Thank you very much for joining us today from the New York Times building in New York. Earlier this morning, Genomma Lab and Oramed subsidiary, Oravax Medical, announced a landmark agreement for Genomma Lab to develop and commercialize Oravax's oral COVID-19 vaccine candidate, initially in Mexico, to ultimately open the gateways throughout Latin America. Manufacturing will also be assessed. I'm joined by Nadav Kidron, CEO of Oramed Pharmaceuticals and chairman of Oravax, and Rodrigo Herrera, chairman of Genomma Lab, who will discuss key highlights of this announcement.
We will begin the program with a short video about Oravax to give you a better sense of the company and tremendous potential of the partnership. Mr. Kidron will then follow with his remarks. Oravax's oral vaccine technology is based on an oral delivery platform for injectable medications developed by Dr. Miriam Kidron, Oramed CSO, and by Nobel laureate Professor Avram Hershko.
Their technology is now being used for their oral insulin candidate, currently in Phase III trials and has been safely dosed thousands of times. Mr. Kidron will discuss the many benefits of an oral vaccine. Mr. Herrera will then provide a brief overview of the joint venture and will discuss the significant opportunity in Mexico and Latin America, Genomma's role in the success of navigating the regional regulatory environment and the development and rollout this innovative life-saving oral vaccine throughout the region. We will have time for your questions after their opening comments. Please note that today's discussion is being webcast, and it includes forward-looking information. Actual results might differ materially from those projected.
We advise you to refer to the information within our joint press release issued this morning, as well as additional information contained within the SEC filing of Oramed Pharmaceuticals and within the Bolsa filing of Genomma Lab concerning factors that could cause future results to differ from forward-looking information. All related materials can be found on the company's respective websites. Let me take this opportunity to share a brief video that introduces Oravax.
Imagine a world with an oral COVID-19 vaccine. As the world races to vaccinate people against the COVID-19 virus, the effort is hampered by the need to keep vaccines at freezing temperatures and have qualified people administer the shots. Imagine if the shots would be required every year or every six months. What if the vaccine could be taken as a pill in the comfort of your own home? An oral vaccine could help quickly vaccinate the most vulnerable and people in remote areas. Oravax, a company based on Oramed Pharmaceuticals' patented oral delivery technology, is developing an oral COVID-19 vaccine.
Oravax's vaccine in development, should it be approved, would not have to be kept at below freezing temperatures and would not have to be administered at central locations. An oral vaccine that could pave the way to a pandemic free world.
Thank you, Barbara, and good morning to everyone and thank you for joining us today. I really think we have something to celebrate here. We started talking with Genomma Lab, I think quite maybe two or three months ago, and we reached this day after a tremendous amount of work. I really want to start off by really thanking the teams from the Oramed side, who put tremendous amount of effort into it, and also from the Genomma side. This is a very important and complex deal to achieve. We felt right from the beginning that there is a strong synergy and chemistry between the companies and between the people who manage those companies. We are really excited today because we are implementing the strategy that we set for Oravax.
As we said previously, what we wanna do is we wanna get the oral vaccine approved ASAP. We want to get to Emergency Use Authorization, and we wanna start with the developing countries. While we work with the United States and other countries where the oral vaccine can serve as a booster, what we're doing here today is we are going into Mexico and potentially into the rest of Latin America in order to enable us to get it approved as soon as possible and to help potentially close to 700 million people who can really enjoy the advantages of the oral vaccine. Why is oral vaccine so interesting? Why is it such a game changer? Think about the oral vaccine. The oral vaccine means that it's easier to take it. Compliance is going to be higher.
The oral vaccine means that you don't need a professional to administer it. Logistically, it's much easier. It doesn't have to be part of the cold chain. A country will want to distribute it to its citizens. Much easier job to get done. Not only that, with the oral vaccine, because we take it orally, there should be less side effects, which again, will help a lot of people take it. Last but not least, the reason that Oravax oral vaccine is so exciting, it's because that this vaccine is made out of three proteins. The idea that we can introduce a vaccine that not only taking the S spike, but also the E and the M, means that we have the potential to have a vaccine that will be good against the variants.
As we look around us and we see what's going on around the world.
We're extremely excited to bring this opportunity that can really help not only hundreds of millions, but potentially billions of people around the world to go back to normal life, to go back to the days of before the COVID-19 if we're gonna do our mission right and we're gonna get it into the right place as soon as possible. I really wanna take this opportunity, and I wanna thank Rodrigo, that it's been such a pleasure working together, sharing the vision, and I have no doubt that the two companies will continue working and trying to do a lot of good things to make this world a better place.
Thank you. Before we turn the conversation over to Rodrigo Herrera, we'd like to turn to a short video on Genomma Lab.
I wanna start by thank you all the team in Oramed and Oravax. At Premas Biotech, Mr. Nadav Kidron, it's a pleasure. It has been a pleasure to make this deal happen. Also Dr. Prabuddha Kundu, and of course, Dr. Miriam Kidron and Professor Avram Hershko, 2004 Nobel Prize winner for this amazing technology which makes this partnership possible. I also want to thank Genomma Lab, investors and analysts that have placed their trust in us. I like to thank our team also which has done an intense work to make this venue possible. Finally, I want to thank all the media companies that are here today covering this event. This strategic alliance continues with our mission to empower people to have amazing health and wellness.
This vaccine technology makes the distribution easy in the geography of our countries, and it doesn't require cold chain, something that has been proven very difficult in the geographies of most of the countries in Latin America. This is very relevant because there are very poor and vulnerable communities that they need access to health, that they need access to this vaccine. Thanks to this incredible pharmaceutical breakthrough after clinical trials and authorization for emergency use, it could allow us to accomplish this goal. We as Mexican and as a Latin America company could be, in our countries, the first adopters for this technology. We still have a lot of work ahead of us. We know as a population that we need to finish vaccinating our communities, and after that, we will require boosters to keep our immunity strong.
The Mexican authorities, as well as many other Latin American authorities, have done a great effort, a great job trying to get in line to get the vaccines. Sometimes after a long line, they have been suffering and struggling to get the vaccines to their citizens. I think it's very important that with this alliance of Oravax and Genomma Lab, capabilities of commercialization and regulatory expertise, we're gonna be able to bring this vaccine first to Mexico and to Latin America. This is a really big deal, and I want to put this into a perspective. It was a team that includes a Nobel Prize winner that were able to put a vaccine into a pill, and on top of that, with no cold chain required.
This really is a big deal and also is very important that for the first time, Mexico and Latin America, we could be the first ones to have this technology available. Now, let me turn it over to a video that describes this technology.
The COVID-19 pandemic triggered the evolution of next-generation vaccine technologies. Current COVID-19 vaccines are hampered by virus mutations, the speed at which such vaccines can be produced and distributed, storage requirements, and administration. Oravax Medical has developed an oral triple antigen vaccine for COVID-19 that could overcome these challenges. The SARS-CoV-2 virus, which causes COVID-19, has four structural components, the spike protein, a nucleoprotein, the membrane protein, and the envelope protein. Since the SARS-CoV-2 virus uses its spike protein to bind with the ACE2 receptor, any antibodies generated against the receptor binding domain of the spike protein will make the virus ineffective. This is why most COVID-19 vaccine candidates only target the spike protein. The challenge, however, is that the spike protein is known to mutate. With said mutation, current vaccines could lose their protection.
Oravax's vaccine candidate is a virus-like particle, VLP, that targets not one, but three structural proteins, spike, membrane, and envelope. Since membrane and envelope proteins are not known to mutate, this should serve as an improved candidate for protection of SARS-CoV-2. The Oravax technology integrates a novel approach to vaccines from Premas Biotech based on its D-Crypt technology with an oral delivery platform from Oramed Pharmaceuticals based on its proprietary protein oral delivery, POD delivery technology. Oravax's VLP vaccine candidate is encapsulated and formulated to protect the vaccine via a highly protective capsule coating that remains intact in the most acidic segments of the GI, along with specialized protease inhibitors, which enables the vaccine's oral delivery. An oral COVID-19 vaccine should eliminate the major barriers to rapid, wide-scale distribution, potentially even enabling people to take the vaccine at home.
The oral administration is also expected to improve vaccine efficacy and reduce the burden on the healthcare system. In an in vivo study, Oravax's oral vaccine candidate triggered an immune response promoting systemic immunity through immunoglobulin G and Immunoglobulin A. Results from human trials are expected soon.
It's important to outline that Mexico just became a member of the ICH. With this, Mexico becomes more a strategic destination to carry out medical trials, eliminating the need to duplicate tests carried out during the research and development of new drugs. Barbara.
With that, at this point, we'd like to turn the conversation over to your Q&A.
We have a question from Jim Martin. Can you give some color on the JV itself?
Thank you, Jim, for the question. The JV is structured in the following manner. Oravax will support Genomma Lab with the technology for the oral vaccine. Genomma Lab is going to run through the process of getting it approved under Emergency Use Authorization in Mexico. Ideally then, we hope we can also get a deal done, but there's still time until we get to that. The Genomma responsibility will be to take it all the way for the approval.
Oravax will support it all the way. Beyond that, we announced it in the press release. Oravax is going to enjoy the capabilities, the contacts, the understanding of Genomma Lab in Latin America in order to open the doors for more countries in South America. We're starting with Mexico, but the idea is really to go way beyond that. On top of that, we also announced that, when we're gonna do a next raise for Oravax, Genomma Lab wants to be a partner in that as well and to have some equity in Oravax. Once that happens, Genomma Lab will also participate in that.
Also the other thing that we're doing as part of this deal is that the two sides, and this one is coming from Oramed and not from Oravax, but in order to align the interest and to deepen the connection and the relationship between Oramed and Genomma, we're actually gonna do a relatively small but a symbolic share swap. Each company will invest in the other company. When Genomma Lab enjoys Mexico and South America, Oramed enjoys it, and vice versa. We're really looking forward to this partnership because it opens the gate for many, many more possibilities for Oramed, Oravax, and our shareholders.
We have a question from Alvaro Garcia, BTG Pactual. Is this agreement exclusive to the COVID-19 vaccine or does it include potential distribution of diabetes-related oral technology?
Thank you, Alvaro, for the question. By now it only includes the COVID-19 vaccine. We haven't get farther in the discussions of the other technologies that Oramed has that are very exciting, but probably in time we'll see after the results what are the possibilities that we can do together in the future.
Question from Lewis Willard. Thank you for the opportunity and congratulations on the announcement. Certainly, COVID has become humanity's ultimate test. Certainly projects like this are much appreciated, so thank you. Now on to the question. Number 1, right now some governments have established proof of vaccination for people to enter the countries. Do you see this oral vaccine to be approved as a means that can really substitute the shots, or are you thinking more along the lines of a booster?
Thank you for the question, and thank you for the introduction to the question. The idea is really to go in two parallel tracks. Number one, people who haven't been vaccinated, we believe that this is going to be the best vaccine. You take a pill, you're vaccinated, and your government, once approved in the specific region, should give you the approval. You can travel, you can do anything, you are vaccinated. I wanna re-emphasize it. Because it's made out of three proteins, this has the potential to be better against the variants. This really has the potential to be a better vaccine than anything available today on the market. We anticipate and hope, and we're gonna work very hard to make sure that the governments that will approve it will obviously treat it accordingly.
Parallel to that, people who have been vaccinated, but by some of the existing vaccines, will be able to take it as a booster, and we believe it should be the preferable booster. We are working towards both areas, Mexico, United States, and other places. At the end of the day, anybody who needs to get vaccinated, the choice for him will be to take the Oravax vaccine.
Question from Vanessa, from Credit Suisse. What additional investments will be needed in addition to the share swap? Did Oramed sign similar JVs for distribution in other parts of the world? Is there an expected timing for the distribution of the vaccine? What happens in a scenario that the vaccine is not approved in the expected timeline?
Okay, maybe I'll answer some of it, and maybe, Rodrigo, you can talk more specifically about the timeline in Mexico. Regarding additional channels, yes, Oravax is currently engaged in discussions about doing deals in a few other territories. The world has 7-8 billion people, and we believe that this is something that will be needed by basically everybody who lives on the planet. The advantage of the oral vaccine is that it's much easier logistically to get it to different parts of Earth, and also it's easier to administer it because you don't need a professional to give you the injection, but you can literally take it with cup of water or without. This is as far as the strategy, and I really hope that more of those discussions will mature into firm agreements.
Obviously, as soon as we have something substantial, we are going to report that. As far as additional investments, right now, Oramed has got a very good balance sheet. There's no immediate need. We are in discussions with potential partners for manufacturing and so on and so forth. We wanna do our best that once it's approved, once we see that it works, then we are in a position that we can meet to the best that we can the demand that we foresee that will come to this. Now I'll ask Rodrigo to really refer on the
timeline and the Mexican procedure.
Yes. Regarding the timeline, we have spoke with the Mexican authorities. They are really eager to begin with these trials. We are filling everything that is needed to expedite the authorization for emergency use. We're gonna have a clear path and a clear timeline in the next couple of months. We are very optimistic about the time that this can be approved.
We have a question from Rodrigo Alcántara from UBS. Can you comment a little bit on the economics of the vaccine? What is the cost per dose, the expected price to the market? To understand the technology, can you please comment about your other oral clinical programs, specifically the insulin, the oral insulin?
Maybe Rodrigo from Rodrigo, you should start, but then I'm happy to take the second question.
This is very important. The main goal that we are looking for is accessibility. We want to make a vaccine that is easy to get to the different communities in our region. We want to get a vaccine that is also affordable. We need to. When we talk about affordable, we need to mention all the costs that are related to a regular vaccination. There is the syringes, the expertise of the people that need to put it, the cold chain. Taking all of those factors into consideration, the economics and the cost is gonna be significantly lower than what is currently costing all of this infrastructure together and combined.
Just to answer the second part. The technology, the POD technology that Oramed has developed, it's basically been since the beginning of Oramed. Right now we're at the later part of a Phase III on oral insulin under the FDA in the United States, Europe and Israel. This technology has been established. The POD technology to deliver peptides orally has been established. Premas Biotech, which is one of the leading biotech firms out of India, developed this VLP that's made out of the three proteins. We combined the technology, and we saw that it works and give us a synergistic effect. That's why we so much excited about it. Oramed has got other things in its pipeline, oral insulin, oral GLP-1 analog and so on and so forth.
How would you compare or contrast the oral pill versus mRNA injected vaccines on efficacy, durability, coverage versus mutants? This was a question from James Molloy.
Thank you, Jim, for the question. I can tell you what we believe, but you have to remember that unlike the Pfizer and Moderna are already in the market, and we're seeing the good and not so good. This one is now starting to go into actual clinical trials. The main difference is that the available mRNA vaccines are only working on the S spike. The S spike is the part of the virus that is most likely to get mutated. By us getting the three proteins, we can really provide a better solution against the variants. But more than that I know a lot of people who don't wanna get vaccinated, got vaccinated, and they felt so bad afterwards.
survey that was made in the United States, I read that spoke about 90 million Americans that wouldn't take a vaccine in an injection form but will take it orally. The oral will give us a higher level of compliance, which will beneficial for anybody here who's living on Earth. It will give us, hopefully, a better protection and with less side effects. That's why I was so happy to find Rodrigo as a partner, who shares the vision that we're really here to try and bring it to the market as soon as possible, because this is something that can really help us accelerate the ability of humanity to deal better with the COVID-19 issue.
We have a question from Areli Villeda. Says, congratulations on the deal. She has three questions. First, she would like to know if the developments of the project in Mexico requires an additional amount of CapEx. That's the first one. The second one, do you have a timeline expected to obtain the approval in Mexico? The third one is, with this deal, in a certain way, are you gonna start using the capacity of the pharma manufacturing facility?
Okay. Well, let me answer those questions. First, I'm gonna start with the third question. Yes, we believe that we're gonna be using some of the capability of the new manufacturing facility. We might need rather some partners in the manufacturing process. We can also manufacture the API abroad and then import it into Mexico and finish the process of the manufacturing in Mexico. At this moment, we don't know exactly what is going to be the volume, and because of that, we don't know if it's going to be the CapEx. Although it's important to mention that we have a huge capability in place right now, so we can respond very rapidly to any needs of manufacturing in terms of volume.
With this question, we'll wrap up the Q&A. Question comes from Jorge Mauro. The agreement between Genomma and Oravax, is that only for distribution or the full profit of manufacturing plus distribution in the JV territories?
Yes, the JV, it's for all the profits. We're splitting 50-50 all the profits for the manufacturing, for the distribution. It's a very transparent joint venture. It's 50-50.
At this point, we have no further time for questions, but please reach out to our company's respective IR contact to follow up.