AIM ImmunoTech Inc. Q1 2023 Earnings Call
Hello and welcome to the Amic Aim Amunotech quarterly update conference call and webcast.
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Joining us on today's call from AIM Leadership Team, our time is equal to Chief Executive Officer and Dr. Christopher McAley, or Society of the Officer. I would now like to turn the call over Mr. Eagles. Please proceed.
Thank you, operator.
As it's been mentioned, I'm Tom equals the CEO of AMIMUNO Tech. And at AMIMUNO Tech, our motto for the company is immunology for a better future.
We're working not just.
for the financial rewards that come from the type of research and development we do, but primarily to bring not just hope, but a cure to people with lethal malignancies and diseases such as long COVID, through our experimental drug amplichin. We're on target.
in these serious disease areas where there's a complete unmet medical need. And in doing that, again, we're trying to create a better future for those many of whom have no hope right now. With regard to our quarterly call today, those of you who attended our last call, which was just a month and a half ago,
recognize that we've had significant improvement over the past 18 months in terms of progress in our clinical trials, especially in our key priority areas of pancreatic cancer, advanced recurrent ovarian cancer, and lung COVID.
Now, I want to talk a little bit about our late stage pancreatic cancer program because we've had a tremendous amount of data come in through our early access.
part of that program, which establishes a very clear measure. And the risks are future clinical work, because in those subjects, we're approaching 50 subjects at this point. We're seeing clear evidence of-
progression free survival and overall survival.
And that is a cancer that is a malignancy, which is projected for 2023 to be one of the top causes of cancer related deaths in the world.
So it's a big market. Advanced recurrent ovarian cancer, our data that we've gathered over the past several months, going back to April of last year, has a very strong indicator of amplogens potential as a therapeutic.
in a number of different solid tumors.
In addition to the progress that we made in the clinic, we had a number of different regulatory approvals of INDs authorizing us to go forward with placebo-controlled clinical trials, for example, in long COVID.
expressing chronic fatigue-like symptoms. And for a randomized controlled phase to impangriatic cancer. So we're making strong regulatory progress that parallels these advances in the clinics. And we've also made some structural changes.
We have made a world renowned biotechnology pioneer, W. Neal Burnett, as the chairman of our scientific advisory board and Nancy Bryan has joined our Board of Directors.
She has a deep and strong pharmaceutical industry background, including a lot of activity that we think will be very valuable in mergers, acquisitions, and licensing.
So we've improved the depth and quality of our management team significantly.
Now, as to our pipeline, if you go to our website, you can get the details for this. But we have prioritized in repurposing Amplage in several years ago into oncology. We have prioritized two areas.
of clinical development that are extremely important to the future of our company.
development that are extremely important to the future of our company. First is pancreatic cancer.
We have an early access program with almost 50 subjects having been treated. This was a use authorization by the Dutch government, which has been underway since late 2016. And in that program, we have demonstrated
progression-free survival and overall survival based on comparison with well-matched historical controls both in locally advanced pancreatic cancer as well as metastatic pancreatic cancer.
And then advanced recurrent ovarian cancer. And as you know, the late stage pancreatic cancer is almost like a death sentence. Well, advanced recurrent ovarian cancer is very much the same. And in advanced recurrent ovarian cancer, we're involved in a phase two at the University of Pittsburgh combining aridrogamplogen.
with Mark's Drug Pembrolysmab, also known as Ketruda. And in that study, we're seeing remarkable results from the preliminary data that was posted. And we're expecting a protocol driven interim report in just a few months.
And it's our hope that that preliminary data will be sustained in this data report set by the protocol because the preliminary data, which was published at the AACR Convention as an abstract, the late-breaking abstract, shows that ampligen, combined with pembrolizumab, is a very important part of the data. And it's our hope that that preliminary data will be sustained in this data report set by the AACR Convention as an abstract, the late-breaking abstract, combined with pembrolizumab, is a very important part of the data report set by the AACR Convention
and cisplatin sensitive patients is creating significant survival advantages, including complete responses and significant partial responses in a disease where that is rarely seen at all. So we're very excited about that. And our long COVID program, we've got an FDA authorization to commence that.
We have numerous sites that are in the final stages of getting up and running and we hope to see the, not only those sites open, but very rapid enrollment and dosing of subjects and with a hit next month when it's ready to take off, 2019 year, with the site...
a selection that we have, we have a reasonable expectation that we'll have all of these subjects treated by the end of this year or certainly in the first quarter of next year.
So I'm very excited about where we're at today and I'd like to take a moment now to introduce our scientific officer. One of the things that we've done recently too is we've promoted Dr. McAleer to scientific officer for the company and he's gonna do a deep dive into some of these programs. Take it on Chris.
Thank you, Tom. I'm happy to be here. As Tom just pointed out, pancreas cancer is our primary focus and that is in large part due to the positive data that was collected as part of that early access program in the Netherlands. As you recall, the VAP was amblygen as a singular amount of therapy following pulperonoxin.
is a reminder of that positive data. And these promising results have led to the design of both our AMP270 locally advanced study, as well as the study in metastatic cancer that I'll be discussing shortly. As you will, as we'll be opening the Erasmus Medical Center as part of both AMP270 and the DORPANK study.
We expect any new patients to be enrolled in each of those two studies, and we will leave this early access program open as an option for patients that don't qualify for either ongoing study.
And while these data have led to the design of these two new studies, the AAP has continued to enroll additional subjects beyond that published in Cancers. And we expect to have an updated analysis, including updated Kaplan-Meier plots for progression-free and overall survival during our Q2 call. And I'll be really excited to show that data. It's quite...
disease express markers of immune upregulation such as IRF4, LTB, and CD83. But more important to that, it's given us insight into differential gene regulation in those who have progressed, such as ARG1 upregulation, which may mediate T cell suppression and ATG12 upregulation, which is implicated in autophagy.
And armed with that information, we can continue to advance our understanding of Ampligen's mechanism of action, as well as find additional potential targets for combinatorial therapies to ultimately improve patient outcome.
In addition, the data that's most striking to me is that patients taking ampligen have shown an increase in KI67 positive populations of both cytotoxic T lymphocytes and T helper cells.
as well as an increase in the population of CV69 positive cytotoxic T lymphocytes and P-helphocels, indicating that the KS67 positive, indicating that these T helper and T lymphocytes can continue to proliferate, but the CV69 expression showing that they have the ability to be activated.
And so while we need to explore these findings further, it points to the potential of ampligen to sustain the pool of T cells and mitigate T cell exhaustion that has been known to occur with checkpoint inhibitors. And that data has made extremely excited.
And the press release and a link to that data presentation will be forthcoming as these data were recently presented by our colleagues at Erasmus Medical Center at the 2023 Pankhurst Club meeting in Chicago.
And the data have me excited because they give me ever more confidence that the M270 study at locally advanced practice cancer and the DORPANG study in metastatic PDAQ will be successful.
And so I want to take a moment to address the AMP 270 study in a little further detail.
We currently have the Gabriel Cancer Center in Cano, Ohio open and they are actively screening patients.
Enrollment at that site has been slower than we expected, but we are working diligently to open additional sites, as well as looking at different methodologies to increase advertisement for the Gabriel Center sites that hopefully increase their enrollment.
The site initiation visit will be occurring at the University of Nebraska Medical Center next week, and we expect that site to be open and enrolling patients before the end of May. Shortly after that, we will have an additional site initiation visit at Virginia Mason Medical Center in Seattle. And beyond that, we are in open contract negotiations in some degree or another with...
Approximately 20 different sites and plan to have additional sites in the US and Europe opening by years end And that does include the Erasmus Medical Center and the Netherlands
And plan to have additional sites in the U's and Europe opening by year's end, and that does include the harrafness Medical Center in Netherlands. With that me said I.
Do still expect the first patient to be enrolled in Q2, but because control patients in this particular study do not receive dosing, it is possible that the first patient, the actual first patient dosing will not be until Q3, but I am cautiously optimistic with the additional sites opening in the very near future that we may still reach that timeline.
And I'll talk about the investigator sponsored door bank study, which will combine AstraZeneca's Dervyumab with Amplogen following Fulfierna.
This is a Phase 1-2 study to investigate the safety and advocacy of that treatment.
As you guys have probably been aware, Amplogen has shown a high common tutorial benefit with checkbook inhibitors, specifically with the PD1 inhibitor, Qtrudus, in both triple negative breast cancer, as well as advanced recurrent ovarian cancer.
We believe the combination of the immune-modulating properties of ampligen and the ability of ampligen to maintain the pools of T cells that I discussed previously.
We combine that with a known high PDL1 expression in tanker's cancer that their value maps should combat.
Those together make for a very intriguing synergistic combination that we believe is likely to show very great promise in extending both progression-free survival and overall survival in those patients with metastatic cancer, tankers cancer, that we all aware are desperate for a cure.
There are some minor comments to the ethics committee that need to be addressed, but otherwise the major hurdles for the initiation of this study have been ironed out.
We have speculated previously that the study will commence in Q4 of 2023, but again, I am cautiously optimistic about our chances of actually beating that projected timeline. And to the end of further investigating the mechanism of amplagence efficacy and treating cancer,
such as further advancing the research from the EAP I discussed earlier. And as well as providing a molecular biology lab space to initiate investigations and other indications, including other cancer indications, I have been able to secure a small lab facility at the SID Martin Biotechnology Hub that is associated with the University of Florida, their UF Innovate Program.
This space will allow us to update and improve protocols and methodologies pertaining to the CMC, the chemistry manufacturing control section of what we expect to be our future NDA and pancreas cancer.
This lab.
will supplement the chemistry lab that we have in New Jersey and it will provide us.
With the necessary lab space to solicit and acquire NIH funding, which I am actively pursuing to help offset costs at a relatively low burden to the stockholders, I personally think that the approximately 20,000 per year that we're spending for this facility is a bargain price to give us access to almost everything we need, including wet lab space, analytical equipment, microscopes, incubators.
and the infrastructure of a world-class research facility, including biohazard waste removal and IACO access, just to name a few. And I think this acquisition will help to advance the fundamental biology and chemistry behind Amplogen and to help ensure that we are prepared for regulatory scrutiny when that day comes. And while oncology is our primary focus, Leadership Council, we have this deeper body and focus of our technology community that states in order to encourage
The primary outcome of that is the promise fatigue score with other secondary outcomes, including some exploratory biomarkers such as immune cell monitoring and advanced exploratory biomarker panel analysis that we hope will shed light on disease ideology as well as
provide some insight into responder population characteristics. We are hopeful that this responder population will be high and that hope is based off the preliminary data that we have collected as part of the 5-11 study amendment that we made to treat patients with post-COVID conditions.
As you may recall, the small population of patients that we had showed improvements in their general fatigue, their ability to exercise, as well as decreases in the post-exertional malaise that is associated with that exercise.
And in addition, these patients demonstrated improvements in their focus, their concentration, and their memory.
And we have currently agreed upon budgets and clinical trial agreements with 10 sites and expect to have all those contracts through the legal process and signed within the next two to three weeks.
Our expectation is to ship drug in the first two weeks of June and have all ten sites open and treating patients in mid to late June .
Our hope and expectations from the site feasibility questionnaires is that enrollment will take no longer than three to four months and the last patient will be enrolled in Q4. And that's a broad overview of the scientific and clinical advancements we've made thus far. And I'll hand it back to Tom to discuss the company finances.
Well, thank you, Chris. Well done. As to our financial position, I think you can see that we're in a very robust position given the accomplishments that we have demonstrated over the past two years.
One of the reasons for that is that much of the clinical work that we've done, for example, at Erasmus, the Early Access Program, much of that was funded through a variety of governmental mechanisms in the Netherlands.
But we were actually paid approximately
a little over $600,000 for the ampligen that we contributed to the study. And the costs of that study were funded through these other sources. Similarly, at Roswell, much of the tremendous clinical achievements that we've made at Roswell were funded through the
various governmental grants, NIH, DOD, that type of thing. At the University of Pittsburgh Medical Center, the tremendous advances that we made in advanced recurrent ovarian cancer, the phase two with the AMBLIT cisplatin sensitive.
Ampligen plus pembrolizumab or Keytruda, that is principally funded by a Merck grant. And that's a very significant phase two study with a projected 45 subjects. So we're not talking about small potatoes there. So our financial situation...
is strong and we have every belief that we have sufficient cash to move through the end of 2024 and accomplish our clinical and regulatory goals that we've set for that period.
and we have every belief that we have sufficient cash to move through the end of 2024 and accomplish our clinical and regulatory goals that we've set for that period. Now, we are, we are one of the people in the community, ????, in the sense that they'll all believe and also want to know every single day what theyanto.
If you look at where we're at and you see how we've used our dollars wisely.
We are moving our clinical programs at an extremely rapid pace, especially when you consider the size of our company.
We have the cache, but we also have the partners and collaborators that we need to make this happen.
You can see on this slide where we're working with AstraZeneca in combining Amplogen with its drug Dervalumam or Amphysi for Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer. We're working with Merck.
in two areas at the University of Pittsburgh and Advanced Recurrent Ovarian Cancer, Amplogen Pluskey Trudeau, at Roswell Comprehensive Cancer Center, Amplogen Pluskey Trudeau and Stage 4 Triple Negative Breast Cancer. And we're seeing...
Fabulous results as the data comes in in those programs. So we have top-notch collaborators that we're working with, top research centers, and world-class researchers. Dr. Edwards is at the top of his field in ovarian cancer.
Dr. Kalinsky is one of the top immuno-on-collegeists in the world. Dr. Van Eyck at Erasmus, probably the preeminent, world preeminent pancreatic cancer specialist. So we have a good team internally and we're collaborating with the best of the best. Dr. Van Eyck at Erasmus, probably the best.
Now, you may ask yourself, why Ampligen? Why AIM? Why now? Well, the reason is that we have an opportunity that presents itself right now. The biotech microcap sector has taken a beating across the board.
And this allows an opportunity to take advantage of where aim is right now. Because I do not believe if you look, you're going to see another company positioned like we are with the cash, with the personnel, with the collaborators, with the partners.
to achieve long-term clinical successes.
in diseases where there are extremely serious unmet medical needs in large market segments.
So that's why aim and that's why now. You know our focus is on creating successes that have the opportunity to lead to big opportunities and deal opportunities down the road. And one of the reasons we repurposed into oncology.
was because there was a tremendous unmet medical need that we thought we might be able to address.
but also for purposes of our investors and our stockholders, you look at the volume of deals in bio-farma and the largest area of volume is oncology deals and the richest deals are oncology deals. So we have put our focus
On target, we're aiming for a target that creates long-term value.
Thank you very much. Now, if anybody has any questions, we'll open the floor for questions.
Thank you. We will now be conducting a question and answer session.
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Our first question is from Valan, and it's Jim Malloy with Alliance Global Partners. Please proceed with your questions.
Thank you, Mourning. Thank you for taking my questions. I had a question on the top three, on slide six on the deck, he has sent out with the presentation this morning. On the top three on college, opportunities, I'll ignore the fourth, because it's an early access.
the three defined clinical trials do you walk through which one of those which are?
Which of the three you're just be having the nearest term catalyst, top line cat or interim catalyst and which of those are eviscared sponsored versus
Your aim is controlling entirely those trials. So the door bank amptus, I'm sorry, the door bank study is an investigator sponsored. So is the event's current over and cancer.
the AMP270 locally advanced pancreas cancer is AIM controlled.
Best interim data, that'll be in the advanced recurrent ovarian cancer. That's an optimal Simon II stage design that is run the number of patients enrolled for that Stage 1 Stage 2 design has been completed.
The formal interim report is being drafted now for us. It's expected to come.
sometime in June . It couldn't get an exact date, but it should be in June . So in terms of immediate line, it would be the recurrent ovarian cancer followed by the doer bank. That's a phase one phase two running. And we expect that it's a three and three design in the phase one. We expect that as safety data to come in with some...
preliminary efficacy data probably in mid Q2 of 2024. I've got answers your question. Sure. By the duraphan, thank you. The duraphan, that's the Ampligenin Dervylo-Movie. By the way, the medisdatic pancreatic ductal study. All right. Ampligenin Dervylo-Movie.
B-dex, okay, great. Then when my dad, what's the name of my dad, James?
James, if I might, our enthusiasm about the study that we're beginning with AstraZeneca utilizing Ampligen and dervalumab is based upon our experience in both stage IV triple negative breast and advanced recurrent ovarian cancer.
seeing a tremendous energy when amplogen was combined with ketruta. I realize ketruta is PD1 checkpoint blockade therapy, but we think in terms of mechanism of action, we should see the same results when combined with the dervalumab, which is PDL1.
All right, thank you. Dr. McCleary, then you're saying on the metastatic PDAC with duralumab, that's a launch in fourth quarter 23. When do you anticipate an interim look there, or when you anticipate potentially data?
All right, thank you Dr. Michael Erick, then you're saying on the, for the Medestatic PDAQ with Duralemab, that's a launch in fourth quarter 23, when you just pay an interim look there or when you pay potentially data. So the,
Well, it'll be open label. So, you know, we'll have that data as a progress, but the stage, so it's a phase one, phase two, three and three run in. The I-X-SPECT based on the enrollment that we've had at Arasmas.
for that to likely be at the end of Q2 of 2024, the transition from the phase one to phase two. That may bleed into Q3. I don't wanna probably should just say Q3 to be safe, but that's days of my expectations. I'm going to ask one way if we are expecting this transition. I'm going to ask one way if we are expecting this transition.
Understood. Thank you very much. And then a quick follow up on the the local advanced pancreatic and ddd Karsanoma with full fear knocks.
You know, the first patient enrollment is expected second quarter, 23. This trial, I believe, was open in third quarter, 22. Is that, was there a...
sort of a, that seems a long time between opening and first patient. Do you anticipate things will start rolling along now or what, was there special circumstances that kind of delayed the first patient coming in?
So we had IRB approval in Q3 of, I'm sorry.
Yeah, we had IRV approval in Q3 of 2022. The first site Gabriel Cancer Center opened in Q4 of 2022. We were optimistic based on their site feasibility questionnaires that they would be able to enroll approximately one patient every month. That has not come to fruition.
The holidays were obviously an issue nobody wants to start treatment over that timeframe. We also...
The legalities of clinical trial agreements was taking longer than we have with these larger institutions. We also had one or two dropout just based on our inability to pay the per patient costs. You know, we're talking three or four times that the average that we have for negotiated budgets across the three or four sites of which we finalized budgets with. But as I stated earlier, we do have...
University of Nebraska to be opened in the next two or three weeks and Virginia Mason Medical Center to follow that by another week or two. And we are finalizing budgets in clinical trial agreements with at least three or four other sites. Now, which I expect those to happen in June or July . So hopefully based on those site feasibility questionnaires, if they're accurate, that we will have the enrollment.
speed up drastically here in the second half of the year. And also with regard to that point, James, at Erasmus, they typically, as we've seen from the Early Access Program, have a backlog of subjects because Dr. Van Eyck and his team are world renowned in this area and...
sort of a focal point for treatment in Europe . To that end, I do expect the Erasmus Medical Center to open as part of the Amp 270 sometime in the summer. We have QP release and drug supply that needs to go over, but all that should be done and sometime in this summer Erasmus will open up, and they are typically high enrolers.
I know the harassment study has been going on for a while. What has taken them so long to get on board to start enrolling? The regulatory process, even though we have an FDA authorized to get on board, has been going on for a while. What has taken them so long to get on board?
trial, they have to go through the European regulatory process for purposes of conducting that trial in the Netherlands. And that is taking a bit longer.
than the FDA process. And also there's certain arrangements that we have to make for drug delivery and that type of thing. But everybody's moving as fast as possible to get Erasmus as a part of AMP270.
And the early access program has been continuing so that we haven't stopped treating people at arasmas. But once these studies are open, then those patients who previously would flow into the early access program will now be directed.
into the clinical trials.
Great. Thank you, Mr. Secretary. Thank you for the questions. Thank you. Welcome. Thank you. Our next question is come from the line of Ed Wu with a send-in capital. Please proceed with your questions.
Yeah, thank you. Congratulations on the progress. My question is on your inventory of Applegion. How does your inventory look like and how far or easy would it be to get additional supplies for your test for your clinical trials? Well, right now, you know, we...
We always budget our clinical activity against existing inventory. And so we don't overextend ourselves, but we are in the process of creating new lots of ampligin.
which I'll let Dr. MacKillar address the details of that process, but it involves both contract manufacturers for new polymer as well as additional fill and finish lines.
Dr. Mackleur addressed the details of that process, but it involves both contract manufacturers for a new polymer as well as additional fill and finish lots. Chris? Yes.
Yeah, so thank you. I think I answered this question a bit ago. So we currently have enough ampligen. All these things are predicated on that ampligen continues to meet its stability testing, which we do every six months. With that being said, projections still look
promising for all the ampligen to continue for quite some time. But right now we have enough ampligen to do both the DORAPANK study, both the AMP270 based on projections of the amount of time that they're going to be taking ampligen. Since it's not a fixed time, it'll be until progression based on the preliminary data we have from the EAP about how long patients will be on ampligen.
plus a 25% buffer. And in addition to the long COVID trial that we have, beyond that we have approximately 8,000 or 9,000 vials, which would be enough to do another Phase II or a small Phase III. I have enough.
Polymer, intermediate active ingredient to make the final ampligen, which we will do sometime around December to do a file fill and finish of another approximately 9 or 10,000 vials.
polymer, intermediate active ingredient, to make the final amplogen, which we will do sometime around December to do a film finish of another approximately 9 or 10,000 miles. I have.
contract without manufacturers to help us both make amplagin but improve the process. Currently our yields are not as high from the initial product. I think we can improve that. So for every lot we have, for every lot we have to...
improve the amount of polymer, eventually improve the amount of the amplogen that we get at the end of that. And that should the next lot of polymer should be made sometime in the middle of 2024. So we have enough amplogen to continue the trials we have if we want to carry on with something beyond that. This particular point at the
Good luck. Thank you very much. We appreciate your interest.
Thank you. I will now hand the call back to Mr. Equals for any closing remarks.
Well, I think in closing, I want to reaffirm that we have been striving to move forward as rapidly as possible with our lead product, the Ampligen.
We're making strong and steady progress in the area of pancreatic cancer in all aspects.
We're also on track for the opening of an important pancreatic cancer program, which is the one we're doing in conjunction with AstraZeneca's Imphysi.
And that could lead to some breakthrough results if we're successful there.
And we have every expectation that the program interim report in advanced recurrent ovarian cancer will confirm the preliminary data, which was spectacular, published as a breaking abstract
at the American Association of Cancer Research Convention in New Orleans. So we're moving forward. We have the cash and the team to execute, and we are very blessed to have the data coming in that supports our program.