Q2 2022 Ocugen Inc Earnings Call
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Good morning and welcome to the Archeogen Second Quarter 2022 Business Update and Financial You are a good morning and welcome to the Archeogen Second Quarter 2022 Business Update.
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 very recorded. I will now turn the call over to Tiffany Hamilton, Occupian Head of Corporate Communications. Thank you.
Thank you, Samantha. Joining me today are Occigian's Chairman, CEO and co-founder, Dr. Shankar Musimari, who will provide a business update can our chief accounting officer and Senior Vice President of Finance, Jessica Cresco, to 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 OccuGen.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.
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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, estimate, anticipate, expect, plan, intent, may, could, might, will, should, or other work that can today uncertainty a future event or outcome to identify before looking straight.
Such forward-looking statements include, but are not limited to, statements about the potential for neocart,
Autologous, congenite derived neocardialage have approved to provide an innovative new option for the parapult thickness region of the neocardialage and adults, as well as oxygen's intention to begin josing in cohort two of the occup 400 of the child this month.
Such statements are subject to numerous important risks.
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 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 FCC. 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, applicants, second quarter 10C will be filed soon after today's call. I will now turn the call to Dr. Muthsonari.
Thank you, Tiffany.
Good morning, everyone, and thank you for joining. We hope you and your families are safe and well.
Courageous innovation is a 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 progress of our entire artisan team and I'm very proud of what we are accomplishing.
Using this mindset of courageous innovation, we are strengthening our dedication to ICare pursuing broader commercialization of our vaccine program and we have expanded our pipeline into the orthopedic space which we will discuss later.
The Ocogen 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 at once or after this.
Today, we're going to provide updates on our vaccines GenN and cell therapy programs.
Starting with the vaccines.
As we enter the third of the COVID pandemic, we are facing new challenges as COVID-19 variants continue to emerge.
that 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 necessary to contain the pandemic.braham,
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, Power Biotech.
Studies have shown coaxing provides durability through immune memory and a broader immune response that may be important for realizing it bolster 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 and the U.S. remains at priority. With a different MOA and the U.S. remains at priority.
The Phase 2-3 immunobridging and broadening clinical trial, RQ002, 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 for that shown in adults.
Nature scientific reports published in study where co-vaccine generated a persistent, self-mediated memory, immune response for up to 12 months. The results of the study were published in study where co-vaccine generated a persistent, native experiences, and the financial label where indeed at the most popular, your shared camera confessing a certain degree and your mind and touching what it's called, you
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 coaxing is effective.
with a terrible safety profile.
Coaxing already has emergency use authorization in Mexico for adults, and we submitted an application for pediatric emergency use. We submitted an application for pediatric emergency use.
in the 2 to 18 H group that is under review. We're currently working on commercializing the vaccine in Mexico. The vaccine in Mexico.
Now, moving on to our gene therapy programs.
And our pounding 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 modified gene therapy, unlike traditional gene therapy, as shown in preclinical models to affect the regulation of genes or 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 net-divitimate diseases that cause blindness. The unbalanced state can lead to disease, that cause blindness. The unbalanced state can lead to disease,
We completed the dosing of subjects with Retnative pigmentosa in cohort one of our phase one, two safety and efficacy clinical trial for RQ400. And the independent data safety. And the independent data safety.
Monitoring board for the clinical trial recommends proceeding to dosing in cohort 2.
We expect to begin dosing in cohort to 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 that the redops invitation and the ophthalmology disease space.
By the end of the study, we will collect data from 18 patients, which will constitute three cohorts of three different doses before moving onto your Phase 3 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 oxygen can bring the region's emulation to bear.
Our sense of urgency for rescuing one's sight 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.
Occasion is currently executing pre-IND studies consistent with their B.A. discussions to support a face-1 through clinical trial, which the company intends to initiate next year.
We have partnered with ConceinoVile to manufacture clinical trial materials and to support the CMC development for RQ400 and RQ410. And to support the CMC development for RQ400 and RQ410.
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 I to A clinical trial next year for OCCU200, 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 OCCY200 clinical materials. Now moving on to regenerative cell therapies.
clinical materials. Now moving on to the region reduced cell therapies.
of our pipeline into cell therapy in the orthopedics, Neocard marks an experimental therapy with the potential to accelerate healing and reduce pain for rebuilding damaged knee cartilage and limiting the progression of osteoarthritis.
Neocort is a tissue engineer, disc of new cartilage that is manufactured by growing connoisseur sites, the cells responsible for maintaining cartilage health, which are derived from the patient.
Recently, Ocogen 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 Neocot for the repair of full thickness lesions of the knee cartilage in adults.
We believe this roadmap designation will accelerate our timeline and getting this product to market.
Ocogen is currently working with the FDA to finalize the Phase III clinical protocol.
necessary to advance the clinical development of Neocard 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 or 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 am very proud of our team who collectively shares in our vision. We were recently named one of the reasons 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 card to Jess to provide our second quarter 2022 financial results.
Yes. 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 30, 2022 were $9 million compared to $18.9 million for the quarter ended June 30, 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 fluaxin. For more information, visit www.aclu.org
General and administrative expenses for the quarter and this June 30th, 2022 were $10.6 million compared to $6.89 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, so a nine cents net loss per share for the quarter and the June 30th, 2022. Compared to a net loss of approximately $26 million or 13 cents net loss per share for the quarter and the June 30th, 2021.
Our cash, cash equivalent, and restricted cash totaled $115 million as of June 30th, 2022.
Compared to $95.1 million dollars of year and December 31, 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 i-V
That concludes my update for the quarter. Definitely that yet.
Thanks, Jeff. With that, we will open the call for questions.
that we will open the call for questions. Thank you.
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 the number one. We will pause for just a moment to compile the Q&A roster.
Your first question comes from a line of Jennifer Kim with Cantor.
Hi everyone, thanks for taking my questions in correct in the quarter. I have a couple of questions here. Maybe to start off with Covaxan, I'm wondering, have you finalized what exactly studies need and the protocols around this study? 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.
Good morning, Jennifer. The current study, immunobridging and broadening study...
That is required that we're just clinical data from US demographic to data generated by the partnership that's where.
Allotge.
Phase III clinical trial they have conducted to collect safety and difficulties. The second one which is required we believe is safety trial in the US 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 plant. TV I suppose if you call it a leadership plan regarding the responsibility for the C informs months of the BLA education for the BLA as we plant. as we plant.
The second part of your question is in the bivalent. You know, 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 bivalent, you know, variants, and we'll be working towards that. However, we will be getting some data from our clinical trial, and we'll do sub-analysis of those subjects of patients who have received currently mRNA vaccines and how they're doing in the future.
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. 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,
I developed a violent vaccine. Our partners are working on that and they're standby, so we'll be ready to do that.
Okay, great.
My second question is on the Auke 400 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 and when can we expect to see, I guess, some real data from the patients in that program?
Yeah, so these periodic updates, so the primary objective of Facement of Clinical Royal Safety. Thank you. Thank you. Thank you.
and we are monitoring multiple efficacy endpoints. We call them observation endpoints.
Depending on the mutation, you know, every mutation may have a different primary endpoint before we move on to the phase 3.
So currently the primary objective on a three month periodic basis Subjected to our protocol and what we agreed with FDA will be monitoring these patients safety outcomes Will come out and again they get reviewed by DSMB on a periodic basis That's a number one outcome and we can no share with the market as it comes along the second part is efficacy and points based on our observation and points and that data typically, you know I don't think we're going to get in
that I think they were just in March, we could see it like six to 12 months from there. It's funny, the good season's to know.
That's right.
That's right.
Okay, and then my last question on with your introduction of New Yorker, I'm wondering what are your thoughts on further expanding or diversifying your pipeline? Is that a priority in your month?
New cut, I mean are you asking specifically about new cut 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 further opportunities to expand?
Yeah, that's a good question. So, Neocart obviously was sitting in our back and 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.
Obviously, this is a tip of the iceberg as you can look into the regenerative space in the cartilage. There is only one product available in the marketplace and we believe we have a superior technology with the 3D. How we grow the sales 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 or pipeline expansion opportunities come up, we'll try to explore them.
But our goal for now in the next couple of years is really to focus on this, work with FDA and work on the manufacturing, work on clinical program and take it to the clinic. That's one of them later. That's one of them later. That's one of them later. That's one of them later.
Okay, that's very helpful. Thanks, guys.
The position comes from line of Jonathan Ash Cough with Roth's capital partners.
Thank you. Good morning, guys. I was curious. What do you think is your best co-vax and pitch for the three different areas of North and Iraq? The pitch is for the three different areas of North and Iraq.
out there. Granted it's differential among the three countries but what is your best pitch in each of those countries you think for you know pushing the utility of kavaxin against what's already out there?
Good morning.
Yes, I'm in.
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 adjuents. So that means it's really a broad immune response. That means you get antibody responses.
Bjorn spike, which may be needed. And also, there is a major publication which talked about, which actually followed the patient up to 12 months and showed a T cell and B cell memory and the patient. And so, there is a major publication. And so, there is a major publication. And so, there is a major publication.
which are important for durability.
So when you have a broad and immune response, when you have durability, when you're going into the future, it's not practical to get booster shots every three months. One has to look for 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 the broadening immune response.
Bordening Immune Response will...
potentially result in adaptive immunity. That means not only current variants, but future variants. And if your system is already prepared with the broadening immune responses, with the memory, and if you do see some variants on which you're going to happen in the future, and at least you'll have the 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, including, 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 this annual bolsters. The reason is the data of partners have generated an Indian pediatric population is very strong.
and not only showed really good immune responses, it also showed solid safety. And then 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.
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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 provision this product.
Okay, thank you. How are talks going for the manufacturing facility in Ontario?
That wasn't a plot part of the Q2 release, I was wondering how that was going.
Yeah, that's going on. Obviously, we are also working with...
Canadian government to get support on that, as we mentioned before. And obviously it's progressing. In fact, you know, and then we were 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 will definitely update the markets.
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?
We have not utilized any of the ATM at this point.
We're going to be after to talk with Miss about our use of it.
Great, thank you very much.
Thank you.
Your next question comes from line up, from the to the you the the the the the the the the the the the the the the the<|translate|> the you
Hi guys, can you hear me?
Yes, good morning. Good morning. So I guess my first question is just to sort of elaborate a little bit on
or get some more color on, OCCU 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 that's helping.
Now go on, I'll ask my... Come on, 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 for any kind of capacity that you may need for the COVAXIN.
Thanks get.
Yeah, thank you.
So, let's start with the RK400 Efficacy Endpoints. As I mentioned, we are
Exploring multiple observation and points for efficacy. So the very way we monitor them is when the patient comes in, and get into the study that we establish a baseline. And get into the study that we establish a baseline.
based on multiple endpoints. So every endpoint gets monitored and then they have this periodic team of visits.
And so if there is no...
decline, stable, it's still good. And so that's how we look into that. And that's what you want to look at it, no further degeneration. And is the baseline stable, it's steady state, and that's good news too. So I think those are the 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 3.
Now, coming on to the second question on manufacturing at the Jubilant Hollister, there are contract manufacturing organizations supporting coaxing drug product manufacturing. The tech transfer is going well.
And we believe we'll be on target to complete our process evaluations in support of our NLPLA next year. And that site will also support any of our needs in the North America, going into the future.
And we're not, you know, too worried about the capacity there constraints. Whenever we get any orders from, you know, potential orders from Mexico or Canada and eventually when we get into the US, we'll be ready to supply.
Okay, thank you.
Your next question, control line of Daniel.
Get a lens with partners in the
Yeah, hi, good morning, guys. Thanks for taking the call. I have a quick question on your cards. Could you give us a brief overview of previous data and what gives you confidence in the program? Because I believe that HISTED Chanics reported data in 2018 that just missed their end points. You just wanted to ask how you're adjusting, how you're thinking about this program going forward, and then show up phase three launch date.
if you can speculate on that. Thank you. Good morning.
So, you're right. Here's to the next, Natalie, this end point. And obviously, we took a deeper dive at the data.
And typically, when you have larger lesions, that's where region rate to 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.
And so we're focusing our effort on that and continuously having a dialogue with FDA to understand and finalize the protocol.
So, I mean, obviously, they generated significant amount of data. And, I mean, obviously, you also learn when you have such data, you know, where it's most useful and you focus on that. 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. So, that's where we are. So, there are two parts to start in 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 will be able to finalize our design with them. The second step is establishing manufacturing.
and 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 co-l's. 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.
Okay, got it. Thank you. And the quick one on collection in Mexico. Do you have any current, the vaccine demand? They're currently and I want to expect reporting a 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. And the government did procure a small amount of vaccines, not a large to vaccinate 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 demographic and look at the Botco board, there is a significant opportunity.
Okay, I understand. Thank you very much.
Okay, welcome.
Your next question, cultural line of Robert LeBoyer with Noble Capital Market.
Good morning. I had a question about Neocard and just the previous data in terms of what the patient's 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 Neocart that it was derived from would have implications or other indications for other restorative medicine injuries.
Yes, good morning. So the data generated in the past, the endpoints, you know, typically for this regenerative therapy what you're looking for is function and pain. Those are the two core primaries in the coming of the score. That's what we'll be monitoring. That's what is important. And the VA 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. There may be other standard that are piece available if the lesion size is too small, and you may not see much difference. And you may not see much difference. And you may not see much difference.
So those are the differentiating factors where 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 frontline orthopedic experts. And so that's how we are 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 is, you know, we have our own scaffold we make. And then we take the autolog ourselves from the patient and the connoisseurite 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 meat cartilage repairs. And obviously we'll in the next few years, we're going to explore, because this is unique, regenerative therapy.
and a lot of ourselves in 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. And there will continue to explore.
Okay, great. Thank you very much.
Your next question, cultural line of say, the Alma Puckola Ramcant with H.C. Wainwright.
Thank you. And this is our case. This is our case from Hitzvahee, Wayne Wright. A lot of my questions have been answered.
that I'm just following up on one of the questions that come earlier.
Great.
I know you are still pursuing Covaxin in the US. 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?
So, the indication doesn't change because the current vaccines are indicated for primary or poster cities and that's what it's going to be. Obviously as the science is evolving, consumers or customers, they're getting more scientific information. I think the market landscape is going to change. As I mentioned before, 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 differentiated vaccines. They look for more vaccine options. I think now, I mean the hospitalization thank God has gone down and so compared to two years ago, so now people have a 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 the pediatricians, and they're going to have a thoughtful process, what is available, what is the science, and what is the
You know, appropriate for me and my family. And that's what is going to happen. So our goal, the indication may not change. Integration say, you know, this vaccine can be given for bolster cities, right? So that's really 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 review journal. There's so much of data in a transparent way they share. And we'll continue to do that as oxygen too. As a data comes out, we'll share it with public.
and peer review is general. So people can review it and they can make data driven decisions. What is appropriate for their families?
I was just wondering about coverage. Is Coaxin, 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, but probably you answered it by the publication of the papers part of the answer.
unless you want to give more clarification.
Yeah, again, the data from our current lymphotrial, I mean, in the bolster, and I mean, it's not a bolster study designed for, but it's immunobraging and broadening. That means some of the patients 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 and you know, you know, so all those things can be negotiated with the FDA. How we put forth. As I mentioned before, if you know, the agency is moving towards violent vaccines, that's more good for in a 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 the publication of Nature Reports which came out two weeks ago, I mean that really substantiates that up to 12 months showing that memory responses is very important.
Thanks for that. And then 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?
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. I believe. 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 you have a second company in line to get the pediatric authorization, we'll have a good opportunity in Mexico.
and I'd also voltsd
No, I think one of the things I think to okay, I just wanted to mention emphasize our vaccine I didn't address before is this vaccine is stored at a refrigerated condition. I just want to emphasize. And so at a refrigerated, with the potential shelf life of two years and it has a good shelf life even room temperature at 25 degrees up to six months. I think that even room temperature at 25 degrees up to six months.
So that makes a big difference for distribution, supply, as well as a stockpile for future use in any country in North America and in Mexico.
And one last question on the Canadian print, any updated on regarding your application there.
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.
Thank you..
Thank you, fantastic, good luck and talk to you soon.
Thank you.
This concludes the Q&A portion. I will now turn the call back over to your host, Tiffany Hammel.
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.
Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you.
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