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spk03: 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 then zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Lisa DeCenza, Vice President of Integrated Communications at Lavoie Health Science, to introduce the Ocugen team. You may begin.
spk04: Thank you, operator. I'd like to welcome you to our conference call. With me today are Ocugen's chairman and CEO, Dr. Shankar Musunuri, and our CFO and head of corporate development, Sanjay Subramanian. Earlier this morning, Ocugen issued a press release including a business update and full year 2020 financial results. We encourage listeners to review the press release, which is available on the Ocugen website, at www.ocugen.com. This call is also being recorded and a replay will be available on the investor section of the Ocugen website for approximately 45 days. Before we begin our formal comments, I'll remind you that various remarks we make today constitute 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 information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts, regulatory submissions, and regulatory authorizations or approvals. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and or launch dates, as well as risks associated with preliminary and interim data including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data. The risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review publication process in the scientific community generally and by regulatory authorities. whether and when data from Bharat Biotech's clinical trials will be published in scientific journal publications, and if so, when and with what modifications, whether the US Food and Drug Administration, the FDA, will be satisfied with the design of and results from preclinical and clinical studies of Covaxin, which have been conducted by Bharat Biotech in India, whether and when any biologics license and or emergency use authorization applications may be filed in the United States for Covaxin, whether and when any such applications may be approved by the FDA, decisions by the FDA impacting labeling, manufacturing processes, safety, and or other matters that could affect the availability or commercial potential of Covaxin in the United States, including development of products or therapies by other companies. 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. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release, whether as a result of new information, future events, or otherwise after the date of this webcast. 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 intend to file our Form 10-K with the SEC tomorrow. Any information we provide on this conference call is provided only as of the day of this call, March 18, 2021, and we undertake no obligation to update any forward-looking statements as we may make on this call on account of new information, future events, or otherwise. I will now turn the call over to Ocogen's Chairman and CEO, Dr. Shankar Musunuri.
spk06: Thank you, Lisa. Good morning, everyone, and thank you for joining. Since this time last year, when we hadn't grasped the full impact of the pandemic and what it would mean in our daily lives, we at Ockogen have made it our personal mission to be part of the solution to help end COVID-19. Through our partnership with Park Biotech, a leading vaccine developer based in India, we are working to potentially bring the COVID-19 vaccine to the United States. Covaxin was developed in partnership between the government of India and Park Biotech and was granted approval for emergency use authorization by the Indian authorities and is currently part of the largest vaccine distribution program in the world. Several million people have received this vaccine in India. It has an excellent safety track record to date. Leading journals such as Nature and Lancet have published the rigorous scientific research conducted on Covaxin to date, which includes preclinical and human phase 1 and phase 2. Covaxin provides an excellent opportunity for oxygen to enter the infectious disease market. It is different from other COVID-19 vaccine options currently authorized for emergency use in the United States. These vaccines rely on new mRNA or adenovirus technology, while Covaxin utilizes a traditional approach as an advanced stage whole variant inactivated vaccine using a viral cell manufacturing platform. This is the same technology that has been successful in producing the polio vaccine for infants globally for decades. Another key differentiator is that Covaxin induces the immune system to target the whole virus, which we believe reduces the possibility of mutant virus escape. The other currently available options in the United States target just the spike antigen to elicit an antibody response, but Covaxin has been shown to induce immune responses against multiple protein antigens, including the spike protein, receptor binding domain, and the nucleocapsid protein of the SARS-CoV-2 virus, along with the strong cellular responses. In fact, data demonstrating Covaxin's ability to neutralize the UK variant of SARS-CoV-2 was published recently. On the data front on March 3rd, we announced that the Covaxin was found to be 81% effective in an interim analysis of the Phase III clinical trial of nearly 26,000 participants in India. Not only did Covaxin demonstrate a high clinical efficacy trend against COVID-19, but it also showed significant immunogenicity against the rapidly emerging UK variant. and has potential to be effective against other emerging variants, too. The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically-attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The Phase III trial, which is being conducted by Bharat Biotech, will result in the final efficacy analysis at 130 confirmed cases. Currently three EUAs for the other COVID-19 vaccine products in the United States do not authorize use in children under age 16. Covaxin's phase two results cover adolescents ages 12 plus. There are over 16 million children in the US between ages of 12 and 16, and most of them must attend middle school or high school. We are planning to use our existing data to potentially cover this age group in our EUA offering a potential significant immediate benefit to vaccinate children. We will consider initiating US clinical trials of Covaxin in additional patient populations, including pediatric and high-risk studies. Oxygen is in active discussions with the FDA to continue to develop the regulatory pathway for Covaxin vaccine candidate EUA application. Based on our discussions, we are planning to file the EUA application in April on additional efficacy and safety data from Phase III clinical trial. We are also in discussions with BARDA, the Biomedical Advanced Research and Development Authority, regarding their role in procuring medical countermeasures for the Strategic National Stockpile. With regard to manufacturing, under our agreement with Barth Biotech, they will supply the initial doses in the United States upon EUA approval. We are already working with an FDA-approved local CRO to establish release testing of the product for the U.S. market. Overall, we are aiming to make up to 100 million doses available this year to support the U.S. COVID-19 immunization program. We are in discussions with potential U.S. manufacturers and planning to work with Bharat Biotech on technology transfer once the initial doses are supplied. Importantly, Covaxin offers additional benefits for stockpiling, storing, and distribution. Because it will be shipped in a ready-to-use liquid formulation, we'll be able to use existing vaccine supply chain channels. Covaxin has an expected shelf life of up to two years in a normal refrigerator temperature and up to three months at room temperature. In summary, we are excited to collaborate with Park Biotech to develop the Covaxin vaccine candidate for the U.S. market. Our management team, as well as the Vaccine Scientific Advisory Board and highly experienced vaccine advisors we assembled at Ockigen, have a strong relationship with the leadership at Bharat Biotech. This collaboration leverages Ockigen's vaccine expertise and R&D, manufacturing, regulatory, and commercialization capabilities in the United States. Under the terms of the agreement, Ockigen will have the US rights to the vaccine candidate and will be responsible for clinical development regulatory approval, including EUA, and commercialization in the United States, and will retain 45% of the net profits. Now, to shift our discussion to ophthalmology pipeline, we're on track to enter the clinic with our first gene therapy candidate, OQ400. Based on our modified gene therapy platform, which provides the potential to address multiple diseases with one product, we're planning to file an I&D to initiate two Phase 1-2 clinical trials later this year for gene mutation-associated retinal diseases. In February, we announced that the European Commission granted Orphan Medicinal Product designation for RQ400 for retinitis pigmentosa and Leber congenital hemorrhosis, which we believe further supports the potential of our modified gene therapy platform to treat many inherited diseases. Inherited retinal diseases associated with retinitis pigmentosa and Leber congenital hemorrhosis diseases are caused by mutations in over 175 genes. And it is impractical to develop therapies that are specific to each gene. ARQ400, a single product, has potential to treat both RP and LCA, including all mutations associated with 175 genes. On the manufacturing side, for ARQ400, we have completed our 200 liter commercial scale-up process. Finally, the development of our novel biologic program, Occu200, and gene therapy candidate, Occupotent, are both progressing well, and we are on track to be in the clinic for both programs next year. Since October 1st last year, we have raised gross proceeds of around $39 million through offerings of our common stock, and now we have a healthy balance sheet. We plan to continue to raise capital as needed to fund our co-vaccine development and ophthalmology pipeline development. We're also seeking potential funding from the U.S. government for co-vaccine development and supply. We made strong progress during 2020 toward our goals of developing a differentiated vaccine to save lives from COVID-19 and developing gene therapies for blindness diseases. We look forward to continuing our momentum in 2021 with the planned U.S. rollout of Covaxin, as well as filing an IND for RQ400 to move our first gene therapy program into the clinic. I will now turn the call over to Sanjay to provide our year-end 2020 financial update. Sanjay?
spk05: Thank you, Shankar, and good morning, everyone. As Shankar mentioned before, 2020 has been a very eventful year for OxyGyn and broadens our mission to cure blindness diseases and save lives from COVID-19. During 2020, we also took the necessary steps to clean our capital structure and raise capital in a prudent and pragmatic manner. I will now provide an overview of key financial results for 2020. We ended the year with cash, cash equivalents, and restricted cash totaling $24.2 million on December 31, 2020, compared to $7.6 million as of the year end 2019. Since the beginning of this year, we have raised an additional $28 million in gross proceeds, and as of February 28, 2021, we had an estimated $46.6 million of cash, cash equivalents, and restricted cash, extending our runway to over 12 months. Our research and development expenses for the year ended December 31, 2020, were $6.4 million compared to $8.1 million for the year ended December 31, 2019. The decrease was primarily due to the discontinuation of the RQ310 program in 2019, partially offset by an increase of severance related charges in 2020. General and administrative expenses for the year ended December 31, 2020 were $8 million compared to $6.1 million for the year ended December 31, 2019. The increase was primarily driven by an increase in insurance premiums and employee related expenses in 2020. Net loss attributable to common stockholders was $34.4 million or 31 cents net loss per share for the year ended December 31, 2020 compared to a net loss of $20.2 million or $1.46 net loss per share for the year ended December 31, 2019. As you are aware, we have a special meeting of stockholders scheduled to reconvene on April 14 at 11 a.m. Eastern Time. The meeting, originally convened on March 16, was adjourned to this date as we did not receive sufficient votes in favor of the proposal to approve and adopt an amendment to the Certificate of Incorporation to increase the number of authorized shares of common stock from 200 million to 295 million. At the meeting held a few days ago, an overwhelming majority of holders who voted voted in favor of this proposal, but it needs to receive the approval of a majority of our outstanding shares as of the record date in order to be adopted. We need your continued support to get additional votes to approve the proposal. We would like to remind stockholders of the importance of this proposal and request all stockholders on the record date of February 11, 2021, to vote in favor. A decision not to vote has the same effect as a vote against the proposal. The increase in authorized shares is critical for the long-term success of the company. It is important to recruit and retain the key talent needed to advance our business. As we grow as a company, we need to have the ability to access the financial markets quickly and strategically, and having available shares will enable us to do so. Without an increase in our number of authorized shares, we will be unable to execute strategic transactions that would accelerate our progress towards achieving our mission and potentially expanding our scope and influence. Thank you to those who have voted or plan to vote in favor of the proposal. We appreciate your continued support of OccuGen's mission to serve patients. With that, we will open up the call for questions. Operator?
spk03: Ladies and gentlemen, if you'd like to ask a question at this time, please press the star, then the number one key on your touchtone telephone. To withdraw your question, press the pound key. Again, that's star, then one, if you'd like to ask a question at this time. Please stand by while we compile the Q&A roster. Our first question comes from Kay Nakai with Jarden.
spk00: Yes, thanks. Good morning. I wonder if you can tell us to what extent you can the flavor, if you will, of the discussions with the FDA regarding EUA. Obviously, the Phase III data has been presented, you know, top line at least. What more is the agency telling you you need to provide to them?
spk06: It's a good question, Kay. I think, yeah, we're in discussions. We believe we have a regulatory pathway. And we have to get additional data just like other companies. One of them is safety, additional safety after booster dose. And obviously, if you look at the Bharat Biotech, they got two interim analysis and one final analysis. So we believe when we go to the second interim, if safety data is available, adequate data, that should be sufficient to submit the UA, just as other companies have done. So that's where we are with that process. So we are anticipating to get that required data by sometime in April. So that's why we're saying we're targeting UA in April. Okay, great.
spk00: If required to do some additional clinical study evaluation in the U.S., are you currently preparing, at least in terms of a planning exercise of trying to line up an activity like that?
spk06: So, Kay, actually, yeah, based on the, you know, the need for this vaccine and under emergency use authorization, I mean, our team and our advisor, what everybody believes strongly, I think there's a pretty good chance that, you know, we can apply for UA. However, we always prepare for clinical trials, as we outlined, and we are planning to conduct, you know, pediatric clinical trials and additional trials in the high risk. And so that we are already planning.
spk00: Okay, great. Let me ask you one more on the manufacturing side. In order to meet the volume goals that you laid out there, in your discussions with potential CDMOs, are you finding that beyond technical capabilities, that they actually would have the open space to be able to engage with you and Bharat on the technology side and then actually have the capacity to produce in your target volumes this year?
spk06: Yes, good question, Keith. Just as anybody else and all the vaccine suppliers, we're working with the government, and we are having discussions with CMOs in the U.S., and obviously we are making progress on that. And then we'll let the market know when we have these plans finalized. And all the initial doses, as I mentioned before, they're going to come from Barth Biotech upon EUA approval. And for the first leg of the phase transition, we have engaged the US CRO, which is approved by FDA, to do the release testing. So the initial doses will be released under oxygen control, testing done by US FDA-approved lab here in Pennsylvania. So that's already ongoing.
spk00: Right. Okay. Let me get back in queue, but thank you. Thank you.
spk03: Our next question comes from with Ross Capital Partners.
spk02: Good morning, guys. Thanks for the update. Just had two really quick questions. So, you've communicated that the vaccine could have some advantages to COVID-19 vaccines, including easy storage, a secure safety program, and then potentially . utility in a data patient population, inclusive of children. So regarding the children, I think, you know, that sounds exciting. The Biden administration does seem very focused on getting kids back into the classroom. So we're just curious how much data you actually have in children, specifically children age 12 and above, you know, that are enrolled into the phase three study and how important that number will be for negotiations. And then the second part is, regarding that is that we do know that the CDC is getting really worried about the variants, but we're wondering for negotiations, you know, how seriously the FDA will consider preclinical data to kind of guide potential efficacy in .
spk06: Yeah, so I think the line was not very clear, but I think I got it. One is, first question is, you know, 12 plus age group. The second one is related to variance, you know, discussions with the government and, you know, what you're hearing from outside. So we do have data from 12 plus, as I mentioned before, at least 16 plus million kids who are mostly in middle school and high school. They would be, you know, really a target for this vaccine because there is a significant unmet need currently. There is one vaccine which has 16 plus out of the three EUAs, and other two are 18 plus. So this is very important. I think we really have to get the kids into the classroom, just like, you know, Biden administration is stating. And upon approval, you know, we'll be able to deploy those doses. Again, we got tens of millions, as we mentioned, from our contractual obligation with Bharat. They're going to supply. And our goal is to at least, you know, get those kids those vaccinations. with the data we have, if they're able to get the UA. And the second step is on the variants. We did publish the data, our collaborator, on the UK variant. The data looks very promising, and no reduction in nucleosing antibodies. And based on that, we believe, based on how this vaccine is developed, we believe it will be potentially effective against other variants, too. So obviously, when you have a broad vaccine like this, even though there are other suppliers in the US, we believe this will have its advantages and it's much needed in the arsenal. If we need to do additional studies as a booster dose to other vaccines, we'll be happy to do that to get this going. So that in our goal is, if this vaccine can protect and slow down or minimize or prevent wireless gate and control the pandemic, we'll do everything we can, you know, to supply this vaccine.
spk04: Thank you, Shankar.
spk03: Our next question comes from with HC Wainwright.
spk07: Thank you. This is RK from HC Wainwright. Good morning, Shankar and Sanjay. Quite a few of my questions have been asked, answered already, but I have a couple of them. Regarding the phase three data and the complete analysis of the phase three data, do you have an idea when Biotech would be able to release that?
spk06: Yeah. Okay. We are anticipating the next interim to come out sometime in April. and as soon as it comes out as the release, we're going to get all the information and get ready for EUA submission. So we're anticipating that in April.
spk07: Sorry, so in April, that's the next, there's another interim, not the final analysis? Did I get that right?
spk06: Yeah, the final analysis will follow. Again, the second interim, you have to hit a certain number of cases, and the final analysis, when you hit 130, And so they are anticipating some time in April, the second interim, and then based on the infectivity rates and how they are hitting, we'll know more when they're going to be able to hit the final 130 number. But we believe by the time they get the second interim, we should have adequate data on the efficacy as well as safety.
spk07: So does the FDA require final analysis data or what you get in April is sufficient for both the pediatric population, when I say pediatric, 12 and above, as well as the adult population to file for the EUA.
spk06: Yeah, so I think FDA has, once again, the efficacy endpoint is one. We believe with that, you know, with already the first interim look, it looks good. And so if it follows, and we believe it will follow the similar trends, it will look, So that should be sufficient. But on the safety side, there is a requirement. You know, you need to get certain data, specific data beyond booster dose for a certain number of participants in the clinical trial. So we believe by the time they get that, that safety data will be available. That's important. And also, you know, this is getting mass immunizations in India. They already dosed millions of participants through the national immunization program. And any data we can get from that, and we're closely working with our partner, and I think they said the government is supporting them, and we'll be happy to support that and submit that in our package.
spk07: Perfect. And then one last question from me is on the stockpiling part of the conversations. Have you initiated that, or do you need to wait for your EUA to be completed and approved before getting into a discussion regarding stockpiling?
spk06: We are already having discussions with BARDA. So we are in active discussions right now, and then we'll continue those. Perfect. Thank you, gentlemen. Talk to you soon. Thank you, Agathe.
spk07: Thank you, Agathe.
spk03: Our next question comes from Kristen Kluska with Cantor Fitzgerald.
spk01: Hi, everybody. This is a break on for Kristen. I have two questions for you guys. Recent surveys in the U.S. have shown that more than 30% of Americans are choosing not to receive the vaccine once they become eligible for many reasons. Have you and your partner, Bharat, thought about different ways that you could educate the general population in the U.S. on ways that Covaxin differentiates from the other vaccines that are currently on the market, particularly as it relates to safety and mechanism
spk06: Yeah, I mean, we're already, you know, educating and then differentiating. It's a whole variant vaccine. It gives a broad spectrum, humoral as well as cellular responses. And this is made with a similar platform technology that, you know, for decades, you know, polio vaccine has been made. So we will definitely do whatever we can to educate the public on the safety aspects, on the coverage aspects, variant aspects, and also this could be an ideal vaccine for all children. That's really important. So we as a company are willing to do any additional studies we need to do because our goal is really focus on the children, make sure we can really get them back to school and whatever we can contribute to create a close to normal life. And that's really important for us. And we're going to work with FDA and work with the government, whatever we can do to help out. to control this pandemic, we're willing to do.
spk01: Okay. And one more quick one, if I may. I know we've talked a lot about the Phase 3 data and how they kind of interact with the new variants that are kind of coming out. But if you have any other color to add on, you know, the COVAX in the context of these other variants, and have you noticed or has your partner noticed any initial trends in the data having to do with circulating variants that maybe you haven't mentioned? And also, you mentioned kind of around kind of an approximate number of the number of people who have currently been vaccinated with Covaxin in India, are you kind of able to give any more specifics on that total number of people that have been vaccinated at this point?
spk06: Yeah, so coming to the variants, yeah, we have data that published on the UK variant. The data looks good. There's no reduction in neutralizing antibody effect. Again, the way they're conducting these studies, they are conducting really appropriate studies how it should be done, not lab-engineered virus, actually taking the viral strains from the patients who are infected and then conducting the neutralizing antibody studies. So that's appropriate to do it. And so with that respect, they got solid data on UK variant. We're also anticipating data in similar studies from other variants, including Brazil. The Brazil one is important because if you look at the New York recently, there is a mutation, E484K. That is very prevalent in Brazil too. And I think the cases in New York are spreading very rapidly. And there's a pretty significant percentage. I think over 20%, if I saw last week, which has the E484K variant. So we're anticipating data, you know, by the time we get the data from other analysis from Biotech next month. And they're also anticipating variant data. As soon as we get that, we are planning to submit all that information as a part of our EUA.
spk01: Okay. That's really great. Thank you very much.
spk06: Thank you.
spk03: That concludes today's question and answer session. I'd like to turn the call back to Lisa Desenza for closing remarks.
spk04: Thanks to everyone for taking time to join this call this morning. We are dedicated to fulfilling the unmet need of saving lives from COVID-19 and fulfilling patient needs by bringing to market transformative therapies for blindness diseases. We look forward to providing further updates in the coming months. Thank you.
spk03: Thank you. Ladies and gentlemen, this concludes today's conference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.
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