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spk03: Hello, and welcome to the AIM Immunotech inaugural fiscal year 2022 update conference call and webcast. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the event, please press star zero on your telephone keypad. Following the presentation, there will be a question and answer session. Note that this webcast is being recorded at the company's request, and a replay will be made available on the company's website following the end of the event. At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations, or future projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and are based on AIM Immunotech's current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports AIM Immunotech files with the Securities and Exchange Commission. These documents are available on the investor section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast relates to or is based on studies, publications, surveys, and other data obtained from third-party sources. and the company's own estimates and research. While the company believes these third-party resources to be reliable as of the date of this presentation, it's not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of or that any independent source has verified any information obtained from third-party sources. Joining us on today's call from the AIM Immunotech leadership team are Thomas Equals, Chief Executive Officer, and Christopher McClure, PhD Scientific Officer. I'd now like to turn the conference over to Thomas Equals, Chief Executive Officer. Mr. Equals, please go ahead.
spk05: Thank you, everyone, for your interest in AIM Immunotech, and welcome to our inaugural earnings call. Today marks an important time in our evolution. We look forward to reviewing today's our many achievements on the operational, clinical, and regulatory fronts. As a reminder, our motto at AIM Immunotech is Immunology for a Better Future. And we look forward to showing you today how, over the past year and going forward, we intend to live up to that motto by developing immunological solutions for serious unmet medical needs. Now, you'll see that we have made tremendous progress over the course of 2022 as we go forward. But you will also see how we are transitioning ourselves into late stage clinical immunopharma development utilizing our lead program, Ampligen. We have built an extremely robust pipeline in high value indications. These are lethal unmet medical needs some of which are in extremely large market opportunities. In addition to this progress, our outreach and our desire to properly communicate our progress as well as our plans is enhanced by the launch of our new website. We invite all of you to come and visit our website and see what we've done and where we're going. Over the course of 2022, we focused on improving communications. Communicating frequently with our stockholders remains a top priority. And we intend, starting with this presentation today and quarterly hereafter, to have earnings calls to discuss our progress as well as our plans for the future. You also see that our social media imprint is stronger and being expanded, consistent with the work we're doing on our website. Now, we are unique in many respects for a company of our size because we have an extremely robust pipeline. We have had a large number of material and significant accomplishments. Our progress is evidenced by the 20-some things you see referenced here that have occurred in 2022. When you go to publications regarding Ampligen or Rintitolamide, you'll see we are regularly publishing papers through independent researchers and top institutions outlining data that shows the potential, the great potential for Ampligen. So this 2022 activity that's referenced here is our foundation for springing forward in 2023. Our pipeline is extremely robust. For a company of our size, very few can boast of the accomplishments that we've made as well as the pipeline that we have in place right now. And this pipeline is addressing clinical activity in serious unmet medical needs. advanced pancreatic cancer, long COVID, advanced recurrent ovarian cancer, stage four triple negative breast cancer. The data on these clinical trials is evolving, and it's been evolving in a very positive fashion. You can read about it in these papers and abstracts that have been published, and you can see that we are in the game, working hard to move our product Ampligen forward along this developmental path. Now, you will find that we also have an extremely well-developed safety profile with the Ampligen, and that safety profile has allowed us to move into clinical trials in multiple high-value disease areas. We have a profile for intravenous use that involves 100,000 doses approximately in humans, and the drug has been found to be generally well tolerated. We have done, as a part of our advanced recurrent ovarian cancer studies, human safety trials to establish intraperitoneal safety for purposes of going forward with those clinical trials, and have successfully done so. Further, we have accomplished what I think in the future will be a major foundation for our clinical activity with an intranasal safety study utilizing Ampligen over a prolonged period of time with doses every two weeks at different dosage levels. Again, it being found generally well tolerated in that study allowing us a basis for going forward into clinical trials related to efficacy. So with that safety foundation, you'll see that we've moved forward with ME-CFS, long COVID, oncology, a number of different solid tumors in oncology, and as an antiviral. And this allows us a very broad spectrum approach for a drug that has, as its mechanism of action, naturally broad spectrum implications. Now, I'd like to discuss what I have prioritized as the company's top program. We have placed our work in pancreatic cancer at the very top of our list, and there's a reason for that. Late-stage pancreatic cancer is basically a death sentence and sometimes with a very short fuse, oftentimes. We first started our program in pancreatic cancer in late 2016 with a Dutch government-approved early access program. And there it was Ampligen as a single agent treating late-stage pancreatic cancer patients. The results of that study were, as of today, we've treated over 40 subjects. is to show with well-established data that Ampligen significantly extends both progression-free survival and overall survival over the standard of care. Now, based on that, we've gotten FDA authorization and commenced a phase two study with Ampligen as a therapy for locally advanced pancreatic cancer. And we are working now to launch another phase two study combining Ampligen with AstraZeneca's drug Dervalumab. And the goal of that is to heighten and even possibly destroy these pancreatic tumors through the combination therapy. That potential is a potential that we have to experiment with as a part of this clinical trial. But we've seen in our other clinical trials that checkpoint blockade therapies in Ampligen can lead to tremendous enhancements in efficacy over the checkpoint blockade drug alone, and in many instances, create complete responses in diseases where few, if any, complete responses are ever seen. If we look at our ongoing clinical programs, I'd like to talk first about our advanced recurrent ovarian cancer program. We had two trials that were started at the University of Pittsburgh's medical school. The first one was phase one to establish intraperitoneal safety. Ampligen was injected into the peritoneal cavity as a part of the protocol in order to better attack these tumors. where they're located. But the second trial, which is a phase two, is funded by a Merck grant principally. And that is a phase two trial where we're using in cisplatin sensitive subjects, Ampligen plus the Merck drug Keytruda or Pembrolizumab. Now, there was initial data published because The progress was extremely dramatic at the American Association of Cancer Research convention in April of 22 by an abstract, a late-breaking abstract, which showed that the ampligen combined with pembrolizumab was achieving, in these initial subjects, tremendous results. They were seeing complete responses slightly in excess of 15%. an additional 20 plus percent of significant partial responses, and a balance going up to 60% for the total clinical benefit related to disease stabilization. What this shows us, especially when we look at the abstract that was published through Roswell Comprehensive Cancer Center in stage four triple negative breast cancer, again, combining Ampligen with Pembrolizumab, is that Ampligen has tremendous potential to create a strong synergistic effect when combined with these checkpoint blockade drugs. So with pancreatic cancer, which tends to express PD-L1, that's why we're working with Dervalumab as the combination therapy in pancreatic cancer, hoping to see the same type of synergy that we saw with Keytruda in these tumors that tend to express PD-1. Now, we also have done a tremendous amount of work in a disease called chronic fatigue syndrome, and the work that we've done in chronic fatigue syndrome led us to believe that Ampligen would have some potential as a therapy in what's called long COVID or post-COVID with chronic fatigue-like conditions. And the reason being is there are a lot of similarities and in many respects, there's almost a complete identity. Now, in chronic fatigue-like conditions post-COVID, you see the exact same symptoms that you see in traditional ME-CFS. Fatigue, and this is profound fatigue, including post-exertional malaise. Brain fog, which is a serious form of cognitive dysfunction, and sleep disorders, as well as joint pain. Now, the phase two study for that has been authorized by the FDA, and we are in the process of commencing that study, but we began that in utilizing a pilot program that was associated with a compassionate care early access program that the FDA authorized for ME-CFS. We have two clinics in the U.S. that are treating severe ME-CFS subjects with Ampligen. And the protocol for that was modified and approved to allow us to begin treating people with those same symptoms where the symptoms arrived post-COVID. So the initial work that we did very strongly suggested that Ampligen might have a positive therapeutic effect. With utilizing that data, we were able to get the phase two authorized. and we intend in Q2 of 2023 to be moving full speed ahead in that program. Now, I'd like to just show you a little bit about Ampligen's efficacy in ME-CFS. This is phase three data that we have, and it's very important to understand why it might be of importance in post-COVID chronic fatigue-like syndrome. Now, you'll see here two graphs. The first one is for the entire population of this Phase III study. And Ampligen was showing a 39% response rate, which is very significant. And you have about a 15% improvement with Ampligen as compared to the placebo control group. But The subjects in this study, some of whom had, not some, many of whom had the disease for more than 10 years, were subjects that we took because it was many, many years before this disease was even recognized to the point that we could move forward with clinical activity. When we wanted to see what kind of subset might be more responsive to Ampligen, we took a midpoint, which is eight years or less from the onset of symptoms, and we see a significant improvement where the Ampligen responders were at 51% compared to a placebo at 17%, which is a 33% improvement. between the ampligen group and the placebo control. So that tells us that in the earlier stages of the disease, from the onset of these chronic fatigue-like syndrome conditions, we are in a position, if treated early, to see a greater improvement or a greater response. Of course, with post-COVID chronic fatigue-like conditions, we have the benefit of being able to catch these people early in the syndrome. So that's why we're moving as fast as possible to get this clinical trial started and see what the data has in store. Now, I'd like to talk a little bit about our finances and our plans. You can see we have great plans based upon the foundation that we've established in 2022. But those plans also include two major Phase II clinical trials, which are going to be fully funded by AIM Immunotech. So we have to look at where we are with cash. And we believe that we have sufficient cash to take us through many of these key clinical milestones. And we're very comfortable in approaching this aggressively utilizing judiciously the cash that we have in place. Now 2023 is clearly poised to be a transformational year for AIM Immunotech. The successes we had in 2022, if the data continues to be so positive, will make big changes in our company and where we're going, and also create opportunities for long-term increases in stockholder value. For Q2, you'll see we have a number of different milestones that we expect to achieve, similarly in Q3 and Q4. These milestones are in collaboration with some of the top big pharma companies and university research centers in the world. The work that we're doing will also be advanced because we expect numerous publications to occur during 2023 that relate to the work that is going on now and is recently, in some instances, recently completed and the data is being compiled. So look forward to a number of important publications and look forward to us achieving these milestones in 2023. We're going to do our very best to hit each and every one of these and, if possible, advance other milestones that may become available during the course of 2023. The work that we're doing here is extremely important, and we appreciate your interest, especially for our stockholders, We appreciate the fact that you are a part of our company, and the work that we're doing, we're doing for you, but we're also doing it for people in these disease areas that really need an immunotherapy, especially in immuno-oncology, that creates hope, not just for a better future, but for life itself. So we've achieved and intend to continue achieving our clinical and regulatory milestones. We hope to continue to establish our growing body of data and expand our clinical opportunities. We are going to work as a company with programs such as the one that we're launching today to elevate the AIM story so that more people have an opportunity to understand what we're doing and why we're doing it. We intend to bring in to our program key opinion leaders, doctors who are doing the research so you can hear from the horse's mouth, so to speak, what we're doing from the people who are doing the actual clinical work. And we are making the changes that we think are necessary to make our stock more attractive to fundamental institutional investors. So all of these things are in progress. The evidence of what we've done, I think, allows you to see that we have a reasonable expectation of progress in the future, and we're going to work very hard for that success. All that having been said, it's important for you to understand the why behind Team AIM. We get up every day. Our passion is that we have an opportunity to make a difference in people's lives by providing a therapy and the hope of a meaningful cure to people who exist under the fear of a wide range of unmet medical needs, especially in oncology. Some of these cancers Where we're making progress are cancers that are extremely lethal, basically a death sentence. So to us, this is very, very important. That's, again, our passion. And it also is good business because we believe that good medicine and good science, where we can accomplish things in these areas where there's a tremendous need, ultimately equates to good business. Again, thank you very much for your interest. I'm ready to open up the program to questions and answers at this time. I have with me Dr. Chris McClure, our science officer. Between the two of us, we hope we can answer any questions you may have. And again, thank you.
spk03: Thank you. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star 1. One moment, please, while we poll for questions. Our first question today is coming from Jason McCarthy from Maxim. Your line is now live.
spk02: Hi, guys. Thanks for taking the question. Sounds like a lot of progress has been made. Can we talk a little bit about the pancreatic program? And maybe first, can you give us a little bit more detail on the Dutch-based study? Was that study following also Sulfurinox treatment? And what were the survival or actually rather response rates in the survival
spk05: Dr. McCarthy, this is Tom Equals. We're happy to answer that question. The Dutch study was conducted at Erasmus Medical Center, and the initial publication lays out all those details. I think there was a publication early last year. that has all the data from the initial 27, and that was using well-established historical controls as a comparator. And it's been followed up with an additional approximately 15 subjects, slightly over 40. I don't remember the exact number. And to some extent, the survival, progression-free survival and overall survival has improved. I'm going to hand this over to Dr. McClure. Dr. McCarthy, so that he can add to that any details that he might want to.
spk01: So, yes, it was following clofirinox treatment. The overall survival increased from 19 months to approximately 30 months, so just about a year increase in the overall survival. We have learned a substantial amount from that initial trial in what responders and non-responders are, at least some portion of them, based on their immune functionality and their CA19.9 levels. We hope that we can actually increase that overall survival as part of this AM270 locally advanced pancreatic as well as what we have going on with their value map.
spk02: Does that address your question? Yeah. Thank you. But in the new study, which is also following Fulfarin-X, what is the expectation in the trial design for the increase in survival? Because the other trials open-label, you get it. Maybe that number comes in a little bit. You know, three or four months is still substantial given pancreatic cancer. Can you give us a little bit more detail on what the Phase II now is going to look like in terms of what it's looking for? Sure.
spk05: It's our hope in AMP 270 to have the treatment over an expanded period of time resulting with Ampligen as a single agent being more successful even than what we saw at Erasmus in locally advanced pancreatic cancer, and then that's following the Fulclorinox treatment. And the proposed future study that we're working on in Europe to get the approvals and everything, combining Ampligen with Dervalumab, our goal, and this is, you know, still has to be considered speculative, is to, with Dervalumab, because of the expression of PD-L1 in pancreatic cancer, a heightened expression, with the use of a PD-L1 checkpoint blockade therapy in ampligen replicate the tremendous synergies that were evidenced in the data derived from the advanced recurrent ovarian cancer with pembrolizumab at the University of Pittsburgh Medical Center and in stage four triple negative breast cancer, the synergies evidenced with Ampligen and Pembrolizumab, you know, both of which indicate to us the potential anyway that a combination therapy with a drug, an anti-PDL one drug such as Drevalumab may have a similar effect. Chris, would you like to?
spk01: If we could get results in AM270 that are similar to the Early Access Program, which it was a single arm burst historical controls, I think that in and of itself would be sufficient to move to a phase three trial. Improving progression-free survival by over three months and overall survival by 12 months should be sufficient to move on, right? And that'll be a randomized control trial that the FDA will consider. Based on the understanding that we have from the initial trial, I think my target is greater than 12 months of overall survival based solely on limiting the responders that will come in. They will be slightly different than the Erasmus study where they're not going to go through eight-week cycles. They'll continue to take Ampligen continuously until they progress instead of taking eight-week cycles and stopping. So if we can get the progression-free survival to be three or four months and the overall survival greater than 12 months in a randomized controlled trial that the FDA will consider, that would be a win for us.
spk05: And we're hoping for better than that. And with regard to the AstraZeneca collaboration, we see that as having the potential for great breakthrough because, for example, in advanced recurrent ovarian cancer, when we combine ampligen with cisplatin and pembrolizumab, We see the poor efficacy of Pembrolizumab alone, certainly without treatment after you've completed the standard of care. It's a very quick and lethal path. But when you add Ampligen, you see a 60 plus percent clinical benefit. You see, and this is very important, 15%, a little over 15% in complete responses. That's unheard of in that deadly cancer. Now, pancreatic cancer is much the same way. You know, there is nothing that creates complete responses and significant partial responses on any kind of a scale to make it a usable therapy. But if we're able to, with Dervalumab, to replicate what we were seeing in our combination work with Pembrolizumab, we could have a major breakthrough in pancreatic cancer. Now, we don't know. how this is gonna work. And that's the whole point of a clinical trial. But the people with pancreatic cancer, late stage pancreatic cancer, don't have any options. So we feel it's important for us to explore every avenue that might bring a meaningful therapy to those people.
spk02: And just briefly on the collaboration with AstraZeneca, so if you have Ampligen and Dervalumab, combined, is that really kind of mutation agnostic? And the reason I ask is I think AstraZeneca just recently started a study of their PARP inhibitor, oliparib, endervalumab in pancreatic cancer, but it was very specific to BRCA1 and BRCA2 mutations, which is a really relatively small population. So it's a long-winded way of saying is the interest here from AstraZeneca because Ampligen is mutation agnostic, and if you can combine it with Dervalumab, you can basically hit almost all pancreatic cancer.
spk01: Yeah, you're spot on. The Dervalumab, there's high PD-L1 expression in pancreas tumors. And so the issue is that the immune regulatory environment is hostile. So even if you can get PD-L1 suppression in the tumor microenvironment, what AstraZeneca has found is that it doesn't necessarily mean that you're going to get a high immune response. What we have shown through Erasmus and through other preclinical data is that ampligen, based on its CXCL10 expression and its regulation of the toll-like receptor on immune cells in the tumor microenvironment, charges them. You have an upregulation of T-effector cells, downregulation of Treg cells, And that primes the immune functionality in the tumor microenvironment regardless of the mutations that exist. And so once we can, you know, we prime the tumor in microenvironment with Ampligen, then hit them with Dervalumab, and that should synergistically fight the tumor regardless of its indication or mutation.
spk02: Dervalumab is approved, I think, in ovarian cancer, too. Is there potential to expand that collaboration out there to ovarian?
spk05: Well, right now our focus is on the work that we've done with Pembrolizumab, and I can't really speak to future business opportunities if we're able to achieve success in pancreatic cancer with AstraZeneca's drug Dervalumab, it might open the opportunity to work with them in other indications. But we haven't reached that point yet.
spk02: Got it. Thank you, guys.
spk05: Well, thank you very much, Dr. McCarthy. We appreciate your interest and your coverage.
spk03: Thank you. Next question is coming from James Malloy from Alliance Resource Partners. The line is now live.
spk00: Hi, this is actually Laura Serial calling in for James Malloy. Thank you for taking our questions. So the first one for Ampligen as against ME-CFS, may you elaborate a bit more on your plans to conduct a confirmatory phase three trial and any timelines associated here? And then also as a follow-up for Ampligen as an antiviral agent, With the newfound promising research that you announced of Ampligen against the Ebola virus, are you looking into expanding this research into the clinic? And then have you also been looking into what other viruses Ampligen may target?
spk05: Yes. First of all, with regard to ME-CFS, and we'll just break this into two parts, Chris and I will. We have a situation right now where we've moved into post-COVID or post-acute COVID, long COVID expression of chronic fatigue-like symptoms because it is almost impossible to find a cohort of early onset patients that have chronic fatigue-like symptoms that didn't have COVID. So our ability to go forward testing Ampligen in this condition almost has to be addressing people who had it as a precursor acute COVID-19 infection. It is our hope that the results from that we'll be able to supplement the work that we've done with MECFS and allow us to use perhaps that data in a confirmatory fashion. But we're not quite there yet. We need to do the trial. We've got an authorization to do the trial. We're in the middle of all those things that we need to do in order to finalize the protocol and move forward very rapidly. But once we see what that data shows, and this is going to be early onset data, so we have every expectation that the subset that was identified eight years or less from the onset of symptoms, actually between two and eight years, you know, will, you know, be true to form in these early onset post-COVID subjects. And in our pilot trial, we had a very high level of efficacy demonstrated, even though it's on a statistically insignificant sample size of four subjects, three of which responded vigorously in a positive manner. One had a marginally positive response. So that's what our goal is. Generally, Chris, would you like to add anything to that?
spk01: No, I think that's sufficient. I think the post-COVID conditions will move more rapidly, I believe, than the ME-CFS at this particular point. The waters are murky between ME-CFS patients and post-COVID patients. If we can identify the post-COVID conditions, I expect the entire trial to be up and running and done by the end of the calendar year. and we move on to a phase three trial, I believe will be sufficient. And once we can get approval for that, we can treat MSDF patients.
spk05: Now, I'd like to, if I may, elaborate on this just a little bit. We did a webinar with one of the major patient advocacy groups called SOLVE, maybe a year ago. And one of the things that they did was they polled some of the ME-CFS patients that were participating in the call, and this is something that anecdotally we had learned as well from the phase three study, is that very, very often, very high percentage of the ME-CFS subjects reported that their chronic fatigue commenced with a flu-like illness. Now, of course, at that point in time, because many of them had had the disease for 12, 14 years, this report is anecdotal because nobody knows what the virus was. But one of the things that I remembered after the SARS outbreak in 2002, 2003, was that there was a study done, I think it was pursuant to an NIH contract, which resulted in a JAMA article, this is the American Medical Association's journal, reporting in survivors of SARS. Now, keep in mind, SARS was the original SARS outbreak, very similar, this is a disease very similar to COVID-19. That virus was SARS-CoV-1 as compared to COVID-19 SARS-CoV-2, but they're in many respects related to pathogenesis, almost identical. But in that study, it was found that of survivors of SARS, two years after the disease, 27% of them met the United States CDC diagnostic criteria for severe chronic fatigue syndrome, or serious, excuse me, chronic fatigue syndrome. Now, that being said, we anticipated that we might see that phenomenon reoccur with COVID-19. And in fact, our utility patent applications related to this were filed in 2020, if I remember correctly. And the idea being that the SARS-CoV-2 virus might create the same chronic fatigue-like conditions seen in SARS-CoV-1 and seen generally in terms of the chronic fatigue syndrome patients that were ampligen responders indicating that their disease began with a flu-like illness. So that is the basis for what we're doing. Chris, do you want to add to that before we jump into Ebola?
spk03: No, I think that's sufficient.
spk05: Can we break this into two parts, if you have any questions related to the CFS? If not, we'll move right into the discussion of the antiviral and the Ebola work that we're doing.
spk00: Yes, that covers the first question.
spk05: Okay, great. Now, with regard to the second question, I'm going to hand that off to Dr. McClure.
spk01: So, the Ebola work that we're doing is part humanitarian and part fiscal in terms of, you know, I'll let Tom handle that portion, but there is a very So the short answer to your question is yes. So investigating the mechanism of actions of multiple lethal viruses like Marburg and equine encephalitis virus and so forth. Looking at the potential future on the horizon as we get further into our pancreas cancer and long COVID, where do we go next? But the work has already been established prior to my arrival here on Ebola, and I think it's highly worth moving forward. So we have been in talks about what logistics look like for a clinical trial to be done, what a confirmatory trial, how do we actually get it up and running in the areas where Ebola is most common. And so whether we pull the trigger on that moving forward, I think it'll be a decision to be made based on cost and logistics and drug supply and and where we are in the individual programs. But the short answer is yes. I think especially for Ebola specifically in its mechanism of action, which even though it's very similar to say something like Marburg, there are distinct differences that need to be taken into account downstream, BP24 and BP35 regulation of interferon-stimulated genes, such that we do need to take into account. But we also, one of the really things that's promising much like the systemic immune activation in pancreas cancer, regardless of the variant that exists or mutations that exist. Ampligen, unlike the current therapies like the MAB100s, they're not specific to a particular variant, right? The mechanism of action and its interferon inhibiting domain of VP35 and its immune functionality don't matter whether it's the Zaire or Bungayanga or whether it's the Sudan variant, which is the latest outbreak. And so we think that there is a very unique opportunity to us where we don't necessarily have to compete with the standard of care if we're looking at one of those. And the question becomes at this point, if we are going to do it, overcoming the logistical hurdles as we speak, then the design of the trial, do we specifically target one of the individual variants that are less common? Or do we say, for instance, put a basket trial together where we put standard of care against the Zaire and individual ampligen care to the other strains? And so I don't know. That's a long-winded way of saying that we have investigated it. We are looking at the logistics behind it. And then we'll have to make an informed decision about whether we pull the trigger and move forward now. The issue is we have to get all the logistics in place and then wait. until the next outbreak comes.
spk00: All right, got it. Thank you for taking the questions.
spk04: Anything else we can help you with?
spk03: Thank you. Our next question is coming from Ed Wu from Ascending Capital Market. Your line is now live.
spk04: Yeah, congratulations on all your progress. My question is on Ampligen. Do you have adequate inventory for all these clinical trials? And can you talk about your manufacturing capabilities for Ampligen?
spk05: Certainly. With regard to the clinical trials, we budget our Ampligen that's in storage so as to be able to meet our clinical obligations. We are in the process of manufacturing fresh lots of Ampligen, utilizing contract manufacturers. We've shifted to a contract manufacturing based system across the board. And we won't overextend ourselves. It's our intention to stay where our clinical activity is within the, I use the word budget, most people think of that in a financial sense, but in the budget that we have established in terms of ampligen that's in stock. And we utilize, you know, top storage facilities for our ampligen supply. And we do have insurance for our ampligen supply. The only thing that would interfere if there were some natural disaster or whatever that interfered with our storage supply of ampligen, that would be a setback that would require a delay of the clinical activity. But we certainly hope that that won't occur. And we are taking every
spk01: reasonable step to utilize the best storage facilities that can be had the the short answer is at this particular point we have more than enough ampligen supply to do both the value map study the amp 270 study based on the time of dosing that we have statistically median dosing paradigms that we collected from the EAP plus I added a 30% improvement, which we're hoping to see. So we've allotted all that drug for AMP270 and the Devalumab study, both phase one and phase two, and all the drug for AMP518, the post-COVID conditions. Beyond that, we have an additional approximately just short of 10,000 vials, which will be sufficient to run either a small phase three or a large phase two. And we have clinical partner, I'm sorry, not clinical, manufacturing partners that we're speaking with now to have another lot of ampligen made sometime near the end of the calendar year to account for the post COVID conditions study, whether or not we'll be moving to a phase three of which we will need new drugs. That'll be an additional approximately eight or 9,000. Plus we're having polymer made in early Q1 of 2024. to have another additional lot of Ampligen ready to be made at any time in 2024 when we may need it. And so at this particular point, we have ample supply of drug on hand for all of our ongoing trials and the next trial that we would be planning, and we have supplies planned to be made to make additional Ampligen should we need so if the state is as promising as we believe it is moving on to phase three.
spk04: Great. Well, thanks for answering my questions, and I wish you guys good luck. Thank you.
spk05: Well, thank you very much, Mr. Will. We appreciate your interest and your coverage.
spk03: Thank you. We have reached the end of our question and answer session. And, ladies and gentlemen, that does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.
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