Earnings Call Transcript - AIM Q4 2022

Operator, Operator

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. 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 that 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 Investors 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, publication, 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 is not independently verified and makes no representation as to the accuracy, 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 AIM ImmunoTech leadership team are Thomas Equels, Chief Executive Officer; and Chris McAleer, Ph.D. Scientific Officer. I'd now like to turn the conference over to Thomas Equels, Chief Executive Officer.

Thomas Equels, CEO

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 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 will 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 immuno-pharma development utilizing our lead program, Ampligen. We've 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 presence 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 rintatolimod, you'll see we are regularly publishing papers through independent researchers and top institutions outlining data that shows 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, lung COVID, advanced recurrent ovarian cancer, and Stage 4 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 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 approximately 100,000 doses 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 antigen 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. 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, where 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 have gotten FDA authorization and commenced a Phase 2 study with Ampligen as a therapy for locally advanced pancreatic cancer. And we are working now to launch another Phase 2 study combining Ampligen with AstraZeneca's drug, durvalumab. The goal of that is to heighten and even possibly destroy these pancreatic tumors through the combination therapy. That potential is something we have to experiment with as part of this clinical trial, but we've seen in our other clinical trials that the checkpoint blockade therapies in Ampligen can lead to tremendous enhancements and 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 Medical School. The first one was Phase 1 to establish intraperitoneal safety. Ampligen is 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 2 trial funded principally by a Merck Grant, is utilizing 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 22 by a late-breaking abstract which showed that Ampligen combined with pembrolizumab was achieving in these initial subjects tremendous results. They were seeing complete responses in excess of slightly more than 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 relation to 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 durvalumab 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. 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. The reason being is there are a lot of similarities and in many respects, there is almost complete identity. Now, in chronic fatigue-like conditions post-COVID, you see the exact same symptoms that you see in traditional ME/CFS fatigue. This includes 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 2 study for that has been authorized by the FDA. We are in the process of commencing that study. We began that utilizing a pilot program that was associated with a compassionate care or 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 the Ampligen. The protocol for that was modified and approved to allow us to begin treating people with those same symptoms where the symptoms arose post-COVID. The initial work that we did very strongly suggested that Ampligen might have a positive therapeutic effect. Utilizing that data, we were able to get the Phase 2 authorized, and we intend to be moving full speed ahead in that program in Q2 of 2023. Now I'd like to just show you a little bit about Ampligen’s efficacy in ME/CFS. This is a Phase 3 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 3 study. Ampligen showed a 39% response rate, which is very significant, and you have about a 15% improvement with Ampligen as compared to the placebo-controlled group. Some of the subjects in this study, some of whom had this disease for not so many years, were chosen 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 51% compared to a placebo at 17%, which is a 33% improvement between the Ampligen group and the placebo control. This 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 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. 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 2 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. 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, 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. 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 it for you, but we're also doing it for people in these disease areas that really need an immunotherapy, especially in immune-oncology that creates hope not just for a better future, but for life itself. 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 more people have an opportunity to understand what we're doing and why we're doing it. We intend to bring in key opinion leaders, doctors who are doing the research, so you can hear directly from them what we're doing from the people who are conducting the actual clinical work. We are making the changes that we think are necessary to make our stock more attractive to fundamental institutional investors. 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 in the hope of meaningful cures 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. To us, this is very, very important. That's again our passion. 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 McAleer, our Scientific Officer. Between the two of us, we hope we can answer any questions you may have. And again, thank you.

Operator, Operator

Thank you. And I'll be conducting a question-and-answer session. Our first question today is coming from Jason McCarthy from Maxim. Your line is now live.

Jason McCarthy, Analyst

Hi guys. Thanks for taking the question. Sounds like a lot of progress has been made. Can you talk a little bit about the pancreatic program? And maybe first, you can – can you give us a little bit more detail on those – the Dutch-based study? Was that study following also for FOLFIRINOX treatment? And what were the survival or rather response rates in the survival time?

Thomas Equels, CEO

Dr. McCarthy, this is Tom Equels. We're happy to answer that question. The Dutch study was conducted at Erasmus Medical Center. 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. It has been followed up with an additional approximately 15 subjects, slightly over 40, I don't remember the exact number. To some extent, survival, progression-free survival, and overall survival have improved. I'm going to hand this over to Dr. McAleer, so that he can add any details that he might want to.

Chris McAleer, Scientific Officer

So yes, it was following FOLFIRINOX treatment. The overall survival increased from an average of 19 months to approximately 30 months. We have learned a substantial amount from that initial trial regarding responders and non-responders based on their immune functionality and their CA 19.9 levels. We hope that we can actually increase that overall survival as part of this AMP-270 locally advanced pancreatic, as well as what we have going on with their value add.

Thomas Equels, CEO

Does that address your question?

Jason McCarthy, Analyst

Yes, thank you. But in the new study, which is also following FOLFIRINOX, what is the expectation in the trial design for the increase in survival, because the other trial is open label to get it, maybe that number comes in a little bit? Three or four months is still substantial given pancreatic cancer. Can you give us a little bit more detail on what the Phase 2 now is going to look like in terms of what it's looking for?

Thomas Equels, CEO

Sure. It's our hope in AMP-270 to have the treatment over an expanded period of time resulting in 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 FOLFIRINOX treatment. The proposed future study that we're working on in Europe to get the approvals and everything involves combining Ampligen with durvalumab. Our goal, and this is still speculative, is with because of the expression of PD-L1 in pancreatic cancer, a heightened expression with the use of a PD-L1 checkpoint blockade therapy and Ampligen, to replicate the tremendous synergies evidenced in the data derived from the advanced recurrent ovarian cancer with pembrolizumab at the University of Pittsburgh Medical Center, and in Stage 4 triple-negative breast cancer. The synergies evidenced with Ampligen in pembrolizumab indicate to us, the potential anyway, that a combination therapy with an anti PD-L1 drug such as durvalumab may have a similar effect.

Chris McAleer, Scientific Officer

If we could get results in AMP-270 that are similar to the Early Access Program, which was a single arm versus historical controls, I think that in itself would be sufficient to move to a Phase 3 trial. Improving progression-free survival by over three months and overall survival by 12 months should be sufficient to move on. That will be a randomized controlled 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 overall survival based solely on limiting the responders. They will come in slightly different than the Erasmus study where they won't go through eight-week cycles. They'll continue to take Ampligen continuously until they progress instead of taking eight-week cycles and stopping. 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.

Thomas Equels, CEO

And we're hoping for better than that. With regard to the AstraZeneca collaboration, we see that as having the potential for a 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 legal path. But when you add Ampligen, you see a 60-plus percent clinical benefit; and this is very important, 15%, a little over 15%, complete responses—that's unheard of in that deadly cancer. Now pancreatic cancer is much the same way. 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 durvalumab, to replicate what we were seeing in our combination work with pembrolizumab, we could have a major breakthrough in pancreatic cancer. We don't know how this is going to work—that's the whole point of a clinical trial. But the people with 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.

Jason McCarthy, Analyst

And just briefly on the collaboration with AstraZeneca—if you have the Ampligen and durvalumab combined, is that really kind of mutation-agnostic? The reason I ask is I think AstraZeneca just recently started the study of their PARP inhibitor olaparib and durvalumab in pancreatic cancer, but it was very specific to BRCA1 and BRCA2 mutations, which is a relatively small population. So the long-winded way of saying is the interest here for AstraZeneca, because Ampligen is mutation-agnostic and if you can combine it with the durvalumab, you can basically hit almost all pancreatic cancer?

Chris McAleer, Scientific Officer

Yes, you're spot on. The durvalumab has high PD-L1 expression in pancreatic tumors. The issue is that the immune regulatory environment is hostile. 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 CXCL pan expression and its regulation of toll-like receptors on immune cells in the tumor microenvironment, charges them. You have an upregulation of T effector cells and down-regulation of Treg cells. That primes the immune functionality in the tumor microenvironment regardless of the mutations that exist. Once we can prime the tumor microenvironment with Ampligen and then hit them with durvalumab, that should synergistically fight the tumor regardless of its indication or mutation.

Jason McCarthy, Analyst

And durvalumab is approved, I think, in ovarian cancer too; is there a potential to expand that collaboration out there to ovarian?

Thomas Equels, CEO

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 durvalumab, it might open the opportunity to work with them in other indications, but we haven't reached that point yet.

Jason McCarthy, Analyst

Got it, thank you guys.

Thomas Equels, CEO

Thank you very much, Dr. McCarthy. We appreciate your interest and your coverage.

Operator, Operator

Thank you. Next question is coming from Laura Searle calling in for James Molloy. Your line is now live.

Unidentified Analyst, Analyst

Hi. Thank you for taking our question. So the first one for Ampligen as against ME/CFS, may you elaborate a bit more on your plan to conduct a confirmatory Phase 3 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 a clinic? And have you also been looking into what other viruses Ampligen may target?

Thomas Equels, CEO

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-19, 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. Our ability to move forward testing Ampligen in this condition almost has to address people who had it as a precursor acute COVID-19 infection. It is our hope that the results from that will be able to supplement the work we’ve done with ME/CFS. This might 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 gotten 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. Once we see what that data shows—this is going to be early onset data—we expect that the subset identified, between two and eight years from the onset of symptoms, will be true to form in these early onset post-COVID subjects. In our pilot trial, we had a very high level of efficacy demonstrated even though on a statistically insignificant sample size of four subjects, three of which responded vigorously in a positive manner, and one had a marginally positive response. That's our goal generally for ME/CFS.

Chris McAleer, Scientific Officer

No, I think that's sufficient. I think the post-COVID conditions will move more rapidly than ME/CFS at this particular point. The waters are murky between ME/CFS patients and post-COVID patients. If we can identify that 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'll move on to a Phase 3 trial I believe will be sufficient. Once we can get approval for that, we can treat ME/CFS patients.

Thomas Equels, CEO

Now, 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. One of the things they did was pull some of the ME/CFS patients that were participating in the call. This is something we had learned anecdotally as well from the Phase 3 study: a very high percentage of ME/CFS subjects reported that their chronic fatigue commenced with a flu-like illness. Keep in mind SARS was the original SARS outbreak, very similar disease to COVID-19. After the SARS outbreak in 2002 and 2003, a study was done pursuant to an NIH contract—which resulted in a JAMA article reporting that survivors of SARS, two years after the disease, 27% of them met the United States CDC diagnostic criteria for severe chronic fatigue syndrome. We anticipated that we might see that phenomenon reoccur with COVID-19, and in fact, our utility patent applications related to these conditions were filed in 2020. This 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?

Chris McAleer, Scientific Officer

No, I think that's sufficient.

Thomas Equels, CEO

Can we break this into two parts, Miss, if you have any questions related to the TFS? If not, we'll move right into the discussion of the antiviral and the Ebola work that we're doing.

Unidentified Analyst, Analyst

Yes, that covers the first question.

Thomas Equels, CEO

Okay, great. Now with regard to the second question, I'm going to hand that off to Dr. McAleer.

Chris McAleer, Scientific Officer

The Ebola work that we're doing is partly humanitarian and partly physical. The short answer to your question is yes. We're investigating the mechanism of actions of multiple lethal viruses like Marburg and equine encephalitis virus and so forth. We're looking at the potential future on the horizon as we get further into our pancreatic cancer and Long COVID, where do we go next? The work has already been established prior to my arrival here on Ebola, and I think it's highly worth moving forward. We have been in talks about what logistics look like for a clinical trial to be done. What would a confirmatory trial look like? How do we actually get it up and running in the areas where Ebola is most common? Whether we pull the trigger on that moving forward will depend on cost, logistics, drug supply, and our progress in individual programs. The short answer is yes. I think especially for Ebola specifically in its mechanism of action, even though it's very similar to Marburg, there are distinct differences that need to be taken into account. We must consider downstream, VP24 and VP35 regulation of interferon-stimulated genes; we need to take these into account. But we also know that Ampligen, unlike the current therapies like the MAV-100s, is not specific to a particular variant. The mechanism of action in the interferon inhibiting domain of VP35 and its immune functionality does not matter whether it's the Zaire, Bundibugyo, or Sudan variant, which is the latest outbreak. We believe there's a unique opportunity for us here where we don't necessarily have to compete with the standard of care. We need to investigate the logistics behind it. The design of the trial needs to be considered: do we specifically target one of the individual variants that are less common? Or do we say, for instance, assemble a best trial where we put standard of care against the Zaire and apply Ampligen care to the other strains? That's a long-winded way of saying we have investigated it. We're looking at the logistics behind it, and we have to make an informed decision about whether we pull the trigger and move forward now or wait until the next outbreak occurs.

Unidentified Analyst, Analyst

All right, got it. Thank you for taking the questions.

Thomas Equels, CEO

Anything else we can help you with?

Operator, Operator

Thank you. Our next question is coming from Ed Woo from Ascendiant Capital Markets. Your line is now live.

Ed Woo, Analyst

Congratulations on all your progress. My question is on Ampligen. Do you have adequate inventory for all these clinical trials? Can you talk about your manufacturing capabilities for Ampligen?

Thomas Equels, CEO

Certainly. With regard to the clinical trials, we budget our Ampligen that's in storage 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. We won't overextend ourselves; it's our intention to stay where our clinical activity is within the budget we have established in terms of Ampligen that's in stock. We utilize top storage facilities for our Ampligen supply, and we do have insurance for our Ampligen supply. The only thing that would interfere would be a natural disaster or another occurrence that interferes with our storage supply of Ampligen, which would set us back and require a delay in clinical activity. But we certainly hope that won't occur, and we are taking every reasonable step to utilize the best storage facilities that can be had.

Chris McAleer, Scientific Officer

The short answer is, at this particular point, we have more than enough Ampligen supply to do both the durvalumab study and the AMP-270 study based on the time of dosing 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 have plenty of drug for AMP-270 and the durvalumab study, both Phase 1 and Phase 2, as well as all the drug for AMP-80 in 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 3 or a large Phase 2 trial. We are speaking with manufacturing partners 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 will be moving to a Phase 3 of which we will need new drug. That will be approximately another 8,000 or 9,000. 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 need it. 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 create additional Ampligen should we need so if this data is as promising as we believe it is moving on to Phase 3.

Ed Woo, Analyst

Great. Well, thanks for answering my questions, and I wish you good luck. Thank you.

Thomas Equels, CEO

Thank you very much Mr. Woo. We appreciate your interest and your coverage.

Operator, Operator

We've reached the end of our question-and-answer session. Ladies and gentlemen, that does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. Thank you for your participation today.