GeoVax Labs, Inc. (GOVX) Earnings Call Transcript & Summary

Good morning, everyone. This is John Heerdink. I'm the Managing Member of Tribe Public, a platform that enables investors to gain direct corporate access to leaders of companies that they care about and about through our in-person, lunch and dinner events across the U.S. now in 34 event sites. And in addition to that, as we started during the last epidemic COVID that we all remember all too well. We started doing this webinar format. And now we're reaching over 30 countries as well. And we've added a few during with the invite that we put out in the press release in regards to today's program, which is titled Now Is Not the Time to Monkey Pox Around. It's featuring GeoVax Labs, CEO, David Dodd. GeoVax, of course, trades under the symbol GOVX on the NASDAQ. And we're also targeting for about a 30-minute session today that will include Q&A that many of the Tribe members have sent in already. And if you feel sort of cline and something comes to mind, we'll try to get it answered any additional questions if you send it through the Zoom chat feature. I have to give -- point you to a couple of disclaimers as I'm an investor as well at our Tribe Public website, please review that. And then also note that I'm an investment adviser at Vista Partners. The website there is vistapglobal.com. Again, the Tribe Public website is tribepublic.com, Vista Partner's website is vistapglobal.com, please review the disclaimers at that side as well. Note if you -- whatever if you want to review this event, we're going to be recording this. And we'll be publishing the video at our Tribe Public YouTube channel, you can do it easily you search it Tribe Public LLC and find it pretty easily. And we'll add to your e-mail to the list, and as a reminder out here for this video and also regards to other events in the future. Today's -- against our co-host is named David Dodd, who's the CEO of GeoVax Labs. It's a biotechnology company developing immunotherapies of vaccines against cancers and infectious disease. So David, if you don't mind, say hello today, and then also pull up your presentation, and let's get started.

Good. Thank you, John, and it's a pleasure to have this opportunity to present and address any questions that members of the Tribe may have. So again, thank you, everyone, wherever you might be seated at this point in time. So let me pull up this presentation. All right. Thank you. I'm going to now move through, and we do again welcome any questions that you may have. So as John mentioned, we are a clinical stage company Phase II, we'll touch on a little bit, but we're going to focus certainly on the Mpox situation and what GeoVax is doing within that critical area of need right now. But we're focused on developing vaccines against some of the most threatening infectious diseases worldwide as well as cancer therapies, specifically against solid tumors. And I don't just touch on that the business -- so the business model that we try to focus on and whatever we do and consider is to be innovative. We have a very strong patent portfolio across 24 different families. We hold worldwide rights for every product we've developed. We look for business partnerships, obviously. We want to differentiate. So we're really focused on populations that are either underserved or unserved by existing standard of care or products. And in doing that, we believe that we have the opportunity to pursue expedited registration pathways. And that's what we're looking to. We -- our business plan is to register all the products -- with every product we develop on a global basis have those been distributed, administered, et cetera, and supported by the partners that we'll have as we continue to build and build our business. And that then focuses obviously on collaboration. Just a little bit about me, and you can look at -- look up on other things. I'll just mention, I've been in the industry obviously many years. You just have red hair, just so if you're wondering. But what's more relevant, I think, and what I'm very proud of is that I've had the opportunity to work with some outstanding teams throughout my career and also to have the opportunity to work and interact with some tremendous mentor. So people who have been senior leaders in the pharmaceutical biotech industry and it's provided the unique opportunities to learn from them, to model act with them, and I greatly appreciate both those with whom I've worked as well as the people under whom I've serve. As -- where -- what if I've been able to accomplish, well I've been proud and honored to have been involved with in a leadership position as either a Managing Director or a CEO, et cetera, the approval of over 10 NDAs or BLAs participated and led over 15 acquisitions or divestitures and also have worked in excess of $2.5 billion in financial transactions -- deals that we've done with others. Some have been acquisitions others have been divestitures. But also have presided over the activities of working with outstanding CFOs, such as today as well as banking relationships, et cetera that have resulted in over $5 billion in incremental enterprise value growth of those entities in which I've had the opportunity to serve. So a little -- that's a little bit of a background. But let's go into what's probably a greater interest, is just [indiscernible] a little over a week ago now, not much more than a week ago, we have the WHO do a declaration basically a global health emergency declaration on August of 14. So that was Wednesday a week ago, the declaring a public health emergency of what is known as International Concern. This is a formal process. It opens up that from the WHO standpoint, there can be a release of funds. They can then -- they have stepped into the -- it's our facilitated role on a global basis, but also interacting with agencies or entities that might be able to provide funding. WHO does not fund companies that are in the process of developing or moving products forward or being able to increase their production capability. That's up to other types of entities, but they play a very strong facilitative role and want such a declaration has been issued by via Director General, then this all then starts coming into play. It's a bureaucratic, but a very important bureaucratic step forward. So what is the big deal with Mpox? Well, we just talked about the declaration. It's different as you'll see in a minute from what occurred 2 years ago. It's a different member of the family, that's referred to as a clade or you think of it, we -- most of the think of it as a strain, but C-L-A-D-E. We're dealing now with Clade 1. It's more virulent. It has a higher mortality rate than Clade 2, which is what we were dealing with 2 years ago. We're going to touch on that. The current Clade 1 is also spread by both flows contact through sex, but it can also be contagious through just casual contact bedding sheets, pillows, those types of things. Clothing, the people might share. That wasn't the case 2 years ago. So what is the big deal? How do you deal with it? Well, vaccination. That is the critical step to reduce morbidity and the threat of mortality. There's been a therapeutic that has been out there, but also on the 14th, I believe it will -- was or maybe it was the 15, but it was last week, it was announced that, that vaccine had missed its primary endpoint in a critically important fit -- clinical trial, the NIH and other entities have sponsored. So we're really focused back on vaccination. Now most of what has been occurring has initially certainly was centered in Africa, but it's now spreading as we've heard. It's now been announced in Wayne County, Michigan, it's spread into Europe. So there's a worldwide need for significant resources, not only the medical care, but vaccine supply, distribution and administration. Having vaccines standing around are useless, they have to be to -- get to the people who need them and be administered to those people. And sometimes in certain locales specifically in African nations and all, they can sit around, and they don't get to the people, the manner in which they should. It's a ugly disease. If you have COVID-19, you pretty much don't see anything. But when you think about it, Mpox, which is very related to Smallpox, creates this [indiscernible] scarring and it will last -- the scarring will last a lifetime. I have friends in certain -- from certain regions of the world that when they were young, they had Mpox, and they still bear the scars today. So it can have severe symptoms, it can lead to mortality. It's an ugly frightening disease, and it will leave someone scarred for life, it's much worse or the Smallpox, Mpox scars and chickenpox, some of us have children who still bear some scars on their arms, right, from when they had chickenpox, this is much more severe. So let's talk about Africa. As of several days ago, 17,000 were impacted not almost all of them in the Democratic Republic of the Congo, although it's been spread. What is different than what we saw 2 years ago is that 70%, almost 3/4 are children. Now why is that? Well, that's because the children today have not received the smallpox vaccination, which is the same vaccine it's utilized for Mpox that many of us such as myself received when we were children in elementary school. We lined up. We have the scars on our shoulder and all, and that's long lasting. And yet most of the children today in the adolescents and teenage are certainly and some young adult have never been inoculated or vaccinated against smallpox, which is the same as being vaccinated against Mpox. And so there's a high risk there. The critical need in Africa, as the Director General of the Africa CDC announced it last week or week before last is they need 20 million doses of the vaccine, but unfortunately, the maximum that will probably be added incrementally is around 2 million doses likely additionally to be available by the end of 2025. What is one of the biggest challenges and one of the most critical issues we're dealing with is there is a single supplier worldwide has a monopoly on supplying the Mpox/Smallpox vaccine, and they have defined limited production capability, and that capability based upon the production method that they utilize cannot be rapidly expand in producing batches and new lots of the vaccine take a significant amount of time up to 6 months at a time. So the question is that Africa, the DRC WHO is focused on, and they've issued formal requests for information to which our company GeoVax are responded last weekend, and we've been on the phone with WHO multiple hours as well as Africa CDC, and we'll touch on that in a minute, is are there other suppliers or potential suppliers that can move somewhat quickly to go forward. And we're going to talk about what does that mean and who might they be? But just to be able to take care of what is going on now, not the vaccine, but to provide medical care and support in Africa alone, they're stating that they need $4 billion. That's the type of funding that they hope to receive and support from a WHO. The issue of getting more product to where it's needed. And not only in Africa but throughout Europe because we've had -- we've seen evidence in Sweden, that's going to spread throughout Europe. Yesterday, I was talking to one of our congressional representatives out of California. He's very concerned and alarmed about this, and I made the comments just a matter of time before we have an announcement about the U.S., and I was interrupted because it just crossed the wire about Wayne County, Michigan. So this thing is fluid. It's migrating far beyond Africa, and it's very threatening. So these are the countries in Africa. This was -- is outdated because I don't have the U.S., Thailand, which now has its first case is not on here. So this is moving. And what we're talking about today is Clade 1 or Clade 1b versus the Clade 2 that we dealt with 2 years ago. So what's the difference? Well, the difference is that the current one is endemic to Central Africa. Previously, it was focused on West Africa, okay? That's where it is. The most common stream is this Clade 1. Clade 2 is a less infectious strain. It also has lower mortality. What we're seeing right now in Africa is 400 new cases per week with the majority of about 70% being children, much more virulent, much more deadly. And certainly, we can remove the question marks on migrating. So what we saw 2 years ago, which basically was the spring of 2022 and dissipated in the fall of 2022 is not what we're dealing with today. If you think about it and you're familiar with SARS-CoV-2, which leads to COVID-19. In 2003, there was a major breakout throughout parts of the world of SARS. That was the first time and it ended up and some people start trying to work on vaccines, et cetera, they were funded, but then it dissipated. It did not keep spreading, and the funding dried up and so there was no further work towards that type of virus. Until we suddenly were hit with it almost 16, 17 years later, and we all know what we went through starting in January of 2020, and how we hit it. So what we have to do is think about longer term, not only with SARS-CoV-2 or coronavirus, but also other infectious threats, especially this poxvirus such as Mpox. So available tools that we have. Well, ACAM2000 is the historical smallpox vaccine. It was designed for Smallpox. It's the one that many of us received as children. It's also affected for Mpox. It's based on a live virus, but it's not a weakened or attenuated live virus. So that's important to know, because that means it's contraindicated in certain populations. It replicates in humans, which means that it could be a challenge. It's contraindicated in pregnant women, in immunocompromised and other populations of humans. And because of its side effects, it is not recommended except as a last chance. And that's what was out there. What is out being utilized today and what is in the strategic national stockpile for the United States government, primarily and initially against Smallpox, but it's the same vaccine is a newer version is called MVA-BN that stands for the single source provider out of the small company out of Denmark, Bavarian Nordic. It goes by different trade names in parts of the world. In the U.S. is called Jynneos with J-Y-N-N-E-O-S. But is MVA-BN is the name of the vaccine. It's a weakened live virus. It does not replicate in humans, but it's safe. Therefore, in immunocompromised patients, pregnant women those different populations for which we can't, which is why ACAM2000 is really not utilized unless there's nothing else. It's better tolerated, much less side effects and -- but the challenge with it is, it utilizes a very challenging manufacturing process. And the solution to the current situation and ongoing is, first of all, everything is being coordinated by WHO, including the interactions with Africa CDC, they have formally requested and seeking, are there other companies who can provide Mpox vaccine. So what does it mean to be a candidate. First of all, you need to be experienced with the technology and the basis of that vaccine. And that's what MVA stands for. It stands for Modified Vaccinia Ankara that modified is critically important because that's the difference between the old ACAM2000, which is a vaccinia-based vaccine, just a typical vaccinia base, which is contraindicated in various populations, it replicates in humans, which means it could be threatening. It has some significant side effects. MVA does not replicate in humans. It is not contraindicated in those populations, and it can be utilized widely because it's extremely safe, because it doesn't replicate in humans. The challenge is that MVA is produced in a very slow cumbersome process. It requires being a manufacturing facility to be relatively close to where certain specialty bread chickens or house, those eggs then are delivered to the manufacturer, the eggs are inoculated with the virus, the MVA virus which then grows cells, which then have to be extracted. They have to go through a complicated multiple-month process than basically purified before you're able to then move forward with the final vaccine. And that's not done in many places around the world. So there is one single supplier that has the bricks-and-mortar structure to do that, and they're based in Denmark. But what in Africa, they're seeking because they need to have local based manufacturing that does not exist anywhere on the African continent for MVA. It doesn't exist throughout the United States, throughout widely parts of Europe, they say there's a single source monopolistic supplier. The critical need to create a vaccine to be able to go forward would be if there is another company that has a good manufacturing practice, or cGMP for current GMP master seed virus of MVA available. That is the critical hurdle to be able to move forward to manufacturing. It's not simply done. And then also, is there any opportunity to move to a more advanced manufacturing process of MVA to be able to produce product owned on a real-time basis not only stockpiling basis because today, it takes a while to manufacture it. They build up the stockpile. Then when we have an outbreak, we deplete the stockpile even though the stockpile is initially developed to provide protection against a bioterrorism threat of smallpox. That's why the stockpile was created. In 2022, we depleted the U.S. government strategic national stockpile down to less than 10,000 doses remaining because everything had to be diverted to the need worldwide of that outbreak of Mpox, and that was not near for virulent as what we're dealing with today. So what we're going to talk about now is what is the solution. And I'll just give you a heads up as part of that could very likely be GeoVax, because GeoVax, again, we recognized 2 years ago that it was a single supplier worldwide unable to meet demand, everything was built upon doing a filling of the stockpile, which the U.S. government has funded over the last several decades, they funded this company that company in excess of $2 billion and then another several billion actually buying product. We looked at that. We are experts as a company using this technology MVA. It is the basis for every infectious disease vaccine that we've developed and that we utilize. Our current COVID-19 vaccine candidate, which recently received an award valued at over $400 million by the U.S. Federal Government by BARDA for a very large Phase IIb trial to go forward with a vaccine that would be a next generation that would give broader protection, fast and greater durability, longer-lasting, et cetera. That is based on MVA. Our vaccine for Zika virus based on MVA that we developed and tested through nonhuman primate. Same thing with our hemorrhagic fevers with the [indiscernible], Ebola, the Sudani Ebola and the marker. So we're experts are utilizing MVA. Following the 2022 outbreak, we acquired the rights of the U.S. NIH MVA with the rights to be able to, on a global basis to develop, manufacture and commercialize our own MVA, which we refer to as GEO-MVA as opposed to the MVA-BN, GEO representing GeoVax. We anticipate being the first U.S.-based supplier of a vaccine, basically MVA which will be utilized both in stockpiling, but also, we'll talk in a minute about our advanced manufacturing. We have completed the production of a cGMP master C virus, which was -- has ended up being very valuable because we're now in discussion to be able to move that forward. We're evaluating options to accelerate our manufacturing. We have an established manufacturing partner that's an expert in manufacturing MVA. They've been in front of various regulatory authorities, both in the U.S. as well as throughout Europe. We're in dialogue with the various stakeholders worldwide such as WHO, Africa CDC, the DRC and others also funding agencies to be able to accelerate. We've been given a rather clear regulatory guidance or guidance on the regulatory path under both the emergency use licensing pathway as well as others. And we announced over the last 1.5 years that we had validated the basis of a -- of an advanced manufacturing process that will not require dependents on these special chickens and their eggs that will be based on a cell line that's derived front, in our case, from ducks because remember, if it's a -- you want it to be nonreplicable in humans, you need something that is different. And so what MVA utilizes since it uses chicken eggs, it uses fowl or avians. So we have evaluated every avian cell line that exists in the United States that as a candidate. There are about 4 of them. We tested all of them. We compare them to the -- our traditional method, we were able to validate a tenfold increase in the production of MVA in that manner, and it would also enable you to produce much faster and at a lower cost. That process is not in process today, but we're in a transition to it. And with the current outbreak, all of this has become discussions that we're having, as you might imagine with others. So that's really where we are, and we're going to touch on that and what it means to us and potential need and opportunity. But the priority programs as a company that we have is, as I mentioned earlier, we announced in June that we have received an award from BARDA for a next-generation COVID-19 vaccine. They specifically look at our vaccine as having the potential based on our existing Phase II clinical data of the 3 trials in which it's in and has been in for the last couple of years, that it is indicating that it provides cross variant protection, meaning you don't have to reconfigure it every time there's a new strain or a new variant, which isn't the case with the first generation. The MRAs have to keep being reconfigured. You just heard the announcement; I think it was yesterday about the new variation of theirs from the FDA. But ours has shown protective immunity from the Wuhan all the way through the Omicron XBB.1.5. Also, it lasts longer from what we're seeing. The current first-generation vaccines tend to last maybe 2 to 6 months, leading and resulting in a continuum of boosters that frustrates people and they quit taking them. Thus far, our data is demonstrating 8 to 12 months. So that's a major program of our -- we'll be initiating that program in Q2 of next year. We already have over 80% of the targeted 100 sites already confirmed. So we're moving very fast with that. We also have what we've been talking about, our Mpox and Smallpox vaccine, which may, and we may find is on even a faster pace than what we had anticipated because of the current outbreak. And then what I'm not going to talk about today, but we recently announced our plans to go forward with a Phase II trial is our Gedeptin technology, which is utilized addressing solid tumors. It's a therapy for that. We recently completed the second clinical trial that was funded -- this one was funded by the FDA under the orphan drug clinical trials program for patients with advanced head and neck cancer. We'll be initiating hopefully, by the end of first half of Q2 next year, a Phase II trial looking at the first recurrence head and neck cancer patients of Gedeptin in conjunction with an immune checkpoint inhibitors. I'm not going to say much more about anything other than the Mpox at this stage. But I just want to give you some insight. What would all this mean to our shareholders, to our company? What is the medical need is out there that if we look at our next-generation COVID-19 vaccine, focusing on immunocompromised patients as well as utilizing as a better booster on top of everyone, which is most people in the world who've been vaccinated with mRNA, that's a $30 billion opportunity. It doesn't mean that's a forecast, but that's the value of it. If we look at what we're talking about on Mpox as well as the stockpile that is for Smallpox/Mpox, then that's over $10 billion on an annual basis. We look at the depth, you can see there, that's another almost $15 billion in opportunity when we look at just head and neck cancer alone, not even mentioning or looking at other solid tumors. So the space in which we currently are working and we're driving in current clinical trials or, in this case, with an accelerated pathway minimal clinical work to move through production with our Mpox vaccine. We're talking about approximately $55 billion in global market opportunity. Obviously, being successful in any of those, we'd be very proud of, but there's significant value there. And then lastly, you may be wondering about our financial information we had reported at the end of Q2, $1.6 million. With all the noise we've experienced in the stock support and activity over the last a little over a week, we traded in 6 trading days since the announcement from -- by WHO, we traded over 200 million shares. We were able to raise additional money. So we now have been able to add from financings in Q3, $12.6 million on a gross basis. We hold no debt. The BARDA award, if you add the $24.3 million it goes up to $45 million that's direct to the company in support of our manufacturing and our work with regulatory issues then to fund our clinical trial. It's another $343 million, which is funded directly to our CRO, which we've announced as Allucent. So we work with them it just was -- it was -- we were pleased that they were selected by BARDA as our CRO because they have been the CRO with whom we've worked on our existing Phase II trials for COVID-19 as well as our Gedeptin trial. But in total there, you can see that's approximately $367 million. If you consider that, that $24.3 million has been agreed upon that it could expand depending on our need up to $45 million. It's up to $388 million, so close to $400 million. Our capital structure, at least as of yesterday, it was 7.5 million common shares outstanding, a 5.6 million dilutive securities at average exercise price of $5.85. So with that, I will hesitate and turn it back to John to go to the questions you may have. John?

Yes, absolutely. Fascinating, David. Thanks for presenting to us today. I know it's on many of our minds across the world and by the judge this very significant problem we got for today's webinar, it's clear that people are interested in what you're doing and wanting to know we'd be prepared for monkeypox. Here's a few questions here. I'll just go right into. First one is in no certain order. Why is that -- and I think you touched on this, why is there only a single source supplier worldwide for Mpox vaccine?

There's probably a couple of reasons why, in my view. First of all, MVA, as I mentioned, the core technology, which is also the vaccine. So it's interesting, but what is a vaccine. It was developed to eradicate the world of smallpox because it had to be modified from vaccinia had ended up being repurposed and it's a very good platform. And that's why we have it for all these other products. So that was one. But remember that the key -- the frustration working with MVA is that it is a very -- it has a lot of nice attributes. It doesn't require being frozen state, which is what mRNA does and traditional vaccine things, it can actually be freeze, drive or lyophilized you can add additional elements into it or antigens. It's not just the single antigen like the first-generation vaccines for COVID-19, ours is a multi-antigen. Well, so it has a lot of wonderful attribute. The challenge is that the manufacturing does not enable you, the traditional manufacturing to respond to epidemic or pandemic. So it's relegated to use for either stockpiling needs, which is what it's been used for or niche markets, ones that aren't that huge or that urgent. And so that's why it was done that. And so traditionally, it's been a very good technology to utilize, I'll call it, in university type settings for gaining understanding of potential vaccines. But other than Bavarian Nordic, and they received their MVA from this German Health Institute, which is similar to how we receive ours from NIH. And so the challenge has always been how do you overcome the manufacturing deficiency. And frankly, Bavarian Nordic is focused on the traditional manufacturing process. Approximately 4 years ago, we looked at the situation, and this was before the outbreak in '22, but we wanted to be able to respond to situations working with CEPI, with Gavi and others all these more real-time urgent ones that might come up. The only way to do that was either to figure out, can you develop a way to manufacture an MVA-based vaccine with a cell line rather than using these special cells, or do you end up focusing and I'm just saying, we'll just do niche markets and stockpiling or do you bringing in new technology? We chose to evaluate all, but we focus very heavily on looking at the avian cell lines, and that's why we think we're going to be a game changer with the new manufacturing and also that there will be others then that will follow our lead and move forward with continues cell line manufacturing. So the reason was twofold. One, there was only one company that decided to utilize that technology to any degree. And then secondly, because that happened to be the vaccine that needed to prevent for bioterrorism then at the time, GeoVax was just focused on a single product, and that was their business strategy, and that was HIV. And so BARDA looking at the need from a bioterrorism standpoint, has been a heavily consistent thunder, which we should all be glad because at least their stockpile of product, if there are is a bioterrorism threat action among smallpox. So that was the reason. We've been developing our expertise starting in 2014. Beyond HIV, only looking at Ebola, Zika virus, look at malaria, other items stuff, COVID-19. So we then began to be the -- I would call it the second in line with demonstrative expertise and experience working with MVA. And that's why today, to my knowledge, you have Bavarian Nordic, which is doing everything they can in their production facility and we are the next closest having that master seed virus under cGMP to be able to be moved with adequate funding into an accelerated production process. So I think that's why, it was just simply. There were other technologies that didn't have the headache of the manufacturing.

Got it. David. Speaking of accelerating Mpox vaccine through manufacturing to distribution administration, what is necessary? And could you touch on also the funding situation to help accelerate that?

Well, like so many things, if you're talking to a small biotech company, it's all about capital. So in 2020, we had operation work speed. One of the recipients of that was a company named MedDerm that has never got the product approved, was working with an unproven technology mRNA that was out of NIH, and the potential we've seen because the need was so critical and they received in excess of $2 billion, and whereas the world had always said, it takes approximately 10 years to develop a vaccine from start to finish to being able to have it ready. We have vaccines at 10 months. So capital is the driver. So the process that we have to go through is taking the master seed virus to a master working virus. That would be the next step. And then into the -- obviously, the scale up and those steps you go through to go to production. But those are the [ critical steps ]. And that -- the requirement for that is additional capital. And as you can imagine, over the last 2 weeks, we are in numerous discussions with potential funders and supporters, both from an equity investment standpoint as well as nondilutive funding to be able to move forward in a more accelerated manner, so that perhaps for the end of next year, we would have evidence of being able to produce product, the faster the better.

Exactly. And that seems to be a common question amongst the Tribe members today is time line, time line, time line.

Exactly.

And I know that's at the top of your mind as well. And there's a number of moving parts here that you're negotiating and have to be negotiating in a situation like that in a crisis that sort of -- that is developing and so on?

Exactly. Yes. And again, WHO doesn't fund those actions, but they sure can facilitate those interactions Africa CDC and others can do that. So there are -- the recognized ones, there's BARDA, there's Gavi, there's CEPI. There are other ones also. There is the capital markets. So we have been in continuous dialogue since before the declaration, but since it became evident in -- it was about a week or so before that the Africa CDC was expressing their critical need. And starting at that point, we became very integrated into the process of discussion.

That's good to hear. Specifically in the U.S., there's a question and/or an understanding that one of the Tribe members has that said that there are more cases the one that's being spoken about in Wayne County suggests that even almost one per day is being reported now or being seen. Do you know anything of -- can you verify that? Or can you speak to where we are today?

Well, that Tribe member, I don't know if the frequency and number that is being communicated is correct, but probably the more than one Mpox is valid. The distinction that becomes important is which -- is the Clade 1 or the Clade 2, because remember, the Clade 2 is less virulent, not as much of a major concern is the Clade 1 that we're dealing with now that carries the greater severity, that carries the greater risk that can be transmitted in a much more casual manner, which means it's going to spread more rapidly. And so it usually takes several days for the determination. So when I was informed yesterday during that discussion, I had just made the pronouncement. It's only a matter of time the U.S. and someone correct me and said, well, there's just been something across the wire, we -- at least from my knowledge, it may have already been distinguished I just in preparation for this webinar, I have not at work. But we have to wait and see which Clade it is, but it is only a matter of time before we're seeing a continued outbreaks and migration of Clade 1 in the United States or North America, let's just say.

Got it, David. Speaking of production, one of the members is very specific, is saying how long would you need to produce 20 million doses?

It depends -- well there's 2 points to that answer, I think they're critical. Because the first -- the overriding question is how long and what would be the fastest process, meaning money is not the answer. So if there is an accelerated path, how fast could you go forward with your master seed virus to be at the point of producing basically clinical grade or commercial grade product that could be reviewed and utilized. And then there is the implementation of that into a production process and what would be the yield of our manufacturing process and all. So there's 2 points on that. So to answer that first big step, which is not just simply taking our master seed virus and putting it into something and pushing a button because you have to go from it to the working virus and doing that and get that ready to then go forward into that. That could be done in less than a year. And I'll use that somewhat vague because there are a lot of questions being asked that we are asking to be able to get back to WHO and others who are interested because that's what we all want to know. We want to know how do we get to that point to where we're actually doing the production. Then the question is what is the full capacity? Remember, our manufacturing is not a company-owned bricks-and-mortar because we want to transition eventually to the cell line. But the first step would be -- which would make sense to produce as much as you can, increase the supply so that you have MVA as essentially MVA, so that you've got more of the same product basically and being produced in the same manner or not. But at the same time, we would be doing the transition, which we've already initiated steps for the cell line process. And at some point, you compare the 2, our own product, produce traditional as well as the other one. And that's what the regulatory authorities want to see. And there'll be some work, there'll be limited clinical work and some efficacy, probably the nonhuman primate work. So the question is, how much does that cost? Let's assume that's not an issue and all how fast can you go. And that's actually -- right now, we don't have the clear answer because that's being determined right now because this is moving in such a fluid manner a time period, but people are getting to answers of that as we speak.

Yes. What I would assume is this situation scales and the pressures on the government's increase as well, that's going to speed up time line in getting results quickly, just like we saw the COVID that the pressures were there, and the community of companies like yourself came to the forefront and spent that process. So it's hard to give a time line exactly at this stage because all of that is -- all those pressures are increasing. And you can anticipate necessary [indiscernible]

Yes. We're fortunate that our strategic partnership with Oxford Biomedica, specifically Oxford Biomedica France, where the manufacturing is based is very strong. They are manufacturing already for us on the BARDA program. They are experts in MVA manufacturing, and they would be probably the quickest alternative route from Bavarian Nordic to move all this forward. It would be my guess.

Okay. Well David, I know we've had you on about 15 minutes longer than I promised or suggested. And I do appreciate all the questions from the Tribe members. Note that I'll get this video up at the Tribe Public YouTube channel of this event. So if you want to review that and speed through and share that with others, please note that's going to be available and I'll be sending out the [indiscernible] that are there.

Appreciate it. Thank you, Tribe members.

Thank you, David. And also, we are sending up the Tribe this week, which is our simple e-newsletter that will include it, and that those that are participate today, I'll do my best to include you in that mail out today after the close.

All right. Thank you. And thank you again, everyone.

Absolutely. And I remind everyone that we have the wish list process. The wish list process is simple process in Tribe Public. If you want to have David back on, just send in through the wish list process at our Tribe Public website, tribepublic.com, if you want to see him in-person, and maybe one of our Tribe cities across the 34 live events or want to have a new group of Tribe Group that wants to meet him in the U.S. here through a dinner or lunch an event or speak engagement, please let us know. And you just send 24/7 365 add his name or the company's name. And if we get enough interest, we'll express it to David and see if he's interested in being able to come out or have the time. I know he's busy these days. So thank you again, all, and look forward to having you back. And David, look forward to having you to get an update sometime soon. I really appreciate it.

Thanks. Everyone, have a great weekend. Thanks. Bye.