This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk06: Good morning and welcome to the Ocugen conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Ken Chowstee, Head of Investor Relations and Communications for Ocugen. Sir, you may begin.
spk04: Thank you, operator. I'd like to welcome you to our conference call. With me today are Octogen's chairman, CEO, and co-founder, Dr. Shankar Musunuri, who will provide a business update, and our chief financial officer and head of corporate development, Sanjay Subramanian, who will provide a financial update. Earlier this morning, we issued a press release including a business update and fourth quarter and full year financial results for 2021. We encourage listeners to review the press release, which is available on our website at www.ocugen.com. This call is also being recorded, and a replay, along with accompanying slide presentation, will be available on the investor section of the Ocugen website for approximately 45 days. As always, I need to advise you that this call will contain certain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty that could cause actual results to differ materially from expectations, including, among other things, the uncertainties inherent in research and development of our product candidates, risks to our business related to the ongoing COVID-19 pandemic, uncertainty regarding whether and when we will be able to submit a biologic license application for Kavaxin to the FDA, and whether and when we will receive regulatory approvals for Kavaxin in the United States or Canada. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission, including the risk factors described in the section entitled Risk Factors in the quarterly and annual reports that we file with the SEC. You should read carefully the risks and uncertainties described in today's press release, as well as the risk factors included in our filings with the SEC. Note that we will intend to file our Form 10-K by March 1st. I will now turn the call over to OccuGEN's chairman and CEO, Dr. Shankar Musanuri.
spk01: Thank you, Ken. Good morning, everyone, and thank you for joining, and we hope you and your families are safe and well. We are here today to review with you some of the most recent activities and events that transpired in the fourth quarter of 2021 and provide some perspective on the full year. 2021 was a transformational time for OccuGEN. especially as we successfully progressed two different assets within our portfolio. Simultaneously, we expanded and diversified our team to match our growing clinical development, commercial, and R&D needs. This was a year in which Oxygen doubled down on what I called courageous innovation. That phrase speaks to our purpose and commitment to drug development with a purpose and grit, searching for new solutions to enduring challenges. from working to bring a new COVID vaccine into U.S. and Canada to initiating a clinical trial for a game-changing, innovative gene therapy that could potentially treat multiple genetic mutations with a single product. I'm proud of this team that has succeeded with our business partners to position us for so much more in 2022. This slide highlights some of the critical milestones for Covaxin in the later part of the year and into 2022. First, it's important to understand the context for the progress we made. We have seen that the science has evolved and our nation's strategies have changed. Today, the focus is on how to achieve ongoing protection and closing the gaps among populations who remain unvaccinated. In just one year, so much has changed. At OxyGEN, our work for Covaxin had to evolve over the months to meet this moment. that led to our IND submission in late October and our EUA submission in early November. That work has paid off. Last week, we received clearance from the FDA to initiate a clinical trial to support a biological licensing application, RBLA. Our clinical program will be a phase two slash three immunobridging and broadening study. We will provide more details over the coming months as the study progresses. On the pediatric EUF front, I'm pleased to say that there are discussions involving the data we have submitted, including Bharat Biotech's immunogenicity data published in a preprint server in late December 2021, our own Omicron research showing effectiveness against this variant, and a database of more than 36 million teens vaccinated with Covaxin in India, with more than 70% of Americans Looking for options. Based on our latest Harris Poll, we know the need is great. We will continue advocating the FDA gives the vaccine a fair shot by having it evaluated by its independent vaccine advisory committee, known as ORFACT. We recognize that many of you have been asking for ongoing regulatory updates and asking why the review can't move faster. We hear you, and we would note two things. The first is that I'm pleased with the timeframe it took to have the clinical hall lifted. That took less than three months. The second is that getting to the critical juncture required significant confidential dialogue with the FDA. Therefore, making public those details would have been detrimental to the review process. So once the review process starts, Very little can be disclosed until there is clear guidance from the agency. In Canada, we have supplied a comprehensive set of responses to Health Canada from follow-up questions contained in what is known as a notice of deficiency. Remember that Covaxin is now under the new drug submission review, which will potentially lead us to full approval. We are following up with Health Canada to determine next steps. And speaking of Canada, there is growing interest from local and provincial government officials about our interest in the manufacturing site owned by Liminal Biosciences outside of Belleville, Ontario. Positive discussions with leaders have centered on the value of reestablishing a manufacturing and R&D hub within the region and for supporting that nation's contribution to innovation and public health. One final note about Covaxin. We're pleased to share with you that we have made good progress toward establishing manufacturing capability at our partner, Jubilant Hollister, in Spokane, Washington. This has involved designing a robust manufacturing process, establishing a means to transport active ingredient and sterile adjuvant from India to the US, selecting primary packaging components, and establishing quality control strategies that will provide additional assurance that the final product meets rigorous FDA standards and can be safely administered to people. The technology transfer is going well, and we expect to complete qualification manufacturing runs at Jubilant by the middle of this year. Now let's turn to our modifier gene therapy program. As you know, We submitted in November of 2021 an investigational new drug application for a phase 1 slash 2 clinical trial for RQ400, our lead candidate in the modifier gene therapy platform for the treatment of retinitis pigmentosa resulting from genetic mutations in R2E3 and rhodopsin. Within 30 days, the FDA accepted our application, and our dose range in clinical trial is now recruiting Details of the study are available on the National Institutes of Health website, clinicaltrials.gov. Our next candidate, Ocu410, has IND-enabling studies underway to support a future Phase 1-2 clinical trial. And our novel biologic, Ocu200, a transferrin-thumbstatin fusion protein that has potential to help those with diabetic macular edema. diabetic retinopathy, and wet age-related macular degeneration is progressing well with IND enabling activities. We are on track to initiate toxicology studies in non-human primates. So 2022 is off to a fast start with clinical trials for two product candidates with the data readouts expected second half of this year. Ongoing discussions with the FDA surrounding our pediatric EUA submission for Covaxin and continued progress on the remaining assets in our portfolio. I would like to thank our partners whose efforts are key to our progress. I'm very pleased with the progress we have made and know that we provide updates throughout the year. I will now turn the call over to Sanjay to provide our fourth quarter and full year 2021 financial update. Sanjay?
spk03: Thank you, Shankar, and good morning, everyone. I will now provide an overview of key financial results for the fourth quarter and full year of 2021. Our research and development expenses for the quarter ended December 31, 2021 were $7.1 million compared to $1.6 million for the fourth quarter ended December 31, 2020. For the full year, Research and development expenses for the year ended December 31, 2021 were $35.1 million compared to $6.4 million for the year ended December 31, 2020. R&D expenses for 2021 included a $15 million upfront payment to Bharat Biotech for the additional right and license to Covaxin in Canada. The remaining increase is attributed to the continued investment in the development activities for Covaxin, and our ocular portfolio. General and administrative expenses for the quarter ended December 31, 2021 were $7.5 million compared to $2.2 million for the fourth quarter ended December 31, 2020. For the full year ended December 31, 2021, G&A costs were $22.9 million compared to $8 million for the year ended December 31, 2020. Our increase in G&A expenses relates to increased infrastructure costs to support the growth of the organization. Net loss was approximately $14.6 million or $0.07 net loss per share for the quarter ended December 31, 2021, compared to a net loss of approximately $3.8 million or $0.02 net loss per share for the previous year's quarter ended December 31, 2020. For the year ended December 31, 2021, Ocugen reported a net loss of approximately $58.4 million or $0.30 net loss per share compared to net loss of approximately $34.4 million or $0.31 net loss per share for the year ended December 31, 2020, which included the in-process R&D expense of $7 million related to the reduction of the carrying value of an asset that was previously recorded as held for sale. Our cash, cash equivalents, and restricted cash totaled $95.1 million as of December 31, 2021, compared to $24.2 million as of December 31, 2020. Earlier this week, we raised net proceeds of $50 million before estimated offering expenses. This further strengthens our balance sheet and extends our runway. That concludes my update. Back to you, Ken.
spk04: Thanks, Sanjay. And with that, we will open up the call for questions. Operator?
spk06: Thank you. At this time, we would like to take any questions that we have for us today. And as a reminder, to ask a question, you may press star, then the number one on your telephone keypad. To withdraw your request, you may press the pound or hash key. Please stand by while we compile the Q&A roster. This will only take a few moments. Our first question comes from the line of from HC Wainwright. Your line is open. You may now go ahead.
spk03: Hi, RK. Good morning, RK.
spk06: We have another question from the line of Zach Bejala from Roth Capital Partner. Your line is open. Please go ahead. Good morning.
spk05: Thanks for taking my questions, and congrats on the progress. I think the first question for me here is if you can just comment on the details around what was required to lift the clinical hold.
spk01: Good morning. Thanks for the question. Clinical hold. When you submit an IND, typically FDA takes their own time. FDA is extremely busy, too. There are so many applications on the vaccine site. So there are the typical questions, if they have any clarifications they need, and those are the questions they asked, and we promptly submitted our responses, as I mentioned on our call, and we're able to wrap up this whole process within three months, which is good, considering in the workload FDA has and everything else going on.
spk05: Thanks. And can you just clarify, so was there any additional data that was needed or just a reanalysis? I'm just trying to get a sense of that to kind of predict perhaps the outcome of the pediatric EUA.
spk01: No, I think, I mean, let me clarify on the IND whole. Additional data was not, there's a clarification questions mostly. We didn't have to generate any additional data. Coming to, so the second question, are you asking about pediatric EUA?
spk05: Yeah, I was just trying to kind of gauge what might be required for the pediatric EUA based on the IND. So if you can just comment on that as well, that would be helpful to the extent that you can.
spk01: Yeah, so the IND is for long-term biological licensing application process. And we're trying to bridge the data from the U.S. demographic with the data generated in a large clinical trial in India. So that's the... phase two slash three immunobridging and broadening study we're embarking on. And that's for BLA. Now, the EUA was submitted emergency use authorization for pediatric population, ages two to 18, based on the data generated by our partners, based on the immunobridging trial, which bridges data to large-scale phase three trials in adults. So that's under active review by FDA.
spk05: Thanks, Shankar. And then as a follow-up, we got this question from investors, and they just kind of wanted some clarity on whether the FDA committed to providing an approval on the BLA if the bridging study comes out positive, meaning that you will not need any additional studies beyond the bridging study to support the BLA approval.
spk01: Yeah, for the BLA approval, there are two things I think FDA looks for. One is immunobridging. Typically, you do that because you cannot keep on. That will bridge with the large-scale safety and efficacy trial typically you do. That's what other companies have done in the U.S. too. When they apply for pediatric population, you bridge the pediatric to large-scale efficacy and safety trial. Similarly, in this case, for the BLA, we are bridging immunobridging on the immunodensity side that's kind of bridging it to efficacy trial. Typically, you also have to conduct a safety study in the U.S. demographic based on 21 CFR, and that bridges the safety of the population in the U.S. with the data collected from elsewhere. So in addition to this immunobridging trial, we foresee doing a safety trial in the U.S. population. So those are the two clinical trials required typically for VLA submission.
spk05: Perfect. Thanks, Shankar. And then just the last bit here, I know this is perhaps still being determined, but I was just wondering if there was agreed upon sample size for the bridging study or for the safety study, and then where are you regarding next steps that need to be completed prior to the initiation of the bridging study, for example, manufacturing, site assessments, et cetera? And I was squeezing my last one here, and maybe Sanjay can just comment now with the recent public offering. can you provide your updated cache one way?
spk01: Okay. So let me take the first few questions. The population for bridging study, typically you need a few hundred subjects for immunogenicity trial. You don't need large population. So that bridges, you know, neutralizing antibodies. And then there are other antibodies you're going to monitor. In our case, we'll be looking at not only spike, we will also be looking at nucleocapsid protein and others, because this vaccine does provide a broadening immune response, unlike spike-based vaccines. And the second question you asked is on safety clinical trial. Typically, that requires, you know, more than what we need for immunogenicity bridge, and those discussions are ongoing with FDA, and once we have the final agreement with them on the number, we'll be providing updates to the market. Go ahead.
spk03: Sure. Thanks for the question. Regarding cash, we are pleased that we did a financing earlier this week. It strengthens our balance sheet even further. The additional capital will help with the investment in our programs and the Covaxin as well as all the ocular programs. As you know, we have the EUA for the pediatric use for Covaxin pending at this point in time, so there's depending upon how that progresses, the potential for near-term revenues. So that could obviously change our cash runway. But if we exclude that or any benefit from that and we have without that, with the capital that we have raised, we have sufficient capital to go well into the first quarter of next year. It gives us ample runway for the investment in our programs and all the trials that we are contemplating to support the program.
spk05: Thanks, Sanjay. I'll get back into the queue because I do have questions about Aki's 100.
spk03: Sure. Thank you. Thank you, Zegba.
spk06: Once again, I would like to remind everyone, if you wish to ask a question, simply press star, then the number one on your telephone keypad. Once again, as a reminder, to ask a question, please press star 1. We have a follow-up question from , from Ross Capital Partner. Your line is open. Please go ahead.
spk05: I guess I have the honors of asking all the questions today. So just kind of moving on here, I think the next question as it relates to the comebacks and opportunities, just having you comment, I guess, on the size of the market opportunity as you think about perhaps being kind of a late player to the U.S. market. And then maybe you can comment a bit on your survey findings as well and perhaps, you know, who you surveyed and some of the details around that.
spk01: Yeah, so the U.S. market, it's still evolving, right? We still have the pandemic, which we believe will continue for the next few years. So currently, obviously, in the pediatric, that's the reason we applied for Pediatric UA. There is a significant unmet medical need. And under age 5 group, there are no vaccines available. From 5 to 18 age group, there's only one vaccine option available. And the vaccination rates, the kids who got two doses from 5 to 11 range, is about 25%. So to increase the vaccination rates, which are extremely important to prevent hospitalization and death, and in the pediatric populations, majority of the parents are looking for options. And that's the reason there is a great need for pediatric vaccines, which are safe and effective. And we have provided significant amount of data set to agency and requesting them to push for the ATCOM meeting. Second thing is, so the second opportunity is booster market. As you know, This pandemic will continue, and people who got the vaccines, eventually they'll be looking for posters. Our people who are unvaccinated, they're also looking for options. And providing an option such as ours with a broadening immune response and the product which is built on known traditional platform technology such as polio vaccine, people can relate to. So some of the vaccine hesitancy folks who are still there who are not unvaccinated to date, And they can also get an option such as our vaccines. So there is a need for options and providing a vaccine with, you know, solid efficacy and safety and also which is built on a traditional platform will have, we believe, significant value because there are people out there that can really provide options to increase the vaccination rates. And in addition to that, the U.S. government is doing a good job through the vaccine diplomacy, you know. They're purchasing vaccines from U.S. companies and donating for global use. Unless global population is vaccinated everywhere up to a certain extent, this pandemic is not going to be under control. Therefore, it's extremely important to having multiple vaccines in the toolkit, especially the vaccine, our vaccine has expected shelf life of two years at refrigerated temperature, six months at room temperature. So this vaccine will be an ideal vaccine for stockpiling and for vaccine diplomacy for global distribution.
spk05: Thanks, Shankar. That's really helpful in terms of, you know, how you're thinking you might have an advantage. But I guess what one would ask then is about how you're thinking about perhaps being able to enroll the study within the U.S. and maybe some strategies around how you you plan to position it, you know, to kind of help with the enrollment of the study, and perhaps even some comments around the timing of how long you think that could take.
spk01: So, I think the clinical trial information will be posted shortly on clinicaltrials.gov on the Covaxin trial design, and the study will allow not only a new population, but it allows subjects who got vaccinated, but there's a pause, I think. They have to have a minimum six months of gap after the last vaccine doses, and they can be enrolled in the study. So we have designed it very creatively, and the details will be posted at clinicalprice.gov. After it's posted in the bar, if you have any further questions, we'll be happy to address them. And again, there's a great need for options in this country, and I mean, we get a lot of calls and questions from people across the country, and we believe we will be able to recruit very quickly in this trial.
spk05: Thanks, Shankar. And then just quickly for our Q400 program that we're very interested in, just kind of wanted to get a sense of when you think data from that study could become available, and how much detail do you think you'll provide at the time of the next update?
spk01: So RQ400 study is recruiting now. If you go to the clinicaltrials.gov, details are given. So this is a phase one to trial for two mutations, and in each mutation, we are planning to recruit nine patients each, and it's a dose escalation. And so we'll be able to recruit those patients. We have identified in multiple sites, and the process is ongoing. and we're very excited about completing the recruitment this year and continue to provide updates in the second half of this year. Safety is the main goal for this study. In addition to that, we'll be looking at efficacy through observational endpoints. So we expect to provide updates in the second half.
spk05: Thank you. And then the key thing about this program is to rally the potential to be able to use it in multiple inherited retinal diseases. And so I was just wondering at what point are we able, are we going to be able to get a sense of its broad efficacy potential? And then can you again comment on what you think the market opportunity could be for this program?
spk01: Yeah, absolutely, Zikba. Great question. So that's the good thing about this program. I mean, not only are we going into MRP3, the master gene mutation itself in our face, onto clinical trial, we also are looking into relapsing mutation, which is a modified approach. So that actually is the, that concept, once we show activity in those patients, it's working, that opens up the door for entire RP population potentially. You're talking about covering 150 mutation within RP. Similar to that, there is a CEP290 mutation, which we are envisioning to initiate in those patients too, within the next one year, and that covers LCA, which is Leber Congenital Amorosis, another 25 mutations. So our goal is to have at least these three mutations covered, which can represent RP and LCA, covering about 175 mutations. Two million patients globally struggle with these diseases. So that's an enormous opportunity to treat, you know, a lot of these patients globally. and significant population within U.S. and EU. U.S. has about 100,000 to 200,000 patients covering between RP and LCA. So it's a huge, big-sized market. And moreover, it would be a great help for these patients to rescue them who are in desperate need. As I mentioned in my past conference calls, many of these patients do become legally blind by the time they're in mid-40s. So it's really important. There is a sense of urgency needed to rescue these patients. We hope we can be there for them.
spk05: Thanks, Shankar, and congrats on the progress.
spk02: Thank you. Great. Thanks, everyone.
spk06: Our next question comes from the line of Brian Cheng from Canterbury. Your line is open. Please go ahead.
spk02: Hey, guys. Thanks for taking... Hey, guys. Hey, guys. Thanks for asking all my questions, and congrats on the progress. So, I have a three-part question for Covaxin. I hope you can answer them. Can you comment on the manufacturing supply and capacity for Covaxin? And just from the capacity ramp-up perspective, I'm just curious how we should think about the capacity, assuming that you will have the pediatric approval near term. And lastly, when you think about the broad vaccine market in North America, Do you expect to look for partners to speed up the production and even reaching out to additional unvaccinated subjects? And then I'll follow up, thanks.
spk01: So thank you, Brian. Thank you. So let me start with the capacity question. The EUA is authorized. Currently, as I mentioned on the call, we are qualifying Jubilant Hollister that tech transfer is progressing really well. By mid-year, we'll be completing qualification runs. However, we have a plan. Our partners in India, as you know, this is an inactivated viral vaccine. It needs BSL-3 facilities. They have actually scaled up to a billion doses a year capacity. And what we have done in the interim, we established a packaging site in the U.S. and a release testing site so that we can release the product to our standards through Archigem in the U.S., and those sites are already established. So initial supply will immediately come from India, from our partners, which gets tested in the U.S. and packaged in the U.S. to release to the public while the drug transfer is ongoing. And we are planning to build up to 100 million dose capacity at Jubilant for drug product. However, as I mentioned to you before, there are three aspects of supply we are envisioning. One, the pediatric use. The second part is booster used in the U.S. market. The third part, U.S. vaccine global diplomacy. So, I mean, government purchasing doses for distribution abroad. So we believe, you know, with our partner's significant capacity and the capacity we are building in the U.S. with our CMOs, we'll be able to supply whatever the needs are. And second question you had, was related to reaching some other states and also the people who are unvaccinated. Currently, the distribution, as you know, is completely done by the government. They purchase the doses. The procurement is 100% done by government. And they take care of the distribution for now. And they distribute to the states and they're using their own network. So in future, obviously, that may change. If at all this pandemic ever moves into endemic and becomes a annual, you know, boosters and others are predicting. And that's the time, you know, when it gets a prioritization, then we have some time to work on those details. But for now, you know, all the vaccines are procured by the government and distributed by the government. And obviously, we'll be working with some states and other governments if there is a need, you know, in certain states for this vaccine because it's an option many subjects are looking for. We'll be happy to help them out.
spk02: And then on partnership, do you think that you will need one eventually to kind of ramp up on the outreach or even ramp up the capacity, you know, as you're thinking about the broader approval to the adult population?
spk01: Yes. I mean, all those options are, you know, will be opportunistic. I mean, our goal is to maximize, you know, supply of this vaccine as needed. So we'll be looking at exploring all those options.
spk02: Okay, thanks, Shankar. And then maybe just one on ARCA-400. I'm curious if you can talk about or remind us about the market size opportunity with the mutations that you are initially targeting. And, you know, in regards to the Phase I-II study that you're running, can you talk about what will you need to see before expanding to other mutation types
spk01: Yes. Typically, I mean, this is a standard clinical trials with the gene therapy in the space. If you look into rare diseases, typical, I mean, our trial follows exactly what others have done. It's a phase one to trial. The primary objective is safety. And you have to monitor these patients for a year. Every three months, you have to check for safety. And for every mutation, you look into the clinical trials. you have multiple observational endpoints. Because then from those observational endpoints, once the study is done after one year, you pick the observational endpoint and make one of them as a primary endpoint into the phase three. So that means in this case, LR2E3 primary endpoint by the time we go to phase three may be different than rhodopsin. So as I mentioned before, rhodopsin truly follows modifier approach. If we show the signal in rhodopsin, it's working the way it's supposed to work, that opens up the door for many, many mutations. I mean, obviously, you know, we also have to be cognizant. These are rare diseases. And therefore, we will methodically, you know, do the clinical trials in few mutations, you know. So to cover part of the RP and cover LCA so that, just as I mentioned before, our goal is to, you know, cover those 175 mutations between RPA and LCA. So the market size, you can look into populations. In the U.S., between RPA and LCA, it's 100,000 to 200,000 patients. And globally, it's about 2 million covering those 175 mutations. Currently, there's only one approved product for RPE65 mutation that I believe has less than 1,000 patients in the U.S. So there's a significant unmet medical need. and a significant opportunity. And for the gene therapy pricing, Brian, I think there are a couple of products in the market, and you can take a look at it. And I think other companies are getting there, and they're pricing based on the similar models.
spk02: Oh, and what do you need to see? Just curious, you know, what would we need to see in terms of efficacy before you expand into other mutation types. I noticed that on one of the slides, you're planning to also expand into CEP290 as well. So just curious, you know, what kind of bar should investors expect in terms of, you know, perhaps the vision improvement before you expand to other investigated mutation types?
spk01: Yes. So on CYP290, Brian, we wanted to start with NR2E3 and rhodopsin. We do have data on CYP292 on the preclinical and other models. It's the same product. Remember that. So we don't have to repeat any talk studies. And so it's a timing issue. So we're going to actually introduce that into the clinic. Since the agency has allowed us to go into rhodopsin, we're confident they'll allow us to go into CYP292. We're also in discussions actively with EMA. And we do have broad RP and LCA indications for the orphan drug designations in the EU. Therefore, we're also in touch with the EMA. And our goal is at least complete the Phase 1 to clinical trials for these three mutations in the U.S. while we are in communications with EMA. Then eventually, when we go into clinical trials after one year, what you're asking is what do you want to see? I mean, obviously, September 90, we don't believe We'll have any issues getting into the clinic with that. I mean, obviously, we'll be monitoring the rescue, you know, disease progression from the, you know, gene therapy, the single dose, and see how it's protecting people who are dosed. And based on the data and the disease progression and rescue, based on those endpoints we're monitoring, we pick the primary endpoint and go into phase three. And once we, and during this process, obviously we believe covering two for RP because it's broad and one for LCA hopefully should allow us for a potentially broad RP and LCA indications. So obviously we'll be collecting a lot of data in phase one, two, and carefully moving into cautiously into phase three for all three mutations. That's the plan to gather between U.S. and EU. So we'll merge the programs with the U.S. and EU. That's the plan. eventually for phase three clinical trials. Typically, the phase one, two is for one year. We hope, you know, the phase three will continue to be in the timeframe because you do have to catch the signal and also show, you know, based on the primary endpoint, adequate duration during the clinical trial.
spk02: Okay, we'll definitely look forward to your next update. Thank you, Shankar. Yep, welcome. Thank you, Brian. Thank you.
spk06: And there are no further questions at this time. Ken, you may continue for any remarks.
spk04: Great. Thank you so much. And we want to thank everybody who took the time to listen in on the call on both Covaxin and our modified gene therapy program. And we look forward to providing updates in the coming months. Thank you very much and have a great weekend. Bye. Bye.
spk06: That just concludes our conference for today. Thank you all for participating. You may now disconnect. Have a great day.
Disclaimer