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.
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'll 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 Ocugen website for approximately 45 days. This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties.
We may, in some cases, use terms such as predicts, believes, 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 chondrocyte-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 OCU400 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 filings with the Securities and Exchange Commission, SEC, including the risk factors described in the section entitled Risk Factors in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this presentation speak only as of 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, Ocugen's second quarter 10-Q will be filed soon after today's call. I will now turn the call to Dr. Musunuri.
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 Ocugen. 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 Ocugen 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 Ocugen 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 vaccines. 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, Bharat 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 II/III 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 Diseases, which is a peer-reviewed journal, recently published the phase II/III clinical trial results for 526 children who demonstrated a superior response in the study to that shown in adults. Scientific Reports published a study where COVAXIN generated a persistent cell-mediated memory immune response for up to 12 months. Additionally, it showed that the 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 two 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. Ocugen 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 I/II safety and efficacy clinical trial for OCU400 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 in 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 Ocugen 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 I/II clinical trial targeting dry age-related macular degeneration. Ocugen is currently executing pre-IND studies consistent with FDA discussions to support a phase I/II clinical trial, which the company intends to initiate next year. We have partnered with Cognate BioServices to manufacture clinical trial materials and to support the CMC development for OCU400 and OCU410. It's also worth noting that we expanded our patent portfolio in June when the United States Patent and Trademark 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 I/II-A clinical trial next year for OCU200, 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 OCU200 clinical materials. Now moving on to our regenerative cell therapies. With the expansion of our pipeline into cell therapy and orthopedics, NeoCart marks an experimental therapy with the potential to accelerate healing and reduce pain by rebuilding damaged knee cartilage and limiting the progression of osteoarthritis. NeoCart 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, Ocugen entered into a collaborative research agreement with Brigham and Women's Hospital, the teaching hospital of Harvard Medical School, to support NeoCart development and explore expansion of the pipeline. Earlier this year, the FDA granted a regenerative medicine advanced therapy or RMAT designation to NeoCart 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 III clinical protocol necessary to advance the clinical development of NeoCart 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. Jess?
Thank you, Shankar. 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 Bharat Biotech in connection with gaining rights to the Canadian market for COVAXIN. General and administrative expenses for the quarter ended June 30th, 2022 were $10.6 million compared to $6.8 million for the second quarter of 2021. The increase in general and administrative expenses relates to the 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 30th, 2021. Our cash equivalents, and restricted cash totaled $115 million as of June 30th, 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.
Thanks, Jess. With that, we will open the call for questions. Samantha?
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. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Jennifer Kim with Cantor Fitzgerald.
Hi, everyone. Thanks for taking my questions and congrats on the quarter. I have a couple of questions here. Maybe to start off with COVAXIN, I'm wondering, have you finalized what exactly studies you need and the protocols around those studies? With the development of bivalents that could come in the fall, has anything changed in your mind in terms of your market opportunity? Thanks.
Good morning, Jennifer. The current study, immuno-bridging and broadening study that is required, that bridges the, you know, clinical data from U.S. demographic to data generated by our partners elsewhere, a large phase III clinical trial they have conducted to collect safety and efficacy. The second one, which is required, we believe, is 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. We believe those two are needed to get the primary series indication for the BLA as we planned. The second part of your question is on the bivalent. You know, FDA recently changed the strategy. I think it's still upcoming. Science is evolving.
If this is the strategy, we're going to go into the future with the bivalent, you know, 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 the memory response. 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. If we have to develop a bivalent vaccine, our partners are working on that and they're on standby. We'll be ready to do that for boosters.
Okay, great. My second question is on the OCU400 program. You mentioned that you're going to start dosing in 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? When can we expect to see, I guess some real data from the patients in that program?
These periodic updates. The primary objective of phase I clinical trial is safety. 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 III. Currently, the primary objective on a 3-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, you know, share with the market as it comes along. The second part is efficacy endpoints based on our observational endpoints. That data typically, you know, I don't think we're going to get anything before 6 months visit for our patients.
From 6 months to 1 year visits, when these patients go through that transition, we may be able to see some observations. When we see them, obviously, we'll go through the internal process and controls, then we'll be able to share that information to the markets.
Okay. Does that mean, I guess, the first patient Cohort One that I think they were dosed in March, we could see it like 6-12 months from there is when we could see some signals?
That's right. That's what it is.
Okay, great. Okay. My last question, with your introduction of NeoCart, I'm wondering what are your thoughts on further expanding or diversifying your pipeline? Is that a priority in your mind?
NeoCart. I mean, are you asking specifically about NeoCart or further diversifying into a cartilage space?
More just how you view priorities of the company. Are you comfortable with where your pipeline sits today, or are you thinking about, you know, further opportunities to expand?
Yeah, that's a good question. NeoCart obviously was sitting in our bag, came through the reverse merger. Now we have very strong R&D and other teams in the organization with a solid biotech footprint. We started looking at it, and obviously it looks very, very promising. There's so much unmet medical need. That's why we started working on it. Obviously, we believe we have a, you know, strong biotech team that can support it for now. Obviously, this is a tip of the iceberg.
As you can look into the regenerative space in the cartilage, you know, there is 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. 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. Our goal for now in the next, you know, couple of years is really focus on this, work with FDA and you know, work on the manufacturing, work on clinical program and take it to the clinic sooner than later.
Okay. That's very helpful. Thanks, guys.
Question comes from the line of Jonathan Ashcroft with Roth Capital Partners.
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?
Good morning. Yeah. I mean, again, the differentiation with COVAXIN compared to three or four authorized vaccines in the US, they're all spike-based. That's a distinct difference. Ours is based on the whole virus-based vaccine with two adjuvants. That means it yields a broad immune response. That means you get antibody responses beyond spike, which may be needed. Also, there is a major publication which actually followed the patient up to 12 months and showed a T-cell and B-cell memory responses, which are important for durability. 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 3 months. One has to look for, you know, almost like a matching, like a flu season, annual booster shots.
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, for the future variants. If you have, 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. That's why it's really important. I think this is a very distinct and unique vaccine in the North American market, including.
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. Not only it showed very good immune responses, it also showed solid safety. I mean, they had a surveillance data after 36 million kids teenage group got first dosed with the vaccine. 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. Those are the distinct features of this vaccine.
That's why we believe we can strongly position this product.
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?
Yeah, that's going on. Obviously, we are also working with the Canadian government to get support on that, as we mentioned before. Obviously, it's progressing. In fact, you know, I mean, we're getting good support from the Canadian government, and we're happy to, you know, share that. As soon as we have something concrete and it takes time to work with governments, but they're very supportive. As we have something concrete, we'll definitely update the markets.
Okay. Need I await the impending 10-Q for this answer, or can you give it to us now? How much of the ATM has been used?
Hi, this is Jess. We have not utilized any of the ATM at this point. We're gonna be opportunistic.
Okay.
about our use of it.
Great. Thank you very much, guys.
Thank you.
Your next question comes from line of Uy Ear with Mizuho.
Hi, guys. Can you hear me?
Yes. Good morning.
Hi. Good morning. I guess my first question is just to sort of elaborate a little bit on or get some more color on OCU400. 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 first one. Yeah.
No, go on.
Yeah, please.
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 site is going, in terms of preparing for, you know, ramping up any kind of capacity that you may need for the COVAXIN. Thanks.
Yeah. Thank you, Uy Ear . I'll tell you, start with the OCU400 efficacy endpoints. As I mentioned, we are exploring multiple observation endpoints for efficacy. The way we monitor them is when the patient comes in, when getting into the study, we establish a baseline based on multiple endpoints. Every endpoint gets monitored when they have these periodic 3-month visits. If there is no decline, it's stable, it's still good. That's how we look into that. That's what you want to look at, you know, not no further degeneration. Is the baseline stable? It's steady state. That's good news, too. I think those are things we'll be slowly observing.
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, you know, look into that, and some of the mutations may have some information out there. 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. 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 III. Now, coming on to the second question on manufacturing at the Jubilant HollisterStier. They're our contract manufacturing organization supporting COVAXIN 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, you know, BLA next year. That site will also support any of our needs in North America going into the future. We're not, you know, too worried about the capacity constraints there. Whenever we get any orders from, you know, potential orders from Mexico or Canada, and eventually when we get into the U.S. we'll be ready to supply.
Okay. Thank you.
Your next question comes from a line of Daniil Gataulin with Chardan.
Yeah. Hi. Good morning, guys. Thanks for taking the call. I have a quick question on NeoCart. 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 endpoint. Just wanted to ask how you're adjusting, how you're thinking about this program going forward and potential phase III launch date, if you can speculate on that. Thank you.
Yeah. Good morning. NeoCart, you're right. Histogenics narrowly missed the endpoint. I mean, obviously we took a deeper dive at the data. Typically, you know, when you have larger lesions, that's where regenerative cell therapy truly helps. We're looking at larger lesions, and we are dissecting the data and see where this is most useful for patients' perspective. We're focusing our effort on that and continuously having a dialogue with FDA to understand and finalize the protocol. I mean, obviously they generated significant amount of data. I mean, obviously you also learn when you have such data, you know, where it's most useful and you focus on that. That'll be definitely improved protocol, much improved compared to what they have done.
That should, you know, increase our probability of success. That's what we believe in. That's where we are. There are two parts to starting the clinical trial. One is getting the input from FDA. They are currently, you know, 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, and which we are internally doing it. We believe, you know, that should be ready sometime next year too. Again, these two things have to be lined up. In the interim, obviously they did have a very good network of investigators and KOLs. This year, we're putting all those pieces together.
Hopefully we can provide a good, you know, roadmap for this program by the end of the year.
Okay. Got it. Thank you. A quick one on COVAXIN in Mexico. Do you have any call on the vaccine demand there currently? When do you expect to record any revenue there?
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. The government did procure a small amount of vaccines, not a large to vaccinate, you know, majority of those kids. That's why we believe there's an opportunity there. They may be looking for other vaccine options for kids. If you look at their, you know, demographic and look at the birth cohort, there is a significant opportunity.
Okay. Understood. Thank you very much.
Mm-hmm. You're welcome.
Your next question comes from a line of Robert LeBoyer with Noble Capital Markets.
Good morning. I had a question about NeoCart 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 gonna be used to design phase three in terms of the new entry criteria and the potential markets. Separately, I was curious as to whether the core technology underlying NeoCart that it was derived from would have implications or other indications for other restorative medicine injuries.
Yeah. Good morning. The data generated in the past, the endpoint, you know, typically for this regenerative therapy, what you're looking for is, function and pain. Those are the two co-primaries, and they're coming up with the score. That's what we'll be monitoring. That's what is important. FDA also, you know, 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. You know? There may be other standard therapies available if the lesion size is too small, and you may not see much difference. Those are the differentiating factors.
We are 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. 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, it's a, you know, we have our own scaffold we make, and then we take the autologous cells from the patient, and chondrocytes, and then we grow these cells, right, into a 3D. That's in a nutshell. This kind of a technology is unique. Obviously, we're starting with the knee cartilage repairs.
Obviously we'll 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. There are a lot of needs in orthopedic space, as you know, and we'll continue to explore.
Okay, great. Thank you very much.
Your next question comes from a line of Swayampakula Ramakanth with H.C. Wainwright.
Hi, RK.
Thank you. This is RK from H.C. Wainwright. A lot of my questions have been answered, but I'm just following up on one of the questions that had come earlier. I know you're still pursuing COVAXIN in the U.S. How are you thinking of differentiating, you know, and 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?
RK, the indication, you know, doesn't change because, you know, the current vaccines are indicated for primary or booster series, 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, it's, I mean, look at the White House meeting like last two weeks ago, and what they're looking into and what the public is looking for is a differentiated vaccines. They are looking for more vaccine options. I think now, you know, I mean, the hospitalization, thank God, has gone down and compared to 2 years ago.
Now people have time to reflect and see what else is available. As the market goes into this booster space, eventually it may turn into private like flu vaccines. About 1/3 of Americans take flu shots every year. 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? That's what is going to happen. Our goal, the indication may not change. Indication says, you know, this vaccine can be given for booster series, right? That's very important. 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. We'll continue to do that as Ocugen too. As the data comes out, we'll share with public and in the peer review journal, so people can review it and they can make, you know, data-driven decisions, what is appropriate for their families.
Yeah, maybe I didn't ask the question right. I was just wondering about coverage. You know, is COVAXIN, has it shown better coverage than what is there in the market with all these new mutations coming up? You know, that's what I was thinking of when I asked the question.
Oh.
Probably you answered it by the publication of the papers, part of the answer. Unless you know, unless you want to give more clarification.
Yeah. Again, the data from our current clinical trial, I mean, it's not a booster study designed for, but it's immuno-bridging and broadening. That means some of the patient population, they must have taken prior mRNA vaccines, we'll have that subgroup. If the data is showing, you know, indirectly we're going to get some booster 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? You're right, you know, so all those things can be negotiated with FDA, how we put forth. As I mentioned before.
Thanks.
If, you know, if the agency is moving towards bivalent vaccines, that's more good for, you know, coverage for the long term. We'll be there for that. Also, the most important factor, as I mentioned before, I want to emphasize, is durability. I think, you know, the publication in Scientific 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.
Thanks for that. On the Mexican market that you were talking about, saying, as you're getting ready to commercialize there, what is, you know, how big is the Mexican market? You know, what's the commercialization strategy there, in Mexico?
Mexico, the current focus is, again, as I mentioned before, it's on kids. There's only one company, they got some procurement. I believe it was probably not covering the entire population, just a fraction. 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 are the second, you know, company in line to get the pediatric authorization, we'll have a good opportunity in Mexico.
Thank you. Go ahead, please.
No, I think one of the things, RK, I just wanted to mention, emphasize our vaccine I didn't address before, is this vaccine stored at a refrigerated condition with potential shelf life of two years. I just wanted to emphasize. It has a good shelf life at even room temperature at 25 degrees, up to six months. That makes a big difference, you know, for distribution, supply, as well as a stockpile for future use, in any country, you know, in North America, including Mexico.
One last question on COVAXIN. On the Canadian front, you know, any update at all regarding your application there?
I don't have any further updates on it. We're still waiting for their response. You know, we submitted all the questions they had, all the responses to them.
Thank you. Fantastic. Good, good luck, and talk to you soon.
Thank you.
Thank you.
This concludes the Q&A portion. I will now turn the call back over to your host, Tiffany Hamilton.
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.