Q3 2023 AIM ImmunoTech Inc Earnings Call
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Hello, and welcome to the aim immuno Tech quarterly update conference call and webcast.
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Arty sources.
Joining us on today's call from the aim leadership team are Thomas equals Chief Executive Officer, and Dr. Christopher Mcaleer Scientific officer.
I would now like to turn the call over to Mr. Equals. Please proceed.
I just wanted to say, thank you very much to our stockholders investors and all of those certified financial analysts that are attending this call.
We deeply appreciate your interest and your support for an immune attack.
We have had great progress over the past 18 months.
2022 was a spectacular year in terms of our clinical development in the first three quarters of this year have been in.
In touch with that same level of progress as we move forward towards multiple value driving milestones you can see what we've accomplished as well as what we have in front of US do we expect to accomplish on our website and also in the Q, We just filed lays out.
Clinical progress that we've made and in great detail.
I'm happy to announce well.
Well I'm not announcing it just to reconfirm that we're moving into our next phase of our business development with the addition of Avenova.
As a merger and acquisition business development specialists to our team.
So in addition to the clinical progress that we're making you know we're bringing in people to help us specialize.
The expertise to help us to move forward in oncology, especially with big pharma.
Yeah.
The primary object our attention our priority drug.
Is ampligen rented told him that based on the extensive and consistent consistently positive clinical progress.
You know, we we've had to give it a priority space in our lineup and.
And it's unique because it's a toll like receptor agonist, which stimulates the immune system and he has immuno modulator qualities, but it's very unique and somewhat rare because it does not.
Have the systemic inflammation the other T LR drugs show.
It has a broad spectrum application.
As an anti viral and anti tumor agents.
Immunologic modulator for immuno deficiency diseases. So so we have a lot of potential over a wide space of opportunity.
Now our pipeline and and this addresses just a few of the major things on our pipeline.
Is is extensive and we've been laying down a lot of important data over the past year our.
Data that supports the proposition that we have extremely good.
Good potential in oncology.
You look at what we've done.
Historically in the early access program in pancreatic cancer, which involve both locally advanced and metastatic patients. We're building on that with a locally advanced pancreatic cancer phase two trial M to 70, as well as a combination therapy ampligen plus your value Mab.
Astrazeneca has dragged your value Matt if you go to our website you can read about the collaboration agreement we entered into with Astrazeneca and that's that study should be rolling out anytime now.
We've made tremendous progress not just in pancreatic cancer, but also in advanced recurrent ovarian cancer and stage for triple negative breast cancer.
Where we're seeing dramatic clinical impacts with ampligen and these are highly lethal.
Cancers, where its a complete and in many cases, a complete unmet medical need because there is no therapy for people once they reach the stage.
Further our work in M C F as in long Covid expressing chronic fatigue like conditions is moving very rapidly as well with a with a major phase two are where we are we've completed our enrollment we've completed treatment we're moving forward.
At work speed, there are with expectation of data within the next six months. So so the pipeline is broad the pipeline is strong and there are a number of other clinical trials that are underway that you can see in detail and Dr. Mcaleer, who's going to discuss as well, so I'm going to turn it over to.
Dr. Christopher Womack, He's our science officer.
Chris.
Thank you Tom.
As Tom stated, we are making progress in our clinical programs and I'd like to take a few minutes to discuss that progress is a little more detail.
We are still awaiting the first patient enrollment Nancy 70, as I discussed in our last quarterly earnings call. Our focus at AME has been on recruiting and opening new sites to that end in the last quarter. We opened at Virginia Mason Cancer Institute in Seattle, We also identified and contacted an additional 33 sites for a total of 103.
30.
<unk> 30 of those sites are interested in are in some stage of the activation process of which 18 of those sites are in the pre selection visit stage.
We do expect Erasmus Medical center to be opened for recruitment in Q4, and we expect to have an additional 12 or set of sites to be opened in the first half of 2024.
In terms of the first patient in the current sites are monitoring many patients. As example university of Nebraska as monitoring multiple patients that have recently completed for <unk> as well as Gabriel cancer research institutions monitoring patients also awful fear knocks the Virginia Mason comprehensive cancer Center has.
Multiple additional patients that they're following.
Potential subject coming for a follow up visit for eligibility this month.
So with all the initial enrollment is eminent at any point in this Joshua Nancy 70, and I think with the additional sites opening in the next few months, we hope for patient recruitment to increase exponentially.
Our.
Our colleagues at Roswell Park comprehensive cancer Center recently published a manuscript in the journal for immunotherapy of cancer and some of the highlights of this data were published previously at ACR, but the manuscript provides a full insight into that study.
In summary, the data shows that when patients with metastatic triple negative breast cancer, where given became a kind of modulation therapy that contains ampligen. Prior September isn't that treatment. They showed an increase in cytotoxic T lymphocyte markers specifically.
<unk> in the tumor microenvironment.
And decided to toxic T lymphocyte Hemotoxin PCL five in Seattle.
And we're also increase intra tumor early.
And so I want you to take notice to these are the <unk> 10 and <unk>.
We'll bring them up again, when we discuss ovarian cancer.
And in addition to that the the T. Reg markers Fox P. Three in their T. Reg attracted in CCL 'twenty two we're not increased and so when you look at that ratio of the cytotoxic T lymphocyte infiltrating chemotactic and the lack of infiltration of CCL 'twenty, two and attraction of a T. Reg the data highlight.
The importance of modulating cold to hot tumors. They also highlight the importance of the timing of ampligen therapy and temporary lesson that treatment and we are anxious to get that next phase of the trials going with a modified treatment regime.
And concerning ampligen as part of Neo adjuvant treatment for triple negative breast cancer that that data was posted to clinical trials dot Gov, a few weeks ago and to summarize the data. It was a phase one trial to replace and Friday, which was discontinued by Merck with a interferon alpha to be in the combination therapy with <unk>.
Just that ampligen, celecoxib interferon and standard chemotherapy.
It was a dose escalation of interferon and that showed no adverse safety profile. Another nine patients. There was a response rate of 67% that was five complete responses, which is the absence of tumor cells that 56%.
A one y P. Tim make which is essentially the presence of only a small number of scattered invasive cells, which is considered lack of tumor and that was 11%.
In this study provides us with a unique opportunity and how we navigate that opportunity from a regulatory strategy is still being discussed.
Since the approval of the first approval of this study pember lithium out plus chemotherapy has replaced standard chemotherapy alone as the Neo adjuvant standard of care and that's mostly on the back of the I spy two and keynote <unk> two study.
The pathological complete response in keynote five Q2 was approximately 65% compared to about 50% PCR of chemotherapy alone.
And how.
However that increase in efficacy comes at a substantial cost of toxicity to the patient.
The incidence of grade three or higher treatment emergent adverse events was 78% in the timber group.
And those side effects of the timber treatment are well established and and for many can be harsh and and really long lasting and so when you look at the response rate using ampligen containing therapy. There is an opportunity for patients to potentially see some equivalent efficacy to the current standard of care without those temporary side effects.
And how we best navigate that strategy is still being discussed.
And so the combination of their value mab in ampligen in metastatic pancreas cancer, what we referred to as Dora pack is on track to open for patient recruitment in Q4, the largest hurdle for that was get in queue for you released for the European Union and import approval for the drug which we have received the drug as plan.
To be shipped to the EU This week and it will be followed by final Q P release.
And based on discussions with Rasmussen and their current population pool, we expect recruitment to go rather quickly and to that end multiple patients have already been identified for potential enrollment and that should be up and running in the next few weeks.
In regards to ampligen for the treatment of advanced recurrent ovarian cancer, we are still awaiting the interim report for this trial for pit. However, our poster and abstract were recently presented at the 2023 Citi Conference that was in San Diego and then highlight the immune modulating aspects of this therapy.
I want to highlight from these data are the increase overtime in the baseline value of <unk> three ligand. That's the top row for those that are following the presentation and the ability of he used to be increased acutely after dosing regimen.
These data presented here are not on similar to data we have seen before using CK am in ovarian cancer and the chemo modulation therapy in triple negative breast cancer, but here, that's without the celecoxib and interferon showing that ampligen itself is likely sufficient to modulate these property and it can do so.
Cross multiple solid tumor types.
And so broadly speaking these data together showed that this regimen is capable of creating a more hostile localized environment and that immune exhaustion does not occur.
And in addition, the heat maps they showed indicate that not only is there a general localized intraperitoneal increase that we showed on the last slide in the CXC are three ligand. There is also a chronic increase and the CXC are three laggan gene expression in the tumor microenvironment itself.
And these data again, a promising because they show ampligen containing therapies can modulate the tumor microenvironment to create a more hot tumor state.
And finally I'd like to discuss our phase two study in long Covid.
As we stated earlier, we have fully enrolled all subjects. The last subject last dose was last week and the last subject last visit will occur this week after.
This will be verification of source data and rectification of data with the sites after which the database can be locked in the unblinded can occur and the data can be extracted.
We are hoping that database lock will occur this quarter and we still expect to have topline data in early Q1 with full data to come sometime around the Q1 Q2 transition.
Well, we do have currently is the safety report and as at the last report I received on November 9th there have been over 1600 doses administered and that's between placebo and the ampligen as this is blinded with a total of 28 adverse events and no serious adverse events.
Which further highlights the the an impeccable safety profile of ampligen.
And I just read an article yesterday in nature medicine, which followed patients over a multiyear period, which discussed a staggering number of patients that have lingering symptoms. After two years and how a potential re infections by different variants can increase that burden and so there is a extremely large market and a significant unmet medical need here.
So we are advancing in our clinical agenda and from a scientific and clinical perspective, I think stockholder should be excited about the short term and long term future of AME and potentially the patients can be excited about our future therapy.
And I'll hand, it back to Tom to discuss the future of aim from a financial perspective, well. Thank you very much Chris a great job of articulating that clinical progress we've made in the fine detail.
And as you can see from what Chris described we have a lot to look forward to based upon what's happened already and that potential and the vision of that success, just as closer and clearer than ever.
We we have met and as you can see the the milestones that we have in Q3.
Successfully and going into Q4 and some of these milestones have already been met in and there's some significant ones coming up as year end approaches and when we move into Q1, we're going to have a number of these clinical trials that are discussed in Europe up and running.
In pancreatic cancer are we we believe we'll be seeing significant progress in the United States as well because of the expansion of the sites are and where we're expecting the data from the post Covid trials. So these things are all good and I also want to mention that.
We're where we are today because of our collaborators we have a great team here at aim a very committed team, but we also have been working with top notch collaborators like Astrazeneca and Merck.
Merck the Erasmus Medical center in the Netherlands, Roswell Park comprehensive Cancer Center in New York University of Pittsburgh in Pennsylvania, and the Buffett cancer Cancer Center at the University of Nebraska.
And and the the investigators at those facilities are world class investigators, so where we've got the best of the best working on these projects.
And are helping us to move forward and in terms of value.
The the Covid post COVID-19.
The condition is extremely important because that's an ever burgeoning market, but anybody who's familiar with deals in biotech knows that the volume of deals and the value of deals is extremely high in the oncology space and that's why we brought in.
No about to assist us with our focused you know outreach.
The two big pharma in that particular space.
Now for our financial snapshot.
We have cash.
In hand, with every expectation of the ability to fund ourselves through the key milestones.
We've outlined outlined in this presentation.
As of September 30th we had approximately $22 $4 million in cash and marketable investments of our expenses.
There are you know very very much in line with with our projections and so our ability to move forward is unimpaired and we we intend to move forward as rapidly as possible with our clinical undertakings because.
It is through data that we create long term stockholder value. So we can't be mistaken.
This is a.
The place where the rubber meets the road in our industry.
We have to continue to push and develop our data and once we have a dataset in any particular disease or as we see what and like in college and several different solid tumors. You know the the value equation is driven by that data. So that's why we have to.
Concentrate on continued clinical progress.
So you know you may ask yourself why aim and why now.
And then there are a number of reasons why this is a very very important time.
Our team at aim continues to build on our solid foundation.
Minimally driving them forward.
We have a growing body of highly encouraging positive clinical data with ampligen in several high value important indications of significant often lethal unmet medical needs.
We have never before been more confident in the potential of ampligen and our ability to work globally with regulatory bodies to ultimately bring ampligen to patients in need and that is what drives our team at aim every single day. We believe what we are witnessing now in our later stage clinical studies not only.
Us confidence and our lead programs, but also a lot.
Line of sight into the broad utility we believe ampligen possesses we are leveraging the scientific and medical communities that are supported by preeminent key opinion leaders and institutions top research into institutions. They play an important role in the development.
And the guiding light for ampligen.
We are also involved in our strategy to further engage with industry for licensing partnerships and M&A opportunities, which we believe has the opportunity and the potential.
Unlocked significant value as we continue to expand our reach across the investment community did garner further validation and support from what we believe represents an exciting investment opportunity we.
We're grateful for your time today.
And we believe we are well positioned for an exciting 'twenty 'twenty four and beyond.
And that I'd like to open up this call for questions and answers and again. Thank you very much for your consideration of AME and ample Jim.
Thank you at this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question. Kim You May press star two if you'd like to remove your question from the queue for participants using speaker equipment, it may be necessary to pick.
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Our first question comes from the line of James Molloy with Alliance Global Partners. Please proceed with your question.
Hello. This is Laura on for Jim and Thank you for taking my questions.
So with all the clinical milestones that you have planned ahead, and you know bringing N as in all of that as well have you seen any increased interest from potential partners and how many you could describe the overall current partnership environment.
Well, where we're just beginning this phase of development and outreach.
The the interactions.
No in the these initial stages.
It would be and it would be premature to make any announcements publicly regarding any talks or.
You know initial discussions.
However, as in Oba as is a highly skilled group with we're using them to top people in the M.
M&A space for oncology.
So we have a high hopes and and a reasonable, but but optimistic expectations as to the progress we'll make.
Got it and then are there also any updates on your plans confirmatory phase three trial of ampligen for chronic fatigue syndrome.
Well at the moment, the chronic fatigue space has been flooded with a post COVID-19.
Chronic fatigue conditions.
And so in focusing on our long Covid trial, we are at the same time I believe developing usable data for chronic fatigue syndrome.
Traditional chronic fatigue syndrome.
Understood and then just one more question from us. So in regards to your early access programs for Ampligen and Theyre asking US Medical center, how many patients have been included in this program. So far and have you seen any additional data.
Yeah, there were over 50, how many how many patients exactly Chris I believe the number is 57, but please don't quote me on that exactly yeah. It's it's it's over 50 for sure and and the Dr.
Dr <unk>, who will talk to the to the data, but it's it's been increasingly positive. So the more the more subjects, we've had the the better the survival.
Aggression free survival and overall survival data get Chris do you want to talk about that a little bit and be happy to.
So if you want to update on that particular data I believe on our website. There is the presentation for that I presented at the Marie Curie Marie Curie School desk, a symposium at Roswell Park and in that presentation. There are a few slides on the updated data.
And so the original 27 patients that were there you showed a considerable improvements in progression free survival and overall survival. We included what I believe is an additional 30, but it might have been 29, it maybe 56 patients, but regardless, it's a equivalent essentially equivalent number of patients and that second.
Set a cohort of patients only confirm the original data that we had and to that point. The overall survival are short term and long term seem to actually improve with the addition of the patients over those historical controls.
And so with that additional data it only makes me more confident that this trial at 270 is going to come out to be exactly the way we thought in my mind, you that that that massive improvement in the EAP is with also with patients with metastatic disease. I think you know when we localize it when we look at this as just locally advanced cancer patients.
<unk> and the anti 70, it might be even better, but that's just speculation and remember that the safety information as well as the data flowing from that early access program. What is the basis for our application for orphan drug designation from both the United States F D. A N Europe's.
<unk> medicines agency and those orphan drug designations, which look at not at the same level of scrutiny as a new drug application, but look at safety and efficacy as a part of the consideration were both granted relatively rapidly by both agencies.
And I also do want to point out that in that presentation.
We looked at our selection criteria for patients and those who have a CA 19 nine less than a thousand.
Seem to respond better where the overall survival and improved by I think two to three months.
Then when we select out that specific cohort of patients and you know that has to do with progression in the there in Texas.
Also those who have a systemic inflammation index below 900, which points to there are the health of their immune system and so you know typically those patients with locally advanced pancreatic cancer meet those criteria. So I think though you know.
That in my previous statement that the empty 70 might respond better even better than what we have from the EAP.
Got it thanks for the insights and for taking the question.
Thank you very much for your interest.
Thank you. Our next question comes from the line of Ed Woo with <unk> capital markets. Please proceed with your question.
Yeah. Congratulations on the progress my question is on Apple Jim Al can you talk about your supply a bit and is there any need for Youtube manufacturer anymore of it.
Anytime soon.
Well.
We're expanding our clinical programs mm mm.
And we have ampligen budgeted and in stock budgeted for for.
That clinical activity, but.
But we are in the process of manufacturing more ampligen so.
But we are we always want to have a sufficient reserve to allow for.
You know any any kind of clinical contingency that might come up where we need additional drug.
And that that process is underway.
To that end.
We have over 16000 units in house.
The Amp to 70 trial is expected to use approximately 10000 of those units.
We shipped a pallet of 1300 and 50 actually goes out tomorrow to do the first approximately a year. We believe at Erasmus Medical center ramp to 70 and to do the phase one of the door pack study, we expect that door paying study to go well right based on the EAP data and in all the science behind it so we <unk>.
The phase two to transition.
You know rather rapidly recruitment at Ras and seems to to go rather quickly. So based on the end of the phase two study in long Cobra that we currently have and the trials that we have ongoing in the drug a lot meant that we have we thought it pertinent to get another.
Production run of Ampligen, approximately somewhere between nine and 10000 vials.
Which is slated to fill and finish.
In December early December.
Right as you manufacturer.
10000 vials la is a cost about the same as it was before has it gone up has it gone down.
Unfortunately inflation.
Has and even greater toll in in our industry. So not only our clinical costs gone up a manufacturing costs have gone up as well. However, you know we are managing those.
Those expenses in a prudent manner and we need to remember too that the manufacturing with these or it may sound like a lot of ampligen, but but.
And this is not a mass production.
The type of manufacturing these are small batches of ampligen, which cost a lot more to manufacture than than it would cost if it were in a mass production.
Uh huh.
Rice of the ample agenda the cost of the ampligen would dropped significantly.
Were picked up by a company that was in a position to make large amounts of ampligen.
Great well, thanks for answering my questions and I wish you guys. Good luck. Thank you well. Thank you very much Jackie.
Thank you. This concludes our question and answer session I will turn it over back to Mr. <unk> for any final comments.
Well as always we are grateful for your time and your interest in aim Andean Ampligen, we're very proud of our accomplishments and the the accomplishments of our collaborators as we go forward and on that foundation.
We'll continue to build our progress through 2023, we are very much looking forward.
To.
Pursuing and heightening this momentum in 2024 and providing this is perhaps the most important thing to us providing hope and opportunity for patients.
Who have unmet medical needs in these serious diseases.
We look forward to working with our medical collaborators our scientific collaborators in those universities that are so important to what we're doing and creating long term value.
For our stockholders.
Thank you very much.
Thank you. This concludes today's conference call you may disconnect. Your lines at this time. Thank you for your participation.