe we created a very good protocol which allows us to monitor multiple endpoints. And so depending on specific mutation type, we believe based on the data we're going to collect will allow us to have a clear path going into phase three. Now coming on to the second question on manufacturing at Jubilant Hollister. They're our contract manufacturing organization supporting coaxing drug product manufacturing. The tech transfer is going well. And we believe we'll be on target to complete our process validations in support of our BLA next year. And that site will also support any of our needs in North America going into the future. And we're not too worried about the capacity there constraints. Whenever we get any potential orders from Mexico, or Canada, and eventually when we get into the U.S., we'll be ready to supply.
spk02: Okay. Thank you.
spk00: Your next question comes from a line of Daniel Gedolin with Chardon.
spk11: Hi. Good morning, guys. Thanks for taking the call. I have a quick question on Neocard. Could you give us a quick overview of previous data and what gives you confidence in the program? Because I believe histogenics reported data in 2018 that just missed their endpoints. I just wanted to ask how you're adjusting, how you're thinking about this program going forward and potential phase three launch date, if you can speculate on that. Thank you.
spk09: Yes, good morning. So Neocot, you're right. Histogenics, Natalie missed the end point. I mean, obviously, we took a deeper dive at the data. And typically, you know, when you have larger lesions, that's where regenerative cell therapy truly helps. We're looking at, you know, looking at larger lesions and we are dissecting the data and see where this is most useful for patients' perspectives. And so we're focusing our effort on that and continuously having a dialogue with FDA to understand and finalize a protocol. So, I mean, obviously, they generated a significant amount of data. And, I mean, obviously, you also learn when you have such data, you know, where it's most useful and focus on that. But that would be definitely improved protocol, much improved compared to what they have done. So that should, you know, increase our probability of success. That's what we believe in. So that's where we are. So there are two parts to starting the clinical trial. One is getting the input from FDA. So they are currently reviewing our protocol, and we are hopeful sometime this year we'll be able to finalize our design with them. The second step is establishing manufacturing, in which we are internally doing it. And we believe that should be ready sometime next year too. So again, these two things have to be lined up. And in the interim, obviously, they did have a very good network of investigators and COALs. And this year, we're putting all those pieces together. So hopefully, we can provide a good roadmap for this program by the end of the year.
spk11: Okay, got it. Thank you. And a quick one on coaxing in Mexico. Do you have any call on the vaccine demand there currently? When do you expect to record any revenue there?
spk09: Yeah, the current vaccine demand, just as any other country, currently only the government is procuring there. I don't think they're allowing at private markets. In the pediatric population, obviously, there's only one company which got authorization to date. That's Pfizer. And the government did procure a small amount of vaccines, not a large amount. to vaccinate, you know, majority of those kids. So that's why we believe there's an opportunity there. They may be looking for other vaccine options for kids. So if you look at their, you know, demographic and look at the cohort, there is a significant opportunity.
spk03: Okay, I understand. Thank you very much. You're welcome.
spk01: Your next question comes from a line of Robert LaBoyer with Noble Capital Markets.
spk08: Good morning. I had a question about Neocard and just the previous data in terms of what the patient entry criteria was and some of the endpoints in the trial, as well as how that information is going to be used to design phase three in terms of the new entry criteria. and the potential markets. And separately, I also was curious as to whether the core technology underlying Neocard that it was derived from would have implications or other indications for other restorative medicine insurance.
spk09: Yeah, good morning. The data generated in the past, the endpoints, typically for this regenerative therapy, what you're looking for is function and pain. Those are the two co-primaries in the coming up with the score. That's what we'll be monitoring. That's what is important. ABA also is directing towards that, so that doesn't change. However, the difference is, as I mentioned before, depending on the lesion size, that's important. There may be other standard therapies available if the lesion size is too small, and you may not see much difference. So those are the differentiating factors. We're carefully looking at the data, what happened in the past, and where it's more beneficial for the patient, and looking at the average lesion size and where did it fit in, working with our KOLs and, you know, frontline orthopedic, you know, experts. And so that's how we're actually designing this clinical trial, and that's number one. Number two, the question is the underlying technology platform. Yeah, it is very unique. The underlying platform technology, you know, we have our own scaffold we make. And then we take the autologous cells from the patient and chondrocyte, and then we grow these cells, right, into a 3D. And that's in a nutshell. And so this kind of a technology is unique. And obviously, we're starting with the knee cartilage repairs. And obviously, in the next few years, we're going to explore because this is unique regenerative therapy and autologous cells, you know, how we can grow into different indications. And there are a lot of needs involved with building space, as you know, and we'll continue to explore.
spk03: Okay, great. Thank you very much.
spk01: Your next question comes from a line of Sayama Pakula Ramkant with HCE Wainwright.
spk10: Hi, RK. This is RK from Head Save and Ride. A lot of my questions have been answered, but I'm just following up on one of the questions that had come earlier. So I know you're still pursuing Covaxin in the U.S. So how are you thinking of differentiating, you know, when you are approaching the FDA, what is the indication that you're putting up such that you can differentiate Covaxin against what is already in the market or what has already been approved by the FDA?
spk09: So, R.K., the indication, you know, doesn't change because, you know, the current vaccines are indicated for primary or poster cities, and that's how it's going to be. Obviously, as the science is evolving, I mean, the consumers or customers You know, they're getting more scientific information. I think the market landscape is going to change. As I mentioned before, I mean, look at the White House meet like the last two weeks ago and what they're looking into and what the public is looking for is a differentiated vaccine. They are looking for more vaccine options. I think now, you know, I mean, the hospitalization, thank God, has gone down. And so compared to two years ago, So now people have time to reflect and see what else is available. And as the market goes into this booster space, eventually it may turn into private like flu vaccines. About one third of Americans take flu shots every year. And the consumers are going to ask. They'll work with their primary care physicians. They'll work with their pediatricians. And they're going to have a thoughtful process. What is available? What is the science? And what is, you know, appropriate for me and my family, and that's what is going to happen. So our goal, the indication may not change. Indications say, you know, this vaccine can be given for poster cities, right? So that's very important. So what we have to do is get the data out there, just like, you know, our partners have published about 14 journal articles in peer-reviewed journals. There's so much of data in a transparent way they shared. And we'll continue to do that as Oxygen, too. As the data comes out, we'll share with the public and peer-reviewed journals so people can review it and they can make data-driven decisions what is appropriate for their families.
spk10: Maybe I didn't ask the question right. I was just wondering about coverage. Is Covaxin, has it shown better coverage than what is there in the market with all these new mutations coming up? That's what I was thinking of when I asked the question. Probably you answered it by the publication of the papers. Part of the answer. Unless you want to give more clarification.
spk09: Yeah, again, the data from our current clinical trial, I mean, in the booster, I mean, it's not a booster study designed for, but it's immunobridging and broadening. That means some of the patient population, they must have taken prior mRNA vaccines, will have that subgroup. And if the data is showing, you know, indirectly we're going to get some bolster data, I mean, as I mentioned before, is that sufficient, you know? Is that providing a good coverage for current variants and potential for future variants? And you're right, you know? So all those things can be negotiated with FDA, how we put forth. As I mentioned before, if, you know, if the agency is moving towards violent vaccines, that's more good for, you know, coverage for the long term. will be there for that. And also, the most important factor, as I mentioned before, I want to emphasize is durability. And I think, you know, the publication in Nature Reports, which came out a few weeks ago, I mean, that really substantiates that up to 12 months, showing the memory responses is very important.
spk10: Thanks for that. On the Mexican market that you were talking about, as you're getting ready to commercialize there, how big is the Mexican market and what's the commercialization strategy there in Mexico?
spk09: Mexico, the current focus is again, as I mentioned before, it's on kids. There's only one company that got some procurement. I believe it was probably not covering the entire population, just a fraction. So that's what currently they procure for kids. And there's a significant opportunity there. I don't want to give any specific numbers, but we believe if we have the second company in line to get the pediatric authorization, we'll have a good opportunity in Mexico.
spk02: And also... Go ahead.
spk09: No, I think one of the things I think, R.K., I just wanted to mention, emphasize our vaccine, I didn't address before, is this vaccine is stored at a refrigerated condition. I just wanted to emphasize. And so it's a potential shelf life of two years. and it has a good shelf life at even room temperature at 25 degrees up to six months. So that makes a big difference, you know, for distribution, supply, as well as a stockpile for future use in any country, you know, not America, including Mexico.
spk10: One last question on Covaxin. On the Canadian front, you know, any update at all regarding your application there?
spk09: I don't have any further updates on it. We're still waiting for their response. We submitted all the questions they had, all the responses to them.
spk10: Thank you. Fantastic. Good luck and talk to you soon.
spk03: Thank you.
spk01: This concludes the Q&A portion. I will now turn the call back over to your host, Tiffany Hamilton.
spk06: Thanks everyone for taking the time to join the call this morning. We look forward to providing further updates in the coming months. Have a great day and a wonderful weekend.
spk07: Thank you.
spk01: Ladies and gentlemen, this concludes today's conference call. You may now disconnect.
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