Transcription
Welcome back. We have an update from Gavax Labs. Trades on the NASDAQ under GOVX. It's a clinical stage biotech company developing novel vaccines for many of the world's most threatening infectious diseases and therapies for solid tumor cancers. So happy to welcome back chairman, president, and CEO David Dodd. David, welcome back.
>> Thank you, Anna. And today what I'd really like to focus on is a very important issue in public health worldwide, and that is addressing the unmet needs of immune compromised patients. That this is a major issue globally, and especially related to COVID-19. And it's a critically important issue because most of us are generally healthy, and we feel like, well, the pandemic's passed us; we don't have to think about it. But you're going to see in a minute that there are significant numbers worldwide at major risk because the current vaccines are inadequate. And that's what I'd like to talk to people about and where Gavax is coming in.
First of all, the current authorized or the developed vaccines, the mRNA vaccines from Fizer, from Madna, and even the Novivvax vaccine that is approved now, are first generation COVID-19 vaccines. Uh, the challenge with those vaccines in particular populations that I'm going to focus on today is that they are limited breath of protection. In other words, every time there's a new, um, a new variant or new strain that comes out, they have to be reconfigured. They don't, and because of that, they don't last long. We were originally told they were 94-95% effective. If you get the vaccine, you won't get COVID. We found out that really was not the case, and in fact, they only last about three to six months, and they had to continuously be reconfigured. And most importantly, people who have medical conditions that result in their bodies not being as responsive from an immune response as they should be, they simply don't work. And so a multi-anigen, as they refer to, or let's call a next generation vaccine, is one that would clearly address those limitations.
Most of all, it, they would address the limitation and provide adequate and appropriate protection, reducing the risk of severe infection, hospitalization, the risk of death for people who have certain medical conditions. Let's talk about those people with various blood cancers, people who may have lupus, multiple scerosis, could be HIV, could be renal disease, kidney disease, could be a diabetic patient. So there's a host of medical conditions. In fact, they represent over 40 million people in the United States alone and over 400 million worldwide who have a medical condition that results in basically depleting or destroying their antibbody immune systems level or ability to respond adequately and provide protection. That means these people, 40, over 40 million individuals in the United States alone, remain at very high risk from COVID-19 of contracting either a severe infection, being hospitalized, or even the risk of death. This is unacceptable. So it's a critical medical need worldwide.
And fortunately, there is a solution, and that is the vaccine that GFX has, which is known as GOC4S1. We have two clinical trials actively underway right now among these populations. One are blood cancer patients who are receiving stem cell transplantation. These are one of the highest risk groups for being at risk of, uh, severe infection, etc. So it's a very important area here. These individuals do not respond to mRNA vaccines or to the novivvax vaccine. And in another blood cancer population for which we are conducting a clinical trial are people with chronic lymphosetic leukemia. Their disease, as well as their therapy, uh, has depleted their body's ability to respond adequately to the first generation vaccine. So they're at very high risk, and they need to have protection. Just, it's not something we can wish away. It's a very important and critical medical need.
We've conducting two clinical trials among those. And what is important so far is that our results have shown that the immune responses coming from our vaccine, in direct comparison to the mRNA vaccines, that ours are exceeding those of either the Fiser, Madna that we're seeing. In fact, in the CLL and the chronic lympositic leukemia population, we announced, and just recently at two international symposia or congresses, we had the data presented comparing specifically our vaccine versus the Fiser vaccine. And the results were, well, first of all, very safe is our vaccine. It's well known; it's been around the technology for many years, so people don't have to worry about it. Most of all, the data safety monitoring board that oversees that study, they halted the Fiser arm because it did not meet its desired end points. The Givax vaccine actually exceeded those. So the remainder of that trial, which is continuing today and hopefully will be completed by the end of this year, is only utilizing the Givax vaccine because it demonstrated immune levels that are protective, considered a protective versus what was seen in the Fiser vaccine. So this is very important and very exciting for us and our shareholders.
Now we also have other programs advancing, and they're in major markets. Our impact smallox vaccine. I gave an update of that recently on this program, on this congress, and, uh, that's continuing to. And our gadep and our solid tumor therapy continues to advance. We have upcoming milestones on all of our programs yet this year into next year. We look forward to announcing updates on those types of, not just on the co-19, but other programs. But with that, I'm going to end and just simply say that keep in mind 40 plus million individuals in the United States alone, over 400 million worldwide, at very high risk, and hopefully our vaccine is going to offer them the type of protection they need. So, I'll halt right there. If you have any questions and we have time, I'm happy to take those. Thank you.
>> Thank you, David. Uh, yes. What's your financial status and plans for the remainder of 2025?
>> Thank you. Good question. We did, uh, we, we, we raised money and added to our balance sheet in, uh, June, in early July. Uh, we currently are looking again to raise additional cash. We expect to probably add between 12 and 15 million by the end of the year. So we're continuing to add capital so that we can support the progress with all of our programs.
>> And do you foresee any strategic events or options over the next year?
>> Not so much strategic. The one we're asked about is based upon the recent announcement that Bavarian Nordic, which is a company that also utilizes the type of platform that we do for vaccines. They're being acquired for $3 billion, and by a private equity firm, they've agreed to that. And because of that similarity in that company, and although we're a much smaller company, uh, we have a lot of questions coming to us from, uh, from interested individuals, uh, especially in the investment community. What do we think that would mean for us? We really don't know what that would mean for us, but we'll stay focused on advancing our programs, and what may, uh, evolve will evolve, and we'll keep everybody updated.
>> And how does the short staffed FDA affect GOVAX?
>> Well, it, it's affecting, um, Givvax, not that much. And the reason why is our current programs are, they're actively underway right now. We're in touch with our FDA program, uh, individuals with whom we interact. There's been no impact on us from that regard. Uh, we stay in close contact with them. So right now everything we have is continuing to go forward successfully. Our biggest challenge as a small company is, you know, continuously building the balance sheet so that we can go at the pace we'd like to and, if at all possible, accelerate the pace.
>> And David, can you talk about your stock price? Uh, what are you doing to boost the stock price? One of our viewers thinks some analysts think your stock should be around five to six a share.
>> Yeah, some of them are saying 8 to 12 even. Uh, well, obviously we agree with those analysts and those predictions in terms of what would translate into how undervalued we are. What we're trying to do is such as what we're doing today. We're trying to be very transparent and communicate as much as possible to the investment community, either existing investors as well as potential investors, of what we're doing, the potential value behind our programs, and why we're so excited to be part of this organization advancing the programs. And if others have better ideas and stuff, we'd love to hear from them. But right now what we're focused on is continuously communicating as much as we can in terms of our progress and what we're seeing out in the investment world and support. We are receiving a lot of interest in terms of from the investment community of wanting to work with GVAX. And so hopefully that will translate not only to additional capital on the balance sheet but also we'll see greater activity behind the stock, meaning liquidity, as well as an increased stock price.
>> Perfect. Thank you, David, for this update. Always a joy having you on our program, and we look forward to the next update real soon.
>> Thank you, and I appreciate all the viewers. Thank you.
>> All right everyone, we'll be right back.