Q2 2023 AIM ImmunoTech Inc Earnings Call

Hello, and welcome to the aim of immune attack quarterly update conference call and webcast.

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Joining us on today's call from the aim leadership team are Thomas Eagle's, Chief Executive Officer, and Christopher Mcaleer Ph D Scientific officer.

I'd now like to turn the call over to Mr. Equals. Please proceed.

I'm extremely pleased with the progress we have made for the first half of this year, we are meeting and in many cases exceeding our expectations on timing and execution related to our clinical programs.

Fundamentally the company has never been stronger and we are clearly in line.

With what our belief is in the vast potential of ampligen, it's our belief that chaired by me and the team at aim and our many collaborators.

And I wanted to take just a moment now to thank my team at aim.

Both our Florida, and New Jersey operations deserve a big thank you.

They've made incredible strides over the past two years, including in this last quarter.

In developing our clinical programs and achieving fantastic clinical progress.

No.

Again, we are focused.

Execution in the clinical trials is our priority and we have a number of important trials going forward.

But let's take a look at what we accomplished in this past quarter.

In our phase two trial.

In long Covid or post COVID-19 chronic fatigue like conditions.

Met and exceeded our milestones by not only enrolling all of the subjects, but as of just a day or two ago. We've begun treatment of all subjects that have been enrolled.

So dosages is underway and that study is expected to end by the end of Q4 and topline data, which we hope will be favorable we'll be coming out in Q1 of 'twenty 'twenty four according to our current best projection.

And we published preclinical data.

As well as clinical data related to pancreatic cancer.

Very very compelling.

And our topline data from the early access program, where we've treated over 50 subjects is extremely positive.

Furthermore, we were working with one of our collaborators astrazeneca.

To do a metastatic pancreatic cancer advanced metastatic pancreatic cancer program at Erasmus M. C. One of Europe's top our research facilities in pancreatic cancer and that's combining our drug ampligen with their drug devalue mountain and all those approvals have been accomplished we're just waiting to get the <unk>.

Party started there.

Finishing some of the numerous things that have to be done in a complicated cancer protocol.

Finally, we are opening sites and recruiting new sites for our locally advanced pancreatic cancer program in the United States, We just signed up and and when we say signed up it's not that simple signing of paper, but there are a lot of steps that have to go we have to go through it Buffett cancer Center at the University of Nebraska.

Oscar.

So you can see based on what we've done over the past two years, but it just looking at what we've done in this past quarter that the team at AME gets things done and when it comes to our goals we deliver now.

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Let's look at our broad pipeline and we have a broad pipeline because ampligen has a broad spectrum impact in oncology in diseases like long COVID-19 or are the actual COVID-19 and anti as an anti viral in the actual COVID-19 infection.

And because its broad spectrum, we cover a lot of ground and we're working hard developing that now you see here that we were doing working in the clinic and locally advanced pancreatic cancer metastatic pancreatic cancer advanced recurrent ovarian cancer.

You know this is this is the type of work in oncology, that's cutting edge. Because these are highly lethal malignancies with clear unmet medical needs in long Covid all of the subjects are enrolled and dosage has begun as I mentioned, we expect topline data in Q1.

So theres a lot of activity going on but it all involves progress you've heard this is it.

You've heard the saying that just because the wheels are turning doesn't mean, you're going forward well. It's the same thing with progress just because it looks like theres a lot of activity doesn't mean, you're going forward, but here you can see where not only have the wheels, turning but we're traveling at 90 miles an hour in the right direction.

Now with regard to the.

Last thing on this list chronic fatigue syndrome.

So we are going to be guided in chronic fatigue syndrome very much by the results that we'll see in Q1 next year from our post Covid.

With chronic fatigue like conditions data.

So all of these programs are moving forward.

Now with that I want to go into the scientific detail and our Science officer.

Dr. Christopher macro there is here to talk with you today on those points.

Thank you Chris.

As Tom pointed out we have a broad pipeline across multiple unmet needs and our primary focus area is cancer, specifically our lead indication in pancreas cancer.

As discussed in the last earnings call. We have continued to enroll patients in the EAP in the Netherlands.

Led to additional data beyond what was presented in the cancerous paper in.

This data has been analyzed I do want to caveat that any grass youll see comprise data that was collected up until June 12 of this year.

But the addition of 30 patients for 57 total confirms the improvements and the progression free survival that were seeing in the original cohort of patients and that improvement a four to five month extension over historical control.

And the analysis of the overall survival confirms the improvements in patient survival in comparison to those historical control. In fact, if you look at the graph on the left there appears to be improvements in short and long term survival with the addition of these 30 patients and that's a comparison of their red and Green Kaplan Meier curves.

We are also doing further analysis of data to help determine subset populations that might respond better to ampligen.

As an example, if you.

Look at a subset of patients who CA 19, nine levels are less than a thousand which encompasses 49 of those 57 patients. There are further increases in progression free survival. That's an additional one month beyond the four to five months and also an overall survival as an additional four months beyond the previous data.

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Yes that those data are compelling, but if the control data in the Amp to 70 compares to the data in EAP, which we have no reason to believe that it won't as you. These additional 30 patient only confirms the original data we had.

The improvements we see in progression free and overall survival should be sufficient for regulators. So it may be unlikely that the subset analyses will be necessary for moving forward and for future approval for that matter, but they are good to have and they help further our understanding of ampligen multifaceted effects.

At $2 70 trial currently is ongoing and awaiting first patient enrollment Gabriel cancer Center in Ohio, and the University of Nebraska are both monitoring multiple patients who are currently undergoing foot paradox treatment to determine their eligibility to enroll an anti 70.

I wanted to take a moment to discuss the trial design and what that means for patient enrollment timeline.

Timeline from patient identification to enrollment depends on where the patient is on their journey when the site open and that can take up to several months.

Each patient must be treated for at least four months with full fear Nox and that treatment can be extended further depending on clinician observation and the patient's ability to handle full fair enough therapy, which is helpful. But also quite toxic.

They must receive a minimum of four months ago and once they stop treatment there given time to recuperate and then after four to six weeks from treatment stopped their monitored again to determine whether the full purion ox treatment worked and stabilizing their disease.

If they are stable they would need to be evaluated and consented before they could enroll which will take about a week or two and.

And then may be randomized and receive treatment.

Clinical sites focus is on patient enrollment and our focus is on opening more clinical sites.

These large institutional sites have defined controls and processes in place that must be followed for example, their IRB only meet once a month cancer committees can meet every one or two months.

We sent a site invitation letter to a proposed site and it took several weeks until the hospital has finalized its internal review processes to begin screening patients.

And these timelines are just realities of the law of the clinical trial process and large institutional sites, but we have some degree of control when identifying and opening additional sites and that must be our focus.

And to that end, we have identified and contacted over 70 sites 31 of those sites have expressed interest of those 31 sites. We are in ongoing contract and or budget negotiations with almost half of them. We are also working with centers like Alleghany hospital in Western Pennsylvania and.

Excuse me and Sarah Cannon Research Institute, who have multiple clinical trial sites that simple logistics suggests that the more states. We opened the faster we can enroll patients and hopefully receive data that resembles that of the EAP and that is our focus for MTI 70.

So based on what I explained it does take time, but when you're at $2 70 data comes in we believe that based on the data we have from the EAP.

This additional 30 patient data that is expected to be well worth the effort and the wait.

In addition to <unk>. We are also working on final European approvals, including <unk> release to start the door pain study in the Netherlands, and Thats to investigate ampligen combined with their value lab for metastatic pancreas cancer patients.

That study is still on track to open for patient enrollment in Q4 of this year.

We are still awaiting interim results for the phase II trial in advance for current ovarian cancer University of Pittsburgh originally expected that data to come in June and that was amended to be in September but the conversations we've had indicate that the data is as good or better than that what was published in ACR.

In addition, they are expecting to present data at the $2023 50 conference concerning immune marker changes in ampligen ability to modulate cytokine release and immune function such as differential T cell changes in cytotoxic T cell upregulation that data is similar to data we've seen in other cancers, but specifically for varian.

Which.

In our opinion further illustrates the broad applicability of ampligen in solid tumors.

We are also working diligently on our study of ampligen to treat post COVID-19 conditions also known as our <unk> hundred 18 study state.

Site initiation and recruitment went very fast with the study and we announced just recently that we hit our target enrollment of 80 patients.

The treatment regimen is for 12 weeks with follow ups.

For two weeks thereafter, this means that the last patient dose will be in mid November and we are expecting top line data as early as Q1 2024, and we are very excited about this trial.

I do want to point out that the last hurdle.

As of the latest update I received which was Thursday of last week between all of the doses, both placebo and ampligen, which at this point numbers in the hundreds there had only been one adverse event, which was a case of a great too high that was remedied by Benadryl treatment and we think that attached to the overall safety.

The profile of Ampligen.

And we are advancing our clinical agenda and from.

The scientific and clinical perspective from my desk, I think stockholders should be excited about the short and long term future of AME.

And I'll hand, it back to Tom to discuss the future of anything from a financial perspective.

Thank you very much Chris.

Yeah.

Chris was mentioning we have a well developed safety profile yeah.

100000, plus doses of IV in humans.

We had.

Had findings that ampligen is generally well tolerated not only IV, but also intraperitoneal Lee and intranasal and.

In phase, one and phase two and phase III testing.

So we have a drug that.

<unk> is generally well tolerated and that allows us to springboard into multiple clinical programs because the safety aspect of that is not a major issue in consideration.

Now I'd like to address our milestones and how we've achieved our milestones.

And the milestones that are coming out.

We're in the third quarter right now in the third quarter, we had projected.

That we would open numerous additional sites in our locally advanced pancreatic cancer program.

We projected that the protocol planned interim results.

It will be.

Published and our advanced recurrent ovarian cancer program and with post Covid conditions.

We had projected that we would enroll patients those patients and in fact, we have enrolled our last patient.

In this phase II trial, and we have begun dosing all of the subjects in this phase II trial.

So many of the milestones for the third quarter have already been accomplished.

With regard to the fourth quarter.

We have every hope that we will begin dosing in metastatic pancreatic cancer.

Certainly begin enrollment by the fourth quarter.

And with regard to post Covid conditions, and we have every hope that we will have enrolled and treated our last subject in that phase II study.

So with the final patient.

We move into the first quarter of 2024 and in the first quarter of 2024 of our Big thing that we believe will be a milestone will be the publication of the topline data from the phase two long Covid study.

Now I'd like to take just a moment to talk about who we do business with.

You know we've all heard the old wisdom, you can sometimes be measured by the company that you keep it.

And we are very fortunate to be in good company here.

We're working in metastatic pancreatic cancer with Astrazeneca in combination with their drug their value map, we've done a number of different studies with Merck as a collaborator using ampligen and their drug Campbellism Maverick Keytruda.

Our investigators sponsored studies and the locations where we're conducting these trials are top world class cancer centers are Rasmus and the Netherlands Roswell Park in New York University of Pittsburgh in Pittsburgh, and the Buffett Cancer Center.

In Nebraska are the crown pillar cramp.

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Cancer centers for cancer research in the areas, where we're working.

So I'd like to now talk a little bit about our position.

In terms of cash or a financial snapshot as you can see we're in an extremely robust position.

Position.

And over the course of the second quarter, our team continued to deliver on timelines and made significant progress.

Ensing ampligen through our clinical trial studies in multiple indications, we continue to be encouraged by the growing body of positive and consistent data and believe ampligen will be a meaningful treatment option in the future and in support of that.

Our operational execution remains fully supported by our strong cash position and we are steadfast in our mission to advance the clinical development of our oncology pipeline.

I think that the numbers speak for themselves in that respect.

So we come to.

Maybe for some of the important question why why now.

When you look at what's happened in the biotech sector, especially the small cap biotech.

A lot of these companies have been wiped out over the past two years.

But we've achieved.

Clinical progress, we stayed true to our goals and milestones and we've done it all awhile by being good stewards of our cash position.

So we're in a we're in a strong cash position, we've got a lot of very positive positive activity going on it's the type of activity that can translate into superior.

Development of stockholder value.

And on behalf of the team at aim.

I want to thank you very much.

For being interested in ampligen and aim of immuno tech.

At this time I'd like to turn.

The presentation over to the operator.

So that we can have Q&A.

Thank you the floor is now open for questions. If you would like to ask a question. Please press star one on your telephone keypad at this time.

Formation tone will indicate your line is in the question queue. You May press star two if he would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up the handset before pressing the star keys.

Thats Star one to register a question at this time. The first question is coming from Jim Malloy of Alliance Global Partners. Please go ahead.

Hey, good morning, Thank you very much for taking my questions.

I wanted to follow up on the 518 could you walk through please.

What data, we should anticipate to see here.

In the first quarter, what's the sort of the primary secondary and what's sort of the dosing with <unk>.

And walk through sort of the.

You walk through the rationale of the trial as well there would be great. Thank you.

Alright, Thank you Jim good to talk to you again.

You know we had a pilot program in 511 that gave us.

Preliminary data are not not in a controlled setting, but we were hit with a positive response four out of four of the subjects.

Three with fairly significant a positive result, so so we use that to derisk and in that sense.

The activities that we were planning for an <unk> 18.

And I hand, this over to our scientific officer, Dr. <unk> to discuss the actual elements of the protocol and the stages.

But youll see this.

It's different from a cancer study, which you know the protocols are long and drawn out everything's moves pretty quick here and he'll go through that and our hope is that in the first quarter of next year and not only will we have the topline data, but it'll be consistent with the pilot study, we did which would be extremely.

<unk> favorable.

Okay.

Thank you for the question Jim.

It was multifaceted so I hope I answer all of it.

The trial design is a double blind placebo controlled there are 40 control patients 40, ampligen treated patients the primary endpoint is <unk>.

Promised fatigue score specific.

Short form eight eight but the secondary outcomes will be brainpower.

From a promise for the premise score as well.

Six minute walk test, we also have a mocha exam for cognitive function.

Theres also some exploratory biomarker analysis, and we expect that data on topline.

<unk>.

The.

I'm sorry, the other parts of your question where.

Well, if you use that if that was most of it right.

Get the trial design, so those dosing and then what would you anticipate.

To get out of this to go into the I presume a phase III confirmatory trial.

Yeah. So the the trial is 12 week dosing with two weeks follow up if the data.

Depending what we do next depends on the quality of the data and we presume that the the next is a type b meeting with the FDA to go to a phase III confirmatory trial, but that'll depend on how well the treatment works right.

That is our top line expectations, and and and remember in order to move forward with the FDA, we need this placebo controlled phase two data.

Not not just move into phase III, but also to the extent that there are fast track and breakthrough type opportunities similar to what you see in cancer that may arise.

With long Covid, which as.

You know right now afflicting in a very serious way disabling 4 million Americans is not an insignificant market and not an insignificant public health impact. So so there may be things that we can take advantage of with this data moving forward, but we have to have this type of placebo controlled trial.

Now in order to present that to the FDA and take advantage of the opportunities for the next steps.

And then we do the 80 patients is small for a phase two with no current therapies. If the data comes out the way we expected based on the preliminary data and our understanding of ampligen mechanism in things like fatigue, and brain fog I expect that.

I hope that that will be sufficient for the phase III.

What's the entry criteria is is it change in promised score from baseline for <unk>.

<unk> and brain fog, what's sort of the entry criteria to get into the trial.

So we're measuring both Ah <unk>.

<unk> from controlled too for the premise fatigue score and secondary measure of change from baseline in individual patients.

Yeah.

Okay.

Okay, Great and then.

You guys have always been excellent stewards of shareholder capital and a lot of your trials being run in partnerships and Isps.

It's the five H and $2 70, those are the only two that have it.

If I understand correctly those are the two that they're under your control and that aim is currently paying for.

That's correct I mean, we provide financial support to some of these other investigator sponsored trials, including the primary component the supply of drug however.

Purposes of Amp 18, and Amp do 70. It was important that these be aimed sponsored trials. So we control the data and we're able to fund those items that are necessary to moving forward rapidly.

Cuz in pancreatic cancer, just like in long Covid, we're dealing with a.

Large unmet medical needs.

<unk> advanced pancreatic cancer.

Is is a horrible lethal malignancy for which there is no therapy currently that provides extended.

Survival or progression free survival. So so so what we perceive that we're doing there is obviously important from a financial potential, but it's even more important in terms of our ability to deliver an immunological solution that may save.

Lives and similarly, with long Covid, where people have post COVID-19 severe chronic fatigue syndrome, and these people are disabled and in many cases bedridden and unable to.

The function to take care of themselves to participate in their family or go to work so our ability to provide a therapy there.

It is also extremely important to us because they don't have.

Any options and if we're able to show that we have a significant therapeutic impact in this phase two we intend to move forward quickly.

With these three if the FDA will allow us because our people deserve more than just b being a prisoner in bed and are not having the option of a therapeutic alternative that might help them have a better life.

So we're doing very important things here in these two areas and these are these are controlled by them. So that we can control the pace and it's our intention to move as fast as we possibly can because the subjects.

<unk> of those trials will provide the proof we need in order to show the FDA and the EMA that a we have a significant therapeutic opportunity for these people to have a better life.

Thank you very last question the AR the University of Pittsburgh recurrent events events occur in the ovarian cancer interim data that'll be coming out in third quarter, which we anticipate.

To see there and whats what's good data data bad data, what's equivocal data what are you guys anticipating to six.

Well you know, we don't know exactly what that data is right now but.

Every indication.

<unk> suggests that it will be consistent with the preliminary data that was published today see or in April of 2020, which was extremely positive. If you remember that abstract was a late breaking abstract.

It was published.

Cuz, it's not normal.

We did see a publication of preliminary data.

But it was it was a proud as an abstract because the data was so powerful in a cancer, where there are a few alternatives advanced recurrent ovarian cancer somewhat like late stage pancreatic cancer is almost like a death sentence. Unfortunately, so so what was shown in that a T. Our abstract.

In addition, I mean it was it was it you know focused.

Focused on showing the the immunological impact of Ampligen, plus penumbra lizardman, but it also it had survival data and it showed in advanced recurrent ovarian cancer. There was a 60 plus percent clinical benefit by combining ampligen with perm realism and far in excess.

What was seen in keynote 100 with Pember Lizardman Malone and then Additionally, this was not just disease stabilization with member Luiza, Ma'am, we were seeing and O R. R of over 35% with 15% plus complete responses and.

Another 20% plus a significant partial responses. So so that data was very powerful.

Assuming this interim analysis of part of the program of the protocol are is similar in and where we're operating based on that assumption, we think that that interim data will be similarly powerful.

Yeah.

Excellent.

I'm looking at the ACR from 'twenty to 'twenty two right now, yes, 61, 8% I think it was seasonal.

Just 1.6% clinical benefit rate.

Will there be does that present any data at ACR this year or do you anticipate something perhaps next year.

I think they're going to approach the.

Present are the this interim program data at <unk> this year.

And that's assuming they're able to do to wrap everything up in a timely fashion and presented but we don't know for sure.

So out of your hands alright. Thank you very much appreciate you taking the questions.

Well thank you Jim.

Thank you. The next question is coming from Ed Woo of ascending capital. Please go ahead.

Yeah. Congratulations on the progress you've made my question is on the long Covid study was that only a U S study and is there any plans to do studies are international Christy in the EU.

<unk>.

Yeah, I'll address that Ed if I may.

Right now, it's only taking place in the U S and and Empire <unk> 18 is an FDA authorized study.

However, we are working.

To conduct a similar not identical study in Europe , probably in the Netherlands.

Great that sounds good and then that's not that's on the drawing board because excuse me at the that's on the drawing board somewhat because you know the you know theres a lot of bureaucracy that you have to go through in order to get one of these things started but we're working on it.

Great No problem and then.

You guys have you guys have a pretty big cash balance is there any considerations to potentially do any acquisitions or are you going to just focus on what you have now.

Well.

Uh huh.

No.

My My father taught me when I was learning baseball is the boy keep your eye on the ball okay.

Do you want to hit it right. So we've got you know we've got a lot of things that we're working on right now that are extremely important and I don't want to lose our focus by moving.

Moving into a merger or acquisition mode.

Or are you know, where we're trying to acquire other technology now that's not to say if an opportunity presented itself, which was compelling and and our you know the.

There's been the biotech sector for the past two years has been a bit of a slaughterhouse. So there's.

Probably things out there that we could we could take advantage of but Oh, you know we want to use the cash we have in the team we have to make sure that as our first priority we deliver on the clinical progress.

That's underway and we meet those milestones, which I think are very important milestones for our stockholders down the road.

Without being diverted.

So I guess that sounds like a politician's answer in a way you know, but you know our first priority is the clinic.

And only if something was so compelling that we couldnt you know turn it away would we do an acquisition.

Yeah.

Great well, thanks for answering my questions and I wish you guys. Good luck. Thank you.

Well, thank you and appreciate your interest.

Thank you at this time I would like to turn the floor back over to Mr. <unk> for closing comments.

Well I want to thank everybody very much and thank you Donna.

In closing I'm extremely pleased with our progress this year and believe we're very well positioned to achieve important operational and clinical milestones throughout the remainder of this year and beyond this is a very exciting time for aim.

And on behalf of team aim and myself I want to thank you for your continued support.

Ladies and gentlemen, thank you for your participation. This concludes today's event you may disconnect. Your lines at this time or log off the webcast and enjoy the rest of your day.

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Yeah.

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